Device safety assessment of bronchoscopic microwave ablation of normal swine peripheral lung using robotic-assisted bronchoscopy

Abstract

Introduction

The aim of this study was to assess the safety of bronchoscopic microwave ablation (MWA) of peripheral lung parenchyma using the NEUWAVE™ FLEX Microwave Ablation System, and robotic-assisted bronchoscopy (RAB) using the MONARCH™ Platform in a swine model.

Methods

Computed tomography (CT)-guided RAB MWA was performed in the peripheral lung parenchyma of 17 Yorkshire swine (40–50 kg) and procedural adverse events (AEs) documented. The acute group (day 0, n = 5) received 4 MWAs at 100 W for 1, 3, 5, and 10 min in 4 different lung lobes. Subacute and chronic groups (days 3 and 30, n = 6 each) received one MWA (100 W, 10 min) per animal.

Results

The study was completed without major procedural complications. No postprocedural AEs including death, pneumothorax, bronchopleural fistula, hemothorax, or pleural effusions were observed. No gross or histological findings suggestive of thromboembolism were found in any organ. One 3-Day and one 30-Day swine exhibited coughing that required no medication (minor AEs), and one 30-Day animal required antibiotic medication (major AE) for a suspected lower respiratory tract infection that subsided after two weeks. CT-based volumetric estimates of ablation zones in the acute group increased in an ablation time-dependent (1–10 min) manner, whereas macroscopy-based estimates showed an increasing trend in ablation zone size.

Conclusion

The NEUWAVE FLEX and MONARCH devices were safely used to perform single or multiple RAB MWAs. The preclinical procedural safety profile of RAB MWA supports clinical research of both devices to investigate efficacy in select patients with oligometastatic disease or primary NSCLC.

Keywords:

• Microwave ablation
• robotic bronchoscopy
• lung cancer
• thermal ablation
• animal model
• bronchoscopic microwave ablation
• computed tomography

Acknowledgements

The authors thank Berit DelGuercio for support on tissue processing for histopathological analyses, and Vivienne Mendoza for administrative and document management assistance.

Disclosure statement

The following authors: HDL, DJ, TM, JPM, and GC are employees of Ethicon, Inc.; KR, and LM are employees of NeuWave Medical, Inc. both Johnson & Johnson MedTech companies. PL, SP, and DW are consultants for Ethicon, Inc.

Data availability statement

The authors confirm that the data supporting the findings of this study are available within the article and its supplementary materials.

Additional information

Funding

This work was funded by Johnson & Johnson MedTech.