The efficacy and safety of percutaneous transluminal angioplasty of tibioperoneal arteries with DEEP Balloon in diabetic patients with critical limb ischemia: a pilot study

This pilot study was to investigate the efficacy and safety of percutaneous transluminal angioplasty (PTA) of tibioperoneal arteries with DEEP Balloon in diabetic patients with critical limb ischemia (CLI). 15 adults diabetic patients with CLI were recruited in this study. All patients underwent PTA of tibioperoneal arteries with DEEP Balloon and were followed up for 6 months post operation. Technical successful rate, ulcer cure rate and limb salvage rate were calculated after the operation; ankle brachial index (ABI), temperature of toes skin (TTS), rest pain visual analogue scale (VAS) was assessed pre, post the surgery, and at month 1 (M1), M3 as well M6. The overall technical successful rate and ulcer cure rate were 93% and 80% respectively. Limb salvage rate at M6 was 87%. Type 2 DM patients presented an increased technical successful rate (100%) compared to Type 1 DM (67%), P=0.038; as well as an elevated limb salvage rate (100% vs 33%, P=0.002). ABI was elevated immediately after PTA surgery compare with Pre-PTA (P<0.001) and M6 (P=0.005). TTS was increase post-PTA and at M6 compared to pre-PTA visit (all P<0.001). And rest pain VAS score was decreased post-PTA operation (P<0.001), but no difference was observed between pain VAS at M6 and pre-PTA (P=0.192). Arterial perforation occurred in 1 patient, and no other PTA operation related complications and death were illuminated. This study revealed that PTA of tibioperoneal arteries with DEEP Balloon was effective and well tolerated for diabetic patients with CLI.