Abstract

Introduction: Ventricular assist devices (VAD) have improved outcomes in children with advanced heart failure. However, despite improvements in adverse event rates, mortality and early post-VAD stroke remain important consequences. We sought to determine pre and post-operative factors that increase the risk of these outcomes utilizing data linked from the ACTION and PC4 registries. Methods: ACTION and PC4 registries are audited, comprehensive, encounter-based registries of patient course and outcomes for pediatric heart failure and pediatric cardiac critical care respectively. Data from patients who underwent initial VAD placement in each registry from 8/2014-7/2020 were linked using indirect patient identifiers. Patient demographics, heart disease, pre and post-operative ICU courses and outcomes were compiled. Appropriate descriptive and univariate statistics assessed association of patient factors with hospital mortality and stroke. Multivariable logistic regression sought independent associations with these outcomes. Results: 248 ACTION subjects were linked to a matching patient in PC4 with 98% match concordance. Median age was 7.7 years (1.5-15.5), weight 21.3kg (9.1-58) and 56% male. The cohort had 66% LVAD, 23% Single ventricle VAD and 10% BiVAD. Of the devices, 52 (21%) were Berlin EXCOR, 95 (38%) intracorporeal continuous flow, and 30 (12%) temporary continuous flow. The primary diagnosis was congenital heart disease in 35% of patients. Overall, 32 patients (13%) had a stroke and 45 patients (18%) died prior to discharge. Multivariable analysis found risk factors for mortality included only congenital heart disease (OR=3.78 [95%CI: 1.16-12.29], p=0.027), INTERMACS profile 1 (OR=6.51 [95%CI: 1.08-39.26], p=0.041), post-operative hepatic dysfunction (OR=37.35 [95%CI: 4.39-317.76], p<0.01) and stroke (OR=5.33 [95%CI: 1.4-20.31], p=0.014). For stroke, no significant independent predictors were identified. Conclusion: Critical care therapies are not independently associated with post-VAD hospital death or stroke. Post-operative liver injury and stroke were associated with mortality.

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