Impact of the period of the day on all-cause mortality and major cardiovascular complications after arterial vascular surgeries.

BACKGROUND: Conflicting results are reported about daytime variation on mortality and cardiac outcomes after non-cardiac surgeries. In this cohort study, we evaluate whether the period of the day in which surgeries are performed may influence all-cause mortality and cardiovascular outcomes in patients undergoing non-cardiac arterial vascular procedures. METHODS: 1,267 patients who underwent non-cardiac arterial vascular surgeries between 2012 and 2018 were prospectively included in our cohort and categorized into two groups: morning (7 a.m. to 12 a.m., 79%) and afternoon/night (12:01 p.m. to 6:59 a.m. in the next day, 21%) surgeries. Primary endpoint was all-cause mortality within 30 days and one year. Secondary endpoints were the incidence of perioperative myocardial injury/infarction (PMI), and the incidence of major adverse cardiac events (MACE, including acute myocardial infarction, acute heart failure, arrhythmias, cardiovascular death) at hospital discharge. RESULTS: After adjusting for confounders in the multivariable Cox proportional regression, all-cause mortality rates at 30 days and one year were higher among those who underwent surgery in the afternoon/night (aHR 1.6 [95%CI 1.1-2.3], P = 0.015 and aHR 1.7 [95%CI 1.3-2.2], P < 0.001, respectively). Afternoon/night patients had higher incidence of PMI (aHR 1.4 [95%CI 1.1-1.7], P < 0.001). There was no significant difference in the incidence of MACE (aHR 1.3 [95%CI 0.9-1.7], P = 0.074). CONCLUSIONS: In patients undergoing arterial vascular surgery, being operated in the afternoon/night was independently associated with increased all-cause mortality rates and incidence of perioperative myocardial injury/infarction.

Rationale and design for the study Apixaban versus ClopidoGRel on a background of aspirin in patient undergoing InfraPoPliteal angioplasty for critical limb ischemia: AGRIPPA trial.

BACKGROUND: New antithrombotic strategies that reduce primary thrombosis and restenosis might improve vascular outcomes in patients with peripheral artery disease (PAD) undergoing arterial angioplasty. The study objective is to evaluate the potential benefit of apixaban plus aspirin compared with standard of care dual antiplatelet therapy (DAPT) in reducing thrombotic restenosis and artery re-occlusion in patients undergoing endovascular infrapopliteal revascularization. STUDY DESIGN: This multicenter, parallel-group, prospective, randomized, open-label, blinded-endpoint adjudication, proof-of-concept, exploratory trial aims to randomize 200 patients 72 hours after successful infrapopliteal angioplasty for critical limb ischemia (CLI). Patients will be randomly assigned in a 1:1 ratio to receive oral apixaban (2.5 mg twice daily) plus aspirin (100 mg once daily) for 12 months or clopidogrel (75 mg daily) for at least 3 months on a background of aspirin (100 mg once daily) for 12 months. The primary endpoint is the composite of target lesion revascularization (TLR), major amputation, or restenosis/occlusion (RAS) in addition to major adverse cardiovascular events - MACE (myocardial infarction, stroke or cardiovascular death) at 12 months. The primary safety endpoint is the composite of major bleeding or clinically relevant non-major bleeding at 12 months. SUMMARY: This study will evaluate the efficacy and safety of apixaban 2.5 mg twice daily plus aspirin compared with DAPT (clopidogrel plus aspirin) in patients with CLI undergoing endovascular infrapopliteal revascularization and might prove the concept of an alternative antithrombotic regimen for these patients to be tested in a future large randomized clinical trial.

Combined Angioplasty Technique of the Carotid Territory and Supra-Aortic Trunk by Double Access (Cervical and Limbs) for Tandem Lesions.

BACKGROUND: The carotid stent angioplasty (CAS) has been the main option for patients with high cardiovascular risk and carotid stenosis. The common femoral artery is still the most used access site; however, the aortic arch manipulation is a critical moment for cerebral embolization. Carotid transcervical access should be considered as a good alternative access route for CAS. Tandem lesions combining supra-aortic trunks and ipsilateral carotid bulb critical stenosis pose a great challenge for the vascular surgeon. METHODS: This is a retrospective descriptive study based on medical records of our institution. We report 2 cases of complex cerebral vascular insufficiency and discuss therapeutic options and strategies to protect the cerebrovascular territory avoiding microembolization, as well as demonstrate an alternative and safe total endovascular approach for those cases. RESULTS: We describe the approach of 2 complex cerebral vascular insufficiency cases: case 1, a 63-year-old male with previous ischemic stroke, right internal carotid artery (ICA) occlusion, left ICA stenosis >70%, and critical stenosis of the origin of common carotid artery (CCA); case 2, a 68-year-old female with previous ischemic stroke, left ICA occlusion, brachiocephalic trunk critical stenosis, hypoplastic right vertebral artery, and aortobi-iliac chronic occlusion. In both cases reported here a challenging solution was chosen, little described in the literature, with cerebral filter protection as the first step. In addition, a literature review was performed to discuss the different approach options for tandem injuries of the supra-aortic trunk and carotid bulb. CONCLUSIONS: Our initial experience with total endovascular treatment of complex tandem lesions of the carotid territory and supra-aortic trunks show that transcervical access, coupled with distal protection filter device on the first step, is a safe and effective technique for preventing neurological events.

Endovascular Therapy Provides Similar Results of Bypass Graft Surgery in the Treatment of Infrainguinal Multilevel Arterial Disease in Patients with Chronic Limb-Threatening Ischemia in All GLASS Stages.

BACKGROUND: Extensive infrainguinal arterial disease still pose a challenge for technical and clinical success of percutaneous angioplasty. The purpose of this study was to compare the results of concomitant femoropopliteal and infrapopliteal percutaneous angioplasty/stenting (PTA/S) with distal bypass graft surgery (BGS) in patients with chronic limb-threatening ischemia (CLTI). METHOD: In a single-center retrospective investigation between 2011 and 2017, 668 revascularization procedures for CLTI were reviewed. Concomitant femoropopliteal and infrapopliteal disease was identified in 153 CLTI patients, treated with BGS (48) using autogenous veins as substitute or PTA/S in a single procedure (105). A subgroup of patients with complex, extensive arterial lesions (GLASS stage III) received additional analysis. Primary outcomes were limb salvage and survival. RESULTS: The mean follow-up time was 21.4 months. Patients treated with PTA/S were significantly older and with predominance of females, diabetes and chronic kidney disease. Smoking was more common in patients treated with BGS. The BGS group showed a 36-month survival rate of 73.4%, whereas the PTA/S group presented a survival of 61.3% in the same interval (P = 0.25). The 36-month cumulative limb salvage rate was 53.3 and 59.7% for BGS and PTA/S, respectively (P = 0.24). For GLASS stage III patients, 36-month limb salvage rates were 54.4% for the PTA/S group and 50.2% for the BGS group (P = 0.29). Multivariate analysis pointed poor runoff status (all endovascular patients) and diabetes (GLASS III endovascular patients) as risk factors for limb loss. CONCLUSION: PTA/S and BGS presented similar results of limb salvage and survival in the treatment of concomitant femoropopliteal and infrapopliteal arterial disease in patients with CLTI, even for patients with extensive and complex arterial disease.

Long-term Results of Endovascular Treatment of Chronic Type B Aortic Dissection by Closure of the Primary Tear.

BACKGROUND: The role of thoracic endovascular aortic repair (TEVAR) in the treatment of chronic type B aortic dissection is controversial. Some advocate open surgery, based on the premise that all tears must be treated, and others prefer branched endografts with the same premise. However, TEVAR, with closure of the primary tear in the thorax, has shown good results in some centers. This single-center cohort study was designed to contribute to the knowledge of the long-term evolution (mean, 4.8 years) of the patients submitted to endovascular closure of the proximal intimal tear. METHODS: A total of 36 patients with asymptomatic chronic aortic dissection had a successful closure of the primary tear by TEVAR and were followed up for a median time of 57.2 months. RESULTS: In 75% of the cases, there was stabilization or decrease in the maximum diameter. Twenty-five percent had diameter increase in the thoracic or abdominal aorta and indication for one or more additional procedures. One patient refused a second procedure and died from rupture one month after the last evaluation; this was the only case of rupture in the series. One patient died of unrelated cause before having been submitted to a second procedure. Thirty-four patients survived without diameter increase in the follow-up period. CONCLUSIONS: Chronic type B aortic dissections can be successfully treated by the coverage of the proximal tear with an endograft. Patients shall be followed carefully, and 25% of them will require one or more additional procedures to achieve a good result.

Medical Therapy for Asymptomatic Patients and Stent Placement for Symptomatic Patients Presenting with Carotid Artery Near-Occlusion with Full Collapse.

PURPOSE: To report long-term results of stent placement and medical therapy for symptomatic and asymptomatic patients, respectively, with carotid artery near-occlusion with full collapse. MATERIALS AND METHODS: Between January 2008 and December 2010, 204 carotid arteries diagnosed by duplex scanning as exhibiting complete occlusion were re-examined with CT angiography; 46 arteries in 46 patients were patent with threadlike lumens and were reclassified as exhibiting near-occlusion with full collapse. Asymptomatic patients (n = 22) received best medical therapy (BMT) alone, and symptomatic patients (n = 24) were referred for carotid artery stent (CAS) placement plus BMT. Patients underwent clinical follow-up for 63.9 months ± 23.6 and duplex surveillance. RESULTS: None of the 22 asymptomatic patients treated with BMT alone experienced neurologic events during the follow-up interval. Four died of unrelated causes, resulting in a cumulative survival rate of 81.8%. Technical failure occurred in 5 of 24 symptomatic patients, but none had perioperative complications related to inability to cross the near-occlusion. Of the 19 patients with procedural success, 1 developed immediate upper limb monoparesis; none had periprocedural myocardial infarction, and none died. At 60-month follow-up, patients who underwent successful CAS placement had neurologic event-free and cumulative survival rates of 89.4% and 89.4%; patients with failed recanalization had neurologic event-free and cumulative survival rates of 0% and 40.0% (P = .01). CONCLUSIONS: Asymptomatic patients with carotid near-occlusion with full collapse experienced good outcomes with BMT alone. Symptomatic patients who underwent CAS placement demonstrated long-term survival and freedom from neurologic event rates comparable to those of asymptomatic patients.

Carotid Plaque Morphology in Asymptomatic Patients with and without Metabolic Syndrome.

BACKGROUND: The aim of this study was to determine the impact of metabolic syndrome (MetS) on the morphology of carotid plaques, as evaluated using duplex ultrasound (DUS) with computer-assisted analysis. METHODS: In this cross-sectional observational study, we analyzed 148 carotid artery plaques in asymptomatic patients. Data were obtained via clinical and laboratory examinations, and DUS was performed by a single operator. All plaques were scanned in a longitudinal fashion, and the best segment was selected, recorded, and evaluated using dedicated software. The main software-based analyses included gray-scale median (GSM) measurements and carotid plaque morphology histograms. RESULTS: MetS was identified in 51.8% of patients. Comparisons of patients with MetS and patients without MetS indicated that the former patients used more classes of antihypertensive drugs (2.49 vs. 1.93; P = 0.004) and were treated with statins for a longer period (71.08 vs. 49.17 months; P = 0.003). Most patients of both types exhibited moderate carotid artery stenosis ranging from 50% to 69% (n = 62; 37.3%), and MetS was not associated with an increased prevalence of severe carotid artery stenosis. The mean GSM was greater in the MetS group than in the non-MetS group (74.18 vs. 61.63; P = 0.012). The histogram analysis revealed that there were lower quantities of blood and fat (2.91 vs. 3.88; P = 0.006; 10.21 vs. 15.08; P = 0.004, respectively) and more fibrous tissue (19.93 vs. 14.55; P = 0.015) in the carotid plaques of patients with MetS than in the carotid plaques of patients without MetS. CONCLUSIONS: The present study demonstrated that MetS did not affect the stenosis grade or did it lead to unstable carotid plaques.

A prospective randomized study comparing polidocanol foam sclerotherapy with surgical treatment of patients with primary chronic venous insufficiency and ulcer.

BACKGROUND: To compare polidocanol foam sclerotherapy with surgical treatment of patients with primary chronic venous insufficiency and active ulcer treated at a single vascular center. METHODS: Fifty-eight limbs of 56 patients with active ulcers were prospectively randomized to undergo either surgical treatment or foam sclerotherapy. Patients completed the Aberdeen Varicose Veins Questionnaire (AVVQ), the Venous Clinical Severity Score (VCSS), and Venous Disability Score (VDS). The follow-up was 502 ± 220 days. RESULTS: The ulcer healed in 100% and 91.3% of patients treated with surgery or foam sclerotherapy, respectively (P > 0.05). There were no significant differences in AVVQ, VCSS, and VDS between the 2 groups after the procedures (P = 0.45, 0.58, and 0.66, respectively; Mann-Whitney U test). Complications occurred in 14.2% and 13.0% in the surgical and foam sclerotherapy groups, respectively. CONCLUSIONS: Surgical treatment and foam sclerotherapy achieved high rates of ulcer healing, without a statistically significant difference. Both treatments led to significant improvements in VCSS, VDS, AVVQ scores, demonstrating improvements in clinical outcomes and quality of life.

Generic versus branded enoxaparin in prophylaxis and treatment of vein thrombosis.

OBJECTIVES: to compare the biological efficacy of generic enoxaparin (HeptronTM) versus branded Sanofi-Aventis enoxaparin for prophylaxis and treatment of lower-extremity deep venous thrombosis (DVT) in a prospective, randomized, open-label study. METHODS: patients with diagnosed lower-extremity DVT (therapeutic branch, n=57) and patients requiring venous thromboembolism (VTE) prophylaxis after arterial vascular surgery or major lower-extremity amputations (prophylactic branch, n=57) were randomized to receive generic or branded enoxaparin for up to seven days. Enoxaparin activity was measured by estimating blood anti-factor Xa levels at the peak plasma concentration. As secondary outcomes, development or progression of VTE events, major adverse events and major bleeding events were considered for efficacy and safety comparisons. RESULTS: DVT therapy: twenty-five patients received generic enoxaparin while 32 received branded enoxaparin (subcutaneous, 1 mg/kg BID). Mean percentages of anti-factor Xa levels within the target ranges were 62 ± 35.4% and 67.5 ± 24.7%, respectively (p= .035 for non-inferiority). No patient presented DVT progression, clinically detectable pulmonary embolism, or major bleeding events in any subgroup. DVT prophylaxis: Thirty patients received generic enoxaparin and 27 received branded enoxaparin (subcutaneous, 40 mg/day). Mean percentages of anti-factor Xa levels within the target ranges were 77.9 ± 30.9% and 77.8 ± 32.9%, respectively (p = .009 for non-inferiority). There were no cases of VTE or major bleeding events in any subgroup. CONCLUSION: generic and branded enoxaparins exhibited similar in vivo responses as measured by the anti-factor Xa activity, as well as similar clinical efficacy and safety outcomes.

Generic versus branded enoxaparin in prophylaxis and treatment of vein thrombosis / Enoxaparina genérica versus padrão-ouro na terapia e profilaxia de trombose venosa

Objectives: to compare the biological efficacy of generic enoxaparin (HeptronTM) versus branded Sanofi-Aventis enoxaparin for prophylaxis and treatment of lower-extremity deep venous thrombosis (DVT) in a prospective, randomized, open-label study. Methods: patients with diagnosed lower-extremity DVT (therapeutic branch, n=57) and patients requiring venous thromboembolism (VTE) prophylaxis after arterial vascular surgery or major lower-extremity amputations (prophylactic branch, n=57) were randomized to receive generic or branded enoxaparin for up to seven days. Enoxaparin activity was measured by estimating blood anti-factor Xa levels at the peak plasma concentration. As secondary outcomes, development or progression of VTE events, major adverse events and major bleeding events were considered for efficacy and safety comparisons. Results: DVT therapy: twenty-five patients received generic enoxaparin while 32 received branded enoxaparin (subcutaneous, 1 mg/kg BID). Mean percentages of anti-factor Xa levels within the target ranges were 62 ± 35.4% and 67.5 ± 24.7%, respectively (p= .035 for non-inferiority). No patient presented DVT progression, clinically detectable pulmonary embolism, or major bleeding events in any subgroup. DVT prophylaxis: Thirty patients received generic enoxaparin and 27 received branded enoxaparin (subcutaneous, 40 mg/day). Mean percentages of anti-factor Xa levels within the target ranges were 77.9 ± 30.9% and 77.8 ± 32.9%, respectively (p = .009 for non-inferiority). There were no cases of VTE or major bleeding events in any subgroup. Conclusion: generic and branded enoxaparins exhibited similar in vivo responses as measured by the anti-factor Xa activity, as well as similar clinical efficacy and safety outcomes. .

Objetivos: comparar a eficácia biológica da enoxaparina genérica (HeptronTM) versus enoxaparina Sanofi-Aventis na profilaxia e no tratamento da trombose venosa profunda (TVP) de membros inferiores em ensaio prospectivo, randomizado e não cego. Método: pacientes com diagnóstico de TVP de membros inferiores (grupo terapêutico, n = 57) e pacientes com indicação de profilaxia de tromboembolismo venoso (TEV), após cirurgias vasculares de grande porte ou amputações maiores (grupo profilático, n = 57), foram randomizados para receber a enoxaparina sob teste (HeptronTM) ou a droga padrão-ouro (Sanofi-Aventis). A atividade da enoxaparina foi mensurada pela análise diária da atividade antifator-Xa no pico de concentração plasmática das drogas. Foram coletados dados de ocorrência ou progressão de TVP/TEV, eventos adversos graves e sangramentos graves; e foram utilizados para a análise de eficácia e segurança clínica como objetivos secundários. Resultados: grupo terapêutico: 25 pacientes receberam enoxaparina genérica, e 32, a droga padrão-ouro (via subcutânea, 1 mg/kg, a cada 12 horas). Os percentuais médios de atividade antifator-Xa dentro dos limites terapêuticos foram de 62 ± 35,4% e 67,5 ± 24,7%, respectivamente (p = 0,035, para não inferioridade). Nenhum paciente apresentou progressão da TVP, embolia pulmonar clinicamente detectável ou sangramentos maiores. Grupo profilático: trinta pacientes receberam enoxaparina genérica, e 27, a droga padrão-ouro (via subcutânea, 40 mg/dia). Os percentuais médios de atividade antifator-Xa dentro dos limites terapêuticos foram de 77,9 ± 30.9% e 77,8 ± 32,9%, respectivamente (p = 0,009, para não inferioridade). Nenhum paciente desenvolveu TVP ou apresentou sangramentos maiores. Conclusão: enoxaparinas genéricas e de marca apresentaram respostas semelhantes em estudos in vivo, quando medidas pela atividade do anti-fator Xa, assim como eficácia clínica e dados de segurança similares. .

Comparison between a new computer program and the reference software for gray-scale median analysis of atherosclerotic carotid plaques.

PURPOSE: To compare a new dedicated software program and Adobe Photoshop for gray-scale median (GSM) analysis of B-mode images of carotid plaques. METHODS: A series of 42 carotid plaques generating ≥50% diameter stenosis was evaluated by a single observer. The best segment for visualization of internal carotid artery plaque was identified on a single longitudinal view and images were recorded in JPEG format. Plaque analysis was performed by both programs. After normalization of image intensity (blood = 0, adventitial layer = 190), histograms were obtained after manual delineation of plaque. Results were compared with nonparametric Wilcoxon signed rank test and Kendall tau-b correlation analysis. RESULTS: GSM ranged from 00 to 100 with Adobe Photoshop and from 00 to 96 with IMTPC, with a high grade of similarity between image pairs, and a highly significant correlation (R = 0.94, p < .0001). CONCLUSIONS: IMTPC software appears suitable for the GSM analysis of carotid plaques.

Obesity is a risk factor for significant carotid atherosclerosis in patients aged 39 to 55 years.

We compared the prevalence of risk factors between young and old individuals with significant carotid atherosclerosis. We retrospectively reviewed the records of patients aged 39 to 55 years (group I) and aged ≥ 60 years (group II) with significant atherosclerotic stenosis at the carotid bifurcation. Group I patients had significantly higher values for the following factors: weight, height, body mass index, diastolic pressure, prevalence of current smoking, total and low-density lipoprotein cholesterol and significant lower values for systolic pressure, creatinine, and prevalence of coronary artery disease. Group I patients were more symptomatic and showed higher rates of carotid occlusion and near occlusion. Atherosclerosis of the carotid bifurcation was more aggressive in the younger group, with a higher rate of occlusion and near occlusion. Obesity and smoking were significant risk factors for young patients in this sample.

Carotid stenosis management: a review for the internist.

Stroke is one of the most important causes of mortality and morbidity worldwide and, for a long time, was the leading cause of death in developed countries. Atherothrombotic carotid stenosis is one of the most important etiologies behind this event. If properly recognized and treated, lives can be saved, as well as long-term disabilities prevented. With population aging and improvements in surgical and clinical care, patients with several comorbidities will be referred for revascularization procedures more frequently, posing a challenge for physicians. The purpose of this review is to provide internists and clinicians with information based on several studies so they can offer to their patients, the best evidence-based care, indicating appropriate medical therapy, as well as referral to a vascular surgeon, or what contraindicates endarterectomy or angioplasty, depending on individual characteristics.