Our 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.
Background:The treatment of chronic venous disease, has largely shifted from high ligation and stripping to endovenous thermal ablation (EVTA) techniques, because of its comparable efficacy and lack of invasiveness. This clinical trial aimed to compare the efficacy of two thermal ablation techniques, endovenous laser ablation (EVLA) 1470-nm with Tulip-Tip TM fiber and radiofrequency ablation (RFA) ClosureFastTM using a noninferiority design for occlusion rate (primary outcome). Methods: A prospective multicenter randomized clinical trial randomized 280 patients for the treatment of great saphenous vein (GSV) reflux. Primary outcome was the GSV occlusion rate, secondary outcome factors were the possible side-effects of the treatment such as pain, ecchymosis, quality of Life (CIVIQ-20), revised Venous Clinical Severity Score (r-VCSS). One-year follow-up period. Results: The total occlusion rates at one year follow-up were 96.4% and 94.5% in the EVLA and RFA groups respectively (P=0.15). Regarding secondary outcomes, such as postoperative CIVIQ-20, r-VCSS, analgesia, absenteeism, there was no significant difference between both treatment groups. Conclusions: RFA and EVLA, using a 1470 nm laser with Tulip-Tip TM fiber, of the GSV results in equal occlusion rates at one year, with comparable postoperative pain and improved quality of life.
IntroductionBreast 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.MethodologyAll 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 disseminationThe 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 numberNCT03210311ConclusionThe 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.
Molecular imaging using magnetic resonance imaging (MRI) is expected to play a crucial future role in oncological diagnosis and in monitoring of therapeutic progress. Targeted nanoparticle contrast media (CM) with high relaxivities are required in order to obtain adequate signal-to-noise ratios as well as visualization of a desired pathologic area of the human body. The aims of this study were to synthesize and define certain physicochemical and enhancement properties of new doubly derivatized polylactic acid–bovine serum albumin (PLA-BSA) nanoparticles (NPs) modified by the covalent coupling of glutaraldehyde as a crosslinking agent. An additional functionalization with endothelial cells (ECs) targeting groups (tomato lectins; LEA) and signal-emitting moieties (DTPA-Gd) enables its use as a macromolecular, biodegradable contrast agent for MRI. The NPs were characterized by different spectroscopies, size exclusion chromatography, and scanning and transmission electron microscopy. In a human vein model, the dynamics of the nanoparticle interactions with the vein wall were examined in MRI, with correlative imaging in electron microscopy. In vitro studies were conducted to show endothelial binding and persistent enhancement at the apical EC surface. NPs with a diameter between 55 and 75 nm, able to carry simultaneous signal emitting, and targeting motifs on a single construct were successfully prepared. A high Gd payload and endothelial binding to blood vessel walls were observed. The binding affinity and specificity of LEA was preserved, and a strong enhancement at the endothelium was achieved. The stabilized core–shell structure of PLA-NP might allow for further encapsulation of lipophilic drugs or for attachment of other targeting molecules, such as antibodies. Graphical abstract
Symptomatische varices hebben een negatieve invloed op de levenskwaliteit van patiënten. Radiofrequente ablatie (RFA) is een endoveneuze behandelingsmethode waarbij varices worden dichtgeschroeid. Het doel van deze studie is om de tevredenheid en de patiënt-gerapporteerde levenskwaliteit te onderzoeken meer dan een jaar na RFA van de vena saphena magna (VSM). Een vragenlijst werd gestuurd naar 200 patiënten die een tot twee jaar geleden behandeld werden met RFA van de VSM in UZ Leuven. De gegevens werden verwerkt in SPSS Statistics 24. 98 van de 200 patiënten (49%) namen deel aan de studie. Van de patiënten was 80,4% (78/97) tevreden en zou 95,8% (92/96) opnieuw voor RFA kiezen. Het zelfbeeld was bij 58,2% (57/98) beter en de algemene gezondheid was bij 29,6% (29/98) beter dan voor de ingreep. Meer dan een jaar na de ingreep had 57,4% (54/94) geen recidieven of nieuwe varices. Ontevredenheid was frequenter bij patiënten met een flebologische voorgeschiedenis, bij patiënten met recidieven of veneuze symptomen en bij patiënten met een postoperatief hematoom. RFA van de VSM leidt tot tevredenheid bij patiënten die deelnamen aan deze studie en heeft een positieve invloed op het zelfbeeld en op de ziektegerelateerde symptomen meer dan een jaar na de ingreep.
Introduction: Breast-cancer-related lymphedema (BCRL) is a frequently occurring and debilitating condition. When lymphedema is diagnosed late, treatment can be expected to be less effective. Lymphofluoroscopy can provide details about the superficial lymphatic architecture and can detect an early disturbance of lymphatic transport (i.e., dermal backflow) before the lymphedema is clinically visible. The main objective of this study is to investigate whether this early disturbance of lymphatic transport visualized by lymphofluoroscopy is a risk factor for the development of BCRL. Methodology: All patients scheduled for unilateral breast cancer surgery with axillary lymph node dissection or sentinel node biopsy were considered. Patients were assessed at baseline and 1, 3, 6, 9, 12, 18, 24 and 36 months postoperatively. During each visit, a clinical assessment was performed to determine the volume difference between both arms and hands (through circumference measurements and water displacement). Clinical BCRL was defined as a ≥5% increase in relative arm volume difference compared to the baseline value. Variables related to (1) the disturbance of lymphatic transport (through lymphofluoroscopy), (2) the demographics and general health of the patient and (3) the breast cancer and treatment of the patient were collected. Results: We included data of 118 patients in the present study. Thirty-eight patients (39.8%) developed BCRL. Early disturbance of lymphatic transport was identified as a risk factor for the development of clinical BCRL (HR 2.808). Breast-cancer- and treatment-related variables such as axillary lymph node dissection (ALND) (HR 15.127), tumor stage (HR 1.745), mastectomy (HR 0.186), number of positive lymph nodes (HR 1.121), number of removed lymph nodes (HR 1.055), radiotherapy of the axilla (HR 2.715), adjuvant taxanes (HR 3.220) and postsurgical complications (HR 2.590) were identified as significant risk factors for the development of BCRL. In the multivariate analysis, age and ALND were withheld as independent risk factors for the development of BCRL. Conclusion: Lymphofluoroscopy can identify an early disturbance of lymphatic transport after breast cancer treatment. Patients with an early disturbance of lymphatic transport are considered to be a high-risk group for the development of BCRL. This study also confirms that age and ALND are predictors for the development of BCRL. Therefore, a surveillance program of these patients with lymphofluoroscopy could be useful to identify lymphedema in subclinical stages.
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