Higuchi Ryosuke, Saji Mike, Hagiya Kenichi, Takamisawa Itaru, Shimizu Jun, Tobaru Tetsuya, Iguchi Nobuo, Takanashi Shuichiro, Takayama Morimasa, Isobe Mitsuaki
Department of Cardiology, Sakakibara Heart Institute, 3-16-1 Asahi-cho, Fuchu, Tokyo, 183-0003, Japan.
Department of Anesthesiology, Sakakibara Heart Institute, Fuchu, Tokyo, Japan.
Heart Vessels. 2020 Sep;35(9):1281-1289. doi: 10.1007/s00380-020-01599-9. Epub 2020 Apr 6.
Futility denotes failure to achieve the projected outcome. We investigated the prevalence, predictors, and clinical risk model of transcatheter aortic valve implantation (TAVI)-related futility. We included 464 consecutive patients undergoing TAVI from 2010 to 2017. Futility was defined as death and/or hospitalization for heart failure (HFH) within 1 year after TAVI. Of 464 patients (mean age: 84.4 years), 69% were females (EuroSCOREII: 6.3%; Society of Thoracic Surgeons [STS] score: 6.9%). Forty-six patients (9.9%) experienced TAVI-related futility, and 36 of 46 patients (69.6%) died within 1 year due to cardiac (37.5%) and non-cardiac (62.5%) causes. Previous HFH (hazard ratio [HR], 2.20; 95% confidence interval [CI]: 1.13-4.35, p = 0.020), chronic obstructive pulmonary disease (COPD) (HR, 3.39; 95% CI: 1.12-8.42, p = 0.033), and moderate/severe mitral or tricuspid regurgitation (HR, 2.98; 95% CI: 1.32-6.27, p = 0.010) were independent predictors of futility. With 1 point assigned to each predictor (total 0 point, futility low-risk; total 1 point, futility intermediate-risk; total 2-3 points, futility high-risk), the futility risk model clearly stratified individual futility risk into three groups (the freedom from futility at 1 year: 96.2%, 82.1%, and 67.9% each). Our futility risk model presented better discrimination than EuroSCOREII, and STS score (c-statistic: 0.73 vs. 0.68 vs. 0.67). Medical futility was recognized in 9.9% of patients undergoing TAVI. Previous HFH, COPD, and concomitant atrioventricular regurgitation were associated with futility. The risk model derived from three predictors showed good performance in predicting futility risk.
无效性是指未能实现预期结果。我们调查了经导管主动脉瓣植入术(TAVI)相关无效性的发生率、预测因素和临床风险模型。我们纳入了2010年至2017年连续接受TAVI的464例患者。无效性定义为TAVI术后1年内死亡和/或因心力衰竭住院(HFH)。在464例患者(平均年龄:84.4岁)中,69%为女性(欧洲心脏手术风险评估系统II[EuroSCOREII]:6.3%;胸外科医师协会[STS]评分:6.9%)。46例患者(9.9%)经历了TAVI相关无效性,46例患者中有36例(69.6%)在1年内因心脏原因(37.5%)和非心脏原因(62.5%)死亡。既往HFH(风险比[HR],2.20;95%置信区间[CI]:1.13 - 4.35,p = 0.020)、慢性阻塞性肺疾病(COPD)(HR,3.39;95%CI:1.12 - 8.42,p = 0.033)以及中度/重度二尖瓣或三尖瓣反流(HR,2.98;95%CI:1.32 - 6.27,p = 0.010)是无效性的独立预测因素。每个预测因素赋予1分(总分0分,无效性低风险;总分1分,无效性中风险;总分2 - 3分,无效性高风险),该无效性风险模型可将个体无效性风险清晰地分为三组(1年无无效性的比例分别为:96.2%、82.1%和67.9%)。我们的无效性风险模型比EuroSCOREII和STS评分具有更好的辨别能力(c统计量:0.73对0.68对0.67)。在接受TAVI的患者中,9.9%被认定存在医疗无效性。既往HFH、COPD以及合并房室反流与无效性相关。由三个预测因素得出的风险模型在预测无效性风险方面表现良好。