new england journal of medicine The established in 1812 october 21 2010 vol 363 no 17 Transcatheter Aortic Valve Implantation for Aortic Stenosis in Patients Who Cannot Undergo Surgery Martin 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 A BS T R AC T Background Many patients with severe aortic stenosis and coexisting conditions are not candidates 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 Methods We 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 Results A total of 358 patients with aortic stenosis who were not considered to be suitable candidates 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 compared 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 Conclusions In 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 n engl j med 363 17 nejm org october 21 2010 From Columbia University Medical Center NewYork Presbyterian Hospital New York M B L C R S J W M Medical City Dallas Dallas M M D L B Stanford University 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 University School of Medicine Atlanta P C B R A G Washington Hospital Center Washington DC A D P Hospital of the University of Pennsylvania Philadelphia J E B H C H Duke University Medical Center Durham NC P S D J L P and London School of Hygiene 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 ml2398 columbia edu The investigators institutions and research 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 1597 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 n e w e ng l a n d j o u r na l of m e dic i n e A whom conventional surgery to replace the aortic valve was associated with high risk Severe aortic stenosis was defined as an aortic valve area of less than 0 8 cm2 a mean aortic valve gradient of 40 mm Hg or more or a peak aortic jet velocity of 4 0 m per second or more All the patients had New York Heart Association NYHA class II III or IV symptoms Patients were divided into two cohorts those who were considered to be candidates for surgery despite the fact that they were at high surgical risk as defined by a Society of Thoracic Surgeons STS risk score of 10 or higher35 on a scale of 0 to 100 with higher scores indicating greater surgical risk or by the presence of coexisting conditions that would be associated with a predicted risk of death by 30 days after surgery of 15 or higher and those who were not considered to be suitable candidates for surgery because they had coexisting conditions that would be associated with a predicted probability of 50 or more of either death by 30 days after surgery or a serious irreversible condition At least two surgeon investigators had to agree that the patient was not a suitable candidate for surgery In this article we report the results for the patients with aortic stenosis who were not considered to be suitable candidates for surgery The randomized trial involving patients at high surgical risk who were nevertheless considered to be candidates for surgery also NCT00530894 is ongoing Pertinent exclusion criteria were a bicuspid or noncalcified aortic valve acute myocardial infarction substantial coronary artery disease requiring revascularization a left ventricular ejection fraction of less than 20 a diameter of the aortic annulus of less than 18 mm or more than 25 mm severe 3 mitral or aortic regurgitation a transient ischemic attack or stroke within the previous 6 months and severe renal insufficiency The complete list of inclusion and exclusion criteria is provided in Table 1 in the Supplementary Appendix available with the full text of this article at
View Full Document
Unlocking...