Genovese Elizabeth A, Dew Mary Amanda, Teuteberg Jeffrey J, Simon Marc A, Kay Joy, Siegenthaler Michael P, Bhama Jay K, Bermudez Christian A, Lockard Kathleen L, Winowich Steve, Kormos Robert L
Artificial Heart Program, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania 15213, USA.
Ann Thorac Surg. 2009 Oct;88(4):1162-70. doi: 10.1016/j.athoracsur.2009.06.028.
Although ventricular assist devices (VADs) provide effective treatment for end-stage heart failure, VAD support remains associated with significant risk for adverse events (AEs). To date there has been no detailed assessment of the incidence of a full range of AEs using standardized event definitions. We sought to characterize the frequency and timing of AE onset during the first 60 days of VAD support, a period during which clinical observation suggests the risk of incident AEs is high.
A retrospective analysis was performed utilizing prospectively collected data from a single-site clinical database including 195 patients aged 18 or greater receiving VADs between 1996 and 2006. Adverse events were coded using standardized criteria. Cumulative incidence rates were determined, controlling for competing risks (death, transplantation, recovery-wean).
During the first 60 days after implantation, the most common AEs were bleeding, infection, and arrhythmias (cumulative incidence rates, 36% to 48%), followed by tamponade, respiratory events, reoperations, and neurologic events (24% to 31%). Other events (eg, hemolysis, renal, hepatic events) were less common (rates <15%). Some events (eg, bleeding, arrhythmias) showed steep onset rates early after implantation. Others (eg, infections, neurologic events) had gradual onsets during the 60-day period. Incidence of most events did not vary by implant era (1996 to 2000 vs 2001 to 2006) or by left ventricular versus biventricular support.
Understanding differential temporal patterns of AE onset will allow preventive strategies to be targeted to the time periods when specific AE risks are greatest. The AE incidence rates provide benchmarks against which future studies of VAD-related risks may be compared.
尽管心室辅助装置（VAD）为终末期心力衰竭提供了有效的治疗方法，但VAD支持仍与不良事件（AE）的重大风险相关。迄今为止，尚未使用标准化事件定义对一系列AE的发生率进行详细评估。我们试图描述VAD支持的前60天内AE发作的频率和时间，临床观察表明在此期间发生AE的风险很高。
利用前瞻性收集的来自单中心临床数据库的数据进行回顾性分析，该数据库包括1996年至2006年间接受VAD的195例18岁及以上患者。不良事件按照标准化标准进行编码。确定累积发病率，并对竞争风险（死亡、移植、恢复-脱机）进行控制。
植入后的前60天内，最常见的AE是出血、感染和心律失常（累积发病率为36%至48%），其次是心包填塞、呼吸事件、再次手术和神经事件（24%至31%）。其他事件（如溶血、肾脏、肝脏事件）则较少见（发生率<15%）。一些事件（如出血、心律失常）在植入后早期显示出陡峭的发作率。其他事件（如感染、神经事件）在60天内逐渐发作。大多数事件的发生率在不同的植入时代（1996年至2000年与2001年至2006年）或左心室与双心室支持之间没有差异。
了解AE发作的不同时间模式将使预防策略能够针对特定AE风险最大的时间段。AE发生率提供了一个基准，可用于比较未来与VAD相关风险的研究。
