Ammirati Enrico, Brambatti Michela, Braun Oscar Ö, Shah Palak, Cipriani Manlio, Bui Quan M, Veenis Jesse, Lee Euyhyun, Xu Ronghui, Hong Kimberly N, Van de Heyning Caroline M, Perna Enrico, Timmermans Philippe, Cikes Maja, Brugts Jasper J, Veronese Giacomo, Minto Jonathan, Smith Saige, Gjesdal Grunde, Gernhofer Yan K, Partida Cynthia, Potena Luciano, Masetti Marco, Boschi Silvia, Loforte Antonio, Jakus Nina, Milicic Davor, Nilsson Johan, De Bock Dina, Sterken Caroline, Van den Bossche Klaartje, Rega Filip, Tran Hao, Singh Ramesh, Montomoli Jonathan, Mondino Michele, Greenberg Barry, Russo Claudio F, Pretorius Victor, Liviu Klein, Frigerio Maria, Adler Eric D
De Gasperis CardioCenter, Niguarda Hospital, Milano, Italy.
Division of Cardiology, Department of Medicine, University of California San Diego, La Jolla, CA, USA.
Int J Cardiol. 2021 Feb 1;324:122-130. doi: 10.1016/j.ijcard.2020.09.026. Epub 2020 Sep 18.
Geographic variations in management and outcomes of individuals supported by continuous-flow left ventricular assist devices (CF-LVAD) between the United States (US) and Europe (EU) is largely unknown.
We created a retrospective, multinational registry of 524 patients who received a CF-LVAD (either HVAD or Heartmate II) between January 2008 and April 2017. Follow up spanned from date of CF-LVAD implant to post-HTx period with a median follow up of 44.8 months.
The cohort included 299 (57.1%) EU and 225 (42.9%) US patients. Although the US cohort was significantly older with a higher prevalence of comorbidities, survival was similar between the cohorts (US 63.1%, EU 68.4% at 5 years, unadjusted log-rank test p = 0.43).Multivariate analyses suggested that older age, higher body mass index, elevated creatinine, use of temporary mechanical circulatory support prior CF-LVAD, and implantation of HVAD were associated with increased mortality. Among CF-LVAD patients undergoing HTx, the median time on CF-LVAD support was shorter in the US, meanwhile US donors were younger. Finally, the pattern of adverse events (stroke, gastrointestinal bleedings, late right ventricular failure, and driveline infection) during support differed significantly between US and EU.
Although waitlisted patients in the US on CF-LVAD have higher risk comorbid conditions, the overall outcome is similar in US and EU. Geographic variations with regards to donor characteristics, duration of CF-LVAD support prior to transplant, and adverse events on support can explain the disparity in the utilization of mechanical bridge to transplant strategy between US and EU.
美国（US）和欧洲（EU）之间，接受连续血流左心室辅助装置（CF-LVAD）支持的个体在管理和治疗结果上的地域差异很大程度上尚不明确。
我们创建了一个回顾性的多国注册研究，纳入了2008年1月至2017年4月期间接受CF-LVAD（HVAD或Heartmate II）的524例患者。随访从CF-LVAD植入日期至心脏移植后阶段，中位随访时间为44.8个月。
该队列包括299例（57.1%）欧盟患者和225例（42.9%）美国患者。尽管美国队列患者年龄显著更大，合并症患病率更高，但两个队列的生存率相似（5年时美国为63.1%，欧盟为68.4%，未校正的对数秩检验p = 0.43）。多变量分析表明，年龄较大、体重指数较高、肌酐升高、在CF-LVAD植入前使用临时机械循环支持以及植入HVAD与死亡率增加相关。在接受心脏移植的CF-LVAD患者中，美国患者接受CF-LVAD支持的中位时间较短，同时美国供体更年轻。最后，美国和欧盟在支持期间不良事件（中风、胃肠道出血、晚期右心室衰竭和导线感染）的模式存在显著差异。
尽管美国等待CF-LVAD的患者合并症风险更高，但美国和欧盟的总体结果相似。供体特征、移植前CF-LVAD支持的持续时间以及支持期间的不良事件方面的地域差异可以解释美国和欧盟在机械性移植桥接策略使用上的差异。
