Fogarty Balloon-Assisted Flow Augmentation Combined With Prostaglandin E1 Versus Prostaglandin E1 Alone for No-Option...

Background No-option chronic limb-threatening ischemia (CLTI) represents a challenging clinical condition in which conventional endovascular or surgical revascularization may not be feasible. In resource-limited settings, treatment options for patients with unreconstructable below-knee disease are particularly restricted. This study evaluated the clinical outcomes of a Fogarty balloon-assisted flow-augmentation technique combined with intravenous prostaglandin E1 (PGE1) compared with PGE1 alone in patients with no-option below-knee CLTI. Methods This prospective, single-center, quasi-experimental study was conducted at Dhaka Medical College and Hospital, Bangladesh, between January and December 2025 and included 100 patients with no-option below-knee CLTI. Patients received Fogarty balloon-assisted flow augmentation plus intravenous PGE1 (n = 50) or PGE1 alone (n = 50) through non-randomized allocation influenced by operating-room and surgeon availability and patient preference. The primary outcomes were six-month limb salvage and major amputation. Secondary outcomes included improvement in Rutherford clinical category, Visual Analog Scale (VAS) pain scores, complete ulcer healing, and all-cause mortality. Patients were followed for six months. The Fogarty technique was performed through an open femoral approach using a low-profile catheter with minimal balloon inflation and was not intended to replicate conventional high-pressure endovascular balloon angioplasty. Results Technical completion of the Fogarty procedure was achieved in 46 of 50 patients (92.0%). At six months, limb salvage was achieved in 82.0% of patients in the intervention group compared with 60.0% in the PGE1-alone group (p = 0.015), while major amputation occurred in 18.0% and 40.0%, respectively (p = 0.015). Improvement of at least one Rutherford clinical category occurred in 80.0% versus 56.0% of patients, respectively (p = 0.010). Among patients with baseline ischemic ulcers, complete ulcer healing occurred in 34 of 41 patients (82.9%) in the intervention group compared with 22 of 34 patients (64.7%) in the PGE1-alone group; this difference was not statistically significant (p = 0.071). Mean VAS pain scores were significantly lower in the intervention group at one, three, and six months (all p < 0.001). Six-month all-cause mortality was comparable between groups (4.0% vs. 6.0%; p = 0.65). Conclusion In this prospective quasi-experimental study, Fogarty balloon-assisted flow augmentation plus intravenous PGE1 was associated with higher limb salvage, lower major amputation, and lower VAS pain scores than PGE1 alone. Complete ulcer healing was numerically higher but not statistically significant. Given the non-randomized, single-center design and lack of routine objective perfusion assessment, these findings are preliminary, and the technique should be considered an exploratory salvage approach rather than a substitute for established revascularization.