Year: 2012
Type: article
Abstract: 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; ClinicalTrials.gov number, NCT00530894.).
Source: New England Journal of Medicine
Authors: Susheel K. Kodali, Mathew R. Williams, Craig R. Smith, Lars G. Svensson, John G. Webb, Raj R. Makkar, Gregory P. Fontana, Todd M. Dewey, Vinod H. Thourani, Augusto D. Pichard, Michael Fischbein, Wilson Y. Szeto, Scott Lim, Kevin L. Greason, Paul S. Teirstein, S. Chris Malaisrie, Pamela S. Douglas, Rebecca T. Hahn, Brian Whisenant, Alan Zajarias, Duolao Wang, Jodi J. Akin, William N. Anderson, Martin B. Leon
Institutions: NewYork–Presbyterian Hospital, Columbia University Irving Medical Center, Cleveland Clinic, University of British Columbia, St. Paul's Hospital, Cedars-Sinai Medical Center, Lenox Hill Hospital, Medical City Dallas Hospital, Emory University, MedStar Washington Hospital Center, Stanford Medicine, Stanford University, Hospital of the University of Pennsylvania, University of Virginia, Mayo Clinic, Scripps Clinic, Northwestern University, Duke Medical Center, Intermountain Medical Center, Barnes-Jewish Hospital, Washington University in St. Louis, London School of Hygiene & Tropical Medicine, Edwards Lifesciences (United States)
Language: English
Subfield: Cardiology and Cardiovascular Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W2166973706