Splanchnic ablation for volume management (SAVM) in heart failure with preserved ejection fraction (HFpEF) was discussed as a late-breaking trial at the Heart Failure Society of America (HFSA) Annual Scientific Meeting 2023 in Cleveland, Ohio.[1,2] The REBALANCE-HF (Endovascular Ablation of the Right Greater Splanchnic Nerve in Subjects Having HFpEF) was a blinded, randomized, sham-controlled study.[1,3] The background is that exertional splanchnic vasoconstriction and subsequent volume redistribution can cause elevated filling pressures and decompensation in patients with HFpEF. The hypothesis was that splanchnic denervation would result in improvements in filling pressure and functional capacity.
The SAVM procedure is performed percutaneously by introducing a catheter from the femoral vein to the intercostal vein via the azygos and then using radiofrequency to ablate the right greater splanchnic nerve. The procedure takes approximately 53 minutes to complete and has a high success rate (98%).[3]
The study investigators randomized 90 patients to the SAVM procedure or to a sham procedure (44 patients in the intervention group, 46 in the sham group). The patients were predominantly older and female (intervention group: mean age 72 years, 55% female; sham group: mean age 71 years, 74% female). The inclusion criteria included elevated exercise wedge pressure (pulmonary capillary wedge pressure ≥25 mm Hg), preserved systolic function with left ventricular ejection fraction ≥50%, New York Heart Association (NYHA) class II-IV heart failure (HF), and stable guideline-directed medical therapy for HF and diuretics for ≥30 days. Patients with orthostatic hypotension (OH) were excluded. The primary outcome was reduction in wedge pressure with passive leg raise and exercise at 1 month post procedure. The secondary outcomes were Kansas City Cardiomyopathy Questionnaire (KCCQ) score, 6-min walk distance, and HF hospitalizations at 1 year post procedure.
The primary and secondary results of the study were negative.[1,3] Delta wedge pressure was -1.6 mm Hg in the sham group and -4.5 mm Hg in the intervention group (p = 0.1). Subgroup analysis showed that approximately 55% of patients in the intervention group were deemed responders. This responder group had clinical and statistical improvements in quality of life, functional capacity, and biomarker levels at the 6-month mark. The clinical features of the responder group were that they had preserved or increased cardiac output during exercise, chronotropic competence, preserved or increased pulse pressure from supine to standing, and less severe diastolic dysfunction by echocardiography (E/A <2). Of note, the procedure was deemed safe; however, there was an 11% rate of OH in the intervention group.
The investigators plan to perform a randomized, sham-controlled trial in the future that focuses on patients who are responders.[3,4]
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