Development and Validation of a Practical Model to Identify Patients at Risk of Bleeding After TAVR.

Autor:	Navarese EP; Interventional Cardiology and Cardiovascular Medicine Research, Department of Cardiology and Internal Medicine, Nicolaus Copernicus University, Bydgoszcz, Poland; Faculty of Medicine, University of Alberta, Edmonton, Alberta, Canada; SIRIO MEDICINE Research Network, Bydgoszcz, Poland. Electronic address: elianonavarese@gmail.com., Zhang Z; Department of Emergency Medicine, Sir Run-Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China., Kubica J; Interventional Cardiology and Cardiovascular Medicine Research, Department of Cardiology and Internal Medicine, Nicolaus Copernicus University, Bydgoszcz, Poland; SIRIO MEDICINE Research Network, Bydgoszcz, Poland., Andreotti F; Department of Cardiovascular and Thoracic Sciences, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy., Farinaccio A; Department of Biotechnology and Biosciences, University of Milano-Bicocca, Italy., Bartorelli AL; Centro Monzino, IRCCS and Department of Biomedical and Clinical Sciences 'Luigi Sacco,' University of Milan, Milan, Italy., Bedogni F; Department of Clinical and Interventional Cardiology, IRCCS Policlinico San Donato, Milan, Italy., Rupji M; Winship Cancer Institute of Emory University, Atlanta, Georgia, USA., Tomai F; Division of Cardiology, European Hospital, Rome, Italy., Giordano A; Unità Operativa di Interventistica Cardiovascolare, Pineta Grande Hospital, Castel Volturno, Italy., Reimers B; Division of Cardiology, CCU and Interventional, Cardiology, Cardio Center, Humanitas Research Hospital IRCCS, Rozzano-Milan, Italy., Spaccarotella C; Cardiovascular Research Center, University Magna Graecia, Catanzaro, Italy., Wilczek K; Cardiac and Lung Transplantation Mechanical Circulatory Support, Silesian Center for Heart Diseases, Pomeranian Medical University, Szczecin, Poland., Stepinska J; National Institute of Cardiology, Warsaw, Poland., Witkowski A; National Institute of Cardiology, Warsaw, Poland., Grygier M; Medical University of Poznań, Poznań, Poland., Kukulski T; Cardiac and Lung Transplantation Mechanical Circulatory Support, Silesian Center for Heart Diseases, Pomeranian Medical University, Szczecin, Poland., Wanha W; Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland., Wojakowski W; Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland., Lesiak M; Department of Cardiology, Poznań University of Medical Sciences, Poznań, Poland., Dudek D; Institute of Cardiology, Jagiellonian University Medical College, Krakow, Poland., Zembala MO; Cardiac and Lung Transplantation Mechanical Circulatory Support, Silesian Center for Heart Diseases, Pomeranian Medical University, Szczecin, Poland., Berti S; Department of Diagnostic and Interventional Cardiology, Gabriele Monasterio Tuscany Foundation, G. Pasquinucci Heart Hospital, Massa, Italy.
Jazyk:	angličtina
Zdroj:	JACC. Cardiovascular interventions [JACC Cardiovasc Interv] 2021 Jun 14; Vol. 14 (11), pp. 1196-1206.
DOI:	10.1016/j.jcin.2021.03.024
Abstrakt:	Objectives: No standardized algorithm exists to identify patients at risk of bleeding after transcatheter aortic valve replacement (TAVR). The aim of this study was to generate and validate a useful predictive model. Background: Bleeding events after TAVR influence prognosis and quality of life and may be preventable. Methods: Using machine learning and multivariate regression, more than 100 clinical variables from 5,185 consecutive patients undergoing TAVR in the prospective multicenter RISPEVA (Registro Italiano GISE sull'Impianto di Valvola Aortica Percutanea; NCT02713932) registry were analyzed in relation to Valve Academic Research Consortium-2 bleeding episodes at 1 month. The model's performance was externally validated in 5,043 TAVR patients from the prospective multicenter POL-TAVI (Polish Registry of Transcatheter Aortic Valve Implantation) database. Results: Derivation analyses generated a 6-item score (PREDICT-TAVR) comprising blood hemoglobin and serum iron concentrations, oral anticoagulation and dual antiplatelet therapy, common femoral artery diameter, and creatinine clearance. The 30-day area under the receiver-operating characteristic curve (AUC) was 0.80 (95% confidence interval [CI]: 0.75-0.83). Internal validation by optimism bootstrap-corrected AUC was 0.79 (95% CI: 0.75-0.83). Score quartiles were in graded relation to 30-day events (0.8%, 1.1%, 2.5%, and 8.5%; overall p <0.001). External validation produced a 30-day AUC of 0.78 (95% CI: 0.72-0.82). A simple nomogram and a web-based calculator were developed to predict individual patient probabilities. Landmark cumulative event analysis showed greatest bleeding risk differences for top versus lower score quartiles in the first 30 days, when most events occurred. Predictivity was maintained when omitting serum iron values. Conclusions: PREDICT-TAVR is a practical, validated, 6-item tool to identify patients at risk of bleeding post-TAVR that can assist in decision making and event prevention. Competing Interests: Funding Support and Author Disclosures Dr. Navarese has received research grants from Abbott, Amgen, and Medtronic; and has received lecture fees and honoraria from Amgen, AstraZeneca, Bayer, Pfizer, and Sanofi-Regeneron, outside the submitted work. Dr. Kubica has received personal fees from AstraZeneca, outside the submitted work. Dr. Berti has been a proctor for Abbott. Dr. Andreotti has received speaker and consulting fees from Amgen, Bayer, Bristol Myers Squibb/Pfizer, and Daiichi-Sankyo, outside the submitted work. Dr. Wojakowski has received speaker or consulting fees from Abbott, Boston Scientific, and Medtronic, outside the submitted work. Dr. Witkowski is a proctor for Edwards Lifesciences and Medtronic. Dr. Dudek has received personal fees from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic, outside the submitted work. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu