Early Experience with a New Concept of Angioplasty Nitinol-Constrained Balloon Catheter (Chocolate®) in Severely Claudicant Patients.

Abstract

To report our experience in treating severely claudicant patients, employing a "nitinol-constrained" balloon (Chocolate, TriReme Medical Inc., Pleasanton, CA-USA) before drug-coated balloon (DCB) in a standardized protocol. Eighty-one (84 limbs) consecutive Rutherford category (RC) 3 patients treated between December 2014 and December 2016 for superficial femoral artery (SFA) and popliteal arterial (PA) disease by nitinol-constrained balloon followed by DCB were enrolled. Bailout stenting was performed by Zilver PTX implantation. Intraoperative technical success and bailout-stenting rates were assessed as well as clinical improvement, ankle-brachial index (ABI) modification, primary patency (PP), and secondary patency (SP) rates at follow-up. Sixty-eight patients (83.9%) were male and 31 (38.2%) diabetics. Fifty-five limbs (65.5%) presented occlusion (CTO); in 18 limbs CTO was longer than 150mm. Bailout stenting rate was 9.5% (8/84). All patients completed 30-day follow-up: PP 100%, 61 patients completely asymptomatic (RC=0). Mean follow-up was 12.3±5.6months; overall PP was 98.8%, and SP was 98.8%. At mid-term analysis, no differences in outcomes were recorded between stenosis and CTOs with a PP of 96.5 and 96%, respectively (p=0.725). CTO length impacted early results: in cases of CTOs<150mm, PP was 100%, while in CTOs>150mm, it was 83.3% (p=0031). ABI at 12-month was significantly higher with respect to preoperative values (p<0.001). In this preliminary experience, our protocol seems to be safe and effective in treating SFA and PA lesions in claudicant patients with satisfactory early and 12-month results.