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Published on: July 20, 2022
100 Episodes of Support With Pulsatile Paracorporeal Ventricular Assist Device in 99 Neonates, Infants, and Children
Mark Steven Bleiweis1, Joseph Philip1, James C Fudge1
1Congenital Heart Center, University of Florida, Gainesville, Florida.
Insights
Berlin Heart ventricular assist device (VAD) support offers a bridge to transplantation for pediatric patients. However, survival rates are lower for smaller children, those with congenital heart disease (CHD), and functionally univentricular circulation, highlighting areas for improved outcomes.
Area of Science:
- Pediatric Cardiology
- Mechanical Circulatory Support
- Congenital Heart Disease
Background:
- Ventricular assist device (VAD) support presents unique challenges in neonates, infants, and children, particularly those with congenital heart disease (CHD), functionally univentricular circulation, or weighing less than 5kg.
- This study reviews the experience with Berlin Heart VAD support at the University of Florida, analyzing risk factors for mortality and outcomes in high-risk pediatric subgroups.
Purpose of the Study:
- To assess the outcomes of Berlin Heart VAD support in a pediatric population.
- To identify risk factors associated with mortality in children receiving VAD support.
- To evaluate outcomes in specific high-risk subgroups, including neonates, infants, children with CHD, functionally univentricular circulation, and those weighing <5kg.
Main Methods:
- A retrospective review of 99 patients (100 VAD support episodes) who received Berlin Heart VAD support.
- Comparison of outcomes between patients with CHD (n=53) and acquired heart disease (n=45).
- Comparison of outcomes between patients with functionally univentricular circulation (n=40) and biventricular circulation (n=59).
- Kaplan-Meier survival analysis and Cox proportional hazard models were used to assess survival and identify prognostic factors.
Main Results:
- Overall 1-year and 5-year survival rates were 74.5% and 69.8%, respectively. For patients <5kg, 1-year and 5-year survival rates were 63.4% and 60.9%.
- Risk factors for mortality included CHD (HR 2.25), liver dysfunction (HR 3.46), and bleeding (HR 3.91).
- Biventricular heart support (HR 0.38) and BiVAD support (HR 0.35) were found to be protective.
- Survival was significantly better in patients with acquired heart disease compared to CHD (log-rank p=0.003) and in those with biventricular circulation compared to univentricular (log-rank p=0.026).
Conclusions:
- Pulsatile VADs, such as the Berlin Heart, serve as effective bridges to transplantation for pediatric patients.
- Survival outcomes are poorer in smaller patients (<5kg) and those with CHD or functionally univentricular circulation.
- These specific pediatric subgroups represent critical areas for future research and therapeutic advancements to improve VAD support outcomes.
Background:
Unique challenges exist with providing ventricular assist device (VAD) support to neonates, infants, and children with congenital heart disease (CHD), functionally univentricular circulation, and those weighing <5 kg. We review our experience with all patients ever supported with Berlin Heart at University of Florida and assess risk factors for mortality and outcomes in high-risk subgroups.
Methods:
Overall outcomes of 99 patients who underwent 100 separate episodes of support with Berlin Heart were assessed; 47 patients weighed <5 kg. Patients with CHD (n =53) were compared with those with acquired heart disease (n = 45), and patients with functionally univentricular circulation (n = 40) were compared with those with biventricular circulation (n = 59). The primary outcome was mortality. Survival was modeled by the Kaplan-Meier method. Univariable Cox proportional hazard models identified prognostic factors for survival. Kaplan-Meier methods and log-rank tests were used to assess group differences in long-term survival.
Results:
Risk factors for mortality were CHD (hazard ratio [HR], 2.25; 95% CI, 1.22-4.13; P = .009), liver dysfunction (HR, 3.46; 95% CI, 1.56-7.69; P = .002), and bleeding (HR, 3.91; 95% CI, 1.87-8.18; P = .0002). Biventricular heart (HR, 0.38; 95% CI, 0.18-0.8; P = .01) and biventricular assist device support (HR, 0.35; 95% CI, 0.16-0.76; P = .007) were protective. Overall survival at 1 and 5 years in all 99 patients was 74.5% (95% CI, 66.4%-83.7%) and 69.8% (95% CI, 61.1%-79.7%). Survival at 1 and 5 years in all 47 patients <5 kg was 63.4% (95% CI, 50.9%-78.9%) and 60.9% (95% CI, 48.3%-76.9%). Longitudinal survival is better in acquired heart disease vs CHD (log-rank P = .003) and biventricular vs univentricular patients (log-rank P = .026).
Conclusions:
Pulsatile VAD facilitates bridge to transplantation in neonates, infants, and children; however, survival is worse in smaller patients, those with CHD, and those with functionally univentricular circulation. These challenging subgroups represent important opportunities for improvement.
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