Jeffrey J Popma1, David H Adams2, Michael J Reardon3, Steven J Yakubov4, Neal S Kleiman3, David Heimansohn5, James Hermiller5, G Chad Hughes6, J Kevin Harrison6, Joseph Coselli7, Jose Diez7, Ali Kafi8, Theodore Schreiber8, Thomas G Gleason9, John Conte10, Maurice Buchbinder11, G Michael Deeb12, Blasé Carabello13, Patrick W Serruys14, Sharla Chenoweth15, Jae K Oh16. 1. Beth Israel Deaconess Medical Center, Boston, Massachusetts. Electronic address: jpopma@bidmc.harvard.edu. 2. Mount Sinai Medical Center, New York, New York. 3. Houston-Methodist-Debakey Heart and Vascular Center, Houston, Texas. 4. Riverside Methodist Hospital, Columbus, Ohio. 5. St. Vincent's Medical Center, Indianapolis, Indiana. 6. Duke University Medical Center, Durham, North Carolina. 7. Texas Heart Institute at St. Luke's Medical Center, Houston, Texas. 8. Detroit Medical Center, Detroit, Michigan. 9. University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania. 10. Johns Hopkins Medical Center, Baltimore, Maryland. 11. Palo Alto Veterans Administration Medical Center, Palo Alto, California. 12. University of Michigan Medical Center, Ann Arbor, Michigan. 13. Baylor College of Medicine, Houston Texas. 14. Thoraxcenter, Rotterdam, the Netherlands. 15. Medtronic, Inc., Minneapolis, Minnesota. 16. Mayo Clinic Foundation, Rochester, Minnesota.
Abstract
OBJECTIVES: This study sought to evaluate the safety and efficacy of the CoreValve transcatheter heart valve (THV) for the treatment of severe aortic stenosis in patients at extreme risk for surgery. BACKGROUND: Untreated severe aortic stenosis is a progressive disease with a poor prognosis. Transcatheter aortic valve replacement (TAVR) with a self-expanding bioprosthesis is a potentially effective therapy. METHODS: We performed a prospective, multicenter, nonrandomized investigation evaluating the safety and efficacy of self-expanding TAVR in patients with symptomatic severe aortic stenosis with prohibitive risks for surgery. The primary endpoint was a composite of all-cause mortality or major stroke at 12 months, which was compared with a pre-specified objective performance goal (OPG). RESULTS: A total of 41 sites in the United States recruited 506 patients, of whom 489 underwent attempted treatment with the CoreValve THV. The rate of all-cause mortality or major stroke at 12 months was 26.0% (upper 2-sided 95% confidence bound: 29.9%) versus 43.0% with the OPG (p < 0.0001). Individual 30-day and 12-month events included all-cause mortality (8.4% and 24.3%, respectively) and major stroke (2.3% and 4.3%, respectively). Procedural events at 30 days included life-threatening/disabling bleeding (12.7%), major vascular complications (8.2%), and need for permanent pacemaker placement (21.6%). The frequency of moderate or severe paravalvular aortic regurgitation was lower 12 months after self-expanding TAVR (4.2%) than at discharge (10.7%; p = 0.004 for paired analysis). CONCLUSIONS: TAVR with a self-expanding bioprosthesis was safe and effective in patients with symptomatic severe aortic stenosis at prohibitive risk for surgical valve replacement. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902).
OBJECTIVES: This study sought to evaluate the safety and efficacy of the CoreValve transcatheter heart valve (THV) for the treatment of severe aortic stenosis in patients at extreme risk for surgery. BACKGROUND: Untreated severe aortic stenosis is a progressive disease with a poor prognosis. Transcatheter aortic valve replacement (TAVR) with a self-expanding bioprosthesis is a potentially effective therapy. METHODS: We performed a prospective, multicenter, nonrandomized investigation evaluating the safety and efficacy of self-expanding TAVR in patients with symptomatic severe aortic stenosis with prohibitive risks for surgery. The primary endpoint was a composite of all-cause mortality or major stroke at 12 months, which was compared with a pre-specified objective performance goal (OPG). RESULTS: A total of 41 sites in the United States recruited 506 patients, of whom 489 underwent attempted treatment with the CoreValve THV. The rate of all-cause mortality or major stroke at 12 months was 26.0% (upper 2-sided 95% confidence bound: 29.9%) versus 43.0% with the OPG (p < 0.0001). Individual 30-day and 12-month events included all-cause mortality (8.4% and 24.3%, respectively) and major stroke (2.3% and 4.3%, respectively). Procedural events at 30 days included life-threatening/disabling bleeding (12.7%), major vascular complications (8.2%), and need for permanent pacemaker placement (21.6%). The frequency of moderate or severe paravalvular aortic regurgitation was lower 12 months after self-expanding TAVR (4.2%) than at discharge (10.7%; p = 0.004 for paired analysis). CONCLUSIONS: TAVR with a self-expanding bioprosthesis was safe and effective in patients with symptomatic severe aortic stenosis at prohibitive risk for surgical valve replacement. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902).
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Authors: Susheel Kodali; Vinod H Thourani; Jonathon White; S Chris Malaisrie; Scott Lim; Kevin L Greason; Mathew Williams; Mayra Guerrero; Andrew C Eisenhauer; Samir Kapadia; Dean J Kereiakes; Howard C Herrmann; Vasilis Babaliaros; Wilson Y Szeto; Rebecca T Hahn; Philippe Pibarot; Neil J Weissman; Jonathon Leipsic; Philipp Blanke; Brian K Whisenant; Rakesh M Suri; Raj R Makkar; Girma M Ayele; Lars G Svensson; John G Webb; Michael J Mack; Craig R Smith; Martin B Leon Journal: Eur Heart J Date: 2016-03-31 Impact factor: 29.983