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OBJECTIVE: Superficial femoral artery (SFA) stenting is a common treatment for peripheral artery disease. It is effective in the short term; however, in-stent restenosis (ISR) limits long-term success. Surveillance with duplex ultrasound (DUS) can identify patients who develop ISR leading to early reintervention, but data to support this practice is sparce. The purpose of this study was to evaluate whether surveillance and subsequent reintervention improves outcomes in patients with SFA stents. METHODS: A single-center, retrospective study was performed with patients undergoing SFA stenting between 2005 and 2020 who had a follow-up with DUS. Five groups were identified based on the presence of ISR on DUS (ISR vs no ISR [NISR]), recurrence of symptoms (symptomatic [SX] vs asymptomatic [ASX]), and if any reintervention was performed (reintervention [R] vs no reintervention [NR]): (1) ISR+SX+R; (2) ISR+SX+NR; (3) ISR+ASX+R; (4) ISR+ASX+NR; and (5) NISR+NR. The primary endpoint was amputation-free survival, and the secondary endpoint was patency. Predictors of mortality and surveillance were identified by multivariable logistic regressions and Cox multivariate regression models. Survival curves were presented as Kaplan-Meier plots using log-rank test for subgroup comparison. RESULTS: Two hundred fifty-seven patients were included in the analysis. The indication for intervention was claudication in 28% and chronic limb-threatening ischemia in 72%. A total of 161 patients (63%) underwent reintervention for ISR. Of patients who had restenosis on DUS, those who were symptomatic and did not undergo reintervention (ISR+SX+NR) did the worst, with 50% amputation rate. In contrast, those who were asymptomatic but did undergo reintervention (ISR+ASX+R) had the lowest amputation rate of 13%. Active smoking was a predictor of both loss of patency and amputation (1.72; 95% confidence interval [CI], 1.00-2.98; P = .050; 3.55; 95% CI, 1.53-8.25; P = .003). Post procedure dual antiplatelet therapy had a positive association with limb salvage (hazard ratio [HR], 0.23; 95% CI, 0.09-0.58; P = .001), whereas diabetes (HR, 2.61; 95% CI, 1.21-6.01; P = .019), stent occlusion (HR, 17.0; 95% CI, 5.93-63.1; P < .001), and chronic limb-threatening ischemia presentations (HR, 4.31; 95% CI, 1.86-11.7; P=.002) were negatively associated with limb salvage. CONCLUSIONS: Routine surveillance DUS and subsequent reintervention on ISR after SFA stenting is associated with improved patency and amputation-free survival. Surveillance DUS should be routine for patients after stenting, with reintervention strongly considered if ISR is identified for both symptomatic and asymptomatic.
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Artéria Femoral , Doença Arterial Periférica , Humanos , Artéria Femoral/diagnóstico por imagem , Artéria Femoral/cirurgia , Isquemia Crônica Crítica de Membro , Estudos Retrospectivos , Resultado do Tratamento , Fatores de Risco , Grau de Desobstrução Vascular , Stents , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/terapia , Constrição PatológicaRESUMO
OBJECTIVE: Breast cancer most commonly occurs in the upper outer quadrant (UOQ) chest wall (CW). The effectiveness of routine leaded aprons to protect this region of the body in interventionalists during fluoroscopically guided interventions (FGIs) is unknown. Given the high lifetime attributable risks of prolonged occupational exposure to ionizing radiation and the increasing number of practicing female vascular surgeons and interventionalists, we sought to determine if the use of a leaded arm shield would offer additional protection to the lateral CW and axilla in operators compared with routine leaded aprons. METHODS: Effectiveness of leaded sleeves in attenuating radiation dose to the axilla and UOQ was evaluated in clinical practice and simulated scenarios. In the clinical setting, optically stimulated luminescence nanoDot detectors were placed at the UOQ lateral CW position, both over and under a standard leaded apron vest with and without the addition of an antimony/bismuth Enviro-Lite sleeve on two vascular surgeons performing FGIs. In the simulation, nanoDots were similarly placed on an anthropomorphic phantom positioned to represent a primary operator performing right femoral access. Fluorography was performed on 12-inch-thick acrylic scatter phantom at 80 kVp for an exposure of 3 Gy reference air kerma. Experiments were done with and without the sleeve. Paired Wilcoxon and χ2 tests were performed to identify the statistical significance of radiation attenuation. RESULTS: Operator UOQ CW dose was measured during 61 FGIs: 33 cases (54%) with and 28 cases (46%) without the sleeve. Median procedure reference air kerma and fluoroscopy time was 180 mGy (interquartile range [IQR], 85-447 mGy) and 21 minutes (IQR, 11-39 minutes) when the sleeve was worn vs 100 mGy (IQR, 67-270 mGy) and 11 minutes (IQR, 6.3-25 minutes) without the sleeve. Radiation dose to the operator's UOQ was reduced by 96% (IQR, 85%-96%) when the sleeve was present and by 62% (IQR, 44%-82%; P < .001) without the sleeve. In the simulated setting, the sleeve reduced the radiation dose to the UOQ compared with the apron alone (96% vs 67%; P < .001). CONCLUSIONS: Routine leaded aprons do attenuate the majority of UOQ chest wall radiation dose; however, the addition of a lead-equivalent sleeve further significantly reduces this dose. Because this area of the body has a high incidence of cancer formation, additional protection, especially to female interventionalists, seems prudent. Vascular surgeons should consider using a protective sleeve with their personal protective equipment when performing complex fluoroscopically guided procedures.
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Exposição Ocupacional , Exposição à Radiação , Proteção Radiológica , Parede Torácica , Humanos , Feminino , Doses de Radiação , Braço , Roupa de Proteção , Exposição Ocupacional/efeitos adversos , Exposição Ocupacional/prevenção & controle , Fluoroscopia , Exposição à Radiação/efeitos adversos , Exposição à Radiação/prevenção & controle , Radiografia Intervencionista/efeitos adversosRESUMO
BACKGROUND AND AIMS: Beyond type 2 diabetes, even a condition of prediabetes is associated with an increased cardiovascular (CV) risk, and HCV infection coexistence represents an exacerbating factor. CV prognosis improvement in prediabetes represents a challenge, due to the increasing prevalence of this metabolic condition worldwide. Hence, we aimed to prospectively assess how direct acting antivirals (DAAs) could affect major cardiovascular events (MACE) in a prediabetic HCV positive cohort. METHODS AND RESULTS: In this prospective multicenter study, we enrolled HCV patients with overt prediabetes. We compared a subgroup of patients treated with DAAs with untreated prediabetic controls. We recorded all CV events occurred during an overall median follow-up of 24 months (IQR 19-34). 770 HCV positive prediabetic patients were enrolled, 398 untreated controls and 372 DAAs treated patients. Overall, the CV events annual incidence was much higher among prediabetic treated patients (1.77 vs. 0.62, p < 0.001), and HCV clearance demonstrated to significantly reduce CV events (RR: 0.411, 95%CI 0.148-1.143; p < 0.001), with an estimated NNT for one additional patient to benefit of 52.1. Moreover, an independent association between a lower rate of CV events and HCV clearance after DAAs was observed (OR 4.67; 95%CI 0.44-53.95; p = 0.016). CONCLUSIONS: HCV eradication by DAAs allows a significant reduction of MACEs in the prediabetic population, and therefore represents a primary objective, regardless of the severity of liver disease and CV risk factors.
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Antivirais/uso terapêutico , Doenças Cardiovasculares/prevenção & controle , Hepatite C/tratamento farmacológico , Estado Pré-Diabético/epidemiologia , Idoso , Antivirais/efeitos adversos , Doenças Cardiovasculares/diagnóstico , Doenças Cardiovasculares/epidemiologia , Feminino , Fatores de Risco de Doenças Cardíacas , Hepatite C/diagnóstico , Hepatite C/epidemiologia , Humanos , Incidência , Itália/epidemiologia , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Estado Pré-Diabético/diagnóstico , Estudos Prospectivos , Fatores de Proteção , Estudos Retrospectivos , Medição de Risco , Fatores de Tempo , Resultado do Tratamento , Carga ViralRESUMO
PURPOSE: Institutional arthroplasty registries are very popular nowadays; however, very few efforts have been made in order to standardize the information to be collected, thus limiting the possibility of inter-institutional data interpretation. This manuscript reports the results of a single-country consensus designed to define the minimum standardized dataset to be recorded within an institutional arthroplasty registry. METHODS: A national consensus was carried out among all members of the Colombian Society of Hip and Knee Surgeons using the Delphi method. Eleven questions and answers comprising every potential domain of an institutional registry of hip and knee arthroplasty were defined. According to the methodology, anonymous voting and multiple discussion rounds were performed. Three levels of agreement were defined: Strong consensus: equal to or greater than 80%, weak consensus between 70 and 79.9%, and no consensus below 70%. RESULTS: All of the questions reached consensus level. The minimum dataset was defined to include demographic and clinical information, intraoperative and implant details, follow-up and early complications, implant survival, and functional outcome scores, as well as the validation model to assess information quality within the database. Currently, this dataset is being implemented voluntarily by the members of our national society. DISCUSSION: A national consensus is a feasible method to build homogeneous arthroplasty registries. We recommend such an exercise since it establishes the basis to compare and add data between institutions and the joint analysis of said information in a national registry.
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Artroplastia de Quadril , Artroplastia do Joelho , Artroplastia de Quadril/efeitos adversos , Artroplastia do Joelho/efeitos adversos , Consenso , Hospitais , Humanos , Sistema de RegistrosRESUMO
AIM: To assess the effect of hepatitis C virus (HCV) eradication on type 2 diabetes mellitus (T2DM). incidence. METHODS: A prospective multicentre case-control study was performed, which included 2426 patients with HCV, 42% of whom had liver fibrosis stage F0-F2 and 58% of whom had liver fibrosis stage F3-F4. The study population consisted of a control group including 1099 untreated patients and 1327 cases treated with direct-acting antivirals (DAAs). T2DM incidence was assessed during a median (interquartile range) follow-up period of 30 (28-42) months. Risk factors for T2DM were assessed using a Cox regression model (relative risk [RR], hazard ratio [HR], Kaplan-Meier analysis). Insulin sensitivity was evaluated by homeostatic model assessment (HOMA) and changes by repeated-measures ANOVA. Factors independently associated with T2DM were assessed by multivariate analysis. RESULTS: The absolute incidence of T2DM for controls and cases was 28 and 7/1000 person-years, respectively (P = 0.001). In cases compared to controls, HCV clearance reduced the RR and HR of T2DM by 81% and 75% to 93%, respectively (P = 0.001). It was calculated that, for every 15 patients who obtained HCV clearance, one case of T2DM was saved. HCV clearance was associated with significant reductions in HOMA-insulin resistance and HOMA-ß-cell function and an increase in HOMA-insulin sensitivity, as assessed in 384 patients before and after HCV clearance. At multivariate analysis, HCV clearance emerged as independently associated with a reduced T2DM risk. CONCLUSION: The results showed that HCV clearance by DAA treatment reduces T2DM incidence probably by restoring the HCV-induced alteration of glucose homeostasis mechanisms.
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Diabetes Mellitus Tipo 2 , Hepatite C Crônica , Antivirais/uso terapêutico , Estudos de Casos e Controles , Diabetes Mellitus Tipo 2/complicações , Diabetes Mellitus Tipo 2/tratamento farmacológico , Diabetes Mellitus Tipo 2/epidemiologia , Hepatite C Crônica/complicações , Hepatite C Crônica/tratamento farmacológico , Hepatite C Crônica/epidemiologia , Humanos , Incidência , Estudos ProspectivosRESUMO
The aim of this paper is to determine the physical proximity of connected things when they are accessed from a smartphone. Links between connected things and mobile communication devices are temporarily created by means of dynamic URLs (uniform resource locators) which may be easily discovered with pervasive short-range radio frequency technologies available on smartphones. In addition, a multi cross domain silent logging mechanism to allow people to interact with their surrounding connected things from their mobile communication devices is presented. The proposed mechanisms are based in web standards technologies, evolving our social network of Internet of Things towards the so-called Web of Things.
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The aim of this paper is to introduce a plug-and-play mechanism for an Internet of Things (IoT) device to instantiate a Software as a Service (SaaS) application in a private cloud, built up with OpenStack. The SaaS application is the digital avatar of a physical object connected to Internet. As a proof of concept, a Vending Machine is retrofitted and connected to Internet with and Arduino Open Hardware device. Once the self-configuration mechanism is completed, it is possible to order a product from a mobile communication device.
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BACKGROUND: Endovascular repair of thoracic aortic aneurysms (TAA) in elective settings has demonstrated successful clinical outcomes. However, life-threatening conditions such as rupture are more often managed with open surgical repair due to the high complexity of arch endovascular repair, lack of available off-the-shelf devices, and limited long-term data. CASE SUMMARY: A 49-year-old female with a recent history of prior ascending aortic repair for Type A10 aortic dissection presented with chest pain and dyspnea. Chest computed tomography angiogram (CTA) revealed acute bilateral pulmonary emboli and a 6.2 cm post dissection aneurysm of the posterior aortic arch with the dissection extending to the right iliac artery. She was treated with thrombolysis and subsequently became hemodynamically unstable. Repeat CTA revealed a massive left hemithorax with concern for aortic arch rupture. Given significant cardiorespiratory compromise and recent open repair, she was considered unfit for redo open repair. Thoracic endovascular aortic repair (TEVAR) with a physician-modified endograft (PMEG) was planned. An Alpha Zenith endograft was modified adding an internal branch for the innominate artery and a fenestration for the left common carotid artery. The left subclavian artery was occluded with a microvascular plug and coil embolization up to the level of the vertebral artery. TEVAR PMEG extension to the celiac artery was performed followed by deployment of a Zenith dissection stent to the aortic bifurcation. Completion angiogram demonstrated successful aneurysm exclusion and patency of target vessels. CONCLUSION: Endovascular treatment of ruptured TAA with PMEGs is feasible. This approach may be an alternative for unfit patients for open repair in emergent settings.
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In recent years, deep venous stenting has increasingly become a treatment strategy for post-thrombotic syndrome. Stent thrombosis can occur, resulting in symptom recurrence despite medical therapy, and there are few options available for durable stent patency restoration. We present a case of a 50-year-old male with prior iliocaval reconstruction that experienced recurrent left lower extremity swelling secondary to occlusion of left external iliac and common iliac vein stents during follow-up. Mechanical thrombectomy with the RevCore System and angioplasty was performed. One month later, the patient demonstrated widely patent bilateral iliac vein stents and complete symptomatic resolution. The RevCore System is a feasible alternative for treatment of chronic in-stent thrombosis.
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Inferior vena cava (IVC) atresia is a rare congenital anomaly. Standardized treatment is not well defined due to its uncommon presentation, with this pathology associated with an increased risk of unprovoked lower extremity deep vein thrombosis (DVT). We present a case of a 32-year-old man who was admitted for bilateral lower extremity edema and pain and was found to have bilateral extensive iliofemoral and femoropopliteal DVT, absence of IVC filling, and extensive tortuous collateralization arising from the pelvic veins to the azygos vein. Bilateral mechanical thrombectomy and endovascular iliocaval reconstruction was performed. Three months later, the patient demonstrated widely patent iliocaval stents and the absence of DVT. Endovascular treatment of IVC atresia is feasible and optimizes the reduction of thrombus burden.
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An abdominal aortic aneurysm (AAA) in children is a rare clinical condition, with idiopathic AAAs even more atypical. We report a case of a 19-month-old girl with incidental findings of an infrarenal AAA and right common iliac artery aneurysm during workup for heart failure. Extensive genetic testing was unremarkable for connective tissue disorders. An aortic bi-iliac artery bypass with a Dacron graft from the infrarenal aorta to the right external iliac artery and left common iliac artery was performed. The patient achieved complete recovery and only required one oral hypertensive medication at 30 days of follow-up. Wide patency of the graft was observed on the 3-month follow-up computed tomography angiogram.
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Endovascular treatment options for vascular injury in pediatric patients are quite limited owing to concerns regarding long-term durability and the lack of devices suitable for the pediatric anatomy. However, in rare circumstances, open surgical therapy will not be an option, and patients will require unconventional endovascular solutions for lifesaving or limb-saving therapies. In the present report, we describe an endovascular treatment of a pediatric patient for whom initial surgical management of a blunt abdominal aortic injury had failed, with subsequent development of an aortic pseudoaneurysm. A 10-year-old girl had presented after a high-speed motor vehicle accident with a seatbelt sign. Multiple abdominal injuries were identified, including blunt aortic injury, significant devitalization of the small bowel, colonic perforation with fecal contamination, multiple lumbar spine fractures, and pulmonary contusions. The patient developed bilateral lower extremity ischemia from the aortic injury and had initially undergone open repair. One month later, the patient had developed a pseudoaneurysm of the aorta near the aortic bifurcation. Because of the hostile abdomen and ensuing short gut syndrome, the pseudoaneurysm was managed using endovascular techniques. The limb of an Excluder internal iliac branch endoprosthesis (W.L. Gore & Associates, Flagstaff, AZ) was used as the endograft. The aortic bifurcation was raised and reconstructed using four Viabahn self-expanding stents (W.L. Gore & Associates). The completion angiogram showed complete resolution of the pseudoaneurysm. The follow-up computed tomography angiogram showed widely patent stent grafts with complete resolution of the pseudoaneurysm. Endovascular management of traumatic vascular injuries in pediatric patients is feasible. The likelihood of reintervention in the future is high with patient growth. However, it is a viable option in lifesaving or limb-saving situations in which open repair is high risk.
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Superior mesenteric artery aneurysms are rare and associated with high mortality rates in cases of rupture. Current Society for Vascular Surgery guidelines recommend treatment of all superior mesenteric artery aneurysms regardless of size. A 53-year-old woman who was admitted for abdominal pain was found with a 14-cm, ruptured superior mesenteric artery branch aneurysm. Endovascular approach was performed with microvascular plug embolization of a feeding branch and aneurysm sac exclusion with a stent graft. Four months later, the patient demonstrated a 21% regression of the aneurysm and stent patency. Thus, timely diagnosis and treatment of superior mesenteric artery aneurysms with endovascular techniques can reduce potential complications.
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BACKGROUND: Kommerell's diverticulum (KD) with a right aortic arch (RAA) and aberrant left subclavian artery (aLSCA) is a rare congenital anomaly of the aortic arch. Treatment is not well defined due to its uncommon presentation, with rupture and dissection risk rates of up to 53%. CASE SUMMARY: A 54-year-old male with a history of chronic obstructive pulmonary disease (COPD) and hypertension presented with difficulty breathing during exercise without dysphagia. Follow-up computerized tomography angiogram (CTA) revealed the presence of a RAA and aLSCA arising from the descending thoracic aorta with an adjacent 58 × 41-mm KD and tracheal and esophageal displacement. Due to the size of the KD, risk of rupture, unsuitable anatomy for total endovascular aortic repair (EVAR), and high COPD burden, the patient was planned to undergo a hybrid surgical repair. Left common carotid (LCCA) artery to LSCA bypass, full aortic debranching, LSCA embolization and percutaneous thoracic endovascular aortic repair (TEVAR) were performed. Successful device position and exclusion of the diverticulum and aneurysmal aorta were observed after completion thoracic aortogram. 18-month follow-up CTA demonstrated patency of the LSCA to LCCA bypass graft and arch vessel branches, as well as stable exclusion of the KD. Persistence of a type II endoleak originated at the right first posterior intercostal artery has been noted and is being followed conservatively since no sac growth has occurred. CONCLUSION: We highlight the presence of a KD with RAA and aberrant subclavian artery, a rare congenital anatomic variation of the aortic arch with complex anatomy. Surgical planning must be individualized according to comorbidities and anatomical variations identified on imaging and 3D reconstructions.
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Anormalidades Cardiovasculares , Divertículo , Doença Pulmonar Obstrutiva Crônica , Masculino , Humanos , Pessoa de Meia-Idade , Aorta Torácica/diagnóstico por imagem , Aorta Torácica/cirurgia , Aorta Torácica/anormalidades , Resultado do Tratamento , Anormalidades Cardiovasculares/complicações , Anormalidades Cardiovasculares/diagnóstico por imagem , Anormalidades Cardiovasculares/cirurgia , Artéria Subclávia/diagnóstico por imagem , Artéria Subclávia/cirurgia , Artéria Subclávia/anormalidades , Aortografia/métodos , Divertículo/diagnóstico por imagem , Divertículo/cirurgiaRESUMO
Pelvic venous insufficiency (PVI) is common in women but has been rarely diagnosed in men. The clinical manifestations include varicocele and pelvic disturbances; however, we were unable to find a previous description of painful ejaculation as a symptom of PVI. We present the case of a 36-year-old man with a 7-year history of severe sharp ejaculatory pain. PVI was suspected after previous treatment attempts. The diagnosis was confirmed by descending phlebography, and he underwent coil embolization of the pelvic vessels and phlebotonic therapy. At 6 months after treatment, he reported a 75% improvement in his condition. Therefore, painful ejaculation should be considered an uncommon manifestation of PVI.
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BACKGROUND: Telangiectasias are dilated blood vessels on the skin that develop progressively because of several diseases, including chronic venous disease. The skin blood flow has differences compared to the rest of the circulatory system. These vessels have a permanent vasoconstrictor tone that can respond to vasoconstriction/vasodilation stimulative substances and higher or lower temperatures. The aim of this study was to investigate any possible telangiectasias vasoconstriction or vasodilation in response to temperature changes. METHODS: This study is a clinical trial with 26 outpatients of vascular surgery with telangiectasias in the lower limbs. We used direct skin digital microscopy to obtain telangiectasias images at room temperature and after the thermal stimulus with cold pads. These photographs were processed using AmScopeAmLite (United Scope LLC Euromex Optics Group b.v., Los Angeles, CA, USA) and the capillary diameter and area were measured in Adobe Illustrator (Adobe Inc., Mountain View, CA, USA). The data collected was analyzed in SPSS Statistics (SPSS Inc., Chicago, IL, USA) with a paired t-test for the telangiectasias area and a Wilcoxon matched-pairs signed-rank test for the telangiectasias diameter. RESULTS: In comparison to telangiectasias measures at room temperature, we found a statistically significant decrease in the diameter (median of -0.04 mm; interquartile range: -0.10 mm to -0.01 mm; P<0.001) and area (mean of -26.54 mm2; 95% Confidence interval (-36.31, -16.76) mm2; P<0.001 in response to the cold stimulus. CONCLUSIONS: Telangiectasias respond to cold patch application with a significantly statistical microscale quantifiable vasoconstriction. This intervention has the potential to improve the current state of telangiectasias sclerotherapy due to its mechanism helping to stabilize the applied foam. We speculate that topic cold used as a neoadjuvant treatment could improve the efficiency, stability, and other outcomes of sclerotherapy. Also, complementary use of topical cold stimulus application may be of interest in the therapeutic management of telangiectasias.
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Telangiectasia , Humanos , Escleroterapia , Pele , Telangiectasia/terapia , Vasodilatação , VeiasRESUMO
BACKGROUND AND AIMS: HCV is associated with an increased risk of cardiovascular events (CV). Whether HCV clearance by direct-acting antivirals (DAA) reduces incident CV disease is poorly understood. We investigate whether HCV eradication reduces CV events. METHODS: In a prospective multicentre study, 2204 HCV patients (F0-F2:29.5%, F3-F4: 70.5%) were enrolled. Males were 48%, median age was 68 (59-74) years and BMI 25.9 (23.1-28); 24.7% were smokers, 18% had diabetes, 13.2% had cholesterol levels >200 mg/dl and 9.1% took statins, 44% had hypertension. During an overall median follow-up of 28 (24-39) months, incident CV events, such as ischemic heart disease (IHD) and ischemic cerebral stroke (ICS), were recorded. An overall of 2204 patients were evaluated as control group and 1668 patients after HCV elimination were followed as a case group. Factors associated with CV events were evaluated by uni- and multi-variate analyses. RESULTS: Incident CV rates per 100 patient years in pre-treatment and untreated controls and treated cases were 1.12, 1.14 and 0.44 (p = 0.0001 vs. controls), respectively, and a decreased of relative risk (RR = 0.379; p = 0.0002) was observed. CV risk was 2.0-3.5 times lower then in controls (HR 3.671; 95%C.I.:1.871-7.201; p < 0.001). The calculated number of patients to be treated to get a benefit in a patient was 55.26. The annual incidence reduction of CV events was 0.68%. HCV clearance was independently associated with CV events reduction (OR, 4.716; 95% C.I.:1.832-12.138; p = 0.001). CONCLUSIONS: HCV clearance by DAA reduces CV events (IHD and ICS) with both clinical and socio-economic benefits.
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Antivirais/uso terapêutico , Hepacivirus/efeitos dos fármacos , Hepatite C Crônica/tratamento farmacológico , Isquemia Miocárdica/prevenção & controle , Acidente Vascular Cerebral/prevenção & controle , Carga Viral/efeitos dos fármacos , Viremia/tratamento farmacológico , Idoso , Antivirais/farmacologia , Comorbidade , Diabetes Mellitus/epidemiologia , Feminino , Hepacivirus/isolamento & purificação , Hepatite C Crônica/virologia , Humanos , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Hipercolesterolemia/tratamento farmacológico , Hipercolesterolemia/epidemiologia , Hipertensão/epidemiologia , Incidência , Itália/epidemiologia , Cirrose Hepática/epidemiologia , Cirrose Hepática/etiologia , Masculino , Pessoa de Meia-Idade , Isquemia Miocárdica/epidemiologia , Estudos Prospectivos , Fatores de Risco , Fumar/epidemiologia , Acidente Vascular Cerebral/epidemiologiaRESUMO
BACKGROUND: Vicriviroc, a novel HIV CCR5 antagonist, demonstrated significant efficacy and favorable tolerability in phase II trials in treatment-experienced subjects, supporting further evaluation in phase III studies. METHODS: Two identical double-blind, placebo (PBO)-controlled trials in CCR5-tropic HIV-infected subjects with documented resistance to two antiretroviral classes were conducted. Subjects were randomized to vicriviroc 30 mg QD (N = 571) or PBO (N = 286) with open-label optimized background therapy (OBT) containing ≥2 fully active antiretroviral drugs. The primary endpoint was percentage of subjects with <50 copies/mL HIV RNA at 48 weeks. It was analyzed in a logistic regression with treatment (vicriviroc + OBT/PBO + OBT), use of enfuvirtide in baseline OBT (yes/no), and baseline HIV RNA (≤100,000/>100,000 copies/mL) as covariates. In addition, a pre-planned analysis to examine other efficacy and safety endpoints was conducted. RESULTS: Baseline characteristics of the pooled mITT population (vicriviroc, n = 486; PBO, n = 235) included mean HIV RNA of 4.6 log(10) copies/mL and mean CD4 count of 257 cells/µL. Approximately 60% of subjects received ≥3 active drugs in the OBT. The percentage of subjects with <50 copies/mL HIV RNA was not significantly different between vicriviroc and PBO at week 48 (64% vs 62%, p = 0.6). However, in subjects receiving ≤2 active drugs in their OBT, the proportion achieving <50 copies/mL HIV RNA was higher in those receiving vicriviroc compared with PBO (70% vs 55%, p = 0.02). CONCLUSIONS: The studies failed to show significant efficacy gains when vicriviroc was added to OBT. However, given the efficacy results of earlier vicriviroc trials and other CCR5 antagonist, studies are needed to define the role of this class of drugs in the treatment of HIV. Clinical trial identifier: http://www.clinicaltrial.gov/: VICTOR-E3 (NCT00523211) and VICTOR-E4 (NCT00474370).
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Fármacos Anti-HIV/administração & dosagem , Infecções por HIV/tratamento farmacológico , HIV-1/genética , Piperazinas/administração & dosagem , Pirimidinas/administração & dosagem , Receptores CCR5/metabolismo , Receptores de HIV/metabolismo , Adulto , Método Duplo-Cego , Feminino , Infecções por HIV/virologia , HIV-1/isolamento & purificação , HIV-1/fisiologia , Humanos , Masculino , Pessoa de Meia-Idade , Placebos/administração & dosagem , RNA Viral/sangue , Resultado do Tratamento , Carga Viral , Viremia/virologiaRESUMO
Se conoce que la transmisión perinatal del VIH de madre a hijo es prevenible con la toma de algunas medidas generales y otras específicas. La acción fundamental para lograr esta prevención es identificar cuales embarazadas son portadoras del VIH temprano durante el embarazo. Para lograr este objetivo es necesario realizar la prueba del ELISA para VIH a toda mujer embarazada en su primera consulta prenatal. Las presentes son unas guías sobre el tema desarrolladas con el fin de facilitar la aplicación de todas las acciones necesarias para la prevención de la transmisión perinatal en Costa Rica, brindando una óptima atención médica a la madre y el recién nacido
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Humanos , Gravidez , Cesárea , Relações Mãe-Filho , Assistência Perinatal , Prevenção Primária , Síndrome da Imunodeficiência Adquirida/fisiopatologia , Síndrome da Imunodeficiência Adquirida/prevenção & controle , Síndrome da Imunodeficiência Adquirida/transmissão , Transmissão de Doença Infecciosa/prevenção & controle , Costa RicaRESUMO
Se conoce que la transmisión perinatal del VIH de madre a hijo es prevenible con la toma de algunas medidas generales y otras específicas. La acción fundamental para lograr esta prevención es identificar cuales embarazadas son portadoras del VIH temprano durante el embarazo. Para lograr este objetivo es necesario realizar la prueba del ELISA para VIH a toda mujer embarazada en su primera consulta prenatal. Las presentes son unas guías sobre el tema desarrolladas con el fin de facilitar la aplicación de todas las acciones necesarias para la prevención de la transmisión perinatal en Costa Rica, brindando una óptima atención médica a la madre y el recién nacido.