CV3 MECHANICALLY EXPANDED VERSUS SELF-EXPANDING TRANSCATHETER AORTIC VALVE REPLACEMENT IN HIGH-RISK PATIENTS WITH AORTIC STENOSIS: A BUDGET IMPACT ANALYSIS

Abstract

Each transcatheter aortic valve replacement (TAVR) technology is associated with device-specific benefits and risks. This study evaluated Medicare costs of TAVR with a mechanically expanded valve (MEV) versus a self-expanding valve (SEV) in high-risk patients with severe aortic stenosis. A 1-year budget impact model was developed from a Medicare perspective. MEV and SEV clinical event rates were obtained from the REPRISE III randomized controlled trial at 12 months of follow-up. The model included all relevant procedural complications, including non-disabling and disabling stroke, repeat TAVR procedure, pacemaker implant, surgical aortic valve replacement, hospitalizations for worsening heart failure (HF), major vascular complications, life-threatening bleeds and acute kidney injury. Patient-level costs were assessed for the index TAVR admission (days 0-7) and post-TAVR short- (days 8-30) and long-term (days 31-365) complications. Acute care costs were obtained from 2019 Medicare MS-DRG rates. Long-term care costs for disabling stroke and worsening HF were derived from REPRISE III and published Medicare analyses. One-way sensitivity analysis (OWSA) was performed. At 1 year, disabling stroke, repeat procedure and HF hospitalization rates were lower for MEV compared to SEV; pacemaker rates were higher for MEV. Other complication rates in the model were similar. Total Medicare costs for MEV were lower than SEV ($45,030 versus $47,006). This difference was attributable to the lower costs of disabling stroke (-$1,370), repeat procedure (-$574) and worsening HF (-$314). Pacemaker costs were higher for MEV ($774) than SEV ($477). OWSA showed TAVR procedure costs and the occurrence rates of disabling stroke, repeat procedures and hospitalizations for worsening HF had the greatest influence on model results. MEV is a less costly alternative to SEV at 1 year from a Medicare perspective. Continued technological innovation in TAVR aimed at reducing complications may result in greater savings for payers.