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1.
Cardiovasc Intervent Radiol ; 45(9): 1314-1321, 2022 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-35680675

RESUMEN

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 (χ2(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.


Asunto(s)
Fracturas por Compresión , Fracturas Osteoporóticas , Fracturas de la Columna Vertebral , Vertebroplastia , Dolor de Espalda/etiología , Femenino , Fracturas por Compresión/diagnóstico por imagen , Fracturas por Compresión/etiología , Fracturas por Compresión/terapia , Humanos , Fracturas Osteoporóticas/cirugía , Estudios Prospectivos , Estudios Retrospectivos , Fracturas de la Columna Vertebral/cirugía , Resultado del Tratamiento , Vertebroplastia/métodos
2.
Eur Radiol Exp ; 6(1): 3, 2022 01 27.
Artículo en Inglés | MEDLINE | ID: mdl-35083595

RESUMEN

BACKGROUND: A procedure for sentinel lymph node biopsy (SLNB) using superparamagnetic iron-oxide (SPIO) nanoparticles and intraoperative sentinel lymph node (SLN) detection was developed to overcome drawbacks associated with the current standard-of-care SLNB. However, residual SPIO nanoparticles can result in void artefacts at follow-up magnetic resonance imaging (MRI) scans. We present a grading protocol to quantitatively assess the severity of these artefacts and offer an option to minimise the impact of SPIO nanoparticles on diagnostic imaging. METHODS: Follow-up mammography and MRI of two patient groups after a magnetic SLNB were included in the study. They received a 2-mL subareolar dose of SPIO (high-dose, HD) or a 0.1-mL intratumoural dose of SPIO (low-dose, LD). Follow-up mammography and MRI after magnetic SLNB were acquired within 4 years after breast conserving surgery (BCS). Two radiologists with over 10-year experience in breast imaging assessed the images and analysed the void artefacts and their impact on diagnostic follow-up. RESULTS: A total of 19 patients were included (HD, n = 13; LD, n = 6). In the HD group, 9/13 patients displayed an artefact on T1-weighted images up to 3.6 years after the procedure, while no impact of the SPIO remnants was observed in the LD group. CONCLUSIONS: SLNB using a 2-mL subareolar dose of magnetic tracer in patients undergoing BCS resulted in residual artefacts in the breast in the majority of patients, which may hamper follow-up MRI. This can be avoided by using a 0.1-mL intratumoural dose.


Asunto(s)
Ganglio Linfático Centinela , Mama , Humanos , Imagen por Resonancia Magnética , Mastectomía Segmentaria , Ganglio Linfático Centinela/diagnóstico por imagen , Ganglio Linfático Centinela/cirugía , Biopsia del Ganglio Linfático Centinela
3.
Aesthet Surg J ; 40(2): 156-164, 2020 01 29.
Artículo en Inglés | MEDLINE | ID: mdl-31242279

RESUMEN

BACKGROUND: Breast implant-related health problems are a subject of fierce debate. Reliable population-based estimates of implant prevalence rates are not available, however, due to a lack of historical registries and incomplete sales data, precluding absolute risk assessments. OBJECTIVES: This study aimed to describe the methodology of a novel procedure to determine Dutch breast implant prevalence based on the evaluation of routine chest radiographs. METHODS: The validity of the new method was first examined in a separate study. Eight reviewers examined a series of 180 chest radiographs with (n = 60) or without (n = 120) a breast implant confirmed by a computed tomography or magnetic resonance imaging scan. After a consensus meeting with best-performing expert reviewers, we reviewed 3000 chest radiographs of women aged 20 to 70 years in 2 large regional hospitals in the Netherlands in 2015. To calculate the national breast implant prevalence, regional prevalence variations were corrected utilizing the National Breast Cancer Screening Program. RESULTS: Eight reviewers scored with a median sensitivity of 71.7% (range, 41.7%-85.0%) and a median specificity of 94.6% (range, 73.4%-97.5%). After a consensus meeting and a reevaluation by best-performing expert reviewers, sensitivity was 79.9% and specificity was 99.2%. The estimated national prevalence of breast implants among women between 20 and 70 years was 3.0%, ranging from 1.7% at 21 to 30 years to 3.9% between 51 and 60 years. CONCLUSIONS: The novel method in this study was validated with a high sensitivity and specificity, resulting in accurate prevalence estimates and providing the opportunity to conduct absolute risk assessment studies on the health consequences of breast implants.


Asunto(s)
Implantes de Mama/estadística & datos numéricos , Mamografía/métodos , Adulto , Anciano , Neoplasias de la Mama/diagnóstico por imagen , Femenino , Humanos , Imagen por Resonancia Magnética , Persona de Mediana Edad , Países Bajos/epidemiología , Prevalencia , Medición de Riesgo , Sensibilidad y Especificidad , Tomografía Computarizada por Rayos X , Adulto Joven
4.
Cardiovasc Intervent Radiol ; 42(7): 991-1000, 2019 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-30941490

RESUMEN

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 (χ2(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 (χ2(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.


Asunto(s)
Estatura , Fracturas por Compresión/cirugía , Fracturas Osteoporóticas/cirugía , Manejo del Dolor/métodos , Fracturas de la Columna Vertebral/cirugía , Vertebroplastia/métodos , Anciano , Cementos para Huesos/uso terapéutico , Femenino , Estudios de Seguimiento , Fracturas por Compresión/complicaciones , Humanos , Masculino , Países Bajos , Fracturas Osteoporóticas/complicaciones , Dolor/etiología , Estudios Prospectivos , Factores de Riesgo , Fracturas de la Columna Vertebral/complicaciones , Columna Vertebral/cirugía , Resultado del Tratamiento , Vertebroplastia/efectos adversos
5.
Cancer Imaging ; 18(1): 44, 2018 Nov 26.
Artículo en Inglés | MEDLINE | ID: mdl-30477587

RESUMEN

PURPOSE: To compare diffusion tensor imaging (DTI), intravoxel incoherent motion (IVIM), and tri-exponential models of the diffusion magnetic resonance imaging (MRI) signal for the characterization of renal lesions in relationship to histopathological findings. METHODS: Sixteen patients planned to undergo nephrectomy for kidney tumour were scanned before surgery at 3 T magnetic resonance imaging (MRI), with T2-weighted imaging, DTI and diffusion weighted imaging (DWI) using ten b-values. DTI parameters (mean diffusivity [MD] and fractional anisotropy [FA]) were obtained by iterative weighted linear least squared fitting of the DTI data and bi-, and tri-exponential fit parameters (Dbi, fstar,and Dtri, ffast,finterm) using a nonlinear fit of the multiple b-value DWI data. Average parameters were calculated for regions of interest, selecting the lesions and healthy kidney tissue. Tumour type and specificities were determined after surgery by histological examination. Mean parameter values of healthy tissue and solid lesions were compared using a Wilcoxon-signed ranked test and MANOVA. RESULTS: Thirteen solid lesions (nine clear cell carcinomas, two papillary renal cell carcinoma, one haemangioma and one oncocytoma) and four cysts were included. The mean MD of solid lesions are significantly (p < 0.05) lower than healthy cortex and medulla, (1.94 ± 0.32*10- 3 mm2/s versus 2.16 ± 0.12*10- 3 mm2/s and 2.21 ± 0.14*10- 3 mm2/s, respectively) whereas ffast is significantly higher (7.30 ± 3.29% versus 4.14 ± 1.92% and 4.57 ± 1.74%) and finterm is significantly lower (18.7 ± 5.02% versus 28.8 ± 5.09% and 26.4 ± 6.65%). Diffusion coefficients were high (≥2.0*10- 3 mm2/s for MD, 1.90*10- 3 mm2/s for Dbi and 1.6*10- 3 mm2/s for Dtri) in cc-RCCs with cystic structures and/or haemorrhaging and low (≤1.80*10- 3 mm2/s for MD, 1.40*10- 3 mm2/s for Dbi and 1.05*10- 3 mm2/s for Dtri) in tumours with necrosis or sarcomatoid differentiation. CONCLUSION: Parameters derived from a two- or three-component fit of the diffusion signal are sensitive to histopathological features of kidney lesions.


Asunto(s)
Imagen de Difusión por Resonancia Magnética/métodos , Imagen de Difusión Tensora/métodos , Neoplasias Renales/diagnóstico por imagen , Anciano , Imagen de Difusión por Resonancia Magnética/normas , Imagen de Difusión Tensora/normas , Femenino , Humanos , Neoplasias Renales/patología , Masculino , Persona de Mediana Edad , Reproducibilidad de los Resultados
6.
BMJ ; 361: k1551, 2018 05 09.
Artículo en Inglés | MEDLINE | ID: mdl-29743284

RESUMEN

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.


Asunto(s)
Dolor de Espalda/cirugía , Cementos para Huesos/uso terapéutico , Fracturas por Compresión/cirugía , Fracturas Osteoporóticas/cirugía , Fracturas de la Columna Vertebral/cirugía , Vertebroplastia , Anciano , Anciano de 80 o más Años , Dolor de Espalda/fisiopatología , Evaluación de la Discapacidad , Método Doble Ciego , Femenino , Fracturas por Compresión/fisiopatología , Humanos , Masculino , Fracturas Osteoporóticas/fisiopatología , Evaluación de Resultado en la Atención de Salud , Dimensión del Dolor , Complicaciones Posoperatorias , Fracturas de la Columna Vertebral/fisiopatología
7.
Eur J Surg Oncol ; 44(5): 700-707, 2018 05.
Artículo en Inglés | MEDLINE | ID: mdl-29449047

RESUMEN

PURPOSE: This study aimed to validate and update a model for predicting the risk of axillary lymph node (ALN) metastasis for assisting clinical decision-making. METHODS: We included breast cancer patients diagnosed at six Dutch hospitals between 2011 and 2015 to validate the original model which includes six variables: clinical tumor size, tumor grade, estrogen receptor status, lymph node longest axis, cortical thickness and hilum status as detected by ultrasonography. Subsequently, we updated the original model using generalized linear model (GLM) tree analysis and by adjusting its intercept and slope. The area under the receiver operator characteristic curve (AUC) and calibration curve were used to assess the original and updated models. Clinical usefulness of the model was evaluated by false-negative rates (FNRs) at different cut-off points for the predictive probability. RESULTS: Data from 1416 patients were analyzed. The AUC for the original model was 0.774. Patients were classified into four risk groups by GLM analysis, for which four updated models were created. The AUC for the updated models was 0.812. The calibration curves showed that the updated model predictions were better in agreement with actual observations than the original model predictions. FNRs of the updated models were lower than the preset 10% at all cut-off points when the predictive probability was less than 12.0%. CONCLUSIONS: The original model showed good performance in the Dutch validation population. The updated models resulted in more accurate ALN metastasis prediction and could be useful preoperative tools in selecting low-risk patients for omission of axillary surgery.


Asunto(s)
Neoplasias de la Mama/patología , Carcinoma/patología , Ganglios Linfáticos/patología , Adulto , Anciano , Área Bajo la Curva , Axila , Neoplasias de la Mama/metabolismo , Neoplasias de la Mama/cirugía , Carcinoma/metabolismo , China , Técnicas de Apoyo para la Decisión , Femenino , Humanos , Modelos Lineales , Escisión del Ganglio Linfático , Ganglios Linfáticos/diagnóstico por imagen , Metástasis Linfática , Mastectomía , Persona de Mediana Edad , Clasificación del Tumor , Estadificación de Neoplasias , Países Bajos , Receptor ErbB-2/metabolismo , Receptores de Estrógenos/metabolismo , Receptores de Progesterona/metabolismo , Reproducibilidad de los Resultados , Biopsia del Ganglio Linfático Centinela , Carga Tumoral , Ultrasonografía
8.
JAMA Oncol ; 4(3): 335-341, 2018 Mar 01.
Artículo en Inglés | MEDLINE | ID: mdl-29302687

RESUMEN

IMPORTANCE: Breast implants are among the most commonly used medical devices. Since 2008, the number of women with breast implants diagnosed with anaplastic large-cell lymphoma in the breast (breast-ALCL) has increased, and several reports have suggested an association between breast implants and risk of breast-ALCL. However, relative and absolute risks of breast-ALCL in women with implants are still unknown, precluding evidence-based counseling about implants. OBJECTIVE: To determine relative and absolute risks of breast-ALCL in women with breast implants. DESIGN, SETTING, AND PARTICIPANTS: Through the population-based nationwide Dutch pathology registry we identified all patients diagnosed with primary non-Hodgkin lymphoma in the breast between 1990 and 2016 and retrieved clinical data, including breast implant status, from the treating physicians. We estimated the odds ratio (OR) of ALCL associated with breast implants in a case-control design, comparing implant prevalence between women with breast-ALCL and women with other types of breast lymphoma. Cumulative risk of breast-ALCL was derived from the age-specific prevalence of breast implants in Dutch women, estimated from an examination of 3000 chest x-rays and time trends from implant sales. MAIN OUTCOMES AND MEASURES: Relative and absolute risks of breast-ALCL in women with breast implants. RESULTS: Among 43 patients with breast-ALCL (median age, 59 years), 32 had ipsilateral breast implants, compared with 1 among 146 women with other primary breast lymphomas (OR, 421.8; 95% CI, 52.6-3385.2). Implants among breast-ALCL cases were more often macrotextured (23 macrotextured of 28 total implants of known type, 82%) than expected (49 193 sold macrotextured implants of total sold 109 449 between 2010 and 2015, 45%) based on sales data (P < .001). The estimated prevalence of breast implants in women aged 20 to 70 years was 3.3%. Cumulative risks of breast-ALCL in women with implants were 29 per million at 50 years and 82 per million at 70 years. The number of women with implants needed to cause 1 breast-ALCL case before age 75 years was 6920. CONCLUSIONS AND RELEVANCE: Breast implants are associated with increased risk of breast-ALCL, but the absolute risk remains small. Our results emphasize the need for increased awareness among the public, medical professionals, and regulatory bodies, promotion of alternative cosmetic procedures, and alertness to signs and symptoms of breast-ALCL in women with implants.


Asunto(s)
Implantes de Mama/efectos adversos , Implantes de Mama/estadística & datos numéricos , Neoplasias de la Mama/epidemiología , Neoplasias de la Mama/etiología , Linfoma Anaplásico de Células Grandes/epidemiología , Linfoma Anaplásico de Células Grandes/etiología , Adulto , Anciano , Implantación de Mama/efectos adversos , Implantación de Mama/estadística & datos numéricos , Estudios de Casos y Controles , Susceptibilidad a Enfermedades/epidemiología , Susceptibilidad a Enfermedades/etiología , Femenino , Humanos , Persona de Mediana Edad , Países Bajos/epidemiología , Riesgo , Factores de Riesgo
9.
Br J Radiol ; 88(1056): 20150634, 2015.
Artículo en Inglés | MEDLINE | ID: mdl-26492466

RESUMEN

OBJECTIVE: Sentinel lymph node biopsy (SLNB) with a superparamagnetic iron oxide (SPIO) tracer was shown to be non-inferior to the standard combined technique in the SentiMAG Multicentre Trial. The MRI subprotocol of this trial aimed to develop a magnetic alternative for pre-operative lymphoscintigraphy (LS). We evaluated the feasibility of using MRI following the administration of magnetic tracer for pre-operative localization of sentinel lymph nodes (SLNs) and its potential for non-invasive identification of lymph node (LN) metastases. METHODS: Patients with breast cancer scheduled to undergo SLNB were recruited for pre-operative LS, single photon emission CT (SPECT)-CT and SPIO MRI. T1 weighted turbo spin echo and T2 weighted gradient echo sequences were used before and after interstitial injection of magnetic tracer into the breast. SLNs on MRI were defined as LNs with signal drop and direct lymphatic drainage from the injection site. LNs showing inhomogeneous SPIO uptake were classified as metastatic. During surgery, a handheld magnetometer was used for SLNB. Blue or radioactive nodes were also excised. The number of SLNs and MR assessment of metastatic involvement were compared with surgical and histological outcomes. RESULTS: 11 patients were recruited. SPIO MRI successfully identified SLNs in 10 of 11 patients vs 11 of 11 patients with LS/SPECT-CT. One patient had metastatic involvement of four LNs, and this was identified in one node on pre-operative MRI. CONCLUSION: SPIO MRI is a feasible technique for pre-operative localization of SLNs and, in combination with intraoperative use of a handheld magnetometer, provides an entirely radioisotope-free technique for SLNB. Further research is needed for the evaluation of MRI characterization of LN involvement using subcutaneous injection of magnetic tracer. ADVANCES IN KNOWLEDGE: This study is the first to demonstrate that an interstitially administered magnetic tracer can be used both for pre-operative imaging and intraoperative SLNB, with equal performance to imaging and localization with radioisotopes.


Asunto(s)
Neoplasias de la Mama/patología , Dextranos , Aumento de la Imagen , Ganglios Linfáticos/patología , Imagen por Resonancia Magnética , Nanopartículas de Magnetita , Cuidados Preoperatorios , Anciano , Medios de Contraste , Estudios de Factibilidad , Femenino , Humanos , Metástasis Linfática , Persona de Mediana Edad , Biopsia del Ganglio Linfático Centinela
10.
Trials ; 12: 93, 2011 Apr 05.
Artículo en Inglés | MEDLINE | ID: mdl-21466679

RESUMEN

BACKGROUND: The standard care in patients with a painful osteoporotic vertebral compression fracture (VCF) is conservative therapy. Percutaneous vertebroplasty (PV), a minimally invasive technique, is a new treatment option. Recent randomized controlled trials (RCT) provide conflicting results: two sham-controlled studies showed no benefit of PV while an unmasked but controlled RCT (VERTOS II) found effective pain relief at acceptable costs. The objective of this study is to compare pain relief after PV with a sham intervention in selected patients with an acute osteoporotic VCF using the same strict inclusion criteria as in VERTOS II. Secondary outcome measures are back pain related disability and quality of life. METHODS: The VERTOS IV study is a prospective, multicenter RCT with pain relief as primary endpoint. Patients with a painful osteoporotic VCF with bone edema on MR imaging, local back pain for 6 weeks or less, osteopenia and aged 50 years or older, after obtaining informed consent, are included and randomized for PV or a sham intervention. In total 180 patients will be enrolled. Follow-up is at regular intervals during a 1-year period with a standard Visual Analogue Scale (VAS) score for pain and pain medication. Necessary additional therapies and complications are recorded. DISCUSSION: The VERTOS IV study is a methodologically sound RCT designed to assess pain relief after PV compared to a sham intervention in patients with an acute osteoporotic VCF selected on strict inclusion criteria. TRIAL REGISTRATION: This study is registered at ClinicalTrials.gov., NCT01200277.


Asunto(s)
Dolor de Espalda/cirugía , Fracturas por Compresión/cirugía , Osteoporosis/complicaciones , Proyectos de Investigación , Fracturas de la Columna Vertebral/cirugía , Vertebroplastia , Enfermedad Aguda , Analgésicos/uso terapéutico , Dolor de Espalda/diagnóstico , Dolor de Espalda/etiología , Evaluación de la Discapacidad , Fracturas por Compresión/diagnóstico , Fracturas por Compresión/etiología , Humanos , Imagen por Resonancia Magnética , Persona de Mediana Edad , Países Bajos , Osteoporosis/diagnóstico , Dimensión del Dolor , Estudios Prospectivos , Calidad de Vida , Fracturas de la Columna Vertebral/diagnóstico , Fracturas de la Columna Vertebral/etiología , Resultado del Tratamiento
11.
Neuroradiology ; 53(1): 19-22, 2011 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-20442991

RESUMEN

INTRODUCTION: During percutaneous vertebroplasty (PV), perivertebral cement leakage frequently occurs. There is some concern that cement deposits may migrate towards the lungs via the veins during follow-up. We used baseline and follow-up computed tomography (CT) to assess the incidence and extend of late cement migration in a large consecutive patient cohort. METHODS: VERTOS II is a prospective multicenter randomized controlled trial comparing PV with conservative therapy for osteoporotic vertebral compression fractures (OVCFs). Patients assigned to PV had baseline postprocedural CT scans of the treated vertebral bodies. After a mean follow-up of 22 months, 54 of 78 patients (69%) had follow-up CT. CT scans were analyzed and compared for perivertebral venous, discal, and soft tissue leakage. RESULTS: Perivertebral cement leakage occurred in 64 of 80 treated vertebrae (80%; 95% CI, 70% to 87%). All patients remained asymptomatic. Perivertebral venous leakage was present in 56 vertebrae (88%), mostly in the anterior external venous plexus (46 of 56, 82%). Discal leakage occurred in 22 of 64 vertebrae (34%) and soft tissue leakage in two of 64 (4%). Mean injected cement volume in vertebrae with leakage was higher (4.5 versus 3.7 cm(3), p = 0.04). Follow-up CT scan showed unchanged perivertebral cement leakages without late cement migration. CONCLUSION: Perivertebral cement leaks during PV for OVCFs occurred frequently in the VERTOS II trial. Cement leakage occurred more frequently with higher injected volumes. However, all patients remained asymptomatic, and late cement migration during follow-up did not occur. Standard postprocedural CT of the treated vertebral body in PV is not necessary.


Asunto(s)
Cementos para Huesos/efectos adversos , Extravasación de Materiales Terapéuticos y Diagnósticos/diagnóstico por imagen , Extravasación de Materiales Terapéuticos y Diagnósticos/etiología , Tomografía Computarizada por Rayos X/métodos , Vertebroplastia/efectos adversos , Adulto , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Países Bajos , Cuidados Posoperatorios/métodos , Resultado del Tratamiento , Adulto Joven
12.
J Vasc Interv Radiol ; 21(9): 1405-9, 2010 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-20800779

RESUMEN

PURPOSE: The authors prospectively determined the natural course of pain in patients with conservatively treated acute osteoporotic vertebral compression fractures (VCF). In addition, the type of conservative therapy that these patients received was assessed. MATERIALS AND METHODS: Patients older than 50 years, referred for spine radiography for acute back pain, were asked to complete a baseline clinical questionnaire. Patients with an acute VCF were followed up at 6 and 23 months with a questionnaire that included a Visual Analog Score (VAS) and type of pain medication and other conservative treatment. Significant pain relief was defined as a decrease in VAS of 50% or more. RESULTS: Forty-nine patients (mean age, 78 years; range, 51-95) with acute VCF were followed up for almost 2 years. Significant pain relief was noted in 22 of 35 patients (63%) at 6 months and in 25 of 36 (69%) at 23 months. In patients with persisting pain at 23 months (mean VAS 6.4), some decrease in VAS was apparent at 6 months but not in the 6-23 months interval. No predictors for significant pain relief could be identified. Patients with significant pain relief used less pain medication and had less physical therapy. CONCLUSIONS: In most patients with an acute VCF, pain decreases significantly with conservative therapy, predominantly in the first 6 months. However, almost 2 years after an acute VCF, a third of patients still had severe pain necessitating pain medication and physical therapy in the majority. No predictors for transition from acute to chronic pain could be identified.


Asunto(s)
Analgesia , Dolor de Espalda/terapia , Fracturas por Compresión/terapia , Osteoporosis/complicaciones , Fracturas de la Columna Vertebral/terapia , Enfermedad Aguda , Anciano , Anciano de 80 o más Años , Analgesia/métodos , Analgésicos/uso terapéutico , Dolor de Espalda/etiología , Enfermedad Crónica , Progresión de la Enfermedad , Femenino , Estudios de Seguimiento , Curación de Fractura , Fracturas por Compresión/diagnóstico por imagen , Fracturas por Compresión/etiología , Humanos , Modelos Logísticos , Masculino , Persona de Mediana Edad , Países Bajos , Procedimientos Ortopédicos , Osteoporosis/diagnóstico por imagen , Dimensión del Dolor , Modalidades de Fisioterapia , Estudios Prospectivos , Radiografía , Medición de Riesgo , Factores de Riesgo , Fracturas de la Columna Vertebral/diagnóstico por imagen , Fracturas de la Columna Vertebral/etiología , Encuestas y Cuestionarios , Factores de Tiempo , Resultado del Tratamiento
13.
Lancet ; 376(9746): 1085-92, 2010 Sep 25.
Artículo en Inglés | MEDLINE | ID: mdl-20701962

RESUMEN

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.


Asunto(s)
Cementos para Huesos/uso terapéutico , Fracturas por Compresión/terapia , Osteoporosis/complicaciones , Manejo del Dolor , Fracturas de la Columna Vertebral/terapia , Vertebroplastia , Anciano , Anciano de 80 o más Años , Bélgica , Cementos para Huesos/economía , Análisis Costo-Beneficio , Femenino , Fracturas por Compresión/economía , Fracturas por Compresión/etiología , Fracturas por Compresión/cirugía , Humanos , Masculino , Persona de Mediana Edad , Países Bajos , Dolor/etiología , Dimensión del Dolor , Estudios Prospectivos , Años de Vida Ajustados por Calidad de Vida , Fracturas de la Columna Vertebral/economía , Fracturas de la Columna Vertebral/etiología , Fracturas de la Columna Vertebral/cirugía , Encuestas y Cuestionarios , Factores de Tiempo , Resultado del Tratamiento , Vertebroplastia/economía
14.
J Vasc Interv Radiol ; 18(7): 835-41, 2007 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-17609441

RESUMEN

PURPOSE: To evaluate clinical and magnetic resonance (MR) imaging results after uterine artery embolization (UAE) in women with symptomatic adenomyosis with or without uterine leiomyomas. MATERIALS AND METHODS: Thirty-eight women with symptomatic adenomyosis with or without uterine leiomyomas were treated with UAE with calibrated tris-acryl gelatin microspheres. Based on MR findings, women were categorized as having pure adenomyosis (group A; n = 15), adenomyosis dominance with fibroid tumors (group B; n = 14), or fibroid tumor dominance with adenomyosis (group C; n = 9). RESULTS: Heavy menstrual bleeding, pain, and bulk-related symptoms at last follow-up at a median of 16.5 months (range, 3-38 months) were compared with baseline symptoms. With follow-up MR imaging at a median of 12 months (range, 3-36 months), changes in uterine volume, leiomyoma volume, junctional zone thickness, and contrast enhancement of adenomyosis were assessed. After embolization, adenomyosis infarction could be depicted on contrast medium-enhanced MR in 44.1% of cases. Median reductions of uterine volume, fibroid tumor volume, and junctional zone thickness were 44.8%, 77.1%, and 23.9%, respectively. In group A, three patients needed additional surgery after UAE, in addition to two in group B and one in group C. In the remaining 32 patients, except for one patient in group C, all preexisting symptoms (eg, bleeding, pain, bulk-related symptoms) improved or resolved after UAE. Overall, 84.2% of women were satisfied with the results of UAE. CONCLUSION: In this study, midterm results (at a median of 16.5 months) showed that UAE in symptomatic adenomyosis with or without uterine leiomyomas is effective. Hysterectomy was avoided in the vast majority of patients. MR imaging showed reduction of uterine volume and junctional zone thickness.


Asunto(s)
Resinas Acrílicas/uso terapéutico , Endometriosis/terapia , Gelatina/uso terapéutico , Leiomioma/terapia , Imagen por Resonancia Magnética/métodos , Neoplasias Uterinas/terapia , Adulto , Medios de Contraste , Embolización Terapéutica , Endometriosis/complicaciones , Endometriosis/diagnóstico , Femenino , Estudios de Seguimiento , Gadolinio DTPA , Humanos , Yohexol , Yopamidol/análogos & derivados , Leiomioma/diagnóstico , Persona de Mediana Edad , Estudios Prospectivos , Resultado del Tratamiento , Neoplasias Uterinas/diagnóstico , Útero/irrigación sanguínea , Útero/patología
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