OP154 LONG-TERM FOLLOW-UP IN DIABETIC NO-CLI PATIENTS TREATED WITH AUTOLOGOUS PERIPHERAL BLOOD MONONUCLEAR CELLS.

Aim: Not revascularised critical limb ischaemia (no-CLI) is affected by a high amputation rate (30% at one year) and high mortality rate (50% at one year). Treatment with autologous peripheral blood mononuclear cells (A-PBMNC) showed promising outcomes in limb salvage and survival rate. A-PBMNC implants are performed in the leg and the perilesional area with a 21 G needle, extremely painful also for neuropathic patients, repeated a maximum of three times. If necessary, foot surgery was performed at the same time as the last implant. In the study we evaluated long-term outcomes and retrospectively compared patient clinical parameters and surgeon comfort in a group treated with deep sedation (DS) in spontaneous breathing and a group treated with popliteal and saphenous block (PSB) under ultrasound guidance. Method: We evaluated 102 diabetic no-CLI patients with similar baseline features and indications who underwent 288 A-PBMNC implants from January 2017 to September 2022: 42 patients with DS (122 implants) and 60 with PSB (166 implants). During the implants all patients underwent no invasive hemodynamic monitoring (blood pressure, heart rate, oxygen saturation) and the post-operative NRS scale. Surgeon comfort as akinesia and side effects are reported. The minimum follow-up period was 12 months. Results / Discussion: During the procedures, SD determined a higher variation in blood pressure (±20 mmHg), heart rate (±20 bpm) and oxygen saturation (±5 mmHg) than in PSB, respectively 35 vs 26; 97 vs 33; 10 vs 7. In 160 PSB procedures, sufficient anaesthesia and akinesia were achieved, but in 6 cases we need to adjunct SD. Only in 32 SD procedures akinesia was achieved. The mean surgical time was 35.7 minutes. After the procedure, each PSB patient was asked to indicate his value on the VAS pain scale (2.4±0,8 during the process; 2.2±0,3 after). No side effects were registered. Sixty-nine patients completed at least a one-year follow-up alive and without recurrences; five patients achieved a five years follow-up, 17 patients a four years follow-up; six patients a three years follow-up; five patients a two-year and 26 patients a 1-year follow-up. The healing rate at the 12-month follow-up was 68% (69/102), and the recurrences rate was 7,2% (5/69). In patients in remission, the mean ulcer-free survival days was 946,4±521,26, and the median ulcer-free survival days was 594,55. The overall mortality rate was 32,3% (33/102). The overall amputation rate was 10.7% (11/102). Conclusion: In A-PBMNC implants, the choice of the best anaesthesia regimen remains an open question and PSB showed to be more effective and as safe as SD. In the long-term follow-up, A-PBMNC therapy effectively improves limb salvage, survival rate, long-term management and remission parameters in diabetic no-CLI patients. [ABSTRACT FROM AUTHOR]