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. 2025 Aug 25;25(1):390.
doi: 10.1186/s12893-025-03136-9.

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

Jia-Cheng Xiang #  1 , Zhi-Yu Xia #  1 , Jian-Xuan Sun  1 , Shao-Gang Wang  2 , Qi-Dong Xia  3
Affiliations

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

Jia-Cheng Xiang et al. BMC Surg. .

Abstract

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.

Keywords: Adverse events; Cancer; IRE; Irreversible electroporation; Nanoknife; Safety.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: Not applicable. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
The screening process of adverse effect cases
Fig. 2
Fig. 2
Overview of the included cases. (A) The proportion of Clavien-Dindo Grade 1–5 in all cases; (B) The number of Nanoknife adverse events in each year; (C) The temporal trends of Clavien-Dindo Grade 1–5 events from 2014 to 2024; The proportion of CDG grading in (D) pancreatic cancer, (E) liver cancer, and (F) prostate cancer
Fig. 3
Fig. 3
The temporal trends of the major adverse events. (A) Temporal trends for device malfunction; (B) Temporal trends for gastrointestinal injures in pancreatic cancer; (C) Temporal trends for arrhythmias in liver cacner; (D) Temporal trends for rectal fistula in prostate cancer
See this image and copyright information in PMC

References

    1. Schaarschmidt BM, Zensen S, Kesch C, Dertnig T, Opitz M, Drews M, Nadjiri J, Forsting M, Hadaschik BA, Haubold J. Current use of percutaneous ablation in renal tumors: an analysis of the registry of the German society for interventional radiology and minimally invasive therapy. Eur Radiol. 2025;35(3):1723–31. - PMC - PubMed
    1. Cheng C, Xu M, Pan J, Chen Q, Li K, Xu D, Jing X, Lu Q, Yang H, Zhao Q, et al. A multicenter, randomized, parallel-controlled clinical trial protocol to evaluate the safety and efficacy of irreversible electroporation compared with radiofrequency ablation for the treatment of small hepatocellular carcinoma. World J Surg Oncol. 2024;22(1): 332. - PMC - PubMed
    1. Wei F-Q, Huang P-S, Zhang B, Guo R, Yuan Y, Chen J, Lin Z-Y. Refining MR-guided thermal ablation for HCC within the Milan criteria: a decade of clinical outcomes and predictive modeling at a single institution. BMC Cancer. 2025;25(1):159. - PMC - PubMed
    1. Scheffer HJ, Nielsen K, de Jong MC, van Tilborg AAJM, Vieveen JM, Bouwman ARA, Meijer S, van Kuijk C, van den Tol PMP, Meijerink MR. Irreversible electroporation for nonthermal tumor ablation in the clinical setting: a systematic review of safety and efficacy. J Vasc Interv Radiol. 2014;25(7):997–1011. - PubMed
    1. Lee EW, Chen C, Prieto VE, Dry SM, Loh CT, Kee ST. Advanced hepatic ablation technique for creating complete cell death: irreversible electroporation. Radiology. 2010;255(2):426–33. - PubMed

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