Implementation and 2‐year outcomes of the first FDA‐approved implantable apheresis vascular access device

Abstract

BACKGROUND Patients requiring chronic apheresis treatments typically lack sufficient peripheral venous access to support long‐term therapy. Historically, central venous tunneled catheters, septum‐bearing subcutaneous ports, and fistulas were used to obtain required blood flow rates for apheresis procedures. In 2017, the US Food and Drug Administration approved the first intravascular device specifically designed for apheresis therapy, the PowerFlow Implantable Apheresis IV Port. METHODS Several preimplementation meetings with key hospital stakeholders were held to determine the most efficient and safest strategy for integrating the PowerFlow device into our practice. Interventional radiologists implanted the apheresis port in patients meeting specified criteria. Performance metrics and adverse events were evaluated over a 2‐year period, July 2017 through June 2019. RESULTS Eighteen patients underwent apheresis therapy using the PowerFlow port. The most common apheresis therapy provided was extracorporeal photopheresis, followed by therapeutic plasma exchange and low‐density lipoprotein apheresis. Flow rates up to 90 mL/min were obtained; the rates were limited by patient tolerance for the apheresis procedure. Complications included infection, obstruction due to fibroblastic sleeve, and migration of the vascular device. The estimated risk of PowerFlow‐associated bloodstream infection in the study population was 0.18 per 1000 intravascular device days. CONCLUSION The PowerFlow Implantable Apheresis IV Port can achieve flow rates necessary for all apheresis therapies and is a promising alternative vascular access device for patients undergoing apheresis.

An update on lipid apheresis for familial hypercholesterolemia

“…Fistula thrombosis has been observed more often in hypercholesterolemia patients than in dialysis patients in our institution (unpublished data), maybe due to even worse vessel quality and more thrombogenic material in these patients. In 2017, the US Food and Drug Administration approved an intravascular port device specifically designed for apheresis therapy, which can be used alternatively [ 42 – 45 ].…”

Should ultrasound evaluation for catheter-related thrombosis always be required before PICC removal?

“…11,12,23 Furthermore, in some of these prospective studies, the ultrasound finding of a FS (a very common pathophysiological phenomenon) is not mentioned, so it may be argued that the incidence of asymptomatic CRT might have been overestimated, due to a confusion between thrombus and sleeve. 17,24 This is largely due to the undisputed fact that FS is a very neglected complication of central venous access devices. 25 Though the morphologic differences between CRT and FS have been described in the literature, few clinicians are properly trained to discriminate one from the other at ultrasound scan.…”