Transcatheter Aortic Valve Replacement Using a Self-Expanding Bioprosthesis in Patients With Severe Aortic Stenosis at Extreme Risk for Surgery
| Autor: | Jeffrey J, Popma, David H, Adams, Michael J, Reardon, Steven J, Yakubov, Neal S, Kleiman, David, Heimansohn, James, Hermiller, G Chad, Hughes, J Kevin, Harrison, Joseph, Coselli, Jose, Diez, Ali, Kafi, Theodore, Schreiber, Thomas G, Gleason, John, Conte, Maurice, Buchbinder, G Michael, Deeb, Blasé, Carabello, Patrick W, Serruys, Sharla, Chenoweth, Jae K, Oh, Lisa, Hermann |
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| Přispěvatelé: | Cardiology |
| Rok vydání: | 2014 |
| Předmět: |
Male
Cardiac Catheterization medicine.medical_specialty medicine.medical_treatment Prosthesis Design outcomes Severity of Illness Index Valve replacement Aortic valve replacement Risk Factors Internal medicine Severity of illness Clinical endpoint Humans Medicine Prospective Studies Heart valve Prospective cohort study Stroke Aged Aged 80 and over Bioprosthesis Heart Valve Prosthesis Implantation business.industry aortic stenosis Aortic Valve Stenosis medicine.disease Surgery Stenosis Treatment Outcome medicine.anatomical_structure Heart Valve Prosthesis Cardiology transcatheter aortic valve replacement Female business Cardiology and Cardiovascular Medicine Follow-Up Studies |
| Zdroj: | Journal of the American College of Cardiology, 63(19), 1972-1981. Elsevier Inc. |
| ISSN: | 0735-1097 |
| DOI: | 10.1016/j.jacc.2014.02.556 |
| Popis: | 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) (C) 2014 by the American College of Cardiology Foundation |
| Databáze: | OpenAIRE |
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