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
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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