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Outcomes After Continuous-Flow Left Ventricular Assist Device Implantation as Destination Therapy at Transplant Versus Nontransplant Centers
Circulation: Heart Failure ( IF 9.7 ) Pub Date : 2018-03-01 , DOI: 10.1161/circheartfailure.117.004384
D. Marshall Brinkley 1 , David DeNofrio 1 , Robin Ruthazer 1 , Amanda R. Vest 1 , Navin K. Kapur 1 , Gregory S. Couper 1 , Michael S. Kiernan 1
Affiliation  

Background: Since Food and Drug Administration’s approval of the HeartMate II left ventricular assist device (LVAD) as destination therapy, the number of hospitals offering LVAD therapy has grown rapidly. A rising number are performed at centers without internal transplant programs. We sought to determine whether outcomes after destination therapy LVAD implantation are similar at transplant and nontransplant centers.
Methods and Results: Adult recipients of a primary, continuous-flow LVAD as destination therapy between January 2012 and March 2014 from the Interagency Registry for Mechanically Assisted Circulatory Support were included. Subjects were classified by implanting center as transplant (n=3323) or nontransplant (n=260). Center volume before 2012 was categorized as <15 or ≥15 implants. Outcomes included overall survival, freedom from death or major adverse event, rates of individual adverse events, rehospitalization, and health-related quality of life. Patients treated at nontransplant centers were generally less sick, with higher Interagency Registry for Mechanically Assisted Circulatory Support patient profiles and more normal laboratory and hemodynamic values. One-month (94.2% [95% confidence interval {CI}, 95.0–93.4] versus 94.2% [95% CI, 97.1–91.4]) and 12-month (76.4% [95% CI, 77.9–74.8] versus 71.3% [95% CI, 77.4–65.2]) survival were similar at transplant and nontransplant centers, respectively (hazard ratio, 0.88 [95% CI, 0.70–1.12]). Risk remained similar after adjustment for baseline characteristics (hazard ratio, 0.88 [95% CI, 0.69–1.12]). Freedom from death or major adverse event at 12 months (29.0% [95% CI, 30.6–27.3] versus 29.8% [95% CI, 36.0–23.6]) was similar at transplant and nontransplant centers (adjusted hazard ratio, 1.01 [95% CI, 0.87–1.18]). Individual adverse event rates, rehospitalization, and postimplant health-related quality of life were also similar.
Conclusions: In a large, modern cohort of destination therapy LVAD recipients, outcomes after implantation were similar at transplant and nontransplant centers.


中文翻译:

连续流左心室辅助装置植入作为移植与非移植中心的目的地疗法后的结果

背景:自从食品药品监督管理局批准将HeartMate II左心室辅助设备(LVAD)用作目的地疗法以来,提供LVAD治疗的医院数量迅速增长。没有内部移植程序的中心进行的人数增加。我们试图确定在移植和非移植中心LVAD植入后的结局结果是否相似。
方法和结果:纳入了2012年1月至2014年3月间来自机械辅助循环支持机构间注册中心的主要连续流LVAD作为目的地治疗的成人接受者。按植入中心将受试者分类为移植(n = 3323)或非移植(n = 260)。2012年之前的中心种植体分类为<15或≥15个种植体。结果包括总体生存,无死亡或重大不良事件发生,个别不良事件发生率,重新住院以及与健康相关的生活质量。在非移植中心接受治疗的患者通常病情较轻,机构间注册的机械辅助循环支持患者概况较高,实验室和血液动力学值较正常。一个月(94.2%[95%置信区间{CI},95.0-93.4],而94.2%[95%CI,97.1-91]。4])和12个月(76.4%[95%CI,77.9-74.8]与71.3%[95%CI,77.4-66.5])的存活率在移植中心和非移植中心分别相似(危险比,0.88 [95%] CI,0.70-1.12])。调整基线特征后,风险仍然相似(危险比,0.88 [95%CI,0.69-1.12])。在移植和非移植中心,在12个月时无死亡或重大不良事件的发生率(29.0%[95%CI,30.6-27.3]比29.8%[95%CI,36.0-23.6])相似(调整后的危险比,1.01 [95] %CI,0.87-1.18])。个体不良事件发生率,再次住院以及与植入后健康相关的生活质量也相似。调整基线特征后,风险仍然相似(危险比,0.88 [95%CI,0.69-1.12])。在移植和非移植中心,在12个月时无死亡或重大不良事件的发生率(29.0%[95%CI,30.6-27.3]比29.8%[95%CI,36.0-23.6])相似(调整后的危险比,1.01 [95] %CI,0.87-1.18])。个体不良事件发生率,再次住院以及与植入后健康相关的生活质量也相似。调整基线特征后,风险仍然相似(危险比,0.88 [95%CI,0.69-1.12])。在移植和非移植中心,在12个月时没有死亡或重大不良事件的发生率(29.0%[95%CI,30.6-27.3]比29.8%[95%CI,36.0-23.6])在移植中心和非移植中心相似(调整后的危险比,1.01 [95] %CI,0.87-1.18])。个体不良事件发生率,再次住院以及与植入后健康相关的生活质量也相似。
结论:在一个大型的现代目的地治疗LVAD接受者队列中,移植和非移植中心的植入后结果相似。
更新日期:2018-03-22
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