The clinical application of cryoplasty for lower extremity arterial occlusive disease

Abstract

Objective To observe the short term efficacy and safety of cryoplasty in treatment of lower extremity arterial occlusive disease. Methods Twenty five patients (27 limbs) scheduled for lower extremity artery balloon angioplasty were randomized to cryoplasty [ group CRYO, 10 patients with 8 male,age ( 76 ± 8 ) years]or conventional balloon angioplasty [ group COBA, 15 patients with 13 male, age ( 68 ±4) years], In CRYO group, the average lesion length and stenosis were (6.7 ±0.9) cm and, (91 ±6)％, respectively. The average ankle-brachial index (ABI) was 0. 46 ±0. 07 before treatment. According to Fontaine clinical stages, 7 patients (7/10) in this group were staged Ⅱ and the other 3 (3/10) were staged Ⅲ. According to Trans Atlantic Inter Society Consensus (TASC), 8 patients (8/10) were classified as TASC type A and the other 2 (2/10) were TASC type B. In COBA group, the average lesion length and stenosis were (6. 5 ± 0. 7 ) cm and ( 89 ± 7 ) ％, respectively. The average ABI was 0. 48 ± 0. 08 before treatment. According to Fontaine clinical stages, 13 patients (13/15) were staged Ⅱ and the other 2(2/15) were staged Ⅲ. And, according to TACS, 13 patients (13/15) were classified as TASC type A and the other 2 (2/15) were TASC type B. The clinical symptoms and signs had no significant difference between the two groups ( P ＞ 0. 05 ). Clinical status was evaluated according to Rutherford classification.The clinical efficacy on the 2nd and 30 th day after the operation was compared using analysis of variance with repeated measurements. Results Technical success was achieved in all patients both in CRYO group (10/10) and in COBA group (15/15). None patient in CRYO group occurred postoperative complication.One patient in COBA group ( 1/15 ) occurred vessel wall dissection. In CRYO group, clinical status were remarkably improved in 8 patients (8/10) and moderately improved in 2 patients (2/10) ; while, in COBA group, they were remarkably improved in 13 patients ( 13/15 ) and moderately improved in 2 patients ( 2/15 ). The average ABI was 0. 84 ± 0. 04 in group CRYO and 0. 84 ± O. 05 in group COBA ( P ＝ 0. 20).The average stenosis was (29 ± 4) ％ in group CRYO and (32 ± 4) ％ in group COBA ( P ＝ 0. 55 ). No significant difference was detected between the two groups. Both the average ABI and stenosis presented statistically significant difference between pre-operation and post-operation in both groups ( P ＜ 0. 01,respectively). Conclusions Cryoplasty is safe for the treatment of lower extremity arterial occlusive disease, which showed a good short-term result in this research. Key words: Angioplasty, balloon; Hypothermia; Arterial occlusive disease; Lower extremity