The Edwards SAPIEN Heart Valve is one of two devices being used for transcatheter aortic valve replacement.
Minimally invasive aortic valve replacement a new option for previously inoperable patients
issue 15 | Spring 2012
Each year, about 100,000 American adults are diagnosed with aortic stenosis, but one-third of patients, because of age or frail health, are considered too high-risk for traditional valve replacement surgery. Without a valve replacement, half of patients with severe aortic stenosis will not survive more than an average of two years after symptoms begin.
"Patients who do not receive an aortic valve replacement have few effective, long-term treatment options to prevent or delay their disease progression," says cardiac surgeon G. Michael Deeb, M.D., director of U-M's multidisciplinary Aortic Clinic and the Herbert Sloan Collegiate Professor of Surgery at the U-M Medical School.
The U-M Cardiovascular Center is among a select group of U.S. hospitals performing transcatheter aortic valve replacement, or TAVR, to replace a patient's diseased aortic valve without heart bypass or open heart surgery. It is also referred to as TAVI, or transcatheter aortic valve implantation.
U-M surgeons and interventional cardiologists now offer comprehensive options to treat aortic stenosis, including the new FDA-approved Edwards SAPIEN Heart Valve and — through a clinical trial — Medtronic's CoreValve prosthesis. The procedures allow access to the aortic valve percutaneously, usually through a femoral artery, rather than through open surgery.
"This gives physicians the tools to take care of patients who we were not able to take care of before," says interventional cardiologist Stanley Chetcuti, M.D., director of the Cardiac Catheterization Lab at the U-M Cardiovascular Center.
The Edwards valve is the only TAVR therapy approved for use in the United States, but some aortic stenosis patients at U-M are also being enrolled in the Medtronic CoreValve U.S. Pivotal trial.
"Studies such as the PARTNER trial with the Edwards valve have substantiated the benefit of TAVR to extend lives," says U-M cardiac surgeon Himanshu Patel, M.D., associate professor of surgery.
Aortic valve replacement team (left to right): Stanley Chetcuti, M.D., Himanshu Patel, M.D., G. Michael Deeb, M.D., and Paul Michael Grossman, M.D.
Research published in 2010 in the New England Journal of Medicine showed that the Edwards SAPIEN valve had a significantly lower mortality rate than standard medical therapy. Seven out of every 10 inoperable patients were alive one year after the procedure, compared with five out of every 10 patients who did not receive a new valve. Patients treated with the Edwards SAPIEN valve also had improved heart function and improved quality of life at one year, as compared with the control group.
QUALITY OF LIFE IS KEY
The goal of aortic valve replacement for these high-risk patients is not only to improve their survival but also to enhance their lives.
"For most of these patients, their quality of life is quite impaired because of severe aortic valve disease. They physically cannot do the things that they want to do," says interventional cardiologist Paul Michael Grossman, M.D., associate professor of Internal Medicine at U-M and director of the Cardiac Catheterization Laboratory at the VA Ann Arbor Healthcare System.
"We're very hopeful that this technology will offer them the opportunity to get back some of the quality of life that they probably have lost in the last several years," he says. "In addition to that, certainly the success will be measured in our ability to collaborate and to learn as surgeons and interventional cardiologists work together."
The U-M aortic program, part of the nationally ranked heart and heart surgery programs at the U-M Cardiovascular Center, performs more than 500 surgical valve procedures a year —more than any other Michigan hospital.