How medical care progresses: A look at one heart valve trial

CORP20160553_05_Heart_valve_blog_largeStep by step, our physician-scientists methodically study possible treatments to advance medicine and to improve your care.

Read how it’s done with our quick summary of one of the 2,000 active research trials at The Ohio State University Wexner Medical Center – including 200+ on heart and vascular issues.

This new clinical trial aims to expand the use of a minimally invasive heart valve replacement procedure developed for elderly and very ill patients who don’t have many treatment options.

What do the researchers hope to achieve? A new treatment possibility for people in their 50s or 60s, with a small incision that would allow them to skip open heart surgery.

Expanding successful therapies to new groups of people is the cornerstone of how medical care gets better, says Scott Lilly, MD, an interventional cardiologist and co-director of the Structural Heart Disease Program at Ohio State Heart and Vascular Center.

“Any time we can provide patients a treatment that is less invasive and gets them back on their feet faster, it is incredibly fulfilling. That is why we do this job,” he says.

Let’s break down some details of this particular study for people with narrowing of the main valve out of the heart, a condition called aortic valve stenosis, which can cause fatigue and shortness of breath because blood isn’t pumping well to the organs and muscles.

Researchers are seeking trial candidates! (See the number to call below.)

The study basics: a simpler option than surgery

  • This research is part of the nationwide trial offering the procedure to younger patients expected to have a smooth open heart surgery but who would prefer a less-invasive option.
  • Outside of the trial, this surgery is limited in the U.S. to patients who shouldn’t have open heart surgery because they are too sick or have a condition that makes the surgery high risk.

The treatment: bypassing open heart surgery

What is this alternative procedure? It’s called transcatheter aortic valve replacement (TAVR). Ohio State is one of a handful of centers in Ohio that does this treatment.

How it works:

  1. Through a small incision in a patient’s groin area, a replacement valve travels via a catheter (a thin, flexible tube) through the main leg artery up to the heart.
  2. The new valve is expanded, pushing the old one out of the way.
  3. Just like that, the blood starts flowing properly again.

Among the benefits: Much faster healing and recovery time. General anesthesia isn’t usually necessary.

Incremental research=big results for care

A timeline of how the treatment has evolved:CORP20160553_05_Heart_Valve_blog_additional_v1

  • Our researchers have been involved with testing and development of this newer technology since 2012.
  • The technology was created originally for the sickest and oldest patients, but was made available to intermediate-risk patients in a clinical trial. The procedure helped extend life expectancy and quality of life for many.
  • Now the Ohio State Richard M. Ross Heart Hospital is one of 80 centers nationwide participating in a five-year study on the effectiveness of TAVR for patients with a low risk for open heart surgery.

“It’s one thing when you put this valve into an elderly patient with an otherwise more limited life expectancy," Dr. Lilly says.

"When you start performing this procedure in otherwise healthy 50 to 60-year-old patients, a new spectrum of questions emerge,” Dr. Lilly says.

“We’re asking ‘How durable is this valve in 10-15 years? Is the durability going to be the same as a surgically implanted valve?’ It’s a much different way of looking at the technology.”

Heart valve trial seeks more participants

If you have severe aortic stenosis then, most likely, you can help! If an evaluation determines that open-heart surgery is low-risk for you, then you have the option of enrolling in the clinical trial. Over five years, researchers will compare effectiveness of the two treatment strategies.

By signing up, you might have access to a minimally invasive surgery that is available to low-risk patients only in clinical trials.

If you might be interested in joining the aortic stenosis heart valve trial, call our Structural Heart Disease staff to learn more.


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