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.”
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 Part of Clinical Trials for Latest Ventricular Assist 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
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
VAD and Heart Transplant
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]
First Implant of Central Sleep Apnea Device Completed at Ohio State
The first U.S. commercial case using the remedē® System to treat central sleep apnea was completed at The Ohio State University Wexner Medical Center in Columbus, Ohio by Ralph Augostini, MD, FACC, FHRS, Bob and Corrine Frick Chair in Cardiac Electrophysiology, Associate Professor of Medicine and co-director of the electrophysiology training program. The first case coincides with the naming of seasoned medical device executive, Peter Sommerness, as CEO of Respicardia and leader of the remedē System U.S. launch.
“The remedē System is a breakthrough technology that uniquely treats central sleep apnea while greatly improving a patient’s quality of life,” stated Dr. Augostini. “I am proud to be a part of the system’s first U.S. commercial case that has the potential to become the standard of care for these patients.”
Central Sleep Apnea (CSA) is a serious breathing disorder that disrupts the normal breathing pattern during sleep and negatively affects quality of life and overall cardiovascular health. CSA results from the brain’s inability to send appropriate signals to the respiratory muscles to stimulate breathing. The remedē System is clinically proven to safely and effectively treat moderate to severe CSA in adult patients and improve quality of life.“Central sleep apnea is very common in cardiac patients, especially patients with heart failure, and is associated with a significantly greater risk for morbidity and mortality,” explained William T. Abraham, MD, Director of the Division of Cardiovascular Medicine at The Ohio State University Wexner Medical Center. “Being able to treat CSA offers a new hope to improve the quality of life for my patients.”
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 surgeonsâ€”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."