PARTNER A: Transfemoral TAVR Improved QOL, Costs vs. Surgery

SAN FRANCISCO, CALIF.—Data from cohort A of the PARTNER trial demonstrated that transcatheter aortic valve replacement (TAVR) improved quality of life and was cost-effective in high-risk patients with severe aortic stenosis who underwent a transfemoral approach. Results for TAVR via the transapical approach, however, were not economically attractive and were associated with little quality of life (QOL) benefit.

“The lack of benefit (and suggestion of worse QOL) among patients ineligible for the transfemoral approach suggests that the transapical approach may not be preferred to conventional surgery in such patients,” David J. Cohen, MD, MSc, of the Saint Luke’s Mid-America Heart Institute, Kansas City, said during his presentation on health-related QOL after TAVR.

Results from the overall PARTNER Cohort A trial demonstrated that TAVR was less invasive and noninferior to surgical AVR in 699 high-risk patients with severe aortic stenosis. Until now, there has been a lack of information on the overall effect of these treatments on health-related QOL from the patient’s perspective.

Cohen and colleagues used the Kansas City Cardiomyopathy Questionnaire (KCCQ) to assess the primary endpoint, comprising HF-specific QOL, as well as symptoms, physical limitations, QOL and social limitations. In addition, the SF-12 health survey was used to evaluate general physical and mental health, and EQ-5D health status measure was used to assess quality-adjusted life years.

There was a significant relationship between treatment effect and access site for the primary endpoint (P=.01) and multiple secondary endpoints, Cohen reported. Based on this relationship between treatment effect and access site, the researchers conducted a separate, non-randomized analysis for the transfemoral and transapical groups.

Access site-specific results

The transfemoral approach was associated with a 10-point increase in the KCCQ at 1 month (P<.001). At 6 and 12 months this finding diminished and was no longer significant compared with surgery. The transapical approach, however, demonstrated a statistically significant 8-point difference in favor of surgery at 6 months (P=.04).

Matthew R. Reynolds, MD, MSc, of Harvard Medical School, Boston, on behalf of the PARTNER investigators, presented similar access site-specific results with respect to 12-month cost-effectiveness of TAVR compared with surgical AVR in PARTNER Cohort A. There was a shorter procedure time by about 87 minutes in the transfemoral arm and 130 minutes in the transapical arm compared with surgery (P<.001 for both), but only the transfemoral approach significantly decreased hospital length of stay (by 6.2 days; P<.001).

Estimated mean TAVR costs were just under $35,000 per patient in the transfemoral group, which was roughly $20,000 per patient higher than the cost for surgical procedures, Reynolds said. “This difference was fully, or perhaps slightly more than fully, offset by the substantial reduction in length of stay, such that the total admission costs were roughly $2,500 per patient lower in the TAVR group. This was not statistically significant.”

The transapical approach was more costly than surgery by about $25,000 per patient in terms of procedural costs. Although non-procedural costs during index admission were higher in the surgical group, this did not fully offset the difference in procedural costs, such that overall costs were roughly $11,000 per patient higher in the transapical group vs. surgery.

According to Cohen, future research is needed to determine whether additional experience and refinements of the transapical approach can overcome the limitations.

 “[Among] patients with severe AS and high surgical risk, TAVR is an economically attractive and possibly dominant strategy compared with AVR, provided that patients are suitable for the transfemoral approach,” Reynolds said. “Current results for TAVR via the transapical approach compared with surgical AVR are unattractive from a health economic perspective.”