Improved outcomes with pulsatile paracorporeal ventricular assist device support in children: A single-center experience
Iaprintsev V, Fricke TA, Buratto E, Zubritskiy A, Perrier S, Eastaugh L, Barnes C, Sheridan B, Naimo PS, Brizard CP, Mathew J, Konstantinov IE (2025) · JTCVS Open · n=75
Характеристика исследования
- Дизайн
- single-center retrospective cohort of all consecutive Berlin Heart EXCOR (BHE) recipients (Royal Children's Hospital Melbourne, 2009-2024)
- Размер выборки (n)
- 75
- Вмешательство
- Modern era BHE management including bivalirudin anticoagulation introduction, lowered threshold for cannula/pump interventions, proactive timing
- Компаратор
- Historical era BHE management (pre-2019)
- Первичная конечная точка
- Hospital survival, freedom from cerebrovascular accidents
- Основной результат
- Post-2019 era HR 0.14 (95% CI 0.03-0.72, p=0.02) for death; fatal CVA decreased 54% to 10% (p=0.03); successful transplant/explant rate 70.8% to 92.6% (p=0.03); transplantation achieved in 64% (48/75); 1/6/12-month survival 87.7/80.9/65.9%
- Длительность наблюдения
- Median 128 days BHE support
- PMID
- 41960081
Ключевые выводы
- 85% relative reduction in death after 2019 management changes (HR 0.14)
- Fatal CVA incidence fell from 54% to 10% post-2019
- Successful outcomes rose from 70.8% to 92.6%
- Bivalirudin introduction one of three key protocol changes
- Median 128-day support to bridge to transplant/recovery
Ограничения
- Single-center retrospective design
- Multiple simultaneous protocol changes confound bivalirudin-specific effects
- Selection bias toward proactive support
- 75-patient sample limits subgroup analysis
- Not applicable to whole-leech hirudotherapy
Клиническое значение
Iaprintsev 2025 documents a 15-year quality improvement journey at Royal Children's Hospital Melbourne where bivalirudin introduction was one of three coordinated changes correlating with dramatic survival improvement and fatal stroke reduction. For ASH, this contemporary pediatric pharmaceutical pathway exemplar contrasts with the K040187 device-leech US clinical practice, where outcomes data are more often case-based and protocol changes are less coordinated.
Связанные исследования
Prospective Randomized Pilot Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric Extracorporeal Membrane Oxygenation
McMichael A, Weller J, Li X, Hatton L, Zia A, Raman L (2024)
Efficacy of Bivalirudin for Therapeutic Anticoagulation in COVID-19 Patients Requiring ECMO Support
Trigonis R, Smith N, Porter S, Anderson E, Jennings M, Kapoor R, Hage C, Moiz S, Garcia J, Rahman O (2021)
Bivalirudin versus heparin anticoagulation in patients receiving extracorporeal membrane oxygenation
Huang D, Guan Q, Qin J, Shan R, Wu J, Zhang C (2022)
Heparin-based versus bivalirudin-based anticoagulation in pediatric extracorporeal membrane oxygenation: A systematic review
Valdes CA, Sharaf OM, Bleiweis MS, Jacobs JP, Mumtaz M, Sharaf RM, Jeng EI, Peek GJ (2023)