Abstract: SA-PO1260
AKI After Hepatic Histotripsy: Insights from the FDA MAUDE Database
Session Information
- Onconephrology: Epidemiological Trends, Risk Stratification, and Clinical Outcomes
October 24, 2026 | Location: Exhibit Hall A, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Onconephrology
- 1600 Onconephrology
Authors
- Kuruvada, Krishna Mohita, Northwell Health, New Hyde Park, New York, United States
- Sakhiya, Vipulbhai, Northwell Health, New Hyde Park, New York, United States
- Wanchoo, Rimda, Northwell Health, New Hyde Park, New York, United States
- Jhaveri, Kenar D., Northwell Health, New Hyde Park, New York, United States
- Bhutta, Salman, Northwell Health, New Hyde Park, New York, United States
Background
Histotripsy is an emerging nonthermal ablation modality for liver tumors. While clinical trials report minimal renal toxicity, post-marketing surveillance may reveal underreported adverse events.
Methods
We queried the FDA Manufacturer and User Facility Device Experience (MAUDE) database for reports of renal complications following hepatic histotripsy. Cases were analyzed for demographics, treatment characteristics, severity, and outcomes.
Results
Eight cases of renal impairment following histotripsy were identified. Patients were predominantly female (age 57–79 years). Treatment volumes were frequently large (>90 cc in most reported cases). Clinical presentations included AKI with hematuria, anuria, and hemodynamic instability. Two patients required dialysis, and two deaths were reported. Several cases were complicated by hypotension, hemorrhage, or ICU admission.
In contrast, milder cases demonstrated recovery with supportive care, primarily intravenous hydration. Device malfunction was not reported in any case. (Figure)
Conclusion
MAUDE data suggest a potential association between histotripsy and AKI, particularly with larger treatment volumes. The observed spectrum ranges from reversible intrinsic injury to severe AKI requiring dialysis or resulting in death. Limitations include incomplete clinical data, reporting bias, and lack of denominator exposure.
Post-marketing data reveal a safety signal for AKI following histotripsy not captured in early trials. Larger treatment volumes may represent a risk factor. Prospective studies are needed to define incidence, mechanisms, and mitigation strategies.