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

BACKGROUND: 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. METHODS AND RESULTS: 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. CONCLUSIONS: Permanent right GSN ablation leads to a reduction in intracardiac filling pressures during exercise, apparent as early as 24 h following the procedure.

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.

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.

Fluoroscopy-Guided Splanchnic Nerve Block for Cancer-Associated Pain.

Pain associated with abdominal malignancies or metastasis can be very severe and can be intractable and resistant to conventional pharmacologic therapies. Typically, narcotics and non-narcotics are used in combination to alleviate the cancer pain, but these are often unsuccessful. Neurolysis and radio-frequency ablation of the celiac plexus and splanchnic nerves is being used with great success for management of the pain associated with abdominal malignancies with added advantages of improving quality of life, pain relief and decreased narcotic consumption. The tumor or associated lymphadenopathy may result in distortion of the celiac plexus anatomy, thus making it hard to reach the celiac plexus. In such cases, splanchnic nerve block can be employed with relative ease as compared to celiac plexus block. Given the nature of the debilitating pain associated with these conditions and inadequate pain relief with narcotics, these blocks are a boon in disguise to such patients with altered anatomy. Post administration of the splanchnic block, the functioning and quality of life of patients with abdominal malignancies improve. Hence, these blocks can be used to decrease the morbidity associated with abdominal malignancies.

Surgical ablation of the right greater splanchnic nerve for the treatment of heart failure with preserved ejection fraction: first-in-human clinical trial.

AIMS: Inappropriate control of blood volume redistribution may be a mechanism responsible for exercise intolerance in heart failure with preserved ejection fraction (HFpEF). We propose to address this underlying pathophysiology with selective blockade of sympathetic signalling to the splanchnic circulation by surgical ablation of the right greater splanchnic nerve (GSN). METHODS AND RESULTS: In a single-arm, prospective, two-centre trial, 10 patients with HFpEF (50% male, mean age 70 ± 3 years) all with New York Heart Association (NYHA) class III, left ventricular ejection fraction >40%, pulmonary capillary wedge pressure (PCWP) ≥15 mmHg at rest or ≥25 mmHg with supine cycle ergometry, underwent ablation of the right GSN via thoracoscopic surgery. Patients were evaluated at baseline, 1, 3, 6 and 12 months after the procedure. The primary endpoint was a reduction in exercise PCWP at 3 months. There were no adverse events related to the blockade of the nerve during 12-month follow-up but three patients had significant peri-procedural adverse events related to the surgical procedure itself. At 3 months post-GSN ablation, patients demonstrated a reduction in 20 W exercise PCWP when compared to baseline [-4.5 mmHg (95% confidence interval, CI -14 to -2); P = 0.0059], which carried over to peak exercise [-5 mmHg (95% CI -11 to 0; P = 0.016). At 12 months, improvements were seen in NYHA class [3 (3) vs. 2 (1, 2); P = 0.0039] and quality of life assessed with the Minnesota Living with Heart Failure Questionnaire [60 (51, 71) vs. 22 (16, 27); P = 0.0039]. CONCLUSION: In this first-in-human study, GSN ablation in HFpEF proved to be feasible, with a suggestion of reduced cardiac filling pressure during exercise, improved quality of life and exercise capacity.

Radiofrequency Ablation of the Splanchnic Nerve and Superior Hypogastric Plexus for Chronic Abdominal Pain Status Post-Abdominal Surgery.

Gastrointestinal cancers, such as malignant carcinoid tumor and pancreatic cancer, are responsible for excruciating and debilitating abdominal pain. Too often, patients are placed on chronic high-dose opioids, but the pain remains poorly controlled. It is incumbent on the medical team to approach the patient's debilitating pain in a thorough multi-modal fashion. Opioids may play an important role, but they make up only a portion of available invasive and noninvasive management. We present a case of a patient who was serendipitously diagnosed with malignant carcinoid tumor after endoscopic polypectomy and Whipple procedure for pancreatic cancer. Her abdominal pain was refractory to opioid and non-opioid medications, and therefore we proposed radiofrequency ablation (RFA) of the splanchnic nerve and superior hypogastric plexus. This technique was preceded by a diagnostic block of these nerves. She experienced significant pain relief and an improved quality of life, and was able to stop all opioid medications. The preferred approach to pain management is a multi-modal one. This includes physical therapy, pharmacological management, and minimally invasive procedures such as RFA. The medical team must consider all available pain management modalities to provide the patient with proper care of such debilitating pain as that described in our case presentation. A systematic approach is important, as demonstrated by our team by first performing diagnostic blocks of the superior hypogastric plexus and splanchnic nerve to test the likelihood of a successful RFA. Only after achieving favorable results, we decided to proceed with RFA treatment of those same nerves. Ultimately, our RFA technique provided significant pain relief for our patient and she did not require any opioid medications.