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同期瓣膜手术在左心室辅助装置植入术中的应用及效果:MagLev 技术在接受机械循环支持治疗的 HeartMate 3 临床试验组合中的多中心研究的综合分析。

Concurrent valvular procedures during left ventricular assist device implantation and outcomes: A comprehensive analysis of the Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 trial portfolio.

机构信息

Department of Surgery, University of Minnesota Medical Center, Minneapolis, Minn.

Cardiovascular Institute, Allegheny Health Network, Pittsburgh, Pa.

出版信息

J Thorac Cardiovasc Surg. 2023 Dec;166(6):1684-1694.e18. doi: 10.1016/j.jtcvs.2022.04.021. Epub 2022 Apr 25.

DOI:10.1016/j.jtcvs.2022.04.021
PMID:35643769
Abstract

BACKGROUND

Correction of valvular disease is often undertaken during left ventricular assist device (LVAD) implantation with uncertain benefit. We analyzed clinical outcomes with HeartMate 3 (HM3; Abbott) LVAD implantation in those with various concurrent valve procedures (HM3+VP) with those with an isolated LVAD implant (HM3 alone).

METHODS

The study included 2200 patients with HM3 implanted within the Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy with HeartMate 3 (MOMENTUM 3) trial portfolio who underwent 820 concurrent procedures among which 466 (21.8%) were HM3+VP. VPs included 101 aortic, 61 mitral, 163 tricuspid; 85 patients had multiple VPs. Perioperative complications, major adverse events, and survival were analyzed.

RESULTS

Patients who underwent HM3+VP had higher-acuity Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profiles (1-2: 41% vs 31%) compared with no VPs (P < .05). The cardiopulmonary bypass time (124 vs 76 minutes; P < .0001) and hospital length of stay (20 vs 18 days; P < .0001) were longer in HM3+VP. A higher incidence of stroke (4.9% vs 2.4%), bleeding (33.9% vs 23.8%), and right heart failure (41.5% vs 29.6%) was noted in HM3+VP at 0 to 30 days (P < .01), with no difference in 30-day mortality (3.9% vs 3.3%) or 2-year survival (81.7% vs 80.8%). Analysis of individual VP showed no differences in survival compared to HM3 alone. No differences were noted among patients with either significant mitral (moderate or worse) or tricuspid (moderate or worse) regurgitation with or without corrective surgery.

CONCLUSIONS

Concurrent VPs, commonly performed during LVAD implantation, are associated with increased morbidity during the index hospitalization, with no effect on short- and long-term survival. There is sufficient equipoise to consider a randomized trial on the benefit of commonly performed VPs (such as mitral or tricuspid regurgitation correction), during LVAD implantation.

摘要

背景

在植入左心室辅助装置(LVAD)期间经常纠正瓣膜疾病,但获益不确定。我们分析了 HeartMate 3(HM3; Abbott)LVAD 植入患者的临床结局,这些患者接受了各种同时进行的瓣膜手术(HM3+VP)和单独植入 HM3 的患者(HM3 单独)。

方法

该研究包括在多中心机械循环支持治疗磁悬浮技术患者的 MagLev 技术研究(MOMENTUM 3 试验组合)中植入 2200 例 HM3 的患者,其中 820 例同时进行了瓣膜手术,其中 466 例(21.8%)为 HM3+VP。VP 包括 101 例主动脉瓣、61 例二尖瓣、163 例三尖瓣;85 例患者有多个 VP。分析围手术期并发症、主要不良事件和生存率。

结果

与无 VP 相比,行 HM3+VP 的患者的急性 INTERMACS(机构间机械循环支持注册)评分更高(1-2:41%比 31%)(P<0.05)。CPB 时间(124 分钟比 76 分钟;P<0.0001)和住院时间(20 天比 18 天;P<0.0001)更长 HM3+VP。HM3+VP 在 0 至 30 天内卒中(4.9%比 2.4%)、出血(33.9%比 23.8%)和右心衰竭(41.5%比 29.6%)的发生率更高(P<0.01),但 30 天死亡率(3.9%比 3.3%)或 2 年生存率(81.7%比 80.8%)无差异。对单个 VP 的分析显示,与 HM3 单独治疗相比,生存率无差异。对于伴有或不伴有矫正手术的严重二尖瓣(中度或更严重)或三尖瓣(中度或更严重)反流的患者,没有差异。

结论

LVAD 植入期间同时进行的常见 VP 与住院期间发病率增加有关,但对短期和长期生存率无影响。对于在 LVAD 植入期间进行常见 VP(如二尖瓣或三尖瓣反流矫正)的益处,存在足够的平衡来考虑随机试验。

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