Two-year outcomes after transcatheter or surgical aortic-valve replacement.

Journal Article (Journal Article;Multicenter Study)

BACKGROUND: The Placement of Aortic Transcatheter Valves (PARTNER) trial showed that among high-risk patients with aortic stenosis, the 1-year survival rates are similar with transcatheter aortic-valve replacement (TAVR) and surgical replacement. However, longer-term follow-up is necessary to determine whether TAVR has prolonged benefits. METHODS: At 25 centers, we randomly assigned 699 high-risk patients with severe aortic stenosis to undergo either surgical aortic-valve replacement or TAVR. All patients were followed for at least 2 years, with assessment of clinical outcomes and echocardiographic evaluation. RESULTS: The rates of death from any cause were similar in the TAVR and surgery groups (hazard ratio with TAVR, 0.90; 95% confidence interval [CI], 0.71 to 1.15; P=0.41) and at 2 years (Kaplan-Meier analysis) were 33.9% in the TAVR group and 35.0% in the surgery group (P=0.78). The frequency of all strokes during follow-up did not differ significantly between the two groups (hazard ratio, 1.22; 95% CI, 0.67 to 2.23; P=0.52). At 30 days, strokes were more frequent with TAVR than with surgical replacement (4.6% vs. 2.4%, P=0.12); subsequently, there were 8 additional strokes in the TAVR group and 12 in the surgery group. Improvement in valve areas was similar with TAVR and surgical replacement and was maintained for 2 years. Paravalvular regurgitation was more frequent after TAVR (P<0.001), and even mild paravalvular regurgitation was associated with increased late mortality (P<0.001). CONCLUSIONS: A 2-year follow-up of patients in the PARTNER trial supports TAVR as an alternative to surgery in high-risk patients. The two treatments were similar with respect to mortality, reduction in symptoms, and improved valve hemodynamics, but paravalvular regurgitation was more frequent after TAVR and was associated with increased late mortality. (Funded by Edwards Lifesciences; number, NCT00530894.).

Full Text

Duke Authors

Cited Authors

  • Kodali, SK; Williams, MR; Smith, CR; Svensson, LG; Webb, JG; Makkar, RR; Fontana, GP; Dewey, TM; Thourani, VH; Pichard, AD; Fischbein, M; Szeto, WY; Lim, S; Greason, KL; Teirstein, PS; Malaisrie, SC; Douglas, PS; Hahn, RT; Whisenant, B; Zajarias, A; Wang, D; Akin, JJ; Anderson, WN; Leon, MB; PARTNER Trial Investigators,

Published Date

  • May 3, 2012

Published In

Volume / Issue

  • 366 / 18

Start / End Page

  • 1686 - 1695

PubMed ID

  • 22443479

Electronic International Standard Serial Number (EISSN)

  • 1533-4406

Digital Object Identifier (DOI)

  • 10.1056/NEJMoa1200384


  • eng

Conference Location

  • United States