Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.
J Am Coll Cardiol. 2013 Dec 10;62(23):2188-96. doi: 10.1016/j.jacc.2013.05.089. Epub 2013 Aug 28.
The aim of this study was to characterize a single-center experience of major bleeding complications during HeartMate II (HMII) (Thoratec Corp., Pleasanton, California) left ventricular assist device support, with focus on the subtypes and temporal patterns of post-operative bleeding.
Bleeding complications are the most common post-operative adverse events after HMII implantation. The timing of bleeding events, relationship to coagulation status, and effect on post-operative survival are incompletely understood.
From October 2004 to June 2010, 139 HMII recipients at the Cleveland Clinic received 145 devices as a bridge to transplant or destination therapy for advanced heart failure. Major bleeding was defined using Interagency Registry for Mechanically Assisted Circulatory Support criteria, with an additional category created to maximize sensitivity for events. Pre-operative variables, coagulation status, and bleeding recurrence were assessed for correlation to primary events using modulated renewal within a multivariable analysis.
The cumulative occurrence of major bleeding was 58% during 171 patient-years of follow-up. There were 1.14 major bleeds per patient-year, with 44% occurring as repeat bleeding events. A first bleed did not predict subsequent bleeding. The greatest risk of bleeding was noted within 2 weeks post-implantation. The international normalized ratio profile correlated poorly with the risk of bleeding. Bleeding early after surgery was associated with reduced survival while on HMII support.
The risk of bleeding peaks early after HMII implantation. Bleeding of thoracic and gastrointestinal sources dominates these events, although many patients undergo transfusions for anemia without an apparent source of hemolysis or bleeding.
本研究旨在描述 HeartMate II（HMII）（加利福尼亚州普莱森顿的 Thoratec 公司）左心室辅助装置支持期间大出血并发症的单中心经验，重点关注术后出血的亚型和时间模式。
出血并发症是 HMII 植入术后最常见的术后不良事件。对出血事件的时间、与凝血状态的关系以及对术后生存的影响尚不完全了解。
从 2004 年 10 月至 2010 年 6 月，克利夫兰诊所的 139 名 HMII 接受者接受了 145 台设备，作为移植或晚期心力衰竭的目的地治疗的桥接。主要出血使用 Interagency Registry for Mechanically Assisted Circulatory Support 标准定义，并创建了一个额外的类别，以最大限度地提高对事件的敏感性。使用多变量分析中的调制更新评估术前变量、凝血状态和出血复发与主要事件的相关性。
在 171 患者年的随访期间，主要出血的累积发生率为 58%。每患者年发生 1.14 次大出血，其中 44%为重复出血事件。首次出血不能预测随后的出血。在植入后 2 周内出血风险最大。国际标准化比值谱与出血风险相关性差。手术后早期出血与 HMII 支持期间的生存降低相关。
HMII 植入后出血风险迅速上升。胸和胃肠道来源的出血主导这些事件，尽管许多患者因贫血接受输血，但没有明显的溶血或出血来源。
