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The importance of the Heart Team evaluation before transcatheter aortic valve replacement: Results from the BRAVO‐3 trial
Author(s) -
Camaj Anton,
Claessen Bimmer E.,
Mehran Roxana,
Yudi Matias B.,
Power David,
Baber Usman,
Hengstenberg Christian,
Lefevre Thierry,
Van Belle Eric,
Giustino Gennaro,
Guedeney Paul,
Sorrentino Sabato,
Kupatt Christian,
Webb John G.,
HildickSmith David,
Hink Hans U.,
Deliargyris Efthymios N.,
Anthopoulos Prodromos,
Sharma Samin K.,
Kini Annapoorna,
Sartori Samantha,
Chandrasekhar Jaya,
Dangas George D.
Publication year - 2020
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.28717
Subject(s) - medicine , mace , stroke (engine) , odds ratio , cardiology , bivalirudin , clinical endpoint , valve replacement , euroscore , adverse effect , randomized controlled trial , surgery , myocardial infarction , stenosis , percutaneous coronary intervention , cardiac surgery , mechanical engineering , engineering
Abstract Background/Objectives Clinicians use validated scores to risk‐stratify patients undergoing transcatheter aortic valve replacement (TAVR). However, evaluation by the Heart Team often deems patients to be at higher risk than their formal scores suggest. We sought to assess clinical outcomes of TAVR patients defined as high‐risk by the Heart Team's assessment versus the patient's logistic EuroSCORE (LES). Methods The BRAVO‐3 trial randomized patients at high risk (LES ≥ 18, or deemed inoperable by the Heart Team) to TAVR with periprocedural anticoagulation with unfractionated heparin versus bivalirudin. Endpoints included net adverse cardiac events (NACE: the composite of all‐cause mortality, MI, stroke, or bleeding), major adverse cardiovascular events (MACE: death, MI, or stroke), the individual components of MACE, major vascular complications, BARC ≥ 3b bleeding and VARC life‐threatening bleeding at 30 days. We compared patients deemed high‐risk based on LES ≥ 18 versus high‐risk by the Heart Team despite lower LES. Results A total of 467/800 (58.4%) patients were deemed high‐risk by the Heart Team despite LES < 18. After multivariable analysis, there were no differences in the odds of endpoints between groups (NACE, OR LES≥18 : 1.32, 95% CI 0.86‐2.02, p = .21; MACE, OR LES≥18 : 1.27, 95% CI 0.72‐2.25, p = .41; major vascular complications, OR LES≥18 : 0.97, 95% CI 0.65‐1.44, p = .88; BARC ≥3b, OR LES≥18 : 1.38, 95% CI 0.82‐2.33, p = .23; and VARC life‐threatening bleeding, OR LES≥18 : 0.99, 95% CI 0.69‐1.41, p = .95). Conclusion Patients undergoing TAVR and labeled high‐risk by LES ≥ 18 or Heart Team assessment despite LES < 18 have comparable short‐term outcomes . Assignment of high‐risk status to over 50% of patients is attributable to Heart Team's clinical assessment.