Cryoplasty as endovascular treatment in the femoropopliteal region: hemodynamic results and follow-up at one year.
BACKGROUND
Cryoplasty represents an alternative endovascular approach to current techniques for femoropopliteal occlusive disease treatment. Its theoretical advantage compared to angioplasty is associated with the lower appearance of recoil, dissection, and intimal hyperplasia. The aim of this study is to assess the efficacy of cryoplasty in femoropopliteal disease.


METHODS
Eleven patients presenting with critical limb ischaemia (CLI) and Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC) II type A or B lesions in the femoropopliteal region were prospectively included in the study between November 2006 and April 2007. All patients but those with severely calcified lesions underwent cryoplasty (Polarcath Cryoplasty System(R)), and were followed up clinically and by Doppler ultrasound. Outcomes evaluated were technical success, patency at 1, 3, 6, and 12 months, mortality, limb salvage, freedom from restenosis, and freedom from occlusion rates. Statistical analysis used Kaplan-Meier curves.


RESULTS
The mean age of the patients was 76 years (range, 65-89), and 81% of them were females.


METHODS
73% diabetes mellitus, 73% arterial hypertension, 64% dyslipemia, 9% smokers. Clinical: 91% CLI IV and 9% CLI III. Location of lesions: 45% popliteal; 18% superficial femoral; 18% superficial femoral and popliteal; 18% popliteal and anterior tibial. Lesion morphology: 73% stenosis, 27% occlusions. TASC II classification: 64% TASC B and 36% TASC A.Technical success: 100%. Primary, primary assisted, and secondary patency: 91%, 91% and 91% at 3 months; 63%, 82%, and 91% at 6 months; 55%, 73% and 91% at 12 months, respectively. Limb salvage and survival of 91% at 3, 6, and 12 months.


CONCLUSIONS
Cryoplasty in the femoropopliteal region showed a good success rate, with no dissections or significant residual stenosis. However, primary patency and freedom from restenosis rates at 1 year are 55%, both demonstrating a low efficacy of the technique in this territory.
Gonzalo
Begoña
B
Servicio de Angiología y Cirugía Vascular Corporació Sanitària Parc Taulí, Sabadell, Barcelona, Spain. bgonzalo@tauli.cat
Solanich
Teresa
T
Bellmunt
Sergi
S
Herranz
Carolina
C
González
Elena
E
Arnedo
Gemma
G
Muñoz
Gemma
G
Florit
Salvador
S
Hospedales
Jaime
J
Lloret
María Dolores
MD
Vallespín
Joaquín
J
Giménez
Antonio
A
D000368:Aged; D000369:Aged, 80 and over; D055109:Ankle Brachial Index; D001157:Arterial Occlusive Diseases / Q000150:complications / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D003251:Constriction, Pathologic; D003452:Cryosurgery / Q000009:adverse effects; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery*; D005500:Follow-Up Studies; D006083:Graft Occlusion, Vascular / Q000209:etiology / Q000503:physiopathology; D006439:Hemodynamics; D006801:Humans; D007511:Ischemia / Q000175:diagnosis / Q000209:etiology / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D053208:Kaplan-Meier Estimate; D023821:Limb Salvage / Q000401:mortality; D008297:Male; D011150:Popliteal Artery / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery*; D011446:Prospective Studies; D012086:Reoperation; D018570:Risk Assessment; D012307:Risk Factors; D013030:Spain; D013997:Time Factors; D016896:Treatment Outcome; D018608:Ultrasonography, Doppler; D014654:Vascular Patency; D014656:Vascular Surgical Procedures / Q000009:adverse effects / Q000401:mortality