McNamara Nicholas, Narroway Harry, Williams Michael, Brookes John, Farag James, Cistulli David, Bannon Paul, Marasco Silvana, Potapov Evgenij, Loforte Antonio
Cardiothoracic Surgical Department, Royal Prince Alfred Hospital, Sydney, Australia.
Faculty of Health and Medicine, University of Sydney, Sydney, Australia.
Ann Cardiothorac Surg. 2021 Mar;10(2):186-208. doi: 10.21037/acs-2021-cfmcs-35.
End stage heart failure is a major cause of morbidity and mortality, and its prevalence is expected to rise with the ageing population. For suitable patients, orthotopic heart transplantation remains the gold standard therapy, however, a paucity of donor organs has led to the development of left ventricular assist devices (LVAD). These devices can be utilized as either a bridge-to-transplant (BTT) or as an alternative to heart transplantation. While these devices can prolong life and improve quality of life, they are associated with a significant number of adverse events. We aim to systematically review the literature to quantify survival and the incidence of adverse events following implantation of continuous-flow LVADs (cf-LVAD).
A systematic review was performed to determine outcomes following implantation of a cf-LVAD. Primary outcomes were survival and frequency of adverse events (such as bleeding, infection, thrombosis, stroke and right ventricular failure). Secondary outcomes included quality of life and assessment of functional status.
Sixty-three studies reported clinical outcomes of 9,280 patients. Survival after cf-LVAD varied between studies. Industry-funded trials generally reported better overall survival than the single- and multi-center case series, which showed significant variation. The largest registry report documented twelve, twenty-four and forty-eight-month survival rates of 82%, 72% and 57% respectively. The most commonly reported adverse events were gastrointestinal bleeding (GIB), device-related infection, neurological events and right heart failure (RHF). Bleeding, RHF and infection were the most frequent complications experienced by those supported with cf-LVAD, occurring in up to 35%, 40% and 55% of patients, respectively. Quality of life as measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ) and functional status as measured with the 6-minute walk test (6MWT) improved after cf-LVAD implantation with no decline evident two years after implantation.
The paucity of donor hearts has led to the development of left-ventricular assist devices as a BTT or as a destination therapy (DT). Outcomes after cf-LVAD implantation are excellent, with short-term survival comparable to heart transplantation, but long-term survival remains limited due to the incidence of post-implantation adverse events. Despite these complications, quality of life and functional status improve significantly post-implantation and remain improved over the long-term. This study demonstrates the potential benefits of cf-LVAD therapy whilst also identifying adverse events as an area of increased morbidity and mortality.
终末期心力衰竭是发病和死亡的主要原因，预计其患病率会随着人口老龄化而上升。对于合适的患者，原位心脏移植仍是金标准治疗方法，然而，供体器官的短缺促使了左心室辅助装置（LVAD）的发展。这些装置既可以用作移植桥接（BTT），也可以作为心脏移植的替代方案。虽然这些装置可以延长生命并改善生活质量，但它们会引发大量不良事件。我们旨在系统回顾文献，以量化连续流左心室辅助装置（cf-LVAD）植入后的生存率和不良事件发生率。
进行了一项系统回顾，以确定cf-LVAD植入后的结果。主要结果是生存率和不良事件（如出血、感染、血栓形成、中风和右心室衰竭）的发生频率。次要结果包括生活质量和功能状态评估。
63项研究报告了9280例患者的临床结果。cf-LVAD植入后的生存率在不同研究中有所差异。由行业资助的试验总体上报告的总生存率高于单中心和多中心病例系列，后者显示出显著差异。最大的登记报告记录了12个月、24个月和48个月的生存率分别为82%、72%和57%。最常报告的不良事件是胃肠道出血（GIB）、与装置相关的感染、神经系统事件和右心衰竭（RHF）。出血、RHF和感染是接受cf-LVAD支持的患者最常出现的并发症，分别发生在高达35%、40%和55%的患者中。使用堪萨斯城心肌病问卷（KCCQ）测量的生活质量和用6分钟步行试验（6MWT）测量的功能状态在cf-LVAD植入后有所改善，植入后两年内无明显下降。
供体心脏的短缺促使了左心室辅助装置作为移植桥接或终末治疗（DT）的发展。cf-LVAD植入后的结果良好，短期生存率与心脏移植相当，但由于植入后不良事件的发生率，长期生存率仍然有限。尽管有这些并发症，但植入后生活质量和功能状态显著改善，并在长期内保持改善。本研究证明了cf-LVAD治疗的潜在益处，同时也将不良事件确定为发病率和死亡率增加的一个领域。
