Irreversible Electroporation for the Treatment of Pediatric Adenotonsillar Hypertrophy.

Background/

Objectives

Irreversible electroporation (IRE) is a non-thermal tissue ablation technology, offering potential advantages such as reductions in pain, bleeding, and procedural time. With this study, we aimed to evaluate the safety and efficacy of IRE for the treatment of adenotonsillar hypertrophy in pediatric patients.

Methods

In this prospective, two-center, interventional case series, we enrolled 31 children aged 3-13 years with adenotonsillar hypertrophy and upper airway obstruction. All procedures were performed under general anesthesia. IRE was applied to the tonsils and adenoids using the ENTire™ system. Postoperative pain was recorded daily for seven days using the Parent's Postoperative Pain Measure. Disease-specific quality of life was assessed at baseline and three months post-procedure using the Obstructive Sleep Apnea questionnaire (OSA-18). Tonsillar size was graded according to the Brodsky Scale.

Results

The mean procedure time was 10:40 ± 03:40, and there was no intraoperative or postoperative bleeding. Patients were discharged on the day of the procedure. The postoperative pain on day 1 was ranked as 3.5 ± 1.5 and resolved completely in all patients by day 7. From baseline to 3 months, the mean OSA-18 decreased from 66.4 ± 14.9 to 24.6 ± 9.9 (Wilcoxon signed-rank test p-value of <0.0001), and the Brodsky grade decreased from 3.26 ± 0.63 to 0.92 ± 0.61 (p < 0.001).

Conclusions

In this preliminary cohort, non-thermal adenotonsillar ablation using irreversible electroporation was safe, well tolerated, and demonstrated short-term improvements in parent-reported symptoms and oropharyngeal tonsillar size in children. These findings support further investigation in larger, multicenter trials with extended follow-ups.