Implementation and 2‐year outcomes of the first FDA‐approved implantable apheresis vascular access device
Autor: | Kristin L Gray, Christine L Pearce, Jill Adamski, Isabella G Steidley, Amy M Bachman, Hollie L Benson |
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Rok vydání: | 2019 |
Předmět: |
Adult
Male medicine.medical_specialty Immunology Vascular access 030204 cardiovascular system & hematology Vascular device Food and drug administration 03 medical and health sciences Catheters Indwelling 0302 clinical medicine Catheterization Peripheral Extracorporeal Photopheresis Humans Immunology and Allergy Medicine In patient Adverse effect Aged Aged 80 and over United States Food and Drug Administration business.industry Patient Selection Hematology Middle Aged United States Surgery Patient tolerance Apheresis Blood Component Removal Female business Vascular Access Devices 030215 immunology |
Zdroj: | Transfusion. 59:3461-3467 |
ISSN: | 1537-2995 0041-1132 |
Popis: | 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. |
Databáze: | OpenAIRE |
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