The short version
- A systematic review of 141 histotripsy studies, 27 of them in people, found an acceptable early safety record in selected settings.
- Across the clinical liver studies, about 6% of patients had a serious complication, most often a blood clot or kidney injury.
- Only 41 of the papers followed patients or animals for at least a week, and several authors consult for the device’s maker.
Researchers from Johns Hopkins, Mayo Clinic Florida, the NIH Clinical Center, the University of Wisconsin and Virginia Tech pulled together every in-vivo study of histotripsy, the technique that breaks up tumors with bursts of focused sound. They found 141: 114 in animals and 27 in people, 25 of those on the liver, covering at most 607 patients. The review was published in CVIR Oncology in October.
Across the clinical liver studies, serious complications (grade 3 or worse on the standard radiology scale) occurred in 6% of patients (95% CI 4–9%). Blood clots ran at about 6% and acute kidney injury at 4%. One five-center series recorded 9 kidney injuries in 146 procedures, two of them fatal. The review also lists one death from liver failure 28 days after treatment, one cancer that spread rapidly afterwards, and bowel perforations in animal work. On the other side, 14 patients in five reports saw untreated tumors shrink, though all were on other cancer drugs.
The gaps are plain. Only 41 papers followed anyone for a week or more. At least four of the authors report ties to HistoSonics, the device’s maker. “Clinical adoption should remain grounded in risk awareness and rigorous science leading to high-level evidence,” they write.
Our histotripsy feature covers the trials behind the approvals.
