Innovations in Care and Research

Read about the latest clinical and research innovations taking place at Ohio State's Heart and Vascular Center. 

Our Newest Heart and Vascular Innovations

Our Newest Heart and Vascular Innovations


Clinical Trial Tests New LV Lead for Heart Pacing Devices Tiny Screw Anchors Attain Stability Quad Lead to Vein Wall

The world’s first Attain StabilityTM Quad lead was recently implanted in a patient at Ohio State’s Ross Heart Hospital by cardiac electrophysiologist Toshimasa Okabe, MD. Part of an international clinical trial sponsored by medical device manufacturer Medtronic, the Attain Stability Quadripolar MRI SureScan Left Ventricular (LV) lead is being tested for its safety and effectiveness.

The multicenter clinical study is prospective and non-randomized. The global study aims to enroll 471 people with severe congestive heart failure across 56 sites in the U.S., Canada, Europe, Hong Kong and Malaysia.

The LV lead is one of three leads that connect to a quadripolar cardiac resynchronization therapy defibrillator (CRT-D) or a CRT-P (pacemaker). The placement and stability of the lead is critical in delivering electrical impulses to both lower heart chambers to help them beat together in a more synchronized pattern.

A More Versatile and Secure Lead

Dr. Okabe notes some distinct advantages of the Attain Stability Quad lead being tested: “This new lead has an active-fixation mechanism—a small screw that bites into the wall of a vein to hold it in place,” Dr. Okabe says.

Dr. Okabe explains that the stability of the lead is critical for patients who have severe congestive heart failure and are prone to infection. “This could be a real breakthrough. When we prevent the lead from moving or dislodging, we don’t have to re-open the pacemaker pocket and expose the patient to potential infection.”

In addition, the lead has four electrodes (quadripolar) rather than the traditional two electrodes (bipolar) to find the optimal location for pacing the heart. “The lead’s four electrodes give us more options on where to pace from,” says Dr. Okabe.

Through a small incision in the chest, the electrophysiologist introduces three wires and places the third wire (the LV lead) in a small vein around the left ventricular chamber. Dr. Okabe notes, “There’s a lot of anatomical variation in where we can implant the LV lead. Some veins are too small or tortuous, or too big. This Attain Stability Quad lead could be placed in big vessels — even major vessels — and would be unlikely to move. We hope this new design will allow us to implant the lead in a location where conventional leads would have been too unstable.”

Implanting the lead quickly and efficiently is important because “faster procedure time directly correlates with a lower rate of infection,” Dr. Okabe adds.

Addressing Safety Concerns

When implanting CRT devices, electrophysiologists know there’s a 1 percent risk of infection with any cardiac device. The only treatment is to remove the CRT and its leads.Dr. Okabe says developers of the new LV lead carefully calculated a design that could be removed without damaging the walls of a blood vessel.

“Clinicians have expressed concern that placing the lead and screwing it into the wall of the vein would rupture the vessel. That hasn’t been the case in animal or human trials,” Dr. Okabe confirms.

In animal studies, researchers extracted the leads after two years with no problems. No one knows if that task will become more difficult with a lead that’s been in place for 10 to 20 years. “We’re weighing the risk of a potential removal at a later date against improving the quality of life and ability to live longer now.”

Dr. Okabe has successfully implanted close to a dozen LV leads in study participants, with no adverse events. Dr. Okabe is one of eight cardiac electrophysiologists at Ohio State participating in the study.

Proving Human Heart’s “Battery” Has Multiple Backups Ohio State Research Team Publishes Findings on Sinoatrial Node

Ohio State researchers have discovered that the human heart’s sinoatrial node (SAN) is hardwired with a backup system—three diverse regions of pacemakers acting as batteries. Up to five conduction pathways act as wires to connect the signal to the atria. This built-in redundancy maintains consistent heart rhythm, even under trying conditions.

 

Vadim Fedorov, PhD, an Ohio State associate professor in the Department of Physiology and Cell Biology, and his team published these findings in the online Science Translational Medicine journal in July 2017.

 

Therapeutic Potential

 

“It’s groundbreaking. This is the first step in explaining why the SAN can be ‘sluggish’ for years before a total failure, allowing the clinician to detect the problem before a catastrophic event,” says Raul Weiss, MD, FACC, a cardiologist and clinical researcher at Ohio State. 

“I think this work can fundamentally change the way we diagnose disease of the heart’s natural pacemaker,” says John Hummel, MD, FACC, a cardiologist and clinical researcher at Ohio State. “In some patients it can be incredibly challenging, and these insights may allow us to diagnose those challenging patients more effectively.”

Because a pacemaker is merely a crutch and can’t fix the underlying problem, Dr. Fedorov’s team is also seeking out ways to improve or restore the impaired portions of the SAN. Their hope is that someday, pacemaker implants could be obsolete. 

Unraveling Mysteries of the Sinoatrial Node

 

Like a battery, the SAN generates electrical impulses to initiate heartbeats. Until now, scientists didn’t know for sure how the SAN protected the heart’s rhythm and how the system failed.

 

“It’s been challenging because our human SAN differs greatly from well-studied animal models, and clinical electrode recordings only capture what’s on the surface,” says Vadim Fedorov, PhD, an associate professor in Ohio State’s Department of Physiology and Cell Biology.

 

Dr. Fedorov and his team applied optical mapping, 3D structural imaging and molecular mapping to 21 explanted human hearts to define the internal function of the SAN. The hearts, which were not viable for human transplant, were donated by heart transplant recipients and Lifeline of Ohio.

 

To resuscitate the hearts, researchers placed them in a glass chamber filled with an oxygenated solution at body temperature and perfused the coronary arteries with warm, oxygenated solution that simulates blood flow, allowing the SAN to beat again with the same rhythm as when it was inside the body for at least 12 hours. Then, the chamber with live heart tissue is surrounded by four highly sensitive infrared cameras, and a fluorescent dye is injected. This dye can visualize spontaneous electrical activity moving within the human SAN in 3D.

“We observed that all three intranodal pacemakers are used, depending on the heart’s needs at rest, or during normal or high exertion,” Dr. Fedorov says. To study how the SAN functions under stress, Dr. Fedorov’s team applied adenosine, a heart rhythm regulator that is overproduced when there is heart failure and inadequate blood supply. 

“The central pacemaker was most affected, as it is highly sensitive to adenosine. The head and tail pacemakers were able to maintain a slower rhythm and prevent complete cardiac arrest. We saw similar shifts in the preferred conduction pathways,” Dr. Fedorov says. Total cardiac arrest occurs only when all pacemakers or conduction pathways fail, whether due to disease or age.

When there is a problem with SAN pacing or conduction, doctors implant an electronic pacemaker to prevent cardiac arrest. Approximately 225,000 Americans get a pacemaker every year, according to the World Society of Arrhythmia.

“Patients are at high risk of cardiac arrest if the SAN gets down to one pacemaker, or one conduction pathway,” Dr. Fedorov says. “Knowing this, our next quest is to work with electrophysiologists to more precisely identify who needs a pacemaker implant, and who still has backups and can get along without one.”

This research was funded by the National Institutes of Health, the American Heart Association, the C.R. Webb Fund in Cardiovascular Research and the TriFit Challenge Discovery Fund. Other Ohio State researchers include: Ning Li, Brian Hansen, Thomas Csepe, Anthony Ignozzi, Lidiya Sul, Stanislav Zakharkin, Anuradha Kalyanasundaram, Jonathan Davis, Brandon Biesiadecki, Ahmet Kilic, Paul Janssen and Peter Mohler.

High-Tech Vest Tested for Heart Failure Management Radar Technology Measures Fluid Buildup in Lungs

Over three months, 59-year-old Kenny McIntyre of Columbus, Ohio, was in and out of the hospital twice. Diagnosed with heart failure, he had several pounds of fluid removed each time.

 

He is one of nearly six million Americans living with heart failure who may benefit from a high-tech vest being tested at The Ohio State University Richard M. Ross Heart Hospital.  The vest measures fluid inside the lungs from outside a person’s clothing and could be a new way to promote better quality of life and prevent repeated trips to the hospital for heart failure symptoms.

 

McIntyre says, “I’m the type that, unless something hurts me, I don’t want to go to a doctor. I just put the vest on, lay back, hit a button, and let it take my measurements. Every now and then they alter my medications.”

 

Cardiologist William Abraham, MD, FACP, FACC, director of Ohio State’s Division of Cardiovascular Medicine, leads the randomized trial that includes approximately 40 sites across the country.

 

Adapting Military Technology: The Radar Vest

 

The SensiVest, created by Sensible Medical, uses radar technology first used by the military and rescue teams to see through walls and rubble in collapsed buildings. Doctors are testing to see if it effectively monitors and manages lung fluid, reduces hospitalizations and improves quality of life.

 

“The technology has been miniaturized and put into a form that allows the radar to go through the chest wall and get an accurate measurement of water inside the lungs,” says Dr. Abraham.

 

Patients use the vest at home. They slip it on over their clothing, lie down and push a button to get a reading. About 90 seconds later, the data goes to a secure server where the patient’s doctor or nurse can catch any trending changes and tell the patient to adjust medication, if it’s needed.

 

“The goal is to keep the patient within a normal range, feeling well and out of the hospital,” Dr. Abraham says.

 

Until now, cardiologists haven’t had a precise, non-invasive way to monitor the fluid buildup in the lungs from a poorly functioning heart.

 

The standard practice of patients weighing themselves daily and reporting symptoms such as swelling or shortness of breath may not alert patients and physicians soon enough to avert hospital treatment.

 

“These methods don’t catch the disease progression early enough, and that’s why hospitalization and re-hospitalization rates for heart failure have changed very little in the last 20 to 30 years,” Dr. Abraham says.

 

How the Trial Works

 

All patients enrolled in the trial receive the highest standard of care for heart failure and are followed for up to nine months.

 

Those randomized to the treatment group also use the lung fluid monitor at home to take daily readings. The data is uploaded to a secure server where the patient’s cardiologist or nurse can review it.

 

“We can use that data to see when the lungs are trending toward being too wet and make adjustments to the medication on an outpatient basis or over the phone,” says Rami Kahwash, MD, director of the Heart and Vascular Research Organization and site leader for the trial at Ohio State. “The goal is to keep the patient within a normal range, feeling well and out of the hospital.”

 

A previous, small observational study compared hospitalizations before and after using the vest. That study showed an 87 percent reduction in heart failure hospitalizations with vest lung fluid monitoring. 

Devices

New devices are being used and tested at Ohio State's Heart and Vascular Center.

Implanted Device Successfully Treats Central Sleep Apnea, Study Finds

Results from an international, randomized study show that an implanted nerve stimulator significantly improves symptoms in those with central sleep apnea, without causing serious side effects. Dr. William Abraham, co-lead author and director of the Division of Cardiovascular Medicine at The Ohio State University Wexner Medical Center, presented findings from the study at the recent European Society of Cardiology Congress in Rome. The study is published today by The Lancet. Unlike the more common obstructive sleep apnea, in which the airway partially collapses and causes pauses in breathing, central sleep apnea (CSA) occurs when the brain fails to control breathing during sleep. 

“CSA is a serious concern because it affects about a third of people with heart failure and it’s known to make the condition worse,” Abraham said. “Currently, we don’t have good treatments available. Positive airway pressure devices have been used, but many patients don’t tolerate them well and a recent study showed them to be harmful.” 

Abraham, along with lead author Dr. Maria Rosa Costanzo at Advocate Heart Institute in Naperville, IL, participated in the study at 31 hospitals in the United States, Germany and Poland. The research team tested the safety and effectiveness of a transvenous phrenic nerve stimulator made by Respicardia Inc. Much like a pacemaker, it sends a regular signal telling the diaphragm to breathe during sleep. In the randomized study, 151 patients were implanted with the device. Ten were excluded due to non-study related medical issues or deaths, exiting the study or missing visits. During the first six months of evaluation, 68 devices were activated for treatment, while 73 were left inactive as the control group. Between six and 12 months of follow-up, all patients received the neurostimulation treatment.

At the six month evaluation, the device reduced CSA events per hour by half or more for 35 of the 68 members (51 percent) of the treatment group. Only eight (11 percent) of those in the control group achieved the same reduction. Other important sleep measures, such as the amount of time spent with a low blood oxygen level, were also significantly improved. About a third of patients in the treatment group reported therapy-related discomfort that was resolved with some reprogramming of the device.

“Not only did we see this reduction in events per hour, the patients also rated themselves better on the Epworth Sleepiness Scale (meaning they were less sleepy during the day) and on a global assessment of their overall quality of life,” Abraham said. “This tells us the effects of neurostimulation are clinically relevant and this could be a promising therapy for those with central sleep apnea.”

In addition to Abraham, Ohio State’s Dr. Rami Khayat and Dr. Ralph Augostini participated in this research, making Ohio State one of the high enrolling centers participating in the study worldwide.

The study was funded by Respicardia. Abraham is a consultant for the company.


Clinical Trial Tests New LV Lead for Heart Pacing Devices Tiny Screw Anchors Attain Stability Quad Lead to Vein Wall

The world’s first Attain StabilityTM Quad lead was recently implanted in a patient at Ohio State’s Ross Heart Hospital by cardiac electrophysiologist Toshimasa Okabe, MD. Part of an international clinical trial sponsored by medical device manufacturer Medtronic, the Attain Stability Quadripolar MRI SureScan Left Ventricular (LV) lead is being tested for its safety and effectiveness.

The multicenter clinical study is prospective and non-randomized. The global study aims to enroll 471 people with severe congestive heart failure across 56 sites in the U.S., Canada, Europe, Hong Kong and Malaysia.

The LV lead is one of three leads that connect to a quadripolar cardiac resynchronization therapy defibrillator (CRT-D) or a CRT-P (pacemaker). The placement and stability of the lead is critical in delivering electrical impulses to both lower heart chambers to help them beat together in a more synchronized pattern.

A More Versatile and Secure Lead

Dr. Okabe notes some distinct advantages of the Attain Stability Quad lead being tested: “This new lead has an active-fixation mechanism—a small screw that bites into the wall of a vein to hold it in place,” Dr. Okabe says.

Dr. Okabe explains that the stability of the lead is critical for patients who have severe congestive heart failure and are prone to infection. “This could be a real breakthrough. When we prevent the lead from moving or dislodging, we don’t have to re-open the pacemaker pocket and expose the patient to potential infection.”

In addition, the lead has four electrodes (quadripolar) rather than the traditional two electrodes (bipolar) to find the optimal location for pacing the heart. “The lead’s four electrodes give us more options on where to pace from,” says Dr. Okabe.

Through a small incision in the chest, the electrophysiologist introduces three wires and places the third wire (the LV lead) in a small vein around the left ventricular chamber. Dr. Okabe notes, “There’s a lot of anatomical variation in where we can implant the LV lead. Some veins are too small or tortuous, or too big. This Attain Stability Quad lead could be placed in big vessels — even major vessels — and would be unlikely to move. We hope this new design will allow us to implant the lead in a location where conventional leads would have been too unstable.”

Implanting the lead quickly and efficiently is important because “faster procedure time directly correlates with a lower rate of infection,” Dr. Okabe adds.

Addressing Safety Concerns

When implanting CRT devices, electrophysiologists know there’s a 1 percent risk of infection with any cardiac device. The only treatment is to remove the CRT and its leads.Dr. Okabe says developers of the new LV lead carefully calculated a design that could be removed without damaging the walls of a blood vessel.

“Clinicians have expressed concern that placing the lead and screwing it into the wall of the vein would rupture the vessel. That hasn’t been the case in animal or human trials,” Dr. Okabe confirms.

In animal studies, researchers extracted the leads after two years with no problems. No one knows if that task will become more difficult with a lead that’s been in place for 10 to 20 years. “We’re weighing the risk of a potential removal at a later date against improving the quality of life and ability to live longer now.”

Dr. Okabe has successfully implanted close to a dozen LV leads in study participants, with no adverse events. Dr. Okabe is one of eight cardiac electrophysiologists at Ohio State participating in the study.

Quest for New and Improved Mechanical Heart Devices

Ohio State recently became the first medical center in Ohio to implant a HeartMate III left ventricular assist device as part of a multicenter clinical trial. This is one of several clinical trials at Ohio State pursuing new ways to prolong life and improve quality of life for people with advanced heart failure.

HeartMate III Left Ventricular Assist Device

Ohio State was one of the first 10 medical centers selected by Thoratec Corporation to test the HeartMate III left ventricular assist device (LVAD), which is smaller and entirely magnetically levitated—designed to produce fewer complications than its predecessor, HeartMate II. The MOMENTUM 3 U.S. IDE Clinical Trial will compare the two devices.

In August 2015, Ohio resident Linda Burton, 67, became Ohio State’s first recipient of the HeartMate III. She has survived stents and two heart attacks and was living daily with the struggles of heart failure. Her symptoms were preventing her from enjoying daily activities, despite using a number of heart failure medications and a biventricular pacemaker. Researchers at up to 60 medical centers across the U.S. hope to enroll at least 1,000 patients to test the device as both a lifelong destination therapy or as a bridge to heart transplant.

“For people with end-stage heart failure, the one-year survival rate is 80 percent with the device. With medicine only, the survival rate is less than 50 percent,” says Ahmet Kilic, MD, director of both clinical and research for Ohio State’s Ventricular Assist Device Program.

The HeartMate III is implanted entirely in the chest cavity and is connected to an external controller and battery system that a patient can place in a vest pocket.

Burton, who will live with the device permanently, now can go walking, golfing and gardening. “It’s amazing how much better I feel,” she says.

Dr. Kilic adds, “Linda has done wonderfully with the implant. My hope is that she leads a much better quality of life with the stamina and energy to do the things

she loves.”

Stem Cell Study Tests for Improved Heart Function

Ohio State is among 25 centers across the U.S. and Canada testing the safety and efficacy of injecting stem cells into the heart during a surgical implant of an LVAD.

Researchers for the trial, titled “Safety & Efficacy of Intramyocardial Injection of Mesenchymal Precursor Cells (MPC) on Myocardial Function in LVAD Recipients,” hope the cells will improve heart function. Researchers have previously noted that MPCs normally present in human bone marrow have been shown to increase the development of blood vessels and new heart muscle cells in the heart.

“With this study, we’re not only wanting to extend quality of life but use the stem cells to recover heart function. The goal is to help the heart repair itself and reverse damage to the heart muscle,” Dr. Kilic says.

Researchers are testing RevascorTM stem cells, obtained from healthy human donors and grown in a laboratory. Patients receiving an LVAD as a bridge to transplant and as a destination therapy are eligible to participate.

SynCardia Total Artificial Heart

Patients with severe biventricular failure are faced with having a heart transplant or replacing both ventricles. The SynCardia Total Artificial Heart provides a temporary option as a bridge to transplant. The size of the already-approved artificial heart is too large for all potential candidates, however. Ohio State is one of a handful of sites in the country testing a smaller version of the artificial heart called 50cc SynCardia Total Artificial Heart, suitable for women, smaller men or adolescents.

About Ohio State’s Ventricular Assist Capabilities

Ohio State has one of the country’s largest ventricular assist device programs and is recognized worldwide for its leadership in cardiac mechanical support. The program has three heart surgeons who specialize in mechanical assist devices. Together, they implant long-term and temporary devices in more than 70 patients per year.

The heart surgeons collaborate with heart failure specialists, nurse practitioners, VAD coordinators, pharmacists, social workers and dietitians—all working in Ohio State’s Heart Failure Disease Clinic—to provide ongoing care for more than 100 patients with long-term VADs.

“Our expertise in providing a continuum of care for heart failure patients through the clinic allows us to provide a better quality of life for some of the most complex and sick patients,” Dr. Kilic states.

In addition to devices currently being tested, Ohio State uses these devices:

  • Heartmate II, the most common VAD implanted worldwide in the chest to promote continuous blood flow from the left side of the heart into the aorta. The VAD is run by a small external computer, which is connected to the pump via a small cable that passes through the upper abdomen.
  • HeartWare, a more recently developed VAD approved as a bridge to transplantation, is awaiting approval as a destination therapy. It is implanted entirely within the heart sac and can be implanted in a wide range of people, including those of smaller stature.

“We have access to every available device,”says Dr. Kilic, “and our short-term and long-term survival rates meet and exceed the national average. Quality in care is something we are very proud of, and we will continue to hold ourselves to the highest expectations for our patients.”

Ohio State enrolls its patients in INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support), a national registry for people who receive mechanical circulatory support device therapy. This database, with more than 10,000 patients from 140 hospitals, helps classify the severity of a patient’s illness and predicts mortality of patients receiving a VAD implant.

“My hope is to continue to build on the VAD program’s strengths and engage the various physicians involved in the care of these complex patients. With seamless communication and early referral, we can continue to care for the ever-increasing number of heart failure patients. 

“The goal is to not only improve their survival but, perhaps more importantly, the quality of life for all of those suffering from advanced heart failure,” Dr. Kilic concludes.

Make a Referral to Ohio State’s Mechanical Assist Device Program

Heart Failure Disease Clinic

614-293-6038

888-293-7677

VAD and Heart Transplant

614-293-3787

800-538-1886

URGENT REFERRAL

If a patient’s condition warrants an urgent outpatient evaluation or inpatient transfer, please notify us so we can expedite the patient’s care.

To arrange a same-day physician consult or patient transfer, call our 24-hour referral and transfer service at 614-293-4444 or 800-824-8236.


Fenestrated Stent Graft Offers Solution for Para-Renal Aortic Aneurysms

Endovascular approach reduces complications, recovery time

Endovascular repair of para-renal aortic aneurysms using a fenestrated stent graft is one of the latest ways the Aortic Center at The Ohio State University Wexner Medical Center is improving patients’ lives.

“We are one of the few medical centers in Ohio with the specialized training to offer this endovascular procedure,” says Patrick Vaccaro, MD, director of the Division of Vascular Surgery at Ohio State.

Up to 4 percent of Americans experience abdominal aortic aneurysms, most commonly affecting men, people over age 65 and smokers. A smaller percentage of the population will have an aneurysm in the aorta near the renal arteries. Dr. Vaccaro says surgeons at Ohio State will likely insert the highly specialized endovascular stent graft in 10 to 15 patients this year.

“We see a potential for growth with this procedure and want to be at the leading edge,” he notes. He adds that the procedure is an excellent option for patients who aren’t good candidates for open surgery.

Advantages Over Open Surgery

Smaller incisions, less blood loss, less discomfort, fewer complications, a shorter hospital stay and faster recovery all are advantages of the endovascular approach as compared to open surgery. The graft is placed in the abdominal aorta in a sheath that is threaded through the femoral arteries.

By contrast, an open surgical procedure requires a much larger incision in the side or abdomen.

Aortic Center Expertise

“Several years ago, we started the Aortic Center to combine the skills and expertise of nearly a dozen vascular and cardiothoracic surgeons. Our excellent results and ongoing research draw patients from throughout Ohio, and beyond,” Dr. Vaccaro says. “We perform a high volume of vascular procedures, and our excellent results have been documented through independent organizations such as Leapfrog.”

Make a Referral

For a referral or more information, call 1-888-293-7677 [ROSS]


Ohio State First to Implant Newly Approved Wireless Heart Failure Monitor

Ohio State's Heart and Vascular Center was the first in the country to begin treating some heart failure patients with a new wireless, implantable hemodynamic monitor just approved by the FDA. The CardioMEMS HF monitoring system will help physicians observe pulmonary artery pressures, optimize treatment and prevent hospitalizations. Dr. William Abraham, director of the Division of Cardiovascular Medicine, was the national co-principal investigator on the clinical trials of the new device. "I consider this to be the first major breakthrough in heart failure management in more than a decade," Abraham says. "For the first time, cardiologists can directly manage a patient's pulmonary pressures rather than managing their symptoms or weight gain.

The CardioMEMS heart sensor is approved for NYHA Class III patients with a history of hospitalizations within the past year. Results from studies show the device has reduced hospital readmissions by more than 30 percent, when compared with standard care. The study also determined the device to be cost-effective, with implant procedures costing approximately $15,000—the same cost as one average hospitalization for heart failure.

The device is about the size of a large paper clip and is implanted in the pulmonary artery using a simple, catheter-based procedure. It takes real-time measurements of pulmonary artery pressure and transmits them to a secure website where cardiologists can review the data and make adjustments to medication, if needed.

"An increase in pulmonary artery pressure is the most direct sign of congestion," Abraham says. "By identifying these elevated pressures early, we can treat patients before they get sick and avoid episodes that lead to repeated hospitalizations."

Dr. Ayesha Hasan, a heart failure cardiologist at Ohio State's Richard M. Ross Heart Hospital, was the study's lead principal investigator at Ohio State.

"I've seen several patients in the clinical trials go from numerous hospitalizations down to zero. Now with federal approval, we're excited that many more people with heart failure can have the monitor and a better quality of life," Hasan says.

Next, Abraham says, he is planning follow-up studies to evaluate the long-term effects of the monitoring system.

New Heart-Assist Device Being Tested at Ohio State

Michele's heart failure symptoms had her in and out of the hospital 10 times in one year. Her physician, based at a community hospital, had exhausted his resources and sent her to Sitaramesh Emani, MD, an Ohio State cardiologist who subspecializes in advanced heart failure.

Dr. Emani notes that Ohio State has been among the leaders in recent years in making strides for heart failure patients.

"Patients have more options now, and they don't have to live with heart failure symptoms," he says.

Ohio State's comprehensive Heart Failure Disease Clinic addresses all levels of heart failure, including the most advanced stages. The clinic follows more than 2,000 patients, many with advanced heart failure.

Board certified heart failure specialists and nurse practitioners work in collaboration with nurses, pharmacists, social workers, dietitians and surgeons—all specialists in heart failure treatment

For Michele, Dr. Emani recommended a C-Pulse, currently in clinical trials at Ohio State. The counterpulsation technology acts like a balloon pump to increase coronary blood flow and cardiac output, and reduce the heart's pumping workload.

The C-Pulse is built for patients with Class III and ambulatory Class IV heart failure. At age 46, Michele needed oxygen 24 hours a day. She also contends with diabetes and hypothyroidism.

"I have a family history of heart disease," she says. "My mom died from CHF and coronary artery disease, and every aunt and uncle has heart problems."

She continues, "I'm borderline for a heart transplant, but Dr. Emani thought this was the safest way to start. I was the first in Columbus and the third in the country to receive the device. The man who developed the pump was there at my surgery."

Michele had a partial sternotomy to implant the device. A port in her stomach allows her to connect to the battery pack she carries with a shoulder strap. She can disconnect the battery for 15 minutes a day to take a shower.

Although she admits the battery pack can be cumbersome at times, "So far, it's worth it. I've only had to use oxygen twice since my procedure in March. A physical therapist comes to my house to help me with strengthening."

Since the implant, she hasn't had any hospitalizations for heart failure. Eventually, Michele will go to cardiac rehab.

"The C-Pulse is just one of many new and innovative treatments available at Ohio State," Dr. Emani says. "Historically, doctors accepted heart failure as something patients had to live with. Now, we're thinking there's something more to be done. Advanced heart failure has become its own specialty, and Ohio State has developed an entire team to address heart failure issues.

"We are constantly pursuing new drug therapies and researching novel devices," adds Emani, noting the ability of Ohio State's heart failure specialists to understand the nuances of heart failure and the latest medications used to treat symptoms and underlying causes.

Ohio's State's advanced heart failure treatment options include:

  • Inpatient and outpatient ultrafiltration treatment.
  • Clinical trials with novel drug therapies and novel device implants. Device implant studies include evaluating expanding indications for resynchronization therapy, hemodynamic monitoring devices to assess filling pressures, alternative mechanical support devices and vagal nerve stimulation in heart failure.
  • High-risk open heart surgery.
  • High-risk percutaneous interventions.
  • Ventricular assist devices (VAD). As one of the larger VAD programs in the country, we continue to increase our implant numbers and currently follow more than 90 patients with long-term VADs
  • A cardiovascular genetics program, offering genetic screening and complete follow-up care.

The team reaches out to sleep medicine for evaluation of sleep apnea, and includes the preventive cardiology team to help reduce controllable risk factors.

In addition, Dr. Emani says, "We spend time with patient education, so patients understand what they can do to help improve their symptoms. Our heart failure readmission rates are among the lowest in the region."

Michele is grateful for the resources Ohio State provides.

"Dr. Emani is awesome," she says. The whole team was wonderful. They answer every single question I have and they check on me."

Since Michele had the C-Pulse implanted, "I'm able to spend more time with my grandkids and family. I can go to church more and go places with my friends. It's good to be home rather than in the hospital. I'm so glad I did it."

Vacuum Device Used to Successfully Remove Life-Threatening Clots

Painful swelling in his legs and severe shortness of breath caused Stephen, an Ohio truck driver, to be life-flighted from his home in Meigs County, Ohio, on the West Virginia border, to Ohio State's Richard M. Ross Heart Hospital, where vascular surgeon Jean Starr, MD was waiting to treat him.

Multiple blood clots in his legs and vena cava were threatening the viability of his legs.

"Stephen's entire vena cava and pelvic veins were clotted off. There was no venous return to the heart," Dr. Starr explains. He also was going into kidney failure.

She knew quick action was needed for this highly unusual emergency. Either blood thinners or surgery would take too long to resolve the life-threatening situation. Ohio State's commitment to providing the most current, leading-edge technology gave Dr. Starr the option to use a newly acquired device.

She says the AngioVac vacuum device was ideal for Stephen's situation, explaining that "No other device or procedure could remove such a large clot burden in such a short time."

Stephen readily agreed to be Ohio State's first AngioVac patient.

During the hour-and-a-half procedure, Dr. Starr inserted a cannula on each side of Stephen's neck: one to aspirate the blood and the other to return it. The catheter acts as a vacuum to pull clots out of the bloodstream. The blood goes into a bypass machine, where a filter strains and heparinizes the clot and then returns it to the body via the second cannula. Because the blood is recirculated, no transfusions are needed.

"Within hours of the procedure, Stephen's kidney function returned to normal," Dr. Starr says. "When he arrived on a nursing unit for recovery, the swelling in his legs had noticeably decreased. By the next day, his legs were remarkably improved."

Up to 600,000 new PEs and one to two million blood clots in the legs are reported each year. Ohio State continues to research and seek out innovative technology and procedures to help patients who have life-threatening and limb-threatening blood clots.

"This case demonstrates that physicians at the Ross Heart Hospital have the skills and resources to treat the most complex patients and diseases," Dr. Starr says.

"Stephen is doing well," she continues. "The last time I saw him, he wanted to take a picture with me. He thought he was going to die, and so did I."

Stephen is grateful for his full recovery and for Dr. Starr's quick action.

"She's totally amazing," he says. "Everybody at Ohio State was super. Everything was perfect."

Surgical Advances

Surgical procedures and advances at Ohio State's Heart and Vascular Center

Fenestrated Graft Expands Possibilities for Aortic Aneurysm Treatment

With the development of the fenestrated aortic graft, patients with aneurysms near the renal arteries have a minimally invasive, endovascular option for their aneurysm repair. The fenestrations, or openings, in the aortic graft align with the arteries that branch off the aorta. Led by vascular surgeon Mounir Haurani, MD, Ohio State’s fenestrated graft team has performed more than 30 fenestrated graft procedures since 2013. Ohio State is one of only three centers in Ohio to perform the procedure and the only one in central Ohio.

 

Who is a Candidate for a Fenestrated Graft?

Patients with pararenal and juxtarenal aneurysms who have intermediate to high risk for open surgery are the primary candidates for the fenestrated aortic graft. In particular, those who are frail, elderly or ill are most likely to benefit because they avoid potential complications of an open procedure. “We can also use the fenestrated graft for people with a failed aneurysm repair,” Haurani says. “With good CT imaging and 3-D views, we can convert an old endograft without doing an open repair.” For younger patients in their 50s or 60s, an open procedure may be the treatment of choice because of a proven record of long-term reliability, Haurani says, noting that this may change with continued improvement and growing evidence of the success of the fenestrated graft.

For now, he says. “Endografts may dislodge or leak over time and need secondary procedures to reseal the aneurysm or do a bypass around it. The endografts are easier upfront but need lifelong follow-up. With the open procedure, we can sew a polyester or Gortex graft in place, and the material is good for life.” Haurani is optimistic about the future. “As the technology emerges in the next 10 to 15 years, we may not need open aneurysm procedures,” he says.

Preparation and Procedure

Preparation before the procedure is critical to its success. Advanced imaging capabilities at Ohio State enable radiologists to capture precise, 2mm slices during a CT scan that can be processed and transformed into 3-D images of the aorta.

“The openings for the kidneys and intestinal arteries are often only 6mm, so we need fine cuts to pin down precise locations of the holes,” Haurani says. It takes about four weeks to manufacture a custom graft according to  specifications, so the procedure cannot be performed emergently. The procedure is technically demanding, requiring three to six hours to ensure precise placement of the graft. Placement of less complex endografts typically takes about one to two hours. Haurani works with the same team of surgical techs, radiology techs and anesthesiologists to optimize procedure outcomes.

“You need a team who really understands the device; there are up to 23 markers on the graft to aid alignment,” he says. “It can be disorienting if you don’t have a good knowledge of the graft design.” The surgeon enters through the femoral artery, similar to a catheterization, and threads the catheter carrying the graft through the iliac arteries and to the proper position in the aorta. Once positioned, the fenestrated graft stays in place through the outward force of the graft pressing against the aorta. The graft gains further stability from its columnar strength and hooks that are above the graft fabric. After the procedure, patients receive care from a dedicated vascular nursing team in the  Ross Heart Hospital and are discharged in two to four days.

Advantages of Fenestrated Graft Procedure

For patients who are not strong candidates for an open surgical procedure, the fenestrated graft offers a safer option to prolong length and quality of life. Notable advantages include:

  • Minimal blood loss
  • No cutting into chest wall muscles, making it easier to breathe postoperatively, which is especially important for people with chronic obstructive pulmonary disease (COPD)
  • Less hemodynamic stress, because the aorta is not clamped
  • Less stress to the kidneys, because circulation is cut off for only a very short time
  • Shorter hospitalization of two to four days versus seven to 10 days with an open vascular procedure
  • Shorter recovery time of two to four weeks versus eight to 10 weeks

To date, Ohio State has been able to deploy all attempted grafts and preserve all target vessels. Patients have experienced no further aneurysm growth, and cases that involve leaking have shown no risk of rupture. Haurani is enthusiastic about the next step, still in clinical trials, which uses a branched graft that has applications even higher in the thoracic aorta.

After the procedure, Ohio State physicians see the patient at one month, six months and annually for follow-up CT scans. If a patient’s kidney function isn’t strong, the vascular lab team monitors the graft long term. Physicians maintain close contact with the referring physician via operative reports and communication about post-operative visits. Case managers work closely with patients to ensure they have appropriate care for their recovery and long-term success. Ohio State enrolls all patients in a Vascular Quality Initiative Registry of the Society for Vascular Surgery to measure long-term success and document how long patients are living with the graft.

Make a Referral

At Ohio State’s Aortic Center of Excellence, a team of surgeons, anesthesiologists and radiologists holds regular conferences to discuss cases and develop an optimal treatment plan for each patient. Even if you think your patient may not be suitable for a fenestrated graft, the multidisciplinary team can offer minimally invasive options, hybrid procedures and open aneurysm repair.

 

To make a referral, call 614-293-8536 or contact the Aortic Center of Excellence at 855-204-1200.

 

After hours, you can call 614-293-8000 and ask the hospital operator to page the vascular surgery physician on call.

 

For urgent matters, contact our transfer center at 614-293-4444.


Clot Removing Pulmonary Surgery Available at Ohio State

Thromboendarterectomy Potentially Curative for Chronic Thromboembolic Pulmonary Hypertension

Pulmonary thromboendarterectomy (PTE) offers the only chance for cure in patients with chronic thromboembolic pulmonary hypertension (CTEPH) — chronic, persistent, organized clots in the pulmonary arteries. Ohio State has two cardiothoracic surgeons who perform the open-chest procedure to remove clots from the pulmonary arteries. As a result, pulmonary pressure returns to normal, cardiac function stabilizes and a patient’s quality of life improves.

The surgery was refined and standardized in the 1990s. It requires a high degree of surgical skill and expert critical care follow-up. Ohio State has been performing the surgery for about 10 years, and recently expanded its program at the Richard M. Ross Heart Hospital.

“The Ross Heart Hospital provides us with world-class resources, including internationally renowned experts in pulmonary hypertension, critical care and imaging,” says cardiothoracic surgeon Bryan Whitson, MD. “Patients don’t have to travel across the country to get this treatment. We have results at Ohio State comparable to international referral centers.”

Dangers of CTEPH

CTEPH is a rare form of pulmonary hypertension, occurring in about one in 100,000 people. Small clots that form in the legs or pelvic area travel to the lungs, where they lodge in the pulmonary artery walls rather than being reabsorbed by the body. Over time, the clots narrow the pulmonary arteries, causing pressure to rise as blood tries to move through the arteries. The right ventricle pumps blood harder in an effort to get sufficient nutrients to lung tissue.

Sustained elevation of pulmonary artery pressures leads to right ventricular failure and death. As little as one episode of pulmonary embolism may lead to development of CTEPH over time. Shortness of breath is the primary symptom, and the condition may look like asthma or heart failure. Risk factors include a history of clotting disorders, deep vein thrombosis or previous pulmonary embolism. The condition can present as early as a person’s 20s or 30s.

A ventilation/perfusion scan, in which the patient breathes in gas and the physician views  X-rays to see where the gas goes in the lungs, can rule out CTEPH if the scan is normal. An abnormal scan will prompt further testing with CT, pulmonary angiography or echocardiogram to look at the pulmonary arteries.

Treatment Options

Our multidisciplinary team of cardiologists, pulmonologists, cardiothoracic surgeons, radiologists and critical care physicians contributes to both diagnosis and treatment of the condition.

PTE is the treatment of choice for patients who are able to tolerate an open-chest surgical procedure. The breastbone is opened to access both lungs, and the patient is put on cardiopulmonary bypass. The patient’s body is cooled down to lower energy needs and to protect organ function. When the surgeon is ready to remove clots, the heart-lung machine is turned off for 20-minute intervals and then turned back on to reinstate circulation.

Patients who undergo PTE require expert postoperative care to address possible complications similar to those of heart surgery. In addition, critical care physicians must be ready to address reperfusion lung injury, the most common complication in the first 48 to 72 hours.

Medication is prescribed for patients with vessels not accessible to the surgeon or who are not suitable candidates for open-chest surgery. Various medications work to improve pulmonary vascular resistance, and therefore, make breathing easier. Occasionally, interventional specialists will attempt dilation of the pulmonary arteries with balloon angioplasty to improve symptoms of non-surgical candidates.

World-Class Heart Hospital

Patients undergoing PTE receive care in Ohio State’s Richard M. Ross Heart Hospital. The heart hospital opened more than a decade ago as the nation’s first comprehensive academic hospital dedicated to cardiovascular care. The 150-bed facility combines the latest technology with patient-focused care to create the best possible healing environment. Each floor is dedicated to a specific service, such as cardiac surgery or vascular medicine. We offer universal patient rooms built to adapt to changing medical needs so a patient can remain in the same private room for the entire hospitalization.

Referrals

We generally see people within two weeks of referral or more urgently, if needed. For referrals or appointments, call 614-293-7677. Our cardiothoracic team maintains close contact with the referring physician throughout the evaluation and treatment process and follows patients over time to track their progress.


New Option for Mitral Valve Regurgitation Repair

Clinical Trial Expands MitraClip® Applications for Mitral Valve Regurgitation

As one of the Midwest’s leading centers for mitral valve replacement and repair, Ohio State’s Heart and Vascular Center offers advanced transcatheter treatment options for mitral valve regurgitation. To eliminate leakage back into the left atrium, our mitral valve team uses a MitraClip® device about the size of a small paper clip to hold together the valve’s anterior and posterior leaflets.

Patients at prohibitive surgical risk who have symptomatic, moderate-to-severe or severe mitral regurgitation are candidates for valve repair with the MitraClip. Applications include:

  • Functional mitral regurgitation due to ischemic or non-ischemic cardiomyopathy. Ohio State is one of a few select centers in Ohio offering this application through the multicenter Clinical Outcomes Assessment of the MitraClip Percutaneous Therapy clinical trial. Patients who qualify enter the randomized trial and receive optimized heart failure medical therapy with or without the MitraClip device.

  • Organic (degenerative) mitral regurgitation. Approved by the Food and Drug Administration.

“As an academic medical center, Ohio State has access to the latest clinical trials and advancements. The transcatheter procedure is a strong component of our Structural Heart Disease Program, which offers a number of options for care and treatment of valve disorders,” says Konstantinos Dean Boudoulas, MD, interventional cardiologist. The center also has surgeons skilled in open mitral valve surgery and cardiologists who are adept at managing symptoms medically.

The Procedure: Minimally Invasive Transcatheter Mitral Valve Repair

During a transcatheter valve repair, our interventional cardiologist inserts a catheter into the femoral vein and advances it to the right atrium where a transeptal puncture is performed to gain access to the left atrium. The physician guides the catheter across the mitral valve into the left ventricle.

A transesophageal echocardiogram and color Doppler guide placement of the clip as its arms open, and the physician places it below the valve leaflets where the leak is seen. The arms of the clip retract to hold together the anterior and posterior leaflets, creating a double orifice to allow blood to flow through the valve but not regurgitate back. The procedure typically takes two to four hours. Patients return home in three days, on average.

Ohio State’s Mitral Valve Team

Our mitral valve team includes surgeons, cardiologists, interventional cardiologists and advanced heart failure specialists, who review cases weekly or biweekly. We offer a range of perspectives on treatment options as we decide what’s best for each patient. Communication and collaboration with the referring physician are priorities.

All patients are treated and cared for at the Richard M. Ross Heart Hospital, which has an entire floor dedicated to patients undergoing cardiac catheterization procedures. Our physicians work closely with a dedicated support staff and cardiac nurses who have earned Magnet® designation for their excellent nursing care.


TAVR

A Lifesaving Alternative for Patients at High Risk for Traditional Surgery

“I was getting tired-er and tired-er, and I could do less and less,” says 85-year-old Howard Shoup of Wooster, Ohio.

When Mr. Shoup came to the Structural Heart Disease Program at The Ohio State University Wexner Medical Center, he was debilitated by shortness of breath caused by congestive heart failure.

Evaluated at Ohio State’s multidisciplinary heart valve clinic, Mr. Shoup was soon scheduled to undergo a transcatheter aortic valve replacement.

“They told me I had a heart valve that was about ready to quit, and it might have been within two or three days of quitting when I had the operation,” Mr. Shoup says.

Since 2010, Ohio State’s Wexner Medical Center has been one of only a few centers in the region that offer this cutting-edge alternative for patients who are considered inoperable or at high risk for conventional surgery.

The procedural outcomes are comparable to those of conventional surgery —– improved quality of life for patients who previously suffered from debilitating shortness of breath, chest pain and/or fatigue. As a result of the minimally invasive approach, there are smaller incisions, reduced hospital stays and shorter recovery times.

“For most of the patients we treat, it is their only option. They all have co-morbidities —–previous surgeries, strokes, many conditions that would make traditional surgery too risky. Without this less invasive option, they would not survive,” says Juan Crestanello, MD, co-director of the Structural Heart Program and assistant professor of Surgery, who performed Mr. Shoup’s procedure.

In the last two years, nearly 60 patients have undergone the procedure at Ohio State’s Wexner Medical Center, and the program is growing as more practitioners become aware of this new treatment option.

Ohio State among the World’s Largest Sites for Valve Trials

illustration of artificial valvePatients undergoing this procedure at Ohio State may receive one of two devices. In addition to the Edwards SAPIEN transcatheter heart valve, which is U.S. Food and Drug Administration-approved for high-risk cases, patients also have unique access to the Medtronic CoreValve System, which is being studied by clinical trial in the United States.

Ohio State was among the highest enrollers in the high-profile Medtronic CoreValve U.S. Pivotal Trial and among the first 20 U.S. centers to participate in the Surgical Replacement and Transcathether Aortic Valve Implantation (SURTAVI) Trial, giving heart patients like Howard Shoup an opportunity not available in most hospitals.

Outstanding Care 

Today, Howard Shoup’s quality of life is dramatically different. Although still in therapy, he is now able to travel, exercise and enjoy reclaimed time with his wife, three children and seven grandchildren.

“They took wonderful care of us,” Mr. Shoup says of the Structural Heart Disease Program. “It was the most outstanding care I’ve ever encountered.”

Ohio State Now Offering Stenting for Coronary Chronic Total Occlusion

Procedure Offers Quality of Life Improvements for Select Patients

Ohio State now offers percutaneous coronary intervention (PCI) for people with chest pain or shortness of breath due to coronary chronic total occlusions (CTOs) of three months or more in coronary arteries. A more complex version of a standard angioplasty and stent placement, the procedure offers an important option for patients who are symptomatic and have failed medical management, had previous coronary bypass surgery or have high-risk anatomy.

“Our goal is to get people feeling better — if we can get vessels re-opened, people can have a much better quality of life,” says interventional cardiologist Ernest Mazzaferri Jr., MD, FACC, FSCAI, medical director of Ohio State’s Richard M. Ross Heart Hospital.

PCI Procedure

The specialized PCI procedure focuses on opening a total occlusion in one of the three major coronary arteries, with blockage resulting either from an acute event or gradual closure. Candidates for the procedure are those with symptoms such as angina, shortness of breath or other signs of heart failure who have not responded to medical management. They may have had a heart attack in the past. In addition, they are unable to have coronary bypass surgery because they have already had a previous surgery, the area of blockage is difficult to reach through surgery or the patient is a high surgical risk.

Patients being evaluated for a CTO PCI often undergo a stress test or viability study and typically have a heart catheterization before the procedure to locate the blocked coronary vessel and plan the upcoming procedure. During the CTO PCI procedure, catheters are inserted into arteries at the wrist and groin, and dye is injected into both sides of the heart simultaneously to pinpoint where stents should be placed.

“The challenge is getting through the occlusion with a rotational atherectomy device or a special catheter or wire to get though the blockage,” Dr. Mazzaferri says.

Once the CTO is open, the procedure continues like a regular stent procedure with a balloon and stent placement. Because the procedure is highly complex, involving multiple vessels, the rate of complication due to bleeding or tearing of a vessel is about 10 percent — higher than the 1 percent complication rate with a standard catheterization.

Both physician and patient weigh potential benefits against possible complications before proceeding with the procedure. Dr. Mazzaferri has been able to open blocked vessels in close to 90 percent of his cases. Less than 10 percent of people have a blockage recur.

“A third of our patients feel better right away. For some, it may take a while longer,” Dr. Mazzaferri comments.

Interventional Expertise

Dr. Mazzaferri has performed thousands of standard stent procedures and views the CTO PCI as an advanced level of that work. He attended a training course at Columbia to use the equipment and techniques required for the procedure. He performs the CTO PCIs with an interventional fellow and a team of specially trained catheterization lab nurses and radiation technicians.

“For really tough cases, we’ll bring in a proctor with more experience to assist us,” he says.

“I get a lot of gratification from doing this procedure and helping people we weren’t able to help before. As improvements evolve throughout the cardiac community, complications will go down and success will go up.”

For a referral or more information call 614-293-7677 or contact ernest.mazzaferri@osumc.edu.


Vascular Experts Achieve Excellent Results for Thoracic Outlet Syndrome

Ohio State's Wexner Medical Center Leads Region in Case Volume and Experience 

In pursuit of a professional dance career, 16-year-old Samantha saw her dancing come to a sudden halt when a blood clot developed in her arm. After a month of testing, consultations and referrals, Samantha'’s family sought the expertise of Michael R. Go, MD, FACS, vascular surgeon and assistant professor of surgery for the Division of Vascular Diseases and Surgery at The Ohio State University Wexner Medical Center.

The vascular surgery team at Ohio State's Wexner Medical Center has earned renown for diagnosing and treating thoracic outlet syndrome (TOS), a rare, debilitating syndrome caused by compression of nerves and blood vessels in the thoracic outlet.

Ninety-five percent of TOS cases are neurogenic, affecting the brachial plexus. Venous and arterial TOS make up the remainder.

Diagnosis

Diagnosis for TOS can be a cloudy subject, and early referral to a vascular center with expertise and patient volumes, such as those at Ohio State's Wexner Medical Center, can provide an accurate diagnosis. The vascular team receives referrals from hematologists, sports medicine physicians, athletic trainers and primary care doctors.

X-ray of a patient with cervical ribs which may cause thoracic outlet syndromeApplying his extensive experience with TOS and the medical center's wealth of diagnostic tools –— ultrasound, EMG nerve conduction studies, scalene muscle injections –— Dr. Go diagnosed Samantha with venous TOS, noting that her collarbone was compressing a vein and causing deep venous thrombosis in her right upper extremity.

The extremely rare venous TOS generally occurs in young people in their teens and 20s, especially in athletes. Samantha's countless hours of extending her arm in the air during ballet practices and performances most likely contributed to the compression of her vein between the clavicle and first rib.

Treatment

Dr. Go recommends surgery for arterial and venous cases; patients with neurogenic TOS often attempt physical therapy before pursuing surgery.

Performing 30 to 50 surgeries a year to relieve compression of nerves and blood vessels in the thoracic outlet, Dr. Go and his fellow surgeons demonstrate surgical volumes and outcomes that surpass any medical center in the region.

In Samantha's case, Dr. Go chose a transaxillary approach, using a three-inch incision. Samantha and her family are pleased that the scarring is barely noticeable.

The TOS surgeons at Ohio State's Wexner Medical Center can also perform the surgery from a supraclavicular approach or infraclavicular approach, depending on which option is most likely to produce the best outcome.

Clinical Expertise That Exceeds Expectations

Few medical centers offer the depth and range of experience Samantha and her family found at Ohio State's Wexner Medical Center. As residents of a Columbus, Ohio, suburb, Samantha and her family felt fortunate to have the medical center close by.

"I didn't see the need to go out of town," says Samantha's mom, Wendy. “I didn't worry for one minute. I knew she was going to be OK."

The highly specialized TOS team routinely achieves positive surgical outcomes, including prevention of permanent nerve damage, prevention of blood clot formation (venous TOS) and elimination of pain, weakness, numbness and tingling in the arm.

The Human Touch

Wendy praised Dr. Go and his surgical team for being "reassuring, comforting, knowledgeable and informative. Nothing was a surprise. The communication was great."

She appreciated Dr. Go's inclusion of Samantha in discussions, his willingness to answer questions and his accessibility by phone.

Samantha received the go-ahead to return to dancing after a 3 ½-week recovery.

"Living with TOS would have limited Samantha's abilities," Wendy comments. "To not be able to dance would be like not being able to breathe. We're grateful Dr. Go provided a solution that allowed her to continue to pursue her dreams."

To refer a patient or learn more about our vascular services, call 614-293-ROSS (7677)

Research

With nearly 200 active trials, researchers at Ohio State's Heart and Vascular Center creating new discoveries to change the lives of heart and vascular patients.

Proving Human Heart’s “Battery” Has Multiple Backups Ohio State Research Team Publishes Findings on Sinoatrial Node

Ohio State researchers have discovered that the human heart’s sinoatrial node (SAN) is hardwired with a backup system—three diverse regions of pacemakers acting as batteries. Up to five conduction pathways act as wires to connect the signal to the atria. This built-in redundancy maintains consistent heart rhythm, even under trying conditions.

 

Vadim Fedorov, PhD, an Ohio State associate professor in the Department of Physiology and Cell Biology, and his team published these findings in the online Science Translational Medicine journal in July 2017.

 

Therapeutic Potential

 

“It’s groundbreaking. This is the first step in explaining why the SAN can be ‘sluggish’ for years before a total failure, allowing the clinician to detect the problem before a catastrophic event,” says Raul Weiss, MD, FACC, a cardiologist and clinical researcher at Ohio State. 

“I think this work can fundamentally change the way we diagnose disease of the heart’s natural pacemaker,” says John Hummel, MD, FACC, a cardiologist and clinical researcher at Ohio State. “In some patients it can be incredibly challenging, and these insights may allow us to diagnose those challenging patients more effectively.”

Because a pacemaker is merely a crutch and can’t fix the underlying problem, Dr. Fedorov’s team is also seeking out ways to improve or restore the impaired portions of the SAN. Their hope is that someday, pacemaker implants could be obsolete. 

Unraveling Mysteries of the Sinoatrial Node

 

Like a battery, the SAN generates electrical impulses to initiate heartbeats. Until now, scientists didn’t know for sure how the SAN protected the heart’s rhythm and how the system failed.

 

“It’s been challenging because our human SAN differs greatly from well-studied animal models, and clinical electrode recordings only capture what’s on the surface,” says Vadim Fedorov, PhD, an associate professor in Ohio State’s Department of Physiology and Cell Biology.

 

Dr. Fedorov and his team applied optical mapping, 3D structural imaging and molecular mapping to 21 explanted human hearts to define the internal function of the SAN. The hearts, which were not viable for human transplant, were donated by heart transplant recipients and Lifeline of Ohio.

 

To resuscitate the hearts, researchers placed them in a glass chamber filled with an oxygenated solution at body temperature and perfused the coronary arteries with warm, oxygenated solution that simulates blood flow, allowing the SAN to beat again with the same rhythm as when it was inside the body for at least 12 hours. Then, the chamber with live heart tissue is surrounded by four highly sensitive infrared cameras, and a fluorescent dye is injected. This dye can visualize spontaneous electrical activity moving within the human SAN in 3D.

“We observed that all three intranodal pacemakers are used, depending on the heart’s needs at rest, or during normal or high exertion,” Dr. Fedorov says. To study how the SAN functions under stress, Dr. Fedorov’s team applied adenosine, a heart rhythm regulator that is overproduced when there is heart failure and inadequate blood supply. 

“The central pacemaker was most affected, as it is highly sensitive to adenosine. The head and tail pacemakers were able to maintain a slower rhythm and prevent complete cardiac arrest. We saw similar shifts in the preferred conduction pathways,” Dr. Fedorov says. Total cardiac arrest occurs only when all pacemakers or conduction pathways fail, whether due to disease or age.

When there is a problem with SAN pacing or conduction, doctors implant an electronic pacemaker to prevent cardiac arrest. Approximately 225,000 Americans get a pacemaker every year, according to the World Society of Arrhythmia.

“Patients are at high risk of cardiac arrest if the SAN gets down to one pacemaker, or one conduction pathway,” Dr. Fedorov says. “Knowing this, our next quest is to work with electrophysiologists to more precisely identify who needs a pacemaker implant, and who still has backups and can get along without one.”

This research was funded by the National Institutes of Health, the American Heart Association, the C.R. Webb Fund in Cardiovascular Research and the TriFit Challenge Discovery Fund. Other Ohio State researchers include: Ning Li, Brian Hansen, Thomas Csepe, Anthony Ignozzi, Lidiya Sul, Stanislav Zakharkin, Anuradha Kalyanasundaram, Jonathan Davis, Brandon Biesiadecki, Ahmet Kilic, Paul Janssen and Peter Mohler.

High-Tech Vest Tested for Heart Failure Management Radar Technology Measures Fluid Buildup in Lungs

Over three months, 59-year-old Kenny McIntyre of Columbus, Ohio, was in and out of the hospital twice. Diagnosed with heart failure, he had several pounds of fluid removed each time.

 

He is one of nearly six million Americans living with heart failure who may benefit from a high-tech vest being tested at The Ohio State University Richard M. Ross Heart Hospital.  The vest measures fluid inside the lungs from outside a person’s clothing and could be a new way to promote better quality of life and prevent repeated trips to the hospital for heart failure symptoms.

 

McIntyre says, “I’m the type that, unless something hurts me, I don’t want to go to a doctor. I just put the vest on, lay back, hit a button, and let it take my measurements. Every now and then they alter my medications.”

 

Cardiologist William Abraham, MD, FACP, FACC, director of Ohio State’s Division of Cardiovascular Medicine, leads the randomized trial that includes approximately 40 sites across the country.

 

Adapting Military Technology: The Radar Vest

 

The SensiVest, created by Sensible Medical, uses radar technology first used by the military and rescue teams to see through walls and rubble in collapsed buildings. Doctors are testing to see if it effectively monitors and manages lung fluid, reduces hospitalizations and improves quality of life.

 

“The technology has been miniaturized and put into a form that allows the radar to go through the chest wall and get an accurate measurement of water inside the lungs,” says Dr. Abraham.

 

Patients use the vest at home. They slip it on over their clothing, lie down and push a button to get a reading. About 90 seconds later, the data goes to a secure server where the patient’s doctor or nurse can catch any trending changes and tell the patient to adjust medication, if it’s needed.

 

“The goal is to keep the patient within a normal range, feeling well and out of the hospital,” Dr. Abraham says.

 

Until now, cardiologists haven’t had a precise, non-invasive way to monitor the fluid buildup in the lungs from a poorly functioning heart.

 

The standard practice of patients weighing themselves daily and reporting symptoms such as swelling or shortness of breath may not alert patients and physicians soon enough to avert hospital treatment.

 

“These methods don’t catch the disease progression early enough, and that’s why hospitalization and re-hospitalization rates for heart failure have changed very little in the last 20 to 30 years,” Dr. Abraham says.

 

How the Trial Works

 

All patients enrolled in the trial receive the highest standard of care for heart failure and are followed for up to nine months.

 

Those randomized to the treatment group also use the lung fluid monitor at home to take daily readings. The data is uploaded to a secure server where the patient’s cardiologist or nurse can review it.

 

“We can use that data to see when the lungs are trending toward being too wet and make adjustments to the medication on an outpatient basis or over the phone,” says Rami Kahwash, MD, director of the Heart and Vascular Research Organization and site leader for the trial at Ohio State. “The goal is to keep the patient within a normal range, feeling well and out of the hospital.”

 

A previous, small observational study compared hospitalizations before and after using the vest. That study showed an 87 percent reduction in heart failure hospitalizations with vest lung fluid monitoring. 

Experimental Device Removes Excess Fluid from Heart Failure Patients

Ohio State One of Two U.S. Test Sites

Ohio State is one of two sites nationwide testing a system to remove excess fluid from congestive heart failure (CHF) patients who are hospitalized. About six million Americans suffer from CHF.

Ohio State cardiovascular researchers are testing the safety and feasibility of inserting a special catheter to improve the flow of fluid from the lymphatic system. Lymphatic vessels help remove fluid from tissues and return it to the body’s circulatory system. Excess fluid is then eliminated by the kidneys.

The lymphatic system typically drains up to two gallons of fluid per day. In acute congestive heart failure, this process is impeded, allowing edema to occur in the lungs and other areas of the body. This novel therapy aims to treat edema, one of the major underlying causes of heart failure.

Catheter Device Aids Hospitalized Heart Failure Patients

The WhiteSwell System, developed by WhiteSwell Medical, is the first known catheter specifically designed to target the lymphatic system internally. The device is placed in the neck under ultrasound guidance in the catheterization lab, and the treatment continues at the bedside using a machine that helps circulate some of the blood.

The first U.S. patient to undergo the procedure was Raynes Rozzelle, 61, treated at Ohio State’s Richard M. Ross Heart Hospital in March 2017. Rozzelle has lived with various heart issues most of his life – from a heart murmur, to an irregular heartbeat, and then a heart attack four years ago. He has been hospitalized multiple times with congestive heart failure over a year. He was eager to try something new that could benefit himself and others.

During his exit interview from the study 30 days post-procedure, Rozelle reported that he was feeling well and experiencing limited heart failure symptoms.

“Most of the recent advancements in heart failure have been for non-hospitalized patients, to help keep them well,” says Sitaramesh Emani, MD, a cardiologist and director of heart failure clinical research at Ohio State, who performed the procedure. “We need new therapies for patients once they’ve become hospitalized. There hasn’t been a lot of new development there.”

Improving on Current Treatments

The study, titled “The Safety and Feasibility of the WhiteSwell System for the Reduction of Interstitial Fluid Overload in Patients with Acutely Decompensated Heart Failure (SWIFT-HF), is also being conducted at Edwards Hospital in Chicago. The trial will enroll 10 patients in the U.S. and another 30 in Israel.

Currently, in-hospital treatment for congestive heart failure involves removing excess fluid with diuretic medication and/or ultrafiltration, in which a machine bypasses the kidneys and filters water and salt from the body. However, the treatments can have unwanted side effects such as low blood pressure and worsening kidney function.

“In some cases, the diuretics provide only partial relief, so there’s a need for new options for treating the congestion  associated with heart failure,” says Garrie Haas, MD, lead investigator on the study and director of the Ohio State advanced heart failure program. “More efficient and effective treatment not only improves the patient’s quality of life, it can reduce re-hospitalizations, so we’re interested in trying this new approach.”

According to the Centers for Disease Control, heart failure is the most common reason for hospital admission in those ages 65 and older, and it accounts for one million admissions each year in the U.S. 


New Molecular Study Aims to Reverse Heart Failure Mechanisms

Heart failure (HF) is projected to increase in the U.S. by 25 percent over the next 20 years, with an estimated annual healthcare cost of $69.7 billion.

“A lot of researchers are working on a cure for heart failure. Right now, most of the medicines we have delay the heart failure process,” says molecular biologist Federica Accornero, PhD, Ohio State assistant professor, Department of Physiology and Cell Biology, Davis Heart and Lung Research Institute.

She has just received a $1.8 million grant from the National Institutes of Health (NIH) to take heart failure research in a new direction. “We would like to get the heart back to a more healthy status. We’re exploring the problem from a different point of view, doing something that’s never been done before.”

To preface her work, she explains that the heart is composed of cardiac cells that express proteins, molecular machines that make the cells function. During stress or injury, protein expression changes inside these cells. Cardiac hypertrophy is mediated by synthesis of new, abnormal proteins, or alteration or elimination of normally present proteins.

Dr. Accornero’s work, titled “Post-Transcriptional Regulation of Cardiac Hypertrophy,” is focused on the process that precedes protein synthesis. She and her research team are focusing on messenger RNA (mRNA), from its birth in the nucleus of a cardiac cell to its end point of being translated into protein in the cytoplasm of that cell.

“There has been very little done to understand mRNA processing in the heart. We want to get a better understanding of the part of the process after transcription [mRNA birth] and before translation [protein production],” she says.

The Significance of Post-Transcriptional Translation

Understanding the mechanisms by which mRNA translates into proteins is critical to developing new therapies that stop or reverse cardiac hypertrophy and heart failure.

The heart’s pumping action is controlled by cardiac cells called cardiomyocytes. These cells are reliant on production of proteins to keep the cell functioning. Proteins are produced from information transmitted by mRNA from DNA in the cell nucleus.

Aging, chest injury, hypertension, myocardial infarction or other insults to the heart can disrupt this normal communication process. Degradation, distortion or disruption of mRNA between its birth in the nucleus and the time it produces proteins can, in turn, alter the proteins themselves.

Dr. Accornero explains, “The understanding of the mechanism by which mRNA translates into proteins will be crucial in developing new interventions aimed at blunting pathological hypertrophy and the development of heart failure.”

As the Ohio State research team investigates both normal and abnormal mRNA life cycles, they also are testing whether specific enzymes can be targeted to alter mRNAs associated with cardiac pathology. Researchers are looking at mRNA-modyfing enzymes using in vivo mouse models and measuring cardiac function, cardiac hypertrophy and other parameters. They also are studying human heart samples, using both diseased and healthy heart tissue.

The NIH grant covers work through 2022, and Dr. Accornero says, “I believe this first study will open the door to many others that will contribute to a better understanding of why the heart fails. This is basic science, the first step toward clinical application.”

She adds, “Understanding how post-transcriptional events regulate protein synthesis in the heart may open the way to the development of new therapeutics for heart disease. It would be ideal to find a medicine that could restore normal cell function and return the heart to a healthier status.”


Ohio State Scientists Uncover What Drives 1 Form of Atrial Fibrillation

Cardiovascular researchers at The Ohio State University Dorothy M. Davis Heart and Lung Research Institute have learned what’s causing a common form of atrial fibrillation in the human heart, and this discovery may soon lead to new ways to treat and prevent the disease. The research, published in the journal Circulation, shows that, compared to the left atrium, the right atrium of the human heart is three times more sensitive to adenosine. This biochemical plays a role in energy transfer among cells. It’s often produced during times of metabolic stress, such as after a heart attack or coronary artery bypass surgery, or during heart failure. Too much adenosine can provoke atrial fibrillation (AF).

“We’ve known that adenosine-induced AF sources may be located more frequently on the right side versus the left, but until now, it wasn’t clear what kinds of sources are there and what caused them on a molecular level,” says Vadim Fedorov, PhD, associate professor in the Department of Physiology and Cell Biology. “Now, we can see there is adenosine hypersensitivity in the right atrium.”

Fedorov and his multidisciplinary team, including cardiac surgeons and electrophysiologists at The Ohio State University Richard M. Ross Heart Hospital, tested a hypothesis that adenosine-induced AF is maintained by re-entrant drivers, which are rotations of electrical signal much like a tiny tornado, in areas of the right atrium with highest expression of adenosine receptors and its downstream potassium channels called GIRKs. Fedorov’s team applied high-resolution optical and immunoblot mapping of the atria from 37 explanted failing and non-failing human hearts, which were donated for research by Lifeline of Ohio and the Division of Cardiac Surgery at Ohio State Wexner Medical Center. Mapping techniques recently developed at Ohio State captured panoramic images from both inside and outside the atrial walls. (left off here)

“We indeed found re-entrant drivers that were maintaining AF localized in the areas of the right atrium with the highest adenosine receptor and GIRK4 expression. Now that we know this, physicians may be able to inject adenosine to unmask the exact location of AF drivers to assist in targeted ablation treatment,” Fedorov says. “It may also be possible, in the future, to avoid invasive surgical ablation treatment altogether by treating this type of AF pharmaceutically with a selective GIRK channel blocker.”

The team evaluated tertiapin, an amino acid peptide derived from honey bee venom, as a treatment for adenosine-induced AF. Fedorov reported that tertiapin is a selective GIRK channel blocker and that it stopped or prevented AF in the study.

“It is very encouraging that we’re able to see this type of human AF is driven by localized re-entrant sources and help physicians better understand how and where the disease is occurring directly so they can better target their treatment,” Fedorov says. This research was supported by grants from the National Institutes of Health. Fedorov also received funding support from The Ohio State University Heart and Vascular Center TriFit Challenge Discovery Fund, the CR Webb Fund in Cardiovascular Research and the American Heart Association.

 

 


Dilated Cardiomyopathy (DCM) Research Receives $12.4 Million Grant

Led by Ohio State’s Ray Hershberger, MD, a Dilated Cardiomyopathy Consortium with 11 clinical sites across the U.S. will use a $12.4 million grant to study a genetic basis for DCM. Funding comes from the National Heart, Lung, and Blood Institute (NHLBI) and the National Human Genome Research Institute (NHGRI).

The study is called “Precision Medicine for Dilated Cardiomyopathy in European and African Ancestry.” Dilated cardiomyopathy (DCM), a condition in which the heart muscle weakens and the left ventricle enlarges, is the most common cause for patients needing a heart transplant and is responsible for about one in three cases of heart failure.

“Newly diagnosed DCM is commonly labeled ‘idiopathic,’ or ‘cause unknown’,” says Dr. Hershberger, a heart failure and heart transplant cardiologist and director of the Division of Human Genetics at Ohio State’s Wexner Medical Center.

“A consensus has emerged that DCM in close family members results from genetic disease; however, most DCM is diagnosed in people who have no obvious family connection. We hypothesize almost all idiopathic DCM has a genetic basis.”

Dr. Hershberger also says proving this hypothesis will transform understanding of DCM and lay the foundation for precision medicine in DCM. Precision medicine seeks to prevent disease and improve medical practice using genetic information.

With the grant funding, the researchers will conduct cardiovascular phenotyping of 1,300 people with DCM and their 5,200 family members from across the United States. Funded by the NHLBI, the team will determine the frequency of a familial link to DCM in patients of European and African ancestry. Additional funding from the NHGRI will add families of Hispanic ethnicity.  

“We believe gathering race-specific data is critical to our understandings,” Dr. Hershberger says. “Far too often, minorities are under-represented in genetic studies.”

The team will also sequence the exomes (the approximate 20,000 genes in the human genome) of individuals with DCM, and then return genetic results in a randomized study to learn how to improve family-based communication of genomic risk.

This new research is the latest development in more than 20 years of Dr. Hershberger and his team looking for ways to translate discoveries about DCM genetics into prevention and early treatment.

“We believe the new information derived from this study will help physicians understand DCM as a genetic disease. This new insight will help prevent DCM in family members and the morbidity and mortality from heart failure that follows,” Dr. Hershberger says.

Dr. Hershberger and his research team are with Ohio State’s Dorothy M. Davis Heart and Lung Research Institute. Collaborating members of the Consortium include Baptist Health South Florida, Cleveland Clinic, Houston Methodist Hospital, MedStar Health, Stanford Health Care, Tufts Medical Center, University of Maryland Medical Center, University of Mississippi Medical Center, University of Pennsylvania Health System and University of Washington Medical Center/UW Medicine.

Additional collaborators include the departments of Genome Sciences and Bioethics and Humanities at the University of Washington and Nationwide Children’s Hospital.  

To learn more about the DCM Research Project, go to dcmproject.com.


Research Seeks Underlying Cause of Heart Failure

NIH-Funded Study Focuses on Heart Muscle’s Force-Frequency Relationship

Since 2009, Ohio State researcher Paul Janssen, PhD, has been studying the relationship between the frequency of heartbeats in the human heart and the force with which the heart muscle contracts. In a healthy human heart, an increase in heart rate results in an increase in the force of contractions (positive force-frequency relationship, or FFR), and an acceleration of contractile kinetics (frequency-dependent acceleration of relaxation, or FDAR).

In human heart failure, the FFR flattens or even becomes negative, while FDAR greatly diminishes. These two phenomena are classic hallmarks of heart failure. Dr. Janssen recently received a sixth National Institutes of Health grant to continue his study of cardiac myofilaments that influence the force-frequency relationship. In previous studies, Dr. Janssen and his team have worked with more than 100 hearts and delivered nearly 20 scientific papers on their findings.

With this new four-year grant project, titled “Frequency-Dependent Modulation of Cardiac Myofilament Function in Health/Disease,” Dr. Janssen’s team proposes to assess the contraction force and speed of healthy and end-stage failing human hearts, and investigate and quantify in depth the processes that contribute to regulating contractile kinetics. They will then investigate whether an engineered protein, with a directed mutation in calcium binding properties, can improve contraction and relaxation in a failing human heart.

“We believe this process is central to understanding heart disease and crucial to the solution of heart failure, which affects millions of people,” he says. The exclusive use of explanted human hearts — from transplant patients receiving new hearts or donor hearts unsuitable for transplantation — is a unique aspect of the study.

Dr. Janssen first studied the correlation between heart rate changes and strength and kinetic changes during his doctoral and post-doctoral studies. “It’s one of the most prominent things that goes wrong in heart failure, but it’s drastically under-studied,” he says.

He explains that the vast majority of researchers use mice and rats in their labs, but this particular heart mechanism in humans doesn’t present similarly in mice and rats. He has previously studied rabbits and human myocardium and is excited to be using only human hearts in this current study.

A Close-up Look

To fully understand the force-frequency relationship, Dr. Janssen and his team are studying cardiac myofilaments, the molecular motors of the heart. The proteins myosin and actin within the myofilaments interact to make the heart contract.

When healthy people start exercising, there’s an increase of myofilament phosphorylation—a process in the body where the addition of a phosphate group to a protein typically makes the protein react faster or stronger. For people with heart failure, exercise and exertion are difficult, because their hearts become weaker as the heart beats faster. The heart contraction process becomes irregular. The period of relaxation between heartbeats slows down, and the heart chambers have insufficient time to fill with blood. Dr. Janssen wants to restore the normal relaxation speed and force of the heart muscle.

As he explains in the study abstract, “The kinetics of relaxation are governed by three interdependent processes: intracellular calcium decline, myofilament calcium binding kinetics and cross-bridge cycling kinetics.”  Dr. Janssen wants to first establish the kinetic rates for the three processes that govern relaxation in failing and non-failing human myocardia.

“Once we know more about the pathways, there are current biochemical compounds to modify this kinetic rate by engineering a different myofilament calcium sensitivity in human failing and non-failing myocardia,” he says. “We can directly test engineered TroponinC proteins on both failing and non-failing hearts to assess whether modification of the kinetic rate governing myofilament calcium responsiveness can restore the acceleration of relaxation in failing human myocardia.”

Contributing to the Big Picture

Dr. Janssen says many factors play into the force-frequency relationship. His work with cardiac myofilaments complements his colleagues’ work with ion channels and calcium sensitivity. “If we’re going to cure heart failure with drugs, we’ll have to learn about multiple targets. Each of these approaches is critical in coming together to solve this problem.”

Dr. Janssen says a positive side benefit of the grant is that he can share myocardium tissue with other colleagues at Ohio State to support their studies.

He notes, “This is unique in the U.S. to work with live myocardia at this scale. We are making steady progress and understanding more and more. I’m confident we can make significant contributions and advance treatment strategies to eventually halt or slow the progression of heart failure.” 


Researchers Discover Novel Inherited Arrhythmia

Ohio State Researchers Identify New Gene Variant and Develop Targeted Drug Therapy

A multidisciplinary team of researchers at The Ohio State University Dorothy M. Davis Heart and Lung Research Institute has discovered a novel and deadly form of inherited arrhythmia involving both the atria and the ventricle. The abnormal rhythm is triggered by a genetic variant in a newly discovered form of the dipeptidyl aminopeptidase-like protein-6 (DPP6) gene. The research team of cardiologists, cardiac surgeons, pharmacists, genetic counselors, biomedical engineers and physiologists also developed a personalized treatment strategy for the condition. The team’s findings were published in a recent issue of the Journal of the American Heart Association.

Pinpointing the Gene Variant

Nearly four million Americans have a heart arrhythmia that ranges from bothersome to deadly. The research that led to the identification of this arrhythmia began with a 37-year-old man who had recurrent ventricular fibrillation (VF) who did not respond to standard therapies, including ablation and various medications. During a 16-month period, the research team recorded 168 discharges from the patient’s implantable cardioverter defibrillator for VF. Additionally, the team noted that the man’s mother had died suddenly and prematurely. 

Based on family history and clinical presentation, the man underwent genetic testing for known causes of arrhythmia, but no known genetic variants were identified. That led the team to sequence every protein-coding gene in the patient’s genome, where they found multiple variants. Among them, researchers identified a protein-coding variant in the DPP6 gene. The team determined that the variant alters how heart muscle cells process electrical impulses, causing an abnormal heart rhythm.

“This particular form of arrhythmia involving both the atria and the ventricle is extremely complex,” says Peter Mohler, PhD, director of Ohio State’s Davis Heart and Lung Research Institute (DHLRI). “We are still only beginning to understand how very small differences in a person’s genetic background influence the rhythm of the heart. We hope these initial findings will help us not only address rare inherited forms of disease but also more common forms of irregular heart rhythms observed in millions of people around the world.”

A Successful Treatment Strategy

Once the team had identified the gene variant causing the rhythm problem, they designed a therapeutic strategy using dalfampridine (generally prescribed for multiple sclerosis symptoms) to normalize the cardiac repolarizing current, combined with cilostazol to accelerate the heart rate, since the current is naturally reduced at faster rates.

“While we are still working to understand the complete picture of this disease, this therapy has significantly reduced the patient’s irregular heart rhythms for nearly two years,” says Cynthia Carnes, PharmD, PhD, professor in Ohio State’s College of Pharmacy and arrhythmia researcher at Ohio State’s DHLRI.

The Potential of Genetic Research

“We are excited about these preliminary findings, and we’re now focusing on how other genetic or environmental factors may contribute to the disease,” says Amy Sturm, MS, LGC, certified and licensed genetic counselor at Ohio State Wexner Medical Center and co-first author on the study.

“It’s important to identify others across the globe with this form of arrhythmia to better understand the disease progression, with the ultimate goal of identifying and treating those at risk before arrhythmia occurs,” Sturm continues. “For families with inherited forms of arrhythmias, it is imperative that we identify at-risk individuals so precautionary measures can be put in place to prevent deadly arrhythmias from occurring. Genetic and genomic testing is a very powerful tool to help us do just that,” she adds.

On a broader spectrum, the study illustrates the power of integrating genetic and genomic approaches with clinical and basic/translational research to provide novel insights into human arrhythmia pathophysiology and disease treatment.

This research was supported by grants from the National Institutes of Health, the James S. McDonnell Foundation and the American Heart Association. Additional researchers include: Crystal Kline, PhD; Jerry Curran, PhD; Ahmet Kilic, MD; Robert Higgins, MD; Philip Binkley, MD; Paul Janssen, PhD; Raul Weiss, MD; and Subha Raman, MD, with The Ohio State University Wexner Medical Center; Thomas Hund, PhD, and Patric Glynn, BS, with The Ohio State University Department of Biomedical Engineering; and Steven Fowler, MD, and Silvia Priori, MD, PhD, with New York University Langone Medical Center.


Abnormal Gene Linked to Arrhythmia, Accelerated Heart Failure

Abnormal Gene Linked to Arrhythmia, Accelerated Heart Failure 

Cardiac Researchers Discover Heart Cell Mutation Cardiovascular researchers at The Ohio State University Wexner Medical Center’s Dorothy M. Davis Heart and Lung Research Institute, collaborating with research teams on three continents, recently directed a study that identifies a new class of inherited human gene variants that predispose the heart to potentially life-threatening rhythm disorders and early heart failure. 

“The novel variant, which showed risk for sudden cardiac death, was identified in a relatively young patient in a cardiology clinic,” says Sakima Smith, MD, the Ohio State cardiologist who oversaw the research study. Dr. Smith is a recent recipient of the Harold Amos Award from the Robert Wood Johnson Foundation and is an assistant professor in Ohio State’s  Division of Cardiology/Department of Internal Medicine.

By combining techniques that bridge clinical and basic research programs, the research teams identified that a new class of mutation altered the interaction between two critical proteins (beta-II spectrin and ankyrin-B) that form the architecture of the heart cell membrane. Without this critical architecture, cardiac electrical circuits are damaged, resulting in abnormal heart rhythms and early signs of heart failure.  Essentially, these proteins act as scaffolds to maintain the integrity of cells, and without this interaction, the stability of the cell membrane is lost, which leads to disease. 

“Imagine putting together a tent where you have canvas and poles but nothing to connect the poles together. In this work, we found that ankyrin and spectrin form critical scaffolds in heart cells to support cell structure and to regulate the electrical infrastructure. When they are absent or are not properly integrated, this infrastructure is altered, resulting in disease,” notes Dr. Smith. 

“With these data, we’ve defined a new molecular pathway that can lead to acquired and inherited arrhythmia and heart failure, and this has spurred a new area of investigation in our lab,” Dr. Smith continues.

An article appeared this spring in the top American Heart Association journal Circulation, titled “Dysfunction in the Beta-II Spectrin-Dependent Cytoskeleton Underlies Human Arrhythmia.” The study received funding from the National Institutes of Health and the American Heart Association.

Revelations in the Lab

The research team used an animal model to mimic what the patient with an abnormal heart rhythm was experiencing. Experimental mice lacked beta-II spectrin in the heart and survived to adulthood.

“We wanted to validate and test the role of beta-II spectrin to see what happens in a normal cell versus when beta-II-spectrin is absent,” Dr. Smith says.

“We found that without beta-II spectrin in the heart, the mice in the study developed early signs of heart failure and developed severe arrhythmias.”

The medical community is aware of beta-II spectrin in the red blood cells, brain and kidneys, but there has been limited data on how lack of this protein in the heart would affect heart rhythm. 

“Our data suggest a prominent role for beta-II spectrin in the heart. With these novel data, we’ve highlighted the importance of the cytoskeleton in cardiovascular disease processes,” Dr. Smith says.

He and his research team want to understand further the protein’s role in heart failure, arrhythmias, possible links to heart transplant rejection and recovery after mechanical ventricular support.

Importance of Translational Research

 Smith notes how challenging it is to treat symptoms of a disease that hasn’t yet been identified. He believes genetic testing and DNA sequencing can continue to decode the genome and unlock abnormalities.

“A patient with a novel variant spurred this research. Without the patient, we wouldn’t have had the opportunity to define these very basic cellular pathways that are clearly fundamental to life,” he says in support of the importance of translational research.

Research Continues

“While our findings have impact on our understanding of human cardiovascular disease, we hope that this work may impact the understanding of other forms of ‘excitable’ cell disease where spectrin and ankyrin proteins also serve critical functions,” Smith notes.

“None of these findings could have occurred without the creativity of teams of dedicated researchers, physicians and genetic counselors at multiple institutions. It is impressive how quickly science can move forward when research programs work together.”

Participating institutions included:

  • The Ohio State University
  • The Ohio State University Wexner Medical Center
  • The Ohio State University College of Pharmacy
  • The Ohio State University College of Engineering
  • Indiana University School of Medicine
  • Baylor College of Medicine
  • University Duisburg-Essen, Germany
  • South University of Science and Technology of China 

Ohio State Hosts National Institutes of Health Regional Innovation Conference

Ohio State’s Heart and Vascular Center is leading efforts to translate research findings to the clinic. Specifically, this spring Ohio State’s Davis Heart and Lung Research Institute hosted the Sixth National Heart, Lung, and Blood Institute (NHLBI) Regional Innovation Conference. More than 300 people attended, where they had the opportunity to connect with NIH-funded companies developing innovative products, learn about early-stage financing from a panel of industry leaders and investors and network with a variety of companies and business leaders.

NHLBI presents these conferences to connect small businesses, angel investors, venture capitalists, strategic partners and business leaders from the biotech, medical device and pharmaceutical industries. Attendees saw featured presentations from NHLBI-funded companies, learned from staff about recent changes in the Federal SBIR/STTR program, and other funding opportunities and cost-free resources available to small businesses.

The Columbus conference included 19 poster presentations and 10 podium presentations in which showcase companies were presented to conference attendees. At the meeting’s close, more than 50 meetings were scheduled with investors, partners and SBIR companies as a result of the Innovation Conference. Over the past four years, Heart and Vascular Center investigators have started multiple companies through Ohio State to push new discoveries. 


CMR Research Advances Detection of Myocardial Inflammation

Cardiovascular Magnetic Resonance (CMR) Pinpoints Inflammation Related to Sarcoidosis and Sepsis

Results of the Ohio State-based studies recently were published in the American Journal of Respiratory and Critical Care Medicine. Two cardiovascular imaging research studies recently completed at Ohio State are helping physicians more accurately diagnose and treat myocardial inflammation in patients with sepsis and sarcoidosis.

Co-principal investigators of the Ohio State-based studies Subha Raman, MD, Ohio State's cardiovascular magnetic resonance medical director, and Elliott Crouser, MD, one of the directors of critical care and the director of the sarcoidosis program at Ohio State, are confident their findings can improve patient outcomes by helping with individual risk stratification and guiding larger studies targeting myocardial inflammation in at-risk patients.

Nonischemic Myocardial Changes Detected by Cardiac Magnetic Resonance in Critical Care Patients with Sepsis

Troponin, a nonspecific serum biomarker for cardiac injury, often is elevated in patients with sepsis, raising suspicion for acute coronary syndrome. For many years, physicians have noted that patients with sepsis have a higher mortality rate if troponin is elevated, as compared with septic patients who don't have an elevated level. Muscle damage was often ascribed to ischemia, prompting treatment with blood thinners and cholesterol-lowering medications, or consideration of heart catheterizations to look for damage-causing coronary artery disease.

Through use of non-contrast cardiac magnetic resonance imaging (CMR), investigators at Ohio State have found that elevated troponin levels in patients with sepsis correspond to an inflammatory pattern of heart muscle injury, with preferential involvement of the subepicardium, rather than myocardial infarction that injures the subendocardium.

With an accurate diagnosis of myocardial inflammation, physicians can consider more tailored treatment options, including avoidance of unnecessary and potentially harmful treatments.

CMR may be helpful in patients with sepsis and elevated troponin level where the cause is uncertain.

Ohio State investigators predict that this study will prompt larger-scale clinical trials to target inflammatory myocardial injury in patients with sepsis and troponin elevation.

Improved Detection of Cardiac Sarcoidosis Using Magnetic Resonance with Myocardial T2 Mapping

Sarcoidosis is a multi-system, granulomatous disease of unknown cause that most commonly affects young adults, particularly black females. Recent studies indicate that sarcoidosis-related mortality is on the rise, perhaps relating to improved disease detection. Cardiac complications are the second leading cause of sarcoidosis-related death, and young adults particularly are at risk.

Cardiac sarcoidosis (CS) is commonly missed during routine clinical screening, including history, exam and electrocardiography (ECG). Most cases are detected for the first time during autopsy.

Cardiac magnetic resonance (CMR) with late gadolinium enhancement (LGE) is emerging as the preferred diagnostic modality. This may be insufficient, however, as LGE does not detect active and potentially reversible disease.

Through a retrospective study of 50 patients with histologically-proven sarcoidosis, Ohio State investigators have shown that more refined CMR-based myocardial characterization improves the detection of active myocarditis compared with LGE alone.

Given that active CS is an inflammatory condition, Ohio State researchers hypothesized that this approach demonstrates quantitative abnormalities in the myocardium of patients with sarcoidosis compared with controls, and myocardial T2 provides complementary myocardial characterization relative to LGE; these together likely form the myocardial substrate for conduction system disease and cardiac arrhythmias.

Ohio State researchers recommend CMR for patients with sarcoidosis who also have ECG abnormalities, palpitations, unexplained shortness of breath or chest pain.

CMR detection of cardiac sarcoidosis holds promise in preventing deadly – and largely under-recognized – complications of the heart by enabling earlier treatment with drugs such as immunosuppressives and steroids.

Dr. Crouser has received funding to expand sarcoidosis research to multiple centers. The investigators hope further implementation of their findings around the country and the world will reduce morbidity and mortality in cardiac disease.

Increasing Donor Lung Supply

Ex-Vivo Lung Perfusion Looks Promising in Clinical Trials

Ohio State’s Comprehensive Transplant Center is the first in Ohio and among only a handful nationwide to test a novel method that could potentially double the number of available lungs for transplantation and save more of the 35 million Americans suffering from chronic lung disease.

Ohio State is one of 17 institutions across the country certified to evaluate the safety and effectiveness of Ex-Vivo Lung Perfusion (EVLP) through participation in the NOVEL extension clinical trial.

“Expanding the number of lifesaving and life-enhancing lung transplants is limited by the number of available donors and the quality of the donated organs. Having the ability to more adequately evaluate potential donor organs and to even repair or resuscitate them is a game changer for lung transplantation,” says Bryan Whitson, MD, PhD, principal investigator and director of the lung transplant program at Ohio State’s Wexner Medical Center.

EVLP treatment assesses the viability of donated lungs for transplantation to expand the donor lung pool, improve the function of donated lungs that might otherwise be considered unsuitable for transplantation and decrease inflammation and rejection for the lung transplant patient. 

“In addition to being able to rescue lungs not traditionally transplantable, EVLP provides us with an opportunity to begin to more actively and routinely repair donated organs in the next couple of years,” Dr. Whitson says.

Once donated lungs are acquired from a deceased organ donor, the EVLP process begins with placing donated lungs inside a sterile plastic incubator-like dome and attaching them to a circuit, which includes a ventilator, perfusion pump and filters. The lungs are maintained or supported on the circuit at normal body temperature and perfused with a bloodless solution containing nutrients, antibiotics and oxygen, which can repair injured lungs and remove excess water. During the three-to-six-hour perfusion process, lung function is consistently monitored against key indicators, such as oxygen exchange, airway pressure and lung compliance. If lungs are deemed suitable after EVLP treatment, they are immediately transplanted into a patient awaiting a lung transplant.

“If all goes well, our hope is to ultimately increase recovery of suitable lungs enough to where we could essentially take all those anxiously awaiting a lifesaving lung transplant off the waiting list,” Dr. Whitson says. 

Each year, less than 2,000 lung transplants are performed in the U.S., as lungs are the most fragile organs to transplant and fewer than 30 percent of all donor lungs meet the criteria for transplantation.

As central Ohio’s only adult transplant center and one of the country’s largest transplant programs, Ohio State’s Comprehensive Transplant Center has performed more than 8,500 lifesaving transplants in almost 50 years. Transplants include lung, heart, heart-lung, kidney, living donor kidney, liver, pancreas and kidney-pancreas. 


New Clinical Trial Explores Transcatheter Aortic Valve Replacement (TAVR) in Low-Risk Patients

TAVR Study at Ohio State Offers Non-Surgical Option for Severe Aortic Stenosis

Patient enrollment has begun for a new clinical trial at Ohio State to test outcomes for transcatheter aortic valve replacement (TAVR) versus surgical aortic valve replacement.

The Ohio State Richard M. Ross Heart Hospital was the first site in central Ohio to implant the CoreValve® Evolut® R Transcatheter Aortic Valve Replacement (TAVR) System in patients with severe aortic stenosis who are at low risk for surgical aortic valve replacement. The trial will evaluate the safety and efficacy of the Medtronic TAVR System for patients at low risk.

“This is a large step forward in cardiac surgery,” says Juan Crestanello, MD, director, Division of Cardiac Surgery and principal investigator for the trial. “It’s the next frontier to treat patients with valve diseases in a less invasive way. This likely will change the way we do valve surgery forever.”

Who is a Candidate for Low-Risk TAVR?

At Ohio State, we are enrolling patients of all ages who have severe symptomatic and asymptomatic aortic stenosis. They must be determined “low risk” during our evaluation, with a predicted risk of mortality with surgical AVR less than 3 percent at 30 days post-procedure.

Low-surgical-risk patients make up about 60 percent of people with severe aortic stenosis. In this randomized trial, a patient will be assigned either to receive surgical aortic valve replacement or TAVR. About 60 centers across the world are conducting the TAVR trial for low-risk patients.

Potential Benefits of TAVR

“With the incorporation of this trial, all patients with aortic stenosis regardless of age and risk category can be considered for transcatheter aortic valve replacement at OSU,” Dr. Crestanello says.

Since 2010, Ohio State and other medical centers around the country have been testing the effectiveness of the procedure, first on patients at high surgical risk and, more recently, in an intermediate-risk group. These previous randomized trials have shown TAVR to be equal to or superior in outcomes when compared with surgery. The outcomes measured are all-cause mortality or disabling stroke by one year after the valve procedure. Results thus far have shown advantages for patients receiving TAVR rather than surgery. These include:

  • Shorter length of stay, with hospital discharge two to three days after the procedure
  • Less blood loss and fewer complications from the procedure, including fewer incidents of atrial fibrillation
  • Shorter recovery time, with ability to resume normal activities within a couple of weeks

The Procedure

At Ohio State, a cardiothoracic surgeon and cardiologist generally perform the procedure in a catheterization lab with the patient under general anesthesia. Conscious sedation is also an option in select circumstances. During the TAVR procedure, the surgeon makes a 5mm incision in the groin, and a catheter is placed into the femoral artery and guided through the heart to the aortic valve. A balloon on the end of the catheter is inflated to stretch the valve open. A new, self-expanding valve is then guided over the catheter to replace the old aortic valve. The procedure typically takes 60 to 90 minutes. In rare cases, arteries in the legs may have severe blockages that prevent catheter access. For these patients, we can insert the catheter through the chest and into the aorta.

Ohio State’s Structural Heart Disease Team

Our weekly Valve Clinic evaluates a patient all in one day, bringing together the expertise of cardiac surgeons, cardiologists and interventional cardiologists for examination and consultation. Our physicians may order a CT scan to study the size of the aorta and groin arteries or conduct other tests to determine surgical risk. Our goal is to serve patients with timely, patient-centered care. The Structural Heart Disease Team includes five cardiac surgeons and five interventional cardiologists, along with cardiologists, nurse practitioners, a research coordinator and research nurses. At weekly multidisciplinary conferences, the team discusses the best way to approach individual patient cases.

“We have an expert team with a lot of experience and very good results,” Dr. Crestanello says. The team’s goal is to accomplish the entire process — from evaluation through treatment —within a month. Ohio State’s physicians maintain close communication with referring physicians and follow up with patients post-procedure at six months, one year and annually for five years.

Call to learn more or to refer a patient: 614-366-0586.

 


Increasing Donor Lung Supply

Ex-Vivo Lung Perfusion Looks Promising in Clinical Trials

Ohio State’s Comprehensive Transplant Center is the first in Ohio and among only a handful nationwide to test a novel method that could potentially double the number of available lungs for transplantation and save more of the 35 million Americans suffering from chronic lung disease. Ohio State is one of 17 institutions across the country certified to evaluate the safety and effectiveness of Ex-Vivo Lung Perfusion (EVLP) through participation in the NOVEL extension clinical trial.

“Expanding the number of lifesaving and life-enhancing lung transplants is limited by the number of available donors and the quality of the donated organs. Having the ability to more adequately evaluate potential donor organs and to even repair or resuscitate them is a game changer for lung transplantation,” says Bryan Whitson, MD, PhD, principal investigator and director of the lung transplant program at Ohio State’s Wexner Medical Center.

EVLP treatment assesses the viability of donated lungs for transplantation to expand the donor lung pool, improve the function of donated lungs that might otherwise be considered unsuitable for transplantation and decrease inflammation and rejection for the lung transplant patient. 

“In addition to being able to rescue lungs not traditionally transplantable, EVLP provides us with an opportunity to begin to more actively and routinely repair donated organs in the next couple of years,” Dr. Whitson says.

Once donated lungs are acquired from a deceased organ donor, the EVLP process begins with placing donated lungs inside a sterile plastic incubator-like dome and attaching them to a circuit, which includes a ventilator, perfusion pump and filters. The lungs are maintained or supported on the circuit at normal body temperature and perfused with a bloodless solution containing nutrients, antibiotics and oxygen, which can repair injured lungs and remove excess water.

During the three-to-six-hour perfusion process, lung function is consistently monitored against key indicators, such as oxygen exchange, airway pressure and lung compliance. If lungs are deemed suitable after EVLP treatment, they are immediately transplanted into a patient awaiting a lung transplant.

“If all goes well, our hope is to ultimately increase recovery of suitable lungs enough to where we could essentially take all those anxiously awaiting a lifesaving lung transplant off the waiting list,” Dr. Whitson says.

Each year, less than 2,000 lung transplants are performed in the U.S., as lungs are the most fragile organs to transplant and fewer than 30 percent of all donor lungs meet the criteria for transplantation.

As central Ohio’s only adult transplant center and one of the country’s largest transplant programs, Ohio State’s Comprehensive Transplant Center has performed more than 8,500 lifesaving transplants in almost 50 years. Transplants include lung, heart, heart-lung, kidney, living donor kidney, liver, pancreas and kidney-pancreas. 


Research Seeks Underlying Cause of Heart Failure

NIH-Funded Study Focuses on Heart Muscle’s Force-Frequency Relationship

Since 2009, Ohio State researcher Paul Janssen, PhD, has been studying the relationship between the frequency of heartbeats in the human heart and the force with which the heart muscle contracts. In a healthy human heart, an increase in heart rate results in an increase in the force of contractions (positive force-frequency relationship, or FFR), and an acceleration of contractile kinetics (frequency-dependent acceleration of relaxation, or FDAR).

In human heart failure, the FFR flattens or even becomes negative, while FDAR greatly diminishes. These two phenomena are classic hallmarks of heart failure. Dr. Janssen recently received a sixth National Institutes of Health grant to continue his study of cardiac myofilaments that influence the force-frequency relationship. In previous studies, Dr. Janssen and his team have worked with more than 100 hearts and delivered nearly 20 scientific papers on their findings.

With this new four-year grant project, titled “Frequency-Dependent Modulation of Cardiac Myofilament Function in Health/Disease,” Dr. Janssen’s team proposes to assess the contraction force and speed of healthy and end-stage failing human hearts, and investigate and quantify in depth the processes that contribute to regulating contractile kinetics. They will then investigate whether an engineered protein, with a directed mutation in calcium binding properties, can improve contraction and relaxation in a failing human heart.

“We believe this process is central to understanding heart disease and crucial to the solution of heart failure, which affects millions of people,” he says. The exclusive use of explanted human hearts — from transplant patients receiving new hearts or donor hearts unsuitable for transplantation — is a unique aspect of the study.

Dr. Janssen first studied the correlation between heart rate changes and strength and kinetic changes during his doctoral and post-doctoral studies. “It’s one of the most prominent things that goes wrong in heart failure, but it’s drastically under-studied,” he says.

He explains that the vast majority of researchers use mice and rats in their labs, but this particular heart mechanism in humans doesn’t present similarly in mice and rats. He has previously studied rabbits and human myocardium and is excited to be using only human hearts in this current study.

A Close-up Look

To fully understand the force-frequency relationship, Dr. Janssen and his team are studying cardiac myofilaments, the molecular motors of the heart. The proteins myosin and actin within the myofilaments interact to make the heart contract.

When healthy people start exercising, there’s an increase of myofilament phosphorylation—a process in the body where the addition of a phosphate group to a protein typically makes the protein react faster or stronger. For people with heart failure, exercise and exertion are difficult, because their hearts become weaker as the heart beats faster. The heart contraction process becomes irregular. The period of relaxation between heartbeats slows down, and the heart chambers have insufficient time to fill with blood. Dr. Janssen wants to restore the normal relaxation speed and force of the heart muscle.

As he explains in the study abstract, “The kinetics of relaxation are governed by three interdependent processes: intracellular calcium decline, myofilament calcium binding kinetics and cross-bridge cycling kinetics.”  Dr. Janssen wants to first establish the kinetic rates for the three processes that govern relaxation in failing and non-failing human myocardia.

“Once we know more about the pathways, there are current biochemical compounds to modify this kinetic rate by engineering a different myofilament calcium sensitivity in human failing and non-failing myocardia,” he says. “We can directly test engineered TroponinC proteins on both failing and non-failing hearts to assess whether modification of the kinetic rate governing myofilament calcium responsiveness can restore the acceleration of relaxation in failing human myocardia.”

Contributing to the Big Picture

Dr. Janssen says many factors play into the force-frequency relationship. His work with cardiac myofilaments complements his colleagues’ work with ion channels and calcium sensitivity. “If we’re going to cure heart failure with drugs, we’ll have to learn about multiple targets. Each of these approaches is critical in coming together to solve this problem.”

Dr. Janssen says a positive side benefit of the grant is that he can share myocardium tissue with other colleagues at Ohio State to support their studies.

He notes, “This is unique in the U.S. to work with live myocardia at this scale. We are making steady progress and understanding more and more. I’m confident we can make significant contributions and advance treatment strategies to eventually halt or slow the progression of heart failure.”

For more information about cardiac myofilament research at Ohio State, contact Dr. Janssen at janssen.10@osu.edu.

Going Beyond Mice and Molecules

Going ‘‘Beyond Mice and Molecules’’ to Human Heart Disease

Cynthia James, PharmD, PhD; Vadin Federov, PhD; Peter Mohler,PhDThe National Institutes of Health recently awarded a more than $1.5 million grant to a team from The Ohio State University Dorothy M. Davis Heart and Lung Research Institute. Three Ohio State faculty members – Cynthia A. Carnes, PharmD, PhD, Vadim V. Fedorov, PhD, and Peter Mohler, PhD, (pictured) – serve as the team of co-principal investigators. Equipped with ground-breaking technological capabilities developed by Dr. Fedorov, pre-clinical techniques enabled by Dr. Carnes, and molecular approaches facilitated with Dr. Mohler, the work will address human sinus node disease, a problem found in the pacemaker of the heart known as the sinoatrial node (SAN). Sinus node disease causes arrhythmias and is a precursor for atrial fibrillation (AF), a condition that currently afflicts over 2.2 million Americans. AF is an area of clinical strength for The Ohio State University Heart and Vascular Center. Ohio State is a national leader in terms of procedural volume in cardiac electrophysiology.

The study’s goal is to find improved therapeutic remedies to the electronic pacemaker, a device that has long been implanted in the heart to mitigate sinus node disease and is the current accepted standard of care.

The Team

The team of Drs. Carnes, Fedorov and Mohler represents a collaboration between Ohio State’s College of Medicine and College of Pharmacy. Dr. Carnes is associate dean for Graduate Studies and Research in the College of Pharmacy. Dr. Mohler is a cardiovascular scientist who serves as director of Ohio State’s Dorothy M. Davis Heart and Lung Research Institute. Dr. Fedorov, who was educated in Moscow, Russia, in physiology, is an assistant professor in Ohio State’s Department of Physiology and Cell Biology. Finally, a critical component of the team is the contribution of dedicated physician-scientists in the Department of Surgery at The Ohio State University Wexner Medical Center, led by Robert Higgins, MD.

Dr. Carnes originally came to Ohio State in the early 1990s to learn more about treating arrhythmias with a fellowship in Cardiovascular Pharmacotherapy. She met Dr. Fedorov at a conference in Washington and the two researchers discovered a mutual interest in sinus node disease. It was a stroke of good fortune a few years ago when Dr. Fedorov arrived at Ohio State. Dr. Carnes says, “Vadim has world-class capabilities when it comes to studying the sinoatrial node, and this dovetails perfectly with my interest in arrhythmias and heart failure.”

Dr. Mohler is director of Ohio State’s Davis Heart and Lung Research Institute where he oversees a group of more than 600 faculty, staff and trainees in eight different colleges. His team is working to understand the mechanisms and treatments for diseases ranging from heart failure, arrhythmia and sudden cardiac death, to pulmonary and cystic fibrosis, diabetes and kidney disease.

The Misson

In the simplest terms, Drs. Carnes, Fedorov and Mohler aspire to fix damaged human hearts. The mission is two-fold. First, they want to better understand how human sinoatrial node pacemakers dysfunction and how that dysfunction leads to atrial fibrillation (AF). Second, they hope to repair SAN dysfunction in patients with either congenital or acquired sinus node disease.

“The lack of understanding of the human pacemaker system, the sinoatrial node, and its complexity remains a critical barrier to the treatment of heart rhythm disorders. Implanting an electronic pacemaker is the default remedy, but really it is a crutch,” says Dr. Fedorov. “Electronic pacemakers beat steadily at one rate. In contrast, the SAN is the internal pacemaker of the heart, so it knows when to beat faster – for example, during exercise – and when to beat slower – during sleep or rest. With this grant, we seek to restore and heal the SAN rather than rely on pacemakers as the only remedy.”

The trio begins with a hypothesis that SAN dysfunction may result from an increased sensitivity to adenosine, a metabolite of the heart that lowers heart rate and thus conductivity. The first priority of the team’s work focuses on blocking the adenosine receptor to test the hypothesis that heart failure results from adenosine-dependent signaling in the SAN.

With Dr. Fedorov’s 3D, high-resolution, near-infrared optical mapping capabilities, he can examine the SAN internally and from all angles. “Seeing the human heart through the eyes of 3D optical fluorescence mapping allows for a broad range of exciting and novel research opportunities,” says Dr. Fedorov.

The Breakthrough

“The work we are doing is truly translational medicine. We are now able to study damaged human hearts, which is something that was just a dream five years ago. Few researchers have ever done this to study sinus node disease – we are going beyond simply mice and molecules to human disease,” says Dr. Mohler.

The team’s ability to use state-of-the-art imaging technology to study a failed heart is what makes this a rare and valuable study. All three investigators cite this development as amazing progress, and they hope and believe it is just the beginning.

The Present and Future

The consensus among the team is that at least another two years of research is needed before they can begin to work on healing the SAN. They first must determine why it is not functioning correctly. At that point, Dr. Carnes believes that drug treatments may be effective. Dr. Fedorov agrees and adds that localized stem cell repairs may also be a viable treatment. Dr. Fedorov sees the work accomplished over the next three and a half years as a cornerstone of innovation.

“The work in this proposal should provide a blueprint for SAN dysfunction. It should also provide a foundation for developing highly targeted and rational treatments for human arrhythmias originating in the SAN pacemaker complex. Future work might then focus on other signaling pathways or pharmacologic treatments or stem cell delivery to modulate SAN function,” says Dr. Federov.

Dr. Carnes believes the future is bright because of the collaborative nature of this project, which is reflective of the collegial spirit endemic to the entire Ohio State community. Having spent nearly three decades at Ohio State, she attests, “We have built a first-class operation with bench-to-bedside research in arrhythmias. Teamwork is integral to everything we do. Working with Drs. Mohler and Fedorov on this project is a great example of that.”

World’s Smallest Pacemaker Being Tested at Ohio State

Wireless Micra device recently implanted in Columbus woman

A tiny pacemaker about the size of a large vitamin pill is being tested in people with bradycardia at The Ohio State University Wexner Medical Center.

The Micra Transcatheter Pacing System is the smallest pacemaker available. Unlike conventional pacemakers that require implantation through a chest incision, this wireless device is threaded to the heart via a catheter through the femoral artery then attached directly to the heart muscle. It turns on only when the heart stops and can last up to 14 years.

Doctors at Ohio State’s Richard M. Ross Heart Hospital recently implanted the mini pacemaker in a Columbus woman as part of a global clinical trial to test its safety and effectiveness.  

“With this investigational device, the battery, the pacing electrodes, everything is in a little piece of metal sitting inside the heart. We believe that will eliminate a lot of risk for infection and complications,” says John Hummel, MD, a cardiologist and principal investigator of the trial at Ohio State.

Ralph Augostini, MD, also a cardiologist at Ohio State, says, “I think this could be a significant development in pacing procedures. This could cut our procedure time by more than half.”

For now, the tiny pacemaker is being tested in people with bradycardia who need single chamber ventricular pacing.

A former librarian, 77-year-old Mary Lou Trejo of Columbus had been suffering from atrial fibrillation for years. Her heart had slowed, despite medication and other treatments to restore rhythm, so she was eager to be among the first in the United States to participate in this clinical trial.

“The new pacemaker sounded so simple, and I have always thought research is important, so I thought this is a way I could contribute,” Trejo says.

The trial will enroll 780 patients in 50 centers worldwide. Investigators are expected to report initial results later this year, once the first 60 patients have been followed for three months.

The Micra Transcatheter Pacing System is made by Medtronic, which is funding the clinical trial. Dr. Hummel is a consultant for Medtronic. Dr. Augostini serves on a Medtronic advisory board. 

About Ohio State’s Electrophysiology Services

Ohio State’s integrated electrophysiology laboratory facility has six procedure rooms and 25 recovery rooms. We have central Ohio’s largest electrophysiology staff, with subspecialty electrophysiologists who provide focused care for a better patient experience and significantly improved outcomes.

For arrhythmia management, we have a dedicated 30-bed inpatient unit in the Richard M. Ross Heart Hospital.

Make a Referral

For a referral or more information, call 1-877-293-7677 (ROSS).  


Health Care Insight

View our insights on the landscape of heart care, cardiovascular physicians and improving the health of the patients we serve.

Conquering Cardiovascular Disease on New Fronts

Health Care Insight from Our Director

We may be winning the war against the world’s number one killer.

A recent study from Europe showed a substantial decline in death rates from cardiovascular disease in most European countries over the past 30 years. This gratifying trend seems to hold true for most countries and age groups, though not all. Similar success has been reported on this side of the Atlantic.

As clinicians, this good news raises two burning questions: Will the trend continue? What more can be done?

Have We Reached The Point of Diminishing Returns?

The credit for these favorable trends over the past half century goes to the decreasing rate at which healthy individuals develop heart disease, largely due to decreased tobacco use, as well as improvements in treating heart disease once it exists. The evidence supports both.

Certainly, early detection and better treatment options have contributed to improved outcomes and longer lives. Bypass surgery, statins, stents, pacemakers, defibrillators and beta blockers are all examples of life-prolonging therapies.

But can the rate of improvement using these methods continue, or will we reach a point of diminishing returns? Some would argue we’re already there. We spend more money than ever before for each incremental improvement. Much of this cost is incurred for advanced disease during the final months or years of life.

Turning Attention to a Different Battlefront

How do we sustain the successes of the past and continue to win the war? The answer is both painfully obvious and exceedingly difficult – prevention.

We cannot afford to continue spending money on the treatment of cardiovascular diseases at the current rate. It’s not cost-effective and our economy can’t sustain it.

We will always need to provide high quality treatment for heart disease, but the focus needs to shift. We must begin to take prevention more seriously. We must learn to do it better; we must invest in it, and we must commit to it.

To this end, Ohio State’s Heart and Vascular Center has started a Wellness Series. This ongoing series of events and initiatives is designed to help our communities get healthy and stay healthy and includes fitness programs, educational events, cooking classes, risk factor screenings and athletic events.

This past summer, we sponsoreda very successful triathlon here in Columbus with more than 600 hundred healthy participants, including many who were participating in their very first triathlon ever – a great testament to such events’ ability to engage beginners on the path to wellness.

We are committed to pursuing prevention for the long-term. We understand that collaboration is critical for success, and we have teamed up with several key groups for the wellness initiatives, including the city of Columbus, Columbus Parks and Recreation, Ohio State’s Athletic Department, the Ohio State University College of Nursing, Sports Medicine, as well as our own Women’s Heart and Prevention Programs.

We are confident that we can make a difference and continue gaining victories over heart disease. What ideas do you have for prevention? I welcome your thoughts and would like to hear what’s working in your community. Please feel free to reach out to me at heartcenter@osumc.edu.

Growing the Health of Our Community

In July, Ohio State's Ross Heart Hospital kicked off its second annual TriFitChallenge Triathlon, growing the event to more than 1,000 participants and marking our triathlon as the largest in central Ohio. The chance to finish on the turf of historic Ohio Stadium, home to The Ohio State University football Buckeyes was a draw to be sure. But what really drove our participants, many of whom were beginner athletes, was the chance to improve their heart health while raising funds for heart and vascular research at Ohio State's Heart and Vascular Center.

The TriFitChallenge triathlon is the signature event of the Ross Heart Hospital Wellness Series. The Series was developed to give our community access to a variety of heart healthy activities to improve the overall health of our community.

"It's not just a nice thing to do…," says Tom Ryan, MD, Director of Ohio State's Heart and Vascular Center, "…it's the right thing to do. As an academic Medical Center, we have both the privilege and the responsibility to improve the health of our community. We developed the Ross Heart Hospital Wellness Series with that goal in mind – to create opportunities for everyone to make a change that will improve their health and his or her life."

The Series spans all forms of wellness from physical activity to nutrition and education. All funds raised through registrations to Series events are used to support cardiovascular research at Ohio State's Davis Heart and Lung Research Institute.

Now in its second year, the Series has evolved to include several beginner fitness events, including run/walk 5Ks and the "mini" distances of the TriFitChallenge Triathlon. This allows people who are just starting on the path to physical fitness the chance to participate in fun, heart healthy activities that keep them motivated to stay fit.

In addition to fitness events, educational events have been added to the Series, including hands-only CPR training events at a popular outdoor shopping center, heart healthy cooking demonstrations at area farmer's markets and a series of evening heart health education events paired with wine and appetizers at upscale area restaurants.

The TriFitChallenge triathlon remains the cornerstone event of the Series, doubling its size in just one year and providing everyone from seasoned triathletes to beginners the chance to participate in a beautifully designed course spanning many of Ohio State's campus area landmarks.

"It's been a remarkable event for its ability to motivate and inspire people," says Dr. Ryan. "I am encouraged by the number of participants who are truly making a lifestyle change. That's exactly why we designed the Ross Wellness Series and it's rewarding to see it making an impact on people in our community."

To learn more about Ohio State's Ross Heart Hospital Wellness Series, visit rosswellnessseries.org.

Still a Role for the Doctor

Insight for Cardiovascular Physicians from our Director 

A few years ago, a computer named Watson faced off against some very smart humans on the TV game show Jeopardy! and won. I subsequently read that Watson was being programmed to function like a physician – taking in complex clinical information in order to render a diagnosis. I don't know how successful that experiment has been, but it is very clear that technology is having an impact and is changing the way we interact with patients.

The most pervasive example? The answer to almost every question is available, within seconds, to anyone with a smart phone. So why should we as clinicians spend time memorizing facts when they are now so readily accessible? There are arguments to be made on both sides for how much of their ‘memory bank' physicians should spend on data and facts that can now be found at the touch a finger.

Looking deeper into the debate though, it becomes clear that making an accurate diagnosis or a correct treatment decision still requires much more than access to information. Integrating data, using clinical judgment, and acting in the best interest of the patient are not yet things that we can "Google." It seems there is still a role for the doctor.

Technology has provided us with capabilities not previously possible. I was reminded of this last week while rounding on one of our teaching services. Stopping outside a patient room with a laptop computer and a tech-savvy intern, it seemed we could learn everything we needed to take care of the patient without even entering the room.

In this case, the data seemed to assure us that all was well – from vital signs to labs to test results – everything was normal. But after just five minutes of talking with the patient, it was evident that the symptoms were real and a problem existed. We were quickly able to develop a plan, communicate it to the patient and family, and assure them that the problem could and would be dealt with – no Google in sight.

The lesson, I pointed out, was a simple one. When it comes to patient care, talking to and examining the patient are still the most important things that we do. Technology will continue to have a profound impact on health care. It provides us with accurate, timely, and convenient access to information, but it does not replace the compassion and intimacy of the doctor-patient relationship. Perhaps that is one of the important lessons we can still teach the new generation of health care providers – the value of personal interaction between the doctor and patient. And it might just be the best way to avoid being replaced by a computer.

Specialty Programs

Targeted, advanced care from specialized teams of experts at Ohio State's Heart and Vascular Center.

Improving Quality of Life for Advanced Heart Failure Patients

 As central Ohio’s largest heart failure program, Ohio State treats more than 2,000 patients and offers all treatments available, even for patients who have exhausted all other options.

“Most of the patients we see have advanced heart failure with persistent symptoms despite standard medical and device therapy,” says Garrie Haas, MD, director of Ohio State’s Heart Failure and Transplant Program. For those with severe heart failure, Ohio State performs implantation and follow-up care with total artificial heart pumps, ventricular assist devices (VADs) and heart transplantation.

With more than 400 heart transplants in over three decades, Ohio State remains central Ohio’s only adult heart transplant program. The transplant team performed 28 procedures last year with survival rates above the national average. The program continues to grow. Ohio State’s large and successful cardiac mechanical support program offers every available device option for patients who require advanced support for the heart. VADs are both a destination therapy and an important bridge to transplant, as they help sustain patients who are awaiting a heart donor.

Heart Failure Disease Clinic

Heart failure specialists and nurse practitioners work in collaboration with nurses, pharmacists, social workers and dietitians — all specialists in heart failure treatment — to provide both routine and acute care at Ohio State’s Heart Failure Disease Clinic. Care plans are tailored to the individual, including ongoing management of transplant patients.

“Our goal is to find out what works for each person and provide excellent, patient-focused care,” Dr. Haas states.

Treatment Options for Advanced Heart Failure

Ohio State’s advanced heart failure team works to exhaust noninvasive treatments before considering advanced therapies. If medication optimization, lifestyle changes and sleep apnea evaluation don’t yield satisfactory results, they evaluate for possible arrhythmias, and consider defibrillators, cardiac resynchronization and right heart catheterization to assess hemodynamics or candidacy for advanced therapies.

When appropriate, Ohio State’s heart failure specialists offer both inpatient and outpatient ultrafiltration for patients not responding to diuretics. Sometimes, high-risk surgeries and percutaneous interventions can improve low ejection fraction, coronary artery disease or structural heart disease. If these measures fail, the heart failure team considers VADs or heart transplant.

“We want to see people as early as possible in the disease process to provide optimal outcomes,” Dr. Haas says. “In the majority of cases, we can help improve the quality of life.”

Even if a patient is not ready for transplant, keeping the window of opportunity open for transplant is helpful. Ohio State’s specialists can work with referring physicians to plan for the possibility, mapping out a timeline and steps to ensure a patient’s health for transplant.

Clinical Research

“In addition to providing the full spectrum of standard heart failure management, our program offers participation in a variety of clinical trials investigating novel drug and device therapies,” Dr. Haas says.

Ohio State’s researchers work diligently, often in collaboration with other disciplines, to improve treatment options. This includes new methods to increase the length of time a heart remains viable for transplantation. A new clinical trial is testing a device that removes excess fluid from hospitalized congestive heart failure patients. The WhiteSwell System, developed by study sponsor WhiteSwell Medical, includes a catheter inserted into the neck to improve the flow and drainage of fluid from the lymphatic system and a machine at the bedside that helps circulate blood.

A leader in another national study, Ohio State was first in the nation to implant the CardioMems wireless hemodynamic heart failure monitor in a patient, following Food and Drug Administration approval. The device is implanted in the pulmonary artery using a simple, catheter-based procedure. It takes real-time measurements of pulmonary artery pressure and transmits them to a secure website where cardiologists can review the data and make adjustments to medication, if needed.

Cardiac Surgery Program Sees Growth in Transplants, Minimally Invasive Techniques

Groundbreaking clinical trials. Heart and lung transplants. Minimally invasive surgical techniques. All are hallmarks of Ohio State’s cardiac surgery program, which ranked 26th in U.S. News & World Report’s 2016 Best Hospitals rankings, the only ranked program in central Ohio for cardiology and heart surgery.

Ohio State’s program provides standard cardiac surgery services — coronary artery bypass surgery, aortic aneurysm repair, aortic valve replacement, mitral valve repair and replacement — and then takes a step beyond. Minimally invasive techniques increasingly replace conventional surgeries. Transcatheter aortic valve replacement (TAVR) is now performed under local sedation, and the patient goes home in two days.

 

For patients with hypertrophic obstructive cardiomyopathy, surgeons perform septal myectomies to shave off muscle tissue from the ventricular septum and improve blood flow from the ventricle to the aorta.

 

“Only a handful of medical centers across the country are doing this procedure,” says Juan Crestanello, MD, director of Ohio State’s Division of Cardiac Surgery. “Our program is seeing great success in helping people in their 50s and 60s who have this genetic disorder.”

 

Certain aspects of the cardiac surgery program merit special notice: “Other areas where we’ve grown the most include lung transplants, heart transplants and ventricular assist devices [VADs],” Dr. Crestanello says.

 

“We were high enrollers for the PREVENT trial, which tested new protocols for preventing thrombosis in implanted LVADs. We’ve also been part of every phase of testing for the TAVR program, and we were a high enroller in the recent SURTAVI trial for intermediate-risk patients with aortic stenosis.” 

 Ohio State continues as a key investigator evaluating TAVR for low-surgical-risk patients and has a total of 29 clinical trials currently under way in cardiac surgery.

 

Heart and Lung Transplants

 

With more than 400 heart transplants in over three decades, Ohio State remains central Ohio’s only adult heart transplant program. The transplant team performed 28 procedures last year and continues to grow.

 

Ohio State’s large and successful cardiac mechanical support program offers every available device option for patients who require advanced support for the heart. VADs are an important bridge to transplant, as they help sustain patients who are awaiting a heart donor.

 

An equally robust lung transplant program at Ohio State recently recorded its 200th lung transplant, and surgeons performed 29 lung transplants last year.

 

“Our survival rates for patients with lung and heart transplants are above the national average,” Dr. Crestanello states. Ohio State and other institutions nationwide are investigating ex-vivo lung perfusion (EVLP) and its potential to double the number of donor lungs available. Currently, fewer than 30 percent of all donor lungs meet the criteria for transplantation. EVLP assesses the viability of donated lungs for transplantation by perfusing them with a bloodless solution containing nutrients, antibiotics and oxygen. Investigators are working toward a process of repairing injured lungs for transplantation.

Continuity of Care

To streamline care for heart patients on their way to the emergency department, Ohio State developed the first Level One Heart and Vascular Emergency Program in Ohio, a rapid response plan for any cardiovascular emergency.

 

Once patients are admitted to the Richard M. Ross Heart Hospital — one of the few academic heart-dedicated hospitals nationwide — they find a floor devoted entirely to surgical care. Patients awaiting a procedure or recovering from surgery receive optimal care from a nursing staff that has earned its third Magnet designation for superior nursing care from the American Nurses Credentialing Center.

 

The surgical floor also has received the prestigious Beacon designation for the third time for optimal patient care. Patient satisfaction routinely measures in the 98th percentile through surveys by Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS).

 

A focus on the whole person is critical to the cardiac surgery program’s success. Ohio State has ramped up its efforts to reduce patient readmissions to the hospital following valve surgery and coronary artery bypass surgery through better follow-up education and communication. The hospital has reduced its readmission rate for 90 days post-surgery by more than 35 percent since June 2015.

 

Dr. Crestanello and his colleagues are tireless in their commitment to their patients.

 

“It’s very rewarding to help patients live longer, better lives,” Dr. Crestanello says. “We love what we do.”



Improved Life Support Technology Offers Alternative for Treating Cardiopulmonary Failure

Technology improvements in extracorporeal membrane oxygenation (ECMO) have elevated the system from a “last-ditch effort” to a valuable tool for patients with cardiopulmonary failure. The Ohio State ECMO Program treats more than 60 patients annually. The ECMO system helps to extend life and quality of life for people with heart and lung failure by clearing carbon dioxide out of a patient’s blood and returning blood that has been oxygenated, warmed and filtered. Ohio State is one of a handful of centers in the Midwest that can provide this temporary treatment option.

Who Benefits from ECMO?

ECMO use falls into three broad categories for patients with:

1) Respiratory failure due to flu, pneumonia, ARDS or inhalation of harmful substances such as smoke or chemicals. Blood is taken out of a vein and goes back into a vein. It is valuable for people with acute onset of influenza whose lungs are non-compliant (or stiff), edematous (full of fluid), and not able to oxygenate and ventilate.

2) Cardiopulmonary failure due to a recent heart attack, cardiomyopathy, myocarditis, surgical recovery or chronic heart failure. ECMO bypasses both heart and lung function and removes blood through a vein and returns it into an artery.

3) Cardiac arrest. ECMO is used during cardiopulmonary resuscitation to do the work of the heart and lungs, taking blood from a vein and returning it to an artery. 

“ECMO provides a way of supporting and rescuing a patient who is decompensating to allow them time to heal,” says Bryan Whitson, MD, PhD, medical director for Ohio State’s ECMO Program for End-Stage Cardiopulmonary Failure. When patients are placed on a ventilator due to other health issues, their lungs can be damaged by the high pressures and levels of oxygen required to support their needs. ECMO gives patients time for their bodies to recover and allows their heart and lungs to rest. Whitson notes the technology’s value for severe cases of flu, when a patient’s lungs need temporary support as they fight their illness.

“ECMO offers a safety net as physicians attempt aggressive therapies or as patients recover post-surgery or struggle with acute or chronic illness,” Whitson adds. Typically, patients with pulmonary failure can stay on ECMO for a couple of weeks to a month. Those with cardiac failure average a week and generally transition to surgery, a ventricular assist device or other therapy.

When to Refer

When evaluating people for ECMO use, Whitson says, the decision is clear-cut about two-thirds of the time. Some people may be too sick, and others may not be sick enough for this invasive therapy. “We use this when a patient’s likelihood of dying is 50 percent with his or her current treatment, without the use of ECMO.” Ohio State’s ECMO Program admits patients directly and has the ability to transport patients on ECMO from other hospitals. This technology allows Ohio State’s Level 1 Trauma Program to provide the entire range of advanced therapies to treat patients with acute cardiopulmonary decompensation.

Whitson encourages referring physicians to contact Ohio State’s ECMO program when a patient:

  • Needs increasing ventilator support or more than 80 percent oxygen for more than a few days
  • Has cardiogenic shock and is requiring more than two IV medications
  • Seems to be worsening and needs expedient evaluation for advanced therapies

“We want an open dialogue with referring physicians about sending patients,” Whitson says. “We’re offering therapy earlier versus later so patients get maximum care earlier in the process and don’t get too sick to transport. As patients get better, we transfer them back to the referring center, especially if it’s out of town.”

Ohio State’s Successes with ECMO

Although Ohio State has been using ECMO since 2008, the greatest successes have come since the program’s upgrade in 2013. “What creates really good outcomes at Ohio State is our multidisciplinary, collaborative team and algorithmic, evidence-based approach about who goes on ECMO and how they get managed,” Dr. Whitson says. Efforts have been aided by improved pump and oxygenator technology, which is now more biocompatible. Ohio State has equipment to manage eight patients and can ramp up capacity during flu epidemics or other community crises.

At Ohio State, approximately 80 percent of patients who have ECMO for lung failure survive and are discharged. This venovenous application is around 20 percent better than the national average. For venoarterial cases, in which heart and lungs are both bypassed, the survival rate at Ohio State is approximately 60 percent, which is around 10 percent above the national average. At Ohio State, at least one surgeon, one intensivist and one other doctor must agree that using ECMO is the best course of action. All patients who undergo ECMO receive care at the Richard M. Ross Heart Hospital.

As Whitson explains, “We have cardiac perfusionists on site, dedicated ICU nurses, and respiratory, physical and occupational therapists who are committed to the process. Therapists get people out of bed and walk them in the halls. The team has seen the results and buys into the benefits.” Complications—such as clotting, red cell breakdown, gastrointestinal bleeding, hemorrhagic stroke or issues with inserting a cannula into the arteries or veins—are minimal at Ohio State.

Whitson notes that the results of using ECMO are gratifying: “We see people with bad flu or cardiogenic shock—who typically would have died—walk out of the hospital.”  


Ohio State Creates New Model with EP Hybrid Suite

Unique Design Accommodates Electrophysiology Patients, Physicians

Ohio State’s new hybrid room designed specifically for electrophysiology (EP) procedures may be among the first of its kind in the country. The EP hybrid room converts from an EP lab to an operating room should complications arise during complex lead extractions, ablations, left atrial appendage closures or other EP procedures.

Its uniqueness lies both in its design for EP procedures and its location within Ohio State’s Arrhythmia Center. Most cardiovascular hybrid rooms are equipped to accommodate a variety of cardiac and vascular disciplines, but this room focuses on EP procedures.

“Vascular surgeons need large imaging equipment for a larger field of view,” says Ralph Augostini, MD, electrophysiologist who holds Ohio State’s Bob and Corrine Frick Chair in Cardiac Electrophysiology. “As EPs, we’re often working within shoulders and need smaller imaging equipment.”

Dr. Augostini interviewed electrophysiologists across the country to achieve a design that promotes work efficiencies and optimal patient outcomes.

The EP hybrid room is located on the same floor with five other state-of-the-art invasive heart rhythm procedure laboratories, just a few feet from all EP supplies, equipment and personnel. A 23-bed recovery room is adjacent.

Staff for EP procedures in the EP hybrid room includes EP and operating room nurses and technicians, anesthesiologists, cardiac surgery staff and perfusionists. All are present for each procedure, even if the patient doesn’t require an open procedure. A cardiothoracic surgeon is called immediately before the procedure begins to make sure this expertise is immediately available.

“Serious complications are rare, but we do mock drills to practice in case an event occurs,” Dr. Augostini says. Performing practice drills helps with communication and teamwork when real emergencies arise.

Dr. Augostini believes the room will spark interest nationwide. “People will want to come see how our hybrid room is designed and how it functions. It will be a model for other programs for hybrid operating concepts.”

EP Hybrid Room Procedures

Ohio State’s nine electrophysiologists have built Ohio’s largest arrhythmia program and one of the nation’s highest-volume programs for arrhythmias. Procedures performed in the new EP hybrid room include:

  • Laser lead extraction of pacemaker and defibrillator leads
  • AngioVac suction for infected tissue surrounding device leads
  • Atrial fibrillation ablation and ventricular tachycardia ablation, often with hemodynamic support
  • Epicardial ablation
  • Convergent procedures, involving a cardiac surgeon and an electrophysiologist for patients with  long-standing atrial fibrillation and associated structural heart changes who do not respond to standard treatments
  • Left atrial appendage closures using The LARIAT Suture Delivery Device or WATCHMAN device
  • Open-chest ablation procedures

Dr. Augostini comments, “Our highest-volume procedure is laser lead extractions. We’re doing catheter-based procedures that are becoming more non-invasive.”

The EP hybrid room also provides an ideal test site for clinical trials of novel pacing therapies for heart failure, neurologic disorders and sleep disorders that impact the heart. Dr. Augostini is currently involved in a trial of a fully implantable sleep apnea pacemaker called remede® by Respicardia. Once he installs the device, heart failure specialists follow up with ongoing patient care. “One of Ohio State’s greatest strengths is its multidisciplinary teams collaborating on projects,” says Dr. Augostini. “We have a productive research group on the forefront of technology for arrhythmia care.”

Advancing Care for Adult Congenital Heart Disease

One of the largest programs in the country, the Columbus Ohio Adult Congenital Heart Disease (COACH) Program at The Ohio State University Wexner Medical Center has pioneered care for adults with congenital heart disease (ACHD) since 2001. With 4,000 outpatient visits per year, the program serves patients across the Midwest.

Four ACHD-trained physicians, including Director Curt Daniels, MD, collaborate with multiple cardiology subspecialists, nurse practitioners and nurses from Ohio State and Nationwide Children’s Hospital to improve quality of life for people with ACHD, both medically and psychosocially.

“These are complex and complicated patients with abnormal heart anatomy and physiology,” says Dr. Daniels, who founded the COACH program and has training in both adult and pediatric cardiology. “Many have had multiple heart surgeries. They touch on every area of cardiology.”

Congenital heart defects are one of the most common birth defects, occurring in approximately one in 100 newborn infants. An estimated 1.8 million Americans are living with ACHD, thanks to dramatic improvements in surgical and medical management of these conditions.

Why Ohio State?

Ohio State’s strengths in diagnosing and managing ACHD include:

Coordinated, lifelong care from birth to adulthood, in collaboration with Nationwide Children’s Hospital. By bridging the gap between pediatric and adult cardiology, we have a greater breadth of capabilities and more opportunities for research, surgery and interventional procedures.

A team approach orchestrated by an ACHD specialist, who evaluates each patient and integrates a cardiac surgeon, an imaging specialist or an interventional cardiologist, as needed. These specialists are highly skilled in diagnosing and treating ACHD. Nearly 20 physicians and staff are part of the COACH team.

Pregnancy program for women with ACHD. Specialists in ACHD and maternal fetal medicine work together to ensure the health of mother and baby. “We’ve taken care of 700 pregnancies with heart disease with outstanding outcomes,” Dr. Daniels says.

An Adult Congenital Electrophysiology Clinic and an Arrhythmia Clinic are among a few in the country to merge pediatric and adult electrophysiology skills in treating arrhythmias.

Collaboration among adult and pediatric interventionists for valvular heart disease. 

Research on heart imaging, surgical techniques, medicines and the latest medical devices. Other key areas of study include neurocognitive development and psychosocial issues. Due to its volume and expertise in the field, Ohio State frequently takes a leading role in clinical trials.

Treating Congenital Heart Defects

At Ohio State, our physicians diagnose and manage all types of congenital heart defects, including:

Atrial septal defect (ASD)

Bicuspid aortic valve 

Coarctation of the aorta 

Congenital aortic stenosis 

Ebstein's anomaly 

Hypoplastic left heart syndrome 

Pulmonary valve stenosis 

Subvalvular aortic stenosis 

Tetralogy of Fallot 

Transposition of the great arteries 

Tricuspid atresia 

Ventricular septal defect 

Rare defects include:

Single Ventricle/Fontan

Primary treatments for adults with CHD include cardiac surgery, interventional cardiac catheterization procedures and arrhythmia management—using ablation techniques, pacemakers and medicines.

“Our goal is to work collaboratively with our team and with referring physicians to provide the best possible care for patients with ACHD and to improve their quality of life,” Dr. Daniels says.

Continuing Progress

For years, pediatric cardiologists cared for patients with CHD. As people survived beyond teen years, a gap existed in the transition from pediatric to adult cardiology. With the evolution of the ACHD specialty, physicians take a more comprehensive, programmatic approach to the disease.

The subspecialty of ACHD recently gained added credibility with a certification exam. Dr. Daniels is on the certification board. He also helped establish Ohio State’s long-standing fellowship program to train the next generation of ACHD specialists. 

Dr. Daniels notes the strides Ohio State and other programs have made in this field and the work that still remains: “Ninety percent of children with CHD now will live to adulthood. Since 2010, there are more adults than kids with CHD. The mean age of death is about 30 years for more complex cases. Our job is to extend and improve their life,” Dr. Daniels says.

“With our experience, research and large volume of patients, we’ve created an environment of high-quality care. We’re very proud not only of the medical care we give but in caring for patients’ psychosocial needs, as well.”

Lung Transplant Expertise Sparks Rapid Growth

Lung Transplant Expertise Sparks Rapid Growth in Transplant Program

Progress Fueled by Research, Organ Procurement Efforts, Transplant Support Structure

Created from the country’s best evidence-based transplant practices and the support structure of Ohio State’s Comprehensive Transplant Center, the Lung Transplant Program at The Ohio State University Wexner Medical Center has achieved significant success since its beginning in 2013:

  • Twenty-nine lung transplants in under two years
  • Patients being transplanted within 38 days of being listed, on average
  • One-year survival above the national average
  • New research grants to explore perfusion methods that will expand the number of donor organs

The program for adult lung transplants serves all of central and southern Ohio, as well as West Virginia, Northern Kentucky and beyond. It operates as part of Ohio State’s comprehensive End-Stage Cardiopulmonary Failure Program, which also includes the Extracorporeal Membrane Oxygenation Program and Pulmonary Thromboendarterectomy Program.

Transplant Expertise

Ohio State’s Comprehensive Transplant Center is a national leader in transplant success rates. As central Ohio’s only adult transplant center, Ohio State has performed more than 7,900 heart, lung, kidney, kidney-pancreas, liver and pancreas transplants since 1967. The center has developed a seamless program for evaluation, diagnosis, treatment and follow-up care.

Lung transplants are performed in the Richard M. Ross Heart Hospital, where a dedicated staff focuses on heart and lung procedures.

“Our integrated team of physicians and staff at the Ross Heart Hospital is very passionate about the transplant process,” says Surgical Director Bryan Whitson, MD, PhD. Transplant surgeons work with pulmonologists, infectious disease specialists, heart failure cardiologists, pharmacists and advanced practice nurses to manage a patient’s health throughout the transplant process.

“This is life changing for patients and families,” says Whitson, “  and we want to make this as easy as possible for them so they can get back to what they care about most in life.”  The program also has a dedicated team of respiratory therapists, physical therapists, occupational therapists, dietitians and social workers who help provide patients with therapies and services to aid their recovery following transplant surgery.

Candidates for Lung Transplant

Dr. Whitson and his colleagues use lung transplantation to treat several end-stage cardiopulmonary conditions. The most common include:

  • Chronic obstructive pulmonary disease (COPD) (single or bilateral transplant)
  • Pulmonary fibrosis (single or bilateral)
  • Cystic fibrosis (CF), as children are living longer with CF and growing into adulthood (bilateral transplant)
  • Primary pulmonary hypertension (bilateral)

“If there’s anyone you have a question about,” Dr. Whitson tells referring physicians, “referring early is always better than late. We can review medical records, examine the person. There may be modifiable risk factors that we can work on before we put people on the transplant list. Plus, it’s better to be prepared for people who can get sick very quickly, such as those with pulmonary fibrosis.”

Ohio State has the capacity to increase its volume of lung transplants and plans to grow by improving organ availability.

Increasing the Donor Pool

 Ohio State works closely with Lifeline of Ohio, central Ohio’s organ procurement organization, and can recover donor organs from anywhere in the country through national networks.

“A limiting factor for any transplant program is having a sufficient number of quality transplantable organs. We are working with Lifeline of Ohio to improve the recovery rate of organs by getting the word out on how to manage organs for optimal use. Our goal in the next year is to start an ex vivo lung perfusion program to resuscitate donor lungs that formerly would not have met our criteria for transplant,” Dr. Whitson explains.

The ex vivo lung perfusion system is a miniaturized bypass circuit that circulates a perfusion solution through the lungs to provide nutrients, proteins and oxygen, and possibly to reverse lung damage. The process is most typically used once the lungs are recovered from the donor’s body.

Promising Transplant Research

Research is currently under way at Ohio State’s Collaboration for Organ Perfusion, Protection, Engineering and Regeneration (COPPER) Laboratory to improve the perfusion process. The lab has received three grants in the last year to pursue enhancements of perfusion solutions.

Dr. Whitson, co-director of the lab with Sylvester Black, MD (an Ohio State abdominal transplant surgeon), and a research team are investigating biomolecules that could be added to the most commonly used perfusion solution to repair damage to a donor lung and keep it alive longer.

“We’re working on both the lung and liver to test the molecule to see whether it repairs injury to the cell membrane and prevents cells from dying,” says Whitson. “We’re also trying to develop our own perfusion solution to see if we can better support oxygen delivery and metabolism to the donor lung.”

 Dr. Whitson adds, “We hope in two to three years to be able to bring this to the bedside, giving us more donor organs to work with.”

Thorough Follow Up to Maximize Success

A patient who receives a lung transplant at the Ross Heart Hospital remains in the Columbus area for at least one month of follow-up care. Our team provides assistance with finding local lodging.

Ohio State physicians see patients twice a week initially, then once a week for the first six months. They perform a bronchoscopy monthly so pathologists can check for subtle signs of early infection or rejection. The transplant surgeon maintains close contact with the referring physician, calling shortly after the transplant procedure and at patient discharge from the hospital.

Through phone calls and letters, Ohio State physicians keep referring physicians apprised of a patient’s progress; they gradually transition the patient’s care back to the referring physician.

To refer a patient to the Lung Transplant Program at The Ohio State University Wexner Medical Center, please call 614-293-5822.

 


Aiding Patients with Heart-Related Side Effects of Cancer Treatment

Aiding Patients with Heart-Related Side Effects of Cancer Treatment

Ohio State Heart Disease Program for Cancer Patients and Cancer Survivors

“As we are saving more patients from cancer with radiation and chemotherapy, the challenge we face is that up to one-fourth of them are now developing heart disease,” says Ragavendra R. Baliga, MD, board certified cardiologist specializing in heart failure and heart transplantation at The Ohio State University Wexner Medical Center’s Ross Heart Hospital.

He and co-director Garrie Haas, MD, also a heart failure specialist, have developed a heart disease program for cancer patients and survivors. Central Ohio’s only cardio-oncology clinic, the two-year-old program sees three to four new patients a week.

“Our numbers are growing, and we see the opportunity to increase significantly,” Dr. Baliga says, especially as Ohio State recently opened its new James Cancer Hospital and Solove Research Institute, creating much greater capacity to treat cancer patients.

Heart-Related Side Effects from Chemotherapy

Chemotherapy drugs introduced over the past 10 years have proved to be highly effective in arresting cancers, but they have created a new risk for heart disease.

Per Food and Drug Administration guidelines, oncologists at leading medical centers, including Ohio State’s Wexner Medical Center, are ordering surveillance echocardiograms as soon as patients begin chemotherapy for cancers of the breast, kidneys and lungs, leukemias, lymphomas, sarcomas and some childhood cancers.

If patients receiving chemotherapy are showing signs of heart failure, cardiomyopathy, hypertension, thrombus or other heart distress, the cardio-oncology clinic at Ohio State can work with patients and their oncologists to manage symptoms so they can resume cancer treatment as quickly and safely as possible.

“If problems are caught early, such as cardiomyopathy, many people recover full heart function,” Dr. Baliga says. “We may see them once a year in follow-up for an MRI to make sure the heart looks good.”

In addition, the clinic oversees newly diagnosed patients with known heart disease who find themselves facing cancer treatment.

Radiation Risks

Radiation to the chest also poses a risk of coronary and valvular disease, often years after the treatment. For example, patients treated with radiation for Hodgkin lymphoma are seven times more likely to die of cardiovascular problems compared with the general population.

Ohio State’s cardio-oncology team of two physicians and two nurses works closely with patients to manage symptoms during routine visits and through frequent follow-up calls.

“Our goal is to keep people out of the hospital by managing their symptoms effectively,” Dr. Baliga says.

Cardio-Oncology Clinic Strives for Improved Outcomes

By bringing cardio-oncology patients under one umbrella, Drs. Baliga and Haas aim to use their expertise to achieve better outcomes for cancer patients and survivors with heart disease. Their strong collaboration with oncologists further ensures optimal care for patients.

They have begun to collect clinical data with hopes of joining an international registry that will capture data on thousands of patients and report trends.

“Cancer patients with heart failure need special treatment beyond what a general cardiologist can provide,” Dr. Baliga comments. “There’s little evidence-based practice to guide physicians. At our clinic, we know the spectrum of side effects, and we’re up-to-date on the literature. With our increasing experience and expertise, we can bring lifesaving treatment to people facing the dual challenge of cancer and heart disease.”

 


Easing the Heart’s Workload

New director, new studies propel Ventricular Assist Device Program forward

With one of the country’s largest ventricular assist device (VAD) programs, The Ohio State University Wexner Medical Center is offering people with advanced heart failure fresh hope for a better quality of life. Ahmet Kilic, MD, newly appointed medical director of Ohio State’s Ventricular Assist Device Program, leads both clinical and research efforts.

Ohio State’s Ventricular Assist Capabilities

Ohio State is recognized worldwide for its leadership in cardiac mechanical support. We have three cardiac surgeons who specialize in mechanical assist devices. Together, they implant long-term and temporary devices in more than 50 patients a year.

“We have the largest heart failure program in central Ohio, and most of our patients have advanced heart failure. Our goal is to recommend the best option for each person and provide excellent, patient-focused care,” says Ayesha Hasan, MD, a cardiothoracic surgeon and associate professor of Cardiovascular Medicine. “We want to see people as early as possible in the disease process to provide optimal outcomes. In the majority of cases, we can help improve the quality of life,” she continues.

Dr. Kilic adds, “Our expertise in providing a continuum of care for heart failure patients through a dedicated Heart Failure Disease Clinic allows us to care for some of the most complex patients.”

Primary reasons to implant long-term devices are as a bridge to heart transplantation or as destination therapy — a permanent solution for patients with advanced heart failure.

Devices include:

  • Heartmate, a VAD implanted in the chest to promote continuous blood flow from the left side of the heart into the aorta. The VAD is run by a small external computer, which is connected to the pump via a small cable that passes through the upper abdomen.
  • HeartWare, a more recently developed VAD approved as bridge to transplantation. It is implanted entirely within the heart sac and can be implanted in a wide range of people, including those of smaller stature. 
  • C-Pulse counterpulsation technology, available only through clinical trials. See below.

In addition, our surgeons can help patients in cardiogenic shock with temporary devices that sit outside the body to provide immediate circulatory support. “We have access to every available ventricular assist device, and our short-term and long-term survival rates exceed the national average. Quality in care is something we are very proud of and we will continue to hold ourselves to the highest expectations for our patients,” Dr. Kilic says.

VAD Research

“We have a very robust research program,” Dr. Kilic explains. “Taking part in national and international trials translates into better care for our patients.”

VAD studies currently under way at Ohio State include:

  • HeartWare clinical trial to evaluate the pump’s effectiveness as a destination therapy in addition to continuation of its Food and Drug Administration-approved use as a bridge to transplant 
  • HeartMate II® Prevent trial to reduce the rate of and prevent  pump thrombosis
  • HeartMate II® Roadmap trial to evaluate and compare the effectiveness of this VAD versus optimal medical management in ambulatory heart failure patients
  • C-Pulse trial to evaluate counterpulsation technology that acts like a balloon pump to increase coronary blood flow and cardiac output and reduce the heart’s pumping workload among patients with Class III and ambulatory Class IV heart failure

Ohio State enrolls its patients in INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support), a national registry with more than 6,000 patients from 145 hospitals that helps classify the severity of a patient’s illness and predict mortality of patients receiving a VAD implant.

Comprehensive Care Model for Heart Failure

Our surgeons collaborate with heart failure specialists, nurse practitioners, VAD coordinators, pharmacists, social workers and dietitians — all working in our Heart Failure Disease Clinic — to provide ongoing care for more than 90 patients with long-term VADs.

Looking Forward

VAD procedure numbers continue to increase at Ohio State, as a long-standing tradition of excellent care continues. “We’re on the forefront with new technology, including clinical trials in 2015 for the next generation of devices,” Dr. Kilic says. “My hope is to continue to build on the VAD Program’s strengths and engage the various physicians involved in the care of these complex patients. With continuous communication and early referral, we can continue to care for the ever-increasing number of heart failure patients. 

“The goal is to not only improve their survival, but perhaps more importantly, the quality of life for all of those suffering from advanced heart failure,” Dr. Kilic concludes.

About Our Medical Director

Ahmet Kilic, MD, joined The Ohio State University Wexner Medical Center in 2011 as a cardiothoracic surgeon, assistant professor of Surgery in the Division of Cardiac Surgery and clinical investigator for the Dorothy M. Davis Heart and Lung Research Institute.

In addition to serving as medical director for the Ventricular Assist Device Program, he helps lead Ohio State’s Level 1 Heart and Vascular Emergency Program and is the director of Education for the Cardiothoracic Surgery Training Program.

Dr. Kilic earned his medical degree from the Medical College of Virginia – Virginia Commonwealth University. He completed his surgical training at the University of Maryland and his cardiothoracic surgery residency at the University of Virginia.

You can reach Dr. Kilic at ahmet.kilic@osumc.edu or at 410-302-1396.

Make a Referral to Ohio State’s Mechanical Assist Device Program

Heart Failure Disease Clinic

614-293-6038

888-293-7677

VAD and Heart Transplant

614-293-3787

800-538-1886

URGENT REFERRAL

If a patient’s condition warrants an urgent outpatient evaluation or inpatient transfer, please notify us so we can expedite the patient’s care. To arrange a same-day physician consult or patient transfer, call our 24-hour referral and transfer service at 614-293-4444 or 800-824-8236.


Unique Collaboration Tackles Difficult Cases, Produces Life-Changing Results

Seeking treatment for a complex arrhythmia problem, a 35-year-old woman with adult congenital heart disease (CHD) traveled from her home in Houston, Texas, all the way to The Ohio State University in Columbus, Ohio. Her physician at Nationwide Children'’s Hospital combined expertise with an adult electrophysiologist at Ohio State'’s Heart and Vascular Center to cross a baffle in her heart constructed during pediatric surgery and successfully complete a complex ablation.

One of Few Adult/Pediatric EP Partnerships in U.S. 

The procedure is one of several performed this past year through a unique collaboration co-led by Adult Electrophysiologist Steven Kalbfleisch, MD, and Pediatric Electrophysiologist Naomi Kertesz, MD (pictured). Their Adult Congenital Electrophysiology collaboration is one of only a few in the country to merge pediatric and adult electrophysiology skills in treating arrhythmias and performing lead extractions in adults with CHD.

Naomi Kartesz, MD and Steven Kalbfleisch, MD"It's rare to have pediatric and adult EPs working together. We have two nationally ranked hospitals actively fostering collaboration among specialists for best outcomes for patients," Dr. Kertesz says.

The physicians spend clinic time together seeing patients and sharing their unique perspectives. They discuss whether the patient would benefit most from medication, a device or ablation.

"We complement each other," Dr. Kalbfleisch explains. "Adult electrophysiologists have a lot of experience with complex ablations such as atrial fibrillation and atrial flutters, and the pediatric electrophysiologists have a better understanding of the complex anatomy and natural history of the congenital abnormality."

Co-led by Drs. Kertesz and Kalbfleisch, other members of the team include adult EPs, pediatric interventional cardiologists who help them reach hard-to-access areas of the heart during complex ablations, and pediatric and adult cardiologists who assist with echocardiograms. Dr. Kalbfleisch's partner works with Dr. Kertesz to perform lead extractions so stents can be inserted into narrowed vessels.

The physicians perform EP procedures at both Ohio State'’s Richard M. Ross Heart Hospital and Nationwide Children's Hospital, depending on which venue is likely to provide optimal care for the patient.

Broader Understanding Yields Better Results

Naomi Kertesz, MD, Director of Electrophysiology and Pacing at The Heart Center at Nationwide Children’s Hospital and Steven Kalbfleisch, MD, Medical Director, Cardiac Electrophysiology at Ohio State’s Heart and Vascular Center.

This collaboration evolved with encouragement from Curt Daniels, MD, director of the Columbus Ohio Adolescent/Adult Congenital Heart Disease (COACH) program, which serves patients at both Ohio State'’s Ross Heart Hospital and Nationwide Children'’s Hospital. Dr. Daniels frequently consulted adult or pediatric EPs, but he rarely had the benefit of their synergistic approach to patient care.

Dr. Kertesz comments, "We have patients come to us whose cases have failed because the doctors weren't ablating in the correct place, or they couldn't get to the correct place because they weren't familiar with the anatomy. We're drawing on expertise of both the pediatric and adult side to help the patient."

Case Study

The 35-year-old woman from Texas is one of more than a million American adults living with CHD.

Dr. Kertesz had first seen the patient during the 1990s and had treated her for arrhythmias. The arrhythmias had been managed with a pacemaker and medications, but symptoms worsened during the spring of 2013. When an ablation attempt failed in Houston and doctors there suggested a new regimen of medications, the patient sought Dr. Kertesz's assistance.

Drs. Kertesz and Kalbfleisch agreed to make another attempt to do an ablation. The patient arrived in June 2013 for a six-hour procedure at Ohio State’s Ross Heart Hospital. With the help of a pediatric interventional cardiologist, they reached both sides of the Mustard baffle constructed during the patient’s childhood to redirect blood flow. The EPs used radiofrequency energy to modify the conduction system tissue to eliminate her arrhythmia.

"She had a very unusual form of atrioventricular node re-entry, which required an approach entirely different from the typical approach." Dr. Kertesz explains. "Without an understanding of her anatomy and without an understanding of the arrhythmias common in this type of heart disease, one would have significant difficulty in trying to take care of this patient's arrhythmia."

Dr. Kertesz continues, "We couldn't completely get rid of the rhythm, but we were able to identify much better what it was. Rather than being on four medicines, the patient is now on one and feels much better than she ever has."

While the initial procedure was performed at Ohio State, subsequent procedures have been performed at Nationwide Children's Hospital. The team chooses the location for each procedure based on the specific needs of the patient and procedure.

Improving Outcomes

"We are succeeding with patients who have had other treatment attempts and failed," Dr. Kertesz says.

As Dr. Kalbfleisch further explains, "Rhythm problems such as atrial flutter and atrial tachycardia are difficult even with normal patients. For congenital patients, it's much more difficult. A typical success rate would be 60 to 70 percent for a person with CHD versus 80 to 90 percent for a normal heart. With this dedicated program, we can be much more successful."

He expects increased collaboration and volume as the collaboration enters its second year.

"Bringing expertise from all of these different areas enhances the quality of patient care and patient outcomes," he adds.

The success of this collaboration has set the stage for other partnerships. Pediatric and adult interventionists are working on valve problems collaboratively, and plans to create a combined genetic arrhythmia collaboration are under discussion.

To learn more, visit: NationwideChildrens.org/HeartCenter or call 614-293-ROSS (7677).

Ohio State's Level One Heart and Vascular Emergency Program

One Couple. Two Heart Attacks. Life-Saving STEMI Care at Work.

When an eastern Ohio couple suffered heart attacks on the same day, The Ohio State University Wexner Medical Center was able to provide the high-level tertiary care that ultimately saved both their lives.

Cindy and Bill GrahamCindy Graham, pictured here with her husband, Bill, was watching TV one morning when she noticed her husband slumped over the table.

“I knew something was wrong immediately,” Cindy says. “I called his name and slapped his face, and then I dialed 9-1-1.”

The dispatcher talked Cindy through CPR while the squad was on its way.

“I had to get him on the floor, which was very hard to do. While I was on the phone, Bill let out a few breaths of air. When the ambulance got here – within about five minutes – they shocked him eight times,” she said.

With Bill in full cardiac arrest, Cindy went outside, crying that her husband was gone. Shortly afterward, a paramedic found her passed out in the yard – Cindy was having a heart attack, too.

When Every Minute Counts

Husband and wife were rushed to their local hospital in Barnesville, Ohio. Bill was assessed for STEMI – ST-segment elevation myocardial infarction – the most serious form of heart attack.

He was transported by air to Ohio State’’s Wexner Medical Center, more than 100 miles away. Cindy followed in an ambulance.

Once at Ohio State’s University Hospital East, Bill received a percutaneous coronary intervention (PCI).

“The treating physician dilated the clogged artery with a balloon and placed a stent. That solved the problem by opening up the artery that caused the heart attack,” says Dr. Vincent Pompili, MD, FACC, director of Interventional Cardiovascular Medicine and Cardiac Catheterization Laboratories at Ohio State’s Wexner Medical Center.

While Bill received his procedure, Cindy was diagnosed with a less time-sensitive type of heart attack – non-ST-segment elevation myocardial infarction (NSTEMI).

The team found multiple blockages and recommended possible open heart surgery because of her high risk. She was transferred to Ohio State’s Richard M. Ross Heart Hospital, but after careful deliberation by her cardiac care team, Cindy received the same cardiac cath procedure as her husband.

A Case Study for Excellent Coordinated Care

Bill and Cindy Graham’s unusual story is a great example of team work delivering advanced care that saves lives through Ohio State’s Level I Heart and Vascular Emergency program. The program works with nearly 200 hospitals in Ohio, West Virginia and Kentucky.

As part of the program, emergency medical personnel transporting patients to Ohio State’s Wexner Medical Center issue a “STEMI alert” from the field. With one phone call, surgeons, cardiologists, nurses and imaging technologists are mobilized to prepare for the arriving patient.

By bypassing the normal triage process in the emergency department and transporting the patient directly to the cardiac catheterization lab, the waiting team of medical specialists can begin treatment immediately.

Thanks to protocols like this one, Ohio State is a leader in STEMI care throughout central Ohio – achieving an average door-to-open-artery time of only 47 minutes. That’s nearly twice as fast as the national average of 90 minutes.

How Ohio State Built a Leading Regional Program

“We set out to maximize excellence in an area where there was an unmet clinical need for improving access and the process for patients in need of STEMI care,” Pompili says.

But success didn’t happen overnight.

“Seven years ago when we started our program, we had excellent clinical care, but many barriers to accessing it. It took true dedication from our leaders to analyze each and every barrier in the process and figure out how to negate them. Each refinement and each barrier removed means faster care for our patients.”

“To this day, we assemble a dedicated team who meets regularly to continue process improvements to push the boundaries of our STEMI program even further,”says Pompili.

In addition to STEMI, Ohio State’s Level I Heart and Vascular Emergency program treats other heart and vascular emergencies, such as ruptured abdominal aortic aneurysm, acute aortic dissection, acute limb ischemia and cardiogenic shock.

Personalized Care Leads to Best Treatment Results for Patients

Today Bill and Cindy are back home and doing well.

“It’s an interesting story with a happy ending on both sides,” says Dr. Pompili. “The fact that she did CPR on her husband is amazing. She was able to save his life until the squad came.”

Both Grahams have quit smoking, with help from nicotine patches provided by the hospital, and they have taken up walking. Bill is in rehab, and Cindy has returned to her job wrapping meat at a local store.

The Grahams were very pleased with the care they received at The Ohio State University Wexner Medical Center.

“Everyone was so nice at both University Hospital East and the Ross. They treated us like old friends when they came into the room and always explained everything to me,” says Cindy. “They were absolutely wonderful.”

Ohio State Creates New Model with EP Hybrid Room

Unique Design Accommodates Electrophysiology Patients, Physicians

Ohio State’s new hybrid room designed specifically for electrophysiology (EP) procedures may well be the first of its kind in the country. The EP hybrid room converts from an EP lab to an operating room should complications arise during complex lead extractions, ablations, left atrial appendage closures or other EP procedures.

Its uniqueness lies both in its design for EP procedures and its location within Ohio State’s Arrhythmia Center. Most cardiovascular hybrid rooms are equipped to accommodate a variety of cardiac and vascular disciplines, but this room focuses on EP procedures.

“Vascular surgeons need large imaging equipment for a larger field of view,” says Ralph Augostini, MD, electrophysiologist who holds Ohio State’s Bob and Corrine Frick Chair in Cardiac Electrophysiology. “As EPs, we’re often working within shoulders and need smaller imaging equipment.” Dr. Augostini interviewed electrophysiologists across the country to achieve a design that promotes work efficiencies and optimal patient outcomes.

The EP hybrid room is located on the same floor with five other state-of-the-art invasive heart rhythm procedure laboratories, just a few feet from all EP supplies, equipment and personnel. A 23-bed recovery room is adjacent. Staff for EP procedures in the EP hybrid room includes EP and operating room nurses and technicians, anesthesiologists, cardiac surgery staff and perfusionists. All are present for each procedure, even if the patient doesn’t require an open procedure. A cardiothoracic surgeon is called immediately before the procedure begins to make sure this expertise is immediately available.

“Serious complications are rare, but we do mock drills to practice in case an event occurs,” Dr. Augostini says. Performing practice drills helps with communication and teamwork when real emergencies arise. Dr. Augostini believes the room will spark interest nationwide. “People will want to come see how our hybrid room is designed and how it functions. It will be a model for other programs for hybrid operating concepts.”

EP Hybrid Room Procedures

Ohio State’s nine electrophysiologists have built Ohio’s largest arrhythmia program and one of the nation’s highest-volume programs for arrhythmias. Procedures performed in the new EP hybrid room include:

  • Laser lead extraction of pacemaker and defibrillator leads
  • AngioVac suction for infected tissue surrounding device leads
  • Atrial fibrillation ablation and ventricular tachycardia ablation, often with hemodynamic support
  • Epicardial ablation
  • Convergent procedures, involving a cardiac surgeon and an electrophysiologist for patients with  long-standing atrial fibrillation and associated structural heart changes who do not respond to standard treatments
  • Left atrial appendage closures using The LARIAT Suture Delivery Device or WATCHMAN device
  • Open-chest ablation procedures

Dr. Augostini comments, “Our highest-volume procedure is laser lead extractions. We’re doing catheter-based procedures that are becoming more non-invasive.”

The EP hybrid room also provides an ideal test site for clinical trials of novel pacing therapies for heart failure, neurologic disorders and sleep disorders that impact the heart. Dr. Augostini is currently involved in a trial of a fully implantable sleep apnea pacemaker called remede® by Respicardia. Once he installs the device, heart failure specialists follow up with ongoing patient care.

“One of Ohio State’s greatest strengths is its multidisciplinary teams collaborating on projects,” says Dr. Augostini. “We have a productive research group on the forefront of technology for arrhythmia care.”

 


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