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RADIOFREQUENCY ABLATION WITH ENDOSCOPIC ULTRASOUND GUIDANCE AS A MINIMALLY INVASIVE, ADRENAL SPARING TREATMENT FOR LEFT ADRENAL ALDOSTERONE PRODUCING ADENOMAS (FABULAS) - OUTCOMES OF A MULTICENTRE FEASIBILITY STUDY

Giulia Argentesi 1, Xilin Wu 1, Alexander Ney 2, Emily Goodchild 1, Kate Laycock 1, Yun-ni Lee 1, Russel Senanayake 3, James MacFarlane 3, Elisabeth Ng 1, Jessica Kearney 1, August Palma 3, Iulis Munteanu 4, Jackie Salsbury 1, Elena Daniela Benu 5, Patrizia Ebano 1, Patrick Wilson 6, Edmund Godfrey 3, George Goodchild 6, Jonathan Bestwick 1, Mark Gurnell 7,3, Heok Cheow 3, Stephen P Pereira 2, William Drake 8, Morris J. Brown 9

Affiliations

1 Queen Mary University of London, London, United Kingdom

2 University College London, London, United Kingdom

3 Addenbrookes Hospital, Cambridge, United Kingdom

4 University College London Hospitals, London, United Kingdom

5 Barts Health NHS Trust, London, United Kingdom

6 The Royal London Hospital, London, United Kingdom

7 University of Cambridge, London, United Kingdom

8 Saint Bartholomew's Hospital, London, United Kingdom

9 Queen Mary University of London, Cambridge, United Kingdom

Summary

AI Generated

A 3-centre feasibility study of 28 patients found endoscopic ultrasound-guided radiofrequency ablation to be a safe adrenal-sparing treatment for left-sided aldosterone producing adenomas in patients with primary aldosteronism unfit for surgery.

No expected serious adverse events (perforation, haemorrhage, or organ infarction) occurred; one patient had a metanephrine rise managed medically and two had discharge-delaying events that rapidly resolved.
Complete biochemical success occurred in 14 patients and partial in 3, with median aldosterone-renin ratio falling from 3975 to 880 at six months.
Blood pressure remained unchanged but antihypertensive drug requirements decreased significantly, from a mean of 2.9 to 2.0 medications and defined daily dose from 4.9 to 2.7.
Imaging showed complete ablation in 6 patients with preserved adjacent adrenal function in all, and 13 of 13 analysed fine-needle aspiration samples confirmed CYP11B2-positive adenomas.
This feasibility study enrolled patients unfit for surgery or with ambiguous unilateral disease; a randomised controlled trial comparing the technique with surgery in 110 patients is underway.

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This summary was generated by an AI large language model based on the content transcript. It is for informational purposes only and should not be considered a substitute for clinical judgment. Always rely on your professional expertise and the full clinical context when making clinical decisions.

Abstract

Introduction

Primary aldosteronism (PA) is a leading cause of secondary hypertension with potentially significant cardiovascular sequelae. Adrenalectomy is the standard treatment for PA caused by a unilateral aldosterone producing adenoma (APA). The often incomplete clinical resolution, procedure complexity, perioperative morbidity and patient hesitancy however, support considerations of less invasive treatment options. Endoscopic ultrasound guided Radiofrequency ablation (EUS-RFA) is an attractive alternative in which trans-gastric access enables access to the left adrenal gland, for selective ablation of unilateral APAs. We assessed the safety (procedure induced catecholamine crises, peri-adrenal and visceral complications) and efficacy of EUS-RFA as an adrenal sparing treatment alternative in a 3-centre feasibility study.

Aims & Methods

As an initial step the cohort was limited to patients unfit for surgery due to co-morbidities or an ambiguous estimation of unilateral PA. The APAs were identified by increased uptake of 11C-metomidate (MTO) on post-dexamethasone PET CT (1). Patients were subjected to α-and ß blockade two weeks before undergoing RFA, which was performed under general anaesthesia or deep sedation. Metanephrines levels were monitored before and during EUS-RFA, which was performed using a 5-10 mm19G Starmed EUSRA^TM ablation probe (Taewoong). After diagnostic fine-needle aspiration (FNA), the probe was introduced into the lesion followed by subsequent multiple, short, precise burns as the catheter was moved around the APA. The primary safety outcome was defined as the absence of perforation, haemorrhage, or infarction of major organs, as assessed by CT performed at 24-48 hours after EUS-RFA. Secondary outcomes included the PASO criteria for success (biochemical/clinical), changes in the aldosterone/renin (ARR) ratio, blood pressure and anti-hypertensive drug requirements, as well as MTO uptake on repeat PET-CT, at six months post EUS-RFA.

Results

EUS-RFA was performed in 28 patients (21 male), aged 57.9 ± 10.2 years, of whom 7 had 2 ablations. None of the expected serious adverse events occurred. A rise in metanephrines levels occurred in one patient, managed with ephedrine and metaraminol injections. Discharge delaying adverse events occurred in two patients (hypokalaemia induced atrial fibrillation, hospital acquired pneumonia) and rapidly resolved. Complete biochemical success was observed in 14 patients and partial in 3. Complete clinical success was noted in 4 patients, partial in 4. The median ARR reduction was from 3975 (IQR 2090-7475) to 880 (369-2670), p<0.001. BP remained unchanged, yet with reduced pharmacological requirements: number of antihypertensives and defined daily dose fell from 2.9 (95% CI 2.4-3.3) to 2 (95% CI 1.5-2) and 4.9 (95% CI 3.6-6.2) to 2.7 (95% CI 1.7-3.6), respectively. In 6 patients, APA MTO uptake was reduced to <50% compared to adjacent adrenal tissue (indicating complete ablation) which was unchanged or minimally reduced in all patients (i.e. preserved adrenal function). Reduction in APA diameter was noted in 21/28 patients. FNA samples analysed to date (13/28) were all positive for CYP11B2, confirming APAs as the treated lesion.

Conclusion

Transgastric EUS-RFA is a safe alternative to adrenalectomy in the treatment of left-sided APAs. A randomised controlled trial comparing EUS-RFA with surgery in 110 patients with PA is under way

References

Wu X, Senanayake R, Goodchild E, Bashari WA, Salsbury J, Cabrera CP, et al. [11C]metomidate PET-CT versus adrenal vein sampling for diagnosing surgically curable primary aldosteronism: a prospective, within-patient trial. Nat Med. 2023 Jan 16;29(1):190–202.

Disclosure

No conflict of interest

Conference

UEG Week Copenhagen 2023

Submission format

Abstract

Session

Advanced endoscopy (Posters)

Citation

United European Gastroenterology Journal 2023; 11 (Supplement 8)

Published

2023

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