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Randomized control study of the outback ltd re-entry catheter vs. manual re-entry for the treatment of chronic total occlusions in the superficial femoral artery.
MedLine Citation:
PMID:  23152133     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
PURPOSE: to assess the efficacy and safety of the Outback device in patients with a chronic total occlusion of the superficial femoral artery and evaluate its impact on fluoroscopy and procedural times. MATERIALS AND METHODS: From October 2006 to March 2007, 52 patients affected by TASC II-D superficial femoral artery chronic total occlusion were treated with subintimal recanalization. Clinical indications for endovascular recanalization were: claudication, tissue loss and at rest leg pain with critical limb ischemia (p.2 Reviewer 1). In 26 patients the manual re-entry technique was used and in 26 the OUTBACK®LTD Re-Entry Catheter was used. Total procedure time, fluoroscopy time and precision in targeting the expected re-entry site have been compared. RESULTS: Technical success was achieved in all cases (100%). In Group 2, the planned in-target re-entry was achieved in 11/26 cases (42.3%). The procedure was performed with a traditional antegrade approach in 23/26 (88.4%) cases and in 3 cases (11.6%) a combined antegrade/retrograde approach was necessary. In Group 1 the in-target re-entry was achieved in 26/26 cases (100%). In Group 2 the mean procedural time was 55.4±14.2 min with a mean fluoroscopy time 39.6±13.9 min compared to 36.0±9.4 min and 29.8±8.9 min respectively of group 1 (p<0.0001). CONCLUSIONS: In our experience the use of this device is very useful for the revascularization of chronic femoral occlusions, even calcific, in which an accurate re-entry cannot be achieved with the conventional subintimal technique. In these cases the Outback device grants high technical success rates and a significant reduction of procedural and fluoroscopy times. © 2012 Wiley Periodicals, Inc.
Authors:
Roberto Gandini; Sebastiano Fabiano; Sergio Spano; Tommaso Volpi; Daniele Morosetti; Antonio Chiaravalloti; Giovanni Nano; Giovanni Simonetti
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-11-14
Journal Detail:
Title:  Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions     Volume:  -     ISSN:  1522-726X     ISO Abbreviation:  Catheter Cardiovasc Interv     Publication Date:  2012 Nov 
Date Detail:
Created Date:  2012-11-15     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  100884139     Medline TA:  Catheter Cardiovasc Interv     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Copyright © 2012 Wiley Periodicals, Inc.
Affiliation:
University Hospital Tor Vergata, Department of Diagnostic Imaging, Molecular Imaging, Interventional Radiology and Radiation Therapy. radiologiainterventistica@hotmail.it.
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