WITHDRAWN Cost-Effectiveness of Alternative Bridging Anticoagulation Therapies in Patients with Left Ventricular Assist Devices

OBJECTIVES: Patients with left ventricular assist devices (LVAD) occasionally require temporary “bridging” anticoagulation to prevent life-threatening thromboembolic complications. Given a lack of clinical trial data, bridging practice varies widely between different LVAD centers. This study evaluated the cost-effectiveness of outpatient management with low-molecular-weight heparin (LMWH) vs hospitalization with unfractionated heparin (UFH) and quantified the potential value of new research assessing adverse events in patients treated with LMWH vs UFH.

METHODS: We projected health and economic outcomes for LMWH vs UFH bridging strategies using a decision analytic model parameterized using data on adverse event rates from a two-center retrospective cohort study of adults with LVAD implantation between January 2014 and December 2018 and from the published literature. Base case analyses used a healthcare sector perspective. The primary outcome was the incremental cost-effectiveness ratio in 2021 US dollars per quality-adjusted life year (QALY) gained. Sensitivity analyses were conducted. Expected value of sample information (EVSI) analyses were conducted using a probabilistic model. EVSI was quantified with net monetary benefit (assuming willingness to pay for health as $100,000/QALY). We calculated discounted population-level EVSI by multiplying per-episode EVSI by the annual number of bridging decisions in the United States and assuming a 10-year time frame of treatment use.

RESULTS: The base-case lifetime cost-effectiveness analysis showed that outpatient management with LMWH was cost-saving. In probabilistic sensitivity analyses, LMWH remained cost-saving in 99% of iterations. Expected population-level societal returns (EVSI minus study costs) of a new trial collecting data on adverse event rates would be negative across different study sample sizes.

CONCLUSIONS: There appears to be very little uncertainty that outpatient management with LMWH is more favorable than inpatient UFH bridging in LVAD patients. A trial in which more information on adverse events associated with the bridging strategies is collected would not represent good value for information.