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

BACKGROUND: 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.