n engl j med 363;17 nejm.org october 21, 20101597The new england journal of medicineestablished in 1812 october 21, 2010 vol. 363 no. 17Transcatheter Aortic-Valve Implantation for Aortic Stenosis in Patients Who Cannot Undergo SurgeryMartin B. Leon, M.D., Craig R. Smith, M.D., Michael Mack, M.D., D. Craig Miller, M.D., Jeffrey W. Moses, M.D., Lars G. Svensson, M.D., Ph.D., E. Murat Tuzcu, M.D., John G. Webb, M.D., Gregory P. Fontana, M.D., Raj R. Makkar, M.D., David L. Brown, M.D., Peter C. Block, M.D., Robert A. Guyton, M.D., Augusto D. Pichard, M.D., Joseph E. Bavaria, M.D., Howard C. Herrmann, M.D., Pamela S. Douglas, M.D., John L. Petersen, M.D., Jodi J. Akin, M.S., William N. Anderson, Ph.D., Duolao Wang, Ph.D., and Stuart Pocock, Ph.D., for the PARTNER Trial Investigators*ABSTR ACTFrom Columbia University Medical Center/NewYork–Presbyterian Hospital, New York (M.B.L., C.R.S., J.W.M.); Medical City Dal-las, Dallas (M.M., D.L.B.); Stanford Uni-versity Medical School, Stanford (D.C.M.), and Edwards Lifesciences, Irvine (J.J.A., W.N.A.) — both in California; Cleveland Clinic Foundation, Cleveland (L.G.S., E.M.T.); University of British Columbia and St. Paul’s Hospital, Vancouver, Canada (J.G.W.); Cedars–Sinai Medical Center, Los Angeles (G.P.F., R.R.M.); Emory Uni-versity School of Medicine, Atlanta (P.C.B., R.A.G.); Washington Hospital Center, Washington, DC (A.D.P.); Hospi-tal of the University of Pennsylvania, Philadelphia (J.E.B., H.C.H.); Duke Uni-versity Medical Center, Durham, NC (P.S.D., J.L.P.); and London School of Hy-giene and Tropical Medicine, London (D.W., S.P.). Address reprint requests to Dr. Leon at Columbia University Medical Center/NewYork–Presbyterian Hospital, 173 Fort Washington Ave., Heart Center, 2nd Fl., New York, NY 10032, or at [email protected].*The investigators, institutions, and re-search organizations participating in the Placement of Aortic Transcatheter Valves (PARTNER) trial are listed in the Supplementary Appendix, available at NEJM.org.This article (10.1056/NEJMoa1008232) was published on September 22, 2010, at NEJM.org.N Engl J Med 2010;363:1597-1607.Copyright © 2010 Massachusetts Medical Society.BackgroundMany patients with severe aortic stenosis and coexisting conditions are not candi-dates for surgical replacement of the aortic valve. Recently, transcatheter aortic-valve implantation (TAVI) has been suggested as a less invasive treatment for high-risk patients with aortic stenosis.MethodsWe randomly assigned patients with severe aortic stenosis, whom surgeons considered not to be suitable candidates for surgery, to standard therapy (including balloon aortic valvuloplasty) or transfemoral transcatheter implantation of a balloon-expandable bovine pericardial valve. The primary end point was the rate of death from any cause.ResultsA total of 358 patients with aortic stenosis who were not considered to be suitable can-didates for surgery underwent randomization at 21 centers (17 in the United States). At 1 year, the rate of death from any cause (Kaplan–Meier analysis) was 30.7% with TAVI, as compared with 50.7% with standard therapy (hazard ratio with TAVI, 0.55; 95% confidence interval [CI], 0.40 to 0.74; P<0.001). The rate of the composite end point of death from any cause or repeat hospitalization was 42.5% with TAVI as com-pared with 71.6% with standard therapy (hazard ratio, 0.46; 95% CI, 0.35 to 0.59; P<0.001). Among survivors at 1 year, the rate of cardiac symptoms (New York Heart Association class III or IV) was lower among patients who had undergone TAVI than among those who had received standard therapy (25.2% vs. 58.0%, P<0.001). At 30 days, TAVI, as compared with standard therapy, was associated with a higher incidence of major strokes (5.0% vs. 1.1%, P = 0.06) and major vascular complications (16.2% vs. 1.1%, P<0.001). In the year after TAVI, there was no deterioration in the functioning of the bioprosthetic valve, as assessed by evidence of stenosis or regurgitation on an echocardiogram.ConclusionsIn patients with severe aortic stenosis who were not suitable candidates for surgery, TAVI, as compared with standard therapy, significantly reduced the rates of death from any cause, the composite end point of death from any cause or repeat hospitalization, and cardiac symptoms, despite the higher incidence of major strokes and major vascular events. (Funded by Edwards Lifesciences; ClinicalTrials.gov number, NCT00530894.)The New England Journal of Medicine Downloaded from nejm.org at WEILL CORNELL MEDICAL LIBRARY on September 9, 2014. For personal use only. No other uses without permission. Copyright © 2010 Massachusetts Medical Society. All rights reserved.The ne w engl and jour na l o f medicinen engl j med 363;17 nejm.org october 21, 20101598A ortic stenosis is an insidious disease with a long latency period1 followed by rapid progression after the appearance of symptoms,2-5 resulting in a high rate of death (approximately 50% in the first 2 years after symp-toms appear) among untreated patients.1,6-8 Sur-gical replacement of the aortic valve reduces symp-toms and improves survival in patients with aortic stenosis,9-11 and in the absence of serious coexist-ing conditions, the procedure is associated with low operative mortality.12,13 However, in clinical practice, at least 30% of patients with severe symp-tomatic aortic stenosis do not undergo surgery for replacement of the aortic valve, owing to ad-vanced age, left ventricular dysfunction, or the presence of multiple coexisting conditions.14-17 For these patients, who are at high surgical risk,18,19 a less invasive treatment may be a worthwhile al-ternative.Transcatheter aortic-valve implantation (TAVI) is a new procedure, in which a bioprosthetic valve is inserted through a catheter and implanted within the diseased native aortic valve. Since 2002, when the procedure was first performed,20,21 there has been rapid growth in its use throughout the world for the treatment of severe aortic stenosis in patients who are at high surgical risk.22-32 The most recent clinical studies showed that the rate of death from any cause at 1 year among patients treated with TAVI was approximately 25%.27-29,31 Thus far, all the studies of TAVI have been obser-vational registry studies, without standardization of end-point definitions33,34 (and unpublished data) and without control
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