Real-world safety of irreversible electroporation therapy for tumors with nanoknife: MAUDE database analysis.

Background: Irreversible electroporation (IRE) is a non-thermal ablation technique using high-voltage, low-energy pulses to induce cell membrane perforation and cell death. As an emerging therapy, IRE has gained increasing application in local tumor treatment, with Nanoknife being the most widely used device. Despite its relative safety compared to traditional therapies, potential adverse reactions still merit the attention of clinicians.

Methods: We analyzed all IRE-related adverse event reports in the Manufacturer and User Facility Device Experience (MAUDE) database, focusing on event types, Clavien-Dindo Grades, the timing of adverse events and temporal trends across cancers.

Results: Device malfunctions with Nanoknife were a significant issue but have declined recently. In pancreatic cancer, gastrointestinal injuries (mainly hemorrhagic lesions) were most commonly reported. In liver cancer, arrhythmias were frequent, with no new cases in recent years. In prostate cancer, rectal fistula was the most common adverse event, with an increasing number of cases being reported.

Conclusions: Theoretically, the Nanoknife is expected to exhibit favorable safety profiles. However, ongoing attention to device maintenance, treatment standardization, and postoperative management is needed to further enhance its safety.