.jpg)
SIR 2025
Interventional Oncology
Scientific Session
Emily A. Knott
Student
Cleveland Clinic Lerner College of Medicine, United States
Chase J. Wehrle, MD
Resident
Cleveland Clinic, United States
Kevin Burns, MD
Staff
Mission Hospital, United States
Evan Ong, MD, MS
Staff
Swedish Health, United States
Allison Couillard, MD
Resident
University of Wisconsin Hospitals and Clinics, United States
Neehar Parikh, MD, MS
Assistant Professor
University of Michigan, United States
Elaine Caoili, MD
Professor
University of Michigan, United States
JaeKeun Kim, MD
Staff
Cleveland Clinic, United States
Frederico Aucejo, MD
Staff
Cleveland Clinic, United States
Andrea Schlegel, MD, MBA
Staff
Cleveland Clinic, United States
Paul F. Laeseke, MD, PhD
Assistant Professor
University of Wisconsin, United States
J. Philip Boudreaux, MD
Professor
Louisiana State University Health System, United States
Phillip von Breitenbuch, MD
Physician
Sheik Tahnoon Medical City, United Arab Emirates
Mikhail Silk, MD
Assistant Attending
Memorial Sloan Kettering Cancer Center, United States
Mohamed Alassas, MD
Staff
Swedish Health, United States
Andrew Guzowski, MD
Staff
Advent Health Cancer Institute, United States
Brian Fuller, BA, MBA
X
Mission Hospital, United States
Erica M. Knavel Koepsel, MD (she/her/hers)
Associate Professor
University of Wisconsin, United States
D. Brock Hewitt, MD, MPH
Assistant Professor
NYU Langone Health, United States
Mishal Mendiratta-Lala, MD
Professor of Radiology
University of Michigan, United States
David CH Kwon, MD
Staff
Cleveland Clinic, United States
Histotripsy is a novel non-invasive, non-ionizing, non-thermal treatment modality that uses focused ultrasound to treat liver tumors {1}. The technology received FDA de novo approval in late 2023 and is now being used worldwide. The purpose of this study was to report short-term safety data from the majority of the centers performing histotripsy internationally.
Materials and Methods:
This was a cross-sectional study of nine medical centers performing histotripsy (Edison System, HistoSonics) of the liver. Short-term safety data within 30 days of treatment was collected from each center between 12/22/23 and 7/26/24. Complications requiring treatment were graded using Clavien-Dindo & Comprehensive Complications Index (CCI) and the National Cancer Institute Common Terminology Criteria for Adverse Events {2,3}. Histotripsy was used to treat 295 patients and 510 tumors at 18 centers. The liver tumors included colorectal (n=140), neuroendocrine (n=46), pancreatic (n=30), and breast metastasis (n=26) and hepatocellular carcinoma (n=31), located in all 8 segments. The most common number of tumors treated per procedure was 1 (n=170), 2 (n=69), and 3 (n=37). Safety data was available for 230 patients from 9 centers. Twelve out of 230 patients (5.2%) experienced complications (Table). Most of the complications were minor (Clavien Grade I/II, n=9, 75%). All three major complications ( > Clavien II) were death from disease progression. All three of these patients had undergone histotripsy with palliative intent for known advanced intra- and extrahepatic disease. Median and mean CCI was 0 (IQR: 0-0) and 0 points (95% CI: 0-0.75). Six patients (2.6%) required re-admission within 30 days, one being procedure-related.
Results:
Conclusion:
This is the first report of safety outcomes on the real-world therapeutic use of histotripsy for liver tumors. Histotripsy was well tolerated with few overall complications and rare serious complications. The safety profile compares favorably with other liver-directed and surgical therapies. Long-term follow-up safety data and oncologic outcomes are being collected.