Paul N.M. Lohle

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.

The risk of new osteoporotic vertebral compression fractures in the year after percutaneous vertebroplasty

PURPOSE To prospectively assess the incidence, location, and possible causative mechanisms of new vertebral compression fractures (VCFs) in 66 symptomatic patients with osteoporotic VCFs treated with percutaneous vertebroplasty (PV) and to study the relation between new VCFs and back pain symptoms. MATERIALS AND METHODS Sixty-six patients with 102 painful symptomatic VCFs were treated with PV. All patients had baseline total spinal magnetic resonance (MR) imaging. Follow-up MR imaging was performed at 3, 6, and 12 months to locate new VCFs. Visual analog scales for pain and pain medication consumption were used to assess clinical outcomes. The following characteristics were compared in patients with new VCFs after PV versus patients without new VCFs: patient age, sex, presence of secondary osteoporosis, bone mineral density, number of preexisting VCFs, shape and grade of VCFs, type of bone cement used for PV, volume of injected cement, and cement leakage in intervertebral disc spaces. RESULTS Sixteen of 66 patients had 26 new VCFs during 1 year of follow-up after PV. Most new VCFs occurred within 3 months of PV, half of new VCFs appeared in levels adjacent to treated levels, and half of the new VCFs were symptomatic. The presence of more than two preexisting VCFs was the only independent risk factor for the development of a new VCF. CONCLUSIONS New VCFs occurred after PV in 24% of patients. Half of new VCFs occurred in levels adjacent to treated levels and half were symptomatic. The presence of more than two preexisting VCFs was the only independent risk factor for the development of a new VCF.

Prospective Clinical Follow-up after Percutaneous Vertebroplasty in Patients with Painful Osteoporotic Vertebral Compression Fractures

PURPOSE To prospectively assess short-term, midterm, and long-term pain relief in patients with painful osteoporotic vertebral compression fractures (VCFs) treated with percutaneous vertebroplasty (PV). MATERIALS AND METHODS Visual analog scale (VAS) scores for pain at the treated vertebral level, analgesic use, and satisfaction with outcome were assessed in 112 patients after PV of 168 VCFs. Serial follow-up was performed at 24 hours and 3, 6, and 12 months and in a small number of patients at 1-3 years. Procedure-related complications were evaluated by physical examination and computed tomography of treated levels. RESULTS After PV, VAS scores for pain at the individual vertebral levels treated and use of analgesic agents were significantly reduced compared with before treatment at every follow-up period. Within 24 hours after the procedure, the decreases in all scores were less compared with scores at later follow-up periods, but this was not significant. The preprocedural mean VAS score was 8.8 (range, 5-10). At follow-up, mean VAS scores ranged from 2.5 to 3.3 (range, 0-10). In the short term after PV, patients used significantly less analgesic drugs and 86% of patients were satisfied with the outcome. At midterm and long-term follow-up, patients used even less analgesic drugs and 95%-100% of patients were satisfied with the outcome of PV. Procedure-related complications with clinical consequences occurred in three patients (2.7%): one patient experienced a cardiovascular reaction, one patient had a pedicle chip fracture, and one had a rib fracture. CONCLUSION PV of painful osteoporotic VCFs provides significant pain reduction in nearly all treated patients.

Improving Diagnosis of Acute Appendicitis: Results of a Diagnostic Pathway with Standard Use of Ultrasonography Followed by Selective Use of CT

BACKGROUND Preoperative imaging has been demonstrated to improve diagnostic accuracy in appendicitis. This prospective study assessed the accuracy of a diagnostic pathway in acute appendicitis using ultrasonography (US) and complementary contrast-enhanced multidetector CT in a general community teaching hospital. STUDY DESIGN One hundred fifty-one patients with clinically suspected appendicitis followed the designed protocol: patients underwent operations after a primary performed positive US (graded compression technique) or after complementary CT (contrast-enhanced multidetector CT) when US was negative or inconclusive. Patients with positive CT findings underwent operations. When CT was negative for appendicitis, they were admitted for observation. Results of US and CT were correlated with surgical findings, histopathology, and followup. RESULTS Positive US was confirmed at operation in 71 of 79 patients and positive CT was confirmed in all 21 patients. All 39 patients with negative CT findings recovered without operations. The negative appendicitis rate was 8% and perforation rate was 9%. The sensitivity and specificity of US was 77% and 86%, respectively. The sensitivity and specificity of CT was both 100%. The sensitivity and specificity of the whole diagnostic pathway was 100% and 86%, respectively. CONCLUSIONS A diagnostic pathway using primary graded compression US and complementary multidetector CT in a general community teaching hospital yields a high diagnostic accuracy for acute appendicitis without adverse events from delay in treatment. Although US is less accurate than CT, it can be used as a primary imaging modality, avoiding the disadvantages of CT. For those patients with negative US and CT findings, observation is safe.

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 patients 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.

A randomised sham controlled trial of vertebroplasty for painful acute osteoporotic vertebral fractures (VERTOS IV)

BackgroundThe standard care in patients with a painful osteoporotic vertebral compression fracture (VCF) is conservative therapy. Percutaneous vertebroplasty (PV), a minimally invasive technique, is a new treatment option. Recent randomized controlled trials (RCT) provide conflicting results: two sham-controlled studies showed no benefit of PV while an unmasked but controlled RCT (VERTOS II) found effective pain relief at acceptable costs. The objective of this study is to compare pain relief after PV with a sham intervention in selected patients with an acute osteoporotic VCF using the same strict inclusion criteria as in VERTOS II. Secondary outcome measures are back pain related disability and quality of life.MethodsThe VERTOS IV study is a prospective, multicenter RCT with pain relief as primary endpoint. Patients with a painful osteoporotic VCF with bone edema on MR imaging, local back pain for 6 weeks or less, osteopenia and aged 50 years or older, after obtaining informed consent, are included and randomized for PV or a sham intervention. In total 180 patients will be enrolled. Follow-up is at regular intervals during a 1-year period with a standard Visual Analogue Scale (VAS) score for pain and pain medication. Necessary additional therapies and complications are recorded.DiscussionThe VERTOS IV study is a methodologically sound RCT designed to assess pain relief after PV compared to a sham intervention in patients with an acute osteoporotic VCF selected on strict inclusion criteria.Trial registrationThis study is registered at ClinicalTrials.gov., NCT01200277.

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.

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.

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.

Acrylamido Polyvinyl Alcohol Microspheres for Uterine Artery Embolization: 12-month Clinical and MR Imaging Results

PURPOSE To report the 12-month clinical and magnetic resonance (MR) imaging results of an ongoing two-center registry involving acrylamido polyvinyl alcohol (PVA) microspheres for uterine artery embolization (UAE) for leiomyomas. MATERIALS AND METHODS A total of 69 patients underwent UAE with 500-700-microm, 700-900-microm, and 900-1,200-mum acrylamido PVA microspheres (BeadBlock). Thirty-three patients underwent UAE with a limited embolization (protocol A) and 36 patients underwent UAE with stasis as the angiographic endpoint (protocol B). Primary objectives were clinical efficacy measured by a leiomyoma-specific quality of life (QOL) questionnaire and infarction rate of leiomyomas on early contrast agent-enhanced MR imaging. Secondary objectives were in-hospital complications, patient satisfaction, and frequency of clinical failure. RESULTS Bilateral embolization was technically successful in 68 of 69 patients. A significant decrease (P < .001) in symptom severity and increase in health-related QOL was observed at 3 and 12 months with no significant differences between embolization protocols. However, contrast agent-enhanced MR imaging showed a significantly lower rate of completely infarcted leiomyomas in protocol A compared with protocol B (P < .05). Early clinical failures in patients treated according to protocol A were caused by incomplete tumor infarction. Minor complications occurred in five of 69 patients. Patient satisfaction was similar between protocols. CONCLUSIONS Acrylamido PVA microspheres are a clinically effective and safe embolic agent for UAE. The use of 500-700-microm spheres and a limited embolization results in an unacceptably high rate of failed tumor infarction. Superior imaging results and fewer repeat interventions can be achieved with use of 700-900-microm spheres and stasis as the angiographic endpoint.