Russo Mark J, Hong Kimberly N, Davies Ryan R, Chen Jonathan M, Sorabella Robert A, Ascheim Deborah D, Williams Mathew R, Gelijns Annetine C, Stewart Allan S, Argenziano Michael, Naka Yoshifumi
Division of Cardiothoracic Surgery, Columbia University, New York, NY, USA.
J Thorac Cardiovasc Surg. 2009 Dec;138(6):1425-32.e1-3. doi: 10.1016/j.jtcvs.2009.07.034.
The purpose of this study was to compare posttransplantation morbidity and mortality in orthotopic heart transplant recipients bridged to transplant with a left ventricular assist device with nonbridged recipients. To account for potential differences across device types, we stratified bridge-to-transplant recipients by type of ventricular assist device: extracorporeal (EXTRA), paracorporeal (PARA), and intracorporeal (INTRA).
The United Network for Organ Sharing provided de-identified patient-level data. The study population included 10,668 orthotopic heart transplant recipients aged 18 years old or older and undergoing transplantation between January 1, 2001, and December 31, 2006. Follow-up data were provided through August 3, 2008, with a mean follow-up time of 3.17 +/- 2.15 years (range, 0-8.11 years). The primary outcome was actuarial posttransplant graft survival. Other outcomes of interest included infection, stroke, and dialysis during the transplant hospitalization; primary graft failure at 30 days; transplant hospitalization length of stay; and long-term complications including diabetes mellitus, transplant coronary artery disease, and chronic dialysis. Multivariable Cox proportional hazards regression (backward, P < .15) was used to determine the relationship between groups and overall graft survival, and multivariable logistic regression analysis (backward, P < .15) was used to determine the relationship between groups and secondary outcome measures.
In multivariable Cox regression analysis, when compared with the nonbridged group, risk-adjusted greater than 90-day graft survival was diminished among the EXTRA group (hazard ratio = 3.54, 2.28-5.51, P < .001), but not the INTRA group (1.04, 0.719-1.51, P = .834) or the PARA group (1.06, 0.642-1.76, P = .809). There were no significant differences in risk-adjusted graft survival across the 4 groups during the 90-days to 1-year or 1- to 5-year intervals. However, at more than 5 years, risk-adjusted graft survival in the INTRA group (0.389, 0.205-0.738, P = .004) was better than in the nonbridged group. The EXTRA, PARA, and INTRA groups all experienced increased risks of infection. The EXTRA group had increased risks of dialysis, stroke, and primary graft failure at 30 days, whereas neither the PARA nor the INTRA group differed from the nonbridged group. Long-term complications did not differ by group.
The use of implantable left ventricular assist devices as bridges to transplantation, including both intracorporeal and paracorporeal devices, is not associated with diminished posttransplant survival. However, 90-day survival was diminished in recipients bridged with extracorporeal devices.
本研究旨在比较使用左心室辅助装置过渡到移植的原位心脏移植受者与未过渡受者移植后的发病率和死亡率。为了考虑不同装置类型之间的潜在差异,我们根据心室辅助装置的类型对过渡到移植的受者进行了分层:体外(EXTRA)、体外旁置(PARA)和体内(INTRA)。
器官共享联合网络提供了去识别化的患者水平数据。研究人群包括10668例年龄在18岁及以上、于2001年1月1日至2006年12月31日期间接受移植的原位心脏移植受者。随访数据截至2008年8月3日,平均随访时间为3.17±2.15年(范围为0 - 8.11年)。主要结局是移植后精算的移植物存活率。其他感兴趣的结局包括移植住院期间的感染、中风和透析;30天时的原发性移植物功能衰竭;移植住院时间;以及长期并发症(包括糖尿病、移植后冠状动脉疾病和慢性透析)。采用多变量Cox比例风险回归(向后法,P < 0.15)来确定组间与总体移植物存活之间的关系,并采用多变量逻辑回归分析(向后法,P < 0.15)来确定组间与次要结局指标之间的关系。
在多变量Cox回归分析中,与未过渡组相比,EXTRA组90天以上经风险调整的移植物存活率降低(风险比 = 3.54,2.28 - 5.51,P < 0.001),但INTRA组(1.04,0.719 - 1.51,P = 0.834)和PARA组(1.06,0.642 - 1.76,P = 0.809)未出现这种情况。在90天至1年或1至5年期间,4组之间经风险调整的移植物存活率无显著差异。然而,在5年以上时,INTRA组经风险调整的移植物存活率(0.389,0.205 - 0.738,P = 0.004)优于未过渡组。EXTRA组、PARA组和INTRA组的感染风险均增加。EXTRA组在30天时透析、中风和原发性移植物功能衰竭的风险增加,而PARA组和INTRA组与未过渡组相比无差异。长期并发症在组间无差异。
使用可植入式左心室辅助装置作为移植过渡手段,包括体内和体外旁置装置,与移植后生存率降低无关。然而,使用体外装置过渡的受者90天生存率降低。