Avvedimento Marisa, Cepas-Guillén Pedro, Ternacle Julien, Urena Marina, Alperi Alberto, Cheema Asim, Veiga-Fernandez Gabriela, Nombela-Franco Luis, Vilalta Victoria, Esposito Giovanni, Campelo-Parada Francisco, Indolfi Ciro, Del Trigo Maria, Muñoz-Garcia Antonio, Maneiro Nicolás, Asmarats Lluís, Regueiro Ander, Del Val David, Serra Vicenç, Auffret Vincent, Modine Thomas, Bonnet Guillaume, Mesnier Jules, Suc Gaspard, Avanzas Pablo, Rezaei Effat, Fradejas-Sastre Victor, Tirado-Conte Gabriela, Fernández-Nofrerias Eduard, Franzone Anna, Guitteny Thibaut, Sorrentino Sabato, Francisco Oteo Juan, Nuche Jorge, Gutiérrez-Alonso Lola, Flores-Umanzor Eduardo, Alfonso Fernando, Monastyrski Andrea, Nolf Maxime, Côté Mélanie, Mehran Roxana, Morice Marie-Claude, Capodanno Davide, Garot Philippe, Rodés-Cabau Josep
Quebec Heart and Lung Institute, Laval University, Quebec City, Canada (M.A., P.C.-G., J.N., M.C., J.R.-C.).
Hôpital Cardiologique Haut-Lévêque, CHU de Bordeaux, Pessac, France (J.T., T.M., G.B.).
Circ Cardiovasc Interv. 2025 Jan;18(1):e014800. doi: 10.1161/CIRCINTERVENTIONS.124.014800. Epub 2024 Oct 30.
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.
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.
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).
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.
瓣膜学术研究联盟高出血风险（VARC-HBR）最近推出了一份共识文件，概述了经导管主动脉瓣置换术患者高出血风险的识别危险因素。本研究的目的是评估VARC-HBR定义在当代大规模经导管主动脉瓣置换人群中的患病率和预测价值。
多中心研究纳入10449例行经导管主动脉瓣置换术的患者。根据共识，确定了21项临床和实验室标准，并分为主要或次要标准。根据VARC-HBR定义，将患者分为低、中、高和极高出血风险组。主要终点是1年时出血学术研究联盟3型或5型出血的发生率，定义为围手术期（30天内）或晚期（30天后）出血的综合情况。
至少有1项VARC-HBR标准的患者（n=9267，88.7%）发生出血学术研究联盟3型或5型出血的风险更高，与风险评估的严重程度成正比（中度、高度和极高风险组分别为10.8%、16.1%和24.6%）。然而，低风险组和中度风险组的出血事件发生率相当。受试者工作特征曲线下面积为0.58。符合VARC-HBR标准的患者1年全因死亡率也逐渐升高，高风险和极高风险组的死亡风险增加高达2倍（风险比分别为1.33[95%CI，1.04-1.70]和1.97[95%CI，1.53-2.53]）。
VARC-HBR共识为指导经导管主动脉瓣置换术中出血风险分层提供了一种实用方法。本研究结果将支持新定义的预测有效性，并促进其在临床实践中的应用，以尽量降低出血风险并改善患者预后。
