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.

Selective Embolisation of a Heavily Bleeding Cervical Fibroid in a Pregnant Woman.

We report a case of a 20-week pregnant woman, who underwent embolisation of a cervical fibroid to end a life-threatening massive bleeding. This is the first reported case in the literature of a super-selective uterine fibroid embolisation (UFE) in a pregnant woman, even though pregnancy is considered an absolute contraindication for UFE. This rare case demonstrates that UFE can be safely performed during pregnancy providing an excellent short- and long-term clinical outcome for both mother and child.

A randomized trial of intraarterial treatment for acute ischemic stroke.

BACKGROUND: In patients with acute ischemic stroke caused by a proximal intracranial arterial occlusion, intraarterial treatment is highly effective for emergency revascularization. However, proof of a beneficial effect on functional outcome is lacking. METHODS: We randomly assigned eligible patients to either intraarterial treatment plus usual care or usual care alone. Eligible patients had a proximal arterial occlusion in the anterior cerebral circulation that was confirmed on vessel imaging and that could be treated intraarterially within 6 hours after symptom onset. The primary outcome was the modified Rankin scale score at 90 days; this categorical scale measures functional outcome, with scores ranging from 0 (no symptoms) to 6 (death). The treatment effect was estimated with ordinal logistic regression as a common odds ratio, adjusted for prespecified prognostic factors. The adjusted common odds ratio measured the likelihood that intraarterial treatment would lead to lower modified Rankin scores, as compared with usual care alone (shift analysis). RESULTS: We enrolled 500 patients at 16 medical centers in The Netherlands (233 assigned to intraarterial treatment and 267 to usual care alone). The mean age was 65 years (range, 23 to 96), and 445 patients (89.0%) were treated with intravenous alteplase before randomization. Retrievable stents were used in 190 of the 233 patients (81.5%) assigned to intraarterial treatment. The adjusted common odds ratio was 1.67 (95% confidence interval [CI], 1.21 to 2.30). There was an absolute difference of 13.5 percentage points (95% CI, 5.9 to 21.2) in the rate of functional independence (modified Rankin score, 0 to 2) in favor of the intervention (32.6% vs. 19.1%). There were no significant differences in mortality or the occurrence of symptomatic intracerebral hemorrhage. CONCLUSIONS: In patients with acute ischemic stroke caused by a proximal intracranial occlusion of the anterior circulation, intraarterial treatment administered within 6 hours after stroke onset was effective and safe. (Funded by the Dutch Heart Foundation and others; MR CLEAN Netherlands Trial Registry number, NTR1804, and Current Controlled Trials number, ISRCTN10888758.).

Long-term MRA follow-up after coiling of intracranial aneurysms: impact on mood and anxiety.

INTRODUCTION: Magnetic resonance angiography (MRA) screening for recurrence of a coiled intracranial aneurysm and formation of new aneurysms long-term after coiling may induce anxiety and depression. In coiled patients, we evaluated effects on mood and level of anxiety from long-term follow-up MRA in comparison to general population norms. METHODS: Of 162 patients participating in a long-term (>4.5 years) MRA follow-up after coiling, 120 completed the EQ-5D questionnaire, a visual analog health scale and a self-developed screening related questionnaire at the time of MRA. Three months later, the same questionnaires were completed by 100 of these 120 patients. Results were compared to general population norms adjusted for gender and age. RESULTS: Any problem with anxiety or depression was reported in 56 of 120 patients (47%; 95%CI38↔56%) at baseline and 42 of 100 patients (42%; 95%CI32↔52%) at 3 months, equally for screen-positives and -negatives. Compared to the reference population, participants scored 38% (95%CI9↔67%) and 27% (95%CI4↔50%) more often any problem with anxiety or depression. Three months after screening, 21% (20 of 92) of screen-negatives and 13% (one of eight) of screen-positives reported to be less afraid of subarachnoid hemorrhage (SAH) compared to before screening. One of eight screen-positives reported increased fear of SAH. CONCLUSIONS: Patients with coiled intracranial aneurysms participating in long-term MRA screening reported significantly more often to be anxious or depressed than a reference group. Screening did not significantly increase anxiety or depression temporarily. However, subjectively, patients did report an increase in anxiety caused by screening, which decreased after 3 months.

De novo aneurysm formation and growth of untreated aneurysms: a 5-year MRA follow-up in a large cohort of patients with coiled aneurysms and review of the literature.

BACKGROUND AND PURPOSE: Rates of development of de novo intracranial aneurysms and of growth of untreated additional aneurysms are largely unknown. We performed MRA in a large patient cohort with coiled aneurysms at 5-year follow-up. METHODS: In 276 patients with coiled intracranial aneurysms and 5±0.5 years of follow-up MRA (totaling 1332 follow-up patient-years), additional aneurysms were classified as unchanged, grown, de novo, or incomparable with previous imaging. We calculated 5-year cumulative incidence of de novo aneurysm formation and growth of untreated aneurysms. We searched PubMed and EMBASE databases for studies assessing aneurysm development, and growth. RESULTS: In 50 of 276 patients (18%), 75 additional aneurysms were present at follow-up MRA. Of these 75, 2 were de novo (both 3 mm), 58 were unchanged, 5 had grown from 1 to 3 mm (7.9% of 63 known additional aneurysms; 95% CI, 1.3%-14.6%), and 10 were incomparable. Five-year cumulative incidence for a de novo aneurysm developing was 0.75%. Four additional aneurysms in 3 patients were treated. Ten previous studies reported annual incidences of growth of additional aneurysms ranging from 1.51% to 22.7%, and 5 studies reported annual incidences of de novo aneurysm formation ranging from 0.3 to 1.8%. CONCLUSIONS: MRA screening of patients with coiled aneurysms within the first 5 years after treatment has a low rate of de novo aneurysm development and growth of additional aneurysms, and an even lower treatment rate.

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.

MR angiography at 3T versus digital subtraction angiography in the follow-up of intracranial aneurysms treated with detachable coils.

BACKGROUND AND PURPOSE: Digital subtraction angiography (DSA) is used to follow-up intracranial aneurysms treated with detachable coils to identify recurrence and determine need for additional treatment. However, DSA is invasive and involves a small risk of neurologic complications. We assessed the feasibility and usefulness of 3D time-of-flight (TOF) MR angiography (MRA) performed at 3T compared with DSA for the follow-up of coil-treated intracranial aneurysms. METHODS: In a prospective study, 20 consecutive patients with 21 intracranial aneurysms treated with coils underwent DSA and nonenhanced and enhanced multiple overlapping thin-slab acquisition 3D TOF MRA at 3T on the same day at a mean follow-up of 6 months (range, 4-14 months) after coil placement. MRA images were evaluated for presence of artifacts, presence and size of aneurysm remnants and recurrences, patency of parent and branch vessels, and added value of contrast material enhancement. MRA and DSA findings were compared. RESULTS: Interobserver agreement of MRA was good, as was agreement between MRA and DSA. All three recurrences that needed additional treatment were detected with MRA. Minor disagreement occurred in four cases: three coil-treated aneurysms were scored on MRA images as having a small remnant, whereas on DSA images these aneurysms were occluded; the other aneurysm was scored on MRA images as having a small remnant, whereas on DSA images this was a small recurrence. Use of contrast material had no additional value. Coil-related MR imaging artifacts were minimal and did not interfere with evaluation of the occlusion status of the aneurysm. CONCLUSION: High-spatial-resolution 3D TOF MRA at 3T is feasible and useful in the follow-up of patients with intracranial aneurysms treated with coil placement.

Coiling of ruptured pericallosal artery aneurysms.

OBJECTIVE: To assess the technical feasibility of treating ruptured pericallosal artery aneurysms with detachable coils and to evaluate the anatomic and clinical results. METHODS: Over a period of 27 months, 12 patients with a ruptured pericallosal artery aneurysm were treated with detachable coils. A retrospective review was performed to assess the clinical and angiographic results. The three men and nine women had a mean age of 46.6 years (range, 35-75 yr). Seven patients presented in Hunt and Hess Grade II, three in Grade III, and two in Grade IV. Six patients had a concomitant intracerebral hematoma, and four had at least one additional aneurysm. RESULTS: In all 12 patients, the pericallosal aneurysm could be reached with a microcatheter and the coils delivered. No procedure-related complications occurred. Angiography demonstrated that the initial occlusion was complete in 11 aneurysms and near-complete in 1. At follow-up angiography at 6 months, one aneurysm had become partially recanalized owing to coil compaction. At a mean clinical follow-up of 9.2 months, 11 patients had an excellent outcome and one patient had mild hemiparesis and aphasia. CONCLUSION: Coiling of ruptured pericallosal artery aneurysms can be considered an alternative to surgical clipping.