TY - JOUR
T1 - Development and Validation of a Practical Model to Identify Patients at Risk of Bleeding After TAVR
AU - Navarese, Eliano Pio
AU - Zhang, Zhongheng
AU - Kubica, Jacek
AU - Andreotti, Felicita
AU - Farinaccio, Antonella
AU - Bartorelli, Antonio L.
AU - Bedogni, Francesco
AU - Rupji, Manali
AU - Tomai, Fabrizio
AU - Giordano, Arturo
AU - Reimers, Bernard
AU - Spaccarotella, Carmen
AU - Wilczek, Krzysztof
AU - Stepinska, Janina
AU - Witkowski, Adam
AU - Grygier, Marek
AU - Kukulski, Tomasz
AU - Wanha, Wojciech
AU - Wojakowski, Wojciech
AU - Lesiak, Maciej
AU - Dudek, Dariusz
AU - Zembala, Michal O.
AU - Berti, Sergio
PY - 2021
Y1 - 2021
N2 - 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.
AB - 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.
KW - TAVR
KW - bleeding risk
KW - risk score
KW - TAVR
KW - bleeding risk
KW - risk score
UR - http://hdl.handle.net/10807/304238
U2 - 10.1016/j.jcin.2021.03.024
DO - 10.1016/j.jcin.2021.03.024
M3 - Article
SN - 1936-8798
VL - 14
SP - 1196
EP - 1206
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
ER -