new england journal of medicine The established in 1812 june 9 2011 vol 364 no 23 Transcatheter versus Surgical Aortic Valve Replacement in High Risk Patients Craig R Smith M D Martin B Leon M D Michael J 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 Mathew Williams M D Todd Dewey M D Samir Kapadia M D Vasilis Babaliaros M D Vinod H Thourani M D Paul Corso M D Augusto D Pichard M D Joseph E Bavaria M D Howard C Herrmann M D Jodi J Akin M S William N Anderson Ph D Duolao Wang Ph D and Stuart J Pocock Ph D for the PARTNER Trial Investigators A bs t r ac t Background The use of transcatheter aortic valve replacement has been shown to reduce mortality among high risk patients with aortic stenosis who are not candidates for surgical replacement However the two procedures have not been compared in a randomized trial involving high risk patients who are still candidates for surgical replacement Methods At 25 centers we randomly assigned 699 high risk patients with severe aortic stenosis to undergo either transcatheter aortic valve replacement with a balloon expandable bovine pericardial valve either a transfemoral or a transapical approach or surgical replacement The primary end point was death from any cause at 1 year The primary hypothesis was that transcatheter replacement is not inferior to surgical replacement The authors affiliations are listed in the Appendix Address reprint requests to Dr Smith at Columbia University Medical Center New York Presbyterian Hospital 177 Fort Washington Ave Milstein Bldg 7 435 New York NY 10032 or at crs2 columbia edu The investigators institutions and research organizations participating in the Placement of Aortic Transcatheter Valves PARTNER trial are in the Supplementary Appendix available at NEJM org N Engl J Med 2011 364 2187 98 Results The rates of death from any cause were 3 4 in the transcatheter group and 6 5 in the surgical group at 30 days P 0 07 and 24 2 and 26 8 respectively at 1 year P 0 44 a reduction of 2 6 percentage points in the transcatheter group upper limit of the 95 confidence interval 3 0 percentage points predefined margin 7 5 percentage points P 0 001 for noninferiority The rates of major stroke were 3 8 in the transcatheter group and 2 1 in the surgical group at 30 days P 0 20 and 5 1 and 2 4 respectively at 1 year P 0 07 At 30 days major vascular complications were significantly more frequent with transcatheter replacement 11 0 vs 3 2 P 0 001 adverse events that were more frequent after surgical replacement included major bleeding 9 3 vs 19 5 P 0 001 and new onset atrial fibrillation 8 6 vs 16 0 P 0 006 More patients undergoing transcatheter replacement had an improvement in symptoms at 30 days but by 1 year there was not a significant between group difference Copyright 2011 Massachusetts Medical Society Conclusions In high risk patients with severe aortic stenosis transcatheter and surgical procedures for aortic valve replacement were associated with similar rates of survival at 1 year although there were important differences in periprocedural risks Funded by Edwards Lifesciences Clinical Trials gov number NCT00530894 n engl j med 364 23 nejm org june 9 2011 2187 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 2011 Massachusetts Medical Society All rights reserved The n e w e ng l a n d j o u r na l A fter the appearance of symptoms aortic stenosis is associated with a high rate of death if left untreated 1 10 Although surgical aortic valve replacement improves symptoms and survival 11 15 observational studies have identified various subgroups of patients i e those with an advanced age and those with poor left ventricular function or other coexisting disorders who are at increased risk for operative complications or death 16 21 In such patients a less invasive treatment may be a desirable alternative Transcatheter aortic valve replacement treats aortic stenosis by displacing and functionally replacing the native valve with a bioprosthetic valve delivered on a catheter through the femoral artery transfemoral placement or the left ventricular apex transapical placement 22 34 In the randomized Placement of Aortic Transcatheter Valves PARTNER trial a subgroup of patients with aortic stenosis who were not candidates for surgical aortic valve replacement and who underwent transfemoral placement had an improvement of 20 in the 1 year survival rate and also had reduced symptoms 35 This report describes results for the highrisk subgroup of patients in the PARTNER trial who were still candidates for surgical valve replacement and who were randomly assigned to undergo either transcatheter or surgical replacement of the aortic valve A video showing transcatheter aortic valve replacement is available at NEJM org 2188 Me thods Patients From May 11 2007 through August 28 2009 we enrolled 699 patients with severe aortic stenosis and cardiac symptoms New York Heart Association NYHA class II function or worse at 22 centers in the United States 2 centers in Canada and 1 center in Germany All the patients were considered to be candidates for conventional surgical aortic valve repair Severe aortic stenosis was defined as an aortic valve area of less than 0 8 cm2 plus either a mean valve gradient of at least 40 mm Hg or a peak velocity of at least 4 0 m per second Patients were deemed to be at high risk for operative complications or death on the basis of coexisting conditions that were associated with a risk of death of at least 15 by 30 days after the procedure The final determination of high operative risk was made by surgeons at each study center but we used as a guideline a score of at least 10 on the risk model developed by the Society for Thoracic Surgeons which uses an algorithm that is based n engl j med 364 23 of m e dic i n e on the presence of coexisting illnesses in order to estimate the 30 day operative mortality Less than 5 of patients in the population from which the algorithm was derived had a predicted operative risk risk score of more than 10 36 Exclusion criteria were a bicuspid or noncalcified valve coronary artery disease requiring revascularization a left ventricular ejection fraction of less than 20 an aortic annulus diameter of less than 18 mm or more than 25 mm severe 4 mitral or aortic
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