From the Duke University Medical Center, Durham, NC (C.M.); University of Michigan Medical Center, Ann Arbor (F.D.P., K.D.A.); University of Louisville, KY (M.S.S.); Tufts University School of Medicine, Boston, MA (D.T.P.); and HeartWare, Inc, Framingham, MA (D.R.H., M.V.J., K.B.N.).
Circulation. 2014 Sep 9;130(11 Suppl 1):S3-11. doi: 10.1161/CIRCULATIONAHA.113.007911.
Cardiac valve procedures are commonly performed concurrently during implantation of left ventricular assist devices, but the added procedural risk has not been studied in detail.
Data from patients receiving the HeartWare Ventricular Assist Device in the ADVANCE bridge to transplant (BTT) trial and continued access protocol were reviewed. Of 382 consecutive patients who completed follow-up between August 2008 and June 2013 (mean time on support 389 days, median 271 days), 262 (68.6%) underwent isolated HeartWare Ventricular Assist Device implantation, 75 (19.6%) a concurrent valve procedure, and 45 (11.8%) concurrent nonvalvular procedures. Of the concurrent valve procedures, 56 were tricuspid, 13 aortic, and 6 mitral. Survival was similar between groups (79% for concurrent valve procedures and 85% for HeartWare Ventricular Assist Device only at 1 year; P=0.33). Concurrent valve procedures were also associated with increased unadjusted early right heart failure (RHF). A multivariable analysis for death and RHF (121 total events) identified female sex (odds ratio=2.0 [95% confidence interval, 1.2-3.3; P=0.0053]) and preimplant tricuspid regurgitation severity (odds ratio=2.9 [95% confidence interval, 1.8-4.8, P<0.0001]) as independent predictors while concurrent tricuspid valve procedures (TVP) were not predictors. Furthermore, patients with significant preimplant tricuspid regurgitation who did not receive a TVP experienced an increased rate of late RHF compared with those who received TVP (0.19 versus 0.05 events per patient-year, respectively; P=0.024).
Compared with HeartWare Ventricular Assist Device alone, survival was equivalent for the concurrent valve procedure group. Tricuspid regurgitation severity was the most important predictor of increased postoperative RHF, and concurrent TVP was not an independent predictor of RHF overall. Concurrent TVP may reduce the rate of late RHF for patients with significant preimplant tricuspid insufficiency.
http://www.clinicaltrials.gov. Unique identifier: NCT00751972.
在植入左心室辅助装置时，通常会同时进行心脏瓣膜手术，但尚未详细研究这种手术带来的附加程序风险。
回顾了在 ADVANCE 桥接移植（BTT）试验和持续准入方案中接受 HeartWare 心室辅助装置治疗的患者的数据。在 2008 年 8 月至 2013 年 6 月期间完成随访的 382 例连续患者中（中位支持时间为 271 天，平均支持时间为 389 天），262 例（68.6%）接受了单纯的 HeartWare 心室辅助装置植入术，75 例（19.6%）同时进行了瓣膜手术，45 例（11.8%）同时进行了非瓣膜手术。同期瓣膜手术中，56 例为三尖瓣，13 例为主动脉瓣，6 例为二尖瓣。各组间生存率无差异（1 年时同期瓣膜手术组为 79%，单纯 HeartWare 心室辅助装置组为 85%；P=0.33）。同期瓣膜手术也与未经调整的早期右心衰竭（RHF）发生率增加相关。对死亡和 RHF（共 121 例事件）的多变量分析确定女性（比值比=2.0 [95%置信区间，1.2-3.3；P=0.0053]）和术前三尖瓣反流严重程度（比值比=2.9 [95%置信区间，1.8-4.8，P<0.0001]）是独立预测因素，而同期三尖瓣手术（TVP）不是预测因素。此外，术前三尖瓣反流严重但未行 TVP 的患者与行 TVP 的患者相比，晚期 RHF 的发生率增加（分别为 0.19 和 0.05 例患者-年；P=0.024）。
与单纯 HeartWare 心室辅助装置相比，同期瓣膜手术组的生存率相当。三尖瓣反流严重程度是术后 RHF 增加的最重要预测因素，而同期 TVP 并不是 RHF 的独立预测因素。对于术前存在严重三尖瓣关闭不全的患者，同期 TVP 可能会降低晚期 RHF 的发生率。
