Background: Intra-arterial infusion of PGE1 alpha-ciclodestrina was achieved by intrafemoral catheter in critical limb ischemia.
Methods: The acute infusion of 10 micrograms in 20 minutes, in 50 ml of saline was followed by chronic infusion 20 micrograms/die of PGE1 alpha-ciclodestrina for 5 days. Three male patients (age 65 +/- 12) with severe critical ischemia and rest pain with initial, localised (> 0.5 cm in diameter) necrosis were treated. There was no possibility of revascularisation in these patient.
Results: No side effects due to the intra-arterial infusion were observed. After the acute infusion skin flux (measured with laser Doppler at the dorsum of the foot) was increased on average 15.2 times (P < 0.01). The increase in flux was still present 10 days after the initial intra-arterial infusion. Pain was greatly decreased or disappeared in the three following 3 weeks.
Conclusion: In conclusion, even on the basis of limited clinical data, intra-arterial infusion acutely improves skin perfusion in critical limb ischemia. It could be considered a fast acting treatment in critical ischemia and also a rapid method to evaluate the possibility of improving distal perfusion with PGE1 alpha-ciclodestrina (i.e. patients not responding to intra-arterial infusion could be considered for amputation).