Pulsed electric field ablation safety and characterization near sensitive structures in lung: a preclinical and clinical case series study.

Background: Since pulsed electric fields (PEFs) can ablate tissue without reliance on ionizing radiation or thermal processes, there is potential for this technique to safely ablate near sensitive structures in the lung in a way that may be distinct from thermal or radiative technologies. The purpose of this study is to demonstrate the ability of Aliya PEFs to be delivered safely in the lungs near critical structures via percutaneous and bronchoscopic access. Methods: This study evaluates performance of the Aliya PEF system in healthy swine lung tissue when specifically delivered near sensitive structures (pleura, diaphragm, large vessels and airways). Clinically, six human subjects who received PEF near similar structures are also presented. These six patients all underwent the Aliya PEF procedure because they presented with lesions adjacent to sensitive structures that were not considered candidates for traditional ablative modalities. Twelve pigs received lung ablations percutaneously (n=6) or endobronchially (n=6). Animals were followed for 3-5 days or 28 days with routine computed tomography and gross and histopathology. Results: There were no intraprocedural concerns in any of the animals, including no incidences of electrocardiogram disturbances. Gross pathology and histology confirm the onset of cell death with retained extracellular matrix integrity without clinically significant alteration of sensitive structures despite intentional device placement near (1-5 mm) these structures. There were no in-life or pathology-based safety or performance concerns and no adverse events during the treatment procedures associated with the use of Aliya System. Clinically, all the patients who received PEF tolerated the procedure well and without significant adverse sequelae. Conclusions: This PEF technology can kill cells while sparing the extracellular matrix and reducing damage to sensitive structures. This study demonstrates that the Aliya PEF may afford a safer alternative to other ablation modalities.