[A new infusion method for a prostacyclin analogue]

Area of Science:

• Vascular Medicine
• Pharmacology
• Biomedical Engineering

Context:

• Severe limb ischemia, often due to peripheral artery disease (PAD), typically requires prolonged hospitalization for intravenous Iloprost therapy.
• Traditional Iloprost infusion involves daily 6-hour intravenous administration in a hospital setting over 28 days.
• Iloprost, a stable prostaglandin I2 analogue, is crucial for managing critical limb ischemia.

Purpose:

• To evaluate the efficacy and patient acceptance of a novel home infusion pump system for delivering Iloprost to patients with severe limb ischemia.
• To assess the feasibility of transitioning Iloprost therapy from hospital to home settings using a portable infusion device.
• To determine if home-based Iloprost infusion impacts treatment outcomes and healthcare costs.

Summary:

• A 28-day Iloprost infusion therapy was administered to 30 patients with severe PAD using a novel home pump after an initial 3-day hospital infusion.
• High-performance liquid chromatography (HPLC) studies confirmed the structural integrity of Iloprost within the home pump, ensuring continuous delivery of active isomers.
• The home pump system allowed for continuous Iloprost infusion at 2 ml/h, with reservoir refills every six days.

Impact:

• The home infusion system was well-received by patients, enabling a more normal lifestyle and significantly reducing hospital stay duration to 3 days.
• Treatment outcomes included complete pain relief and ulcer healing in 9 patients, improvement in 6 patients, with 4 major amputations and 1 death among the 30 participants.
• The home pump system represents a cost-effective alternative to traditional inpatient Iloprost administration for severe limb ischemia and PAD.