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David F Kallmes - One of the best experts on this subject based on the ideXlab platform.
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investigational Vertebroplasty efficacy and safety trial invest a randomized controlled trial of Percutaneous Vertebroplasty
BMC Musculoskeletal Disorders, 2007Co-Authors: Leigh A Gray, Jeffrey G Jarvik, Patrick J Heagerty, William Hollingworth, Lydia Stout, Bryan A Comstock, Judith A Turner, David F KallmesAbstract: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.
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the effects of cement volume on clinical outcomes of Percutaneous Vertebroplasty
American Journal of Neuroradiology, 2006Co-Authors: Timothy J Kaufmann, Andrew T Trout, David F KallmesAbstract:BACKGROUND AND PURPOSE: There exists significant variability in the volume of polymethylmethacrylate cement injected during Percutaneous Vertebroplasty. Larger cement volumes injected may be associated with better clinical outcomes, but larger volumes may also be associated with greater risk of complications related to cement leakage. We describe an analysis of the association between clinical and procedural variables, including cement volume injected, and the clinical outcomes of patients treated with single-level Vertebroplasty. METHODS: Retrospective analysis of 158 patients treated with single-level Vertebroplasty was performed. Relationships among patient and procedural variables and relationships between these variables and ordinal clinical outcome scores of pain and medication use at postprocedure time points from 1 week to 2 years were evaluated with bivariate and multivariable analyses. RESULTS: There was no significant association between the volume of cement injected and the clinical outcomes of postprocedure pain (P = .159–.871) and medication use (P = .223–.875). CONCLUSION: Vertebroplasty operators need not feel compelled to achieve particular cement volumes injected in the pursuit of better clinical outcomes but should strive to achieve the maximal safe filling of individual vertebral bodies.
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lack of preoperative spinous process tenderness does not affect clinical success of Percutaneous Vertebroplasty
Journal of Vascular and Interventional Radiology, 2002Co-Authors: John R Gaughen, Timothy J Kaufmann, Mary E Jensen, William F Marx, Patricia A Schweickert, David F KallmesAbstract:PURPOSE Some operators use the lack of point tenderness over compression fractures to exclude patients from undergoing Percutaneous Vertebroplasty procedures. The purpose of this study was to determine whether this lack of tenderness portends a poorer clinical outcome after Vertebroplasty than is achieved in patients with such tenderness. MATERIALS AND METHODS The authors conducted a retrospective review of consecutive Percutaneous Vertebroplasty procedures performed at their institution to define two populations. Group 1 included 90 patients with tenderness to palpation over the spinous process of the fractured vertebra, whereas group 2 included 10 patients without such tenderness. This second group presented with back pain and demonstrated tenderness distant from the fracture ( n = 5), tenderness lateral to the fracture ( n = 4), or no focal tenderness at all ( n = 1). All were treated because of edema seen on magnetic resonance (MR) imaging and/or increased activity on bone scan. Clinical outcomes were assessed by quantitative measurements of preand postoperative levels of pain (11-point scale) and mobility (five-point scale). RESULTS Pain improvement of three points or greater occurred in 77 of the 85 patients (91%) in group 1 who complied with follow-up and nine of nine such patients (100%) in group 2, with mean postoperative pain levels of 1.82 and 0.33 points, respectively ( P = .14). Forty of 45 patients (89%) in group 1 with impaired preoperative mobility reported improvement postoperatively, as did two of three such patients (67%) in group 2. Mean levels of postoperative impaired mobility for groups 1 and 2 were 0.27 and 0.67 points, respectively ( P = .27). CONCLUSION Pain on palpation over the fractured vertebra is not a necessary requirement in selecting patients who will benefit from Percutaneous Vertebroplasty. Other factors, such as MR evidence of edema or increased uptake on bone scan, should be weighed considerably in the decision to treat a patient.
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cardiovascular effects of polymethylmethacrylate use in Percutaneous Vertebroplasty
American Journal of Neuroradiology, 2002Co-Authors: Timothy J Kaufmann, Mary E Jensen, Gabriele Ford, Lena L Gill, William F Marx, David F KallmesAbstract:BACKGROUND AND PURPOSE: Previous investigators have described an association between polymethylmethacrylate (PMMA) use in hip arthroplasty and cardiovascular derangement. Our purpose was to evaluate the effects of PMMA injection on patient vital signs during Percutaneous Vertebroplasty. METHODS: We retrospectively reviewed patient charts at our institution to gather blood pressure, heart rate, and arterial oxygen saturation data for the following time points: before, during, 5 minutes after, and 10 minutes after PMMA injection during Percutaneous Vertebroplasty. These data were obtained for 142 injections (78 patients), and preinjection vital signs were compared with vital signs during and after PMMA injection. Multivariable regression modeling was used to ascertain the effects of cardiopulmonary comorbidities on vital signs. RESULTS: Mean arterial blood pressure and heart rate during, 5 minutes after, and 10 minutes after PMMA injection were not significantly different from their respective preprocedure values ( P = .19–.92). Values for oxygen saturation during PMMA injection and 5 minutes thereafter were not significantly different from preprocedure values ( P = .80 and .89, respectively). Oxygen saturation was significantly lower at 10 minutes after injection than before injection ( P = .007), although the mean difference was negligible (0.6%). CONCLUSION: We find no generalized association between PMMA injection during Percutaneous Vertebroplasty and systemic cardiovascular derangement.
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relevance of antecedent venography in Percutaneous Vertebroplasty for the treatment of osteoporotic compression fractures
American Journal of Neuroradiology, 2002Co-Authors: John R Gaughen, Timothy J Kaufmann, Mary E Jensen, William F Marx, Patricia A Schweickert, David F KallmesAbstract:BACKGROUND AND PURPOSE: Controversy exists regarding the utility of antecedent venography in Percutaneous Vertebroplasty. Our purpose was to determine whether antecedent venography improves clinical outcomes and/or decreases extravertebral cement extravasation in these procedures. METHODS: We retrospective reviewed outcomes of consecutive Percutaneous Vertebroplasty procedures performed at our institution to define two populations, each consisting of 24 patients treated at 42 vertebral levels. Group 1 included patients who underwent antecedent venography, and group 2 included patients treated without venography. Clinical outcomes were assessed with quantitative measurements of pain and mobility. Venograms and postprocedural radiographs were interpreted to evaluate the number of vertebrae with extravertebral cement extravasation, degree of extravasation at each level, and correlation between venography and Vertebroplasty. RESULTS: Pain improved in 19 of 20 group 1 patients, compared with 21 of 22 group 2 patients; mean postoperative pain levels were 1.3 and 1.8, respectively (P = .50), on a scale of 0 (no pain) to 10 (worst pain). All 11 group 1 patients with impaired preoperative mobility reported postoperative improvement, as did all 12 group 2 patients; mean levels of postoperative impaired mobility for groups 1 and 2 were 0.35 and 0.27, respectively (P = .43). Twenty-two of 42 vertebrae treated in group 1 demonstrated extravasation, compared with 28 of 42 in group 2 (P = .266); amounts of extravasation did not differ. Among 22 levels of extravasation in group 1, venograms in 14 showed correlative extravasation. CONCLUSION: Antecedent venography does not significantly improve the effectiveness or safety of Percutaneous Vertebroplasty performed by qualified, experienced operators.
Jongun Lee - One of the best experts on this subject based on the ideXlab platform.
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acute respiratory distress syndrome associated with pulmonary cement embolism following Percutaneous Vertebroplasty with polymethylmethacrylate
Spine, 2004Co-Authors: Kyung Yeon Yoo, Seong W Jeong, Woong Yoon, Jongun LeeAbstract:STUDY DESIGN A case of acute respiratory distress syndrome following Percutaneous Vertebroplasty is described. OBJECTIVE To alert clinicians to the potential occurrence of acute respiratory distress syndrome following use of polymethylmethacrylate bone cement. SUMMARY OF BACKGROUND DATA Noncardiogenic pulmonary edema has not been reported following intravertebral injection of polymethylmethacrylate. METHODS A 68-year-old woman underwent Percutaneous Vertebroplasty for a painful L5 compression fracture under local anesthesia. A contralateral transpedicular approach was made to inject polymethylmethacrylate. RESULTS On the third postoperative day, she developed arthralgia, myalgia, fever, and frequent coughing. Chest radiography revealed bilateral, multifocal, patchy consolidations, suggestive of acute respiratory distress syndrome, and a 5-cm-long tubular radiopacity in the right pulmonary artery. She died 20 days after the Vertebroplasty. CONCLUSION This case illustrates that clinicians must be aware of the potential occurrence of acute respiratory distress syndrome in patients who received Percutaneous Vertebroplasty.
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acute respiratory distress syndrome associated with pulmonary cement embolism following Percutaneous Vertebroplasty with polymethylmethacrylate
Spine, 2004Co-Authors: Kyung Yeon Yoo, Seong W Jeong, Woong Yoon, Jongun LeeAbstract:A case of acute respiratory distress syndrome following Percutaneous Vertebroplasty is described. To alert clinicians to the potential occurrence of acute respiratory distress syndrome following use of polymethylmethacrylate bone cement. Noncardiogenic pulmonary edema has not been reported following intravertebral injection of polymethylmethacrylate. A 68-year-old woman underwent Percutaneous Vertebroplasty for a painful L5 compression fracture under local anesthesia. A contralateral transpedicular approach was made to inject polymethylmethacrylate. On the third postoperative day, she developed arthralgia, myalgia, fever, and frequent coughing. Chest radiography revealed bilateral, multifocal, patchy consolidations, suggestive of acute respiratory distress syndrome, and a 5-cm-long tubular radiopacity in the right pulmonary artery. She died 20 days after the Vertebroplasty. This case illustrates that clinicians must be aware of the potential occurrence of acute respiratory distress syndrome in patients who received Percutaneous Vertebroplasty.
Louis A Gilula - One of the best experts on this subject based on the ideXlab platform.
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Percutaneous Vertebroplasty for malignant compression fractures with epidural involvement
Radiology, 2004Co-Authors: Joshua S Shimony, Louis A Gilula, Andrew J Zeller, Daniel B BrownAbstract:PURPOSE: To evaluate safety and effectiveness of performance of Percutaneous Vertebroplasty (PVP) in patients with malignant compression fractures and involvement of the epidural space. MATERIALS AND METHODS: PVP was performed in 50 patients with metastatic disease or multiple myeloma between June 1998 and April 2002. Twenty-five women (mean age, 62.3 years; range, 38–85 years) and 25 men (mean age, 63.1 years; range, 37–92 years) were included. Cases were retrospectively reviewed. Patients who had undergone cross-sectional imaging were classified into three groups. First group had no epidural involvement; second group, mild epidural involvement without contact with spinal cord or nerve roots; third group, moderate involvement and contact with spinal cord or nerve roots. Procedural safety was evaluated with review of all post-PVP complications and their treatment. Effectiveness was evaluated with follow-up phone calls for assessment of change in pain level and activity after PVP. Follow-up calls were perf...
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Percutaneous Vertebroplasty in patients with spinal canal compromise
American Journal of Roentgenology, 2004Co-Authors: Noah B Appel, Louis A GilulaAbstract:OBJECTIVE. The American College of Radiology Standard for Performance of Percutaneous Vertebroplasty lists as relative contraindications to the procedure conditions causing “significant spinal canal compromise.” We believe Percutaneous Vertebroplasty can be performed safely and efficaciously in individuals without radicular symptoms who present with canal compromise, with or without cord compression.MATERIALS AND METHODS. We reviewed all vertebroplasties performed at our institution over the past 4 years. Cases in which Vertebroplasty was performed at levels showing complete effacement of the epidural space, particularly those with cord compression, were included in the review. Follow-up data obtained from questionnaires routinely sent to our Vertebroplasty patients were used to evaluate symptomatic response in this subset of patients as well as the occurrence of any complications.RESULTS. Of 686 levels treated over the past 4 years, 26 levels in 23 patients qualified for our review. Follow-up ranged from...
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Percutaneous Vertebroplasty treatment of painful vertebral compression fractures with intraosseous vacuum phenomena
American Journal of Roentgenology, 2003Co-Authors: W C G Peh, Louis A Gilula, Michael S Gelbart, Dallas D PeckAbstract:OBJECTIVE. This study was undertaken to determine the efficacy of Percutaneous Vertebroplasty in treating patients with painful compression fractures of the thoracic and lumbar vertebrae that contain intraosseous vacuum phenomena.MATERIALS AND METHODS. Nineteen cases of painful vertebral compression fractures with intraosseous phenomena occurring in 18 patients (six men, 12 women; age range, 59-88 years; mean age, 75.5 years) were identified from 393 Percutaneous vertebroplasties performed in 199 patients during 32 and a half months. All patients had osteoporosis, with severe vertebral compression to less than one third of the vertebral body height in 13 of 19 cases. Affected levels were T6 (n = 1), T8 (n = 2), T9 (n = 1), T11 (n = 1), T12 (n = 4), L1 (n = 5), L2 (n = 2), L3 (n = 1), L4 (n = 1), and L5 (n = 1). All cases had the typical intravertebral body vacuum cleft appearance on radiographs. Imaging and clinical features were analyzed.RESULTS. The mean volume of polymethyl methacrylate injected was 7....
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Percutaneous Vertebroplasty indications contraindications and technique
British Journal of Radiology, 2003Co-Authors: W C G Peh, Louis A GilulaAbstract:Percutaneous Vertebroplasty is an emerging interventional technique in which surgical polymethylmethacrylate is injected via a large bore needle into a vertebral body under imaging guidance. This technique provides increased strength and pain relief in vertebrae weakened by a variety of bone diseases. The current indication for Vertebroplasty is intractable non-radicular pain caused by compression fractures due to osteoporosis, myeloma, metastases and aggressive vertebral haemangioma. Contraindications include bleeding disorder, unstable fracture and lack of definable vertebral collapse. Our technique of Percutaneous Vertebroplasty is illustrated in this pictorial review.
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Percutaneous Vertebroplasty for severe osteoporotic vertebral body compression fractures
Radiology, 2002Co-Authors: W C G Peh, Louis A Gilula, Dallas D PeckAbstract:PURPOSE: To determine the efficacy of Percutaneous Vertebroplasty in treating severe vertebral body compression fractures, or vertebra plana, in patients with osteoporosis. MATERIALS AND METHODS: In 155 patients, 310 Percutaneous vertebroplasties were performed during 25 months and 15 days. Of these, 37 patients (27 women, 10 men; mean age, 73.6 years) underwent 48 vertebroplasties for severe osteoporotic vertebral body compression fractures. The fractures were defined as vertebrae that have collapsed to less than one-third of their original height. Imaging and clinical features were analyzed, including the extent of vertebral collapse, location of the involved vertebra, pattern of vertebral compression, volume of polymethylmethacrylate injected, Vertebroplasty complications, and clinical outcome. RESULTS: Vertebral body collapse averaged 23% (range, 4.5%–33.0%) of the original height. Involved vertebrae were located from levels T5 to L5, with one-half affected at the thoracolumbar junction. Patterns of v...
Kyung Yeon Yoo - One of the best experts on this subject based on the ideXlab platform.
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acute respiratory distress syndrome associated with pulmonary cement embolism following Percutaneous Vertebroplasty with polymethylmethacrylate
Spine, 2004Co-Authors: Kyung Yeon Yoo, Seong W Jeong, Woong Yoon, Jongun LeeAbstract:STUDY DESIGN A case of acute respiratory distress syndrome following Percutaneous Vertebroplasty is described. OBJECTIVE To alert clinicians to the potential occurrence of acute respiratory distress syndrome following use of polymethylmethacrylate bone cement. SUMMARY OF BACKGROUND DATA Noncardiogenic pulmonary edema has not been reported following intravertebral injection of polymethylmethacrylate. METHODS A 68-year-old woman underwent Percutaneous Vertebroplasty for a painful L5 compression fracture under local anesthesia. A contralateral transpedicular approach was made to inject polymethylmethacrylate. RESULTS On the third postoperative day, she developed arthralgia, myalgia, fever, and frequent coughing. Chest radiography revealed bilateral, multifocal, patchy consolidations, suggestive of acute respiratory distress syndrome, and a 5-cm-long tubular radiopacity in the right pulmonary artery. She died 20 days after the Vertebroplasty. CONCLUSION This case illustrates that clinicians must be aware of the potential occurrence of acute respiratory distress syndrome in patients who received Percutaneous Vertebroplasty.
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acute respiratory distress syndrome associated with pulmonary cement embolism following Percutaneous Vertebroplasty with polymethylmethacrylate
Spine, 2004Co-Authors: Kyung Yeon Yoo, Seong W Jeong, Woong Yoon, Jongun LeeAbstract:A case of acute respiratory distress syndrome following Percutaneous Vertebroplasty is described. To alert clinicians to the potential occurrence of acute respiratory distress syndrome following use of polymethylmethacrylate bone cement. Noncardiogenic pulmonary edema has not been reported following intravertebral injection of polymethylmethacrylate. A 68-year-old woman underwent Percutaneous Vertebroplasty for a painful L5 compression fracture under local anesthesia. A contralateral transpedicular approach was made to inject polymethylmethacrylate. On the third postoperative day, she developed arthralgia, myalgia, fever, and frequent coughing. Chest radiography revealed bilateral, multifocal, patchy consolidations, suggestive of acute respiratory distress syndrome, and a 5-cm-long tubular radiopacity in the right pulmonary artery. She died 20 days after the Vertebroplasty. This case illustrates that clinicians must be aware of the potential occurrence of acute respiratory distress syndrome in patients who received Percutaneous Vertebroplasty.
Terrence H Diamond - One of the best experts on this subject based on the ideXlab platform.
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clinical outcomes after acute osteoporotic vertebral fractures a 2 year non randomised trial comparing Percutaneous Vertebroplasty with conservative therapy
The Medical Journal of Australia, 2006Co-Authors: Terrence H Diamond, Carl Bryant, Lois Browne, William A ClarkAbstract:Objective: To assess the safety and efficacy of Percutaneous Vertebroplasty for the treatment of acute osteoporotic vertebral fractures. Design: A prospective, non-randomised, intention-to-treat 2-year study. Patients and setting: 126 consecutive patients (39 men and 87 women, aged 51-95 years) with acute osteoporotic vertebral fractures presenting to St George Hospital from November 2000 to December 2002. They comprised 88 patients treated by Percutaneous Vertebroplasty and 38 by conservative therapy. Main outcome measures: Primary outcomes - changes in patients' pain score and level of function recorded at 24 hours, 6 weeks, 6-12 months and 24 months after therapy. Secondary outcomes - occurrence of new clinical or radiological vertebral fractures and survival at 2 years. Results: Three minor complications (fractured pedicle and psoas muscle haemorrhage) occurred in the Vertebroplasty group during the first year of the study. Outcomes in Vertebroplasty-treated patients (60% reduction in visual analogue pain scores from 20 to 8; P < 0.001), a rapid return to normal function (29% improvement in physical functioning from 14 to 18; P < 0.001) and lower rates of hospitalisation (43% reduction in the mean number of hospital bed-days occupied) were better than those treated conservatively (P< 0.001 for the comparison of all variables at 24 hours). Lower pain scores persisted in the Vertebroplasty-treated group at 6 weeks (P< 0.001), but no differences between the two groups were evident at 12 and 24 months. In the Vertebroplasty-treated group compared with the control group, the rates of new vertebral fractures (clinically and by radiographic assessment) (hazard ratio, 1.13; 95% Cl, 0.52-2.46; P=0.76) and death (hazard ratio, 1.07; 95% Cl, 0.42-2.76; P= 0.89) showed no significant difference. Conclusion: The analgesic benefit of Percutaneous Vertebroplasty and the low complication rates suggest that it is a useful therapy for acute painful osteoporotic vertebral fractures.
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Percutaneous Vertebroplasty for acute vertebral body fracture and deformity in multiple myeloma a short report
British Journal of Haematology, 2004Co-Authors: Terrence H Diamond, Tabitha Hartwell, William Clarke, Arumugam ManoharanAbstract:We describe seven patients with multiple myeloma who were treated for acute vertebral body fractures with Percutaneous Vertebroplasty to a total of 14 vertebrae. Six of the seven patients had at least a 50% decrease in their pain scores at 24 h following Vertebroplasty. There were no procedure-related complications. These encouraging results prompt us to suggest further large-scale evaluation of this procedure in myeloma patients.
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management of acute osteoporotic vertebral fractures a nonrandomized trial comparing Percutaneous Vertebroplasty with conservative therapy
The American Journal of Medicine, 2003Co-Authors: Terrence H Diamond, Bernard Champion, William A ClarkAbstract:PURPOSE: We sought to determine whether Percutaneous Vertebroplasty—which involves the injection of cement to stabilize a fractured vertebral body—may be an effective treatment for vertebral fracture. METHODS: We enrolled 79 consecutive osteoporotic patients (24 men and 55 women; ages 51 to 93 years) presenting with acute vertebral fractures. Clinical characteristics and bone densitometry were measured at baseline. Pain scores (o na0t o 25 scale) and levels of function (o na0t o 20scale) were recorded on presentation, at 24 hours, at 6 weeks, and 6 to 12 months after therapy. RESULTS: Fifty-five patients (70%) were treated by Percutaneous Vertebroplasty and 24 (30%) were treated by conservative therapy alone. They were followed for a mean of 215 days (range, 57 to 399 days). The baseline clinical characteristics, bone densitometry, and fracture data were similar in the two groups. Twenty-four hours after Vertebroplasty, there was a 53% reduction in pain scores (from 19 to 9; P 0.0001) and a 29% improvement in physical functioning (from 14 to 18; P 0.0001), whereas pain scores and physical functioning remained unchanged at 24 hours in the patients treated conservatively (both P 0.0001 compared with the changes after Percutaneous Vertebroplasty). Thirteen patients (24%) treated by Percutaneous Vertebroplasty were able to cease all analgesia after 24 hours (P 0.0001 compared with none of the 24 patients treated conservatively). Clinical outcomes at 6 weeks and 6 to 12 months were similar in both groups. CONCLUSION: When compared with conservative therapy, Percutaneous Vertebroplasty results in prompt pain relief and rapid rehabilitation. In experienced hands, it is a safe and effective procedure for treating acute osteoporotic vertebral compression fractures. Am J Med. 2003;114:257–265. ©2003 by Excerpta Medica Inc.
