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The flaws in the detail of an observational study on transcatheter aortic valve implantation versus surgical aortic valve replacement in intermediate-risks patients.

  • Barili, Fabio1
  • Freemantle, Nick2
  • Folliguet, Thierry3
  • Muneretto, Claudio4
  • De Bonis, Michele5
  • Czerny, Martin6
  • Obadia, Jean Francois7
  • Al-Attar, Nawwar8
  • Bonaros, Nikolaos9
  • Kluin, Jolanda10
  • Lorusso, Roberto11
  • Punjabi, Prakash12
  • Sadaba, Rafael13
  • Suwalski, Piotr14, 15
  • Benedetto, Umberto16
  • Böning, Andreas17
  • Falk, Volkmar18
  • Sousa-Uva, Miguel19
  • Kappetein, Pieter A20
  • Menicanti, Lorenzo21
  • 1 Department of Cardiac Surgery, S. Croce Hospital, Cuneo, Italy. , (Italy)
  • 2 Department of Primary Care and Population Health, University College London, London, UK.
  • 3 Department of Cardiac Surgery, Centre Hospitalo-Universitaire Brabois ILCV, Nancy, France. , (France)
  • 4 Department of Cardio-Thoracic Surgery, University of Brescia-Spedali Civili, Brescia, Italy. , (Italy)
  • 5 Department of Cardiac Surgery, S. Raffaele University Hospital, Milan, Italy. , (Italy)
  • 6 Department of Cardiovascular Surgery, University Heart Center Freiburg- Bad Krozingen, Germany. , (Germany)
  • 7 Department of Cardio-Thoracic Surgery, Hopital Cardiothoracique Louis Pradel, Lyon, France. , (France)
  • 8 Department of Cardiac Surgery, Golden Jubilee National Hospital, Glasgow, UK.
  • 9 Department of Cardiac Surgery, Innsbruck Medical University, Innsbruck, Austria. , (Austria)
  • 10 Department of Cardio-Thoracic Surgery, AMC, Amsterdam, Netherlands. , (Netherlands)
  • 11 Department of Cardio-Thoracic Surgery, Heart and Vascular Centre-Maastricht University Medical Centre, Maastricht, Netherlands. , (Netherlands)
  • 12 Department of Cardio-Thoracic Surgery, Imperial College Heathcare NHS Trust and Imperial College School of Medicine, London, UK.
  • 13 Department of Cardiac Surgery, Complejo Hospitalario de Navarra - NavarraBiomed. Pamplona, Spain. , (Spain)
  • 14 Department of Cardiac Surgery, Central Clinical Hospital of the Ministry of the Interior, Warsaw, Poland. , (Poland)
  • 15 Pulaski University of Technology and Humanities, Radom, Poland. , (Poland)
  • 16 Bristol Heart Institute, University of Bristol, School of Clinical Sciences, Bristol, UK.
  • 17 Department of Cardio-Vascular Surgery, University Hospital Giessen, Giessen, Germany. , (Germany)
  • 18 Department of Cardio-Thoracic Surgery, Deutsches Herzzentrum Berlin, Charite Berlin, Germany. , (Germany)
  • 19 Department of Cardiac Surgery, Hospital Cruz Vermelha, Lisbon, and Faculdade de Medicina da Universidade do Porto, Portugal. , (Portugal)
  • 20 Thoraxcenter, Erasmus MC, Rotterdam, Netherlands. , (Netherlands)
  • 21 Department of Cardiac Surgery, IRCCS Policlinico S. Donato, Milan, Italy. , (Italy)
Published Article
European Journal of Cardio-Thoracic Surgery
Oxford University Press
Publication Date
Jun 01, 2017
DOI: 10.1093/ejcts/ezx058
PMID: 28531333


The PARTNER group recently published a comparison between the latest generation SAPIEN 3 transcatheter aortic valve implantation (TAVI) system (Edwards Lifesciences, Irvine, CA, USA) and surgical aortic valve replacement (SAVR) in intermediate-risk patients, apparently demonstrating superiority of the TAVI and suggesting that TAVI might be the preferred treatment method in this risk class of patients. Nonetheless, assessment of the non-randomized methodology used in this comparison reveals challenges that should be addressed in order to elucidate the validity of the results. The study by Thourani and colleagues showed several major methodological concerns: suboptimal methods in propensity score analysis with evident misspecification of the propensity scores (PS; no adjustment for the most significantly different covariates: left ventricular ejection fraction, moderate-severe mitral regurgitation and associated procedures); use of PS quintiles rather than matching; inference on not-adjusted Kaplan-Meier curves, although the authors correctly claimed for the need of balancing score adjusting for confounding factors in order to have unbiased estimates of the treatment effect; evidence of poor fit; lack of data on valve-related death.These methodological flaws invalidate direct comparison between treatments and cannot support authors' conclusions that TAVI with SAPIEN 3 in intermediate-risk patients is superior to surgery and might be the preferred treatment alternative to surgery. © The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

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