Department of Cardiac Surgery, University of Michigan, Ann Arbor, Michigan.
Kirklin Institute for Research in Surgical Outcomes, University of Alabama at Birmingham, Birmingham, Alabama.
Ann Thorac Surg. 2022 Apr;113(4):1172-1182. doi: 10.1016/j.athoracsur.2021.05.017. Epub 2021 Jun 1.
The Society of Thoracic Surgeons (STS) Intermacs Registry represents a real-world data source of durable, left ventricular assist devices that can address knowledge gaps not informed through randomized clinical trials. We sought to compare survival with contemporary left ventricular assist device technologies using multiple analytic approaches to assess concordance of treatment effects and to validate prior STS Intermacs observations.
Patients (≥19 years of age) enrolled into STS Intermacs between August 2017 and June 2019 were stratified by device type (continuous flow, centrifugal left ventricular assist device with hybrid levitation [CF-HL] or full magnetic levitation [CF-FML]). The primary outcome was 1-year survival assessed by 3 statistical methodologies (multivariable regression, propensity score matching, and instrumental variable analysis).
Of 4448 patients, 2012 (45.2%) received the CF-HL and 2436 (54.8%) received the CF-FML. One-year survival for the CF-FML was 88% vs 79% for the CF-HL (overall P < .001), with a hazard ratio for mortality of 3.18 for the CF-HL (P < .0001) after risk adjustment. With propensity score matching (n = 1400 each cohort), 1-year survival was 87% for the CF-FML vs 80% for the CF-HL, with a hazard ratio of 3.20 for mortality with the CF-HL (P < .0001) after risk adjustment. With an instrumental variable analysis, the probability of receiving the CF-HL was associated with a hazard ratio of 3.11 (P < .0001).
Statistical methodology using propensity score matching and instrumental variable analysis increased the robustness of observations derived from real-world data and demonstrates the feasibility of performing comparative effectiveness research using STS Intermacs. These analyses provide additional evidence supporting a survival benefit of the CF-FML vs CF-HL.
胸外科医师学会（STS）Intermacs 注册代表了一个真实世界的耐用性左心室辅助设备数据来源，可以解决通过随机临床试验无法了解的知识空白。我们试图使用多种分析方法比较使用当代左心室辅助设备技术的存活率，以评估治疗效果的一致性，并验证之前 STS Intermacs 的观察结果。
2017 年 8 月至 2019 年 6 月期间在 STS Intermacs 注册的患者（年龄≥19 岁）按设备类型（连续流、带混合悬浮（CF-HL）或全磁悬浮（CF-FML）的离心左心室辅助装置）分层。主要结局是通过 3 种统计方法（多变量回归、倾向评分匹配和工具变量分析）评估的 1 年生存率。
在 4448 名患者中，2012 名（45.2%）接受了 CF-HL，2436 名（54.8%）接受了 CF-FML。CF-FML 的 1 年生存率为 88%，而 CF-HL 为 79%（总体 P<0.001），CF-HL 的死亡风险比为 3.18（P<0.0001），经过风险调整。在倾向评分匹配（每组 n=1400）后，CF-FML 的 1 年生存率为 87%，而 CF-HL 为 80%，CF-HL 的死亡风险比为 3.20（P<0.0001），经过风险调整。通过工具变量分析，接受 CF-HL 的概率与风险比为 3.11（P<0.0001）相关。
使用倾向评分匹配和工具变量分析的统计方法提高了从真实世界数据中得出的观察结果的稳健性，并证明了使用 STS Intermacs 进行比较有效性研究的可行性。这些分析提供了额外的证据，支持 CF-FML 与 CF-HL 相比具有生存优势。
