Journal of the American College of Cardiology 2014 by the American College of Cardiology Foundation Published by Elsevier Inc Vol 63 No 19 2014 ISSN 0735 1097 36 00 http dx doi org 10 1016 j jacc 2014 02 556 Transcatheter Aortic Valve Replacement Using a Self Expanding Bioprosthesis in Patients With Severe Aortic Stenosis at Extreme Risk for Surgery Jeffrey J Popma MD David H Adams MD y Michael J Reardon MD z Steven J Yakubov MD x Neal S Kleiman MD z David Heimansohn MD k James Hermiller JR MD k G Chad Hughes MD J Kevin Harrison MD Joseph Coselli MD Jose Diez MD Ali Ka MD Theodore Schreiber MD Thomas G Gleason MD yy John Conte MD zz Maurice Buchbinder MD xx G Michael Deeb MD kk Blas Carabello MD Patrick W Serruys MD PHD Sharla Chenoweth MS Jae K Oh MD yyy for the CoreValve United States Clinical Investigators Boston Massachusetts New York New York Houston Texas Columbus Ohio Indianapolis Indiana Durham North Carolina Detroit and Ann Arbor Michigan Pittsburgh Pennsylvania Baltimore Maryland Palo Alto California Rotterdam the Netherlands and Minneapolis and Rochester Minnesota Objectives This study sought to evaluate the safety and ef cacy 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 ef cacy 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 speci ed 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 con dence 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 Ef cacy 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 J Am Coll Cardiol 2014 63 1972 81 2014 by the American College of Cardiology Foundation From the Beth Israel Deaconess Medical Center Boston Massachusetts yMount Sinai Medical Center New York New York zHouston Methodist Debakey Heart and Vascular Center Houston Texas xRiverside Methodist Hospital Columbus Ohio kSt Vincent s Medical Center Indianapolis Indiana Duke University Medical Center Durham North Carolina Texas Heart Institute at St Luke s Medical Center Houston Texas Detroit Medical Center Detroit Michigan yyUniversity of Pittsburgh Medical Center Pittsburgh Pennsylvania zzJohns Hopkins Medical Center Baltimore Maryland xxPalo Alto Veterans Administration Medical Center Palo Alto California kkUniversity of Michigan Medical Center Ann Arbor Michigan Baylor College of Medicine Houston Texas Thoraxcenter Rotterdam the Netherlands Medtronic Inc Minneapolis Minnesota and the yyyMayo Clinic Foundation Rochester Minnesota A complete list of the investigators institutions and research organizations participating in the CoreValve US Extreme Risk Study is in the Online Appendix This study was sponsored by JACC Vol 63 No 19 2014 May 20 2014 1972 81 Degenerative aortic valve disease resulting in severe stenosis is the most common form of valvular heart disease in developed countries 1 Surgical aortic valve replacement SAVR remains the therapy of choice for most patients with severe aortic stenosis and this therapy is associated with an improvement in both symptoms and survival 2 A signi cant number of patients with severe aortic stenosis however are not candidates for SAVR due to pre existing comorbidities frailty and disabilities 3 Patients denied surgery have a dismal prognosis with an estimated mortality rate of 50 within 1 year after surgical evaluation 4 Transcatheter aortic valve replacement TAVR is an alternative to SAVR in selected patients with aortic stenosis 5 6 Balloon expandable TAVR in patients deemed unsuitable for surgery reduced 12 month mortality compared with medical therapy albeit with a higher 30 day incidence of major stroke vascular complication and paravalvular regurgitation 4 each of which was associated with late mortality 4 7 The CoreValve self expanding transcatheter bioprosthetic heart valve Medtronic Inc Minneapolis Minnesota has been widely used worldwide 8 9 but a rigorous prospective evaluation of this device in patients recognized to be at an extreme risk for surgery has not been performed The CoreValve Extreme Risk Pivotal Trial evaluated patients who were deemed to have an extreme risk for SAVR and were treated with this self expanding transcatheter heart valve THV Our objective was to evaluate the clinical safety and ef cacy of self expanding TAVR in patients at extreme risk for SAVR Popma et al TAVR in Extreme Risk Patients 1973 Patient selection Patients with New York Heart Association NYHA class II or greater symptoms related to aortic valve disease were eligible for the trial Severe aortic stenosis was de ned as an aortic valve area 0 8 cm2 or aortic valve index 0 5 cm2 m2 and either a mean aortic valve gradient 40 mm Hg or a peak aortic valve velocity 4 0 m s at rest or with a dobutamine stress if the left ventricular ejection fraction was 50 Patients were considered at extreme risk if 2 cardiac surgeons and 1 interventional cardiologist at the clinical site estimated a 50 or greater risk for mortality or irreversible morbidity at 30 days with SAVR Principal exclusion criteria were an active
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