Study shows promising results for minimally invasive heart valve replacement option

September 22, 2010

KANSAS CITY, Mo. — Patients who are considered non-operable for conventional open heart valve surgery may have promising options using a new treatment available in the region only through Saint Luke's Mid America Heart Institute.

A study published in the Sept. 23 New England Journal of Medicine evaluated patients who were considered too high-risk for conventional aortic valve replacement. In the study, 358 patients were divided between continued medical therapy without surgery or a novel transcatheter aortic valve replacement. At one year, patients who had the transcatheter valve replacement had a 54 percent lower risk of death or hospitalization from heart failure compared to those managed with standard medical therapy alone. 

Saint Luke's Mid America Heart Institute is the only hospital in the region and one of only 17 centers across the U.S. selected to participate as an investigative site in the PARTNER pivotal clinical trial. The trial evaluated the Edwards SAPIEN transcatheter aortic heart valve in patients with severe aortic stenosis (a narrowing of the valve that severely restricts blood flow) who were not candidates for traditional valve replacement surgery. Since September 2008, Saint Luke's has enrolled 39 patients in the study.

The PARTNER trial is the world's first randomized, controlled pivotal trial of a transcatheter aortic heart valve, a collapsible valve that can be introduced into the body through a catheter-based delivery system via one of two approaches: through a small incision through the groin (similar to coronary angioplasty or stenting) or between the ribs. The valve replaces a patient's diseased “native” valve without traditional open-heart surgery and while the patient's heart continues to beat. 

Advancements in transcatheter technologies hold promise for a large number of high-risk patients suffering from severe aortic stenosis. According to Edwards Life Sciences, up to 1.5 million people in the U.S. suffer from aortic stenosis, a progressive disease that affects the aortic valve of their hearts. Within this group of patients, approximately 300,000 people suffer from severe aortic stenosis, often developing debilitating symptoms that can restrict normal day-to-day activities, such as walking short distances or climbing stairs. Such patients can often benefit from surgical valve replacement, but many are deemed too high-risk for surgery either because of advanced age or additional coexisting medical conditions. 

Edwards received conditional approval for the trial from the FDA in March 2007. 

Doctors at Saint Luke's were chosen for the trial because of their expertise in valve replacement surgery and vast experience in interventional procedures. 

“We are delighted to have contributed to this research and excited that we can offer such an important breakthrough to our patients,” said cardio-thoracic surgeon A. Michael Borkon, M.D., co-principal investigator of the PARTNER trial along with cardiologist David J. Cohen, M.D.

“These results are very gratifying and demonstrate that even for patients who are not candidates for traditional valve surgery, transcatheter aortic valve replacement can improve long-term survival and quality of life in a meaningful way,” said Dr. Cohen.

Co-investigator and surgeon Keith Allen, M.D., added, “In the two years we've been involved in this study, Saint Luke's has evaluated many patients from around the Midwest who've been denied therapy for their aortic stenosis. It's been extremely rewarding to be able to offer a procedure to this particularly ill group of patients and obtain such impressive results.”

The procedure marries the expertise of two distinct cardiac disciplines for which Saint Luke's is well known nationally – interventional cardiology and cardiothoracic surgery. Saint Luke's performs the procedure in its hybrid suite, a state-of-the-art cath lab/operating room that houses all the equipment, imaging and monitoring devices necessary to perform open-heart surgeries, like coronary bypass grafting, as well as percutaneous coronary interventions and procedures like balloon valvuloplasty and percutaneous repair of aortic aneurysms.

For more information about the study, visit Edwards Life Sciences at www.edwards.com or the New England Journal of Medicine at www.nejm.org.