Generalizability of Trial Data to Real-World Practice: An Analysis of The Society of Thoracic Surgeons Intermacs Database.

ABSTRACT Background While the current wide-scale adoption of the HeartMate 3 left ventricular assist device (LVAD) can be attributed to favorable clinical trial outcomes, restrictive clinical trial eligibility criteria may result in lack of generalizability to real-world populations. We assessed the generalizability of LVAD clinical trial outcomes and evaluated the prognostic value of specific inclusion/exclusion criteria. Methods MOMENTUM 3 (Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Therapy with HeartMate 3) eligibility criteria were applied to patients identified in The Society of Thoracic Surgeons Interagency Registry for Mechanically Assisted Circulatory Support who underwent HeartMate 3 implantation [n=4610] between August 2017–March 2020. Patients were categorized as trial-eligible or trial-ineligible and by number of ineligibility criteria. The effect of trial eligibility on mortality was estimated using Cox models. Results Indications for HeartMate 3 implant included destination therapy (n=2827, 61%), bridge-to-candidacy (n=969, 21%), and bridge-to-transplant (n=702, 15%). A total of 1941 (42%) recipients were trial-ineligible, with 1245 (27%) meeting 1 ineligibility criterion, 470 (10%) meeting 2, and 226 (5%) meeting ≥3. Estimated 1-year mortality for trial-ineligible recipients was higher than for trial-eligible recipients (17±1% vs. 10±1%, p Conclusions Despite differences in mortality, both trial-eligible and trial-ineligible HeartMate 3 recipients had excellent outcomes in real-world practice, suggesting future trial eligibility criteria could be expanded.