Berastegui García Elisabet, Camara Rosell Maria Luisa, Estevez Cid Francisco, Sanchez Dominguez Eladio, Rios Barrera Remedios, Sbraga Fabrizio, Garcia Puente Julio, Rosello Diez Elena, Cuerpo Caballero Gregorio Pablo, Bustamante Munguira Juan, Reyes Copa Guillermo, Tena Pajuelo Marian, Serrano Fiz Santiago, Buendía Miñano Jose Alfonso, García Martin Ivan, Cuenca Castillo Jose, Cánovas Lopez Sergio, Gonzalez Pinto Angel, Ruyra Baliarda Xavier
Department of Cardiac Surgery, Hospital Germans Trias i Pujol, Badalona, Spain.
Department of Cardiac Surgery, Complejo Hospitalario Universitario A Coruña, CHUAC, A Coruña, Spain.
Interact Cardiovasc Thorac Surg. 2018 Apr 1;26(4):596-601. doi: 10.1093/icvts/ivx384.
The development of new percutaneous and surgical techniques has reduced the risk associated with aortic valve replacement procedures. We present the results of a Spanish register after initiating a programme for sutureless prostheses in moderate-high-risk patients.
This prospective multicentre study was carried out from November 2013 to November 2016. Data were obtained from 448 patients in whom a Perceval S prosthesis was implanted.
The mean age was 79.24 (standard deviation [SD] 4.1) years, and 61.2% were women. The estimated EuroSCORE I log risk was 11.15% (SD 7.6), with an observed mortality of 4.4% (20 patients). Isolated aortic valve replacement was performed on 69.26% of patients, with 64% involving ministernotomy. The incidence of neurological events was 2%, with 2 permanent cerebrovascular accidents, and 41 (9.2%) patients were implanted with a permanent endocavitary pacemaker. At discharge, 12 (2.6%) patients presented minimal periprosthetic leakage, and 4 (0.89%) patients had moderate leakage. There were 3 reinterventions during follow-up (2 endocarditis and 1 dysfunction due to periprosthetic leak progression). The mean gradient at discharge, 6 months and 1 year was 12.94 (SD 5.3) mmHg, 12.19 (SD 4.7) mmHg and 11.77 (SD 4.7) mmHg, respectively; 59.4% of the patients were octogenarians, with a survival rate of 98% at both 6 months and 1 year at discharge. There was neither valve migration nor early structural degeneration. The mean follow-up was 12 ± 3 months. The 6-month and 1-year mortality was 1.4% and 2.1%, respectively.
This is a prospective multicentric study on the largest cohort of patients with sutureless valves conducted in Spain to date. It is a reproducible procedure that has enabled surgery on patients with a moderate-high risk with low morbidity and mortality, providing good haemodynamic results.
新型经皮和外科技术的发展降低了主动脉瓣置换手术相关风险。我们公布了一项针对中高危患者启动无缝合人工瓣膜项目后的西班牙注册研究结果。
这项前瞻性多中心研究于2013年11月至2016年11月开展。数据来自448例植入Perceval S人工瓣膜的患者。
平均年龄为79.24（标准差[SD]4.1）岁，女性占61.2%。估计欧洲心脏手术风险评估系统（EuroSCORE）I的对数风险为11.15%（SD 7.6），观察到的死亡率为4.4%（20例患者）。69.26%的患者接受了单纯主动脉瓣置换术，其中64%采用了胸骨上段小切口。神经系统事件发生率为2%，有2例永久性脑血管意外，41例（9.2%）患者植入了永久性心腔内起搏器。出院时，12例（2.6%）患者出现轻微人工瓣膜周漏，4例（0.89%）患者出现中度漏血。随访期间有3例再次干预（2例心内膜炎，1例因人工瓣膜周漏进展导致功能障碍）。出院时、6个月和1年时的平均跨瓣压差分别为12.94（SD 5.3）mmHg、12.19（SD 4.7）mmHg和11.77（SD 4.7）mmHg；59.4%的患者为八旬老人，出院时6个月和1年的生存率均为98%。既没有瓣膜移位，也没有早期结构退变。平均随访时间为12±3个月。6个月和1年的死亡率分别为1.4%和2.1%。
这是西班牙迄今为止对最大规模无缝合瓣膜患者队列进行的前瞻性多中心研究。这是一种可重复的手术方法，能够为中高危患者进行手术，发病率和死亡率低，血流动力学结果良好。
