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Early Hemodynamic Changes following Surgical Ablation of the Right Greater Splanchnic Nerve for the Treatment of Heart Failure with Preserved Ejection Fraction.

ABSTRACT: Permanent ablation of the right greater splanchnic nerve (GSN) has previously been demonstrated to improve quality of life and functional outcomes, as well as reduce abnormally high intracardiac filling pressures, in patients with heart failure with preserved ejection fraction (HFpEF) at 1, 3 and 12 months following the procedure. We hypothesize that hemodynamic changes that ensue from surgical right GSN ablation would be apparent as early as 24 h after the medical intervention. This is a prespecified analysis of a single-arm, two-center, open-label study evaluating the effects of right GSN ablation via thoracoscopic surgery in HFpEF patients with pulmonary capillary wedge pressure (PCWP) ≥15 mmHg at rest or ≥25 mmHg with supine cycle ergometry. A total of seven patients (median age 67 years, 29% female) underwent GSN removal followed by invasive right heart catheterization within 24 h. GSN ablation resulted in a significant reduction in PCWP 24 h after the procedure compared to baseline for both 20 W exercise (baseline (28.0 ± 4.3 mmHg) to 24 h (19.6 ± 6.9 mmHg); p = 0.0124) and peak exercise (baseline (25.6 ± 2.4 mmHg) to 24 h (17.4 ± 5.9 mmHg); p = 0.0025). There were no significant changes in resting or leg-up hemodynamics. Permanent right GSN ablation leads to a reduction in intracardiac filling pressures during exercise, apparent as early as 24 h following the procedure.

SUBMITTER: Gajewski P

PROVIDER: S-EPMC8878100 | biostudies-literature | 2022 Feb

REPOSITORIES: biostudies-literature

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Early Hemodynamic Changes following Surgical Ablation of the Right Greater Splanchnic Nerve for the Treatment of Heart Failure with Preserved Ejection Fraction.

Gajewski Piotr P Fudim Marat M Kittipibul Veraprapas V Engelman Zoar J ZJ Biegus Jan J Zymliński Robert R Ponikowski Piotr P

Journal of clinical medicine 20220218 4

<h4>Background</h4>Permanent ablation of the right greater splanchnic nerve (GSN) has previously been demonstrated to improve quality of life and functional outcomes, as well as reduce abnormally high intracardiac filling pressures, in patients with heart failure with preserved ejection fraction (HFpEF) at 1, 3 and 12 months following the procedure. We hypothesize that hemodynamic changes that ensue from surgical right GSN ablation would be apparent as early as 24 h after the medical interventio ...[more]

PMID: 35207336

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Project description: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 < 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).ConclusionThe 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.

Project description:BackgroundHeart failure with preserved ejection fraction (HFpEF) and atrial fibrillation (AF) often coincide. Female sex is associated with both increased prevalence of HFpEF and reduced therapeutic efficacy of catheter ablation of AF. This sub-analysis of the previously published AFFECT-study evaluates outcome after cryoballoon-ablation in women with and without HFpEF.MethodsOne-hundred-and-two patients (LVEF ≥ 50%) scheduled for cryoballoon-ablation of AF were prospectively enrolled. Forty-two were female. Comprehensive baseline assessment included echocardiography, stress echocardiography, six-minute-walk-test, biomarker- and quality-of-life-assessment (QoL, SF-36), and was repeated at follow-up ≥12 months after AF-ablation. Baseline parameters, procedural characteristics and outcome after AF-ablation were compared between women with and without HFpEF.ResultsWomen with HFpEF (n = 20) were characterized by higher median left atrial volume index (35.8 ml/m2 vs. 25.8 ml/m2, P < 0.001), left ventricular hypertrophy (median left ventricular mass index: 92.0 g/m2 vs. 83.0 g/m2, P = 0.027), reduced distance in the 6-min-walk-test (median: 453 m vs. 527 m, P = 0.008) and higher left atrial pressures (median: 14.0 mmHg vs.9.5 mmHg, P = 0.008) compared to women without HFpEF (n = 21). During follow-up, HFpEF-patients more often experienced AF-related re-hospitalization (36.8% vs. 9.1%, P = 0.039) and numerically higher AF-recurrence-rates (57.9% vs. 31.1%, P = 0.109). There was no significant improvement of heart failure-related symptoms, echocardiographic parameters and cardiac biomarkers levels. QoL showed no significant improvement in both subgroups. Women with HFpEF still exhibited a lower SF-36 Physical Component Summary Score vs. women without HFpEF (median: 41.2 vs. 52.1, P < 0.001).ConclusionWomen with HFpEF constitute a distinct subgroup with high rates of AF-related events after AF-ablation, and persistence of both symptoms and functional hallmarks of HFpEF. Consideration of sex-specific cardiac co-morbidities is crucial for personalization and optimization of AF-therapy.Clinical trial registrationClinicalTrials.gov Identifier NCT05603611.

Dataset Information

Early Hemodynamic Changes following Surgical Ablation of the Right Greater Splanchnic Nerve for the Treatment of Heart Failure with Preserved Ejection Fraction.

Publications

Early Hemodynamic Changes following Surgical Ablation of the Right Greater Splanchnic Nerve for the Treatment of Heart Failure with Preserved Ejection Fraction.

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