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

European Journal of Cardio-thoracic Surgery : Official Journal of the European Association for Cardio-thoracic Surgery
Fabio BariliLorenzo Menicanti

Abstract

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 dea...Continue Reading

References

Feb 12, 1998·Annals of Internal Medicine·D B Rubin
Jan 10, 2002·The Journal of Thoracic and Cardiovascular Surgery·Eugene H Blackstone
Apr 1, 2008·The Journal of Thoracic and Cardiovascular Surgery·Cary W AkinsUNKNOWN Ad Hoc Liaison Committee for Standardizing Definitions of Prosthetic Heart Valve Morbidity
Mar 2, 2012·European Journal of Cardio-thoracic Surgery : Official Journal of the European Association for Cardio-thoracic Surgery·Samer A M NashefUlf Lockowandt
Aug 28, 2012·European Journal of Cardio-thoracic Surgery : Official Journal of the European Association for Cardio-thoracic Surgery·Alec VahanianUNKNOWN European Association for Cardio-Thoracic Surgery (EACTS)
Oct 3, 2012·European Journal of Cardio-thoracic Surgery : Official Journal of the European Association for Cardio-thoracic Surgery·Arie Pieter KappeteinUNKNOWN Valve Academic Research Consortium (VARC)-2
Oct 3, 2012·European Heart Journal·Fabio BariliAlessandro Parolari
Mar 14, 2013·Sociological Methodology·Yu XieBen Jann
Oct 27, 2015·The Annals of Thoracic Surgery·Fabio BariliAlessandro Parolari
Oct 28, 2015·Journal of the American Heart Association·Timothy C TanJonathan Afilalo
Feb 16, 2016·The Journal of Thoracic and Cardiovascular Surgery·Sarah A SchubertRavi K Ghanta
Apr 5, 2016·The New England Journal of Medicine·Martin B LeonUNKNOWN PARTNER 2 Investigators

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Citations

Jul 22, 2017·Journal of the American College of Cardiology·Arie Pieter Kappetein, Alec Vahanian
Sep 29, 2017·European Journal of Cardio-thoracic Surgery : Official Journal of the European Association for Cardio-thoracic Surgery·Fabio BariliAlessandro Parolari
May 23, 2018·European Journal of Cardio-thoracic Surgery : Official Journal of the European Association for Cardio-thoracic Surgery·Nick Freemantle, Domenico Pagano
Sep 29, 2017·European Journal of Cardio-thoracic Surgery : Official Journal of the European Association for Cardio-thoracic Surgery·Ankur Kalra, Michael J Reardon
Jan 26, 2021·Journal of Cardiac Surgery·Anoop S SumalNarain Moorjani
Jan 11, 2021·The Journal of Thoracic and Cardiovascular Surgery·Fabio Barili, Alessandro Parolari

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