Continuous Flow LVAD(CF-LVAD) are widely used as BTT among patients with Advance Heart Failure. The current study aimed to determine the impact of device related complications on waitlist mortality or delisting due to worsening clinical conditions.
Methods: Patients who were bridged to heart transplant with a continuous flow LVAD (CF-LVAD) between April 2008 and September 2015 were identified from the UNOS heart transplant registry. They were then categorized by the presence or absence of CF-LVAD complications while on the wait list. Cox proportional hazards and Kaplan Meier survival curves were used for time-to-event analysis for the primary outcome.
Results: Out of 7070 patients who were bridged to heart transplant, 4434(63%) got transplanted and 2510(36%) developed device related complications while on the waiting list. The primary outcome was present in 1631(23%) patients. Independent predictors of primary outcome were Age (HR/increasing unit: 1.01, 95% CI: 1.01-1.02, p value: <0.0001.), ABO blood group(O vs. A HR: 1.20, 95% CI: 1.20-1.36, p value: 0.003), Etiology of cardiomyopathy (Congenital vs. Ischemic HR: 3.46, 95% CI: 3.46(2.15-5.27, p value: <0.0001, Restrictive vs. Non-ischemic HR: 2.66, 95% CI: 1.67-3.99, p value: 0.0001), history of diabetes mellitus(HR: 1.18, 95% CI: 1.05-1.34, p value: 0.006). Developing one device-related complication was associated with a HR of 2.59 of having the primary outcome, (p<0.0001). The hazard risk however increased to 3.45 when ≥ 2 of the defined complications occurred.
Conclusion: In conclusion, findings from the current study add to the existing literature: the incidence of morbidity and mortality in the current BTT era. While the development of any device-related adverse event is significantly associated with waitlist mortality or delisting, the occurrence of ≥ 2 almost doubles the risk. Improvement in clinical management strategies is needed to ensure optimal benefit of CF-LVADs for BTT therapy.