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定义最佳左心室辅助装置短期结局可能有助于了解项目质量评估。

Defining optimal left ventricular assist device short-term outcomes may provide insight into programmatic quality assessment.

机构信息

Henry Ford Heart and Vascular Institute, Detroit, Michigan.

Piedmont Heart Institute, Atlanta, Georgia.

出版信息

J Heart Lung Transplant. 2024 Nov;43(11):1777-1787. doi: 10.1016/j.healun.2024.08.006. Epub 2024 Aug 12.

Abstract

BACKGROUND

Patients have substantial variability in perioperative outcomes after left ventricular assist device (LVAD) implant. A perioperative multidimensional tool integrating mortality, adverse events (AEs), and patient-reported outcomes to assist in quality improvement initiatives is needed.

METHODS

Patients undergoing HeartMate 3 LVAD implant (January 1, 2017 to January 31, 2024) in the Society of Thoracic Surgeons' Intermacs registry were studied. Cox proportional hazard multivariable analyses incorporating AEs as time-varying covariates for mortality out to 180 days was used to generate the INtermacs Short term composITE quality score (INSITE score derivation), reflecting the adjusted hazard ratio (HR) for mortality contributed by each AE, applying the global ranking methodology. In those alive and on support at 6 months, multivariable logistic regression (odds ratio) was used to examine the impact of AEs on health-related quality of life (QOL) at 180 days, captured through the INSITE-QOL score. Failure to achieve ≥1 point increase in visual analog scale from baseline was the event.

RESULTS

Of 13,148 patients, 4,389 (33.4%) suffered at least 1 AE or death through 180 days. Stroke (survival: HR 13.1; QOL: HR 1.7), dialysis (survival: HR 31.4; QOL: HR 4.2), prolonged respiratory failure (survival: HR 5.7; QOL: HR 2.3), reoperation (survival: HR 3.4; QOL: HR 1.6), and right heart failure (survival: 5.0; QOL: HR 1.4), contributed to both mortality and failure to improve QOL at 180 days (all p < 0.05). The median INSITE and INSITE-QOL scores were 0.0 [0.0, 1.6] and 0.0 [0.0, 0.0], respectively. At 9.4% (n = 17) of centers, a high INSITE score (≥13) was present in 15% of patients, while the top 25% of centers had perfect INSITE-QOL scores in at least 75% of patients.

CONCLUSIONS

AEs after LVAD confer differential impact on mortality and QOL, enabling the development of global rank outcome scores. Given the high mortality hazard conferred by 180-day AEs, center-specific quality interventions aimed at reducing early complications provide the greatest opportunity to improve long-term survival and QOL.

摘要

背景

左心室辅助装置 (LVAD) 植入后,患者的围手术期结局存在很大差异。需要一种围手术期多维工具,将死亡率、不良事件 (AE) 和患者报告的结果整合在一起,以协助进行质量改进计划。

方法

研究了在胸外科医师学会的 Intermacs 注册中心接受 HeartMate 3 LVAD 植入术的患者(2017 年 1 月 1 日至 2024 年 1 月 31 日)。采用 Cox 比例风险多变量分析,将 AE 作为死亡率的时间变化协变量,分析 180 天内的死亡率,生成 INtermacs 短期综合质量评分(INSITE 评分推导),反映每个 AE 对死亡率的调整风险比 (HR),应用全球排名方法。对于存活且在 6 个月时仍在接受支持的患者,采用多变量逻辑回归(比值比)来评估 AE 对 180 天时健康相关生活质量 (QOL) 的影响,通过 INSITE-QOL 评分进行评估。未能实现从基线到视觉模拟量表增加≥1 分的情况是事件。

结果

在 13148 名患者中,有 4389 名(33.4%)患者在 180 天内至少发生了 1 次 AE 或死亡。中风(存活:HR 13.1;QOL:HR 1.7)、透析(存活:HR 31.4;QOL:HR 4.2)、延长的呼吸衰竭(存活:HR 5.7;QOL:HR 2.3)、再次手术(存活:HR 3.4;QOL:HR 1.6)和右心衰竭(存活:HR 5.0;QOL:HR 1.4)均导致死亡率和 QOL 改善失败,两者均在 180 天内达到统计学意义(均 p<0.05)。INSITE 和 INSITE-QOL 评分的中位数分别为 0.0[0.0,1.6]和 0.0[0.0,0.0]。在 9.4%(n=17)的中心,有 15%的患者的 INSITE 评分较高(≥13),而前 25%的中心有至少 75%的患者的 INSITE-QOL 评分达到完美。

结论

LVAD 术后 AE 对死亡率和 QOL 有不同的影响,从而可以制定全球排名结局评分。鉴于 180 天 AE 导致的高死亡率风险,针对减少早期并发症的特定中心质量干预措施提供了改善长期生存和 QOL 的最大机会。

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