RESUMO
BACKGROUND: Despite recent data suggesting improved outcomes with bivalirudin vs heparin in pediatric Ventricular assist devices (VAD), higher costs remain a barrier. This study quantified trends in bivalirudin use and compared outcomes, resource utilization, and cost-effectiveness associated with bivalirudin vs heparin. METHODS: Children age 0 to 6 year who received VAD from 2009 to 2021 were identified in Pediatric Health Information System. Bivalirudin use was evaluated using trend analysis and outcomes were compared using Fine-Gray subdistrubtion hazard ratios (SHR). Daily-level hospital costs were compared due to differences in length of stay. Cost-effectiveness was evaluated using incremental cost-effectiveness ratio (ICER). RESULTS: Of 691 pediatric VAD recipients (median age 1 year, IQR 0-2), 304 (44%) received bivalirudin with 90% receiving bivalirudin in 2021 (trend p-value <0.01). Bivalirudin had lower hospital mortality (26% vs 32%; adjusted SHR 0.57, 95% CI 0.40-0.83) driven by lower VAD mortality (20% vs 27%; adjusted SHR 0.46, 95% CI 0.32-0.77) after adjusting for year, age, diagnosis, and center VAD volume. Post-VAD length of stay was longer for bivalirudin than heparin (median 91 vs 64 days, respectively, p < 0.001). Median daily-level costs were lower among bivalirudin (cost ratio 0.87, 95% CI 0.79-0.96) with higher pharmacy costs offset by lower imaging, laboratory, supply, and room/board costs. Estimated ICER for bivalirudin vs heparin was $61,192 per quality-adjusted life year gained with a range of $27,673 to $131,243. CONCLUSIONS: Bivalirudin use significantly increased over the past decade and is now used in 90% young pediatric VAD recipients. Bivalirudin was associated with significantly lower hospital mortality and an ICER <$65,000, making it a cost-effective therapy for pediatric VAD recipients.
Assuntos
Coração Auxiliar , Humanos , Criança , Lactente , Recém-Nascido , Pré-Escolar , Análise Custo-Benefício , Estudos Retrospectivos , Hirudinas , Heparina/uso terapêutico , Fragmentos de Peptídeos/uso terapêutico , Proteínas Recombinantes/uso terapêutico , Resultado do TratamentoRESUMO
BACKGROUND: Mechanical circulatory support (MCS) is an option for the treatment of medically intractable end-stage heart failure. MCS therapy, however, is resource intensive. OBJECTIVE: The purpose of this report was to systematically review the MCS cost-effectiveness literature as it pertains to the treatment of adult patients in end-stage heart failure. METHODS: We conducted a systematic search and narrative review of available cost- effectiveness and cost-utility analyses of MCS in adult patients with end-stage heart failure. RESULTS: Eleven studies analyzing the cost-effectiveness or cost-utility of MCS were identified. Seven studies focused on bridge to transplantation, three studies focused on destination therapy, and one study presented analyses of both strategies. Two articles evaluated the cost-effectiveness of the HeartMate II (Thoratec Corp., Pleasanton, CA). Incremental cost-effectiveness ratios between MCS and medical management ranged between $85,025 and $200,166 for bridge to transplantation and between $87,622 and $1,257,946 for destination therapy (2012 Canadian dollars per quality-adjusted life-year). Sensitivity analyses indicated that improvements in survival and quality of life and reductions in device and initial hospital-stay costs may improve the cost-effectiveness of MCS. CONCLUSIONS: Current studies suggest that MCS is likely not cost-effective with reference to generally accepted or explicitly stated thresholds. Refined patient selection, complication rates, achieved quality of life, and device/surgical costs, however, could modify the cost-effectiveness of MCS.