Ont Health Technol Assess Ser. 2016 Feb 08;16(3):1-60. eCollection 2016.
Left Ventricular Assist Devices for Destination Therapy: A Health Technology Assessment.
Ontario health technology assessment series
[No authors listed]
PMID: 27026798
PMCID: PMC4761917
Abstract
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.
References
- J Card Fail. 2015 Feb;21(2):160-6 - PubMed
- J Heart Lung Transplant. 2011 Feb;30(2):115-23 - PubMed
- J Clin Epidemiol. 2011 Apr;64(4):380-2 - PubMed
- N Engl J Med. 2009 Dec 3;361(23):2241-51 - PubMed
- Circ Heart Fail. 2012 Mar 1;5(2):241-8 - PubMed
- Int J Technol Assess Health Care. 2013 Jul;29(3):254-60 - PubMed
- J Heart Lung Transplant. 2014 Jun;33(6):555-64 - PubMed
- J Heart Lung Transplant. 2012 Jan;31(1):27-36 - PubMed
- Circ Heart Fail. 2014 May;7(3):470-8 - PubMed
- J Am Coll Cardiol. 2010 Apr 27;55(17):1826-34 - PubMed
- Circ Heart Fail. 2012 Jan;5(1):10-6 - PubMed
- J Am Coll Cardiol. 2013 Oct 15;62(16):e147-239 - PubMed
- J Am Coll Cardiol. 2013 Mar 26;61(12):1209-21 - PubMed
- J Clin Epidemiol. 2010 May;63(5):513-23 - PubMed
- Artif Organs. 2010 Feb;34(2):93-7 - PubMed
- J Thorac Cardiovasc Surg. 2012 Sep;144(3):584-603; discussion 597-8 - PubMed
- Eur J Cardiothorac Surg. 2008 Aug;34(2):289-94 - PubMed
- CMAJ. 2012 Oct 2;184(14):E765-73 - PubMed
- Circulation. 2013 Feb 12;127(6):743-8 - PubMed
- N Engl J Med. 2001 Nov 15;345(20):1435-43 - PubMed
- Congest Heart Fail. 2005 May-Jun;11(3):133-8 - PubMed
- Health Technol Assess. 2013 Nov;17(53):1-499, v-vi - PubMed
- J Thorac Cardiovasc Surg. 2005 Jan;129(1):9-17 - PubMed
- Can J Cardiol. 2013 Dec;29(12):1712-20 - PubMed
- BMC Med Res Methodol. 2007;7:10 - PubMed
- N Engl J Med. 2002 Jun 13;346(24):1902-5 - PubMed
- Circulation. 2007 Jul 31;116(5):497-505 - PubMed
- J Am Coll Cardiol. 2014 May 6;63(17):1751-7 - PubMed
- J Cardiovasc Electrophysiol. 2002 Jan;13(1 Suppl):S73-91 - PubMed
- Circulation. 2011 Apr 12;123(14):1552-8; discussion 1558 - PubMed
- Eur Heart J. 2000 Aug;21(15):1246-50 - PubMed
- Exp Clin Cardiol. 2013 Spring;18(2):139-47 - PubMed
MeSH terms
Publication Types