Development and Validation of a Noninvasive Model for the Detection of High-Risk Varices in Patients with Unresectable HCC.

BACKGROUND & AIMS: Noninvasive variceal risk stratification systems have not been validated in patients with hepatocellular carcinoma (HCC), which presents logistical barriers for patients in the setting of systemic HCC therapy. We aimed to develop and validate a noninvasive algorithm for the prediction of varices in patients with unresectable HCC. METHODS: We performed a retrospective cohort study in 21 centers in the United States including adult patients with unresectable HCC and Child-Pugh A5-B7 cirrhosis diagnosed between 2007 and 2019. We included patients who completed an esophagogastroduodonoscopy (EGD) within 12 months of index imaging but before HCC treatment. We divided the cohort into a 70:30 training set and validation set, with the goal of maximizing negative predictive value (NPV) to avoid EGD in low-risk patients. RESULTS: We included 707 patients (median age, 64.6 years; 80.6% male; 74.0% White). Median time from HCC diagnosis to EGD was 47 (interquartile range, 114) days, with 25.0% of patients having high-risk varices. A model using clinical variables alone achieved an NPV of 86.3% in the validation cohort, whereas a model integrating clinical and imaging variables had an NPV 97.4% in validation. The clinical and imaging model would avoid EGDs in more than half of low-risk patients while misclassifying 7.7% of high-risk patients. CONCLUSIONS: A model incorporating clinical and imaging data can accurately predict the absence of high-risk varices in patients with HCC and avoid EGD in many low-risk patients before the initiation of systemic therapy, thus expediting their care and avoiding treatment delays.

Long-term outcome of uterine artery embolization of leiomyomata.

OBJECTIVE: To determine the long-term outcome from uterine artery embolization for leiomyomata. METHODS: In a prospective study, 200 consecutive patients treated with uterine embolization were each followed for 5 years. Outcome, including symptom status compared with baseline, reinterventions, menstrual status, and satisfaction were recorded. Summary statistics were used to report baseline characteristics and outcome at each interval. Predictors of subsequent interventions, failure, and satisfaction with treatment were analyzed using logistic regression and Cox proportional hazards models. Failure was defined as subsequent hysterectomy, definitive myomectomy, repeat embolization, or failure of symptom improvement at the patient's final follow-up interval. RESULTS: Of the 200 patients initially treated, 5-year follow-up was completed in 182 (91%), with 18 patients missing. At 5 years after treatment, 73% had continued symptom control, whereas 36 (20%) had failed or recurred. There had been 25 hysterectomies (13.7%), 8 myomectomies (4.4%), and 3 repeat embolizations (1.6%). Long-term failure was more likely in those not improved at 1 year (relative risk [RR] 5.73; 95% confidence interval [CI] 2.32-14.12, P < .001) and in those with baseline leiomyoma volumes greater than the median (RR 2.18; 95% CI 1.05-4.51, P = .036). After adjustment, patients in the first tertile of leiomyoma volume reduction (< or = 30.5%) were 3 times more likely to be dissatisfied with outcome compared with women in the third tertile (> or = 56.3% volume reduction) (RR 3.23; 95% CI 1 07-9.81, P = .037). CONCLUSION: Uterine embolization provides durable symptom relief for most patients, with a 25% chance of failure of symptom control or recurrence over the course of a 5-year follow-up. LEVEL OF EVIDENCE: II-3.

Spherical polyvinyl alcohol versus tris-acryl gelatin microspheres for uterine artery embolization for leiomyomas: results of a limited randomized comparative study.

PURPOSE: To compare the outcomes of uterine artery embolization (UAE) for leiomyomas with use of tris-acryl gelatin microspheres (TAGM) versus spherical polyvinyl alcohol (PVA) particles. MATERIALS AND METHODS: Patients undergoing UAE were randomly assigned to receive TAGMs or PVA. Embolization was performed in a standardized manner. Outcome data were collected at 3 months after embolization, including assessment of clinical symptoms, scores from a fibroid tumor-specific symptom and quality of life (QOL) questionnaire, and findings on contrast material-enhanced magnetic resonance (MR) imaging, including the degree of tumor infarction and volume reduction. Data were analyzed with use of t tests, the Mann-Whitney U test, and chi2 tests as appropriate. RESULTS: Thirty-six patients were treated. There were no differences in the two treatment groups at baseline. Clinical follow-up was obtained in 35 patients. Among the clinical outcome measures, QOL score improvement was greater for UAE with TAGMs compared with PVA (49.0 vs 27.9; P = .02), but no other differences were noted. Of the 25 patients in whom 3-month MR imaging follow-up was completed, those treated with TAGM were significantly more likely to have complete infarction of all leiomyomas (six patients vs one patient; P = .02), were more likely to have at least 90% tumor infarction (eight patients vs four patients; P = .03), and had a lower mean percent of residual perfused fibroid tumor tissue (9.6% vs 44.3%; P = .004) compared with patients treated with PVA. Based on these differences between the embolic agents, enrollment in this study was terminated. CONCLUSION: The use of spherical PVA particles in the manner described herein results in an unacceptably high rate of failed tumor infarction in UAE.

Polyvinyl alcohol particles and tris-acryl gelatin microspheres for uterine artery embolization for leiomyomas: results of a randomized comparative study.

PURPOSE: To determine if the type of embolic material used for uterine artery embolization (UAE) for leiomyomas has an impact on short-term recovery or the effectiveness of embolization. MATERIALS AND METHODS: One hundred patients were randomly assigned to undergo UAE with polyvinyl alcohol (PVA) particles or tris-acryl gelatin microspheres. Short-term, in-hospital medication use and pain levels were recorded. After discharge, symptom severity, temperature, and medications used were recorded daily for 1 week and symptom levels were measured for weeks 2-4. Three months after embolization, contrast material-enhanced magnetic resonance imaging examinations were evaluated blindly to determine the extent of leiomyoma infarction. Symptom and quality of life (QOL) status was determined with use of questionnaires. Analysis was completed with use of chi(2) analysis, Fisher exact tests, Student t tests, and analysis of variance as appropriate. Regression analysis was used to analyze the impact on outcome of baseline factors (other than type of embolic agent). RESULTS: No significant differences were noted at baseline between the two treatment groups. On average, there were significantly higher volumes of tris-acryl microspheres used (9.0 mL vs 3.0 mL; P =.0001), whereas microcatheter occlusion was more common with PVA (28% vs 4%, P =.001). There were no differences in pain severity, other postprocedural symptoms, or medication use between the two treatment groups. There were also no differences in the frequency of incompletely infarcted leiomyomas, degree of improvement in symptom score, patient satisfaction, or QOL. CONCLUSION: No substantive differences were detected between outcomes of embolization with PVA particles or tris-acryl gelatin microspheres.

Recovery after uterine artery embolization for leiomyomas: a detailed analysis of its duration and severity.

PURPOSE: To determine the duration and severity of recovery after uterine artery embolization (UAE) for leiomyomas. MATERIALS AND METHODS: As part of a study comparing different embolic materials used for UAE, detailed data on the severity of postprocedural recovery were gathered in 99 patients. These data included patient-controlled analgesia records, visual analogue scale (VAS) pain scores of daily peak pain levels for 7 days, medication use in the first week, and severity of constitutional symptoms experienced over the course of the first month after the procedure. The VAS scale assesses acute pain severity on a 10-cm linear scale and yields a continuous measure from 1 to 10. The constitutional symptoms were scored based on a questionnaire. The data were analyzed with use of summary statistics, and linear regression analysis was used to determine the impact of various baseline factors on the severity of recovery. RESULTS: The mean peak VAS score for the first 24 hours after UAE was 3.03 (SD, 0.26) and the mean maximum score in the first week was 4.89 (SD, 0.26). Only 11 patients had an in-hospital VAS score greater than 7, and 19 had a VAS score of greater than 7 on any of the first 7 days after discharge. The mean number of oral narcotic tablets used per patient was 10.8 in the first week. Although 33 patients had a temperature higher than normal sometime in the first postprocedural week, high temperature (>38.5 degrees C) occurred in only two patients. There were no differences detected in the measured parameters based on the type of embolic material used. CONCLUSION: Despite the reputation of UAE to the contrary, when current techniques are used, recovery after UAE for fibroids is relatively mild, with few instances of severe pain, high fever, or severe constitutional symptoms.