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Left Ventricular Assist Device (LVAD) As Destination Therapy for Patients with Endstage Heartfailure

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Left Ventricular Assist Device (LVAD) As Destination Therapy for Patients with Endstage Heartfailure Left ventricular assist device (LVAD) as destination therapy for patients with endstage heartfailure This is an excerpt from the full technical report, which is written in Norwegian. The excerpt provides the report’s main messages in English. N0. 14–2013 Health technology assessment (HTA) Title Left ventricular assist device (LVAD) as destination therapy for patients with endstage heartfailure Norwegian title Hjertepumper (LVAD) som varig behandling av pasienter med alvorlig hjertesvikt Institution Norwegian Knowledge Centre for the Health Services (Nasjonalt kunnskapssenter for helsetjenesten) Magne Nylenna, Director Authors Lauvrak,Vigdis, Project leader, Researcher Skår, Åse, Senior Advisor Arentz-Hansen, Helene, Researcher Hamidi, Vida, Health economist Fure, Brynjar, Research manager ISBN 978-82-8121-640-2 ISSN 1890-1298 Report No. 14 – 2013 Project number Type of report Health Technology Assessment No. of pages 73 (121 incl. attachments) Client The Norwegian Directorate of Health Subject heading Heart Failure; Heart-Assist Devices (MeSH) Citation Lauvrak V, Skår Å, Arentz-Hansen H, Hamidi V, Fure B. Left ventricular assist device (LVAD) as destination therapy for patients with endstage heartfailure. Report from Kunnskapssenteret no. 14−2013. Oslo: Norwegian Knowledge Centre for the Health Services, 2013. Norwegian Knowledge Centre for the Health Services summarizes and disseminates evidence concerning the effect of treatments, methods, and interventions in health services, in addition to monitoring health service quality. Our goal is to support good decision making in order to provide patients in Norway with the best possible care. The Centre is organized under The Norwegian Directorate for Health, but is scientifically and professionally independent. The Centre has no authority to develop health policy or responsibility to implement policies. We would like to thank all contributers for their expertise in this project. Norwegian Knowledge Centre for the Health Services assumes final responsibility for the content of this report. Norwegian Knowledge Centre for the Health Services Oslo, November 2013 Title: Key messages (English) Left ventricular assist device (LVAD) as destination therapy for patients with endstage heartfailure ------------------------------------------ Type of publication: Health technology assessment The Norwegian National Council for Priority Setting in the Health Health technology assessment Care recommended in 2008 that left ventricular assist device (LVAD) (HTA) is a multidisciplinary should be offered to patients only for a limited period of time, for ex- process that summarizes in- formation about the medical, ample while awaiting heart transplantation. This recommendation social, economic and ethical may be reconsidered. We have assessed LVAD as destination therapy. issues related to the use of a In 2008, there was one randomized controlled trial (RCT) comparing health technology in a system- atic, transparent, unbiased, first-generation LVAD with optimal medical treatment. A literature robust manner. Its aim is to search performed in June 2013 provided an RCT from 2009 that com- inform the development of pared second-generation LVAD with first-generation LVAD, a few re- safe, effective health policies cent prospective case series, registry data and two relevant interna- that are patient focused and that seek to achieve best val- tional cost-effectiveness analyses. Our main conclusions are: ue. ------------------------------------------ Compared with optimal medical therapy LVAD can provide ex- Doesn’t answer eve- tended life time and improved quality of life for selected patients rything: with end-stage heart failure. The magnitude of the clinical effect is - Excludes studies that fall uncertain. outside of the inclusion criteria - No recommendations There are no studies comparing LVAD with heart transplantation. ------------------------------------------ Publisher: The most common complications associated with LVAD are bleed- Norwegian Knowledge Centre ing, infections, need for pump replacement, stroke and right ven- for the Health Services tricular heart failure. These complications are the major cause of ------------------------------------------ death the first two years following pump insertion. Updated: Last search for studies: The costs of LVAD have been reduced since 2008, but they are still June, 2013. high. International cost-effectiveness analyses are associated with uncertainty. A Norwegian cost-effectiveness analysis has not been ------------------------------------------ performed. Peer review: Both to offer and not to offer LVAD as destination therapy is ethi- Arnt Fiane, Odd Geiran, Einar Gude, Gro Sørensen, Vinod cally challenging. Kumar Mishra, OUS. Truls Myrmel, UNN, Morten Grundtvig, Norsk hjertesvikt- register. 8 Key messages (English) Executive summary Background Cardiac transplantation is currently the preferred long-term treatment of eligible patients with end-stage advanced heart failure. The availability of donor hearts is limited and not all patients may tolerate cardiac transplantation. Implantable left ventricular assist devices (LVADs), that fully or partly support the left ventricle, are suggested as an alternative therapy for patients with end-stage advanced heart fail- ure. In our report from 2008, we concluded that LVAD may prolong life and im- prove quality of life, yet the number of complications and costs were very high. New- er types of LVADs were at the time under investigation in clinical trials. The Nation- al Council for Priority Setting in the Health Care recommended in 2008 that LVAD should only be offered to patients for a limited period, for example while awaiting cardiac transplantation (bridge to transplant). Questions to reconsider the recom- mendations have been raised. We were commissioned by the Norwegian Directorate of Health to perform a health technology assessment (HTA) on LVAD as destination therapy. Methodology We have restricted the assessment to LVAD as destination therapy for adults with advanced heart failure. Questions regarding clinical effectiveness, safety and costs were assessed based on a systematic literature search performed in June 2013 look- ing for HTA-reports, systematic reviews, studies with relevant control groups (in- cluding randomised controlled trials (RCTs)), prospectively collected registry data that report drop-outs and follow-up time, as well as any study reporting Norwegian experiences. Questions concerning disease, technology and ethical challenges were assessed based on selected sources and input from Norwegian experts. We have not conducted cost-effectiveness analysis or comprehensive organisational impact anal- ysis. 9 Executive summary Results Disease and description of technology Advanced heart failure Heart failure is a condition where the heart is unable to pump enough blood to cover the needs of the body. The most common cause of heart failure is narrowing or blockage of the coronary arteries. Patients with advanced heart failure have signifi- cantly reduced quality of life and shortened life span. The New York Heart Associa- tion (NYHA) functional classification provides a simple way of classifying the extent of heart failure, of which NYHA class IV is the most severe. The number of patients in Norway in NYHA class IV is probably between 500 to 1000. Most of these receive medical treatment including lifestyle measures, drugs, pacemakers, defibrillators (ICD) and synchronization therapy (CRT). Cardiac transplantation is only relevant for a limited number of eligible patients below 70 years through a nationwide func- tion at Oslo University Hospital (OUH). The transplantation rate in Norway is ap- proximately 35 hearts per year. With the current criteria for transplantation the real need is approximately 50 transplantations per year. Medical treatment of patients with end-stage heart failure, i.e. patients who do not respond to medical treatment and who are not eligible for transplantation, is primarily to reduce symptoms (i.e. palliative treatment). LVAD Long-term LVAD is used as a bridge to transplantation while awaiting a suitable heart or as destination therapy, e.g. for permanent use. First-generation LVADs were large pulsatile pumps, while the second- and third-generation are smaller and provide a continuous blood flow. Destination therapy with LVAD is considered both as life prolonging and palliative care. Eligible patients for LVAD The number of patients eligible for LVAD is uncertain. The recommendations from clinical experts at OUH are to include patients that are considered for transplanta- tion, but do not meet the criteria for transplantation although below 70 years of age. According to the experts, this concerns about 40 patients per year. In addition, a small number of carefully selected elderly patients may also be eligible. It is very likely that technological advancement and changes in indication for use may in- crease the number of patients eligible for LVAD. Current use Currently, LVAD as destination therapy is not offered in Norway. Long-term treat- ment with LVAD as a bridge to transplantation is offered only at OUH as part of the nationwide function within transplantation. The number of patients treated with LVAD at OUH in 2013 is estimated to be between eight and ten. The use of LVAD in different European countries is highly variable. As of October 2013, patients in Eng- 10 Executive summary land were not offered LVAD as destination therapy. In year 2012, 100 cardiac
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