Document Detail

Quantitative evaluation of local drug delivery using the InfusaSleeve catheter.
MedLine Citation:
PMID:  9286553     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Restenosis is the most common long-term complication after angioplasty. Local delivery of pharmacologic agents at the site of angioplasty holds promise as a means of achieving higher concentrations of drug in the arterial wall than can be obtained by systemic infusion. In this study, a novel local drug delivery catheter system, the InfusaSleeve catheter, was evaluated in a porcine coronary balloon injury model. The purpose of the study was to evaluate the efficacy of solute transfer to the arterial wall and the influence of varying supporting angioplasty balloon pressure. METHODS AND RESULTS: Ten pigs (total of 22 arterial segments) underwent overstretch balloon injury (artery/balloon ratio 1:1.29) with a standard angioplasty balloon. In 7 animals (16 arterial segments) horseradish peroxidase (HRP; 10 mg/ml) was administered locally after injury, by tracking the local infusion catheter as a sheath over the angioplasty balloon to the intended site of arterial drug delivery. Supporting angioplasty balloons were inflated to one of the three different pressures. In 3 pigs HRP (10 mg/ml) was administered intravenously. No significant arterial injury caused by the local delivery device was evident on histological examination (disruption of the internal lamina elastica, arterial media, or thrombosis). Radial concentrations of the HRP reaction product in the first 150 microns of the arterial wall were quantified against known standards by measurement of light transmission through tissue sections. Mean HRP concentrations were not significantly different from those obtained by intravenous infusion using a supporting pressure of 1 atm or a supporting pressure of 3 atm of the underlying angioplasty balloon. However, a supporting pressure of 6 atm resulted in a 6-fold greater mean HRP concentration in the arterial wall than that which could be achieved by systemic administration of an equal volume of tracer (P < 0.001). CONCLUSION: Thus solute can be delivered throughout the coronary media by the InfusaSleeve, with the magnitude of wall uptake related to support pressure. Local delivery at 6 atm support pressure produced substantially greater uptake than did systemic delivery.
M Gottsauner-Wolf; Y Jang; M S Penn; A Kaplan; S G Ellis; G M Chisolm; E J Topol; A M Lincoff
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Catheterization and cardiovascular diagnosis     Volume:  42     ISSN:  0098-6569     ISO Abbreviation:  Cathet Cardiovasc Diagn     Publication Date:  1997 Sep 
Date Detail:
Created Date:  1997-10-23     Completed Date:  1997-10-23     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  7508512     Medline TA:  Cathet Cardiovasc Diagn     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  102-8     Citation Subset:  IM    
Department of Cardiology, Joseph J. Jacobs Center for Thrombosis and Vascular Biology, Cleveland Clinic Foundation, Ohio 44195, USA.
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MeSH Terms
Angioplasty, Transluminal, Percutaneous Coronary*
Constriction, Pathologic
Coronary Vessels / pathology*
Disease Models, Animal
Drug Delivery Systems*
Evaluation Studies as Topic
Horseradish Peroxidase / administration & dosage
Macromolecular Substances
Reg. No./Substance:
0/Macromolecular Substances; EC 1.11.1.-/Horseradish Peroxidase

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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