Groin surgical site infection incidence in vascular surgery with intradermal suture versus metallic stapling skin closure: A study protocol for a pragmatic open-label parallel-group randomized clinical trial (VASC-INF trial).

BACKGROUND: Surgical site infection is 1 of the most frightening complications in vascular surgery due to its high morbimortality. The use of intradermal sutures for skin closure might be associated with a reduction in infections incidence. However, the data available in the literature is scarce and primarily built on low-evidence studies. To our knowledge, no multicenter clinical trial has been published to assess if the intradermal suture is associated with a lower surgical site infection incidence than metallic staples in patients who will undergo revascularization surgery requiring a femoral approach. METHODS: VASC-INF is a pragmatic, multicenter, multistate (Spain, Italy, and Greece), randomized, open-label, clinical trial assessing the surgical site infection incidence in patients undergoing revascularization surgery requiring a femoral approach. Patients will be randomized on a 1:1 ratio to intradermal suture closure (experimental group) or to metallic staples closure (control group).The primary outcome is the number (percentage) of patients with surgical site infection (superficial and/or deep) associated with a femoral approach up to 28 (±2) days after surgery. Among the secondary outcomes are the number (percentage) of patients with other surgical wound complications; the number (percentage) of patients with surgical site infections who develop sepsis; type of antibiotic therapy used; type of microorganisms' species isolated and to describe the surgical site infection risk factors. DISCUSSION: Intradermal suture closure may be beneficial in patients undergoing revascularization surgery requiring a femoral approach. Our working hypothesis is that intradermal suture closure reduces the incidence of surgical site infection respect to metallic staples closure.

Mortality and bleeding complications of COVID-19 critically ill patients with venous thromboembolism.

BACKGROUND: Venous thromboembolism (VTE) disease in COVID-19 patients is a remarkable issue, especially its relationship with bleeding events and mortality. The objective of this study was to describe the outcomes of critically ill patients with COVID-19, hospitalized in the Intensive Care Unit (ICU), in relationship with VTE during their stay. METHODS: This is a prospective cohort study of critically ill COVID-19 patients in two hospitals that underwent a venous ultrasound at the beginning of follow-up of both lower limbs in April 2020. In case of clinical suspicion of new VTE during the 30-day follow-up, additional ultrasound or thoracic CT were performed. Global VTE frequency, major bleeding events and survival were collected, and their predictors were studied. RESULTS: We included 230 patients. After 30 days of follow-up, there were 95 VTE events in 86 patients (37.4%). Thirteen patients (5.7%) developed major bleeding complications and 42 patients (18.3%) died. None of the comorbidities or previous treatments were related with bleeding events. D-Dimer at admission was significantly related with VTE development and mortality. Independent predictors of mortality in the regression model were older age (>66 years), D-Dimer at admission (>1.500 ng/mL) and low lymphocyte count (<0.45×109/L) with an AUC in the ROC curve of 0.81 (95% CI: 0.73-0.89). Patients presenting these three conditions presented a mortality of 100% in the predictive model. CONCLUSIONS: VTE frequency in ICU COVID-19 patients is high and risk of major bleeding is low. Comorbidities and laboratory parameters of admission in these patients can be a useful tool to predict mortality.

COVID-19 Infection in Critically Ill Patients Carries a High Risk of Venous Thrombo-embolism.

OBJECTIVE: The coronavirus disease of 2019 (COVID-19) due to SARS-CoV-2 infection has been found to cause an increased risk of venous thrombo-embolism (VTE). The aims of the study were to determine the frequency of VTE in critically ill patients with COVID-19 and its correlation with D dimer levels and pharmacological prophylaxis. METHODS: This was a cohort study of critically ill patients due to COVID-19. All patients admitted to the intensive care unit on the same day of April 2020 were selected, regardless of length of stay, and a single bilateral venous duplex ultrasound in the lower extremities was performed up to 72 hours later. Pulmonary embolism (PE) was diagnosed by computed tomography angiography. Asymptomatic and symptomatic VTE were registered, including pre-screening in hospital VTE. Characteristics of patients, blood test results, doses of thromboprophylaxis received, VTE events, and mortality after seven day follow up were recorded. RESULTS: A total of 230 critically ill patients were studied. The median intensive care unit stay of these patients was 12 days (interquartile range [IQR] 5 - 19 days). After seven days follow up, the frequency of patients with VTE, both symptomatic and asymptomatic, was 26.5% (95% confidence interval [CI] 21% - 32%) (69 events in 61 patients): 45 with DVT and 16 with PE (eight of them with concomitant DVT). The cumulative frequency of symptomatic VTE was 8.3% (95% CI 4.7% - 11.8%). D dimer values ≥ 1 500 ng/mL were diagnostic of VTE, with a sensitivity of 80% and a specificity of 42%. During follow up after screening, six patients developed new VTE. Three of them developed a recurrence after a DVT diagnosed at screening, despite receiving therapeutic doses of heparin. Mortality rates at seven day follow up were the same for those with (6.6%) and without (5.3%) VTE. CONCLUSION: Patients with severe COVID-19 infection are at high risk of VTE, and further new symptomatic VTE events and recurrence can occur despite anticoagulation. The prophylactic anticoagulant dose may need to be increased in patients with a low risk of bleeding.

Thoracic Aortic Mural Thrombus, Right Ventricular Clot and Pulmonary Embolism in a Patient With COVID-19 Pneumonia.

Since the outbreak of the COVID-19 pandemic, increasing evidence suggests that infected patients present a high incidence of thrombotic complications. We report a 67-year-old-woman admitted for severe acute respiratory syndrome coronavirus 2 infection. Chest CT images showed bilateral ground glass opacities, bilateral pulmonary embolism, right ventricular clot in transit and 2 thoracic aortic mural thrombus. Therapy was initiated with subcutaneous low-molecular-weight heparin, and the patient was discharged at 20 days asymptomatic. Complete resolution of the aortic thrombus was observed in a 1-month surveillance CT angiogram. Our case illustrates vascular complications in a COVID-19 patient and its effective treatment with anticoagulation.

Endovascular Infrarenal Aortic Aneurysm Repair Performed in a Hybrid Operating Room Versus Conventional Operating Room Using a C-Arm.

BACKGROUND: To compare contrast usage and radiation exposure during endovascular aneurysm repair (EVAR) using mobile C-arm imaging in a conventional operating room (OR) or fixed angiographic equipment in a hybrid OR (HR). METHODS: A retrospective unicenter study from May 2016 to August 2019. All consecutive patients undergoing standard EVAR were included. Patients were divided into 2 groups. Group OR included EVARs performed in a conventional OR with a mobile C-arm (May 2016 to April 2018) and group HR included EVARs performed with a fixed angiographic equipment in an HR (May 2018 to August 2019). Data collected included patient demographics, aneurysm diameter, neck length, radiation dose: median dose-area product (DAP), fluoroscopy time, total operative time, contrast use, and 30-day clinical outcomes. RESULTS: A total of 77 patients were included in the study (42 patients in group OR and 35 patients in group HR). There was no difference in age, body mass index (BMI), mean aneurysm, and neck length between groups. Patients in the group HR received less contrast volume (108.6 mL [±41.5] vs. 162.5 mL [±52.6]; P < 0.001), but higher radiation dose (154 Gy cm2 [±102.9] vs. 61.5 Gy cm2 [±42.4]; P < 0.001). There were no differences in fluoroscopy time (20.4 min [±8.5] vs. 23.2 min [±12.4]; P = 0.274) and total operative time (106.4 [±22.3] vs. 109.4 [±25.8]; P = 0.798). No difference was found in terms of 30-day complication rates or operative mortality between groups. DAP was positively correlated with BMI in the group OR (Spearman's rank correlation coefficient rs, 0.580; P < 0.001), but no correlation could be seen in the group HR (rs, 0.408; P = 0.028). CONCLUSIONS: Routine EVAR performed in a hybrid fixed-imaging suite may be associated with less contrast usage, but higher radiation exposure in our center. The significantly higher radiation exposure when the mobile C-arm is replaced by an HR should not be underestimated.

Prospective Multicenter Study of the Low-Profile Relay Stent-Graft in Patients with Thoracic Aortic Disease: The Regeneration Study.

BACKGROUND: To evaluate the early safety and clinical performance of the new low-profile RelayPro Thoracic Stent-Graft System in patients with thoracic aortic disease. METHODS: This was an international, prospective, single-arm study in patients diagnosed with thoracic aorta disease (aneurysm, pseudoaneurysm, dissection, penetrating atherosclerotic ulcer, or intramural hematoma) and treated with a RelayPro stent-graft (in bare stent and/or nonbare stent configurations). The primary endpoints were freedom from aneurysm or dissection-related mortality and stent-graft performance. RESULTS: A total of 31 patients were treated with the RelayPro thoracic stent-graft between 2014 and 2015 at 8 sites in Italy and Spain. Mean age was 72.1 (±10.2) years and 77% were male, 74% with hypertension, and 42% with a history of smoking. Twenty-four (77%) had aneurysms (fusiform in 46%, saccular in 42%, pseudoaneurysm in 12%); 5 (16%) had penetrating atherosclerotic ulcer; and 2 (6%) had chronic Type B dissection. Mean vascular access diameter was 9.1 mm (6-13 mm); 7 patients (23%) had vascular access of 7 mm or less. Technical success was 100% (primary, 90%; assisted primary, 10%). Freedom from aneurysm/dissection-related mortality through 30 days was 100%. Freedom from device-related major adverse events through 30 days was 94%. At 1 year, there was 1 (3%) type Ib and 1 (3%) type II endoleak, 1 (3%) nonaneurysm-related late death, and 1 (3%) secondary intervention (to correct type Ib endoleak). CONCLUSIONS: The RelayPro has a 3-4 French profile reduction to allow endovascular repair of thoracic aortic disease in patients with smaller anatomies. This study shows good initial stent-graft performance and a favorable early safety profile.

Neuromuscular electrostimulation: a new therapeutic option to improve radio-cephalic arteriovenous fistula maturation in end-stage chronic kidney disease patients.

BACKGROUND: Radio-cephalic arteriovenous fistula (RCAVF) is the gold standard vascular access for end-stage chronic kidney disease patients. Exercises after arteriovenous fistula (AVF) creation improve maturation. No articles are published regarding neuromuscular electrostimulation (NMES) in AVF maturation. OBJECTIVES: To assess the usefulness of a NMES programme on RCAVF maturation process. METHODS: An 8-week single-centre prospective study. Two groups were established: control group (CG): underwent usual RCAVF forearm exercises and electrostimulation group (ESG): underwent RCAVF NMES programme. Handgrip (HG) measurement, preoperative Doppler ultrasonography (DUS) parameters, clinical and DUS maturation as well as surgical complications were assessed. RESULTS: Thirty-six patients (54% men). Mean age 67.9 ± 14.3 years; 12 ESG and 24 CG. Demographic data, comorbidities, medical treatment, HG and DUS measurement at baseline were similar. HG increased in both groups at the end of the study (CG 24.5 ± 9.5 vs. 26.1 ± 10.1 kg, p 0.048; ESG 25.8 ± 10.3 vs. 26.3 ± 11.6 kg, p 0.644). RCAVF forearm vein diameter (CG 3.1 ± 0.7 vs. 5.7 ± 1.1 mm; ESG 2.9 ± 0.8 vs. 6.1 ± 1.7 mm) and humeral artery blood flow rate (CG 110.5 ± 20.7 vs. 1053.4 ± 510.7 ml/min; ESG 118.2 ± 31.6 vs. 954.1 ± 542.2 ml/min) statistically increased for both groups. A significant increase in clinical maturation in ESG (62.5 vs. 91.7%, p 0.046) at 8 weeks was observed. Four patients in each group developed juxta-anastomotic stenosis and were surgically repaired. No adverse NMES effects were registered. CONCLUSIONS: NMES of forearm muscles is a safe and effective technique to improve RCAVF maturation and constitutes a novel alternative to forearm isometrics exercises. Nevertheless, further studies are required to confirm the potential effect of NMES in the vascular access maturation process.

Clinical Utility of a New Predicting Score for Radiocephalic Arteriovenous Fistula Survival.

BACKGROUND: Radiocephalic arteriovenous fistula (RC-AVF) is the recommended first choice for vascular access (VA). The CAVeA2T2 scoring system was recently published (ipsilateral central venous catheter access, age >73 years, vein <2.2 mm, lower limb angioplasty, and absent intraoperative thrill). The aim of the present study was to assess the clinical utility of the CAVeA2T2 scoring system for predicting RC-AVFs survival in our center and its subsequent application in VA management. MATERIAL AND METHODS: In this single-center retrospective study, all RC-AVFs performed from January 2010 to July 2014 were included. The CAVeA2T2 was applied. Primary, assisted primary, and secondary patency rates were measured. RESULTS: Sixty RC-AVFs were analyzed. Mean age was 64.3 ± 14.7 years. Mean CAVeA2T2 score was 1.23 ± 1.2. The median fistula secondary patency was 13.7 ± 1.6 months. Secondary patency was at 6 weeks and at 6, 12, and 24 months: 88.3%, 66.7%, 55%, and 31.7%, respectively. Increasing score (≥2) was associated with a decrease in primary (log-rank, χ2 = 16.7, dif = 1, P = 0.0001) and secondary patency rate survival (log-rank, χ2 = 5.4, dif = 1, P = 0.0001). In addition, stratification of the CAVeA2T2 score into 3 groups (scores 0-1, 2, and 3+) retained its significance for primary (log-rank, χ2 = 19.4, dif = 2, P = 0.0001) and secondary patency rate survival (log-rank, χ2 = 5.5, dif = 2, P = 0.046) at the end of the study. CONCLUSIONS: In the present study, the CAVeA2T2 scoring system has proved to be a useful, easy to apply tool that is highly predictive of RC-AVF survival. Based on our results, we should avoid perform RC-AVFs, in those patients with CAVeA2T2 score ≥2 and late nephrology referral. Prospective studies should be designed to establish the management of patients with a higher CAVeA2T2 score.

Treatment of a complicated penetrating ulcer of the descending thoracic aorta using a scalloped stent graft.

We show the use of a proximal scalloped stent graft for an pseudoaneurysm of the descending thoracic aorta to avoid occlusion of the left subclavian artery. A 63-year-old man with sudden onset dysphonia was diagnosed with left vocal fold paralysis and the presence of a lung mass. A computed tomography scan revealed saccular dilatation of the aortic arch (proximal neck: <10 mm) with suggestive images of a penetrating ulcer and degenerative pseudoaneurysm. A RELAY Plus thoracic stent graft (Bolton Medical, Sunrise, FL) with proximal scallop was implanted to preserve the left subclavian artery. A custom made prosthesis with proximal scallop provides a good alternative to a carotid-subclavian bypass because it is less aggressive and can be used in nonurgent cases.

Rubeosis iridis as a sign of underlying carotid stenosis.

Severe carotid stenosis may be associated with uncommon clinical symptoms. We report a case of ocular ischemic syndrome and subsequent rubeosis iridis due to a high-grade carotid stenosis. The patient recovered visual acuity and his normal iris coloring after carotid endarterectomy. Rubeosis iridis may be the only clinical sign associated with severe carotid stenosis, making it mandatory to rule out the presence of carotid narrowing when it is detected. Establishing an early diagnosis is essential to improve quality of life, prognosis, and patients' outcome.

Aortofemoral bypass to bridge end-stage renal disease patients with severe iliac calcification to kidney transplantation.

Patients undergoing hemodialysis have a lower survival rate than those who receive a kidney transplant. Mortality among hemodialysis patients is approximately 14.5% compared with 1.5% for transplant recipients. One of the exclusion criteria for renal transplant is severe iliac artery calcification. We performed an aortofemoral bypass in these patients to make them eligible for renal transplantation. Eleven patients were selected to receive an aortofemoral bypass. All had severe calcification of iliac arteries. Eight patients required a bypass from the thoracic aorta and two from the infrarenal level. Revascularization was successful in 10 patients. Patency was 100%. Surgery could not be performed in one owing to severe calcification of the femoral artery. One patient died owing to gastrointestinal bleeding. Two patients developed complications; one needed a splenectomy, and the other developed meningitis and paralytic ileus. To date, four patients have received transplants, and the viability of the transplanted kidney is good in all cases. Renal transplantation is the only method known to improve survival and quality of life for hemodialysis patients. We consider that if patients with severe iliac calcification are well informed of the morbidity and mortality risk of an aortic bypass, this intervention can be justified in this setting.

Role of temporary arterial shunt in the reimplantation of a traumatic above-elbow amputation.

Although the feasibility of reimplantation has increased greatly with the development of new surgical techniques, long-term functional prognosis is unpredictable. Injury to a major nerve is an important factor in long-term outcome, and prolonged ischemia time also has a negative effect. We present a 26-year-old woman whose right arm was sectioned above the elbow in an accident. The limb presented a complete section, with soft tissue loss of the humeral artery and vein, basilic vein, and cephalic vein. Median and radial nerve tissue was missing, and a supracondylar fracture with substantial loss of the humerus was also observed. During reimplantation surgery, a temporary arterial shunt reduced ischemia time. A venous and arterial bypass was performed, and the 12-month results were good.

Caso excepcional de thrombosis del Sistema venoso cava inferior / No disponible

Se trata de un caso excepcional de thrombosis que afectó todo el sistema venosos profundo de la extremidad y la vena cava inferior. Clínicamente se presentó como una flegmasía cerúlea dolens, manifestación grave de la enfermedad tromboembólica venosa (ETEV). Para l a valoración diagnóstica se realizó tomografía computerizada observándose trombosis de la vena cava inferior hasta su nivel hepático. El tratamiento fue contundente con fibirnolíticos y heparina de bajo peso molecular, presentando una buena evolución y ninguna complicación (AU)

This is an exceptional case of thrombosis that affected all extremity Deep venous system and inferior digging. Clinically appeared like a serious manifestation of the venous thrombosis-embolism disease (ETEV). For diagnosis evaluation was made a tomography being observed vein inferior digs until its liver level. Treatment was forceful with fibrionolitics and low molecular weight heparine, displaying a good evolution and no complication (AU)