Cryoplasty for the treatment of femoropopliteal arterial disease: Results of a prospective, multicenter registry

John Laird, Michael R. Jaff, Giancarlo Biamino, Thomas McNamara, Dierk Scheinert, Patrick Zetterlund, Elaine Moen, James D. Joye

Research output: Contribution to journalArticle

104 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1067-1073
Number of pages7
JournalJournal of Vascular and Interventional Radiology
Volume16
Issue number8
DOIs
StatePublished - Aug 2005
Externally publishedYes

Fingerprint

Registries
Pathologic Constriction
Femoral Artery
Angioplasty
Therapeutics
Popliteal Artery
Tobacco Products
Multicenter Studies
Ultrasonography

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Radiological and Ultrasound Technology

Cite this

Cryoplasty for the treatment of femoropopliteal arterial disease : Results of a prospective, multicenter registry. / Laird, John; Jaff, Michael R.; Biamino, Giancarlo; McNamara, Thomas; Scheinert, Dierk; Zetterlund, Patrick; Moen, Elaine; Joye, James D.

In: Journal of Vascular and Interventional Radiology, Vol. 16, No. 8, 08.2005, p. 1067-1073.

Research output: Contribution to journalArticle

Laird, John ; Jaff, Michael R. ; Biamino, Giancarlo ; McNamara, Thomas ; Scheinert, Dierk ; Zetterlund, Patrick ; Moen, Elaine ; Joye, James D. / Cryoplasty for the treatment of femoropopliteal arterial disease : Results of a prospective, multicenter registry. In: Journal of Vascular and Interventional Radiology. 2005 ; Vol. 16, No. 8. pp. 1067-1073.
@article{538d46190f4f4dabb5195b8c40091559,
title = "Cryoplasty for the treatment of femoropopliteal arterial disease: Results of a prospective, multicenter registry",
abstract = "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.",
author = "John Laird and Jaff, {Michael R.} and Giancarlo Biamino and Thomas McNamara and Dierk Scheinert and Patrick Zetterlund and Elaine Moen and Joye, {James D.}",
year = "2005",
month = "8",
doi = "10.1097/01.RVI.0000167866.86201.4E",
language = "English (US)",
volume = "16",
pages = "1067--1073",
journal = "Journal of Vascular and Interventional Radiology",
issn = "1051-0443",
publisher = "Elsevier Inc.",
number = "8",

}

TY - JOUR

T1 - Cryoplasty for the treatment of femoropopliteal arterial disease

T2 - Results of a prospective, multicenter registry

AU - Laird, John

AU - Jaff, Michael R.

AU - Biamino, Giancarlo

AU - McNamara, Thomas

AU - Scheinert, Dierk

AU - Zetterlund, Patrick

AU - Moen, Elaine

AU - Joye, James D.

PY - 2005/8

Y1 - 2005/8

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=23844461471&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=23844461471&partnerID=8YFLogxK

U2 - 10.1097/01.RVI.0000167866.86201.4E

DO - 10.1097/01.RVI.0000167866.86201.4E

M3 - Article

C2 - 16105918

AN - SCOPUS:23844461471

VL - 16

SP - 1067

EP - 1073

JO - Journal of Vascular and Interventional Radiology

JF - Journal of Vascular and Interventional Radiology

SN - 1051-0443

IS - 8

ER -