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 evidenceBivalirudin: drug studies
Sample size of this trial compared with other Bivalirudin: drug studies trialsMehran R 20093602Huang D 20221232Fuchs J 1995410Valdes CA 2023313Hamzah M 2023225Wang ZD 2022210Iaprintsev V 202575Zhang Y 202442Trigonis R 202142Chaudhry-Waterman N 20253
This trial (highlighted) by sample size alongside other indexed Bivalirudin: drug studies 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

  • Case series of catheter-directed bivalirudin thrombolysis in pediatric mechanical circulatory support
  • 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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