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.
Nazareth, T., Saadi, R., Thompson, M., Ferko, N., & Spaulding, C. (2011). PMD13 Cost Analysis of Vascular Closure Devices (VCD) in the United States. Value in Health, 14(7), A246. https://doi.org/10.1016/j.jval.2011.08.086