Dávila-Román Victor G, Waggoner Alan D, Kennard Elizabeth D, Holubkov Richard, Jamieson W R Eric, Englberger Lars, Carrel Thierry P, Schaff Hartzell V
AVERT Echocardiography Core Laboratory and the Cardiovascular Imaging and Clinical Research Core Laboratory, Cardiovascular Division, Washington University School of Medicine, St. Louis, Missouri 63110, USA.
J Am Coll Cardiol. 2004 Oct 6;44(7):1467-72. doi: 10.1016/j.jacc.2003.12.060.
The purpose of this study was to determine the prevalence and severity of paravalvular regurgitation (PVR) in the Artificial Valve Endocarditis Reduction Trial (AVERT) cohort.
The initial AVERT cohort consisted of 807 patients randomized to receive either a Silzone-coated prosthetic valve or a conventional prosthetic valve; early clinical reports showed higher rates of valve explant caused by PVR for Silzone-coated prosthetic valve.
Of the 678 eligible patients, 575 (85%) underwent postoperative transthoracic echocardiograms. The presence and severity of PVR were identified by color flow Doppler. Reviewers were blinded to the type of prosthetic valve and the demographic and clinical variables.
Among those who underwent echocardiography (Silzone-coated prosthetic valve, n = 285 and conventional prosthetic valve, n = 290), 59% had prosthetic aortic valves, 32% prosthetic mitral valves, and 9% had both; demographic and clinical findings (i.e., prosthetic valve endocarditis, thromboembolism, bleeding, and all-cause death) were similar for the two groups. Echocardiographically determined PVR was present in 50 valves: Silzone-coated prosthetic valve, 29 of 285 (10%) and conventional prosthetic valve, 21 of 290 (7%, p = NS); the severity of PVR was similar in both groups. Kaplan-Meier analysis showed no significant differences in PVR at 24 months from valve implantation between the two groups (24-month event-free rate: 93% Silzone-coated prosthetic valve vs. 94% conventional prosthetic valve, p = NS).
Excluding those patients who had initial prosthetic valve explant, the two-year echocardiographic follow-up of the AVERT cohort shows no statistically significant differences in the prevalence or severity of PVR in the Silzone-coated prosthetic valve compared with the conventional prosthetic valve. Further monitoring is warranted to determine whether these clinical outcomes remain similar on long-term follow-up.
本研究旨在确定人工瓣膜心内膜炎减少试验（AVERT）队列中瓣周反流（PVR）的发生率和严重程度。
最初的AVERT队列由807例随机接受Silzone涂层人工瓣膜或传统人工瓣膜的患者组成；早期临床报告显示，Silzone涂层人工瓣膜因PVR导致瓣膜置换的发生率更高。
在678例符合条件的患者中，575例（85%）接受了术后经胸超声心动图检查。通过彩色多普勒确定PVR的存在和严重程度。审查人员对人工瓣膜类型以及人口统计学和临床变量不知情。
在接受超声心动图检查的患者中（Silzone涂层人工瓣膜组，n = 285；传统人工瓣膜组，n = 290），59%有人工主动脉瓣，32%有人工二尖瓣，9%两者都有；两组的人口统计学和临床结果（即人工瓣膜心内膜炎、血栓栓塞、出血和全因死亡）相似。超声心动图确定50个瓣膜存在PVR：Silzone涂层人工瓣膜组，285个中有29个（10%）；传统人工瓣膜组，290个中有21个（7%，p = 无统计学意义）；两组PVR的严重程度相似。Kaplan-Meier分析显示，两组在瓣膜植入后24个月时PVR无显著差异（24个月无事件发生率：Silzone涂层人工瓣膜组为93%，传统人工瓣膜组为94%，p = 无统计学意义）。
排除最初进行人工瓣膜置换的患者后，AVERT队列的两年超声心动图随访显示，与传统人工瓣膜相比，Silzone涂层人工瓣膜在PVR的发生率或严重程度方面无统计学显著差异。需要进一步监测以确定长期随访时这些临床结果是否仍然相似。
