Interventional CardiologyTranscatheter Aortic Valve Replacement Using a Self-Expanding Bioprosthesis in Patients With Severe Aortic Stenosis at Extr ...MethodsPatient selectionStudy deviceProcedural detailsStudy designAnalysis populationsStudy endpointsEchocardiographic analysisStatistical analysisResultsPatient enrollmentPatient demographicsProcedural outcomesClinical endpointsEchocardiographic findingsDiscussionRisk assessmentMortality and major strokeAortic regurgitationConduction system disturbancesStudy limitationsConclusionsReferencesAppendixTranscatheter Aortic Valve ReplacementUsing a Self-Expanding Bioprosthesis inPatients With Severe Aortic Stenosis atExtreme Risk for SurgeryJeffrey J. Popma, MD,* David H. Adams, MD,y Michael J. Reardon, MD,z Steven J. Yakubov, MD,xNeal 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 Kafi, MD,**Theodore Schreiber, MD,** Thomas G. Gleason, MD,yy John Conte, MD,zzMaurice Buchbinder, MD,xx G. Michael Deeb, MD,kk Blasé Carabello, MD,{{Patrick W. Serruys, MD, PHD,## Sharla Chenoweth, MS,*** Jae K. Oh, MD,yyyfor the CoreValve United States Clinical InvestigatorsBoston, 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, MinnesotaObjectives This study sought to evaluate the safety and efficacy of the CoreValve transcatheter heart valve (THV) for thetreatment 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 valvereplacement (TAVR) with a self-expanding bioprosthesis is a potentially effective therapy.Methods We performed a prospective, multicenter, nonrandomized investigation evaluating the safety and efficacy ofself-expanding TAVR in patients with symptomatic severe aortic stenosis with prohibitive risks for surgery. Theprimary endpoint was a composite of all-cause mortality or major stroke at 12 months, which was compared witha pre-specified objective performance goal (OPG).Results A total of 41 sites in the United States recruited 506 patients, of whom 489 underwent attempted treatmentwith the CoreValve THV. The rate of all-cause mortality or major stroke at 12 months was 26.0% (upper 2-sided95% confidence bound: 29.9%) versus 43.0% with the OPG (p < 0.0001). Individual 30-day and 12-month eventsincluded 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 paravalvularaortic regurgitation was lower 12 months after self-expanding TAVR (4.2%) than at discharge (10.7%; p ¼ 0.004for paired analysis).Conclusions TAVR with a self-expanding bioprosthesis was safe and effective in patients with symptomatic severe aortic stenosisat prohibitive risk for surgical valve replacement. (Safety and Efficacy Study of the Medtronic CoreValve Systemin the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need AorticValve Replacement; NCT01240902) (J Am Coll Cardiol 2014;63:1972–81) ª 2014 by the American College ofCardiology FoundationFrom the *Beth Israel Deaconess Medical Center, Boston, Massachusetts; yMountSinai Medical Center, New York, New York; zHouston-Methodist-Debakey Heartand Vascular Center, Houston, Texas; xRiverside Methodist Hospital, Columbus,Ohio; kSt. Vincent’s Medical Center, Indianapolis, Indiana; {Duke UniversityMedical Center, Durham, North Carolina; #Texas Heart Institute at St. Luke’sMedical Center, Houston, Texas; **Detroit Medical Center, Detroit, Michigan;yyUniversity of Pittsburgh Medical Center, Pittsburgh, Pennsylvania; zzJohnsHopkins Medical Center, Baltimore, Maryland; xxPalo Alto Veterans AdministrationMedical Center, Palo Alto, California; kkUniversity of Michigan Medical Center,Ann Arbor, Michigan; {{Baylor College of Medicine, Houston Texas; ##Thorax-center, Rotterdam, the Netherlands; ***Medtronic, Inc., Minneapolis, Minnesota; andthe yyyMayo Clinic Foundation, Rochester, Minnesota. A complete list of the in-vestigators, institutions, and research organizations participating in the CoreValve USExtreme Risk Study is in the Online Appendix. This study was sponsore d byJournal of the American College of Cardiology Vol. 63, No. 19, 2014 2014 by the American College of Cardiology Foundation ISSN 0735-1097/$36.00Published by Elsevier Inc. http://dx.doi.org/10.1016/j.jacc.2014.02.556Degenerative aortic valve disease resulting in severe stenosis isthe most common form of valvular heart disease in developedcountries (1). Surgical aortic valve replacement (SAVR) re-mains the therapy of choice for most patients with severe aorticstenosis, and this therapy is associated with an improvement inboth symptoms and survival (2). A significant number of pa-tients with severe aortic stenosis, however, are not candidatesfor SAVR, due to pre-existing comorbidities, frailty,and disabilities (3). Patients denied surgery have a dismalprognosis, with an estimated mortality rate of 50% within 1year after surgical evaluation (4).Transcatheter aortic valve replacement (TAVR) is analternative to SAVR in selected patients with aortic stenosis(5,6). Balloon-expandable TAVR in patients deemed un-suitable for surgery reduced 12-month mortality comparedwith medical therapy, albeit with a higher 30-day incidenceof major stroke, vascular complication, and paravalvularregurgitation (4), each of which was associated with latemortality (4,7). The CoreValve self-expand ing transcatheterbioprosthetic heart valve (Medtronic, Inc., Minneapolis,Minnesota) has been widely used worldwide (8,9), but arigorous, prospective evaluation of this device in pa tientsrecognized to be at an extreme risk for surgery has not beenperformed.The CoreValve Extreme Risk Pivotal Trial evaluatedpatients who were deemed to have an extreme risk for SAVRand were treated with this self-expanding transcatheter heartvalve (THV). Our objective was to evaluate the clinical safetyand efficacy of self-expanding TAVR in patients at
View Full Document
Unlocking...