Cost Effectiveness of Splenic Artery Embolization versus Splenectomy after Trauma in the Netherlands.

PURPOSE: To demonstrate that splenic artery embolization (SAE) is more cost-effective than splenectomy from a societal perspective in the Netherlands. MATERIALS AND METHODS: Patient-level data obtained from the SPLENIQ study were used to populate a health economic model and were supplemented with expert opinion when necessary. Propensity score matching was used to correct for baseline differences in injury severity scores. The health economic model consisted of 3 health states (complications after intervention, SAE failure, and recovery) and a dead state. Model outcomes were incremental quality-adjusted life years (QALYs) and incremental costs of SAE over splenectomy. The Dutch health economic guidelines were followed. The model used a lifetime time horizon. Uncertainty was assessed using probabilistic sensitivity analysis and scenario analyses. RESULTS: Patients undergoing SAE had a higher life expectancy than patients undergoing splenectomy. Incremental QALYs were 3.1 (mostly explained by difference in life expectancy), and incremental costs were €34,135 (explained by costs related to medical consumption and lost productivity in additional life years), leading to an incremental cost-effectiveness ratio of €11,010 per QALY. SAE was considered cost-effective in >95% of iterations using a threshold of €20,000 per QALY. CONCLUSIONS: SAE results in more QALYs than splenectomy. Intervention costs for SAE are lower than that for splenectomy, but medical consumption and productivity costs in later years are higher for SAE due to better survival. SAE was found to be cost-effective compared with splenectomy under appropriate Dutch cost-effectiveness thresholds.

Uterine Artery Embolization for Symptomatic Adenomyosis: Proceedings from a Society of Interventional Radiology Foundation Research Consensus Panel.

Adenomyosis poses an important diagnostic and therapeutic challenge in women's health because of a variety of clinical/imaging presentations and frequent coexistence with other benign gynecologic conditions. In recent years, uterine artery embolization (UAE) for the treatment of adenomyosis has shown encouraging and favorable outcomes and long-term symptom improvement. To expand the current understanding of adenomyosis pathophysiology, imaging diagnostic criteria, and treatment outcomes, the Society of Interventional Radiology Foundation gathered a multidisciplinary Research Consensus Panel with experts from diverse backgrounds. The topics addressed were centered around the following: (i) the clinical presentation and imaging findings to diagnose adenomyosis; (ii) the currently available medical, interventional, and surgical treatment options; and (iii) existing literature for and experiences with UAE in symptomatic disease. The panel acknowledged that before the pursuit of a clinical trial, it would be necessary to first evaluate the imaging criteria for adenomyosis and correlate them with pathology and symptoms to establish a noninvasive imaging classification system. Second priority was given to the development of a quality of life questionnaire to assess patient outcomes following treatment. The third priority was the performance of a prospective clinical trial comparing UAE with medical therapy, which would help establish UAE in the treatment algorithm and societal guidelines for symptomatic adenomyosis.

Uterine Artery Embolization for the Treatment of Adenomyosis: A Systematic Review and Meta-Analysis.

The effect of uterine artery embolization (UAE) on symptomatic adenomyosis was evaluated in a systematic review and meta-analysis. Four groups were evaluated: short-term (< 12 months) pure adenomyosis, short-term adenomyosis with fibroids (combined adenomyosis), long-term (> 12 months) pure adenomyosis, and long-term combined adenomyosis. Improvement of symptoms occurred in 83.1% (872/1,049) of patients. Reported symptom reduction was 4.8% greater in the short-term combined group (P = .169) and 11.4% greater in the long-term combined group (P = .003). Uterine volume was reduced in all patients at 3 months. The effects of UAE on symptom improvement and uterine volume reduction in patients with adenomyosis are encouraging.

Volumetric MR-guided high-intensity focused ultrasound versus uterine artery embolisation for treatment of symptomatic uterine fibroids: comparison of symptom improvement and reintervention rates.

PURPOSE: To compare the effectiveness of magnetic resonance-guided high-intensity focused ultrasound (MR-HIFU) with that of uterine artery embolisation (UAE) for treatment of uterine fibroids. METHODS: Between January 2010 and January 2013, 51 women with symptomatic uterine fibroids underwent MR-HIFU. Follow-up and MR imaging were compared to 68 women treated with UAE, who fulfilled eligibility criteria for MR-HIFU - e.g., size (≤ 12 cm) and number (≤ 5) of fibroids. We compared median symptom severity (tSSS), total health-realted quality of life (HRQoL) scores, and reintervention rates. The adjusted effect on symptom relief and HRQoL improvement was calculated using multivariable linear regression. Cox regression was applied to calculate the adjusted risk of reintervention between both treatments. RESULTS: Median tSSS improved significantly from baseline to three-month follow-up (P < 0.001) for both MR-HIFU (53.1 (IQR [40.6-68.8]) to 34.4 (IQR [21.9-46.9]) and UAE (65.3 (IQR [56.3-74.2]) to 21.9 (IQR [9.4-34.4]). In addition, significantly better HRQoL scores were observed after three months (P < 0.001). However, in multivariate analysis, UAE had a stronger effect on symptom relief and HRQoL improvement than MR-HIFU (P < 0.001). Patients treated with MR-HIFU had a 7.1 (95 % CI [2.00-25.3]; P = 0.002) times higher risk of reintervention within 12 months (18/51 vs. 3/68). CONCLUSION: Both MR-HIFU and UAE result in significant symptom relief related to uterine fibroids. However, MR-HIFU is associated with a higher risk of reintervention. KEY POINTS: • This study compared outcomes between volumetric MR-HIFU and UAE for uterine fibroids. • Both MR-HIFU and UAE result in significant symptom relief and quality of life improvement. • UAE had a stronger positive effect on the clinical outcomes. • Reintervention rate after MR-HIFU ablation was significantly higher than after UAE.

Mid-term clinical efficacy of a volumetric magnetic resonance-guided high-intensity focused ultrasound technique for treatment of symptomatic uterine fibroids.

OBJECTIVE: To assess the mid-term efficacy of magnetic resonance-guided high-intensity focused ultrasound (MR-HIFU) using a volumetric ablation technique for treating uterine fibroids. METHODS: Forty-six premenopausal women with 58 symptomatic uterine fibroids were prospectively included for MR-HIFU. After treatment, CE-MRI allowed measurement of the non-perfused volume (NPV) ratio, defined as the non-enhancing part of the fibroid divided by fibroid volume. Clinical symptoms and fibroid size on T2W-MRI were quantified at 3 and 6 months' follow-up. The primary endpoint was a clinically relevant improvement in the transformed Symptom Severity Score (tSSS) of the Uterine Fibroid Symptom and Quality of Life questionnaire, defined as a 10-point reduction. RESULTS: Volumetric ablation resulted in a mean NPV ratio of 0.40 ± 0.22, with a mean NPV of 141 ± 135 cm(3). Mean fibroid volume was 353 ± 269 cm(3) at baseline, which decreased to 271 ± 225 cm(3) at 6 months (P < 0.001), corresponding to a mean volume reduction of 29 % ± 20 %. Clinical follow-up showed that 54 % (25/46) of the patients reported a more than 10-point reduction in the tSSS. Mean tSSS improved from 50.9 ± 18.4 at baseline to 34.7 ± 20.2 after 6 months (P < 0.001). CONCLUSION: Volumetric MR-HIFU is effective for patients with symptomatic uterine fibroids. At 6 months, significant symptom improvement was observed in 54 % of patients. KEY POINTS: • Volumetric MR-guided high-intensity focused ultrasound is a novel ablation technique for leiomyomatosis. • We prospectively evaluated the outcome of volumetric MR-HIFU ablation for symptomatic fibroids. • This study showed that volumetric MR-HIFU results in an effective treatment. • A randomised controlled trial would set this technique in an appropriate context.

Emergency embolization of a massive life-threatening placenta percreta bleeding following delivery by Cesarean section.

The rise in the number of Cesarean sections (CS) worldwide has increased the incidence of the placenta accreta spectrum disorders in the past years. About 5% of patients undergoing a CS develop placenta percreta. A 30-year-old woman, G2P1 with previous uncomplicated CS delivery had an elective CS delivery at 37w6d. The delivery was complicated by a substantial hemorrhage. On emergency laparotomy a placenta percreta was seen in the broad ligament, which could not be removed surgically. Embolization was performed with Gelfoam particles until stasis in the right uterine artery with placement of a coil. Patient discharge was 12 days after intervention. Emergency embolization is an effective treatment in bleeding complications due to placenta percreta at partus.

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) VAS pain score at 12 months were investigated. RESULTS: 20.7% of patients in the PV group demonstrated a VAS ≥ 5 at the 12-month, compared to 40.1% in the conservative or sham group, with a significant difference (χ2(1) = 15.26, p < 0.0001, OR = 2.57, 95% CI = 1.59 to 4.15). In the subgroup analysis, we detected five predictors for the risk of high pain scores (VAS ≥ 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.

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<0·0001) at 1 month and 2·0 (1·13-2·80, p<0·0001) at 1 year. No serious complications or adverse events were reported. 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. FUNDING: ZonMw; COOK Medical.

Is an intrauterine device a contraindication for uterine artery embolization? A study of 20 patients.

The presence of an intrauterine device (IUD) has been traditionally considered a risk factor for postprocedural infection in patients undergoing uterine artery embolization (UAE). The authors retrospectively evaluated the occurrence of infectious complications following embolization in 20 women with IUDs. After a mean follow-up of 20.5 months, none of the patients developed an infectious complication. One patient required hysterectomy following embolization for persistent pain. Pathologic evaluation of the hysterectomy specimen demonstrated ischemia without evidence of inflammation. This experience suggests that the presence of an IUD might not be considered a contraindication for UAE.

Embolization of uterine leiomyomas with polyzene F-coated hydrogel microspheres: initial experience.

PURPOSE: To evaluate effectiveness and safety of Polyzene F-coated hydrogel microspheres for uterine artery embolization (UAE) in women with symptomatic uterine leiomyomas. MATERIALS AND METHODS: Between August 2006 and August 2008, 86 nonconsecutive premenopausal women (mean age, 43.9 years; median, 44 y; range, 28-54 y) were treated with UAE. Calibrated microspheres of 500, 700, and 900 µm, alone or in combination, were used as embolic agents. Change in uterine and tumor volume and tumor infarction rate during follow-up were assessed with magnetic resonance imaging. Clinical follow-up was evaluated by the Uterine Fibroid Severity and Quality Of Life (UFS-QOL) questionnaire at baseline, 3 months, and last follow-up in November 2008. RESULTS: At 3 months, mean volume reductions of the dominant leiomyoma and uterus were 45% and 42%, respectively, and complete infarction of the dominant leiomyoma was achieved in 69 patients (80%). Complete infarction of the overall tumor burden was achieved in 52 patients (60%). Infarction rates of the dominant tumor and overall tumor burden were more than 90% in 81 patients (94%) and 79 patients (91%), respectively. During follow-up, permanent amenorrhea developed in seven women (8.1%). Four women (4.7%) had additional therapy after UAE; three had a hysterectomy and one had a second embolization. The UFS-QOL showed significant improvement in symptom severity and quality of life after 3 months that continued to improve at last follow-up (mean, 12.8 months). CONCLUSIONS: In this preliminary study, Polyzene F-coated hydrogel microspheres for UAE resulted in good dominant and overall tumor infarction in most patients, with corresponding improvement of symptoms. Determining optimal sizing of the material and comparing outcomes versus those of other embolic agents requires additional study.

Clinical course of pain in acute osteoporotic vertebral compression fractures.

PURPOSE: The authors prospectively determined the natural course of pain in patients with conservatively treated acute osteoporotic vertebral compression fractures (VCF). In addition, the type of conservative therapy that these patients received was assessed. MATERIALS AND METHODS: Patients older than 50 years, referred for spine radiography for acute back pain, were asked to complete a baseline clinical questionnaire. Patients with an acute VCF were followed up at 6 and 23 months with a questionnaire that included a Visual Analog Score (VAS) and type of pain medication and other conservative treatment. Significant pain relief was defined as a decrease in VAS of 50% or more. RESULTS: Forty-nine patients (mean age, 78 years; range, 51-95) with acute VCF were followed up for almost 2 years. Significant pain relief was noted in 22 of 35 patients (63%) at 6 months and in 25 of 36 (69%) at 23 months. In patients with persisting pain at 23 months (mean VAS 6.4), some decrease in VAS was apparent at 6 months but not in the 6-23 months interval. No predictors for significant pain relief could be identified. Patients with significant pain relief used less pain medication and had less physical therapy. CONCLUSIONS: In most patients with an acute VCF, pain decreases significantly with conservative therapy, predominantly in the first 6 months. However, almost 2 years after an acute VCF, a third of patients still had severe pain necessitating pain medication and physical therapy in the majority. No predictors for transition from acute to chronic pain could be identified.

The evidentiary basis of vertebral augmentation: a 2019 update.

No aspect of neurointerventional practice has been associated with as longstanding contention and debate as to its effectiveness as has vertebroplasty (VP). Four blinded randomized controlled trials published since 2009 have demonstrated conflicting results regarding a conferred benefit in pain reduction and functional improvement for patients who undergo VP for osteoporotic vertebral compression fractures. Significant heterogeneity exists between each of these trials, which has resulted in difficulty for interventionalists and surgeons to translate the trial findings into routine clinical practice. In addition, patients and their families are ever more enlightened and enabled via the internet and social media to review both medical literature and websites. Without the proper background and context, their decisions may be lacking appropriate and necessary scientific discussion. This review article summarizes the randomized controlled trial data to date, with particular focus on the aforementioned four blinded studies. We will also evaluate the profound impact of the decrease in vertebral augmentation utilization on short- and long-term patient morbidity and mortality using available national and administrative datasets from both within the USA and internationally. We also consider future trial design to help evaluate this procedure and determine its role in modern neurointerventional practice.

Safety and effectiveness of uterine artery embolization in patients with pedunculated fibroids.

PURPOSE: To assess complications and outcomes of uterine artery embolization (UAE) in women with pedunculated fibroids in a large single-center patient cohort. MATERIALS AND METHODS: From a database with prospectively collected data from 716 women treated with UAE between 1996 and 2008, 29 women were identified with 31 pedunculated fibroids. Magnetic resonance images obtained before and 3 months after UAE were used to calculate stalk diameter change and volume reduction of both the pedunculated fibroid and uterus. Two observers assessed the overall percentage infarction and infarction of pedunculated fibroid. Complications were recorded and long-term clinical follow-up (mean, 33 months; range, 10-78 months) assessed with use of a questionnaire. RESULTS: The mean reduction in uterine and pedunculated fibroid volume was 37% and 33%, respectively. The mean reduction in stalk diameter was 0.3 cm (95% confidence interval [CI]: 0.18, 0.52 cm) or 13% from initial mean diameter. Stalk enhancement was not affected by UAE. The mean pedunculated fibroid infarction and mean overall infarction rates were 87% and 92%, respectively, for observer 1 and 88% and 92% for observer 2, with good interobserver variability. All women returned the questionnaire and no early or late complications of UAE were reported (0%; 95% CI: 0.0%-13.9%). CONCLUSIONS: In this small series of pedunculated subserosal fibroids treated with UAE, no complications occurred. The findings suggest that the use of UAE to treat pedunculated subserosal fibroids may be safe and effective.

Uterine artery embolisation in women with symptomatic adenomyosis.

Adenomyosis is frequently called the "forgotten" diagnosis, because of its non-characteristic clinical appearance. Similar to fibroid symptoms, adenomyosis may be the cause of disabling symptoms such as heavy menstrual bleeding, in particular pain (abdominal-, pelvic-, low back- and menstrual pain), with or without bulk related symptoms and fertility issues in premenopausal women. The current literature demonstrates durable symptom improvement in patients with adenomyosis following uterine artery embolisation. It is no longer justified to withhold women the option of uterine artery embolisation for symptomatic adenomyosis with or without fibroids.

Uterine artery embolisation in women with symptomatic uterine fibroids.

The most common indication for selective uterine artery angiography is embolisation of symptomatic uterine fibroids (leiomyomas or leiomyomata). It is a safe and effective treatment with worldwide acceptance and may be considered a first-line therapy for women who are finished with childbearing and interested in a minimally invasive uterine-sparing therapy, with only few relative and absolute contraindications remaining. Women interested in pregnancy may be offered embolisation, but only after careful counselling and consideration of other possibilities and patient's reasonable expectations, needs and preferences.

Implementation of uterine artery embolization for symptomatic fibroids in the Netherlands: an inventory and preference study.

BACKGROUND AND PURPOSE: The Dutch national guideline on heavy menstrual bleeding was updated and published in 2013. It recommended (for the first time) that uterine artery embolization (UAE) should be part of counseling of women with symptomatic fibroids. We aimed to evaluate the implementation of UAE for symptomatic uterine fibroids in the Netherlands and to investigate gynecologists preference and other influential factors. METHODS: The primary outcome was to examine the UAE/hysterectomy ratio before and after introduction of the 2013 guideline by the use of annual hospital reports. The secondary outcome assessed factors that could influence implementation by means of a questionnaire to gynecologists. RESULTS: A total of 29/30 (97%) UAE+ hospitals and 36/52 (69%) UAE- hospitals sent their annual reports. The UAE/hysterectomy percentages in 2012, 2013 and 2014 were 7,0%, 7.0% and 6.9%, respectively. Regarding the questionnaire, the response rates were 88% and 91%, respectively. In both groups we observed a high self-perceived tendency for UAE counseling (90% versus 70%, p = .001). Approximately 50% of gynecologists from UAE- hospitals indicate they have insufficient information about UAE for appropriate counseling and 40% doubts the effectiveness of UAE. Furthermore, in the majority of gynecologists some 'urban myths' about the effectiveness and side-effects of UAE seem to persevere. CONCLUSION: Adding UAE as a treatment option to the national guideline did not change the number of performed UAEs for symptomatic fibroids. It might be useful to develop an option grid in order to offer appropriate, independent counseling and encourage shared decision making.

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.

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. METHODS: VERTOS IV is a prospective, multicentre, randomised controlled trial comparing PV with sham therapy in 180 patients. New OVCFs 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 protects against progressive vertebral height loss. In addition, PV does not increase the risk of new adjacent and distant OVCFs. LEVEL OF EVIDENCE: Level 1a, therapeutic study. ClinicalTrials.gov number, NCT01200277.

Vertebroplasty versus sham procedure for painful acute osteoporotic vertebral compression fractures (VERTOS IV): randomised sham controlled clinical trial.

OBJECTIVE: To assess whether percutaneous vertebroplasty results in more pain relief than a sham procedure in patients with acute osteoporotic compression fractures of the vertebral body. DESIGN: Randomised, double blind, sham controlled clinical trial. SETTING: Four community hospitals in the Netherlands, 2011-15. PARTICIPANTS: 180 participants requiring treatment for acute osteoporotic vertebral compression fractures were randomised to either vertebroplasty (n=91) or a sham procedure (n=89). INTERVENTIONS: Participants received local subcutaneous lidocaine (lignocaine) and bupivacaine at each pedicle. The vertebroplasty group also received cementation, which was simulated in the sham procedure group. MAIN OUTCOME MEASURES: Main outcome measure was mean reduction in visual analogue scale (VAS) scores at one day, one week, and one, three, six, and 12 months. Clinically significant pain relief was defined as a decrease of 1.5 points in VAS scores from baseline. Secondary outcome measures were the differences between groups for changes in the quality of life for osteoporosis and Roland-Morris disability questionnaire scores during 12 months' follow-up. RESULTS: The mean reduction in VAS score was statistically significant in the vertebroplasty and sham procedure groups at all follow-up points after the procedure compared with baseline. The mean difference in VAS scores between groups was 0.20 (95% confidence interval -0.53 to 0.94) at baseline, -0.43 (-1.17 to 0.31) at one day, -0.11 (-0.85 to 0.63) at one week, 0.41 (-0.33 to 1.15) at one month, 0.21 (-0.54 to 0.96) at three months, 0.39 (-0.37 to 1.15) at six months, and 0.45 (-0.37 to 1.24) at 12 months. These changes in VAS scores did not, however, differ statistically significantly between the groups during 12 months' follow-up. The results for secondary outcomes were not statistically significant. Use of analgesics (non-opioids, weak opioids, strong opioids) decreased statistically significantly in both groups at all time points, with no statistically significant differences between groups. Two adverse events occurred in the vertebroplasty group: one respiratory insufficiency and one vasovagal reaction. CONCLUSIONS: Percutaneous vertebroplasty did not result in statistically significantly greater pain relief than a sham procedure during 12 months' follow-up among patients with acute osteoporotic vertebral compression fractures. TRIAL REGISTRATION: ClinicalTrials.gov NCT01200277.

Uterine Artery Embolization for Symptomatic Adenomyosis: 7-Year Clinical Follow-up Using UFS-Qol Questionnaire.

PURPOSE: The purpose of this study was to assess clinical outcomes 7 years after uterine artery embolization (UAE) in the treatment of symptomatic adenomyosis. MATERIALS AND METHODS: In this prospective cohort study, one specialized hospital in the Netherlands recruited patients with symptomatic adenomyosis or adenomyosis in combination with fibroids for UAE. The 7-year post-intervention outcomes were health-related quality of life (HRQOL), symptom severity scores (SSS), satisfaction, menopause and re-interventions. RESULTS: Twenty-nine patients with adenomyosis (15 with fibroids) were treated with UAE between September 2006 and January 2010. The 7-year questionnaire was mailed in November 2016. The mean follow-up was 95 months (SD 9.0) at a mean age of 50 (SD 5.4). Questionnaires were returned by 24/29 patients (83%). The remaining five patients were contacted through telephone. One of these patients was untraceable. Seven years after treatment 5 of 28 patients (18%) underwent a secondary hysterectomy. The HRQOL and SSS scores as measured by UFS-QOL at 3 months after UAE showed significant improvement of -57 points (score: 15) and +40 points (score: 91), respectively. These scores remained comparable stable up unto 7 years. The SSS showed a significant difference of 17 points (0-100) in favor of the adenomyosis in combination with fibroids group (p = 0.020). Menopause was reported by 10/28 patients (36%). Twenty-one of 29 (72%) patients declared to be at least fairly satisfied about UAE. CONCLUSIONS: After 7 years of follow-up, in 82% of UAE-treated patients with symptomatic adenomyosis a hysterectomy was avoided.