Gonzálvez-García Ariana, Cepas-Guillén Pedro, Ternacle Julien, Urena Marina, Alperi Alberto, Cheema Asim N, Veiga-Fernández Gabriela, Nombela-Franco Luis, Vilalta Victoria, Esposito Giovanni, Campelo-Parada Francisco, Idolfi Ciro, Del Trigo María, Muñoz-García Antonio, Maneiro Nicolás, Asmarats Luis, Regueiro Ander, Del Val David, Serra Vicenç, Auffret Vincent, Jonveaux Melchior, Bonnet Guillaume, Mesnier Jules, Gaspard Suc, Avanzas Pablo, Rezaei Effat, Fradejas-Sastre Víctor, Tirado-Conte Gabriela, Fernández-Nofrerías Eduard, Franzone Anna, Guitteny Thibaut, Sorrentino Sabato, Oteo Juan Francisco, Díez-Delhoyo Felipe, Gutiérrez-Alonso Lola, Vidal Pablo, Alfonso Fernando, Monastyrski Andrea, Nolf Maxime, Pelletier-Beaumont Emilie, Avvedimento Marisa, Rodés-Cabau Josep
Department of Cardiology, Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada; Servicio de Cardiología, Hospital Universitario La Paz, Madrid, Spain. Electronic address: https://x.com/@ari_gonzalvez.
Department of Cardiology, Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada. Electronic address: https://x.com/@pedro_cepas.
Rev Esp Cardiol (Engl Ed). 2025 Jul;78(7):618-627. doi: 10.1016/j.rec.2024.12.005. Epub 2024 Dec 24.
The Valve Academic Research Consortium (VARC)-3 definition of the early safety (ES) composite endpoint after transcatheter aortic valve replacement (TAVR) lacks clinical validation. The aim of this study was to determine the incidence, predictors, and clinical impact of ES after TAVR as defined by VARC-3 criteria.
We performed a multicenter study including 10 078 patients with severe aortic stenosis undergoing transarterial TAVR. According to VARC-3 criteria, ES at 30 days was defined as freedom from all-cause mortality, stroke, VARC type 2-4 bleeding, major vascular, access-related, or cardiac structural complications, acute kidney injury stages 3-4, moderate or severe aortic regurgitation, new permanent pacemaker implantation, and surgery or intervention related to the device. Baseline, procedural, and follow-up data were prospectively collected in a dedicated database.
ES was achieved in 6598 patients (65.5%). The main factors associated with a lack of ES were the occurrence of type 2-4 bleeding (18.9%), and new pacemaker implantation (13.6%). Advanced age, peripheral artery disease, chronic kidney disease, and balloon postdilation were associated with an increased risk of no-ES (P<.01 for all). Failure to achieve ES was associated with higher all-cause mortality up to 1-year after TAVR (HR, 3.17; 95%CI, 2.76-3.65; P<.001).
VARC-3 ES was not achieved in up to one-third of contemporary TAVR patients, which was associated with worse mid-term outcomes. The factors associated with increased risk were advanced age, baseline comorbidities, and some procedural features (postdilation). These findings highlight the importance of continued efforts to minimize the risk of TAVR-related procedural complications.
经导管主动脉瓣置换术（TAVR）后早期安全性（ES）复合终点的瓣膜学术研究联盟（VARC）-3定义缺乏临床验证。本研究的目的是确定根据VARC-3标准定义的TAVR后ES的发生率、预测因素及临床影响。
我们进行了一项多中心研究，纳入10078例接受经动脉TAVR的严重主动脉瓣狭窄患者。根据VARC-3标准，30天时的ES定义为无全因死亡、卒中、VARC 2-4型出血、重大血管、入路相关或心脏结构并发症、急性肾损伤3-4期、中度或重度主动脉瓣反流、新的永久性起搏器植入以及与器械相关的手术或干预。基线、手术及随访数据前瞻性收集于一个专用数据库。
6598例患者（65.5%）实现了ES。与未实现ES相关的主要因素是2-4型出血的发生（18.9%）和新的起搏器植入（13.6%）。高龄、外周动脉疾病、慢性肾脏病和球囊后扩张与未实现ES的风险增加相关（所有P<0.01）。未实现ES与TAVR后1年内较高的全因死亡率相关（HR，3.17；95%CI，2.76-3.65；P<0.001）。
在当代TAVR患者中，高达三分之一的患者未实现VARC-3定义的ES，这与较差的中期结局相关。风险增加的相关因素包括高龄、基线合并症和一些手术特征（后扩张）。这些发现凸显了持续努力将TAVR相关手术并发症风险降至最低的重要性。
