Summary 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.
To prospectively assess the short-term clinical outcome of patients with subacute or chronic painful osteoporotic vertebral compression fractures (VCF) treated with percutaneous vertebroplasty (PV) ...compared with optimal pain medication (OPM).
Randomization of patients in 2 groups: treatment by PV or OPM. After 2 weeks, patients from the OPM arm could change therapy to PV. Patients were evaluated 1 day and 2 weeks after treatment. Visual analog score (VAS) for pain and analgesic use were assessed before, and 1 day and 2 weeks after start of treatment. Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO) and Roland-Morris Disability (RMD) questionnaire scores were assessed before and 2 weeks after start of treatment. Follow-up scores in patients requesting PV treatment after 2 weeks OPM treatment were compared with scores during their OPM period.
Eighteen patients treated with PV compared with 16 patients treated with OPM had significantly better VAS and used less analgesics 1 day after treatment. Two weeks after treatment, the mean VAS was less but not significantly different in patients treated with OPM, whereas these patients used significantly less analgesics and had better QUALEFFO and RMD scores. Scores in the PV arm were influenced by occurrence of new VCF in 2 patients. After 2 weeks OPM, 14 patients requested PV treatment. All scores, 1 day and 2 weeks after PV, were significantly better compared with scores during conservative treatment.
Pain relief and improvement of mobility, function, and stature after PV is immediate and significantly better in the short term compared with OPM treatment.
AbstractObjectiveTo assess whether percutaneous vertebroplasty results in more pain relief than a sham procedure in patients with acute osteoporotic compression fractures of the vertebral ...body.DesignRandomised, double blind, sham controlled clinical trial.SettingFour community hospitals in the Netherlands, 2011-15.Participants180 participants requiring treatment for acute osteoporotic vertebral compression fractures were randomised to either vertebroplasty (n=91) or a sham procedure (n=89).InterventionsParticipants 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 measuresMain 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.ResultsThe 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.ConclusionsPercutaneous 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 registrationClinicalTrials.gov NCT01200277.
PV is increasingly used as treatment for osteoporotic VCFs. However, controversy exists as to whether PV increases the risk for new VCFs during follow-up. The purpose of our research was to assess ...the incidence of new VCFs in patients with acute VCFs randomized to PV and conservative therapy.
VERTOS II is a prospective multicenter randomized controlled trial comparing PV with conservative therapy in 202 patients. Incidence, distribution, and timing of new VCFs during follow-up were assessed from spine radiographs. In addition, further height loss during follow-up of treated VCFs was measured.
After a mean follow-up of 11.4 months (median, 12.0; range, 1-24 months), 18 new VCFs occurred in 15 of 91 patients after PV and 30 new VCFs in 21 of 85 patients after conservative therapy. This difference was not significant (P = .44). There was no higher fracture risk for adjacent-versus-distant vertebrae. Mean time to new VCF was 16.2 months after PV and 17.8 months after conservative treatment (logrank, P = .45). The baseline number of VCFs was the only risk factor for occurrence (OR, 1.43; 95% CI, 1.05-1.95) and number (P = .01) of new VCFs. After conservative therapy, further height loss of treated vertebrae occurred more frequently (35 of 85 versus 11 of 91 patients, P < .001) and was more severe (P < .001) than after PV.
Incidence of new VCFs was not different after PV compared with conservative therapy after a mean of 11.4 months' follow-up. The only risk factor for new VCFs was the number of VCFs at baseline. PV contributed to preservation of stature by decreasing both the incidence and severity of further height loss in treated vertebrae.
Patients with fusiform basilar trunk aneurysms have a poor prognosis. Reconstructive endovascular therapy is possible with modern devices. We describe the clinical presentation, radiologic features, ...and clinical outcome of 13 patients with fusiform basilar trunk aneurysms treated with flow diverters, stents, and coils.
Of the 13 patients, 7 were men and 6 were women with a mean age of 59.7 years. Clinical presentation was SAH in 3 patients, mass effect on the brain stem in 4 patients, vertebral artery dissection in 1 patient, and the aneurysm was an incidental finding in 5 patients. Mean aneurysm size was 21 mm. All except 1 were large or giant aneurysms. Nine aneurysms were partially thrombosed.
Stents were used in all 13 patients, in 2 patients with additional flow diverters and in 11 patients with additional coils. In 4 patients, 1 vertebral artery was subsequently occluded with coils to decrease flow into the aneurysm. Of 13 patients, 9 had a good outcome with adequate aneurysm occlusion and stable size on follow-up of 6-72 months. One of 3 patients who presented with SAH died of a rebleed 1 month later. One other patient died soon after treatment of in-stent thrombosis, and another patient became mute after treatment. In 2 of 3 patients who presented with symptoms of mass effect, there was improvement at a follow-up of 6-24 months.
Reconstructive endovascular therapy of fusiform and dissecting basilar trunk aneurysms is feasible but carries substantial risks. The safety and effectiveness in relation to natural history has not yet been elucidated.
We analyzed the natural course of conservatively treated osteoporotic vertebral compression fractures from VERTOS II, a randomized trial of vertebroplasty and conservative therapy in 202 patients ...with vertebral compression fractures. We assessed the proportion of patients who developed chronic back pain and possible risk factors.
In VERTOS II, the VAS score was assessed at regular intervals until 1 year follow-up. We followed 95 conservatively treated patients until sufficient pain relief, defined as a VAS score ≤3. These patients were censured at the involved follow-up interval. In addition, baseline clinical and imaging data, and class of pain medication used in patients with a VAS score ≤3 at any follow-up interval were compared with those in patients with a VAS score >3 at every follow-up by using logistic regression analysis.
During 1 year of follow-up, 57 of 95 patients (60%) had sufficient pain relief with VAS scores ≤3. Thirty-eight patients (40%) still had pain with VAS-scores ≥4 at the last follow-up interval of 12 months, despite the use of higher class pain medication. Statistical analysis showed no risk factors.
In the VERTOS II trial, most conservatively treated patients with acute osteoporotic compression fractures had sufficient pain relief during the first 3 months. However, after 1 year, a substantial proportion of patients still had disabling pain despite higher class pain medication used. There were no predictors for the development of chronic pain. Patients with continuing pain ≥3 months after the fracture may be candidates for vertebroplasty.
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.
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.
To demonstrate that splenic artery embolization (SAE) is more cost-effective than splenectomy from a societal perspective in the Netherlands.
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.
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.
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.
Purpose
This study was designed to assess midterm outcome of uterine artery embolisation (UAE) for women with therapy-resistant adenomyosis using polyzene F-coated hydrogel microspheres.
Methods
...Between September 2006 and January 2010, 29 consecutive women with adenomyosis (15 in combination with fibroids) were treated with UAE using polyzene F-coated hydrogel microspheres. Junction zone thickness was assessed with MRI at baseline and 3 months. Women filled out the uterine fibroid symptom and quality of life questionnaire at baseline, 3 months and after a mean clinical follow-up of 37 months (median 35, range 29–64 months).
Results
At baseline, symptom severity score of 29 women was mean 67 (median 72, range 23–100). At 3 months, this score decreased to mean 22 (median 15, range 0–66) and mean 15 (median 17, range 0–34) at final follow-up. At final follow-up of mean 37 months (median 35, range 29–64 months), 22 of 29 (76 %) patients were asymptomatic. Of these 22 women, 3 underwent a second UAE at 6, 7, and 14 months. The remaining seven patients clinically improved but still had symptoms; one underwent a hysterectomy. There was no difference in outcome between women with pure adenomyosis and women with additional fibroids. The junction zone of 4 women with additional therapy was significantly thicker compared with the remaining 25 patients.
Conclusions
In women with therapy resistant adenomyosis, UAE using polyzene F-coated hydrogel microspheres resulted in 3 years preservation of the uterus in 28 of 29 (97 %) with good clinical outcome in the vast majority of patients. Initial thickness of the junction zone is related to additional therapy.
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