Cryoplasty for the treatment of femoropopliteal arterial disease: extended follow-up results.
OBJECTIVE
To report the findings from a multicenter study of patients treated with cryoplasty who were then followed for an average of > 2 years post-treatment.


METHODS
Extended clinical follow-up was obtained for 70 patients (45 men; mean age 70.5 +/- 8.8 years) who originally received cryoplasty therapy to treat symptoms of intermittent claudication as part of a multicenter investigational device exemption (IDE) study. For all subjects, cryoplasty was used to treat stenoses or occlusions < or = 10 cm in the femoropopliteal arteries. The original IDE study protocol enrolled 102 patients with a primary endpoint of target lesion patency at 9 months post-treatment. This collection of additional longer term follow-up data was initiated 2.5 years after the onset of study enrollment.


RESULTS
Extended clinical follow-up ranged from 11 to 41 months (mean 31). The clinical patency rate (freedom from target lesion revascularization) calculated by the Kaplan-Meier method was 83.2% after the original follow-up period of 300 days. After > 3 years (1253 days), the clinical patency rate was well maintained at 75.0%.


CONCLUSIONS
Long-term data indicate that cryoplasty is a durable therapy, with relatively low long-term restenosis rates compared to other endovascular treatment approaches.
Laird
John R
JR
Cardiovascular Research Institute, Washington Hospital Center, Washington, DC 20010, USA. John.R.Laird@medstar.net
Biamino
Giancarlo
G
McNamara
Thomas
T
Scheinert
Dierk
D
Zetterlund
Patrick
P
Moen
Elaine
E
Joye
James D
JD
D000368:Aged; D000800:Angioplasty, Balloon; D001157:Arterial Occlusive Diseases / Q000150:complications / Q000000981:diagnostic imaging / Q000628:therapy*; D002986:Clinical Trials as Topic; D017679:Cryotherapy / Q000295:instrumentation / Q000379:methods; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging; D005500:Follow-Up Studies; D006801:Humans; D007383:Intermittent Claudication / Q000000981:diagnostic imaging / Q000209:etiology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011150:Popliteal Artery / Q000000981:diagnostic imaging; D011859:Radiography