Endovascular ablation of the right greater splanchnic nerve in heart failure with preserved ejection fraction: early results of the REBALANCE-HF trial roll-in cohort.

التفاصيل البيبلوغرافية
العنوان:	Endovascular ablation of the right greater splanchnic nerve in heart failure with preserved ejection fraction: early results of the REBALANCE-HF trial roll-in cohort.
المؤلفون:	Fudim M; Duke University Medical Center, Durham, NC, USA., Fail PS; Cardiovascular Institute of the South, Houma, LA, USA., Litwin SE; Medical University of South Carolina and Ralph H. Johnson, Veterans Affairs Medical Center, Charleston, SC, USA., Shaburishvili T; Tbilisi Heart and Vascular Clinic, Tbilisi, Georgia., Goyal P; Weill Cornell Medicine, New Yok, NY, USA., Hummel SL; Michigan School of Medicine, University of Michigan, Ann Arbor, MI, USA., Borlaug BA; Mayo Clinic, College of Medicine, Rochester, MN, USA., Mohan RC; Scripps Clinic, La Jolla, CA, USA., Patel RB; Northwestern University Feinberg School of Medicine, Chicago, IL, USA., Mitter SS; Mount Sinai Hospital - Icahn School of Medicine at Mount Sinai, New York, NY, USA., Klein L; University of California San Francisco, San Francisco, CA, USA., Rocha-Singh K; Prairie Heart Institute at St. John's Hospital, Springfield, IL, USA., Patel MR; Duke University Medical Center, Durham, NC, USA., Reddy VY; Mount Sinai Hospital - Icahn School of Medicine at Mount Sinai, New York, NY, USA., Burkhoff D; Cardiovascular Research Foundation, New York, NY, USA., Shah SJ; Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
المصدر:	European journal of heart failure [Eur J Heart Fail] 2022 Aug; Vol. 24 (8), pp. 1410-1414. Date of Electronic Publication: 2022 May 29.
نوع المنشور:	Journal Article; Randomized Controlled Trial; Research Support, U.S. Gov't, Non-P.H.S.; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't
اللغة:	English
بيانات الدورية:	Publisher: Wiley Country of Publication: England NLM ID: 100887595 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1879-0844 (Electronic) Linking ISSN: 13889842 NLM ISO Abbreviation: Eur J Heart Fail Subsets: MEDLINE
أسماء مطبوعة:	Publication: 2014- : Chichester : Wiley Original Publication: Amsterdam ; New York : Elsevier Science, c1999-
مواضيع طبية MeSH:	Heart Failure*/surgery, Aged ; Female ; Humans ; Male ; Pulmonary Wedge Pressure ; Splanchnic Nerves ; Stroke Volume ; Ventricular Function, Left
مستخلص:	Aims: In heart failure (HF) with preserved ejection fraction (HFpEF), excessive redistribution of blood volume into the central circulation leads to elevations of intracardiac pressures with exercise limitations. Splanchnic ablation for volume management (SAVM) has been proposed as a therapeutic intervention. Here we present preliminary safety and efficacy data from the initial roll-in cohort of the REBALANCE-HF trial. Methods and Results: The open-label (roll-in) arm of REBALANCE-HF will enrol up to 30 patients, followed by the randomized, sham-controlled portion of the trial (up to 80 additional patients). Patients with HF, left ventricular ejection fraction (LVEF) ≥50%, and invasive peak exercise pulmonary capillary wedge pressure (PCWP) ≥25 mmHg underwent SAVM. Baseline and follow-up assessments included resting and exercise PCWP, New York Heart Association (NYHA) class, Kansas City Cardiomyopathy Questionnaire (KCCQ), 6-min walk test, and N-terminal pro-B-type natriuretic peptide (NT-proBNP). Efficacy and safety were assessed at 1 and 3 months. Here we report on the first 18 patients with HFpEF that have been enrolled into the roll-in, open-label arm of the study across nine centres; 14 (78%) female; 16 (89%) in NYHA class III; and median (interquartile range) age 75.2 (68.4-81) years, LVEF 61.0 (56.0-63.2)%, and average (standard deviation) 20 W exercise PCWP 36.4 (±8.6) mmHg. All 18 patients were successfully treated. Three non-serious moderate device/procedure-related adverse events were reported. At 1-month, the mean PCWP at 20 W exercise decreased from 36.4 (±8.6) to 28.9 (±7.8) mmHg (p < 0.01), NYHA class improved by at least one class in 33% of patients (p = 0.02) and KCCQ score improved by 22.1 points (95% confidence interval 9.4-34.2) (p < 0.01). Conclusion: The preliminary open-label results from the multicentre REBALANCE-HF roll-in cohort support the safety and efficacy of SAVM in HFpEF. The findings require confirmation in the ongoing randomized, sham-controlled portion of the trial. (© 2022 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)
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معلومات مُعتمدة:	R01 HL107577 United States HL NHLBI NIH HHS; R01 HL127028 United States HL NHLBI NIH HHS; R01 HL140731 United States HL NHLBI NIH HHS; U54 HL160273 United States HL NHLBI NIH HHS
فهرسة مساهمة:	Keywords: Clinical trial; Heart failure with preserved ejection fraction; Splanchnic nerve ablation; Therapeutics
تواريخ الأحداث:	Date Created: 20220522 Date Completed: 20220817 Latest Revision: 20221016
رمز التحديث:	20221213
مُعرف محوري في PubMed:	PMC9388552
DOI:	10.1002/ejhf.2559
PMID:	35598154
قاعدة البيانات:	MEDLINE

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تدمد:	1879-0844
DOI:	10.1002/ejhf.2559