Abstract
Introduction
The concept and method of repeatedly connecting an extracorporeal blood pump to produce elevated pancycle inflow pressures to ischaemic limbs is presented. The aim of this study was to determine if intermittent increased perfusion would improve the clinical picture in peripheral arterial disease.
Methods
Animal studies—to determine the safety and efficacy of the pumping and the access device were performed on 12 sheep. Following successful completion of that study, pilot studies of 18 patients were treated using the Peripheral Access Device (PAD) and Hypertensive Extracorporeal Limb Hyperperfusion (HELP). Treatment was offered to patients who had no other alternative than major amputation. Patients were treated for less than 100 hours of total pumping, broken over three or less treatment periods over approximately one week. Improvement was measured by pain scores, clinical examination and digital thermography.
Results
In all cases access and desired flow parameters were shown to be reliably achieved. In all cases an improvement was found to peripheral circulation, with the longest follow up at more than three years and mean CFI improving from 0.6 to 1.1. Mortality and infection rates in the pilot study were lower than expected for amputation, with a third of patients retaining their limbs.
Conclusion
It is shown that blood flow through collaterals can be very significantly augmented by the HELP treatment and that pancycle hyperperfusion can be safely repeated by implantation of the PAD arterial access device, offering a potential new treatment modality for Critical Limb Ischaemia.
