Bryant Roosevelt, Zafar Farhan, Castleberry Chesney, Jefferies John L, Lorts Angela, Chin Clifford, Morales David L S
From the *Division of Cardiac Surgery, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio; †University of Cincinnati College of Medicine, Cincinnati, Ohio; ‡Division of Cardiology, St. Louis Children's Hospital Medical Center, St. Louis, Missouri; and §Division of Cardiology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.
ASAIO J. 2017 Jan/Feb;63(1):80-85. doi: 10.1097/MAT.0000000000000439.
The Berlin Heart EXCOR pediatric ventricular assist device (VAD) is approved by the Food and Drug Administration for bridge to cardiac transplantation (BTT) in children. As the clinical outcomes of the EXCOR continue to be evaluated in the United States, data on post-transplant survival are needed. The UNOS database was used to identify patients <18 years old undergoing orthotopic heart transplantation (OHT) from June 2004 to June 2014. Patients undergoing BTT with the EXCOR were identified. A matched cohort of (358) patients undergoing OHT without pretransplant mechanical circulatory support (no-MCS) was also identified as control subjects. The post-transplant survival between the two groups was compared. There were 2,885 pediatric OHT during the study period. Of these, 358 (50%) patients were BTT with the EXCOR. At time of listing, inotrope use was 51.7% vs. 53.4%, (p = 0.653) in the EXCOR cohort and the no-MCS cohort, respectively. At the time of transplantation, end-organ function was equivalent with same median creatinine levels (0.4, p = 0.203) and median total bilirubin (0.5, p = 0.682) for the EXCOR and the no-MCS cohorts. Kaplan-Meier post-transplantation survival did not differ between the two cohorts (30 day, 1 year, and 5 year post-transplant survival was 94%, 90%, and 72% [EXCOR cohort] vs. 98%, 91%, and 77% [no-MCS cohort]; p = 0.160). Short- and mid-term post-transplant survival using the EXCOR Pediatric VAD as a BTT in children is equivalent to patients who underwent OHT without pretransplant MCS.
柏林心脏EXCOR儿童心室辅助装置(VAD)已获得美国食品药品监督管理局批准,用于儿童心脏移植桥接(BTT)。由于EXCOR的临床结果仍在美国进行评估,因此需要有关移植后生存率的数据。使用器官共享联合网络(UNOS)数据库识别2004年6月至2014年6月期间接受原位心脏移植(OHT)的18岁以下患者。确定了接受EXCOR进行BTT的患者。还确定了一组匹配的(358名)接受OHT且无移植前机械循环支持(无MCS)的患者作为对照对象。比较了两组之间的移植后生存率。在研究期间,共有2885例儿童OHT。其中,358例(50%)患者使用EXCOR进行BTT。在列入名单时,EXCOR队列和无MCS队列中使用血管活性药物的比例分别为51.7%和53.4%(p = 0.653)。在移植时,EXCOR队列和无MCS队列的终末器官功能相当,肌酐中位数水平相同(0.4,p = 0.203),总胆红素中位数相同(0.5,p = 0.682)。两个队列的Kaplan-Meier移植后生存率没有差异(移植后30天、1年和5年生存率分别为94%、90%和72%[EXCOR队列]与98%、91%和77%[无MCS队列];p = 0.160)。在儿童中使用EXCOR儿童VAD作为BTT的短期和中期移植后生存率与未接受移植前MCS的OHT患者相当。