SAN FRANCISCO, CA – NOVEMBER 10, 2011 – Results of the PARTNER Cohort A QOL study demonstrate that transcatheter aortic valve replacement (TAVR) results in improved quality of life compared with surgical valve replacement, but only when performed via the transfemoral approach. The results of the study were presented today at the 23rd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation.
Over the past decade, TAVR has been developed as a less invasive alternative to surgical valve replacement (AVR) for high-risk patients with severe aortic stenosis. In the landmark PARTNER trial, reported earlier this year at the ACC Scientific Sessions, TAVR was found to be non-inferior to surgical AVR for the primary endpoint of one-year mortality among high risk patients with severe aortic stenosis. However, the overall impact of this alternative treatment on the patients' health-related quality of life has not been previously reported.
Researchers measured quality of life using the Kansas City Cardiomyopathy Questionnaire (KCCQ, the primary endpoint), the SF-12 Health Status Survey, and the EuroQOL (EQ-5D). Patients were assessed on a broad range of factors, such as their symptoms, physical and social limitations and overall quality of life upon enrollment in the trial and at follow-up intervals of one month, six months and 12 months. A total of 699 patients were randomized to either TAVR (N=348) or SAVR (N=351).
The study population was then broken down between the patients who were eligible for transfemoral (TF) valve implantation (n=492) and a separate group of patients for whom only a transapical (TA) approach through a small incision in the chest was possible (n=207).
At one year follow-up, patients who underwent either surgical or transcatheter aortic valve replacement experienced substantial improvement in disease-specific and generic health quality of life measures. For TF patients, TAVR resulted in substantial quality of life benefits compared with surgical AVR at one month with similar benefits at later time points. For patients eligible only for the TA approach, there was no benefit of TAVR over AVR at any time point, and quality of life measures tended to be better with surgical AVR at both one and six months.
"Taken together with previous data, these findings demonstrate that for patients suitable for a transfemoral approach, transcatheter aortic valve replacement provides meaningful clinical benefits compared with surgical aortic valve replacement from the patient's perspective," said David J. Cohen, MD, the principal investigator for the quality of life sub-study. Dr. Cohen is Professor of Medicine at the University of Missouri-Kansas City and Director of Cardiovascular Research at Saint Luke's Mid America Heart Institute.
"The lack of benefit and suggestion of worse outcomes among patients ineligible for the transfemoral approach suggest that the transapical approach may not be preferable to surgical aortic valve replacement in such patients. Whether further experience and refinements in the transapical approach can overcome these limitations should be the subject of future investigation."
The trial is funded by a research grant from Edwards Lifesciences, Inc. Dr. Cohen reported no other financial relationship with the company.
About CRF and TCT
The Cardiovascular Research Foundation (CRF) is an independent, academically focused nonprofit organization dedicated to improving the survival and quality of life for people with cardiovascular disease through research and education. Since its inception in 1991, CRF has played a major role in realizing dramatic improvements in the lives of countless numbers of patients by establishing the safe use of new technologies, drugs and therapies in interventional cardiovascular medicine.
Transcatheter Cardiovascular Therapeutics (TCT) is the annual scientific symposium of the Cardiovascular Research Foundation. TCT gathers leading medical researchers and clinicians from around the world to present and discuss the latest developments in the field.
For more information, visit www.crf.org.