The rates of mortality and reintervention at 10 years were higher in patients at intermediate risk who underwent TAVR with the second-generation SAPIEN XT valve than those who underwent surgery in the PARTNER 2A trial, according to an analysis published June 16 in a valvular heart disease focus issue of JACC. Also published in the focus issue, an analysis of data from PARTNER 2A and the prospective Partner 2 SAPIEN 3 Intermediate-Risk Registry (P2S3i), found that the rates of mortality and reintervention were similar after propensity-matching in patients who underwent TAVR and surgery. All patients had severe symptomatic aortic stenosis.

In the PARTNER 2A trial, 974 patients were randomized to TAVR with the SAPIEN XT system, with the transfemoral approach used in 77%, and 936 patients to surgery. The mean age of patients was 82 years, 46% were women and their mean Society of Thoracic Surgeons score was 5.8%. At five years, at the end of the original trial, patients reconsented to continue in the 10-year extension. Outcomes for this analysis were available in about 90% of each group.

Results showed a similar rate of all-cause mortality at 10 years: 86% with TAVR and 83% with surgery (hazard ratio [HR], 1.13; p=0.02). Looking at mortality by access route, rates were comparable for transfemoral TAVR and surgery (84% and 82%; p=0.27) but were higher for transapical/transaortic TAVR vs. surgery (93% vs. 85%; p<0.001; p_int=0.03).

For aortic valve reintervention, cumulative incidence rates were 6% for TAVR and 2% for surgery (p<0.001).

"Patients requiring [transapical/transaortic] access represent a distinct clinical phenotype, as these patients are typically selected because of unfavorable iliofemoral anatomy or advanced peripheral vascular disease, which is associated with a greater burden of systemic atherosclerotic disease and cardiovascular comorbidity," write Vinod H. Thourani, MD, FACC, and colleagues for the PARTNER 2 Investigators. The transfemoral approach is used in about 95% of TAVR procedures in the U.S.

For the P2S3i analysis, Tamim Nazif, MD, Martin B. Leon, MD, FACC, et al., used propensity matching of the patients in the prospective S3 registry, all of whom received the third-generation, balloon-expandable SAPIEN 3 valve, and the patients who underwent surgery in the PARTNER 2A trial to explore 10-year outcomes. There were 783 patients in both groups after the matching, and baseline characteristics were similar.

Results were similar in the TAVR and surgery groups, respectively, for all-cause mortality (83.4% and 82.3%) and aortic valve reintervention (2% for each group, adjusted for competing mortality).

Notably, there were comparable mortality rates for transfemoral TAVR and surgery (85% and 82%) and transapical/transaortic TAVR and surgery (87% and 84%).

"It is possible that the design improvements of the [SAPIEN 3] may have translated to improved long-term results," Nazif, et al., write. "Given the continued rapid evolution of the TAVR field during this period, these differences [compared to SAPIEN XT] may also reflect improvements in TAVR operator techniques and patient screening, for example, with routine use of computed tomography imaging for valve sizing and less reliance on [transapical/transaortic] access."

"The central question [regarding TAVR] has never been whether deterioration occurs, but rather when it becomes clinically meaningful and how it compares with surgical bioprostheses over the long term," write Davide Capodanno, MD, and Kamil Bujak, MD, in an accompanying editorial comment. "In this context, the 10-year outcomes from the [PARTNER 2A] trial and the [P2S3i] represent a major milestone, allowing the field to move beyond midterm follow-up."

While Michael A. Borger, MD, FACC, writes in an another editorial comment that the results regarding SAPIEN 3 are promising, he cautions against a "full steam ahead" approach, noting the population of older, higher risk patients. "We therefore need to look at the results in younger, lower-risk patient populations to guide us on current TAVR decision-making processes," he writes. "Will technologic advances continue to push TAVR into the ever-shrinking SAVR patient population? Only time will tell."

"For heart teams, the takeaway is both reassuring and demanding," concludes JACC Executive Associate Editor Aakriti Gupta, MD, FACC, in an Editor's Note. "These studies raise the standard for what constitutes an acceptable index result. Residual paravalvular leak, marginal sizing or a nonfemoral access strategy may be more consequential than we think. Over time, they may shape the patient's symptoms, need for reintervention and long-term survival."