PARTNER Cohort A: Quality of life, costs improved with TAVR

TCT 2011

SAN FRANCISCO — Transcatheter aortic valve replacement improved quality of life and saved costs for high-risk patients with severe aortic stenosis compared with surgical valve replacement, but only when performed via the transfemoral approach.

Results of the landmark PARTNER trial, reported earlier in 2011 at the American College of Cardiology Scientific Sessions, found transcatheter aortic valve replacement (TAVR) noninferior to surgical aortic valve replacement (AVR) for the primary endpoint of 12-month mortality among high-risk patients with severe aortic stenosis.

Superior quality of life

Data from a new analysis by David J. Cohen, MD, MSc, and the PARTNER trial investigators reveal substantial improvements in disease-specific and generic health-related quality of life measures at 1 year with TAVR and surgical AVR.

The researchers measured quality of life using the Kansas City Cardiomyopathy Questionnaire, the SF-12 health status survey and the EuroQOL. Patients were assessed on a broad range of factors, such as symptoms, physical and social limitations, and overall quality of life upon enrollment in the trial and at follow-up intervals of 1, 6 and 12 months. Six hundred ninety-nine patients were randomly assigned to TAVR (n=348) or surgical AVR (n=351). The study population was then separated between patients who were eligible for transfemoral valve implantation (n=492) and those for whom only a transapical approach through a small incision in the chest was possible (n=207).

For transfemoral patients, TAVR resulted in substantial quality-of-life benefits vs. surgical AVR at 1 month, with similar benefits at later time points. For patients eligible only for the transapical approach, there was no benefit of TAVR over surgical AVR at any time point, and quality-of-life measures tended to be better with surgical AVR at both 1 and 6 months.

“Taken together with previous data, these findings demonstrate that for patients suitable for a transfemoral approach, TAVR provides meaningful clinical benefits compared with surgical AVR from the patient’s perspective,” said Cohen, who is professor of medicine at the University of Missouri-Kansas City and director of CV 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 AVR in such patients. Whether further experience and refinements in the transapical approach can overcome these limitations should be the subject of future investigation,” Cohen said.

Cost reductions

The cost-effectiveness of TAVR compared with surgical AVR depends on whether TAVR is performed via the femoral artery or transapically, new data suggest.

Among high-risk patients eligible for the transfemoral approach, TAVR provided small but significant gains in 12-month quality-adjusted life expectancy (0.06 to 0.07 quality-adjusted life years) and was associated with higher procedural costs but slightly lower index hospitalization and 12-month costs vs. surgical AVR.

However, not all patients qualify medically for the transfemoral approach. Among those only eligible for the transpical approach, TAVR provided no increase, and a possible decrease, in quality-adjusted life years and increased procedural, index admission and 12-month costs by about $10,000 per patient.

Researchers used data from the Cohort B arm of the PARTNER trial to combine cost data with survival and quality-of-life data to estimate the 1-year cost-effectiveness of both procedures and to explore potential differences in costs and cost-effectiveness of TAVR vs. AVR for the transfemoral vs. transapical populations.

“Results of this trial indicate that for patients with severe aortic stenosis and high surgical risk, TAVR is an economically attractive and possibly dominant strategy compared with surgical AVR, provided that patients are suitable for the transfemoral approach,” Matthew R. Reynolds, MD, director of the Economics and Quality of Life Research Center at Harvard Clinical Research Institute, said in a press release.

“Current results for TAVR via the transapical approach, compared with surgical AVR, are unattractive from a health economic perspective. Whether the transapical approach can be refined to provide faster recovery and better results from a cost perspective should be the subject of further study,” Reynolds said.

Disclosure: The trial is funded by a research grant from Edwards Lifesciences. Dr. Cohen reports no relevant financial disclosures. Dr. Reynolds reports that his research organization receives grant support from Edwards Lifesciences.

For more information:

Cohen DJ. Plenary session XIII. Late-breaking clinical trials and first report investigations II.
Reynolds MR. Both presented at: the 2011 Transcatheter Cardiovascular Therapeutics Scientific Symposium; Nov. 7-11; San Francisco.