Feature
April
21
Local Physician Leads Clinical Trial
by Anne Kowle
Dr. Peter Fail, Cardiovascular Institute of the South cardiologist and Director of Interventional Cardiology, is a site principal lead investigator for the EVEREST II clinical trial, which recently released 2-year research findings that were published in “The New England Journal of Medicine” and discussed at the American Cardiology Conference, one of the world’s largest, most prestigious cardiovascular meetings held in New Orleans April 2-5.
The trial is evaluating the safety and effectiveness of a non-surgical procedure using a small device, known as the MitraClip® system, to treat patients with mitral regurgitation (MR), the most common type of heart valve problem. The study’s 2-year results, which were presented at the A.C.C. conference and published in The New England Journal of Medicine, revealed that the MitraClip repair ranked superior in safety with similar clinical outcomes to valve surgery.
This less-invasive procedure to repair the valve uses the MitraClip device to bring the “swinging doors” of the valve together, allowing it to close properly. This valve repair is performed in a cardiac catheterization laboratory under general anesthesia. In addition to improving blood flow through the heart, the procedure may also relieve symptoms such as the fatigue and shortness-of-breath that often affect patients with chronic significant MR although it may not be as effective in decreasing mitral regurgitation grade in some patients.
“I think what is encouraging about the 2-year data is that, by intention-to-treat analysis, the MitraClip approach has an early safety advantage,” said Dr. Peter Fail. “As we continue to implant the device and analyze the data, I feel that there is clearly a place for this device to be used on select patients with mitral regurgitation.”
Cardiovascular Institute of the South cardiologists Drs. Eric Engeron and Darrell Solet have both served as sub-investigators in the study. Cardiovascular Institute of the South and Terrebonne General Medical Center in Houma are among nearly 40 medical centers in North America participating in this clinical research study. The trial is conducted under an Investigational Device Exemption approved by the United States Food and Drug Administration and the devices were developed and manufactured by Abbott.
About the American College of Cardiology
The American College of Cardiology is a non-profit medical society with nearly 40,000 members, including physicians, nurses, nurse practitioners, pharmacists, and many more medical professionals.
About Cardiovascular Institute of the South
The Cardiovascular Institute of the South is one of the most respected groups of cardiologists, representing nearly every specialty in heart and circulatory medicine. With a team of nearly 450 dedicated team members, C.I.S. serves communities throughout Louisiana, as well as national and international patients, at its 12 clinics. The Cardiovascular Institute of the South consistently positions itself at the forefront of technology by providing the most up-to-date technology coupled with compassionate care. This mission has guided the institute for more than 27 years of service to south Louisiana.
About MR
An estimated four million people in the United States have significant MR, with an annual incidence of 250,000 newly diagnosed patients. In these patients, blood leaks backward through the mitral valve with each heartbeat, causing the heart to work harder to circulate blood to the body. There are no medications that specifically treat or cure MR, though some patients receive drugs to manage their symptoms. Both the American Heart Association and the American College of Cardiology currently recommend open-heart surgery to repair or replace the mitral valve for patients who suffer from moderate-to-severe or severe MR. However, only 20 percent of these patients, or approximately 50,000, undergo surgery each year.
If left untreated, the heart becomes damaged and eventually is unable to compensate for the MR, leading to congestive heart failure. Patients with significant MR may become weakened by their condition and require open-heart surgery to repair or replace the leaking mitral valve. The two most common causes of MR are valve “degeneration” (so-called “floppy valve”) and heart muscle abnormalities (referred to as “functional” MR) caused primarily by coronary artery disease or cardiomyopathy.
