American Society of Hirudotherapy

Catheter-Directed Bivalirudin for Local Anticoagulation and Clot Dissolution in Children Requiring Mechanical Circulatory Support

Chaudhry-Waterman N, Schardt TQ, Soderstrom RM, Warren BB, Buckvold S, Morgan G, Kim JS (2025) · ASAIO Journal · n=3

RCT evidence detailTrial reference
GRADE Very LowInsufficient evidenceCondition: 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
case series of three pediatric mechanical circulatory support patients receiving catheter-directed bivalirudin for localized thrombolysis (Children's Hospital Colorado)
Sample size (n)
3
Intervention
Direct bivalirudin delivery via catheter to localized intracardiac/circuit thrombosis in MCS patients
Comparator
Historical alteplase-based catheter-directed thrombolysis
Primary endpoint
Thrombus resolution and bleeding complications after catheter-directed bivalirudin
Primary result
Direct bivalirudin delivery associated with rapid thrombus resolution in all three cases; novel application combining anticoagulant prevention with active fibrin-bound thrombin clearance
Follow-up duration
Acute MCS course
PMID
40960390

Key Findings

  • First reported pediatric catheter-directed bivalirudin thrombolysis series
  • All three cases achieved rapid thrombus resolution
  • Used in patients with alteplase contraindications (bleeding history)
  • Leverages bivalirudin's fibrin-bound thrombin inhibition
  • Novel application warranting larger series

Limitations

  • Only 3 cases - hypothesis-generating only
  • Single-center experience
  • No control comparison
  • Dosing not standardized for catheter-directed application
  • Not applicable to whole-leech hirudotherapy

Clinical Implications

Chaudhry-Waterman 2025 introduces novel catheter-directed bivalirudin use for localized thrombolysis in pediatric MCS patients. For ASH, this case series demonstrates the ongoing innovation cycle in the synthetic hirudin-derivative pharmaceutical pathway - new applications discovered through reasoning about mechanism (fibrin-bound thrombin inhibition). The K040187 device-leech US clinical practice operates under a more stable indication landscape without analogous novel-use innovation.

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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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