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
Hirulog in the treatment of unstable angina. Results of the Thrombin Inhibition in Myocardial Ischemia (TIMI) 7 trial
Fuchs J, Cannon CP (1995)
Bivalirudin in patients undergoing primary angioplasty for acute myocardial infarction (HORIZONS-AMI): 1-year results of a randomised controlled trial
Mehran R, Lansky AJ, Witzenbichler B, Guagliumi G, Peruga JZ, Brodie BR, Dudek D, Kornowski R, Hartmann F, Gersh BJ, Pocock SJ, Wong SC, Nikolsky E, Gambone L, Vandertie L, Parise H, Dangas GD, Stone GW (2009)
Experience with pharmacologic leeching with bivalirudin for adjunct treatment of venous congestion of head and neck reconstructive flaps
Harun A, Kruer RM, Lee A, Boahene K, Byrne PJ, Richmon JD (2018)
Heparin and Bivalirudin in Percutaneous Coronary Intervention for Acute Coronary Syndromes: A Review Article
Wang G, Qi K, Li X, Zuo S, Zhang R, Zhao Y, Sun S, Zhang J, Liu X (2024)