Cardiac patients once considered too risky for surgery are now being given another chance at life.
If you could peer inside your heart, you would see that the valves are busy maintaining a steady rhythm—open, close, open, close—to pump blood throughout your body. But what happens when something interferes with that rhythm? In patients with severe aortic stenosis (AS)—a narrowing of the aortic valve—the valve does not open properly, thereby forcing the heart to work harder and, over time, weakening the heart muscle. As the disease progresses, so too do the symptoms of heart failure; patients may experience everything from fatigue and shortness of breath to fainting and chest pain. Left untreated, severe AS can become debilitating—even life-threatening.
Until recently, the only treatment for severe AS was valve replacement with open-heart surgery—a procedure considered too risky for many people with advanced co-morbidities or for many elderly patients. But earlier this year, the FDA approved CoreValve, a transcatheter aortic valve replacement (TAVR), for patients of prohibitive risk—those with a combined mortality and irreversible morbidity (like a stroke or kidney failure) greater than 50 percent. Atlantic Health System’s Gagnon Cardiovascular Institute was one of 45 sites nationwide to participate in the Extreme Risk Study of the CoreValve U.S. Pivotal Trial, which led to the FDA approval of the CoreValve System in January. “We did about 200 procedures in the three years since we were engaged in the study, and we expect to do another hundred this year,” says interventional cardiologist Robert Kippermam, MD, FACC, of Associates in Cardiovascular Disease. He explains that CoreValve is not a surgery, but rather an incision-less, percutaneous treatment. Using fluoroscopy (x-ray) and often echocardiography (ultrasound) for guidance, physicians are able to run a catheter from the femoral artery in the thigh all the way to the heart. A wire is passed through an artery through the stenotic valve; then a balloon is passed over the wire, advanced to the stenotic valve, inflated (like angioplasty), and removed to prepare the native valve for the replacement valve. Next the valve within a catheter is threaded over the same wire and advanced within the native valve and deployed (like a stent procedure). Patients typically are discharged from the hospital three or four days after the procedure.
“This is for patients who are too sick for surgery, but who are candidates to have a valve replaced,” says Kipperman, noting that he has used CoreValve to treat patients as old as 97. “We don’t yet know how this valve will hold up over time because the procedure is new, but chances are that CoreValve patients will do as well as surgical patients—the five-year data are comparable. The outcomes we’ve seen have been excellent, with low complication rates and high success rates.” In fact, it is expected that CoreValve will soon be FDA-approved for the treatment of patients in the high-risk category (less risk of mortality than the prohibitive group, but still at significant risk for not being able to survive an open-heart valve replacement).
Adds interventional cardiologist Barry Cohen, MD, FSCAI, FACC, also of Associates in Cardiovascular Disease and the Medical Director of Morristown Medical Center’s Cath Lab, “Open-heart valve replacement remains the gold standard, but for patients who cannot tolerate that, CoreValve is a much less invasive procedure. It’s giving patients an option to improve their quality of life.”
Another percutaneous technique that is improving lives is the mitral valve clip (MitraClip®), used when there is a leaky mitral valve causing heart failure or when there is a weakened heart muscle. Kipperman explains that one type of surgical repair for the mitral valve (in select patients) consists of sewing together the center of the leaflets, but doctors are able to achieve the same outcome less invasively with a catheter procedure and a mitral valve clip.
Says Kipperman, “These procedures represent the next era of medicine.”
For more information about Gagnon Cardiovascular Institute, call (973) 971-5000.
It Starts With a Study
Clinical trials help deliver next-generation care to today’s patients.
The success of CoreValve illustrates how clinical trials help to define patient care. There are currently 12 active cardiac clinical trials at Overlook Medical Center, reports Donna Watridge, Nurse Manager of Cardiac Research for Atlantic Health System. “We’re providing patients access to cutting-edge therapies and specialized care.”
Among the trials underway are several investigational trials of new drugs that may lower lipid profiles, as well as a prophylactic therapy for the prevention of deep vein thrombosis (clots in the lower extremities) among inpatients. There is also an active registry program to track patients who have had heart attacks, to gauge how they recover.
For more information on these studies and others, call the Research Office at (908) 522-6277.