PMID- 37288061 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20230610 IS - 2474-8714 (Electronic) IS - 2474-8706 (Print) IS - 2474-8706 (Linking) VI - 6 IP - 5 DP - 2022 Oct TI - Endovascular Baroreflex Amplification With the MobiusHD Device in Patients With Heart Failure and Reduced Ejection Fraction: Interim Analysis of the First-in-Human Results. PG - 100086 LID - 10.1016/j.shj.2022.100086 [doi] LID - 100086 AB - BACKGROUND: Endovascular baroreflex amplification with the MobiusHD, a self-expanding stent-like device that is implanted in the internal carotid artery, was designed to reduce the sympathetic overactivity that contributes to progressive heart failure with reduced ejection fraction. METHODS: Symptomatic patients (New York Heart Association class III) with heart failure with reduced ejection fraction (left ventricular ejection fraction [LVEF] /=400 pg/mL in whom carotid ultrasound and computed tomographic angiography demonstrated absence of carotid plaque were enrolled. Baseline and follow-up measures included 6-minute walk distance (6MWD), Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ OSS), and repeat biomarkers and transthoracic echocardiography. RESULTS: Twenty-nine patients underwent device implantation. The mean age was 60.6 +/- 11.4 years, and all had New York Heart Association class III symptoms. Mean KCCQ OSS was 41.4 +/- 12.7, mean 6MWD was 216.0 +/- 43.7 m, median NT-proBNP was 1005.9 pg/mL (894, 1294), and mean LVEF was 34.7 +/- 2.9%. All device implantations were successful. Two patients died (161 days and 195 days) and one stroke occurred (170 days) during follow-up. For the 17 patients with 12-month follow-up, mean KCCQ OSS improved by 17.4 +/- 9.1 points, mean 6MWD increased by 97.6 +/- 51.1 meters, a mean 28.4% reduction from the baseline NT-proBNP concentration was found, and mean LVEF improved by 5.6% +/- 2.9 (paired data). CONCLUSION: Endovascular baroreflex amplification with the MobiusHD device was safe and effected positive changes in quality of life, exercise capacity, and LVEF, consistent with observed reductions in NT-proBNP levels. CI - (c) 2022 The Author(s). FAU - Piayda, Kerstin AU - Piayda K AD - CardioVascular Center Frankfurt, Frankfurt, Germany. FAU - Sievert, Kolja AU - Sievert K AD - CardioVascular Center Frankfurt, Frankfurt, Germany. FAU - Sievert, Horst AU - Sievert H AD - CardioVascular Center Frankfurt, Frankfurt, Germany. FAU - Shaburishvili, Tamaz AU - Shaburishvili T AD - Tbilisi Heart and Vascular Clinic, Tbilisi, Georgia. FAU - Gogorishvili, Irakli AU - Gogorishvili I AD - Helsicore Hospital, Tbilisi, Georgia. FAU - Rothman, Martin AU - Rothman M AD - Vascular Dynamics Inc, Irvine, California, USA. FAU - Januzzi, James L Jr AU - Januzzi JL Jr AD - Massachusetts General Hospital, Harvard Medical School, Baim Institute for Clinical Research, Boston, Massachusetts, USA. FAU - Lindenfeld, JoAnn AU - Lindenfeld J AD - Vanderbilt University Medical Center, Nashville, Tennessee, USA. FAU - Stone, Gregg W AU - Stone GW AD - The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA. LA - eng PT - Journal Article DEP - 20220916 PL - United States TA - Struct Heart JT - Structural heart : the journal of the Heart Team JID - 101743256 PMC - PMC10242580 OTO - NOTNLM OT - Chronic heart failure OT - Endovascular baroreceptor amplification OT - HFrEF COIS- Dr. H. Sievert has received institutional honoraria, travel expenses, and consulting fees from 4tech Cardio, Abbott, Ablative Solutions, Ancora Heart, Append Medical, Bavaria Medizin Technologie GmbH, Bioventrix, Boston Scientific, Carag, CardiacDimensions, Cardimed, Celonova, Comed B.V., Contego, CVRx, Dinova, Edwards Lifesciences, Endologix, Hemoteq, Hangzhou Nuomao Medtech, Holistick Medical, Lifetech, Maquet Getinge Group, Medtronic, Mokita, Occlutech, Recor, RenalGuard, Terumo, Vascular Dynamics, Vectorious Medtech, Venus, Venock, and Vivasure Medical. Dr. Januzzi is a Trustee of the American College of Cardiology, a Board member of Imbria Pharmaceuticals, has received grant support from 10.13039/100014386Abbott Diagnostics, Applied Therapeutics, Innolife, Jana Care, Novartis Pharmaceuticals, Prevencio and Roche Diagnostics, consulting income from Abbott, Janssen, Novartis, Prevencio, and Roche Diagnostics, and participates in clinical endpoint committees/data safety monitoring boards for Abbott, AbbVie, Amgen, Bayer, CVRx, Janssen, MyoKardia, Takeda, and Vifor. Dr. Lindenfeld receives grant funding from 10.13039/100004325AstraZeneca, NovoNordisk, and Volumetrix and consulting fees from AstraZeneca, Abbott, Alleviant, Boston Scientific, Boehringer Ingelheim, CVRx, Edwards Lifesciences, Medtronic, Merck, TegoSense, Vascular Dynamics, and V-Wave. Dr. Rothmann is an employee of Vascular Dynamics. Dr. Stone has received speaker honoraria from Medtronic, Pulnovo, Infraredx; has served as a consultant to Valfix, TherOx, Robocath, HeartFlow, Ablative Solutions, Vectorious, Miracor, Neovasc, Abiomed, Ancora, Elucid Bio, Occlutech, CorFlow, Apollo Therapeutics, Impulse Dynamics, Vascular Dynamics, Shockwave, V-Wave, Cardiomech, Gore, Amgen; and has equity/options from Ancora, Cagent, Applied Therapeutics, Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, Valfix, Xenter. Dr. Stone's daughter is an employee at Medtronic. Institutional disclosure: Dr. Stone's employer, Mount Sinai Hospital, receives research support from 10.13039/100000046Abbott, Abiomed, Bioventrix, 10.13039/100016476Cardiovascular Systems Inc, Phillips, 10.13039/100007497Biosense-Webster, Shockwave, Vascular Dynamics, and V-wave. All other authors have nothing to disclose. EDAT- 2023/06/08 06:42 MHDA- 2023/06/08 06:43 PMCR- 2022/09/16 CRDT- 2023/06/08 04:28 PHST- 2022/04/29 00:00 [received] PHST- 2022/07/27 00:00 [revised] PHST- 2022/08/04 00:00 [accepted] PHST- 2023/06/08 06:43 [medline] PHST- 2023/06/08 06:42 [pubmed] PHST- 2023/06/08 04:28 [entrez] PHST- 2022/09/16 00:00 [pmc-release] AID - S2474-8706(22)01876-0 [pii] AID - 100086 [pii] AID - 10.1016/j.shj.2022.100086 [doi] PST - epublish SO - Struct Heart. 2022 Sep 16;6(5):100086. doi: 10.1016/j.shj.2022.100086. eCollection 2022 Oct.