PMD13 Cost Analysis of Vascular Closure Devices (VCD) in the United States

Abstract

OBJECTIVES: Recent literature suggests complication rates associated with current VCDs are comparable or reduced when compared to manual compression (MC). However, well-documented differences exist among VCDs regarding the type and magnitude of complications. An indirect comparison was conducted to estimate the cost savings associated with use of novel VCD EXOSEAL™ vs. VCDs ANGIOSEAL ™, MYNX™, PERCLOSE™ and STARCLOSE™ from the US hospital system perspective. METHODS: Crude VCD-specific complication rates were calculated for occlusion, access-site infection (ASI), femoral pseudoaneurysm (FAP), retroperitoneal hemorrhage (RPH), other access-site bleeds (OASB), and arteriovenous fistula (AVF) using prospective clinical studies identified in the most recent VCD instructions for use. A literature review (i.e., 2005 to current) was conducted to identify rates of complication consequences (i.e., amputation, vascular surgery, endovascular procedure, transfusion, ultrasound-guided intervention) and associated US costs were then applied to clinical consequence rates. The one-year budget impact was estimated assuming 100% use of EXOSEALTM vs. current VCD market-share for percutaneous coronary intervention (PCI) procedures. Device costs were assumed identical. RESULTS: Complication rates for occlusion, ASI, RPH, FAP, OASB, and AVF were calculated for each VCD as follows: EXOSEALTM [0.00%, 0.00%, 0.56%, 0.00%, 0.00%, 0.00%], ANGIOSEALTM [0.33%, 0.00%, 0.33%, 0.00%, 0.00%, 0.33%], MYNXTM [0.00%, 0.00%, 0.00%, 0.53%, 0.53%, 0.00%], PERCLOSETM [0.00%, 0.78%, 0.52%, 0.26%, 0.52%, 0.00%] and STARCLOSETM [0.20%, 0.00%, 0.00%, 0.20%, 0.41%, 0.00%]. Results predicted that 100% use of EXOSEALTM vs. combined use of VCDs could save approximately $70 USD per procedure and approximately $70,240 USD per 1,000 annual PCI procedures (i.e., typical hospital). Assuming 550,000 PCIs that use VCDs annually in the US, this translates to a predicted yearly cost-savings of $38,631,949 USD for the US hospital system. CONCLUSIONS: This analysis suggests use of EXOSEAL™ in patients undergoing PCI procedures may result in important costsavings for US hospitals. Additional data will be required to confirm low complication rates with EXOSEALtm.