Transvenous Right Greater Splanchnic Nerve Ablation in Heart Failure and Preserved Ejection Fraction: First-in-Human Study.

Autor:	Fudim M; Duke University Medical Center, Durham, North Carolina, USA; Duke Clinical Research Institute, Durham, North Carolina, USA. Electronic address: https://twitter.com/FudimMarat., Zirakashvili T; Tbilisi Heart and Vascular Clinic, Tbilisi, Republic of Georgia., Shaburishvili N; Tbilisi Heart and Vascular Clinic, Tbilisi, Republic of Georgia., Shaishmelashvili G; Tbilisi Heart and Vascular Clinic, Tbilisi, Republic of Georgia., Sievert H; Cardiovascular Center Frankfurt, Sankt Katharinen, Frankfurt, Germany; Goethe University Frankfurt, Frankfurt, Germany., Sievert K; Cardiovascular Center Frankfurt, Sankt Katharinen, Frankfurt, Germany; Goethe University Frankfurt, Frankfurt, Germany., Reddy VY; Mount Sinai Heart Health System, New York, New York, USA., Engelman ZJ; Axon Therapies, New York, New York, USA., Burkhoff D; Cardiovascular Research Foundation, New York, New York, USA., Shaburishvili T; Tbilisi Heart and Vascular Clinic, Tbilisi, Republic of Georgia., Shah SJ; Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA. Electronic address: sanjiv.shah@northwestern.edu.
Jazyk:	angličtina
Zdroj:	JACC. Heart failure [JACC Heart Fail] 2022 Oct; Vol. 10 (10), pp. 744-752. Date of Electronic Publication: 2022 Jul 06.
DOI:	10.1016/j.jchf.2022.05.009
Abstrakt:	Background: Ablation of the right-sided greater splanchnic nerve (GSN) can reduce excessive splanchnic vasoconstriction, potentially improving the handling of volume shifts in patients with heart failure with preserved ejection fraction (HFpEF). Objectives: The purpose of this study was to assess a novel catheter procedure of right-sided GSN ablation to treat HFpEF: splanchnic ablation for volume management. Methods: This trial included 11 HFpEF patients (8 women, age 70 ± 8 years) with New York Heart Association functional class II or III symptoms, ejection fraction ≥50%, and elevated pulmonary capillary wedge pressure at rest or with exercise. After splanchnic ablation for volume management, follow-up at 1, 3, 6, and 12 months included 6-minute walk test, Kansas City Cardiomyopathy Questionnaire (KCCQ), and echocardiography. Results: There were no device-related adverse cardiac events or clinical sequelae following right GSN ablation through 12 months. Patients experienced clinical improvements by 1 month that were sustained through 12 months. KCCQ score improved from baseline median 48 (IQR: 35-52) to 65 (IQR: 58-77) at 1 month and 80 (IQR: 77-88) at 12 months (P < 0.05). The 6-minute walk test distance increased from baseline 292 ± 82 m to 341 ± 88 m at 1 month and 359 ± 75 m at 12 months (P < 0.05). The NT-proBNP decreased from a baseline mean of 1,292 ± 1,186 pg/mL to 1,202 ± 797 pg/mL (P = 0.585) at 1 month, to 472 ± 226 pg/mL (P = 0.028) at 6 months, and to 379 ± 165 pg/mL (P = 0.039) at 12 months. Conclusions: In this open-label, single-arm feasibility study, right-sided GSN ablation was safe and improved mostly subjective clinical metrics in patients with HFpEF over 12 months. (Endovascular GSN Ablation in Subjects With HFpEF; NCT04287946). Competing Interests: Funding Support and Author Disclosures This work was supported by Axon Therapies. Dr Fudim was supported by the National Heart, Lung, and Blood Institute (NHLBI) (K23HL151744), the American Heart Association (20IPA35310955), Mario Family Award, Duke Chair’s Award, Translating Duke Health Award, Bayer, Bodyport and BTG Specialty Pharmaceuticals; and has received consulting fees from Abbott, Audicor, AxonTherapies, Bodyguide, Bodyport, Boston Scientific, CVRx, Daxor, Edwards LifeSciences, Feldschuh Foundation, Fire1, Gradient, Intershunt, NXT Biomedical, Pharmacosmos, PreHealth, Splendo, Vironix, Viscardia, and Zoll. Dr Reddy has served as a consultant to and holds stock options in Axon Therapies related to this work; has served as a consultant for Abbott, Biosense-Webster, BioTel Heart, Biotronik, Boston Scientific, Cardiofocus, Cardionomic, CoreMap, EBR, Fire1, Gore and Associates, HRT, Impulse Dynamics, Medtronic, Philips, and Pulse Biosciences; has served as a consultant for and has equity in Ablacon, Acutus Medical, Affera, Apama Medical, APN Health, Aquaheart, Atacor, Autonomix, Backbeat, BioSig, Cardiac Implants, CardiaCare, CardioNXT/AFTx, Circa Scientific, Corvia Medical, Dinova-Hangzhou DiNovA EP Technology, East End Medical, EPD, Epix Therapeutics, EpiEP, Eximo, Farapulse, Intershunt, Javelin Lld, Kardium, Keystone Heart, LuxMed, Medlumics, Middlepeak, Nuvera, Restore Medical, and Sirona Medical; and has equity in Manual Surgical Sciences, Newpace, Surecor, Valcare and Vizaramed unrelated to this work. Dr Burkhoff has received consulting fees from Axon Therapies. Dr Shah has received research grants from the National Institutes of Health (U54 HL160273, R01 HL107577, R01 HL127028, R01 HL140731, R01 HL149423), Actelion, AstraZeneca, Corvia, Novartis, and Pfizer; and has received consulting fees from Abbott, Actelion, AstraZeneca, Amgen, Aria CV, Axon Therapies, Bayer, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardiora, Coridea, CVRx, Cyclerion, Cytokinetics, Edwards Lifesciences, Eidos, Eisai, Imara, Impulse Dynamics, Intellia, Ionis, Ironwood, Lilly, Merck, MyoKardia, Novartis, Novo Nordisk, Pfizer, Prothena, Regeneron, Rivus, Sanofi, Shifamed, Tenax, Tenaya, and United Therapeutics. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu