Pagani FD, Cantor R, Cowger J, Goldstein D, Teuteberg J, Mahr C, Atluri P, Kilic A, Maozami N, Habib R, Naftel D, and Kirklin JK. Concordance of Treatment Effect: An Analysis of The Society of Thoracic Surgeons Intermacs Database. Ann Thorac Surg 2021.
The Annals of thoracic surgery
BACKGROUND: 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.
METHODS: Patients (aged > 19 years) enrolled into STS Intermacs between August 2017 - June 2019 were stratified by device type (centrifugal device with hybrid levitation [CF-HL] or full magnetic levitation [CF-FML]). The primary outcome was 1-year survival assessed by three statistical methodologies (multivariable regression, propensity score matching, and instrumental variable analysis).
RESULTS: Of 4,448 patients, 2,012 (45.2%) received CF-HL and 2,436 (54.8%) received CF-FML. One-year survival for CF-FML was 88% vs. 79% for CF-HL (overall p < .001), with a hazard ratio for mortality of 3.18 for CF-HL (p<0.0001) after risk adjustment. With propensity score matching (n=1400 each cohort), 1-year survival was 87% for CF-FML vs. 80% for CF-HL, with a hazard ratio of 3.20 for mortality with CF-HL (p<0.0001) after risk adjustment. With an instrumental variable analysis, the probability of receiving CF-HL was associated with a hazard ratio of 3.11 (p<0.0001).
CONCLUSIONS: 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 CF-FML versus CF-HL.
ePub ahead of print