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.

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.

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.

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.

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.

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.

Uterine artery embolization in patients with a large fibroid burden: long-term clinical and MR follow-up.

Uterine artery embolization (UAE) in patients with a large fibroid burden is controversial. Anecdotal reports describe serious complications and limited clinical results. We report the long-term clinical and magnetic resonance (MR) results in a large series of women with a dominant fibroid of >10 cm and/or an uterine volume of >700 cm(3). Seventy-one consecutive patients (mean age, 42.5 years; median, 40 years; range, 25-52 years) with a large fibroid burden were treated by UAE between August 2000 and April 2005. Volume reduction and infarction rate of dominant fibroid and uterus were assessed by comparing the baseline and latest follow-up MRIs. Patients were clinically followed at various time intervals after UAE with standardized questionnaires. There were no serious complications of UAE. During a mean follow-up of 48 months (median, 59 months; range, 6-106 months), 10 of 71 patients (14%) had a hysterectomy. Mean volume reduction of the fibroid and uterus was 44 and 43%. Mean infarction rate of the fibroid and overall fibroid infarction rate was 86 and 87%. In the vast majority of patients there was a substantial improvement of symptoms. Clinical results were similar in patients with a dominant fibroid >10 cm and in patients with large uterine volumes by diffuse fibroid disease. In conclusion, our results indicate that the risk of serious complications after UAE in patients with a large fibroid burden is not increased. Moreover, clinical long-term results are as good as in other patients who are treated with UAE. Therefore, a large fibroid burden should not be considered a contraindication for UAE.

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.

Long-term outcome of uterine artery embolization for symptomatic uterine leiomyomas.

PURPOSE: To evaluate long-term outcomes and factors associated with treatment failure after uterine artery embolization (UAE) in women with symptomatic uterine leiomyomas. MATERIALS AND METHODS: One hundred consecutive women treated with UAE for symptomatic uterine leiomyomas participated. Clinical outcome data (ie, changes in symptoms, menstrual status, subsequent therapies) and satisfaction data were collected. Treatment failure was defined by subsequent major surgery (ie, hysterectomy or myomectomy), a second embolization, or a lack of symptom improvement at the patient's final follow-up interval. Possible predictors of failure were age, clinical baseline characteristics (ie, bleeding, pain, and bulk), and imaging results (eg, percent volume reduction of the dominant tumor). Cox proportional-hazards analysis was used to determine factors associated with failure. RESULTS: Follow-up was available in 93 women (median follow-up, 54 months; range, 45-87 y). Continued symptom relief was observed in 72% of patients (n = 67). Among the 26 women with treatment failure (28%), 11 (42%) underwent hysterectomy, four (15%) myomectomy, and eight (31%) repeat embolization. Three (12%) reported no improvement. In women without any additional surgery (n = 70), heavy menstrual bleeding, pain, and bulk-related symptoms improved in 97%, 93%, and 92%. Ninety percent of all women (n = 93) were satisfied or very satisfied at final follow-up. Predictors of failure were a lack of improvement in bleeding (hazard ratio [HR], 9.0; 95% CI, 3.1-26.3; P < .001) or pain (HR, 7.4; 95% CI, 2.2-24.4; P < .001) at 1 year after UAE and the percent reduction in dominant tumor volume (HR, 0.97; 95% CI, 0.95-0.99; P = .007). CONCLUSIONS: UAE in women with symptomatic leiomyomas leads to long-term symptom improvement. Predictors of failure were a lack of improvement in bleeding or pain at 1 year and the percent reduction in dominant tumor volume.

Uterine artery embolization for symptomatic adenomyosis with or without uterine leiomyomas with the use of calibrated tris-acryl gelatin microspheres: midterm clinical and MR imaging follow-up.

PURPOSE: To evaluate clinical and magnetic resonance (MR) imaging results after uterine artery embolization (UAE) in women with symptomatic adenomyosis with or without uterine leiomyomas. MATERIALS AND METHODS: Thirty-eight women with symptomatic adenomyosis with or without uterine leiomyomas were treated with UAE with calibrated tris-acryl gelatin microspheres. Based on MR findings, women were categorized as having pure adenomyosis (group A; n = 15), adenomyosis dominance with fibroid tumors (group B; n = 14), or fibroid tumor dominance with adenomyosis (group C; n = 9). RESULTS: Heavy menstrual bleeding, pain, and bulk-related symptoms at last follow-up at a median of 16.5 months (range, 3-38 months) were compared with baseline symptoms. With follow-up MR imaging at a median of 12 months (range, 3-36 months), changes in uterine volume, leiomyoma volume, junctional zone thickness, and contrast enhancement of adenomyosis were assessed. After embolization, adenomyosis infarction could be depicted on contrast medium-enhanced MR in 44.1% of cases. Median reductions of uterine volume, fibroid tumor volume, and junctional zone thickness were 44.8%, 77.1%, and 23.9%, respectively. In group A, three patients needed additional surgery after UAE, in addition to two in group B and one in group C. In the remaining 32 patients, except for one patient in group C, all preexisting symptoms (eg, bleeding, pain, bulk-related symptoms) improved or resolved after UAE. Overall, 84.2% of women were satisfied with the results of UAE. CONCLUSION: In this study, midterm results (at a median of 16.5 months) showed that UAE in symptomatic adenomyosis with or without uterine leiomyomas is effective. Hysterectomy was avoided in the vast majority of patients. MR imaging showed reduction of uterine volume and junctional zone thickness.

Limited uterine artery embolization for leiomyomas with tris-acryl gelatin microspheres: 1-year follow-up.

PURPOSE: To assess the safety and efficacy of uterine artery embolization (UAE) using large calibrated tris-acryl gelatin microspheres. MATERIALS AND METHODS: One hundred fifty-eight women with symptomatic uterine fibroids underwent UAE. Embosphere was used in 105 women and Embogold microspheres in 53 women. Major and minor complications were assessed. At 12 months, relief of symptoms and patient satisfaction were assessed and volume reductions of the uterus and dominant fibroid were calculated. RESULTS: Median age of the subjects was 43 years (mean, 42.3 y; range, 23-53 y). Preprocedural symptoms were heavy menstrual bleeding in 89%, pain in 64%, and bulk related symptoms in 57%. At 12 months follow-up, the proportion of women with heavy menstrual bleeding, pain, and bulk-related symptoms had decreased to 9%, 8%, and 8%, respectively. Patient satisfaction was grouped as follows: very satisfied 57%, satisfied 36%, and not satisfied 7%. Mean uterine and dominant fibroid volumes before UAE were 532 cm(3) and 201 cm(3), respectively. At 12-month follow-up MR imaging, mean uterine volume decreased to 260 cm(3) and mean dominant fibroid volume to 78 cm(3). These differences were statistically significant (P < .0001). There were no procedure-related deaths. No emergency hysterectomy was needed. Permanent amenorrhea occurred in 11% of women. Transient amenorrhea occurred in 13% of women, and fibroid expulsion occurred in 10% of women. Twelve women (7.6%) had additional therapy: nine underwent additional embolization and three had hysterectomy. CONCLUSION: Targeted UAE using large calibrated microspheres is safe and effective in the relief of symptoms in the majority of patients. At 12 months, a marked fibroid and uterine volume reduction is obtained.

Mid-term clinical results and patient satisfaction after uterine artery embolization in women with symptomatic uterine fibroids.

PURPOSE: To evaluate the mid-term clinical results and patient satisfaction following uterine artery embolization (UAE) in women with symptomatic fibroids. METHODS: Between August 1998 and December 2002, 135 patients had UAE for symptomatic uterine fibroids. All patients were asked to fill in a questionnaire. Questions were aimed at changes in bleeding, pain, and bulk-related symptoms. Symptoms after UAE were scored as disappeared, improved, unchanged or worsened. Adverse events were noted, such as vaginal dryness and discharge, menopausal complaints or fibroid expulsion. Patient satisfaction after UAE was assessed. Patient satisfaction of women embolized with polyvinyl alcohol (PVA) particles was compared with satisfaction of women embolized with calibrated microspheres. RESULTS: The questionnaire was returned by 110 of 135 women (81%) at a median time interval of 14 months following UAE. In 10 women additional embolization or hysterectomy had been performed. Of the 110 responders, 86 (78%) were satisfied with the result of UAE. The proportion of satisfied women was higher in the group embolized with calibrated microspheres than in women embolized with PVA, although this difference was not statistically significant (p = 0.053). CONCLUSION: UAE in women with symptomatic uterine fibroids leads to improvement of symptoms and patient satisfaction is good in the vast majority after a median follow-up period of 14 months.