Endoscopic, ultrasound guided, radiofrequency ablation of aldosterone producing adenomas: A prospective, proof-of-concept trial

Abstract Unilateral aldosterone-producing adrenal adenomas (APAs) are the potentially curable cause of 5% of all cases of hypertension. At present surgical removal of a whole gland is the only approved option for achieving cure, with uncertain long-term outcomes. Endoscopic ultrasound-guided trans-gastric radiofrequency ablation (EUS-RFA) offers a less invasive alternative to total adrenalectomy for the treatment of left-sided APAs. We aimed to determine whether EUS-RFA of APAs is safe and evaluate its likelihood of success in curing primary aldosteronism. We conducted a multi-centre feasibility study of EUS-RFA as a nonsurgical, adrenal-sparing treatment for left-sided APAs. The primary endpoint was safety, judged by the occurrence of pre-specified major hazards (intestinal haemorrhage, infarction or viscus perforation); and the secondary endpoints were biochemical and clinical efficacy (Primary Aldosterone Surgical Outcome (PASO) criteria). 28 participants (21 male, 7 female, mean age 57.7 +/- 10.3 years; 16 White, 11 Black, 1 Asian), underwent 35 ablations on one (n=21) or two (n=7) occasions. None of the pre-specified major hazards occurred. There were 21 biochemical and 12 clinical successes. These were complete in 16 and 4 participants, respectively, associated with >75% eradication of the APA, judged by molecular imaging. EUS-guided trans-gastric RFA is a safe alternative to total adrenalectomy for the treatment of left-sided APAs and can lead to complete PASO success when most of the APA is ablated.