Cost-Effectiveness of a Small Intrapericardial Centrifugal LVAD versus Medical Management and Heart Transplantation

Abstract

Purpose There is limited data on the cost-effectiveness of continuous-flow Left Ventricular Assist Devices (LVADs) in the U.S. and especially for the bridge to transplant indication. We studied for the first time the cost-effectiveness of a small intrapericardial centrifugal LVAD in its primary indications compared to medical management and subsequent heart transplantation using the respective clinical trial data. Methods We developed a Markov economic framework to assess the cost-effectiveness of a small intrapericardial centrifugal LVAD. Survival and quality of life (QoL) inputs for the LVAD arm were based on individual patient data (IPD) from the ADVANCE-BTT + CAP, ENDURANCE and ENDURANCE Supplemental clinical trials. To better assess survival in the medical management arm, and in the absence of contemporary trials randomizing patients to LVAD and medical management, estimates from the Seattle Heart Failure Model (SHFM) had to be used. Costs inputs were calculated based on Medicare cost data (Instant Health Data, IHD) and, when appropriate prior published literature. Time horizon was lifetime. One-way, Scenario and Probabilistic Sensitivity Analyses were conducted. Costs and benefits were appropriately discounted at 3% per year. Results The incremental cost-effectiveness ratio (ICER) of the small intrapericardial centrifugal LVAD was calculated $76,240 per quality-adjusted life years (QALY) and $64,415 per life-years gained (LY) for the bridge to transplant (BTT) indication. Costs and utilities were $384,829 and 7.08 QALYs for the LVAD arm vs. $104,645 and 3.41 QALYs for the medical management arm. These results suggest substantial improvement, to the ICER of LVADs in the BTT indication, driven by long-term data, technological advancements and payment variations. This re-opens the discussion of LVADs’ cost-effectiveness. Conclusion In this analysis assessing the cost-effectiveness a small intrapericardial centrifugal LVAD, we found an ICER of $76,240 per QALY for the BTT indication. These outcomes signify a substantial improvement and re-open the discussion around LVAD's cost-effectiveness.