1. 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
- Author
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Fudim, Marat, Fail, Peter S, Litwin, Sheldon E, Shaburishvili, Tamaz, Goyal, Parag, Hummel, Scott L, Borlaug, Barry A, Mohan, Rajeev C, Patel, Ravi B, Mitter, Sumeet S, Klein, Liviu, Rocha‐Singh, Krishna, Patel, Manesh R, Reddy, Vivek Y, Burkhoff, Daniel, and Shah, Sanjiv J
- Subjects
Biomedical and Clinical Sciences ,Cardiovascular Medicine and Haematology ,Clinical Sciences ,Clinical Research ,Clinical Trials and Supportive Activities ,Patient Safety ,Prevention ,Heart Disease ,Cardiovascular ,Aged ,Female ,Heart Failure ,Humans ,Male ,Pulmonary Wedge Pressure ,Splanchnic Nerves ,Stroke Volume ,Ventricular Function ,Left ,Heart failure with preserved ejection fraction ,Splanchnic nerve ablation ,Therapeutics ,Clinical trial ,Cardiorespiratory Medicine and Haematology ,Cardiovascular System & Hematology ,Cardiovascular medicine and haematology - Abstract
AimsIn 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 resultsThe 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
- Published
- 2022