PARTNER II trial offers aortic valve replacement without open-heart surgery
Building on its history of cardiology research, Beaumont Hospital, Royal Oak launched the Partner II transcatheter aortic valve implantation research trial on Sept. 15, providing aortic valve replacement without open-heart surgery for high-risk patients.
The Partner II trial is a follow-up to previous research testing the safety and effectiveness of the Edwards SAPIEN transcatheter heart valve, a collapsible heart valve implanted with a catheter-based delivery system, rather than through open-heart surgery. In 2005, Beaumont was the first hospital in North America to implant an Edwards transcatheter aortic valve, replacing a patient's diseased heart valve without surgery which requires opening the patient's chest and stopping his heart.
Since 2005, Beaumont cardiologists and cardiac surgeons have performed 22 transcatheter aortic valve replacements, more than any other hospital in Michigan.
"In the PARTNER II trial we are evaluating a new valve that we think will be more durable and a smaller delivery system that will allow us to treat more patients with fewer vascular complications," says George Hanzel, M.D., director, Cardiac Catheterization Laboratory, Beaumont Hospital, Royal Oak.
Study patients will be randomized to the SAPIEN valve tested in the earlier trial, or a new, thinner SAPIEN XT valve. The FDA-approved multi-center trial will involve 600 patients in about 35 centers in the U.S. The SAPIEN valve has been in use for seven years with a track record of durability. Beaumont is the only hospital in Michigan that is implanting the SAPIEN valve through participation in the Partner trial.
Patients who are candidates for the study are those with severe aortic valve narrowing who are at high risk for open-heart surgery.
"This research offers patients who are too high risk for surgery with a potential new treatment alternative to improve and extend their lives," says Frank Shannon, M.D., Beaumont cardiovascular surgeon and a co-investigator in the trial.
For more information on the study, call 248-898-2697.
The SAPIEN valve is placed into the body using a catheter that can be inserted through the patient's femoral artery in the groin, or through a small, 1-1/2 inch chest incision between the ribs for patients who have severe peripheral (arm or leg) vascular disease, are small in stature or have had previous open-heart surgery. The valve is crimped down to about the diameter of a pencil when it is inserted in the catheter, and expanded with a balloon when it is placed in the heart.
The Partner I trial, the world's first randomized study of transcatheter heart valve replacement, compared the results of 358 inoperable patients with severe aortic stenosis treated with the SAPIEN transcatheter valve versus standard therapy. In results published in the New England Journal of Medicine in Sept. 2010, the rate of death from any cause at one year for standard therapy patients was 50.7 percent compared with 30.7 percent for those receiving the transcatheter valve.
Up to 1.5 million people in the U.S. have aortic stenosis, a progressive disease affecting the aortic valve. Severe aortic stenosis is the narrowing or obstruction of the aortic heart valve and is most often caused by calcium deposits on the valve's leaflets, impairing the ability to open and close properly to ensure proper blood flow. This leads to debilitating symptoms, such as shortness of breath, chest pain, fatigue, fainting, and dizziness, that can restrict normal daily activities, such as walking short distances or climbing stairs.
More than 12,000 patients have been implanted with Edwards SAPIEN valves worldwide.
Beaumont offers a wide range of minimally invasive heart procedures, including hybrid approaches that combine the expertise of interventional cardiologists and cardiac surgeons. Beaumont is Michigan's, and one of the nation's, most experienced providers of heart care, ranking on the 2011 U.S. News & World Report list of "America's Best Hospitals" for heart and heart surgery.
Video and animation of heart valve