Left Ventricular Assist Devices for Destination Therapy: A Health Technology Assessment.

BACKGROUND: Left ventricular assist devices (LVADs) provide circulatory support to assist the damaged left ventricle in patients with end-stage heart failure. Implantation of an LVAD is sometimes a last resort for patients with end stage heart failure who are ineligible for heart transplantation (destination therapy). First-generation LVADs used pulsatile pumps to mimic the natural pulsing action of the heart. Implanted second-generation LVADs use a rapidly spinning rotor to produce a continuous flow of blood into the systemic arterial system.

OBJECTIVES: Our objectives were to: Determine the clinical effectiveness of LVADs for destination therapy for patients with end-stage heart failure who are ineligible for heart transplantationEstimate the cost-effectiveness of destination-therapy LVAD for patients with end-stage heart failure who are ineligible for heart transplantation and to estimate the potential budget impact for the Ontario Ministry of Health and Long-Term Care over the next 5 years.

METHODS: We performed a narrative review of the clinical and economic literature for effectiveness and cost-effectiveness and a budget impact analysis from the perspective of the Ministry of Health and Long-Term Care. We did not conduct a meta-analysis of the clinical evidence owing to differences in the type of LVADs included in the studies.

RESULTS: Three systematic reviews and one observational study contributed to the clinical evidence. Three economic reviews contributed to the economic evidence. There is moderate quality evidence that treatment with continuous-flow LVADs improves survival but has higher adverse events rates compared with drug therapy. Low quality evidence suggests treatment with a continuous-flow LVADs improves quality of life. The incremental cost-effectiveness ratio associated with destination-therapy LVAD over optimal medical management is relatively high and exceeds the traditionally accepted thresholds ($50,000 to $100,000 per quality-adjusted life-year). The estimated net budget impact is $13.6 million in 2015, $20.7 million in 2016, $27.8 million in 2017, $35.8 million in 2018, and $45.0 million in 2019.

CONCLUSIONS: For patients with end-stage heart failure who are ineligible for heart transplantation, permanent treatment with continuous-flow LVADs is effective at improving survival and quality of life compared with drug therapy. However, permanent continuous-flow devices have higher adverse event rates than drug therapy. Although it improves survival and quality of life, the device itself and the surgery to implant it are very expensive.