Histotripsy: Less invasive does not equal less risk

For histotripsy, as with every disruptive medical technology, the transition from carefully controlled clinical trials to clinical practice has inevitably revealed adverse events that were not apparent during premarket evaluation, says Vlasios S Sotirchos (New York, USA).^1-3 Here, he discusses how this pattern is neither unique to histotripsy nor unexpected; rather, it reflects the natural evolution of innovation as new technologies are applied to broader patient populations and increasingly complex clinical scenarios.

Histotripsy is a new technology with potentially important applications in tumour ablation. By using focused ultrasound to generate acoustic cavitation and mechanically destroy tissue without needles or thermal injury, histotripsy has generated considerable enthusi­asm among clinicians and patients alike.

Recent reports describing portal vein throm­bosis, vascular injury, and acute kidney injury should therefore be viewed within this context.^4-6 Overall, these adverse events appear relatively uncommon, and early clinical expe­rience has already suggested poten­tial mitigation strategies, including tailored anticoagulation proto­cols, careful treatment planning for centrally located tumours, and greater awareness of treatment-vol­ume thresholds. These observations also empha­sise that histotripsy should be performed within an appropriately equipped multidisciplinary environment, where intraprocedural computed tomography (CT) and interventional expertise are available to facilitate the prompt recognition and management of procedure-related complications.

The more important question is not whether adverse events occur, but how systematically the field responds to them. Large prospective regis­tries and multicentre studies will be instrumental in quantifying adverse event rates, identifying patient- and procedure-specific risk factors, and refining best practices. Equally important, future studies should move beyond procedural safety alone. Histotripsy should be evaluated using standardised oncologic endpoints that have been established for other image-guided abla­tive therapies, including local tumour progres­sion, progression-free survival, overall survival, and quality-of-life measures. Adoption of these established endpoints will facilitate meaningful comparisons with existing ablative modalities and provide the evidence needed to define the appropriate role of histotripsy within interven­tional oncology.

As enthusiasm for histotripsy grows, scien­tific rigour must keep pace with technological innovation. The next phase of clinical devel­opment should prioritise prospective studies with standardised adverse event reporting and established oncologic outcome meas­ures. By applying the same stand­ards that have guided the evolution of other technologies, the interven­tional oncology (IO) community can ensure that histotripsy realises its considerable promise while build­ing a robust evidence base that supports its long-term integration into clinical practice.

References:

1. Mendiratta-Lala M, Wiggermann P, Pech M, et al. The #HOPE­4LIVER single-arm pivotal trial for histotripsy of primary and metastatic liver tumors. Radiology. 2024;312(3):e233051.
2. Wehrle CJ, Burns K, Ong E, et al. The first international experience with histotripsy: A safety analysis of 230 cases. J Gastrointest Surg. 2025;29(4):102000.
3. Worlikar T, Caoili E, Navarro A, et al. Management and preven­tion of histotripsy-induced acute bland portal vein thrombosis in histotripsy treated liver tumors. J Vasc Interv Radiol. 2026. Article 108883. Epub ahead of print.
4. Poe LL, Kisting AL, Mendiratta-Lala M, et al. Histotripsy-induced acute kidney injury following liver tumor treatment: A prelimi­nary report of 9 cases. J Vasc Interv Radiol. 2026. Article 108882. Epub ahead of print.
5. Breuer JA, Mendiratta-Lala M, Lee FT Jr, et al. Vascular injury after histotripsy: A case series of hemorrhage and pseudoan­eurysm complications in human patients. J Vasc Interv Radiol. 2026;37(6):108576.
6. Cornelis FH, Bokhari R, Solomon SB. Public interest and aca­demic trends in percutaneous ablations: Histotripsy’s reversed innovation pathway. CVIR Oncol. 2025;1(1):14.

Vlasios S Sotirchos is an interventional radiologist at Memorial Sloan Kettering Cancer Center in New York, USA.