The #HOPE4LIVER Single-Arm Pivotal Trial for Histotripsy of Primary and Metastatic Liver Tumors.

Background Histotripsy is a nonthermal, nonionizing, noninvasive, focused US technique that relies on cavitation for mechanical tissue breakdown at the focal point. Preclinical data have shown its safety and technical success in the ablation of liver tumors. Purpose To evaluate the safety and technical success of histotripsy in destroying primary or metastatic liver tumors. Materials and Methods The parallel United States and European Union and England #HOPE4LIVER trials were prospective, multicenter, single-arm studies. Eligible patients were recruited at 14 sites in Europe and the United States from January 2021 to July 2022. Up to three tumors smaller than 3 cm in size could be treated. CT or MRI and clinic visits were performed at 1 week or less preprocedure, at index-procedure, 36 hours or less postprocedure, and 30 days postprocedure. There were co-primary end points of technical success of tumor treatment and absence of procedure-related major complications within 30 days, with performance goals of greater than 70% and less than 25%, respectively. A two-sided 95% Wilson score CI was derived for each end point. Results Forty-four participants (21 from the United States, 23 from the European Union or England; 22 female participants, 22 male participants; mean age, 64 years ± 12 [SD]) with 49 tumors were enrolled and treated. Eighteen participants (41%) had hepatocellular carcinoma and 26 (59%) had non-hepatocellular carcinoma liver metastases. The maximum pretreatment tumor diameter was 1.5 cm ± 0.6 and the maximum post-histotripsy treatment zone diameter was 3.6 cm ± 1.4. Technical success was observed in 42 of 44 treated tumors (95%; 95% CI: 84, 100) and procedure-related major complications were reported in three of 44 participants (7%; 95% CI: 2, 18), both meeting the performance goal. Conclusion The #HOPE4LIVER trials met the co-primary end-point performance goals for technical success and the absence of procedure-related major complications, supporting early clinical adoption. Clinical trial registration nos. NCT04572633, NCT04573881 Published under a CC BY 4.0 license. Supplemental material is available for this article. See also the editorial by Nezami and Georgiades in this issue.

Embolized Watchman Removal With Modified Hangman Technique.

In this case report, we explore a novel technique to remove an embolized Watchman device (Boston Scientific) into the thoracic aorta endovascularly. The technique involves a wire + snare combination that is threaded through the metal struts of the Watchman. This combination technique along with the threading provides increased stability during removal and decreases the risk of the Watchman slipping from the devices and causing further embolization. Further work is required to elucidate the efficacy of this technique in other scenarios.

Multicenter Quantification of Radiation Exposure and Associated Risks for Prostatic Artery Embolization in 1476 Patients.

Background Prostatic artery embolization (PAE) is a safe, minimally invasive angiographic procedure that effectively treats benign prostatic hyperplasia; however, PAE-related patient radiation exposure and associated risks are not completely understood. Purpose To quantify radiation dose and assess radiation-related adverse events in patients who underwent PAE at multiple centers. Materials and Methods This retrospective study included patients undergoing PAE for any indication performed by experienced operators at 10 high-volume international centers from January 2014 to May 2021. Patient characteristics, procedural and radiation dose data, and radiation-related adverse events were collected. Procedural radiation effective doses were calculated by multiplying kerma-area product values by an established conversion factor for abdominopelvic fluoroscopy-guided procedures. Relationships between cumulative air kerma (CAK) or effective dose and patient body mass index (BMI), fluoroscopy time, or radiation field area were assessed with linear regression. Differences in radiation dose stemming from radiopaque prostheses or fluoroscopy unit type were assessed using two-sample t tests and Wilcoxon rank sum tests. Results A total of 1476 patients (mean age, 69.9 years ± 9.0 [SD]) were included, of whom 1345 (91.1%) and 131 (8.9%) underwent the procedure with fixed interventional or mobile fluoroscopy units, respectively. Median procedure effective dose was 17.8 mSv for fixed interventional units and 12.3 mSv for mobile units. CAK and effective dose both correlated positively with BMI (R2 = 0.15 and 0.17; P < .001) and fluoroscopy time (R2 = 0.16 and 0.08; P < .001). No radiation-related 90-day adverse events were reported. Patients with radiopaque implants versus those without implants had higher median CAK (1452 mGy [range, 900-2685 mGy] vs 1177 mGy [range, 700-1959 mGy], respectively; P = .01). Median effective dose was lower for mobile than for fixed interventional systems (12.3 mSv [range, 8.5-22.0 mSv] vs 20.4 mSv [range, 13.8-30.6 mSv], respectively; P < .001). Conclusion Patients who underwent PAE performed with fixed interventional or mobile fluoroscopy units were exposed to a median effective radiation dose of 17.8 mSv or 12.3 mSv, respectively. No radiation-related adverse events at 90 days were reported. © RSNA, 2024 See also the editorial by Mahesh in this issue.

Partial splenic embolization treats recurrent left pleural effusions in a patient with portal venous system thrombosis.

A 56-year-old female with thrombocythemia complicated by portal venous system thrombosis presented with recurrent left pleural effusions after failed recanalization via mechanical thrombectomy and stenting at an outside center. With no other cause, splenic vein thrombosis and left-sided portal hypertension was suggested as a possible etiology. Partial splenic embolization was performed with immediate decrease in effusions and resolution by 8 weeks. Portal and splenic venous system thrombosis may cause recurrent pleural effusions from left-sided portal hypertension and fluid leakage across diaphragmatic defects. Upper pole partial splenic embolization may treat recurrent left pleural effusions and offer an alternative to splenectomy.

Development of Research Agenda in Prostate Artery Embolization: Summary of Society of Interventional Radiology Consensus Panel.

PURPOSE: To summarize the Society of Interventional Radiology Foundation's Research Consensus Panel development of a research agenda on prostate artery embolization (PAE). MATERIALS AND METHODS: PAE for the treatment of lower urinary tract symptoms has been shown to be safe and effective in decreasing symptoms and prostate size. Lack of randomized controlled trials (RCTs) on PAE in the United States has prevented inclusion in American Urologic Association guideline recommendations for treatment of lower urinary tract symptoms resulting from benign prostatic hyperplasia. Recognizing the need for well-designed trials, the SIR Foundation funded a Research Consensus Panel to prioritize a research agenda. The panel included interventional radiologists, urologists, SIR Foundation leadership, and industry representatives. The goal of the meeting was to discuss weaknesses with current data and study design for development of US trials to report long-term outcomes data. RESULTS: Final consensus on a research design could not be made because the group was split on 3 research designs: (i) RCT of PAE versus sham with crossover of the sham group. (ii) RCT of PAE versus simple prostatectomy. (iii) RCT of PAE versus holmium laser enucleation of the prostate/thulium laser enucleation of the prostate. The panel recommended a nonindustry-funded registry to obtain real-world data. CONCLUSIONS: Level 1 data are required to be included in the American Urologic Association guidelines for treatment of benign prostatic hyperplasia. Because of concerns with all 3 study designs, the panel did not reach a consensus. Further meetings are planned with the panel to select among these research designs.

Radiologic versus Endoscopic Placement of Gastrostomy Tube: Comparison of Indications and Outcomes at a Tertiary Referral Center.

OBJECTIVES: Percutaneous gastrostomy tube placement is performed in patients requiring long-term enteral nutrition. Although both endoscopic and fluoroscopic techniques may be used, there are inherent risks and potential complications associated with both procedures that are not generally known to referring physicians. The purpose of this study was to compare and contrast indications for placement and procedurally related complications between fluoroscopic and endoscopic gastrostomy tubes techniques at a tertiary care facility. METHODS: A retrospective cohort study was performed. All consecutive patients with either percutaneous endoscopic (PEG) or percutaneous radiologic (PRG) gastrostomy tube placement between October 2011 and January 2013 were eligible for inclusion. Basic demographic information, American Society of Anesthesiologists score, procedure indication, laboratory data, and use of anticoagulation were recorded. Both direct and indirect procedural complications were documented if they occurred 30 days after gastrostomy tube placement, and were classified and scored based on severity and need for further intervention. RESULTS: A total of 297 patients met the inclusion criteria, 150 of whom had gastrostomy tubes placed fluoroscopically and 147 of whom had them placed endoscopically. There was no statistically significant difference in direct complications within the first 30 days (PEG 6.8% vs PRG 8%); however, the type of complication observed varied between the two groups. Although superficial wound infections and buried bumpers were more common in the PEG group, bleeding was more common in the PRG group. CONCLUSIONS: Placement of gastrostomy tubes either endoscopically or fluoroscopically is relatively safe with similar indications. Although the complication rate between the two groups was not significant, the types of procedural complications observed did vary.