Material and Methods Patient Population. – From July 2005 through December 2008, 130 patients (130 procedures, 154 limbs, 185 lesions) were treated using.

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Presentation transcript:

Material and Methods Patient Population. – From July 2005 through December 2008, 130 patients (130 procedures, 154 limbs, 185 lesions) were treated using CryoPlasty® therapy (Polar Cath Peripheral Dilatation System; Boston Scientific Corp, Natick, Mass).

Table 1 Summarises patient histories and risk factors according to the Society for Vascular Surgery classification (6). Clinical HistoryPatient No. (%) Type I Diabetes29 (23) Type II Diabetes41 (32) Hypertension83 (64) Tobacco36 (28) Cardiac Disease48 (37) Carotid Disease10 (8) Hyperlipidemia32 (25)

Material and Methods Out of the 130 patients (102 males, mean age of 69,5 and 28 females, mean age of 77,6), indications for treatment therapy were: – gangrene (3 patients) – minor tissue ulceration (54 patients) – rest pain (24 patients) – severe claudication (49 patients)

Material and Methods Number of tibial run-off arteries was: one artery n= 36 two arteries n= 49 three arteries n= 45

Material and Methods Number of treated lesions was: one lesion n=85 two lesions n=35 three lesions n=10

Material and Methods Lesion localization n=138 (74,5%) n=28 (10,3%) n=19 (10,3%)

Material and Methods Lesion TASC II classification

Material and Methods Technique – Femoral access was achieved by using a 6F introducer sheath. In 49% patients access was ipsilateral and in 51% contralateral. – Total number of treated lesions was 185 with a mean lesion length of 45.9 mm (range 5-75 mm).

Material and Methods Technique – Balloon lengths varied depending on the length of the lesion to be treated with the 6 cm and 8 cm balloons being used predominantly. – Balloon diameter varied as it was chosen to equal the size of the artery to be treated. The 5 mm and 6 mm diameters were used predominantly.

Material and Methods Technique – All patients received intravenous heparin at a dose of 3000 U. – Manual compression was used to achieve groin hemostasis in most patients. An Angioseal closure device was used in 32 patients.

Material and Methods Follow up – All patients were followed up clinically and with ankle-brachial pressure index (ABI) measurements in a vascular laboratory within 1 month of the procedure and every 6 months thereafter during three years.

Material and Methods Statistical analysis – Patients were entered into a computerized registry (Access, Windows 07). – Statistical software was used to perform Kaplan- Meyer curves to estimate the cumulative percentage patency rate versus time of follow- up.