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INTRODUCTION: Significant health inequalities in major adverse limb events exist. Ethnically minoritized groups are more prone to have a major adverse event following peripheral vascular interventions. This systematic review and meta-analysis aimed to describe the postoperative implications of racial and ethnic status on clinical outcomes following vascular interventions for claudication and chronic limb-threatening ischemia. METHODS: Searches were conducted across seven databases from inception to June 2021 and were updated in October 2022 to identify studies reporting claudication or chronic limb-threatening ischemia in patients who underwent open, endovascular, or hybrid procedures. Studies with documented racial and ethnic status and associated clinical outcomes were selected. Extracted data included demographic and clinical characteristics, vascular interventions, and measured outcomes associated with race or ethnicity. Meta-analyses were performed using random-effect models to report pooled odds ratios (ORs) with 95% confidence intervals (CIs). RESULTS: Seventeen studies evaluating the impact of Black versus White patients undergoing amputation as a primary intervention were combined in a meta-analysis, revealing that Black patients had a higher incidence of amputations as a primary intervention than White patients (OR: 1.91, 95% CI: 1.61-2.27). Another meta-analysis demonstrated that Black patients had significantly higher rates of amputation after revascularization (OR: 1.56, 95% CI: 1.28-1.89). Furthermore, multiple trends were demonstrated in the secondary outcomes evaluated. CONCLUSIONS: Our findings suggest that Black patients undergo primary major amputation at a significantly higher rate than White patients, with similar trends seen among Hispanic and First Nations patients. Black patients are also significantly more likely to be subjected to amputation following attempts at revascularization when compared to White patients.
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Objectives: We developed a new simulator for hands-on teaching of vascular surgical skills, the Leipzig Latex Patch Model (LPM). This study aimed to quantify the effectiveness and acceptance of the LPM evaluated by students, as well as evaluation of the results by experienced vascular surgeons. Methods: A prospective, single-center, single-blinded, randomized study was conducted. Fifty 5th-year medical students were randomized into two groups, first performing a patch suture on the LPM (study group) or established synthetic tissue model (control), then on porcine aorta. The second suture was videotaped and scored by two surgeons using a modified Objective Structured Assessment of Technical Skill (OSATS) score. We measured the time required for suturing; the participants completed questionnaires. Results: Participants required significantly less time for the second suture than the first (median: LPM 30 min vs. control 28.5 min, p = 0.0026). There was no significant difference in suture time between the groups (median: 28 min vs. 30 min, p = 0.2958). There was an increase in confidence from 28 % of participants before to 58 % after the course (p < 0.0001). The cost of materials per participant was 1.05 (LPM) vs. 8.68 (control). The OSATS-scores of the LPM group did not differ significantly from those of the control (median: 20.5 points vs. 23.0 points, p = 0.2041). Conclusions: This pilot study demonstrated an increase in technical skills and confidence through simulator-based teaching. Our data suggests comparable results of the LPM compared to the conventional model, as assessed by the OSATS-score. This low-cost, low-threshold training model for vascular suturing skills should make hands-on training more accessible to students and surgical residents. Key message: We developed and validated a low-cost, low-threshold training model for vascular suturing skills. This should make hands-on training more accessible to medical students and surgical residents in the future.
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Pseudoaneurysm of the lateral perforating branch of the peroneal artery is exceedingly rare. To our knowledge, eight cases are described in the current literature, with five occurring as a result of trauma and the remainder being iatrogenic. We present a pseudoaneurysm of the lateral perforating peroneal artery in a professional athlete following an inversion-plantarflexion injury of the ankle. He described persistent pain and fluctuant swelling to the lateral aspect of the right ankle with sudden onset of increased pain and swelling 10 days after the initial injury. Arterial duplex identified a pseudoaneurysm of the right lateral perforating peroneal artery. Endovascular coil embolisation of the aneurysm resulted in almost immediate improvement in symptoms. The patient has since regained full function of the affected ankle. This case report highlights the necessity for clinicians to maintain a high index of suspicion in order to promptly investigate and appropriately manage this pathology.
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Aneurisma Falso , Traumatismos del Tobillo , Embolización Terapéutica , Humanos , Aneurisma Falso/terapia , Aneurisma Falso/etiología , Aneurisma Falso/diagnóstico por imagen , Embolización Terapéutica/métodos , Masculino , Traumatismos del Tobillo/complicaciones , Traumatismos del Tobillo/terapia , Adulto , Procedimientos Endovasculares/métodosRESUMEN
This case report details the challenging management of a 45-year-old male construction worker who suffered severe multiple injuries after a fall and subsequent collision with cement mixers. The patient presented with extensive injuries, including amputation, fractures and internal bleeding, leading to a state known as the 'triangle of death'. Despite the initial grim prognosis, evidenced by an ISS score of 28 and a mortality risk coefficient of 89.56%, the patient was successfully resuscitated and managed through a multidisciplinary approach. This included damage control resuscitation, emergency vascular interventions and targeted temperature management for brain protection. The patient's recovery highlights the effectiveness of comprehensive trauma management and the critical role of coordinated care in severe multi-trauma cases.
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We present the management of a 16-year-old female patient with a complete transection of the right brachial artery, following a close-range high velocity penetrating gunshot wound. Due to the unique challenges posed in a regional setting, lack of formal vascular expertise on-site, and inability to transfer to a vascular trauma centre, a Temporary Intravascular Shunt was employed using a paediatric feeding tube to revascularise the limb. This article highlights the successful temporary revascularization approach and the importance of resourcefulness in managing complex vascular trauma in non-specialized centres.
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Retropharyngeal internal carotid artery (ICA) is a rare, yet well-described anatomical variant that poses significant challenges to the management of carotid artery stenosis. In this case report, we discuss the treatment of symptomatic ICA stenosis with a retropharyngeal ICA using the transcarotid artery revascularization (TCAR) technique. A 70-year-old female with comorbidities presented with neurological symptoms and severe ICA stenosis. After diagnostic evaluation, TCAR was chosen for surgical intervention. The patient did well postoperatively. This case emphasizes the importance of considering TCAR when treating ICA stenosis in patients with anatomic variation of ICA location. It also supports adding anatomic variants such as retropharyngeal ICA to the list of indications for TCAR.
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Acute limb ischemia (ALI) is the sudden onset of decreased blood supply to the extremities and carries a poor prognosis for the affected limb and survival. A rare but well-recognized embolic etiology is a paradoxical embolism, the translocation of a thrombus from venous to arterial circulation through an intracardiac communication, most commonly a patent foramen ovale. The presentation of ALI secondary to a PFO-mediated paradoxical embolism is most often accompanied by combinations of deep vein thrombosis (DVT), pulmonary embolism (PE), and an acute cerebral or visceral ischemia. We present the first documented case of a Rutherford class I ALI secondary to a PFO-mediated paradoxical embolism, ipsilateral DVT, and PE in a 29-year-old female who was surgically managed for her disabling claudication rather than limb salvage. The overlapping presentation of a viable ALI and ipsilateral DVT created a challenging clinical diagnosis. Our review of the literature on PFO-mediated paradoxical emboli involved 43 reports including 51 patients with various arterial thromboses; 19 of these cases involved lower extremity ALI. This case report is the first case to date that demonstrates a paradoxical embolism causing acute lower extremity ischemia with ipsilateral DVT and no additional limb/visceral ischemia to suggest the diagnosis of ALI. We also highlight the role that quality of life plays in vascular surgical decision-making, extending ALI management goals to not only reducing mortality and major amputations, but also improving quality of life.
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Tromboembolia Venosa , Humanos , Tromboembolia Venosa/prevención & control , Atención Perioperativa/métodos , Atención Perioperativa/normas , Europa (Continente) , Procedimientos Quirúrgicos Cardiovasculares/efectos adversos , Anticoagulantes/uso terapéutico , Anticoagulantes/administración & dosificación , Guías de Práctica Clínica como Asunto , Complicaciones Posoperatorias/prevención & controlRESUMEN
INTRODUCTION: This study sought to determine the rupture risk of asymptomatic abdominal aortic aneurysms (AAAs) undergoing interventions as a function of time to establish a maximal acceptable surgical delay. METHODS: A literature review was performed from inception to August 30, 2021, to assess the risk of rupture of aneurysms over time. The analysis was limited to men with asymptomatic AAAs. The data on AAA rupture risk according to diameter and follow-up time were extracted. The acceptable mortality risk for AAA patients as a function of surgical delay was further evaluated. This acceptable mortality risk was based on the acceptable risk of cardiovascular death associated with the accepted delays of coronary revascularization in coronary artery disease populations. Data on estimated surgical delays and risks were extracted using a free web-based software (WebPlotDigitizer) and plotted using Microsoft Excel. RESULTS: Our study identified minimal evidence as it pertains to AAA rupture risk as a function of surgical delay. The data on rupture risk of AAAs according to diameter and time were extracted from a single review and a single meta-analysis (Figure 1). The acceptable delays of semiurgent and nonurgent invasive treatment for coronary artery disease found in literature are 6 and 12 wks respectively. These acceptable delays are associated with an estimated acceptable cardiovascular mortality risk threshold of 0.47% at 6 and 12 wks. Using this threshold of estimated maximum acceptable risk and the data on the natural history of AAAs found in our review, we found that the acceptable surgical delays for AAAs would be estimated at 13-27 ds for AAAs ≥ 7 cm, 20-42 ds for 6-6.9 cm, and 32-49 ds for 5.5-5.9 cm (Figure 1). CONCLUSIONS: This study identified estimated surgical delays for patients with AAAs based on the acceptable maximum risk. These estimations may be used cautiously to triage patients with asymptomatic AAAs, particularly in the setting of triaging patients during local and global crises.
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Existing evidence of the effect of spinal anesthesia (SA) on cardiac systolic function is scarce and inconclusive. This study aimed to evaluate the effects induced by a single injection of SA for elective vascular surgery on left (LV) and right (RV) ventricular systolic performance using transthoracic echocardiography (TTE). A prospective study. Single-center study, university hospital. Adult patients undergoing elective vascular surgery with SA. During patients' evaluations fluid administration was targeted using arterial waveform monitoring. All patients underwent TTE studies before and after SA induction for the assessment of indices reflective of LV and RV systolic function. Blood samples were drawn to measure troponin and brain natriuretic peptide (BNP) levels. A total of 62 patients (88.7% males, 71.00 ± 9.42 years) were included in the study. The primary outcome was the difference before and after SA in LV ejection fraction (LVEF) and tricuspid annular plane systolic excursion (TAPSE). In total population, LVEF significantly increased after SA 53.07% [16.51]vs 53.86% [13.28]; p < 0.001). End-systolic volume (ESV, 69.50 [51.50] vs. 65.00 [29.50] ml; p < 0.001) decreased while stroke volume (SV) insignificantly increased (70.51 ± 16.70 vs. 73.00 ± 18.76 ml; p = 0.131) during SA. TAPSE remained unchanged (2.23 [0.56] vs. 2.25 [0.69] mm; p = 0.558). In patients with impaired compared to those with preserved LV systolic function, the changes evidenced in LVEF (7.49 ± 4.15 vs. 0.59 ± 2.79; p < 0.001), ESV (-18.13 ± 18.20 vs-1.53 ± 9.09; p < 0.001) and SV (8.71 ± 11.96 vs-1.43 ± 11.89; p = 0.002) were greater. This study provides evidence that SA in patients undergoing elective vascular surgery improved LV systolic function, while changes in RV systolic function are minimal.
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Although robot-assisted surgical procedures using the da Vinci robotic system (Intuitive Surgical, Sunnyvale, CA) have been performed in more than 13 million procedures worldwide over the last two decades, the vascular surgical community has yet to fully embrace this approach (Intuitive Surgical Investor Presentation Q3 (2023) https://investor.intuitivesurgical.com/static-files/dd0f7e46-db67-4f10-90d9-d826df00554e . Accessed February 22, 2024). In the meantime, endovascular procedures revolutionized vascular care, serving as a minimally invasive alternative to traditional open surgery. In the pursuit of a percutaneous approach, shorter postoperative hospital stay, and fewer perioperative complications, the long-term durability of open surgical vascular reconstruction has been compromised (in Lancet 365:2179-2186, 2005; Patel in Lancet 388:2366-2374, 2016; Wanhainen in Eur J Vasc Endovasc Surg 57:8-93, 2019). The underlying question is whether the robotic-assisted laparoscopic vascular surgical approaches could deliver the robustness and longevity of open vascular surgical reconstruction, but with a minimally invasive delivery system. In the meantime, other surgical specialties have embraced robot-assisted laparoscopic technology and mastered the essential vascular skillsets along with minimally invasive robotic surgery. For example, surgical procedures such as renal transplantation, lung transplantation, and portal vein reconstruction are routinely being performed with robotic assistance that includes major vascular anastomoses (Emerson in J Heart Lung Transplant 43:158-161, 2024; Fei in J Vasc Surg Cases Innov Tech 9, 2023; Tzvetanov in Transplantation 106:479-488, 2022; Slagter in Int J Surg 99, 2022). Handling and dissection of major vascular structures come with the inherent risk of vascular injury, perhaps the most feared complication during such robotic procedures, possibly requiring emergent vascular surgical consultation. In this review article, we describe the impact of a minimally invasive, robotic approach covering the following topics: a brief history of robotic surgery, components and benefits of the robotic system as compared to laparoscopy, current literature on "vascular" applications of the robotic system, evolving training pathways and future perspectives.
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Procedimientos Quirúrgicos Robotizados , Procedimientos Quirúrgicos Vasculares , Procedimientos Quirúrgicos Robotizados/métodos , Procedimientos Quirúrgicos Robotizados/tendencias , Humanos , Procedimientos Quirúrgicos Vasculares/métodos , Laparoscopía/métodos , Procedimientos Endovasculares/métodosRESUMEN
As reimbursement from the Medicare Physician Fee Schedule (PFS) continues to decline, cuts to practice expense relative value units disproportionately impact office-based interventionalists and private practices that rely on high-cost equipment. For 195 codes, specialties such as radiation oncology, vascular surgery, and interventional radiology are paid at rates less than their direct costs calculated by the Centers for Medicare and Medicaid Services itself. While reimbursement in the office-based setting continues to decline, high-cost hospital settings receive more payment for the same services. This disparity aligns with trends in care moving to the hospital setting and practice consolidation, resulting in increased costs to the healthcare system and decreased access to care. The current PFS is outdated, and the removal of high-cost supplies and equipment from the PFS is a critical step to reform.
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INTRODUCTION: Foot drop is a disorder characterized by weakness in the dorsiflexor muscles of the foot, caused by various pathologies, including neurological, muscular, spinal, and autoimmune conditions. Sometimes, it can be iatrogenic due to direct nerve compression, traction, or ischemia. The occurrence and underlying mechanism of foot drop following aortobifemoral bypass surgery are not well-documented in literature. CASE PRESENTATION: A 40-year-old male, with short distance claudication secondary to multi-level lower limb arterial occlusions, mainly, external iliac arteries and superficial femoral arteries. The patient underwent an uneventful aortobifemoral bypass. Post-operatively, the patient developed left sided foot drop with no clear etiology. With intensive physiotherapy, the patient improved and eventually recovered. DISCUSSION: After excluding other causes of the manifestation, this case could potentially give an insight to a rare postoperative complication following aortobifemoral bypass surgery. Despite a smooth intraoperative course, the patient developed foot drop, a rarely reported complication, suggesting a potential link between the procedure and foot drop. CONCLUSION: This case report highlights a rare postoperative complication after aortobifemoral bypass surgery, emphasizing the need for further research to elucidate the direct mechanisms behind this rare occurrence.
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BACKGROUND AND OBJECTIVES: Considering the absence of integrated vascular surgery residency programs in Saudi Arabia, and the need for planning training pathways, we aim to identify how many medical students are interested in vascular surgery, and the factors affecting students' opinions on pursuing vascular surgery. MATERIALS AND METHODS: A cross-sectional study was conducted using an online questionnaire that was distributed to medical students nationwide via social media and email. Data were collected from 13 February 2022 to 1 March 2022. RESULTS: A total of 408 students participated. Among them, 152 students were interested in general surgery, of which 103 were considering vascular surgery as a possible future fellowship. However, only 29 out of 408 (7.1%) students picked vascular surgery as their 1st choice. The main motivating factors for students to pursue vascular surgery as a career were: an interest in vascular cases (cardiovascular science), the use of emerging technologies, and the endovascular capabilities of vascular surgeons. The negative factors were simply a preference for another specialty, followed by a lack of experience in vascular surgery. CONCLUSION: This study reveals that only 7.1% of students consider vascular surgery their first choice. Both the lack of vascular surgeons and students' experience in vascular surgery affected awareness levels. Interaction with vascular surgeons through virtual rotations for under-served medical schools and the introduction of vascular sciences within the cardiology blocks during basic science years are recommended strategies.
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Selección de Profesión , Internado y Residencia , Estudiantes de Medicina , Procedimientos Quirúrgicos Vasculares , Humanos , Arabia Saudita , Estudios Transversales , Procedimientos Quirúrgicos Vasculares/educación , Estudiantes de Medicina/psicología , Femenino , Masculino , Encuestas y Cuestionarios , Adulto , Adulto JovenRESUMEN
OBJECTIVE: Many surgical residencies have passed along attendings preferences and procedural knowledge as a highly utilized but informal resource. The objective was to assess the effect of providing operative steps and attending preferences on surgical resident performance. DESIGN: This was a prospective observational study with a survey-based design. SETTING: We created and shared vascular surgery operative steps including institutional and attending preferences with junior residents at the Massachusetts General Hospital. PARTICIPANTS: There were a total of 31 residents who completed a survey to assess self-perception of performance in operative knowledge and Accreditation Council for Graduate Medical Education (ACGME) Milestone criteria. RESULTS: Advice from colleagues was the most utilized resource, followed by web-based materials. Of the web-based materials, almost all residents utilized Google searches over other web-based resources designed to specifically help surgical trainees. The vascular surgery resource was used by 90% of residents more than 3 times per week to prepare for operative cases. There was significant improvement in patient positioning, instrument selection, operative field exposure, anatomy, sequence of procedure, procedure choices, and peri-operative care knowledge. CONCLUSIONS: Development of institutional resources that specifically capture attending surgeon procedural variations can improve resident performance, encourage resident autonomy, and provide a catalog of approaches to challenging operative situations.
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Competencia Clínica , Internado y Residencia , Procedimientos Quirúrgicos Vasculares , Estudios Prospectivos , Procedimientos Quirúrgicos Vasculares/educación , Proyectos Piloto , Humanos , Educación de Postgrado en Medicina/métodos , Femenino , Masculino , Massachusetts , Adulto , Encuestas y CuestionariosRESUMEN
Artificial Intelligence (AI) made its first appearance in 1956, and since then it has progressively introduced itself in healthcare systems and patients' information and care. AI functions can be grouped under the following headings: Machine Learning (ML), Deep Learning (DL), Artificial Neural Network (ANN), Convolutional Neural Network (CNN), Computer Vision (CV). Biomimetic intelligence (BI) applies the principles of systems of nature to create biological algorithms, such as genetic and neural network, to be used in different scenarios. Chronic limb-threatening ischemia (CLTI) represents the last stage of peripheral artery disease (PAD) and has increased over recent years, together with the rise in prevalence of diabetes and population ageing. Nowadays, AI and BI grant the possibility of developing new diagnostic and treatment solutions in the vascular field, given the possibility of accessing clinical, biological, and imaging data. By assessing the vascular anatomy in every patient, as well as the burden of atherosclerosis, and classifying the level and degree of disease, sizing and planning the best endovascular treatment, defining the perioperative complications risk, integrating experiences and resources between different specialties, identifying latent PAD, thus offering evidence-based solutions and guiding surgeons in the choice of the best surgical technique, AI and BI challenge the role of the physician's experience in PAD treatment.
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OBJECTIVE: This biomechanical pre-clinical study aimed to assess the consequences on mechanical properties of long term cold storage (+2/+8 °C) of arterial allografts. METHODS: Femoropopliteal arterial segments were collected from multiorgan donors and stored at +2/+8 °C for 12 months in saline solution with added antibiotics. Mechanical characterisation was carried out using two different tests, with the aim of defining the physiological modulus and the maximum stress and strain borne by the sample before rupture. These characterisations were carried out after 0, 6, and 12 months of storage for each sample (T0, T6, and T12, respectively). For comparison, the same tests were performed on cryopreserved popliteal femoral segments after thawing. RESULTS: Twelve refrigerated allografts (RAs), each divided into three segments, and 10 cryopreserved allografts (CAs) were characterised. The median (interquartile range [IQR]) Young's modulus was not statistically significantly different between the storage times for cold stored allografts: RAT0, 164 (150, 188) kPa; RAT6, 178 (141, 185) kPa; RAT12, 177 (149, 185) kPa. The median (IQR) Young's modulus of the CA group (153 [141, 185] kPa) showed no significant differences from the RA groups, irrespective of storage time. Furthermore, median (IQR) maximum stress and strain values were not significantly different between the different groups: for maximum stress: RAT0, 1.58 (1.08, 2.09) MPa; RAT6, 1.74 (1.55, 2.36) MPa; RAT12, 2.25 (1.87, 2.53) MPa; CA, 2.25 (1.77, 2.61) MPa; and for maximum strain: RAT0, 64% (50, 90); RAT6, 79% (63, 84); RAT12, 72% (65, 86); CA, 67% (50, 95). CONCLUSION: Cold storage for up to 12 months appears to have no impact on the mechanical characteristics of human arterial allografts. Therefore, this preservation method, which would greatly simplify routine care, seems feasible. Other indicators are being studied to verify the safety of this preservation process before considering its use in vivo.
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INTRODUCTION: Endovenous laser ablation (EVLA) is associated with an excellent outcome in the treatment of great saphenous vein (GSV) incompetence. However, the use of thermal ablation requires tumescent anaesthesia and is associated with a risk of thermal damage. Mechanochemical endovenous ablation (MOCA) is a non-thermal ablation (NTA) alternative, which combines mechanical endothelial damage with the infusion of a sclerosant liquid or foam. Tumescent anaesthesia is not required. Preliminary experiences with MOCA using the Clarivein device show less intraprocedural and postprocedural pain and a faster clinical improvement compared with EVLA. Flebogrif (Balton, Poland) is a relatively new MOCA device. To determine the role of MOCA using Flebogrif, a well-designed, randomised controlled clinical trial of sufficient sample size and follow-up time is required. In this article, we provide the study protocol for the REBORN trial, aiming to demonstrate that MOCA using Flebogrif is not inferior to EVLA for the outcome of anatomical success in the treatment of GSV incompetence. METHODS AND ANALYSIS: This multicentre, open-label, non-inferiority, observer-blinded, randomised controlled trial randomises patients who are diagnosed with GSV incompetence and aged 18-80 years between Flebogrif and EVLA. 310 patients in 3 participating centres (Northwest Clinics Alkmaar, Skin and Vein Clinic Oosterwal Alkmaar and Red Cross Hospital Beverwijk) will be included. The primary outcome is anatomical success at 12 months. Secondary outcomes are intraprocedural pain, operation time, technical success, postprocedural pain, safety, anatomical success during other follow-up moments, complications, clinical success, aesthetic result, disease-specific quality of life, reinterventions, anterior accessory saphenous vein reflux and neovascularisation. Patients will be followed up at 1 week, 1, 6, 12, 24 and 60 month(s) after treatment. ETHICS AND DISSEMINATION: The institutional review board (Medical Ethical Review Committee of the Vrije Universiteit Medical Center) approved this study on 17 May 2021 under case number 2020.0740. Written informed consent is obtained by the coordinating investigator from all participants prior to study enrolment. After completion of the trial, the results will be submitted to an international scientific journal for peer-reviewed publication. TRIAL REGISTRATION NUMBER: Overzicht van Medisch-wetenschappelijk Onderzoek in Nederland, NL-OMON25145, previously NL9527; Centrale Commissie Mensgebonden Onderzoek, NL74491.029.20.
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Procedimientos Endovasculares , Terapia por Láser , Vena Safena , Insuficiencia Venosa , Humanos , Vena Safena/cirugía , Insuficiencia Venosa/cirugía , Terapia por Láser/métodos , Terapia por Láser/efectos adversos , Procedimientos Endovasculares/métodos , Estudios de Equivalencia como Asunto , Resultado del Tratamiento , Estudios Multicéntricos como Asunto , Femenino , Adulto , Escleroterapia/métodos , Soluciones Esclerosantes/uso terapéutico , Soluciones Esclerosantes/administración & dosificación , MasculinoRESUMEN
INTRODUCTION: Endovascular therapy has emerged as a prominent strategy for managing femoropopliteal peripheral artery disease, offering acceptable safety and efficacy compared with open surgical bypass. Both paclitaxel-eluting stents and heparin-bonded covered stents have exhibited enhanced clinical outcomes compared with bare metal stents. However, there is currently a lack of level I evidence comparing the safety and efficacy of paclitaxel-eluting stents and heparin-bonded covered stents. Therefore, the primary objective of this study is to systematically evaluate the efficacy and safety outcomes of these two types of stents. METHODS AND ANALYSIS: The ELITE trial is a prospective, multicentre, parallel, randomised controlled trial. A total of 450 patients will be recruited. The primary endpoints of the study include primary patency at 1 year post-index procedure. ETHICS AND DISSEMINATION: Ethical approval for this study was obtained from the Ethics Committee of West China Hospital of Sichuan University (approval number: 2023-1186). The results will be submitted to a major clinical journal for peer review and publication. TRIAL REGISTRATION: ELITE trial was registered on 27 September 2023 in the Chinese Clinical Trials Registry (ChiCTR2300076236).
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Stents Liberadores de Fármacos , Arteria Femoral , Heparina , Enfermedad Arterial Periférica , Arteria Poplítea , Humanos , Heparina/administración & dosificación , Heparina/uso terapéutico , Enfermedad Arterial Periférica/terapia , Enfermedad Arterial Periférica/cirugía , Arteria Poplítea/cirugía , Estudios Prospectivos , Arteria Femoral/cirugía , China , Paclitaxel/administración & dosificación , Paclitaxel/uso terapéutico , Ensayos Clínicos Controlados Aleatorios como Asunto , Estudios Multicéntricos como Asunto , Resultado del Tratamiento , Procedimientos Endovasculares/métodos , Masculino , Femenino , Stents , Grado de Desobstrucción VascularRESUMEN
BACKGROUND: Postoperative carotid endarterectomy (CEA) patch infection is a rare but well-recognized complication of CEA. It is important for otolaryngologists to be aware of the presentation and challenges in its diagnosis. METHODS: Patients who presented with a neck mass or hemorrhage and a known prior history of carotid endarterectomy with synthetic patch reconstruction were worked up with ultrasound, CT, or MRI imaging. In one case, fine needle aspiration biopsy was performed. Ultimately, all patients were taken to the operating room for neck exploration. RESULTS: Of the three patients presented in this case series, two presented with a chronic neck mass, two-to-three years after carotid endarterectomy. One patient presented acutely with hemorrhage from the carotid endarterectomy site. Carotid patch infection was diagnosed after neck exploration in all cases. Vascular surgery was consulted intra-operatively to perform definitive vascular repair. CONCLUSIONS: Infected carotid patch should be suspected in patients with a history of prior CEA, as many of the presenting complaints may resemble or mimic pathology managed by otolaryngology. The onset of symptoms can be perioperative or very delayed. A multidisciplinary approach with vascular surgery and infectious disease is required for appropriate management of these patients.