American Society of Hirudotherapy

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

RCT evidence detailTrial reference
GRADE LowCohort / case seriesCondition: Venous Congestion in Surgical Flaps →
Sample size of this trial compared with other Venous Congestion in Surgical Flaps trialsHuang D 20221232Valdes CA 2023313Hamzah M 2023225Iaprintsev V 202575Trigonis R 202142McMichael A 202430Engel ER 202422Sonmez E 201120Brandewie K 202410Chaudhry-Waterman N 20253
This trial (highlighted) by sample size alongside other indexed Venous Congestion in Surgical Flaps trials. Larger trials generally carry more statistical weight.

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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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)

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