The Society of Thoracic Surgeons Intermacs database annual report: Evolving indications, outcomes, and scientific partnerships
The Society of Thoracic Surgeons Intermacs database annual report: Evolving indications, outcomes, and scientific partnerships
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DOI：
10.1016/j.healun.2018.11.013
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发表时间：
2019-02-01
影响因子：
8.9
通讯作者：
Kirklin, James K.
中科院分区：
文献类型：
--
作者：
Kormos, Robert L.;Cowger, Jennifer;Kirklin, James K.
背景技术背景：机械辅助循环支持机构间登记处（Intermacs）是国家心肺血液研究所、美国食品药品监督管理局、医疗保险和医疗补助服务中心等机构的共同努力，于2005年在伯明翰的亚拉巴马大学成立。该登记研究检查了接受美国食品和药物管理局批准的持久机械循环支持（MCS）装置治疗晚期心力衰竭的患者的临床结局和生活质量指标。2018年1月1日，Intermacs数据库成为胸外科医师协会国家数据库的一部分，为质量评估和改进以及科学进步提供了额外的资源。方法：Intermacs数据库年度报告总结了2006年6月23日至2017年12月31日期间接受耐用MCS植入物的患者（≥ 19岁）的结局。列出了接受隔离连续流左心室辅助装置（CF LVAD）支持、CF LVAD支持并伴随右心室辅助装置（RVAD）植入或全人工心脏植入的患者的结局。CF LVAD患者的分析按轴流和离心流配置分层。由于年龄与结局的相关性，生存分析仅限于2012年至2016年植入的孤立CF LVAD。有25，145例MCS成人患者报告给Intermacs，其中18，539例（74%）接受了CF LVAD，667例（74%）接受了CF LVAD。339例（1.3%）接受了全人工心脏，20例（0.07%）接受了单独的RVAD。在CF LVAD中，平均年龄为57 ± 1岁，26%登记接受移植，51%术前存在心源性休克（特征1至2）。CF LVAD包括14，527件轴流式（78%）和4，012件离心式（22%）器械。Intermacs患者表型随着时间的推移而演变，包括更多轮廓3的患者（2006年至2011年为26%，2012年至2016年为35%），特征2的患者较少（40%与35%），术前肾功能和肝功能标志物更好的患者，以及更多接受植入物用于目标治疗的患者（29%与48%）。2017年，离心流植入物（51%）与轴流装置（49%）接近。平均CF LVAD支持持续时间为20个月（31，563患者年）。孤立CF LVAD的1年生存率为83%，5年生存率为46%。离心式与轴流式装置的一年存活率分别为85%和84%。需要伴随RVAD支持的患者的1年和5年生存率分别为58%和28%。1个月时无全因再入院率为70%，1年时为20%。在1年时，20%的离心流患者和13%的轴流支持患者发生卒中（p < 0.001），消化道出血影响20%的患者离心流装置和25%的患者轴流装置（p < 0.001），28%的离心流装置患者发生泵相关感染，而25%的轴流装置患者发生泵相关感染（p = 0.01）。神经功能障碍（19%的死亡）和多系统器官功能障碍（15%）是最常见的死因。结论：随着MCS的演变，患者的表型和结果也随着时间的推移而变化。CF LVAD支持越来越多地用于病情较轻的患者表型，更多的患者得到了目的地治疗的支持。平均生存期现在接近5年，但不良事件，特别是神经系统事件，继续对CF LVAD支持的成功产生不利影响。(C)2019胸外科医师协会。爱思唯尔公司出版国际心肺移植协会的代表All rights reserved.
BACKGROUND: The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs), a joint effort among the National Heart, Lung, and Blood Institute, the Food and Drug Administration, the Centers for Medicare and Medicaid Services, and others, was established in 2005 at the University of Alabama at Birmingham. The registry examined clinical outcomes and quality-of-life metrics of patients who received an Food and Drug Administration-approved durable mechanical circulatory support (MCS) device to treat advanced heart failure. On January 1, 2018, the Intermacs Database became part of The Society of Thoracic Surgeons National Database, providing additional resources for quality assessment and improvement and scientific advancement.METHODS: The Intermacs Database Annual Report summarizes outcomes in patients (>= 19 years of age) who underwent durable MCS implant between June 23, 2006, and December 31, 2017. Outcomes are presented for patients who underwent isolated continuous flow left ventricular assist device (CF LVAD) support, CF LVAD support with concomitant right ventricular assist device (RVAD) implant, or total artificial heart implant. Analyses of patients with CF LVADs are stratified by axial flow and centrifugal flow configurations. Because of the association of era with outcomes, the survival analyses are restricted to isolated CF LVADs implanted in the 2012 to 2016 era.RESULTS: There were 25,145 adult patients with MCS reported to Intermacs, of whom 18,539 (74%) received CF LVADs, 667 (2.6%) had an RVAD with CF LVAD, 339 received a total artificial heart (1.3%), and 20 (0.07%) received an isolated RVAD. Of the CF LVADs, mean age was 57 +/- 1 years, 26% were listed for transplantation, and 51% were in cardiogenic shock (profile 1 to 2) preoperatively. CF LVADs included 14,527 axial flow (78%) and 4,012 centrifugal flow (22%) devices.Intermacs patient phenotype has evolved over time to include more patients with profile 3 (26% in 2006 to 2011 versus 35% in 2012 to 2016) and fewer patients with profile 2 (40% versus 35%), patients with better markers of preoperative renal and hepatic function, and more patients who received implants for destination therapy (29% versus 48%) indication. In 2017, centrifugal flow implants (51%) approximated that of axial flow devices (49%).Mean CF LVAD support duration was 20 months (31,563 patient-years). One-year survival for isolated CF LVADs was 83% and 5-year survival was 46%. One-year survivals for centrifugal versus axial flow devices were 85% and 84%, respectively. Patients who required concomitant RVAD support had 1- and 5-year survivals of 58% and 28%, respectively. Freedom from all-cause readmission was 70% at 1 month and 20% at 1 year. At 1 year, stroke occurred in 20% of patients on centrifugal flow and 13% of patients on axial flow support (p < 0.001), gastrointestinal bleeding affected 20% of patients with centrifugal flow devices and 25% of patients with axial flow devices (p < 0.001), and pump-related infection occurred in 28% of patients with centrifugal flow devices versus 25% of patients with axial flow devices (p = 0.01). Neurologic dysfunction (19% of deaths) and multisystem organ dysfunction (15%) were the most common causes of death.CONCLUSIONS: With the evolution of MCS, patient phenotype and outcomes are also changing over time. CF LVAD support is increasingly being used in the less ill patient phenotype and more patients are supported for destination therapy. Mean survival is now approaching 5 years, but adverse events, especially neurologic events, continue to have a detrimental impact on the success of CF LVAD support. (C) 2019 The Society of Thoracic Surgeons. Published by Elsevier Inc. on behalf of International Society for Heart and Lung Transplantation. All rights reserved.