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The importance of the Heart Team evaluation before transcatheter aortic valve replacement: Results from the BRAVO-3 trial.
Catheter Cardiovasc Interv. 2020 Jan 13 [Online ahead of print]CC

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+Show Affiliations

The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.Austin Health, Heidelberg, Victoria, Australia.The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.DZHK (German Centre for Cardiovascular Research), partner site Munich Heart Alliance, Munich, Germany, and Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.Institut Cardio Vasculaire Paris Sud, Hôpital Privé Jacques Cartier, Massy, France.Department of Cardiology and INSERM UMR 1011, University Hospital, and CHRU Lille, Lille, France.The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.Sorbonne Université, ACTION Study Group, INSERM UMRS_1166 Institut de cardiologie (AP-HP), Paris, France.Division of Cardiology, Department of Medical and Surgical Sciences, Magna Graecia University, Catanzaro, Italy.LMU Munich, Munich, Germany.St. Paul's Hospital, Vancouver, British Columbia, Canada.Sussex Cardiac Centre-Brighton & Sussex University Hospitals NHS Trust, Brighton, East Sussex, UK.Universitätsmedizin Mainz, Mainz, Germany.Science and Strategy Consulting Group, Basking Ridge, New Jersey.Arena Pharmaceuticals, Inc., Zurich, Switzerland.The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31943717

Citation

Camaj, Anton, et al. "The Importance of the Heart Team Evaluation Before Transcatheter Aortic Valve Replacement: Results From the BRAVO-3 Trial." Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions, 2020.
Camaj A, Claessen BE, Mehran R, et al. The importance of the Heart Team evaluation before transcatheter aortic valve replacement: Results from the BRAVO-3 trial. Catheter Cardiovasc Interv. 2020.
Camaj, A., Claessen, B. E., Mehran, R., Yudi, M. B., Power, D., Baber, U., Hengstenberg, C., Lefevre, T., Van Belle, E., Giustino, G., Guedeney, P., Sorrentino, S., Kupatt, C., Webb, J. G., Hildick-Smith, D., Hink, H. U., Deliargyris, E. N., Anthopoulos, P., Sharma, S. K., ... Dangas, G. D. (2020). The importance of the Heart Team evaluation before transcatheter aortic valve replacement: Results from the BRAVO-3 trial. Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions. https://doi.org/10.1002/ccd.28717
Camaj A, et al. The Importance of the Heart Team Evaluation Before Transcatheter Aortic Valve Replacement: Results From the BRAVO-3 Trial. Catheter Cardiovasc Interv. 2020 Jan 13; PubMed PMID: 31943717.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The importance of the Heart Team evaluation before transcatheter aortic valve replacement: Results from the BRAVO-3 trial. AU - Camaj,Anton, AU - Claessen,Bimmer E, AU - Mehran,Roxana, AU - Yudi,Matias B, AU - Power,David, AU - Baber,Usman, AU - Hengstenberg,Christian, AU - Lefevre,Thierry, AU - Van Belle,Eric, AU - Giustino,Gennaro, AU - Guedeney,Paul, AU - Sorrentino,Sabato, AU - Kupatt,Christian, AU - Webb,John G, AU - Hildick-Smith,David, AU - Hink,Hans U, AU - Deliargyris,Efthymios N, AU - Anthopoulos,Prodromos, AU - Sharma,Samin K, AU - Kini,Annapoorna, AU - Sartori,Samantha, AU - Chandrasekhar,Jaya, AU - Dangas,George D, Y1 - 2020/01/13/ PY - 2019/09/13/received PY - 2019/12/14/revised PY - 2019/12/29/accepted PY - 2020/1/17/pubmed PY - 2020/1/17/medline PY - 2020/1/17/entrez KW - Heart Team KW - TAVR KW - logistic EuroSCORE JF - Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions JO - Catheter Cardiovasc Interv N2 - 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. SN - 1522-726X UR - https://www.unboundmedicine.com/medline/citation/31943717/The_importance_of_the_Heart_Team_evaluation_before_transcatheter_aortic_valve_replacement:_Results_from_the_BRAVO-3_trial L2 - https://doi.org/10.1002/ccd.28717 DB - PRIME DP - Unbound Medicine ER -
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