PARTNER Analyses Provide Important Insights into TAVR

MIAMI BEACH, FLA.—Three experts at the Valvular Heart Disease Summit provided an in-depth look at data from the PARTNER trial on gender differences, quality of life and early insights into the cost effectiveness of TAVR.

Ajay J. Kirtane, MD, SM, of Columbia University Medical Center, New York, provided a review of gender differences in the PARTNER trial and highlights from two abstract sessions that will be presented on Tuesday.

“In PARTNER, there appears to be differences in the clinical outcomes of TAVR in women compared with men, consistent with prior observational studies. Some of this may correlate with baseline differences,” said Kirtane.

Among inoperable patients in PARTNER cohort B, there were similar mortality benefits of TAVR over standard therapy in both women (30.9% vs. 48.4%) and men (30.5% vs. 51.2%; P=.8 for intraction); however, Kirtane noted there was a higher rate of procedural complications in women (see Figure). Intention-to-treat analysis of cohort B revealed no differences in outcomes between TAVR and standard therapy when stratified by gender, according to data that will be presented Tuesday by Susheel K. Kodali, MD, also of Columbia.

In an analysis of high-risk patients in PARTNER cohort A, differences in mortality among women treated with TAVR vs. surgical aortic valve replacement did not reach statistical significance (28.2% vs. 37.3%; P=.07).

“Independent predictors of outcomes may actually differ based upon whether a woman or man is treated with TAVR,” Kirtane said.

Lessons from QOL studies

For inoperable patients, TAVR provided substantial and sustained QOL improvements across a broad range of disease-specific and generic domains. The QOL benefit in these patients is comparable to an approximate 10-year reduction in age, according to David J. Cohen, MD, MSc, of Saint Luke’s Mid America Heart Institute. The question remains, however, how to prospectively identify patients who will not benefit from TAVR, he said.

For high-risk surgical candidates, the impact of TAVR on QOL differed according to access site. The transfemoral approach was associated with substantial early QOL benefits compared with AVR, with similar results at later time points in the PARTNER trial. The transapical approach was associated with no benefit of TAVR over AVR at any time point.

Early cost estimates of TAVR

Early insights from the PARTNER trial suggest that TAVR is cost effective for inoperable patients, according to Matthew R. Reynolds, MD, MSc, of Harvard Clinical Research Institute, Boston, Mass.

Reynolds reviewed data on TAVR admission costs, suggesting that TAVR is associated with approximately $73,563 per patient in hospital and physician fees.

Independent analyses of the cost effectiveness of TAVR in inoperable patients have yielded consistent results, he said. However, model-based estimates of cost effectiveness for TAVR in high-risk operable patients have differed from the only trial-based estimate. Model results are heavily influenced by nonrandomized comparisons of cost, he added.

“In operative candidates, with noninferiority study designs, TAVR must be close to cost-neutral to be perceived as cost effective. This requires sufficient reductions in length of stay to offset higher valve prices,” Reynolds said.