Understanding histotripsy ablation safety: a systematic review of pre-clinical and clinical adverse events

Abstract Histotripsy is the first cavitation-based ablation modality. Given limited clinical experience, synthesis of pre-clinical and early clinical data is essential to guide safe adoption. A PubMed and SCOPUS search was performed focused on pre-clinical and clinical adverse events (AEs) from Histotripsy ablation of parenchymal tissues in vivo (n = 141 total studies, n = 27 clinical reports). Early data suggest an acceptable acute safety profile in select settings; however, reports of serious AEs including pre-clinical bowel perforations, clinical acute kidney injuries, clinical vascular injuries and thromboses, and a clinical case report of hyperprogression raise caution. These highlight the need for proper technique, understanding of mechanism nuances, and longer-term follow-up to assess effects. Recognition of mechanism-specific AEs provides a framework to guide future assessments and safer adoption of Histotripsy. Level of Evidence No level of evidence (review).