Tallahassee Memorial HealthCare (TMH), home to the region’s only structural heart program, continues to bring innovative techniques for treating life-threatening heart disorders to patients in the Big Bend region and throughout the Southeast. One of the latest therapies – the MitraClip – is a minimally invasive valve repair procedure used to treat high-risk patients who have mitral regurgitation, also known as a “leaky valve.” The procedure doesn’t require open-heart surgery and instead uses a catheter inserted into a vein near the groin to repair the leaky mitral valve leaflets. For high risk patients, this procedure is safer than surgery and has a much easier recovery, with the vast majority going home the morning after their procedure.
Most recently, Tallahassee Memorial HealthCare, the Tallahassee Research institute (TRI) and Southern Medical Group, P.A. (SMG) collaborated on a pivotal study called the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) Trial. TMH was a major contributor to the study with the first local implantation of the device performed in 2011. The COAPT study was a large-scale national clinical trial designed to evaluate the long-term safety and effectiveness of the minimally invasive MitraClip procedure compared to medicine alone in patients with functional mitral regurgitation and heart failure. The goal of the study was to determine whether treating functional mitral regurgitation with the MitraClip would alter the course of the disease, improve the symptoms, or both. The results of the COAPT trial were highlighted recently in New England’s Journal of Medicine.
“The study demonstrated that the MitraClip dramatically reduced mortality (saving lives), and markedly improved symptoms in patients with mitral regurgitation and heart failure,” said Wayne Batchelor, MD, MHS, FACC, FSCAI, interventional cardiologist at TMH and COAPT trial site principal investigator. “This is some of the biggest news to come out of interventional cardiology in the last decade, and we’re proud to have been major contributors to such a pivotal trial.”
The New England Journal of Medicine publication reported that patients in the trial who were diagnosed with heart failure and mitral regurgitation due to left ventricular dysfunction (weak heart muscle) – who previously suffered from a very poor prognosis – lived longer and better after implantation of the MitraClip. Death from any cause occurred in 29 percent of patients treated with the MitraClip, compared with 46 percent of patients who were assigned to medical therapy alone.
Not only did the MitraClip procedure lower mortality, it also cut hospitalization rates for heart failure in half. Patients who received the MitraClip experienced a 36 percent rate of hospitalization compared with 68 percent in patients who did not receive the MitraClip. Although still awaiting final FDA approval for this indication, this new procedure is expected to secure a more promising future for heart failure patients.
Along with Dr. Batchelor, Thomas Noel, MD, FACC, another interventional cardiologist at TMH, and David Saint, MD, a cardiothoaracic surgeon at TMH, were co-investigators in the COAPT trial and instrumental in helping develop this minimally invasive therapy locally and offering it to patients in the region. TMH was only the second hospital in Florida to offer the procedure when it was first introduced.
“This procedure has been changing lives since it was first introduced,” said Dr. Saint. “But now with the results of the COAPT trial, we can see that it not only has a huge impact on patients with mitral regurgitation, but for patients who have heart failure, as well. This procedure has completely changed the way we can treat patients with heart failure, and hopefully, this will offer them a little more hope.”