BACKGROUND: One third of high- and prohibitive-risk TAVR patients remain severely symptomatic or die 1 year after treatment. There is interest in identifying individuals for whom this procedure is futile and should not be offered. METHODS: We performed a systematic review of the highest reported stratum of risk in TAVR clinical predictive models (CPMs). We explore whether currently available predictive models can identify patients for whom TAVR is futile, based on a quantitative futility definition and the observed and predicted outcomes for patients in the highest stratum of risk. RESULTS: 17 TAVR CPMs representing 69,191 treated patients were published from 2013 to 2018. When reported, the median number of patients in the highest stratum of risk was 569 (range 1 to 1759). Observed mortality for this risk stratum ranged from 9% at 30 days to 59% at 1 year after TAVR. Statistical confidence in these observed event rates was low. The highest predicted event rates ranged from 11.0% for in-hospital mortality to 75.1% for the composite of mortality or high symptom burden 1 year after TAVR. CONCLUSION: No high-risk TAVR group in currently available TAVR CPMs had an appropriate event rate and adequate statistical power to meet a quantitative definition of futility.
BACKGROUND: One third of high- and prohibitive-risk TAVR patients remain severely symptomatic or die 1 year after treatment. There is interest in identifying individuals for whom this procedure is futile and should not be offered. METHODS: We performed a systematic review of the highest reported stratum of risk in TAVR clinical predictive models (CPMs). We explore whether currently available predictive models can identify patients for whom TAVR is futile, based on a quantitative futility definition and the observed and predicted outcomes for patients in the highest stratum of risk. RESULTS: 17 TAVR CPMs representing 69,191 treated patients were published from 2013 to 2018. When reported, the median number of patients in the highest stratum of risk was 569 (range 1 to 1759). Observed mortality for this risk stratum ranged from 9% at 30 days to 59% at 1 year after TAVR. Statistical confidence in these observed event rates was low. The highest predicted event rates ranged from 11.0% for in-hospital mortality to 75.1% for the composite of mortality or high symptom burden 1 year after TAVR. CONCLUSION: No high-risk TAVR group in currently available TAVR CPMs had an appropriate event rate and adequate statistical power to meet a quantitative definition of futility.
Entities:
Keywords:
Clinical Cardiology; Interventional Cardiology; Non-invasive and minimally invasive Cardiology
Authors: Martin B Leon; Craig R Smith; Michael Mack; D Craig Miller; Jeffrey W Moses; Lars G Svensson; E Murat Tuzcu; John G Webb; Gregory P Fontana; Raj R Makkar; David L Brown; Peter C Block; Robert A Guyton; Augusto D Pichard; Joseph E Bavaria; Howard C Herrmann; Pamela S Douglas; John L Petersen; Jodi J Akin; William N Anderson; Duolao Wang; Stuart Pocock Journal: N Engl J Med Date: 2010-09-22 Impact factor: 91.245
Authors: Philippe Debonnaire; Laura Fusini; Ron Wolterbeek; Vasileios Kamperidis; Philippe van Rosendael; Frank van der Kley; Spyridon Katsanos; Emer Joyce; Gloria Tamborini; Manuela Muratori; Paola Gripari; Jeroen J Bax; Nina Ajmone Marsan; Mauro Pepi; Victoria Delgado Journal: Am J Cardiol Date: 2014-10-29 Impact factor: 2.778
Authors: Joseph E Bavaria; Carl L Tommaso; Ralph G Brindis; John D Carroll; G Michael Deeb; Ted E Feldman; Thomas G Gleason; Eric M Horlick; Clifford J Kavinsky; Dharam J Kumbhani; D Craig Miller; A Allen Seals; David M Shahian; Richard J Shemin; Thoralf M Sundt; Vinod H Thourani Journal: J Am Coll Cardiol Date: 2018-07-18 Impact factor: 24.094
Authors: Oren Zusman; Ran Kornowski; Guy Witberg; Adi Lador; Katia Orvin; Amos Levi; Abid Assali; Hana Vaknin-Assa; Ram Sharony; Yaron Shapira; Alexander Sagie; Uri Landes Journal: Am J Cardiol Date: 2017-09-18 Impact factor: 2.778
Authors: James B Hermiller; Steven J Yakubov; Michael J Reardon; G Michael Deeb; David H Adams; Jonathan Afilalo; Jian Huang; Jeffrey J Popma Journal: J Am Coll Cardiol Date: 2016-07-26 Impact factor: 24.094
Authors: Howard C Herrmann; Philippe Pibarot; Irene Hueter; Zachary M Gertz; William J Stewart; Samir Kapadia; E Murat Tuzcu; Vasilis Babaliaros; Vinod Thourani; Wilson Y Szeto; Joseph E Bavaria; Susheel Kodali; Rebecca T Hahn; Mathew Williams; D Craig Miller; Pamela S Douglas; Martin B Leon Journal: Circulation Date: 2013-05-09 Impact factor: 29.690
Authors: Glen P Martin; Matthew Sperrin; Peter F Ludman; Mark A de Belder; Simon R Redwood; Jonathan N Townend; Mark Gunning; Neil E Moat; Adrian P Banning; Iain Buchan; Mamas A Mamas Journal: Heart Date: 2017-12-07 Impact factor: 5.994