The PARTNER trial was 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.
Saint Luke’s Mid America Heart Institute was the only hospital in the region and one of a few centers across the country selected to participate as an investigative site in the trial.
The device was approved on Nov. 2 by the Food and Drug Administration for transfemoral (TF) delivery of the valve for the treatment of inoperable patients with severe aortic stenosis (a narrowing of the valve that severely restricts blood flow).
Over the past decade, transcatheter aortic valve replacement (TAVR) has been developed as a less invasive alternative to surgical valve replacement for high-risk patients with severe aortic stenosis. In research reported earlier this year, 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 relative benefits of TAVR or conventional valve surgery on patients’ health-related quality of life have 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 TF valve implantation and a separate group of patients for whom only a transapical (TA) approach through a small incision in the chest was possible.
At the one-year follow-up, patients who underwent either surgical or transcatheter AVR 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 important benefits compared with surgical aortic valve replacement from the patient’s perspective,”
“The lack of benefit and suggestion of worse quality of life among patients ineligible for the transfemoral approach suggest that the transapical approach may not be preferable to surgical aortic valve replacement in such patients,” said Dr. Cohen. “Whether further experience and refinements in the transapical approach can overcome these limitations should be the subject of future investigation.”
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-
The trial was funded by a research grant from Edwards Lifesciences. The symposium was sponsored by the Cardiovascular Research Foundation.
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 http://www.crf.org.
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Saint Luke's Health System based in Kansas City, Mo., consists of 11 area hospitals in northwest Missouri and eastern Kansas, and several primary and specialty care practices. We provide a range of inpatient, outpatient, and home care services.