Development and Validation of a Practical Model to Identify Patients at Risk of Bleeding After TAVR
Eliano Pio Navarese, Zhongheng Zhang, Jacek Kubica, Felicita Andreotti, Antonella Farinaccio, Antonio L Bartorelli, Francesco Bedogni, Manali Rupji, Fabrizio Tomai, Arturo Giordano, Bernard Reimers, Carmen Spaccarotella, Krzysztof Wilczek, Janina Stepinska, Adam Witkowski, Marek Grygier, Tomasz Kukulski, Wojciech Wanha, Wojciech Wojakowski, Maciej Lesiak, Dariusz Dudek, Michal O Zembala, Sergio Berti, a Joint Effort of the Italian and Polish Cardiac Interventional Societies, Eliano Pio Navarese, Zhongheng Zhang, Jacek Kubica, Felicita Andreotti, Antonella Farinaccio, Antonio L Bartorelli, Francesco Bedogni, Manali Rupji, Fabrizio Tomai, Arturo Giordano, Bernard Reimers, Carmen Spaccarotella, Krzysztof Wilczek, Janina Stepinska, Adam Witkowski, Marek Grygier, Tomasz Kukulski, Wojciech Wanha, Wojciech Wojakowski, Maciej Lesiak, Dariusz Dudek, Michal O Zembala, Sergio Berti, a Joint Effort of the Italian and Polish Cardiac Interventional Societies
Abstract
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.
Keywords: TAVR; bleeding risk; risk score.
Conflict of interest statement
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.
Source: PubMed