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Getting to the Heart of Device Trials

Given the regional community’s high rates of heart disease, Baptist Health Lexington considers it vital to offer patients access to the most advanced technology and therapies through participation in clinical trials. I met with Dr. Gery Tomassoni, medical director of the hospital’s research entity, Lexington Cardiac Research Foundation, to learn about some of the Foundation’s work.

Kentucky Doc: Can you tell us a little about how you got started in clinical research?

Dr. Tomassoni: I’m an electrophysiologist, dealing with electrical abnormalities of the heart. I started out as an assistant professor at the University of Kentucky Medical Center. That’s where we started doing some of the research protocols that we now do here. After a year or so, I came to Baptist Health Lexington.

Our first few years doing clinical research were mainly doing IDE trials – clinical trials for individual device companies in the electrophysiology world. When they have a new device, in order to get it approved, they submit an IDE trial which usually involves multiple sites in the United States.

Then we also started doing our own research here at Baptist Health. These are clinical trials, dealing with patient populations and determining the need for different kinds of procedures, mainly devices and catheter ablation. In electrophysiology, we put in defibrillators and pacemakers. The defibrillators are put in patients who are at risk for sudden cardiac death, usually because of abnormal heart rhythms; the pacemakers are put in patients who have slow heart rates.

We also deal with a large portion of the population who have weak heart pumps, congestive heart failure. We’ve been one of the leading implanters of special devices that not only work as a defibrillator but also work to pace their heart to help it pump stronger. If we can improve the way that their heart pumps, they can live longer with fewer heart failure symptoms.

The last area of research that we do, but another large area for us, is abnormal heart rhythms. Atrial fibrillation is an extremely common abnormal heart rhythm. The top part of their heart has a fast rhythm, placing them at risk for stroke. We put a small catheter inside the heart to find the source of the abnormal rhythm. Then we send either heat or freezing energy through the catheter to destroy that problem tissue.

Kentucky Doc: How did the Lexington Cardiac Research Foundation come about?

Dr. Tomassoni: For the first four or five years, we operated as our own entity with the hospital, doing our own clinical research. In 2006, we developed a separate entity, the Lexington Cardiac Research Foundation. The Foundation not only does electro-physiology research, but also general cardiology, interventional cardiology, and cardio-thoracic protocols.

Kentucky Doc: Are there any heart health aspects specific to Kentucky that you have noticed?

Dr. Tomassoni: Kentucky’s population is at high risk for developing heart failure from underlying coronary disease and atrial fibrillation, so the area and our research fit very well.

Kentucky Doc: And how receptive are patients to the idea of participating in a trial?

Dr. Tomassoni: A significant number of patients are very receptive because if they are not enrolled in these trials, they wouldn’t be able to receive the possible benefits of the devices.

Once the FDA trial is over, the device stays implanted in the patient. Usually, these are devices that are already approved for other patient populations but they are expanding their indications for different patient populations.

Kentucky Doc: What are the biggest benefits of the device trials, both for you and for the patients?

Dr. Tomassoni: Our biggest benefit is that we can offer patients different opportunities to get better clinically. If we did not have the Foundation or perform the research that we do, many of these patients would either have to go elsewhere or would not be able to receive treatment for their underlying condition. As a clinical physician, the biggest benefit is that I can provide extra help to improve a patient’s quality of life and their longevity. And that’s what clinical research is really all about.

By Fiona Young-Brown, Editor, KY Doc Magazine

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