An arterial access system for targeted chemotherapy delivery and arterial-arterial extracorporeal recirculation for ‘end stage’ peripheral vascular disease

Abstract

Background: Vascular access via a single arterial catheter for targeted chemotherapy delivery has difficulties with concentration, dilution, drug retention, plasma binding, and lack of control of the tumour microcirculation. An implantable arterial access system to accommodate multi-catheter access was developed address these problems. The system was also adapted for isolated arterial-to-arterial extracorporeal suprasystolic perfusion for end stage peripheral vascular disease. The arterial-to-arterial logistics were compared with standard venovenous and arteriovenous fistulae access employed in haemodialysis. Methods: Targeted chemotherapy delivery was addressed in a pilot study of vascular liver isolation. Ten patients with secondary colorectal cancer, were treated with multiple infusions employing up to five individually steered catheters. The arterial-to-arterial extracorporeal access system was also used to treat end stage peripheral vascular disease in 20 patients where amputation was the only option. The trial was named Hypertensive Extracorporeal Limb Perfusion (HELP). Results: Multiple day only infusions produced a partial response or stable disease in six out of the ten patients in an ‘end stage’ setting. The mean survival was 11.2 months. Of the twenty patients facing amputation 40% had avoided amputation at follow-up 22 months and 20% had delay of 4 months. Conclusion: The access system allows repeatable steerable multi-catheter arterial access for chemotherapy delivery to address difficulties of concentration, dilution, plasma binding and microvascular control. The access system supports multiple repeatable suprasystolic extracorporeal arterial to arterial access. It is cardiac independent generating flows of greater than 1 L/min with zero flow in between treatments. The device logistics compares favourably with arteriovenous and venovenous access systems.