Iris Feng BS , Gabriel Dardik BS , Yuji Kaku MD , Yanling Zhao MS, MPH , Henry del Carmen BBA , John DePaolo MD, PhD , Marisa Cevasco MD, MPH , Mauer Biscotti MD , Joyce W. Wald DO , Justin A. Fried MD , Koji Takeda MD, PhD
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Patients were stratified by standard (≤14 days) (n = 143) versus prolonged (>14 days) (n = 114) device support.</div></div><div><h3>Results</h3><div>At baseline, the etiology of shock was more likely to be acute decompensated heart failure (74.6% vs 52.4%; <em>P</em> < .001) in patients requiring prolonged support. Duration of device support ranged from 1 to 133 days with median being 25.0 days (interquartile range [IQR], 19.0-36.0 days) and 7.0 days (IQR, 5.0-11.0 days) in prolonged and standard cohorts, respectively. Bridge to decision (42.1% vs 29.4%; <em>P</em> = .046) and ultimate destination of transplant (36.8% vs 15.8%; <em>P</em> < .001) were more common in the prolonged cohort. Incidence of stroke (10.5% vs 8.4%; <em>P</em> = .712), bleeding requiring surgical exploration (7.0% vs 4.9%; <em>P</em> = .650), and in-hospital mortality (23.0% vs 30.1%; <em>P</em> = .262) were similar between groups, although surgical site infection was more common in the prolonged cohort (11.4% vs 3.5%; <em>P</em> = .026). Cumulative incidence analysis showed stroke was rare beyond 30 days of device duration. In patients who survived to device explant, 60-day survival after explant was equivalent between groups (91.8% vs 88.8%; <em>P</em> = .430).</div></div><div><h3>Conclusions</h3><div>Extended Impella 5.5 device support beyond 14 days was not associated with increased incidence of mortality, major bleeding, or stroke in our study, and may be effective for patients requiring extended ventricular assist device support as bridge to heart transplant.</div></div>","PeriodicalId":74032,"journal":{"name":"JTCVS open","volume":"25 ","pages":"Pages 173-189"},"PeriodicalIF":1.9000,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Outcomes of prolonged support on surgically implanted microaxial left ventricular assist devices for refractory cardiogenic shock\",\"authors\":\"Iris Feng BS , Gabriel Dardik BS , Yuji Kaku MD , Yanling Zhao MS, MPH , Henry del Carmen BBA , John DePaolo MD, PhD , Marisa Cevasco MD, MPH , Mauer Biscotti MD , Joyce W. Wald DO , Justin A. Fried MD , Koji Takeda MD, PhD\",\"doi\":\"10.1016/j.xjon.2025.03.023\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Objective</h3><div>The US Food and Drug Administration approved the use of Impella 5.5 (Abiomed) for mechanical circulatory support for up to 14 days, but many patients require longer duration of support. This study sought to compare outcomes of standard versus prolonged Impella 5.5 support.</div></div><div><h3>Methods</h3><div>A retrospective review of 257 patients implanted with the Impella 5.5 device between 2020 and 2024 for cardiogenic shock at 2 high-volume institutions was conducted. Patients were stratified by standard (≤14 days) (n = 143) versus prolonged (>14 days) (n = 114) device support.</div></div><div><h3>Results</h3><div>At baseline, the etiology of shock was more likely to be acute decompensated heart failure (74.6% vs 52.4%; <em>P</em> < .001) in patients requiring prolonged support. Duration of device support ranged from 1 to 133 days with median being 25.0 days (interquartile range [IQR], 19.0-36.0 days) and 7.0 days (IQR, 5.0-11.0 days) in prolonged and standard cohorts, respectively. Bridge to decision (42.1% vs 29.4%; <em>P</em> = .046) and ultimate destination of transplant (36.8% vs 15.8%; <em>P</em> < .001) were more common in the prolonged cohort. Incidence of stroke (10.5% vs 8.4%; <em>P</em> = .712), bleeding requiring surgical exploration (7.0% vs 4.9%; <em>P</em> = .650), and in-hospital mortality (23.0% vs 30.1%; <em>P</em> = .262) were similar between groups, although surgical site infection was more common in the prolonged cohort (11.4% vs 3.5%; <em>P</em> = .026). Cumulative incidence analysis showed stroke was rare beyond 30 days of device duration. 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引用次数: 0
摘要
目的:美国食品和药物管理局批准使用Impella 5.5 (Abiomed)进行长达14天的机械循环支持,但许多患者需要更长的支持时间。本研究旨在比较标准与延长的Impella 5.5支持的结果。方法回顾性分析2020年至2024年在2家大容量机构植入Impella 5.5装置治疗心源性休克的257例患者。患者按标准(≤14天)(n = 143)和延长(>;14天)(n = 114)器械支持进行分层。结果基线时,休克的病因更可能是急性失代偿性心力衰竭(74.6% vs 52.4%;P & lt;.001)。延长队列和标准队列的设备支持持续时间为1 ~ 133天,中位数分别为25.0天(四分位数范围[IQR], 19.0 ~ 36.0天)和7.0天(IQR, 5.0 ~ 11.0天)。决策桥梁(42.1% vs 29.4%;P = 0.046)和最终移植目的地(36.8% vs 15.8%;P & lt;.001)在长期队列中更为常见。卒中发生率(10.5% vs 8.4%;P = .712),出血需要手术探查(7.0% vs 4.9%;P = .650),住院死亡率(23.0% vs 30.1%;P = .262)组间相似,尽管手术部位感染在长期队列中更为常见(11.4% vs 3.5%;P = .026)。累积发生率分析显示,超过30天的设备使用时间,中风是罕见的。在移植后存活的患者中,两组患者移植后60天生存率相当(91.8% vs 88.8%;P = .430)。结论:在我们的研究中,延长的Impella 5.5装置支持超过14天与死亡率、大出血或卒中发生率增加无关,并且对于需要延长心室辅助装置支持作为心脏移植桥梁的患者可能有效。
Outcomes of prolonged support on surgically implanted microaxial left ventricular assist devices for refractory cardiogenic shock
Objective
The US Food and Drug Administration approved the use of Impella 5.5 (Abiomed) for mechanical circulatory support for up to 14 days, but many patients require longer duration of support. This study sought to compare outcomes of standard versus prolonged Impella 5.5 support.
Methods
A retrospective review of 257 patients implanted with the Impella 5.5 device between 2020 and 2024 for cardiogenic shock at 2 high-volume institutions was conducted. Patients were stratified by standard (≤14 days) (n = 143) versus prolonged (>14 days) (n = 114) device support.
Results
At baseline, the etiology of shock was more likely to be acute decompensated heart failure (74.6% vs 52.4%; P < .001) in patients requiring prolonged support. Duration of device support ranged from 1 to 133 days with median being 25.0 days (interquartile range [IQR], 19.0-36.0 days) and 7.0 days (IQR, 5.0-11.0 days) in prolonged and standard cohorts, respectively. Bridge to decision (42.1% vs 29.4%; P = .046) and ultimate destination of transplant (36.8% vs 15.8%; P < .001) were more common in the prolonged cohort. Incidence of stroke (10.5% vs 8.4%; P = .712), bleeding requiring surgical exploration (7.0% vs 4.9%; P = .650), and in-hospital mortality (23.0% vs 30.1%; P = .262) were similar between groups, although surgical site infection was more common in the prolonged cohort (11.4% vs 3.5%; P = .026). Cumulative incidence analysis showed stroke was rare beyond 30 days of device duration. In patients who survived to device explant, 60-day survival after explant was equivalent between groups (91.8% vs 88.8%; P = .430).
Conclusions
Extended Impella 5.5 device support beyond 14 days was not associated with increased incidence of mortality, major bleeding, or stroke in our study, and may be effective for patients requiring extended ventricular assist device support as bridge to heart transplant.