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

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, 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.

• Authors: Anton Camaj, Bimmer E Claessen, Roxana Mehran, Matias B Yudi, David Power, Usman Baber, Christian Hengstenberg, Thierry Lefevre, Eric Van Belle, Gennaro Giustino, Paul Guedeney, Sabato Sorrentino, Christian Kupatt, John G Webb, David Hildick-Smith, Hans U Hink, Efthymios N Deliargyris, Prodromos Anthopoulos, Samin K Sharma, Annapoorna Kini, Samantha Sartori, Jaya Chandrasekhar, George D Dangas
• Journal: Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions (Catheter Cardiovasc Interv) Vol. 96 Issue 7 Pg. E688-E694 (12 2020) ISSN: 1522-726X [Electronic] United States
• PMID: 31943717 (Publication Type: Comparative Study, Journal Article, Multicenter Study)
• Copyright: © 2020 Wiley Periodicals, Inc.

Chemical References

• Anticoagulants
• Antithrombins
• Hirudins
• Peptide Fragments
• Recombinant Proteins
• Heparin
• bivalirudin

Topics

• Aged
• Aged, 80 and over
• Anticoagulants (therapeutic use)
• Antithrombins (therapeutic use)
• Aortic Valve (diagnostic imaging, physiopathology, surgery)
• Aortic Valve Stenosis (diagnostic imaging, mortality, physiopathology, surgery)
• Clinical Decision-Making
• Decision Support Techniques
• Female
• Hemodynamics
• Heparin (therapeutic use)
• Hirudins
• Humans
• Male
• Patient Care Team
• Patient Selection
• Peptide Fragments (therapeutic use)
• Postoperative Complications (etiology)
• Predictive Value of Tests
• Randomized Controlled Trials as Topic
• Recombinant Proteins (therapeutic use)
• Retrospective Studies
• Risk Assessment
• Risk Factors
• Severity of Illness Index
• Transcatheter Aortic Valve Replacement (adverse effects, mortality)
• Treatment Outcome