PMID- 36944369 OWN - NLM STAT- MEDLINE DCOM- 20230323 LR - 20240210 IS - 1464-5157 (Electronic) IS - 0265-6736 (Linking) VI - 40 IP - 1 DP - 2023 TI - Device safety assessment of bronchoscopic microwave ablation of normal swine peripheral lung using robotic-assisted bronchoscopy. PG - 2187743 LID - 10.1080/02656736.2023.2187743 [doi] AB - 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. FAU - De Leon, Hector AU - De Leon H AUID- ORCID: 0000-0001-7627-5578 AD - Ethicon, Inc, Raritan, NJ, USA. FAU - Royalty, Kevin AU - Royalty K AD - NeuWave Medical Inc, Madison, WI, USA. FAU - Mingione, Louie AU - Mingione L AD - NeuWave Medical Inc, Madison, WI, USA. FAU - Jaekel, David AU - Jaekel D AD - Ethicon, Inc, Redwood City, CA, USA. FAU - Periyasamy, Sarvesh AU - Periyasamy S AD - School of Medicine and Public Health, University of Wisconsin, Madison, WI, USA. FAU - Wilson, David AU - Wilson D AD - Schneck Pulmonology, Schneck Medical Center, Seymour, IN, USA. FAU - Laeseke, Paul AU - Laeseke P AD - School of Medicine and Public Health, University of Wisconsin, Madison, WI, USA. FAU - Stoffregen, William C AU - Stoffregen WC AD - Northstar Preclinical and Pathology Services, LLC, Lake Elmo, MN, USA. FAU - Muench, Tim AU - Muench T AD - Ethicon, Inc, Raritan, NJ, USA. FAU - Matonick, John P AU - Matonick JP AD - Ethicon, Inc, Raritan, NJ, USA. FAU - Kaluza, Grzegorz L AU - Kaluza GL AD - CRF Skirball Center for Innovation, Orangeburg, NY, USA. FAU - Cipolla, Gustavo AU - Cipolla G AD - Ethicon, Inc, Raritan, NJ, USA. LA - eng GR - F30 CA250408/CA/NCI NIH HHS/United States GR - T32 GM140935/GM/NIGMS NIH HHS/United States PT - Journal Article PT - Research Support, Non-U.S. Gov't PL - England TA - Int J Hyperthermia JT - International journal of hyperthermia : the official journal of European Society for Hyperthermic Oncology, North American Hyperthermia Group JID - 8508395 SB - IM MH - Animals MH - Swine MH - *Robotic Surgical Procedures/adverse effects MH - Bronchoscopy MH - Microwaves/therapeutic use MH - Equipment Safety MH - Lung/diagnostic imaging/surgery/pathology MH - *Lung Neoplasms/surgery MH - *Catheter Ablation/methods OTO - NOTNLM OT - Microwave ablation OT - animal model OT - bronchoscopic microwave ablation OT - computed tomography OT - lung cancer OT - robotic bronchoscopy OT - thermal ablation EDAT- 2023/03/22 06:00 MHDA- 2023/03/24 06:00 CRDT- 2023/03/21 20:02 PHST- 2023/03/21 20:02 [entrez] PHST- 2023/03/22 06:00 [pubmed] PHST- 2023/03/24 06:00 [medline] AID - 10.1080/02656736.2023.2187743 [doi] PST - ppublish SO - Int J Hyperthermia. 2023;40(1):2187743. doi: 10.1080/02656736.2023.2187743.