PMID- 37667319 OWN - NLM STAT- MEDLINE DCOM- 20231205 LR - 20231205 IS - 2055-5822 (Electronic) IS - 2055-5822 (Linking) VI - 10 IP - 6 DP - 2023 Dec TI - Baroreflex activation therapy in patients with heart failure with reduced ejection fraction: a single-centre experience. PG - 3373-3384 LID - 10.1002/ehf2.14508 [doi] AB - AIMS: Heart failure with reduced ejection fraction (HFrEF) is associated with excessive sympathetic and impaired parasympathetic activity. The Barostim Neo device is used for electronical baroreflex activation therapy (BAT) to counteract autonomic nervous system dysbalance. Randomized trials have shown that BAT improves walking distance and reduces N-terminal prohormone of brain natriuretic peptide (NT-proBNP) levels at least in patients with only moderate elevation at baseline. Its impact on the risk of heart failure hospitalization (HFH) and death is not yet established, and experience in clinical routine is limited. METHODS AND RESULTS: We report on patient characteristics and clinical outcome in a retrospective, non-randomized single-centre registry of BAT in HFrEF. Patients in the New York Heart Association (NYHA) Classes III and IV with a left ventricular ejection fraction (LVEF) <35% despite guideline-directed medical therapy were eligible. Symptom burden, echocardiography, and laboratory testing were assessed at baseline and after 12 months. Clinical events of HFH and death were recorded at routine clinical follow-up. Data are shown as number (%) or median (inter-quartile range). Between 2014 and 2020, 30 patients were treated with BAT. Median age was 67 (63-77) years, and 27 patients (90%) were male. Most patients (83%) had previous HFH. Device implantation was successful in all patients. At 12 months, six patients had died and three were alive but did not attend follow-up. NYHA class was III/IV in 26 (87%)/4 (13%) patients at baseline, improved in 19 patients, and remained unchanged in 5 patients (P < 0.001). LVEF improved from 25.5 (20.0-30.5) % at baseline to 30.0 (25.0-36.0) % at 12 months (P = 0.014). Left ventricular end-diastolic diameter remained unchanged. A numerical decrease in NT-proBNP [3165 (880-8085) vs. 1001 (599-3820) pg/mL] was not significant (P = 0.526). Median follow-up for clinical events was 16 (10-33) months. Mortality at 1 (n = 6, 20%) and 3 years (n = 10, 33%) was as expected by the Meta-Analysis Global Group in Chronic Heart Failure risk score. Despite BAT, event rate was high in patients with NYHA Class IV, NT-proBNP levels >1600 pg/mL, or estimated glomerular filtration rate (eGFR) <30 mL/min at baseline. NYHA class and eGFR were independent predictors of mortality. CONCLUSIONS: Patients with HFrEF who are selected for BAT are in a stage of worsening or even advanced heart failure. BAT appears to be safe and improves clinical symptoms and-to a modest degree-left ventricular function. The risk of death remains high in advanced disease stages. Patient selection seems to be crucial, and the impact of BAT in earlier disease stages needs to be established. CI - (c) 2023 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology. FAU - Blanco, Carola AU - Blanco C AD - Department of Internal Medicine and Cardiology, Heart Centre Dresden, University Hospital, Technische Universitat Dresden, Dresden, Germany. FAU - Madej, Tomas AU - Madej T AD - Department of Cardiac Surgery, Heart Centre Dresden, University Hospital, Technische Universitat Dresden, Dresden, Germany. FAU - Mangner, Norman AU - Mangner N AD - Department of Internal Medicine and Cardiology, Heart Centre Dresden, University Hospital, Technische Universitat Dresden, Dresden, Germany. FAU - Hommel, Jennifer AU - Hommel J AD - Faculty of Medicine, Technische Universitat Dresden, Dresden, Germany. FAU - Grimm, Susanna AU - Grimm S AD - Department of Internal Medicine and Cardiology, Heart Centre Dresden, University Hospital, Technische Universitat Dresden, Dresden, Germany. FAU - Knaut, Michael AU - Knaut M AD - Department of Cardiac Surgery, Heart Centre Dresden, University Hospital, Technische Universitat Dresden, Dresden, Germany. FAU - Linke, Axel AU - Linke A AD - Department of Internal Medicine and Cardiology, Heart Centre Dresden, University Hospital, Technische Universitat Dresden, Dresden, Germany. FAU - Winzer, Ephraim B AU - Winzer EB AUID- ORCID: 0000-0002-1752-8528 AD - Department of Internal Medicine and Cardiology, Heart Centre Dresden, University Hospital, Technische Universitat Dresden, Dresden, Germany. LA - eng PT - Journal Article DEP - 20230904 PL - England TA - ESC Heart Fail JT - ESC heart failure JID - 101669191 SB - IM MH - Aged MH - Female MH - Humans MH - Male MH - Baroreflex/physiology MH - *Electric Stimulation Therapy/adverse effects MH - *Heart Failure MH - Retrospective Studies MH - Stroke Volume/physiology MH - Ventricular Function, Left MH - Middle Aged PMC - PMC10682889 OTO - NOTNLM OT - Baroreflex activation therapy OT - Barostim Neo OT - Chronic heart failure OT - Device therapy COIS- A.L. reports grants from Novartis; personal fees from Abbott, Abiomed, AstraZeneca, Bayer, Boehringer Ingelheim, Boston Scientific, Edwards Lifesciences, Medtronic, Novartis, and Pfizer; and other fees from Claret Medical, Picardia, and Transverse Medical outside the submitted work. N.M. has received personal fees from Edwards Lifesciences, Medtronic, Biotronik, Novartis, Sanofi Genzyme, AstraZeneca, Pfizer, Bayer, Abbott, Abiomed, and Boston Scientific outside the submitted work. M.K. has received personal fees from Boston, CVRx, Medtronic, Philips, and Zoll outside the submitted work. E.B.W. reports grants from Boehringer Ingelheim and personal fees from Amarin, Amgen, AstraZeneca, Daiichi Sankyo, Bayer, Boehringer Ingelheim, CVRx, and Novartis outside the submitted work. All remaining authors do not report any possible conflicts of interest connected to the submitted work. EDAT- 2023/09/05 00:42 MHDA- 2023/11/29 06:43 PMCR- 2023/09/04 CRDT- 2023/09/04 23:49 PHST- 2023/07/20 00:00 [revised] PHST- 2023/04/17 00:00 [received] PHST- 2023/08/07 00:00 [accepted] PHST- 2023/11/29 06:43 [medline] PHST- 2023/09/05 00:42 [pubmed] PHST- 2023/09/04 23:49 [entrez] PHST- 2023/09/04 00:00 [pmc-release] AID - EHF214508 [pii] AID - 10.1002/ehf2.14508 [doi] PST - ppublish SO - ESC Heart Fail. 2023 Dec;10(6):3373-3384. doi: 10.1002/ehf2.14508. Epub 2023 Sep 4.