Theron Alexis, Ravis Eleonore, Grisoli Dominique, Jaussaud Nicolas, Morera Pierre, Candolfi Pascal, Boleckova Jana, Lagier David, Amanatiou Cecile, Messous Lyna, Gariboldi Vlad, Collart Frederic
Department of Cardiac Surgery, La Timone Hospital, Marseille, France.
Department of Biostatistics, Edwards Lifesciences, Nyon, Switzerland.
Interact Cardiovasc Thorac Surg. 2017 Jul 1;25(1):68-74. doi: 10.1093/icvts/ivx050.
This study aimed to evaluate the safety and effectiveness of rapid-deployment aortic valve replacement (RDAVR) for severe aortic stenosis (AS).
All consecutive patients with severe AS who underwent RDAVR with the EDWARDS INTUITY bioprosthesis were prospectively included in a single-centre, cohort study between July 2012 and April 2015. Clinical examination and transthoracic echocardiography were performed preoperatively and at 1-month and 1-year follow-up.
We included 150 patients: mean age 76.8 ± 6.2 years, 68.7% male and mean EuroSCORE II 3.4 ± 3.7%. Implantation was successful in all: 103 (68.7%) had isolated aortic valve replacement (AVR) and 47 (31.3%) had concomitant procedures. For isolated AVR, mean cross-clamp and cardiopulmonary bypass times were 37.6 ± 13.3 and 59.9 ± 20.4 min, respectively. Overall, the 1-year Kaplan-Meier survival rate was 97.1% (95% confidence interval 92.4-98.9%). At 1 year, stroke occurred in 5 patients (3.34%), myocardial infarction in 1 (0.69%), endocarditis in 1 (0.69%), early explantation in 1 (0.67%), pacemaker implantation in 8 (5.6%) and Grade 2 periprosthetic regurgitation in 4 (3.2%; no grade 3 of 4). There were significant decreases from baseline ( P < 0.001) in the proportion at New York Heart Association Class III/V (35.3-4.1%), mean gradient (54.9 ± 17.3 mmHg to 11.3 ± 4.8 mmHg) and mean left ventricular mass index (160.3 ± 44.8 g/m 2 to 118.5 ± 39.4 g/m 2 ). Mean indexed effective orifice area at 1 year was 1.02 ± 0.37 cm 2 /m 2 . Ten patients (6.6%) had severe patient-prosthesis mismatch.
RDAVR for severe AS provided favourable outcomes over 1 year.
本研究旨在评估快速部署主动脉瓣置换术（RDAVR）治疗重度主动脉瓣狭窄（AS）的安全性和有效性。
2012年7月至2015年4月期间，所有连续接受EDWARDS INTUITY生物瓣膜进行RDAVR的重度AS患者均前瞻性纳入一项单中心队列研究。术前、术后1个月及1年进行临床检查和经胸超声心动图检查。
共纳入150例患者，平均年龄76.8±6.2岁，男性占68.7%，平均欧洲心脏手术风险评估系统（EuroSCORE）II评分为3.4±3.7%。所有患者植入均成功，其中103例（68.7%）接受单纯主动脉瓣置换术（AVR），47例（31.3%）接受同期手术。对于单纯AVR，平均主动脉阻断时间和体外循环时间分别为37.6±13.3分钟和59.9±20.4分钟。总体而言，1年的Kaplan-Meier生存率为97.1%（95%置信区间92.4 - 98.9%）。1年时，5例（3.34%）发生卒中，1例（0.69%）发生心肌梗死，1例（0.69%）发生心内膜炎，1例（0.67%）早期瓣膜置换，8例（5.6%）植入起搏器，4例（3.2%）发生2级人工瓣膜反流（无3或4级）。纽约心脏协会心功能分级III/IV级患者比例（35.3% - 4.1%）、平均跨瓣压差（54.9±17.3 mmHg降至11.3±4.8 mmHg）和平均左心室质量指数（160.3±44.8 g/m²降至118.5±39.4 g/m²）较基线均显著降低（P < 0.001）。1年时平均指数化有效瓣口面积为1.02±0.37 cm²/m²。10例（6.6%）患者存在严重的人工瓣膜-患者不匹配。
重度AS患者行RDAVR术后1年预后良好。
