Search

To determine whether the reported pain severity changed significantly on the basis of specific types of pain questions posed to patients with spine augmentation.Institutional review board approval and patient consent were obtained for this HIPAA-compliant, prospective study. Patients presenting for consideration of spine augmentation between November 2008 and May 2009 were enrolled. Twenty-four patients were asked at initial presentation and at 30 days to grade their severity of back pain on a 10-point numeric rating scale in response to nine pain questions modified by the relative severity (most vs least severe), by activity (at rest vs with activity), and over time (previous day vs previous week). Statistical analysis included paired t tests to detect any differences in responses to the questions at both time points.Of the 24 patients, 15 (63%) underwent spine augmentation. For patients undergoing spine augmentation, baseline mean numeric rating score for "worst pain with activity over the past week" was 8.9 ± 1.5 (standard deviation), compared with 2.9 ± 2.7 for "least pain at rest over the past day" (P = .001). Interval change between baseline and 30-day assessments was relatively small for all nine questions (mean, 1.6; range, 0.2-2.2); the mean difference for eight of the nine questions did not reach statistical significance. The modifiers worst versus least and with activity versus at rest had a significant impact on the reported severity, while previous week versus previous day had minimal impact.Wide variation in the reported pain can be achieved simply by modifying specific pain questions to patients with spine augmentation.

BACKGROUND AND PURPOSE: INVEST is a recently published double-blind placebo controlled randomized trial that demonstrated similar improvements in pain between blinded vertebroplasty and sham-vertebroplasty groups. LABEL is a trial determining the efficacy of pain relief of an injection of lidocaine and bupivacaine at the site of painful osteoporotic vertebral compression fractures in unblinded patients. We compared outcomes from the unblinded LABEL trial with those of blinded control patients from the lead site of the INVEST, exploring the role of blinding on the benefit of local anesthesia infusion for painful vertebral compression fractures. MATERIALS AND METHODS: Nineteen patients with painful osteoporotic vertebral compression fractures underwent unblinded injection of lidocaine and bupivacaine at the site of painful osteoporotic vertebral compression fractures. Patients were given the option of undergoing vertebroplasty at any time following the procedure. Primary outcome measures were change in the RDQ and pain (at rest, with activity, and average 24-hour pain) at days 1 and 3 following the injection. Day 3 change in RDQ scores and change in average 24-hour pain were compared for LABEL and INVEST control patients from the lead site (n = 16). RESULTS: Among patients in the LABEL trial, we detected no significant improvement in RDQ scores, pain at rest, and average 24-hour pain at days 1 and 3, whereas pain with activity improved significantly at both time points. INVEST control patients from the lead site experienced significantly greater improvement in average pain during 24 hours at days 1 (P = .03) and 3 (P = .04) and significantly greater improvements in RDQ scores at day 3 (P = .006) than patients from LABEL. CONCLUSIONS: An unblinded injection of local anesthesia is ineffective in treating pain from osteoporotic compression fractures. This suggests that factors other than local anesthesia were responsible for the observed improvement in the control group in INVEST.

Purpose To determine whether vertebroplasty increases the risk of new (ie, incident) vertebral fractures by comparing the rates of incident fractures among a group of patients with painful vertebral fractures who did not undergo vertebroplasty with a group of patients who did. Materials and Methods A retrospective chart review was performed to identify new-onset fractures after initial vertebroplasty evaluation in two groups, including patients who underwent vertebroplasty within 1 week of initial evaluation (group 1) and those who did not (group 2). Group 2 was further limited to patients with acute or subacute prevalent fractures (group 2A) after exclusion of those with exclusively chronic prevalent fractures. Survival analyses were performed to compare time to diagnosis and frequency of incident fractures in these three groups of patients. Results Group 1 included 269 patients, group 2 included 107 patients, and group 2A included 82 patients. Compared with group 2, incident fractures in group 1 occurred significantly earlier (log-rank statistic, 0.01) and more frequently (hazard ratio, 2.9; 95% CI, 1.2–8.4). Conclusions Among patients with acute or subacute vertebral fractures presenting for consideration of vertebroplasty, those who undergo the procedure experience more and earlier incident fractures than those who do not, but the observed differences failed to reach statistical significance. Further work is needed in this area to better define relative risks of incident fracture between treated and nontreated patients.

To determine if operator variability, prior vertebroplasty experience, or acquired vertebroplasty experience affects clinical outcomes.Informed consent was obtained from all patients and all data were handled in a manner consistent with institutional review board guidelines and the Health Insurance Portability and Accountability Act. Outcomes from 841 vertebroplasties, sorted by operator, were studied; two operators had previous vertebroplasty experience and five were neurointerventionalists who were initially new to the procedure. Objective (Roland-Morris Disability Questionnaire [RDQ] and analog pain scales) and subjective (mobility, narcotic use) scores were monitored before and after vertebroplasty at specified intervals following treatment. Perioperative cement volume utilization, complications, and number of treated levels were recorded. Random-effects and repeated-measures analyses of variance were used to assess operator differences and variability in clinical outcomes while generalized linear mixed-model regression analyses were used to track changes in clinical outcomes over time.All operators provided similar average durable clinical improvements in postoperative pain and disability with nonsignificant interoperator variability. However, generalized linear model regression suggests that four of five initially novice operators showed significant changes in several procedural measures and clinical outcomes over the study timeframe, including cement volume utilization (reduction of 3.64 to 4.63 cm(3)), 1 week RDQ score (reduction of 4.79 to 8.62 points) and postoperative rest pain (reduction of 1.18 to 2.03 points).Changes over time in measured outcomes suggest the presence of a training effect among novice operators. Cement volume utilization and immediate postprocedural pain decrease with experience but long-term clinical outcomes are insensitive to operator experience.

Background Vertebroplasty is commonly used to treat painful, osteoporotic vertebral compression fractures. Methods In this multicenter trial, we randomly assigned 131 patients who had one to three painful osteoporotic vertebral compression fractures to undergo either vertebroplasty or a simulated procedure without cement (control group). The primary outcomes were scores on the modified Roland–Morris Disability Questionnaire (RDQ) (on a scale of 0 to 23, with higher scores indicating greater disability) and patients' ratings of average pain intensity during the preceding 24 hours at 1 month (on a scale of 0 to 10, with higher scores indicating more severe pain). Patients were allowed to cross over to the other study group after 1 month. Results All patients underwent the assigned intervention (68 vertebroplasties and 63 simulated procedures). The baseline characteristics were similar in the two groups. At 1 month, there was no significant difference between the vertebroplasty group and the control group in...

SUMMARY: Percutaneous vertebroplasty has been deferred due to potential complications from urinary tract infections (UTIs). Our aim was to help sort out the types of treatment needed for percutaneous vertebroplasty patients and the length delay for performing the procedure. We searched for information regarding the ramifications of infection from the literature and devised a plan of treatment for the various infectious problems that may occur in patients undergoing percutaneous vertebroplasty. We devised a plan of action for the screening, testing, diagnosis and treatment of patients with a potential UTI who are presenting for a percutaneous vertebroplasty.

BACKGROUND AND PURPOSE: Limited data exists regarding the efficacy of percutaneous vertebroplasty for multiple synchronous and metachronous vertebral compression fractures. The purpose of this study was to evaluate whether the number of vertebral levels treated during percutaneous vertebroplasty procedures or the number of separate vertebroplasty procedures performed on a given patient affect clinical outcomes. MATERIALS AND METHODS: We defined 3 patient populations in our retrospective study. Group 1 included 328 patients who underwent 1 single-level vertebroplasty procedure. Group 2 included 226 patients who underwent a single procedure in which 2 or more vertebral levels were treated. Group 3 included 101 patients who underwent 2 or more separate vertebroplasty procedures. Follow-up was performed between 1 week and 2 years postoperatively. Clinical outcomes were assessed through analysis of quantitative measurements of pre- and postoperative levels of pain with and without activity (0–10) as well as mobility improvement. The Kruskal-Wallis rank sum test was used to evaluate the differences among groups. Univariate and χ2 analyses were performed to show the proportion of underlying diseases in each group. RESULTS: Mean pain improvement with/without activity at 2-year follow-up was 5.8/3, 4.9/3.7, and 5.4/3.1 in groups 1, 2, and 3, respectively; and mean mobility improvement in 2-year follow-up was 0.67, 0.63, and 0.65 for groups 1, 2, and 3, respectively. CONCLUSIONS: There was no significant difference in pain relief and mobility improvement in patients treated for multiple synchronous or metachronous vertebral compression fractures in comparison with those treated for solitary isolated fractures.

Single-agent thalidomide (THAL) at “conventional” doses (> 100 mg/d) has been evaluated in myelofibrosis with myeloid metaplasia (MMM) based on its antiangiogenic properties and the prominent neoangiogenesis that occurs in MMM. THAL monotherapy at such doses produces approximately a 20% response rate in anemia but is poorly tolerated (an adverse dropout rate of > 50% in 3 months). To improve efficacy and tolerability, we prospectively treated 21 symptomatic patients (hemoglobin level

Objective: To describe the experience with liver irradiation in advanced cases of myelofibrosis with myeloid metaplasia (MMM). Methods: Over a 20-yr period, 14 patients with MMM were treated with a total of 25 courses of liver, abdominal, or abdominal and pelvic irradiation for symptomatic hepatomegaly with (5 patients) or without (9 patients) ascites. All 14 patients had advanced disease and 11 (79%) had previous splenectomy. The median radiation therapy (RT) dose per course was 150 cGy (range 50–1000) administered at a median of six fractions. Four patients received two to six courses. Results: Twelve of the 14 patients (86%) had a transient (median 3 months) subjective response from RT. However, in only 35% of these was there a transient (median 3 months) decrease in palpable liver size. Four of the five patients with ascites experienced a short-term response from RT. Eight of the 13 patients suitable for evaluation (62%) had treatment-associated cytopenia, often in the form of anemia and/or thrombocytopenia. At last follow-up, 10 patients (71%) had died after a median of 7 months (range 0.1–23) and 4 were alive at 3, 20, 33, and 57 months after RT. Conclusions: Low-dose abdominal RT for symptomatic hepatomegaly or ascites associated with advanced-stage MMM is myelosuppressive and provides only temporary and mainly subjective and short-lived relief.

The New South Wales Environment Protection Authority has recently completed a programme to evaluate the impact on near-shore shelf sediments, following the commissioning of three new deepwater sewage outfalls off Sydney, Australia. These outfalls discharge a total of around 1300 ML day−1 of primary treated sewage derived from domestic and industrial sources. The study compared three locations that were close to the outfalls (likely impacted) and three locations far from the outfalls (likely non-impacted). Four zones were sampled within each location to provide estimates of spatial variability. Three samples of surface sediment were collected from each zone at six monthly intervals over a three year period which encompassed the commissioning of the outfalls. The results of the study suggest that, associated with the commissioning of the three deepwater outfalls, there has not been a significant effect on the concentration of trace metals in the sediments surrounding the outfalls. The concentrations of trace metals in the whole sediment generally were close to the world-wide background levels quoted in the literature, and generally reflected the distribution pattern of the sedimentary fines (

BACKGROUND AND PURPOSE: Vertebroplasty is an effective treatment for painful compression fractures refractory to conservative management. Because there are limited data regarding the survival characteristics of this patient population, we compared the survival of a treated with an untreated vertebral fracture cohort to determine whether vertebroplasty affects mortality rates. MATERIALS AND METHODS: The survival of a treated cohort, comprising 524 vertebroplasty recipients with refractory osteoporotic vertebral compression fractures, was compared with a separate historical cohort of 589 subjects with fractures not treated by vertebroplasty who were identified from the Rochester Epidemiology Project. Mortality was compared between cohorts by using Cox proportional hazards models adjusting for age, sex, and Charlson indices of comorbidity. Mortality was also correlated with pre-, peri-, and postprocedural clinical metrics (eg, cement volume use, RDQ score, analog pain scales, frequency of narcotic use, and improvement in mobility) within the treated cohort. RESULTS: Vertebroplasty recipients demonstrated 77% of the survival expected for individuals of similar age, ethnicity, and sex within the US population. Compared with individuals with both symptomatic and asymptomatic untreated vertebral fractures, vertebroplasty recipients retained a 17% greater mortality risk. However, compared with symptomatic untreated vertebral fractures, vertebroplasty recipients had no increased mortality following adjustment for differences in age, sex, and comorbidity (HR, 1.02; 95% CI, 0.82–1.25). In addition, no clinical metrics used to assess the efficacy of vertebroplasty were predictive of survival. CONCLUSIONS: Vertebroplasty recipients have mortality rates similar to those of individuals with untreated symptomatic fractures but have worse mortality compared with those with asymptomatic vertebral fractures.

Background Increased mobility and physical activity after successful vertebral augmentation procedure might increase the risk of new-onset fractures. Purpose To determine whether new-onset fracture following vertebroplasty is associated with specific type of physical activity. Material and Methods A total of 107 patients underwent at least two procedures of percutaneous vertebroplasty. Among them, 30 patients who sustained a post-vertebroplasty fracture(s), were stratified by fracture-causing activity and examined the incidence of the initial and post-vertebroplasty fractures, time to post-vertebroplasty fractures, duration of anti-osteoporotic therapy, T-score, and body mass index. Results The following percentages correspond to patients with fractures sustained pre- and post-vertebroplasty, respectively; spontaneous fractures in 17% and 7% ( P = 0.20), sitting in 7% and 3% ( P = 0.50), walking or standing in 7% and 20% ( P = 0.10), housework in 3% and 3% ( P > 0.99), coughing or sneezing in 0% and 20% ( P = 0.003), exercise in 7% and 17% ( P = 0.20), lifting in 10% and 17% ( P = 0.40) and falling in 50% and 13% ( P = 0.002). Different levels of activity were not significantly associated with time to incidence of post-vertebroplasty fractures. Anti-osteoporotic medications were administered to 33% of patients before vertebroplasty and 37% after the vertebroplasty ( P = 0.78); medications were administered to these groups for 16 and 25 months, respectively ( P = 0.39). Conclusion A significantly elevated risk of new onset fracture with increased physical activity was not identified. However, patients should be carefully counseled after vertebroplasty to optimize medical therapy for osteoporosis and also to use extreme care when engaging in even moderate physical activity.

BACKGROUND AND PURPOSE: A positive correlation between HCT and CT attenuation of intravascular blood has long been assumed but has never been established by using substantial patient numbers and modern CT equipment. The purpose of this study was to determine whether apparent increased attenuation on CT in cerebral venous sinuses can be attributed to hemoconcentration alone and to assess whether sinus thrombosis can be differentiated from hemoconcentrated blood based on attenuation values alone. MATERIALS AND METHODS: We measured HUs in a region of interest within the confluence of dural venous sinuses in 166 unenhanced head CTs and correlated these data with HCT and HGB values in male and female patients aged 2 to 100 years. We then compared these data with similar measurements in 8 patients with recent venous sinus thrombosis. Two-tailed t test and linear regression analyses were performed to evaluate HGB and HCT between groups and with measured CT attenuation of intravascular blood, respectively. RESULTS: A statistically significant relationship was noted between both HCT and HGB with CT attenuation. Seven of 8 patients with sinus thrombosis had attenuation values >70, but none of the normal subjects had HUs >70. CONCLUSIONS: Hemoconcentration correlates with CT attenuation in cerebral venous sinuses. Our findings suggest that comparing the ratio of HUs to HCT may be useful in gauging concern for sinus thrombosis.

The anti-fibrotic and cytokine modulatory properties of pirfenidone suggest its usefulness in the treatment of myelofibrosis with myeloid metaplasia (MMM). In a prospective study, 28 patients with MMM were treated with oral pirfenidone. Twelve patients completed 1 year of therapy; 13 were withdrawn because of disease progression and three because of drug intolerance. Only one patient experienced a clinically relevant benefit with respect to anaemia and splenomegaly. The overall lack of clinical benefit correlated with no significant improvement in the bone marrow morphological features of the disease. We conclude that pirfenidone has no significant clinical or biological activity in MMM.

BACKGROUND AND PURPOSE: Endovascularly coiled intracranial aneurysms are increasingly being followed up with noninvasive MRA imaging to evaluate for aneurysm recurrences. It has not been well-established which MRA techniques are best for this application, however. Our aim was to prospectively compare 4 MRA techniques, TOF and CE-MRA at 1.5T and 3T, to a reference standard of DSA in the evaluation of previously endovascularly coiled intracranial aneurysms. MATERIALS AND METHODS: Fifty-eight subjects with 63 previously coiled intracranial aneurysms underwent all 4 MRA techniques within 8 days of DSA. There were 2 outcome variables: coil occlusion class (class 1, complete; class 2, dog ear; class 3, residual neck; class 4, aneurysm filling) and change in degree of occlusion since the previous comparison. Sensitivity and specificity were computed for each MRA technique relative to the reference standard of DSA. Differences among the MRA techniques were evaluated in pair-wise fashion by using the McNemar test. RESULTS: For the detection of any aneurysm remnant, the sensitivity was 85%–90% for all MRA techniques. Sensitivity dropped to 50%–67% when calculated for the detection of only the class 3 and 4 aneurysm remnants, because several class 3 and 4 remnants were misclassified as class 2 by MRA. CE-MRA at 1.5T and 3T misclassified fewer of the class 3 and 4 remnants than did TOF-MRA at 1.5T, as reflected by the significantly greater sensitivity for larger aneurysm remnants with CE-MRA relative to TOF-MRA at 1.5T ( P = .0455 for both comparisons). CONCLUSIONS: CE-MRA is more likely than TOF-MRA to classify larger aneurysm remnants appropriately. We recommend performing both CE-MRA and TOF-MRA in the follow-up of coiled intracranial aneurysms and at 3T if available.

BACKGROUND AND PURPOSE: Multiple case series of vertebroplasty outcomes have been published, though no large, placebo controlled trial has yet been performed. Our aim was to report baseline characteristics for the Investigational Vertebroplasty Efficacy and Safety Trial (INVEST), a randomized blinded controlled study of vertebroplasty. MATERIALS AND METHODS: We compared baseline demographics, pain scores, and scores on the modified Roland-Morris Disability Scale (RMDS), a back pain−specific metric, between 2 groups. One group included subjects enrolled at the lead INVEST site ( n = 27 to date). The second group consisted of eligible patients seen concurrently at the lead INVEST site, who declined enrollment ( n = 70). Comparisons were made by using 2-sample t tests. RESULTS: Mean ages were similar between groups, averaging approximately 74 years among study participants and 77 years among nonenrolled eligible patients ( P = .17). Approximately 75% of subjects were female in both groups. RMDS scores of enrolled patients at the lead site (18.0 ± 4.2) were not statistically different from those of eligible nonenrolled patients at the lead site (18.6 ± 3.6, P = .49). Pain scores in the enrolled subjects were measured as “average intensity over the prior 24 hours” with mean scores of 7.6 ± 2.1 among enrolled patients at the lead site. Pain scores in eligible nonenrolled patients were measured as “pain at rest,” with mean score of 3.4 ± 3.3, and “pain with activity,” with mean score of 8.5 ± 2.0. CONCLUSIONS: Patient demographics among subjects enrolled in the INVEST are similar to those in a cohort of eligible nonenrolled patients. Back pain−specific disability was similar between subjects enrolled in the INVEST study and eligible nonenrolled patients at the lead site.

BACKGROUND AND PURPOSE: Although abundant literature has reported success with vertebroplasty for the treatment of painful compression fractures, none has accounted for a potential expectation-related placebo effect. We report the results of vertebroplasty for painful vertebral body compression fractures in a small cohort of patients with dementia with the assumption that this patient subgroup is subjected to a decreased placebo effect. MATERIALS AND METHODS: All patients with objective evidence of dementia ( N = 10) who had undergone vertebroplasty at our institution were identified from a comprehensive prospectively constructed vertebroplasty data base. The patients’ pain at rest and activity, mobility, and pain-medication use were analyzed at 2 hours postprocedure, 1 week, 1 month, 6 months, and 1 year. RESULTS: Pain with activity decreased or resolved in 80%–100% of patients at each time point, whereas pain at rest decreased or resolved in 78%–100% of all patients at each time point. Improved mobility was reported in 80%–100% of patients at all time points. Pain medication was decreased or stopped in 67% of patients at 1 week and in 100% of patients at 6 months and 1 year. CONCLUSION: Treatment of painful compression fractures in patients with dementia demonstrates a high rate of success regarding pain relief and mobility. This study offers additional evidence that vertebroplasty has true benefit.

BACKGROUND AND PURPOSE: Despite the literature supporting the efficacy of vertebroplasty for treatment of osteoporotic vertebral compression fractures, few reports exist documenting its use in the treatment of compression fractures in multiple myeloma patients. Accordingly, we sought to characterize the imaging characteristics, clinical course, and outcomes in myeloma patients treated with vertebroplasty. MATERIALS AND METHODS: We performed a retrospective review of clinical outcome data from 67 multiple myeloma patients treated with vertebroplasty since October 2000. Quantitative outcome data including the Roland Morris Disability Questionnaire (RDQ) and Visual Analog Scales for pain and qualitative outcome data (self-reported pain, mobility, and narcotic use) were collected preoperatively, immediately after vertebroplasty, and at 1 week, 1 month, 6 months, and 1 year after treatment. RESULTS: Significant improvements in all of the outcome measures were observed postoperatively and throughout the duration of follow-up. Quantitative outcome measures (RDQ, analog pain scale 0–10, with rest and activity) improved by 11.0 (48%; P < .0001), 2.7 (25%; P < .001), and 5.3 (48%; P < .0001) points, respectively, with persistent improvement at 1 year (P < .01; P < .03; P < .001). Eighty-two percent and 89% of patients experienced a significant improvement in subjective rest pain and activity pain, respectively. Subjective scores achieved durable improvements, with 65% of patients requiring fewer narcotics after vertebroplasty and 70% having improved mobility. CONCLUSION: Vertebroplasty provides significant and durable pain relief for patients with intractable spinal pain secondary to compression fractures resulting from multiple myeloma.

Background The treatment of painful osteoporotic vertebral compression fractures has historically been limited to several weeks of bed rest, anti-inflammatory and analgesic medications, calcitonin injections, or external bracing. Percutaneous vertebroplasty (the injection of bone cement into the fractured vertebral body) is a relatively new procedure used to treat these fractures. There is increasing interest to examine the efficacy and safety of percutaneous vertebroplasty and to study the possibility of a placebo effect or whether the pain relief is from local anesthetics placed directly on the bone during the vertebroplasty procedure. Methods/Designs Our goal is to test the hypothesis that patients with painful osteoporotic vertebral compression fractures who undergo vertebroplasty have less disability and pain at 1 month than patients who undergo a control intervention. The control intervention is placement of local anesthesia near the fracture, without placement of cement. One hundred sixty-six patients with painful osteoporotic vertebral compression fractures will be recruited over 5 years from US and foreign sites performing the vertebroplasty procedure. We will exclude patients with malignant tumor deposit (multiple myeloma), tumor mass or tumor extension into the epidural space at the level of the fracture. We will randomly assign participants to receive either vertebroplasty or the control intervention. Subjects will complete a battery of validated, standardized measures of pain, functional disability, and health related quality of life at baseline and at post-randomization time points (days 1, 2, 3, and 14, and months 1, 3, 6, and 12). Both subjects and research interviewers performing the follow-up assessments will be blinded to the randomization assignment. Subjects will have a clinic visit at months 1 and 12. Spine X-rays will be obtained at the end of the study (month 12) to determine subsequent fracture rates. Our co-primary outcomes are the modified Roland score and pain numerical rating scale at 1 month. Discussion Although extensively utilized throughout North America for palliation of pain, vertebroplasty still has not undergone rigorous study. The study outlined above represents the first randomized, controlled study that can account for a placebo effect in the setting of vertebroplasty. Trial Registration Current Controlled Trials ISRCTN81871888

BACKGROUND AND PURPOSE: Remodeling balloons are used to assist in endovascular coiling of aneurysms. We evaluated our experience with balloon-assisted coiling (BAC) in an attempt to determine whether this technique increased the rate of thrombus formation or symptomatic thromboembolic complications. MATERIALS AND METHODS: In 3 years, we treated 221 patients with intracranial aneurysms. Statistical analysis was performed to assess whether BAC increased the rate of thrombus formation or symptomatic thromboembolic complications. Patient demographics, aneurysm size, location, neck width, antiplatelet therapy, and rupture status were evaluated. RESULTS: We detected no statistically significant difference in rates of thrombus formation (14% versus 9% with and without BAC, respectively, P = 0.35) or symptomatic thromboembolic events (7% versus 5% with and without BAC, respectively, P = 0.76), though our power to detect small differences was limited. There was also no correlation with age, sex, rupture status, aneurysm size, or location. There was a significant increase in the rates of thrombus formation (6% versus 16%, P = 0.02) and symptomatic thromboembolic complications (3% versus 10%, P = 0.04) in aneurysms that were classified as narrow- or wide-necked, respectively. The use of clopidogrel was associated with a decrease in the rate of complications ( P = 0.01). CONCLUSION: In this series, we detected no significant increase in the rates of either intraprocedural thrombus formation or symptomatic thromboembolic events in patients treated with BAC. Larger studies are required to confirm our observations. Wide-necked aneurysms were independently associated with increased rates of thrombus formation and symptomatic thromboembolic complications, whereas the use of clopidogrel was protective ( P = 0.01).

BACKGROUND AND PURPOSE: Vertebroplasty is frequently offered to patients hospitalized for refractory pain due to vertebral fractures, because it is assumed that the procedure will facilitate resolution of pain and a rapid hospital discharge. We report our experience with inpatient vertebroplasty, with attention to rapidity of discharge and relevant clinical parameters. METHODS: We retrospectively reviewed the duration of hospitalization in patients admitted with primary diagnoses of back pain or vertebral fracture who were treated with vertebroplasty. We cataloged outcomes in the form of verbal pain scales (graded 0–10), in-hospital medication use (graded 0–6), and posthospitalization medication use. Outcomes were assessed at baseline and at 1 week, 1 month, 6 months, 1 year, and 2 years postvertebroplasty. RESULTS: We identified 66 such patients who had a median total hospital stay of 6.0 days (range, 1–26 days). Median length of stay before and after vertebroplasty were 4.0 (range, 1–24 days) and 1.5 days (range, 0–7 days), respectively. Ten (15%) patients were discharged the day of vertebroplasty. By days 2 and 3, 33 (50%) and 48 (72.7%) of the 66 patients had been discharged. Patients who received vertebroplasty earlier in the course of hospitalization demonstrated greater decreases in medication strength by discharge (P = .045). There was significant improvement in all outcome measures by 1 week, with continued improvement at 1 and 6 months. CONCLUSION: This study confirms that vertebroplasty facilitates a rapid hospital discharge as well as long-term improvement in patients admitted for refractory pain. Vertebroplasty administered earlier in hospitalization also leads to greater decreases in analgesic requirements.

Patients with polycythemia vera and essential thrombocythemia are at risk for thrombotic and bleeding complications. Currently, no diagnostic test can predict thrombohemorrhagic complications. In a prospective study of 86 patients with polycythemia vera (43 patients) or essential thrombocythemia (43 patients), we examined the possible role of polymorphisms of platelet adhesion receptors [glycoprotein (GP) Ibalpha, GPIa, GPIIIa) and clotting factor II (prothrombin's G20210A mutation) and clotting factor V (Leiden mutation) in determining the risk of thrombotic or bleeding complications. Except for an association between vasomotor symptoms and prothrombin mutation (P < 0.001), no significant correlation between polymorphism of clotting factors and thrombohemorrhagic complications was identified. When the entire patient cohort was considered, the polymorphisms of platelet adhesion receptors were not associated with the risk for thrombotic or bleeding complications. However, among patients with polycythemia vera, the presence of the PlA2 allele of GPIIIa was associated with an increased risk of arterial thrombosis. In view of previous studies linking the presence of the PlA2 allele of GPIIIa to a higher risk for coronary artery thrombosis, our data have physiologic relevance. However, they need to be confirmed in a larger study.

In a phase 2 study, 23 patients with myelofibrosis with myeloid metaplasia were treated with imatinib mesylate at a constant dose of 400 mg/d. Treatment was held in 16 patients (70%), after 1 to 12 weeks, because of side effects (neutropenia, 6 patients; musculoskeletal pain, 5 patients; thrombocytosis, 4 patients; edema, 3 patients; diarrhea and hyperbilirubinemia, 1 patient). Including patients in whom retreatment at a reduced dose was possible, 11 patients (48%) were able to continue treatment beyond 3 months. None of the patients experienced a response in anemia, and only 2 had partial responses in splenomegaly. A greater than 50% increase in platelet count was documented in 11 (48%) patients, but not in those with baseline platelet counts of less than 100 × 109/L. In vitro, imatinib mesylate caused variable degrees of growth suppression of myeloid and erythroid progenitors that unfortunately did not translate into clinical benefit.

Patients with myelofibrosis with myeloid metaplasia (MMM) often experience debilitating constitutional symptoms such as drenching night sweats, profound fatigue, unexplained fevers, and unintentional weight loss. Tumor necrosis factor (TNF) contributes to organ fibrosis and hypercatabolic symptoms in a variety of disease states. We conducted an open-label pilot study of etanercept, a soluble TNF receptor, administered at a dose of 25 mg subcutaneously twice weekly for up to 24 weeks in 22 patients with MMM. Of 20 evaluable patients, 12 (60%) experienced an improvement in constitutional symptoms, and 4 (20%) had an objective response (improvement in peripheral cytopenias or spleen size). The degree of marrow fibrosis was unchanged, and only minor changes in overall marrow cellularity were observed. Toxicity was mild, with injection site reactions (20%) and minor infections (10%) as the most common side effects. One patient developed reversible pancytopenia. Etanercept may be useful for palliation of constitutional symptoms in MMM.