PMID- 30092774 OWN - NLM STAT- MEDLINE DCOM- 20190610 LR - 20190613 IS - 1471-2261 (Electronic) IS - 1471-2261 (Linking) VI - 18 IP - 1 DP - 2018 Aug 9 TI - An early analysis of cost-utility of baroreflex activation therapy in advanced chronic heart failure in Germany. PG - 163 LID - 10.1186/s12872-018-0898-x [doi] LID - 163 AB - BACKGROUND: This study aimed to evaluate cost-utility of baroreflex activation therapy (BAT) using the Barostim neo device (CVRx Inc., Minneapolis, MN, USA) compared with optimized medical management in patients with advanced chronic heart failure (NYHA class III) who were not eligible for treatment with cardiac resynchronization therapy, from a statutory health insurance perspective in Germany over a lifetime horizon. METHODS: A decision analytic model was developed using the combination of a decision tree and the Markov process. The model included transitions between New York Heart Association (NYHA) health states, each of which is associated with a risk of mortality, hospitalization, cost, and quality of life. The effectiveness of BAT was projected through relative risks for mortality (obtained by application of patient-level data to the Meta-analysis Global Group in Chronic Heart Failure risk prediction model) and hospitalization owing to worsening of heart failure (obtained from BAT Randomized Clinical Trial). All patients were in NYHA class III at baseline. RESULTS: BAT led to an incremental cost of euro33,185 (95% credible interval [CI] euro24,561-38,637) and incremental benefits of 1.78 [95% CI 0.45-2.71] life-years and 1.19 [95% CI 0.30-1.81] quality-adjusted life-years (QALYs). This resulted in an incremental cost-effectiveness ratio of euro27,951/QALY (95% CI euro21,357-82,970). BAT had a 59% probability of being cost-effective at a willingness-to-pay threshold of euro35,000/QALY (but 84% at a threshold of euro52,000/QALY). CONCLUSIONS: BAT can be cost-effective in European settings in those not eligible for cardiac resynchronization therapy among patients with advanced heart failure. FAU - Borisenko, Oleg AU - Borisenko O AUID- ORCID: 0000-0002-1361-2431 AD - Synergus AB, Danderyd (Stockholm), Sweden. oleg.borisenko@synergus.com. FAU - Muller-Ehmsen, Jochen AU - Muller-Ehmsen J AD - Department of Internal Medicine 3, Asklepios Klinik Altona, Hamburg, Germany. FAU - Lindenfeld, JoAnn AU - Lindenfeld J AD - Heart Failure and Transplantation Section Vanderbilt Heart and Vascular Institute Medical Center, Nashville, TN, USA. FAU - Rafflenbeul, Erik AU - Rafflenbeul E AD - Department of Internal Medicine 1, Asklepios Klinik Barmbek, Hamburg, Germany. FAU - Hamm, Christian AU - Hamm C AD - Kerckhoff Heart and Thoraxcenter, Bad Nauheim and Medical Clinic I, University of Giessen, Giessen, Germany. LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20180809 PL - England TA - BMC Cardiovasc Disord JT - BMC cardiovascular disorders JID - 100968539 SB - IM MH - *Baroreflex MH - Chronic Disease MH - Cost-Benefit Analysis MH - Decision Support Techniques MH - Decision Trees MH - Disease Progression MH - Electric Stimulation Therapy/adverse effects/*economics/instrumentation MH - Germany MH - *Health Care Costs MH - Heart Failure/diagnosis/*economics/physiopathology/*therapy MH - Humans MH - Implantable Neurostimulators/*economics MH - Markov Chains MH - Models, Economic MH - Pressoreceptors/*physiopathology MH - Quality of Life MH - Quality-Adjusted Life Years MH - Recovery of Function MH - Time Factors MH - Treatment Outcome PMC - PMC6085633 OTO - NOTNLM OT - Baroreflex activation therapy OT - Barostim OT - Cost-utility OT - Germany OT - Health economics OT - Markov modeling COIS- Clinical data were obtained by the manufacturer (CVRx Inc., Minneapolis, MN, USA) with patient consent and after ethical approval. For the aims of present study, no further ethical approval was required, because the data were supplied by the manufacturer in an anonymous form. Not applicable. OB is the employee of the medical consulting company Synergus AB, which received a grant from CVRx Inc. to develop a decision analytic model. JME has received speaker honoraria from CVRx Inc. JL provided paid consulting support to CVRx Inc. CH is the member of the Advisory Board to CVRx Inc. and has received speaker honoraria from CVRx Inc. ER does not have any conflict of interest to report. Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. EDAT- 2018/08/11 06:00 MHDA- 2019/06/14 06:00 PMCR- 2018/08/09 CRDT- 2018/08/11 06:00 PHST- 2017/04/18 00:00 [received] PHST- 2018/07/25 00:00 [accepted] PHST- 2018/08/11 06:00 [entrez] PHST- 2018/08/11 06:00 [pubmed] PHST- 2019/06/14 06:00 [medline] PHST- 2018/08/09 00:00 [pmc-release] AID - 10.1186/s12872-018-0898-x [pii] AID - 898 [pii] AID - 10.1186/s12872-018-0898-x [doi] PST - epublish SO - BMC Cardiovasc Disord. 2018 Aug 9;18(1):163. doi: 10.1186/s12872-018-0898-x.