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
Study Profile
- Design
- single-center retrospective cohort of all consecutive Berlin Heart EXCOR (BHE) recipients (Royal Children's Hospital Melbourne, 2009-2024)
- Sample size (n)
- 75
- Intervention
- Modern era BHE management including bivalirudin anticoagulation introduction, lowered threshold for cannula/pump interventions, proactive timing
- Comparator
- Historical era BHE management (pre-2019)
- Primary endpoint
- Hospital survival, freedom from cerebrovascular accidents
- Primary result
- 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%
- Follow-up duration
- Median 128 days BHE support
- PMID
- 41960081
Key Findings
- 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
Limitations
- 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
Clinical Implications
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.
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