These findings suggest that while treatment for patients who are ineligible for left ventricular assist device (LVAD) trial inclusion should be weighed against medical management, more consideration could be given to designing trials with eligibility criteria that reflect real-world experience.

This cohort study examined 14 679 patients undergoing primary, intracorporeal continuous-flow LVAD implantation (with or without a right ventricular assist device) in 181 North American centers from January 1, 2012, to June 30, 2017, identified in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS).

Among 14,679 recipients, mean (SD) age was 57 (13) years, 11 503 individuals (78.4%) were men, and 11 406 individuals (77.7%) presented with New York Heart Association class IV heart failure.

A total of 6,429 recipients (43.8%) were ineligible for trial inclusion, of whom 4,226 individuals (65.7%) met 1 ineligibility criterion, 1,442 individuals (22.4%) met 2 criteria, and 761 individuals (11.8%) met 3 or more criteria.

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