Preclinical Evaluation of a Rheolytic™ Catheter for Percutaneous Coronary Artery/Saphenous Vein Graft Thrombectomy

Timothy D. Henry

Research output: Contribution to journalArticlepeer-review

10 Scopus citations

Abstract

The presence of thrombus increases the rate of acute complications and restenosis in percutaneous revascularization of native coronary arteries and saphenous vein grafts. Rheolytic thrombectomy uses high velocity saline jets to create a Bernoulli effect for thrombus entrainment, dissociation, and evacuation of debris, providing a novel approach to the treatment of thrombotic lesions. The study objective was to determine the preclinical safety and effectiveness of a 5 French rheolytic thrombectomy catheter designed for use in coronary arteries and saphenous vein grafts. In vitro testing was performed to evaluate catheter effectiveness (clot removal rate) and safety (particle generation and hemolysis). This was followed by acute (n = 6) and chronic (n = 6) canine studies to determine hemodynamic, angiographic, and histopathologic effects of the catheter. The results showed effective clot removal with minimal embolization: 99.4% of the total clot volume was removed with only 0.1% proximal embolization and 0.5% distal embolization. 98.4% of the embolie particles were less than 10 μm. Canine studies revealed no significant angiographic, hemodynamic, histopathologic, or electrocardiographic abnormalities with the exception of transient heart block in one animal. There was transient hemolysis which normalized within 24 hours with no adverse effects. These results demonstrate the effectiveness and safety of coronary rheolytic thrombectomy and provided the basis for clinical trials to further evaluate this promising new approach for coronary thrombectomy.

Original languageEnglish (US)
Pages (from-to)475-484
Number of pages10
JournalJournal of Invasive Cardiology
Volume11
Issue number8
StatePublished - Dec 1 1999

Keywords

  • Coronary thrombosis
  • Thrombectomy
  • Thrombus

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