The importance of the Heart Team evaluation before transcatheter aortic valve replacement: Results from the BRAVO‐3 trial

The importance of the Heart Team evaluation before transcatheter aortic valve replacement: Results from the BRAVO‐3 trial

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 pa...

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Published in:Catheterization and cardiovascular interventions Vol. 96; no. 7; pp. E688 - E694
Main Authors: 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., Hildick‐Smith, David, Hink, Hans U., Deliargyris, Efthymios N., Anthopoulos, Prodromos, Sharma, Samin K., Kini, Annapoorna, Sartori, Samantha, Chandrasekhar, Jaya, Dangas, George D.
Format: Journal Article
Language:English
Published: Hoboken, USA John Wiley & Sons, Inc 01-12-2020
Wiley Subscription Services, Inc
Wiley
Subjects:
Aortic valve
Bleeding
Heart
Heart Team
Heparin
Life Sciences
logistic EuroSCORE
TAVR
TAVR
logistic EuroSCORE
Heart Team
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Summary: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, ORLES≥18: 1.32, 95% CI 0.86‐2.02, p = .21; MACE, ORLES≥18: 1.27, 95% CI 0.72‐2.25, p = .41; major vascular complications, ORLES≥18: 0.97, 95% CI 0.65‐1.44, p = .88; BARC ≥3b, ORLES≥18: 1.38, 95% CI 0.82‐2.33, p = .23; and VARC life‐threatening bleeding, ORLES≥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.
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The Medicines Company
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ISSN:1522-1946
1522-726X
DOI:10.1002/ccd.28717