A preliminary study about role of the endovascular profundoplasty in extremely high-risk surgical patients

BACKGROUND: The aim of this study was to report our experience in treating high risk critical limb threatening ischemia (CLTI) patients with severe profunda femoris artery (PFA) disease, employing a "nitinol-constrained" balloon, followed by drug coating balloons (DCB) in a standardized protocol. METHODS: Consecutive CLTI patients considered unfit for open PFA repair treated between April 2021 and May 2023 employing a "nitinol-constrained" balloon (Chocolate; Medtronic AVE, Santa Rosa, CA, USA), followed by DCB (LegFlow; Cardionovum, Bonn - Germany). Study endpoints were technical success, immediate (30-day) and 12-month primary patency (PP), primary assisted patency (PAP), secondary patency, clinical improvements during follow-up, rate of minor and major lower limb amputations. RESULTS: Seven patients were treated during the study period; mean age was 76±10 years. Four patients presented rest pain (Rutherford Class 4 - RC) while the remaining three procedures were performed for gangrene (RC5). All patients were treated under local anesthesia. Per protocol, all procedures were performed by PTAof PFAwith Chocolate balloon followed by LegFlow DCB. Isolated PFAtreatment was performed in 4 cases, while in the remaining patients an adjunctive treatment was performed. Technical success was achieved in all cases. At one-month follow-up, mean ABI significantly improved from 0.36±0.17 to 0.57±0.20 (P<0.001); 6 patients presented a clinical improvement. PP was maintained in all cases. At twelve-month follow-up, PAP was maintained in all surviving patients, and improvement of preoperative clinical status was still evident in all but one patient; no major amputation recorded. Three patients reached the 2-year follow-up, limb salvage was achieved in 2 of them, while one patient required an above the knee amputation. CONCLUSIONS: Although preliminary, our experience seems to demonstrate that PFAendovascular treatment with unconventional nitinolconstrained angioplasty balloon is a safe and effective option in high-risk patients.