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Impact of a compression garment, on top of the usual care, in patients with breast cancer with early disturbance of the lymphatic transport: protocol of a randomised controlled trial

Introduction Breast cancer-related lymphoedema (BCRL) is a common phenomenon. When lymphoedema is diagnosed late, options for treatment are diminished. Therefore, early diagnosis and treatment are very important to alter the potential deleterious evolution. Lymphofluoroscopy visualises the superficial lymphatic architecture in detail, giving the opportunity to detect a disturbance in the lymphatic transport (ie, dermal backflow) before the lymphoedema is clinically visible.The main objective is to investigate if there is an additional effect of a compression garment on top of the usual care (ie, information and exercises) in patients with early disturbance of the lymphatic transport after breast cancer treatment. Development of clinical lymphoedema and/or deterioration of the dermal backflow visualised by lymphofluoroscopy is investigated.Methodology All patients scheduled for breast cancer surgery with unilateral axillary lymph node dissection or sentinel node biopsy in the Multidisciplinary Breast Clinic of the University Hospitals Leuven are being considered. Patients are assessed before surgery and at 1, 3, 6, 9, 12, 18, 24 and 36 months postoperatively. At each visit, a clinical assessment is performed determining the volume difference between both arms and hands (through circumference measurements and water displacement), the water content, the extracellular fluid, the pitting status and the skinfold thickness. Quality of life questionnaires are filled in. At each visit, a lymphofluoroscopy is performed as well. When a disturbance of the lymphatic transport is seen on lymphofluoroscopy, without the presence of clinical lymphoedema, the patient is randomised in either a control group receiving usual care or a preventive treatment group receiving usual care and a compression garment (whether or not combined with a glove).Ethics and dissemination The trial is conducted in compliance with the principles of the Declaration of Helsinki (2008), the principles of Good Clinical Practice and in accordance with all applicable regulatory requirements. This protocol has been approved by the Ethical Committee of the University Hospitals Leuven. Results will be disseminated by peer-reviewed scientific journals and presentation at international congresses.Trial registration number NCT03210311Conclusion The investigators hypothesise that development of clinical BCRL can be prevented and/or the dermal backflow can be stabilised or improved, if a preventive treatment with compression garment is started in the early phase of disturbance

The influence of gender on patency rates after iliac artery stenting

ObjectiveThe purpose of this study was to investigate the influence of gender on the long-term outcome after iliac artery stenting and to assess gender-specific differences of the influence of risk factors on treatment success and patency rates.MethodsBetween January 2000 and December 2006, 404 percutaneous transluminal angioplasties with primary stent deployment for symptomatic iliac artery occlusive disease were performed at our center. These included 128 interventions in women and 276 interventions in men.ResultsWhereas average age was significantly higher (65.9 ± 12.9 years; P = .007) and arterial hypertension more frequent (60.9% vs 49.3%; P = .032) in women, hyperuricemia (7.0% vs 14.1%; P = .047) and a positive smoking status (61.7% vs 74.3%; P = .014) were more frequently observed in men. Fontaine stage was more advanced (stages III and IV) in women than in men (P = .028; P < .001). Technical success was 97.7% in women and 99.3% in men. Overall complication rate was higher in women compared with men (P = .002), mostly caused by access site hematomas (4.7% vs 0.4%) and pseudoaneurysms (8.6% vs 2.5%). Patients were followed up for 45.0 ± 33.3 months. Restenosis developed in 16.8% of cases in women and in 14.6% of cases in men and was treated in 73.7% by an endovascular approach. Primary patency rates at 1, 3, 5, and 7 years were 90.3%, 77.2%, 60.2%, and 46.4% in women and 89.9%, 71.5%, 63.6%, and 59.7% in men, respectively (P = .524; log-rank, .406). Secondary patency rates were 97.2%, 91%, 81.5%, and 70.3% in women and 97.1%, 89.1%, 82.6%, and 78% in men, respectively (P = .959; log-rank, .003). Multivariate analysis identified lower age as the only independent risk factor for recurrent disease in both groups. Age-defined subgroup analysis showed a restenosis/reocclusion rate of 23.9% in men and 22.1% in women older than 63.5 years (P = .861) but 32.1% in men and 49.1% in women younger than that (P = .034).ConclusionsOur data suggest that although women are older and present with a more advanced stage of peripheral arterial occlusive disease, endovascular therapy is equally effective irrespective of gender. Surprisingly, the subgroup of young female patients had a specifically poor outcome

Impact of a compression garment, on top of the usual care, in patients with breast cancer with early disturbance of the lymphatic transport: protocol of a randomised controlled trial.

INTRODUCTION: Breast cancer-related lymphoedema (BCRL) is a common phenomenon. When lymphoedema is diagnosed late, options for treatment are diminished. Therefore, early diagnosis and treatment are very important to alter the potential deleterious evolution. Lymphofluoroscopy visualises the superficial lymphatic architecture in detail, giving the opportunity to detect a disturbance in the lymphatic transport (ie, dermal backflow) before the lymphoedema is clinically visible.The main objective is to investigate if there is an additional effect of a compression garment on top of the usual care (ie, information and exercises) in patients with early disturbance of the lymphatic transport after breast cancer treatment. Development of clinical lymphoedema and/or deterioration of the dermal backflow visualised by lymphofluoroscopy is investigated. METHODOLOGY: All patients scheduled for breast cancer surgery with unilateral axillary lymph node dissection or sentinel node biopsy in the Multidisciplinary Breast Clinic of the University Hospitals Leuven are being considered. Patients are assessed before surgery and at 1, 3, 6, 9, 12, 18, 24 and 36 months postoperatively. At each visit, a clinical assessment is performed determining the volume difference between both arms and hands (through circumference measurements and water displacement), the water content, the extracellular fluid, the pitting status and the skinfold thickness. Quality of life questionnaires are filled in. At each visit, a lymphofluoroscopy is performed as well. When a disturbance of the lymphatic transport is seen on lymphofluoroscopy, without the presence of clinical lymphoedema, the patient is randomised in either a control group receiving usual care or a preventive treatment group receiving usual care and a compression garment (whether or not combined with a glove). ETHICS AND DISSEMINATION: The trial is conducted in compliance with the principles of the Declaration of Helsinki (2008), the principles of Good Clinical Practice and in accordance with all applicable regulatory requirements. This protocol has been approved by the Ethical Committee of the University Hospitals Leuven. Results will be disseminated by peer-reviewed scientific journals and presentation at international congresses. TRIAL REGISTRATION NUMBER: NCT03210311 CONCLUSION: The investigators hypothesise that development of clinical BCRL can be prevented and/or the dermal backflow can be stabilised or improved, if a preventive treatment with compression garment is started in the early phase of disturbance.status: Published onlin

The influence of gender on patency rates after iliac artery stenting

ObjectiveThe purpose of this study was to investigate the influence of gender on the long-term outcome after iliac artery stenting and to assess gender-specific differences of the influence of risk factors on treatment success and patency rates.MethodsBetween January 2000 and December 2006, 404 percutaneous transluminal angioplasties with primary stent deployment for symptomatic iliac artery occlusive disease were performed at our center. These included 128 interventions in women and 276 interventions in men.ResultsWhereas average age was significantly higher (65.9 ± 12.9 years; P = .007) and arterial hypertension more frequent (60.9% vs 49.3%; P = .032) in women, hyperuricemia (7.0% vs 14.1%; P = .047) and a positive smoking status (61.7% vs 74.3%; P = .014) were more frequently observed in men. Fontaine stage was more advanced (stages III and IV) in women than in men (P = .028; P < .001). Technical success was 97.7% in women and 99.3% in men. Overall complication rate was higher in women compared with men (P = .002), mostly caused by access site hematomas (4.7% vs 0.4%) and pseudoaneurysms (8.6% vs 2.5%). Patients were followed up for 45.0 ± 33.3 months. Restenosis developed in 16.8% of cases in women and in 14.6% of cases in men and was treated in 73.7% by an endovascular approach. Primary patency rates at 1, 3, 5, and 7 years were 90.3%, 77.2%, 60.2%, and 46.4% in women and 89.9%, 71.5%, 63.6%, and 59.7% in men, respectively (P = .524; log-rank, .406). Secondary patency rates were 97.2%, 91%, 81.5%, and 70.3% in women and 97.1%, 89.1%, 82.6%, and 78% in men, respectively (P = .959; log-rank, .003). Multivariate analysis identified lower age as the only independent risk factor for recurrent disease in both groups. Age-defined subgroup analysis showed a restenosis/reocclusion rate of 23.9% in men and 22.1% in women older than 63.5 years (P = .861) but 32.1% in men and 49.1% in women younger than that (P = .034).ConclusionsOur data suggest that although women are older and present with a more advanced stage of peripheral arterial occlusive disease, endovascular therapy is equally effective irrespective of gender. Surprisingly, the subgroup of young female patients had a specifically poor outcome

Evaluation of volumetric measurements in patients with acute type B aortic dissection – thoracic endovascular aortic repair (TEVAR) vs conservative

ObjectiveThe aim of this retrospective study was to evaluate aortic volume changes in patients with acute type B aortic dissection (TBD), treated either by thoracic endovascular aortic repair (TEVAR) or conservatively.Materials and MethodsFrom July 1996 through March 2008, 76 patients presenting with acute TBD were referred to our department. To ensure a follow-up of at least 24 months, only 64 of them were included in the present study, with the cut-off for inclusion being March 2006. Twenty-nine of these patients underwent TEVAR and 35 patients underwent conservative treatment. Indications for TEVAR were life-threatening symptoms. Follow-up was performed postinterventionally in patients after TEVAR and at 3, 6, and 12 months, and yearly thereafter in both groups. It included clinical examinations, computed tomography (CT) scans, analysis of volume changes in true thoracic lumen (TTL), false thoracic lumen (FTL), thoracic lumen (TL), abdominal lumen (AL), and aortic diameter measurements. In addition, the extent of thrombosis and its influence on volume changes were assessed.ResultsMean follow-up was 41 months after TEVAR and 46 months in the conservatively-treated patients. At 60 months, cumulative rates of freedom from dissection-related death and rupture-free survival were 82.6% and 93.1% in the TEVAR group, respectively. They were 74.9% and 88.5% in the conservatively-treated group, respectively. In the conservatively-treated patients, 3 patients died of late aortic rupture, 4 were converted to open surgery, and 2 to TEVAR. Evaluation of volume changes showed better results in the TEVAR group within 24 months. However, within 60 months the difference between the two groups was no longer relevant. Relating to thrombosis of the FTL, analyses showed slightly better overall results and promotion of thrombus formation after TEVAR. However, at 60 months the results showed a tendency towards approximation between the two groups.ConclusionOur data suggest that TEVAR seems to delay the natural course of the disease but not to stop it

Evaluation of safety and performance of a new prototype self-expandable nitinol venous stent in an ovine model

Objective: Our study was a prospective in vivo study performed on an animal model to evaluate the safety and performance of a novel venous stent designed specifically for venous applications. Methods: The novel stents were implanted in the inferior vena cava of nine sheep. The stents were deployed with different distances between the closed cell rings to test for if the segments might migrate after being deployed at maximal distance. Three different total lengths were 9, 11, and 13 cm. After 1, 3, and 6 months, vascular injury, thrombus, neointima coverage, and stent migration were evaluated through computed tomography venography and histopathology. Imaging, histology, and integration data were analyzed for each group. Results: All stents were deployed successfully, and all sheep survived until the time of harvesting. In all cases, the native blood vessel sections were intact. The segmented stent parts showed a differently pronounced tissue coverage, depending on the duration of the implantation. Conclusions: The new nitinol stent is safe and feasible to implant in the venous system with a rapid surface coverage. Alteration of stent length did not affect the development of neointimal formation and did not cause migration. : Clinical Relevance: The clinical relevance of our study titled ''Evaluation of Safety and Performance of a New Prototype Self-Expandable Nitinol Stent in an Ovine Model'' lies in its potential to advance the field of venous intervention. Stent implantation is a common procedure used to treat deep venous obstruction, and the use of self-expandable nitinol stents has been shown to be effective in improving the patency rates. However, the safety and efficacy of new stent prototypes must be evaluated thoroughly before they can be used in clinical practice. Our study contributes to the evaluation of a new prototype self-expandable nitinol stent by demonstrating its excellent mechanical properties, biocompatibility, and histopathological response in an ovine model. The results of our study may provide valuable insight for researchers and clinicians in developing and implementing new stent technologies, ultimately improving patient outcomes in the treatment of chronic venous obstruction