Diagnostic accuracy of supplemental three-dimensional breast ultrasound in the work-up of BI-RADS 0 screening recalls

Objective: To evaluate the diagnostic accuracy of supplemental 3D automated breast ultrasound (ABUS) in the diagnostic work-up of BI-RADS 0 recalls. We hypothesized that 3D ABUS may reduce the benign biopsy rate. Materials and methods: In this prospective multicenter diagnostic study, screening participants recalled after a BI-RADS 0 result underwent bilateral 3D ABUS supplemental to usual care: digital breast tomosynthesis (DBT) and targeted hand-held ultrasound (HHUS). Sensitivity, specificity, positive predictive value, and negative predictive value of 3D ABUS, and DBT plus HHUS, were calculated. New 3D ABUS findings and changes of management (biopsy or additional imaging) were recorded. Results: A total of 501 women (median age 55 years, IQR [51–64]) with 525 BI-RADS 0 lesions were included between April 2018 and March 2020. Cancer was diagnosed in 45 patients. 3D ABUS sensitivity was 72.1% (95% CI [57.2–83.4%]), specificity 84.4% (95% CI [80.8–87.4%]), PPV 29.2% (95% CI [21.4–38.5%]), and NPV 97.1% 95.0–98.4%). Sensitivity of DBT plus HHUS was 100% (95% CI [90.2–100%]), specificity 71.4% (95% CI [67.2–75.2%]), PPV 23.8% (95% CI [18.1–30.5%]) and NPV 100% (95% CI [98.7–100%]). Twelve out of 43 (27.9%) malignancies in BI-RADS 0 lesions were missed on 3D ABUS, despite being detected on DBT and/or HHUS. Supplemental 3D ABUS resulted in the detection of 57 new lesions and six extra biopsy procedures, all were benign. Conclusion: 3D ABUS in the diagnostic work-up of BI-RADS 0 recalls may miss over a quarter of cancers detected with HHUS and/or DBT and should not be used to omit biopsy. Supplemental 3D ABUS increases the benign biopsy rate. Trial registration: Dutch Trial Register, available via https://www.onderzoekmetmensen.nl/en/trial/29659 Critical relevance statement: Supplemental 3D automated breast ultrasound in the work-up of BI-RADS 0 recalls may miss over a quarter of cancers detected with other methods and should not be used to omit biopsy; ABUS findings did increase benign biopsy rate. Key Points: Automated breast ultrasound (ABUS) may miss over 25% of cancers detectable by alternative methods. Don’t rely solely on 3D ABUS to assess indication for biopsy. New findings with supplemental 3D ABUS increase the benign biopsy rate. Graphical Abstract: (Figure presented.

Predictive factors for sustained pain after (sub)acute osteoporotic vertebral fractures:Combined results from the VERTOS II and VERTOS IV trial

PURPOSE: Osteoporotic vertebral compression fractures are treated conservatively or in selected cases with percutaneous vertebroplasty (PV). The purpose of this retrospective analysis is to determine predictive factors for a high visual analogue scale (VAS) pain score after conservative, sham or PV and is based on previously published randomized trials. METHODS: The VERTOS II compared conservative versus PV, and VERTOS IV compared sham versus PV treatment. The conservative group received pain medication. The sham and PV group received subcutaneous lidocaine/bupivacaine. In addition, the PV group received cementation, which was simulated in the sham group. Nineteen different predictors of high (≥ 5) versus low ( 8, long-term baseline pain, mild/severe Genant and new fractures. CONCLUSIONS: Statistically significant more patients had a high pain score at 12 months in the sham and conservative group when compared with the PV group. Five predictors were identified for sustained high local back pain, regardless of the received treatment. Patients with moderate fracture deformity were less likely to have high pain scores at 12 months if they received PV than if they had sham or conservative therapy. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s00270-022-03170-7

Vertebroplasty versus active control intervention for chronic osteoporotic vertebral compression fractures:The VERTOS V randomized controlled trial

Background Evidence regarding percutaneous vertebroplasty (PV) for chronic painful osteoporotic vertebral compression fractures (OVCFs) remains limited. Purpose To compare pain relief, quality of life, and disability between PV and active control (anesthetic infiltration) interventions for chronic OVCF. Materials and Methods This prospective randomized clinical trial was conducted between May 2013 and June 2019 in participants with pain due to OVCF lasting longer than 3 months with bone marrow edema present at MRI. Study participants were randomly assigned to undergo PV ( n = 40) or active control intervention ( n = 40). The primary outcome was pain severity, assessed with the visual analog scale (VAS) (range, 0-10) during 12 months after treatment. Secondary outcomes included Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO) score (range, 0-100) and Roland Morris Disability Questionnaire (RMDQ) score (range, 0-100). Outcomes were analyzed according to a longitudinal multilevel model used to test the difference between groups in change from baseline across follow-up. Results The mean age of the 80 participants (54 women) was 69 years ± 10 (SD) in the PV group and 71 years ± 10 in the active control group. VAS score was 7.6 (95% CI: 7.0, 8.2) in the PV group and 7.3 (95% CI: 6.9, 7.8) in the active control group at baseline ( P = .47) and 3.9 (95% CI: 3.1, 4.8) and 5.1 (95% CI: 4.3, 6.0), respectively, at month 12 ( P = .045). At month 12, the group difference from baseline was 1.3 (95% CI: 0.1, 2.6; P = .02) for VAS, 5.2 (95% CI: 0.9, 9.4; P = .02) for QUALEFFO, and 7.1 (95% CI: -3.3, 17.5; P = .18) for RMDQ, favoring the PV group. Conclusion In the treatment of pain caused by chronic OVCFs, PV is more effective for pain relief and quality of life improvement than anesthetic injection alone, with similar improvement for disability between the groups. </p

Uterine Artery Embolization in Women with Symptomatic Cervical Leiomyomata: Efficacy and Safety

Purpose: To perform an evaluation on safety and efficacy of uterine artery embolization (UAE) in the patients with symptomatic cervical leiomyomata. Methods: Patients with symptomatic cervical leiomyomata who underwent UAE in one specialized hospital were retrospectively analyzed, both clinically and with MR imaging. The 3-month outcomes were assessed with MR imaging and a validated questionnaire. Long-term follow-up was assessed by direct contact or file review. To determine the efficacy of UAE for cervical leiomyomata, the primary objective was to assess the clinical outcome with the UFS-QOL questionnaire, containing the health-related quality of life (HRQOL) and symptom severity score (SSS). To assess safety, the secondary objective included leiomyomata volume reduction, the infarction/complication rate and secondary interventions were needed. Results: Between 2006 and 2017, eight of 1180 patients underwent UAE and were eligible for inclusion. All embolizations were technically successful (n = 8). At 3 months, all patients showed cervical leiomyomata volume reduction with a median reduction of 41.5% (38.8 cm3) compared to baseline (p = 0.012). No complications occurred. At a median follow-up of 3 months (range 1–7, n = 7), the HRQOL and SSS improved with a median difference of 13 points (range − 5 to 60, p = 0.063) and − 13 points (range − 79 to 3, p = 0.046), respectively. Long-term follow-up showed two secondary interventions (median of 43.5 months). Six patients reported no symptom recurrence. Conclusion: UAE in women with symptomatic cervical leiomyomata is effective and safe with significant improvement in symptoms and quality of life. UAE is a valuable option for women seeking a non-surgical solution

Predictive factors for sustained pain after (sub)acute osteoporotic vertebral fractures: Combined results from the VERTOS II and VERTOS IV trial

Purpose Osteoporotic vertebral compression fractures are treated conservatively or in selected cases with percutaneous vertebroplasty (PV). The purpose of this retrospective analysis is to determine predictive factors for a high visual analogue scale (VAS) pain score after conservative, sham or PV and is based on previously published randomized trials. Methods The VERTOS II compared conservative versus PV, and VERTOS IV compared sham versus PV treatment. The conservative group received pain medication. The sham and PV group received subcutaneous lidocaine/bupivacaine. In addition, the PV group received cementation, which was simulated in the sham group. Nineteen different predictors of high (>= 5) versus low (= 5 at the 12-month, compared to 40.1% in the conservative or sham group, with a significant difference (chi(2)(1) = 15.26, p = 5 after 12 months follow-up), namely: female, baseline VAS > 8, long-term baseline pain, mild/severe Genant and new fractures. Conclusions Statistically significant more patients had a high pain score at 12 months in the sham and conservative group when compared with the PV group. Five predictors were identified for sustained high local back pain, regardless of the received treatment. Patients with moderate fracture deformity were less likely to have high pain scores at 12 months if they received PV than if they had sham or conservative therapy

Percutaneous vertebroplasty is no risk factor for new vertebral fractures and protects against further height loss (VERTOS IV)

Background: Percutaneous vertebroplasty (PV) is an alternative option to treat pain after an osteoporotic vertebral compression fracture (OVCF). Controversy exists as to whether PV increases the risk of new OVCFs or prevents further vertebral height loss in treated levels. We assessed both during 1-year follow-up in patients with acute OVCF randomised to PV or a sham procedure. Mehods: VERTOS IV is a prospective, multicentre, randomised controlled trial comparing PV with sham therapy in 180 patients. NewOVCFs and further vertebral height loss were assessed at 3, 6, and 12 months. Results: After a median follow-up of 12 months (interquartile range (IQR) = 12-12) 31 new fractures were reported in 15 patients from the PV group and 28 new fractures in 19 patients from the sham group. The occurrence of new vertebral fractures did not significantly differ between the groups (χ2(1) = 0.83, p = 0.36, OR = .71, 95%CI = 0.33-1.50). There was no higher fracture risk of adjacent versus distant vertebrae. After sham procedure, further height loss of treated vertebrae occurred more frequently (7 patients (8%) in the PV group and 39 (45%) in the sham group (χ2(1) = 28.85, p < 0.001, OR = 9.84, 95%CI = 4.08-23.73)) and was more severe (p < .001) than after PV. Conclusions: The risk of further vertebral height loss is significantly lower after PV compared to a sham intervention, i.e. PV protectsagainst progressive vertebral height loss. In addition, PV does not increase the risk of new adjacent and distant OVCFs

Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open-label randomised trial

Background Percutaneous vertebroplasty is increasingly used for treatment of pain in patients with osteoporotic vertebral compression fractures, but the efficacy, cost-effectiveness, and safety of the procedure remain uncertain. We aimed to clarify whether vertebroplasty has additional value compared with optimum pain treatment in patients with acute vertebral fractures. Methods Patients were recruited to this open-label prospective randomised trial from the radiology departments of six hospitals in the Netherlands and Belgium. Patients were aged 50 years or older, had vertebral compression fractures on spine radiograph (minimum 15% height loss; level of fracture at Th5 or lower; bone oedema on MRI), with back pain for 6 weeks or less, and a visual analogue scale (VAS) score of 5 or more. Patients were randomly allocated to percutaneous vertebroplasty or conservative treatment by computer-generated randomisation codes with a block size of six. Masking was not possible for participants, physicians, and outcome assessors. The primary outcome was pain relief at 1 month and 1 year as measured by VAS score. Analysis was by intention to treat. This study is registered at ClinicalTrials.gov, number NCT00232466. Findings Between Oct 1,2005, and June 30,2008, we identified 431 patients who were eligible for randomisation. 229 (53%) patients had spontaneous pain relief during assessment, and 202 patients with persistent pain were randomly allocated to treatment (101 vertebroplasty, 101 conservative treatment). Vertebroplasty resulted in greater pain relief than did conservative treatment; difference in mean VAS score between baseline and 1 month was -5.2 (95% CI -5.88 to -4.72) after vertebroplasty and -2.7 (-3.22 to -1.98) after conservative treatment, and between baseline and 1 year was -5.7 (-6.22 to -4.98) after vertebroplasty and -3-7 (-4.35 to -3.05) after conservative treatment. The difference between groups in reduction of mean VAS score from baseline was 2.6 (95% CI 1.74-3.37, p Interpretation In a subgroup of patients with acute osteoporotic vertebral compression fractures and persistent pain, percutaneous vertebroplasty is effective and safe. Pain relief after vertebroplasty is immediate, is sustained for at least a year, and is significantly greater than that achieved with conservative treatment, at an acceptable cost