Document Detail

Cryoplasty for the treatment of femoropopliteal arterial disease: results of a prospective, multicenter registry.
MedLine Citation:
PMID:  16105918     Owner:  NLM     Status:  MEDLINE    
PURPOSE: Despite suboptimal results, angioplasty of femoropopliteal arterial lesions has been a mainstay of endovascular therapy for many years. The recent introduction of cryoplasty marks a potential advance in the ability to effectively treat peripheral arterial atherosclerotic stenoses. This article presents the results of a prospective, multicenter trial that evaluated the efficacy of cryoplasty for femoropopliteal disease. MATERIALS AND METHODS: One hundred two patients with claudication and lesions of the superficial femoral and popliteal arteries of no greater than 10 cm were studied. All patients were treated with a primary strategy of stand-alone cryoplasty with use of the PolarCath cryoplasty system. The primary endpoints of the study were acute technical success and clinical patency at 9 months. Technical success was defined as the ability to achieve residual angiographic stenosis no greater than 30% and residual stenosis less than 50% by duplex ultrasound (US) imaging. Clinical patency was defined as freedom from target lesion revascularization within 9 months. Primary patency was defined by a duplex US systolic velocity ratio no greater than 2.0. RESULTS: A total of 102 patients were enrolled at 16 centers. Of those treated, 31% had diabetes and 31% were active cigarette smokers. The majority of the lesions were confined to the superficial femoral artery (84.3%) and 14.7% presented with total occlusions. The mean vessel diameter treated was 5.5 mm +/- 0.5, the mean stenosis diameter was 87% +/- 10%, and the mean lesion length was 4.7 cm +/- 2.6. The technical success rate was 85.3% with a mean residual stenosis after cryoplasty of 11.2% +/- 11.2% (P < .05 vs baseline). Clinical patency in this group was 82.2%, as only 16 patients required target lesion revascularization during the 9-month surveillance period. Primary patency determined by duplex US was 70.1%. CONCLUSIONS: Cryoplasty demonstrated a high degree of acute angiographic success and a low frequency of target lesion revascularization. The patency rate observed compares favorably to that previously documented with conventional angioplasty.
John Laird; Michael R Jaff; Giancarlo Biamino; Thomas McNamara; Dierk Scheinert; Patrick Zetterlund; Elaine Moen; James D Joye
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study    
Journal Detail:
Title:  Journal of vascular and interventional radiology : JVIR     Volume:  16     ISSN:  1051-0443     ISO Abbreviation:  J Vasc Interv Radiol     Publication Date:  2005 Aug 
Date Detail:
Created Date:  2005-08-17     Completed Date:  2005-12-29     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9203369     Medline TA:  J Vasc Interv Radiol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1067-73     Citation Subset:  IM    
Washington Hospital Center, Division of Cardiology, Indianapolis, IN, USA.
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MeSH Terms
Arterial Occlusive Diseases / physiopathology,  radiography,  therapy*,  ultrasonography
Cryotherapy* / instrumentation
Femoral Artery* / radiography
Intermittent Claudication / physiopathology,  therapy
Popliteal Artery* / radiography
Treatment Outcome
Ultrasonography, Doppler, Duplex
Vascular Patency
Comment In:
J Vasc Interv Radiol. 2005 Aug;16(8):1051-4   [PMID:  16105915 ]

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

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