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.
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 (
χ
2
(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.
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.
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 (
χ
2
(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 (
χ
2
(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
To assess accuracy of contrast material-enhanced magnetic resonance (MR) angiography as compared with three-dimensional (3D) time-of-flight (TOF) MR angiography and reference digital subtraction ...angiography (DSA) in diagnosis of carotid artery stenosis.
Enhanced and 3D TOF MR angiography and DSA were performed in 51 consecutive patients suspected of having carotid artery stenosis at duplex ultrasonography. Stenoses were measured by two independent observers blinded to clinical information and other test results. Pearson correlation coefficients were used, and kappa for interobserver variabilities was estimated. Sensitivity and specificity of enhanced and 3D TOF MR angiography were calculated and compared with those of DSA.
Pearson correlation coefficients were 0.94 (P <.01) for enhanced angiography versus DSA, 0.92 (P <.01) for 3D TOF angiography versus DSA, and 0.93 (P <.01) for enhanced versus 3D TOF angiography for observer 1 and 0.94 (P <.01), 0.95 (P <.01), and 0.94 (P <.01), respectively, for observer 2. kappa statistics were 0.81 for enhanced angiography, 0.79 for 3D TOF angiography, and 0.78 for DSA. Stenosis measurements of observer 1 at enhanced MR angiography, with inclusion of carotid arteries on the symptomatic side only, compared with those of DSA yielded a sensitivity of 90% (95% CI: 68%, 99%) and a specificity of 77% (95% CI: 55%, 92%). 3D TOF angiography yielded a sensitivity of 86% (95% CI: 67%, 97%) and a specificity of 73% (95% CI: 50%, 89%) compared with those of DSA. For observer 2, sensitivity and specificity for enhanced angiography were 91% (95% CI: 70%, 99%) and 76% (95% CI: 52%, 91%), respectively, and 90% (95% CI: 68%, 99%) and 77% (95% CI: 51%, 92%), respectively, for 3D TOF angiography.
Accuracy of enhanced MR angiography in diagnosis of severe stenosis is similar to that of 3D TOF MR angiography.
Carotid endarterectomy has been shown to be beneficial in symptomatic patients with a severe stenosis (70% to 99%) of the internal carotid artery (ICA). Digital subtraction angiography (DSA) is the ...standard of reference in the diagnosis of carotid artery stenosis but has a relatively high complication rate. In a diagnostic study we investigated the accuracy of noninvasive testing compared with DSA.
In a prospective diagnostic study we performed duplex ultrasound (DUS), magnetic resonance angiography (MRA), and DSA on 350 consecutive symptomatic patients. Stenoses were measured with the observers blinded for clinical information and other test results. Separate and combined test results of DUS and MRA were compared with the reference standard DSA. Only the stenosis measurements of the arteries on the symptomatic side were included in the analyses.
DUS analyzed with previously defined criteria resulted in a sensitivity of 87.5% (95% CI, 82.1% to 92.9%) and a specificity of 75.7% (95% CI, 69.3% to 82.2%) in identifying severe ICA stenosis (70% to 99%). Stenosis measurements on MRA yielded a sensitivity of 92.2% (95% CI, 86.2% to 96.2%) and a specificity of 75.7% (95% CI, 68.6% to 82.5%). When we combined MRA and DUS results, agreement between these 2 modalities (84% of patients) gave a sensitivity of 96.3% (95% CI, 90.8% to 99.0%) and a specificity of 80.2% (95% CI, 73.1% to 87.3%) for identifying severe stenosis.
MRA showed a slightly better accuracy than DUS in the diagnosis of carotid artery stenosis. To achieve the best accuracy, however, both tests should be performed subsequently.
This report describes a rare vascular complication of surgical placement of a marking clip and a possible approach to problem solving. A 55-year-old patient presented with loss of sensation in the ...fingers and loss of peripheral pulsations in the right arm 4 days after right upper lobectomy for a pT2N1 moderately differentiated adenocarcinoma of the lung. Duplex examination and computed tomography were performed the same day and showed a subtotal stenosis of the right subclavian artery, which was caused by the surgical placement of a metal clip to mark the surgical boundary. Selective angiography was subsequently performed. Percutaneous transluminal angioplasty (PTA) successfully dilated the stenosis and pushed the clip off. Flow in the right subclavian artery (RSA) was completely restored as were neurology and peripheral pulses. In conclusion, arterial stenosis by a surgical (marking) clip may be feasibly treated with PTA.
Two surgical trials established that carotid endarterectomy is beneficial to symptomatic patients who have a severe internal carotid artery (ICA) stenosis on angiograms. Duplex ...ultrasonography-derived hemodynamic parameters show a good correlation with angiography and are often used for detecting severe ICA stenoses. However, duplex performance is ultrasound machine and operator dependent. Over time both may change, possibly affecting duplex performance. We compared duplex performance of 2 time periods in 1 specific vascular laboratory using angiography as the gold standard.
Consecutive patients who underwent both angiography and duplex examinations of the ICA were evaluated (first period, 60 patients; second period, 61 patients). Peak systolic velocity and several other hemodynamic parameters and ratios were analyzed by receiver operating characteristic curves in their ability to detect severe ICA stenoses. The optimal parameter and threshold were determined for each period. Subsequently, duplex test characteristics were compared after the optimal thresholds of both the first and the second periods were applied in the second period.
In both periods peak systolic velocity of the ICA was the best test parameter; areas under the receiver operating characteristic curve were similar (0.957 and 0.954, respectively). However, the optimal threshold was different. The optimal threshold in the second period was 270 cm/s. When the optimal threshold of 210 cm/s of the first period was applied in the second period, test characteristics changed significantly. Sensitivity increased from 98% to 100%, and specificity decreased from 85% to 71% (P=0.004).
The optimal threshold for detecting severe ICA stenoses with duplex ultrasonography in our laboratory changed over time. Individual laboratories should assess duplex accuracy regularly and adjust adopted criteria if necessary to keep diagnostic performance optimal.
Atherosclerosis of femoropopliteal arteries is an important cause of morbidity and mortality. Percutaneous transluminal angioplasty (PTA) has only limited success in treating these arteries, mainly ...because of the high rate of recurrent stenosis. Cryoplasty has been proposed as a technique which might improve treatment outcome. This study reports our single-center experience with cryoplasty. Thirty-two claudicants, 33 arteries, in whom conservative therapy failed, were consecutively included. Duplex ultrasound (US), angiography, and ankle-brachial index (ABI) measurement were performed before the procedure; ABI and duplex US, 2 weeks and 3, 6, and 12 months after the procedure. Patients’ symptoms were categorized according to the Rutherford classification. Lesions were classified as TASC A, B, or C according to angiographic appearance. Differences in ABI before and after the procedure were defined as significant at
p
< 0.05 by paired
t
-test. Patency was evaluated using duplex US by determining the peak systolic velocity ratio. Sixteen TASC A lesions, 13 TASC B lesions, and 4 TASC C lesions were included. ABI improved significantly for TASC A lesions 2 weeks and 3 months postprocedure. Patency after 2 weeks, 6 months, and 12 months was 93%, 67%, and 64% for TASC A lesions, 83%, 31%, and 31% for TASC B lesions, and 100%, 50%, and 33% for TASC C lesions, respectively. In conclusion, cryoplasty has good immediate success rates and patency rates similar to the results of conventional PTA in the literature.
To assess how often rotational angiography depicts more severe internal carotid arterial stenosis compared with conventional intraarterial digital subtraction angiography (DSA) in two or three ...projections and how frequently this factor may affect patient treatment.
Rotational angiography (16 or 32 projections) was performed in addition to DSA in 47 stenotic internal carotid arteries (ICAs) in 38 symptomatic patients. ICA stenosis was measured independently at DSA and at rotational angiography with North American Symptomatic Carotid Endarterectomy Trial criteria. The degree of stenosis was categorized as 0%-29%, 30%-49%, 50%-69%, or 70%-99%.
In three ICAs, rotational angiography was nondiagnostic. In 28 of the remaining 44 ICAs, the degree of stenosis was categorized similarly with DSA and rotational angiography, whereas with rotational angiography, 15 ICAs were classified one category higher and one ICA was classified two categories higher, owing to the increased number of projections available. Seventy percent to 99% stenosis was demonstrated in 18 ICAs with DSA and in 25 ICAs with rotational angiography. Thus, rotational angiography could have facilitated a change in the optimal treatment (from nonsurgical treatment to carotid arterial endarterectomy) in seven ICAs.
Compared with DSA in two or three projections, rotational angiography frequently depicts more severe ICA stenosis. This indicates a limitation of DSA in depicting the maximum ICA stenosis.
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