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.
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.
Authors: Ralph J Petrucci; Joseph G Rogers; Laura Blue; Colleen Gallagher; Stuart D Russell; Dzifa Dordunoo; Brian E Jaski; Suzanne Chillcott; Benjamin Sun; Tammy L Yanssens; Antone Tatooles; Lalig Koundakjian; David J Farrar; Mark S Slaughter Journal: J Heart Lung Transplant Date: 2012-01 Impact factor: 10.247
Authors: Gordon H Guyatt; Andrew D Oxman; Holger J Schünemann; Peter Tugwell; Andre Knottnerus Journal: J Clin Epidemiol Date: 2010-12-24 Impact factor: 6.437
Authors: James K Kirklin; David C Naftel; Robert L Kormos; Lynne W Stevenson; Francis D Pagani; Marissa A Miller; Karen L Ulisney; J Timothy Baldwin; James B Young Journal: J Heart Lung Transplant Date: 2011-02 Impact factor: 10.247
Authors: Soon J Park; Carmelo A Milano; Antone J Tatooles; Joseph G Rogers; Robert M Adamson; D Eric Steidley; Gregory A Ewald; Kartik S Sundareswaran; David J Farrar; Mark S Slaughter Journal: Circ Heart Fail Date: 2012-01-26 Impact factor: 8.790
Authors: James K Kirklin; David C Naftel; Francis D Pagani; Robert L Kormos; Lynne W Stevenson; Elizabeth D Blume; Marissa A Miller; J T Baldwin; J Timothy Baldwin; James B Young Journal: J Heart Lung Transplant Date: 2014-04-21 Impact factor: 10.247
Authors: Joseph G Rogers; Keith D Aaronson; Andrew J Boyle; Stuart D Russell; Carmelo A Milano; Francis D Pagani; Brooks S Edwards; Soon Park; Ranjit John; John V Conte; David J Farrar; Mark S Slaughter Journal: J Am Coll Cardiol Date: 2010-04-27 Impact factor: 24.094
Authors: Mark S Slaughter; Joseph G Rogers; Carmelo A Milano; Stuart D Russell; John V Conte; David Feldman; Benjamin Sun; Antone J Tatooles; Reynolds M Delgado; James W Long; Thomas C Wozniak; Waqas Ghumman; David J Farrar; O Howard Frazier Journal: N Engl J Med Date: 2009-11-17 Impact factor: 91.245
Authors: Mattias Neyt; Ann Van den Bruel; Yolba Smit; Nicolaas De Jonge; Michiel Erasmus; Diederik Van Dijk; Joan Vlayen Journal: Int J Technol Assess Health Care Date: 2013-06-14 Impact factor: 2.188
Authors: Peter Cram; Saket Girotra; John Matelski; Maria Koh; Bruce E Landon; Lu Han; Douglas S Lee; Dennis T Ko Journal: Circ Cardiovasc Qual Outcomes Date: 2020-01-20