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.
KEYWORDS
Abbreviations:
ACTION (advanced cardiac therapies improving outcomes network), AT3 (antithrombin 3), CCC (chronic complex comorbidity), CHA (children's hospital association), CHD (congenital heart disease), ECMO (extracorporeal membrane oxygenation), ICER (incremental cost-effectiveness ratio), ICU (intensive care unit), LOS (length of stay), PHIS (pediatric health information system), pRBC (packed red blood cell), QALY (quality-adjusted life years), RCC (ration of cost-to-charge), VAD (ventricular assist device), VAQOL (visual analog quality of life scale)To read this article in full you will need to make a payment
Purchase one-time access:
Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online accessOne-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
Subscribe:
Subscribe to The Journal of Heart and Lung TransplantationAlready a print subscriber? Claim online access
Already an online subscriber? Sign in
Register: Create an account
Institutional Access: Sign in to ScienceDirect
References
- Fourth Annual Pediatric Interagency Registry for Mechanical Circulatory Support (Pedimacs) Report.Ann Thorac Surg. 2020; 110: 1819-1831
- Resource utilization in pediatric patients supported with ventricular assist devices in the United States: a multicenter study from the Pediatric Interagency Registry for Mechanically Assisted Circulatory Support and the Pediatric Health Information System.J Am Heart Assoc. 2018; 7e008380https://doi.org/10.1161/JAHA.117.008380
- Resource utilization in children with paracorporeal continuous-flow ventricular assist devices.J Heart Lung Transplant. 2021; 40: 478-487
- Outcomes of children supported with devices labeled as “temporary” or short term: a report from the Pediatric Interagency Registry for Mechanical Circulatory Support.J Heart Lung Transplant. 2018; 37: 54-60
- Utilization and outcomes of children treated with direct thrombin inhibitors on paracorporeal ventricular assist device support.Asaio J. 2020; 66: 939-945
- Postapproval outcomes: the Berlin Heart EXCOR Pediatric in North America.Asaio J. 2017; 63: 193-197
- Prospective trial of a pediatric ventricular assist device.N Engl J Med. 2012; 367: 532-541
- Berlin Heart EXCOR and ACTION post-approval surveillance study report.J Heart Lung Transplant. 2021; 40: 251-259
- ABCs of stroke prevention: improving stroke outcomes in children supported with a ventricular assist device in a Quality Improvement Network.Circ Cardiovasc Qual Outcomes. 2020; 13e006663
- Pediatric complex chronic conditions classification system version 2: updated for ICD-10 and complex medical technology dependence and transplantation.BMC Pediatr. 2014; 14: 199
- Using the E-value to assess the potential effect of unmeasured confounding in observational studies.Jama. 2019; 321: 602-603
- Sensitivity analysis in observational research: introducing the E-value.Ann Intern Med. 2017; 167: 268-274
- Costs associated with ventricular assist device use in children.Ann Thorac Surg. 2008; 86: 1592-1597
- The International Thoracic Organ Transplant Registry of the International Society for Heart and Lung Transplantation: 23rd pediatric heart transplantation report-2020; focus on deceased donor characteristics.J Heart Lung Transplant. 2020; 39: 1028-1037
- Bivalirudin experience in a heterogeneous ventricular assist device population.Asaio J. 2020; 66: 677-682
- Pulsatile ventricular assist device as a bridge to transplant for the early high-risk single-ventricle physiology.J Thorac Cardiovasc Surg. 2021; 162 (e404): 405-413
- Time in therapeutic range for bivalirudin among pediatric ventricular assist device recipients.Asaio J. 2021; 67: 588-593
- Description of bivalirudin use for anticoagulation in pediatric patients on mechanical circulatory support.Ann Pharmacother. 2021; 55: 59-64
- Cost-effectiveness of pediatric heart transplantation.J Heart Lung Transplant. 2006; 25: 409-415
- Cost-utility analysis of salvage cardiac extracorporeal membrane oxygenation in children.J Thorac Cardiovasc Surg. 2005; 129: 1084-1090
- Cost-effectiveness analysis of palivizumab in premature infants without chronic lung disease.Arch Pediatr Adolesc Med. 2006; 160: 1070-1076
- Antithrombotic therapy in a prospective trial of a pediatric ventricular assist device.Asaio J. 2016; 62: 719-727
Article info
Publication history
Published online: October 11, 2022
Identification
Copyright
© 2022 International Society for Heart and Lung Transplantation. All rights reserved.