Marisa Avvedimento, Pedro Cepas-Guillén, Julien Ternacle, Marina Urena, Alberto Alperi, Asim Cheema, Gabriela Veiga-Fernandez, Luis Nombela-Franco, Victoria Vilalta, Giovanni Esposito, Francisco Campelo-Parada, Ciro Indolfi, Maria Del Trigo, Antonio Muñoz-Garcia, Nicolás Maneiro, Lluís Asmarats, Ander Regueiro, David Del Val, Vicenç Serra, Vincent Auffret, Thomas Modine, Guillaume Bonnet, Jules Mesnier, Gaspard Suc, Pablo Avanzas, Effat Rezaei, Victor Fradejas-Sastre, Gabriela Tirado-Conte, Eduard Fernández-Nofrerias, Anna Franzone, Thibaut Guitteny, Sabato Sorrentino, Juan Francisco Oteo, Jorge Nuche, Lola Gutiérrez-Alonso, Eduardo Flores-Umanzor, Fernando Alfonso, Andrea Monastyrski, Maxime Nolf, Mélanie Côté, Roxana Mehran, Marie-Claude Morice, Davide Capodanno, Philippe Garot, Josep Rodés-Cabau
{"title":"瓣膜学术研究联盟对接受 TAVR 患者高出血风险定义的验证。","authors":"Marisa Avvedimento, Pedro Cepas-Guillén, Julien Ternacle, Marina Urena, Alberto Alperi, Asim Cheema, Gabriela Veiga-Fernandez, Luis Nombela-Franco, Victoria Vilalta, Giovanni Esposito, Francisco Campelo-Parada, Ciro Indolfi, Maria Del Trigo, Antonio Muñoz-Garcia, Nicolás Maneiro, Lluís Asmarats, Ander Regueiro, David Del Val, Vicenç Serra, Vincent Auffret, Thomas Modine, Guillaume Bonnet, Jules Mesnier, Gaspard Suc, Pablo Avanzas, Effat Rezaei, Victor Fradejas-Sastre, Gabriela Tirado-Conte, Eduard Fernández-Nofrerias, Anna Franzone, Thibaut Guitteny, Sabato Sorrentino, Juan Francisco Oteo, Jorge Nuche, Lola Gutiérrez-Alonso, Eduardo Flores-Umanzor, Fernando Alfonso, Andrea Monastyrski, Maxime Nolf, Mélanie Côté, Roxana Mehran, Marie-Claude Morice, Davide Capodanno, Philippe Garot, Josep Rodés-Cabau","doi":"10.1161/CIRCINTERVENTIONS.124.014800","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>The Valve Academic Research Consortium for High Bleeding Risk (VARC-HBR) has recently introduced a consensus document that outlines risk factors to identify high bleeding risk in patients undergoing transcatheter aortic valve replacement. The objective of the present study was to evaluate the prevalence and predictive value of the VARC-HBR definition in a contemporary, large-scale transcatheter aortic valve replacement population.</p><p><strong>Methods: </strong>Multicenter study including 10 449 patients undergoing transcatheter aortic valve replacement. Based on consensus, 21 clinical and laboratory criteria were identified and classified as major or minor. Patients were stratified as at low, moderate, high, and very high bleeding risk according to the VARC-HBR definition. The primary end point was the rate of Bleeding Academic Research Consortium type 3 or 5 bleeding at 1 year, defined as the composite of periprocedural (within 30 days) or late (after 30 days) bleeding.</p><p><strong>Results: </strong>Patients with at least 1 VARC-HBR criterion (n=9267, 88.7%) had a higher risk of Bleeding Academic Research Consortium 3 or 5 bleeding, proportional to the severity of risk assessment (10.8%, 16.1%, and 24.6% for moderate, high, and very-high-risk groups, respectively). However, a comparable rate of bleeding events was observed in the low-risk and moderate-risk groups. The area under receiver operating characteristic curve was 0.58. Patients with VARC-HBR criteria also exhibited a gradual increase in 1-year all-cause mortality, with an up to 2-fold increased mortality risk for high and very-high-risk groups (hazard ratio, 1.33 [95% CI, 1.04-1.70] and 1.97 [95% CI, 1.53-2.53], respectively).</p><p><strong>Conclusions: </strong>The VARC-HBR consensus offered a pragmatic approach to guide bleeding risk stratification in transcatheter aortic valve replacement. The results of the present study would support the predictive validity of the new definition and promote its application in clinical practice to minimize bleeding risk and improve patient outcomes.</p>","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":"e014800"},"PeriodicalIF":6.1000,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11748903/pdf/","citationCount":"0","resultStr":"{\"title\":\"Validation of the Valve Academic Research Consortium High Bleeding Risk Definition in Patients Undergoing TAVR.\",\"authors\":\"Marisa Avvedimento, Pedro Cepas-Guillén, Julien Ternacle, Marina Urena, Alberto Alperi, Asim Cheema, Gabriela Veiga-Fernandez, Luis Nombela-Franco, Victoria Vilalta, Giovanni Esposito, Francisco Campelo-Parada, Ciro Indolfi, Maria Del Trigo, Antonio Muñoz-Garcia, Nicolás Maneiro, Lluís Asmarats, Ander Regueiro, David Del Val, Vicenç Serra, Vincent Auffret, Thomas Modine, Guillaume Bonnet, Jules Mesnier, Gaspard Suc, Pablo Avanzas, Effat Rezaei, Victor Fradejas-Sastre, Gabriela Tirado-Conte, Eduard Fernández-Nofrerias, Anna Franzone, Thibaut Guitteny, Sabato Sorrentino, Juan Francisco Oteo, Jorge Nuche, Lola Gutiérrez-Alonso, Eduardo Flores-Umanzor, Fernando Alfonso, Andrea Monastyrski, Maxime Nolf, Mélanie Côté, Roxana Mehran, Marie-Claude Morice, Davide Capodanno, Philippe Garot, Josep Rodés-Cabau\",\"doi\":\"10.1161/CIRCINTERVENTIONS.124.014800\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>The Valve Academic Research Consortium for High Bleeding Risk (VARC-HBR) has recently introduced a consensus document that outlines risk factors to identify high bleeding risk in patients undergoing transcatheter aortic valve replacement. The objective of the present study was to evaluate the prevalence and predictive value of the VARC-HBR definition in a contemporary, large-scale transcatheter aortic valve replacement population.</p><p><strong>Methods: </strong>Multicenter study including 10 449 patients undergoing transcatheter aortic valve replacement. Based on consensus, 21 clinical and laboratory criteria were identified and classified as major or minor. Patients were stratified as at low, moderate, high, and very high bleeding risk according to the VARC-HBR definition. The primary end point was the rate of Bleeding Academic Research Consortium type 3 or 5 bleeding at 1 year, defined as the composite of periprocedural (within 30 days) or late (after 30 days) bleeding.</p><p><strong>Results: </strong>Patients with at least 1 VARC-HBR criterion (n=9267, 88.7%) had a higher risk of Bleeding Academic Research Consortium 3 or 5 bleeding, proportional to the severity of risk assessment (10.8%, 16.1%, and 24.6% for moderate, high, and very-high-risk groups, respectively). However, a comparable rate of bleeding events was observed in the low-risk and moderate-risk groups. The area under receiver operating characteristic curve was 0.58. Patients with VARC-HBR criteria also exhibited a gradual increase in 1-year all-cause mortality, with an up to 2-fold increased mortality risk for high and very-high-risk groups (hazard ratio, 1.33 [95% CI, 1.04-1.70] and 1.97 [95% CI, 1.53-2.53], respectively).</p><p><strong>Conclusions: </strong>The VARC-HBR consensus offered a pragmatic approach to guide bleeding risk stratification in transcatheter aortic valve replacement. The results of the present study would support the predictive validity of the new definition and promote its application in clinical practice to minimize bleeding risk and improve patient outcomes.</p>\",\"PeriodicalId\":10330,\"journal\":{\"name\":\"Circulation: Cardiovascular Interventions\",\"volume\":\" \",\"pages\":\"e014800\"},\"PeriodicalIF\":6.1000,\"publicationDate\":\"2025-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11748903/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Circulation: Cardiovascular Interventions\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1161/CIRCINTERVENTIONS.124.014800\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/10/30 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"CARDIAC & CARDIOVASCULAR SYSTEMS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Circulation: Cardiovascular Interventions","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1161/CIRCINTERVENTIONS.124.014800","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/10/30 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
Validation of the Valve Academic Research Consortium High Bleeding Risk Definition in Patients Undergoing TAVR.
Background: The Valve Academic Research Consortium for High Bleeding Risk (VARC-HBR) has recently introduced a consensus document that outlines risk factors to identify high bleeding risk in patients undergoing transcatheter aortic valve replacement. The objective of the present study was to evaluate the prevalence and predictive value of the VARC-HBR definition in a contemporary, large-scale transcatheter aortic valve replacement population.
Methods: Multicenter study including 10 449 patients undergoing transcatheter aortic valve replacement. Based on consensus, 21 clinical and laboratory criteria were identified and classified as major or minor. Patients were stratified as at low, moderate, high, and very high bleeding risk according to the VARC-HBR definition. The primary end point was the rate of Bleeding Academic Research Consortium type 3 or 5 bleeding at 1 year, defined as the composite of periprocedural (within 30 days) or late (after 30 days) bleeding.
Results: Patients with at least 1 VARC-HBR criterion (n=9267, 88.7%) had a higher risk of Bleeding Academic Research Consortium 3 or 5 bleeding, proportional to the severity of risk assessment (10.8%, 16.1%, and 24.6% for moderate, high, and very-high-risk groups, respectively). However, a comparable rate of bleeding events was observed in the low-risk and moderate-risk groups. The area under receiver operating characteristic curve was 0.58. Patients with VARC-HBR criteria also exhibited a gradual increase in 1-year all-cause mortality, with an up to 2-fold increased mortality risk for high and very-high-risk groups (hazard ratio, 1.33 [95% CI, 1.04-1.70] and 1.97 [95% CI, 1.53-2.53], respectively).
Conclusions: The VARC-HBR consensus offered a pragmatic approach to guide bleeding risk stratification in transcatheter aortic valve replacement. The results of the present study would support the predictive validity of the new definition and promote its application in clinical practice to minimize bleeding risk and improve patient outcomes.
期刊介绍：
Circulation: Cardiovascular Interventions, an American Heart Association journal, focuses on interventional techniques pertaining to coronary artery disease, structural heart disease, and vascular disease, with priority placed on original research and on randomized trials and large registry studies. In addition, pharmacological, diagnostic, and pathophysiological aspects of interventional cardiology are given special attention in this online-only journal.
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