First Clinical Series of Patients Undergoing Nanosecond Pulsed Field Ablation for Symptomatic Benign Thyroid Nodules in a Clinic Setting.

BACKGROUND

The nPulse™ Vybrance™ Percutaneous Electrode System delivers nanosecond pulsed field ablation (nsPFA), a nonthermal technology that permeabilizes cell membranes while preserving surrounding structures. As a novel therapeutic approach in the United States, nsPFA may offer a nonsurgical alternative for symptomatic benign thyroid nodules (BTNs). This study evaluates the short-term clinical outcomes and safety of nsPFA treatment performed in a clinic setting, focusing on changes in nodule volume and treatment-related complications.

METHODS

A retrospective chart review was conducted of 38 patients (48 symptomatic BTNs) treated with nsPFA. Benign cytology was confirmed via fine-needle aspiration biopsy. Since some patients underwent nsPFA of multiple BTNs, analysis of volume reduction was performed at the nodule level using a repeated measures approach, which accounts for within-patient correlation when estimating average changes over time.

RESULTS

Average nodule volume reduction at 1, 3, 6, and 12 months was 49.0% [confidence interval (CI) 42.5-55.4], 53.5% [CI 48.6-58.4], 51.8% [CI 45.2-58.5], and 50.2% [CI 34.9-65.5], respectively. Primary nodules received a median of 37 low-voltage and 24 default-voltage cycles, with additional nodules requiring fewer total cycles. No procedural or post-procedural complications were observed. All patients reported symptomatic improvement, often as early as 2 weeks following treatment. Three patients with toxic nodules and one with a nontoxic nodule were initially on antithyroid medication; all successfully discontinued antithyroid medication within 1 month of nsPFA. Subsequent thyroid function monitoring showed no abnormalities across patients with toxic and nontoxic nodules.

CONCLUSIONS

This study represents the first reported clinical series of nsPFA outcomes for thyroid nodules in North America and the first in the world in a clinic setting. Early findings suggest that nsPFA is a promising, minimally invasive alternative to surgery for symptomatic BTNs, offering significant volume reduction and an excellent safety profile. The rapid symptomatic improvement and durable volume reductions during limited follow-up support further investigation. The modest sample size, retrospective design, and loss to follow-up at later time points may affect the interpretation of sustained effectiveness. Larger, prospective studies with extended follow-up are warranted to validate these results, assess long-term outcomes, and compare procedural environments.