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1.
J Vasc Surg ; 79(5): 1090-1100.e4, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38185214

RESUMO

OBJECTIVE: To determine the safety and efficacy of treating abdominal aortic aneurysm (AAA) sacs with polyurethane shape memory polymer (SMP) devices during endovascular aneurysm repair (EVAR), using a technique to fully treat the target lumen after endograft placement (aortic flow volume minus the endograft volume). SMP devices self-expand in the sac to form a porous scaffold that supports thrombosis throughout its structure. METHODS: Two identical prospective, multicenter, single-arm studies were conducted in New Zealand and the Netherlands. The study population was adult candidates for elective EVAR of an infrarenal AAA (diameter of ≥55 mm in men and ≥50 mm in women). Key exclusion criteria were an inability to adequately seal a common iliac artery aneurysm, patent sac feeding vessels of >4 mm, and a target lumen volume of <20 mL or >135 mL. Target lumen volumes were estimated by subtracting endograft volumes from preprocedural imaging-based flow lumen volumes. SMP devices were delivered immediately after endograft deployment via a 6F sheath jailed in a bowed position in the sac. The primary efficacy end point was technical success, defined as filling the actual target lumen volume with fully expanded SMP at the completion of the procedure. Secondary efficacy outcome measures during follow-up were the change in sac volume and diameter, rate of type II endoleak and type I or III endoleaks, and the rate of open repair and related reinterventions, with data collection at 30 days, 6 months, and 1 year (to date). Baseline sac volumes and diameters for change in sac size analyses were determined from 30-day imaging studies. Baseline and follow-up volumes were normalized by subtraction of the endograft volume. RESULTS: Of 34 patients treated with SMP devices and followed per protocol, 33 patients were evaluable at 1 year. Preprocedural aneurysm volume was 181.4 mL (95% confidence interval [CI], 150.7-212.1 mL) and preprocedural aneurysm diameter was 60.8 mm (95% CI, 57.8-63.9 mm). The target lumen volume was 56.3 mL (95% CI, 46.9-65.8 mL). Technical success was 100% and the ratio of SMP fully expanded volume to estimated target lumen volume was 1.4 ± 0.3. Baseline normalized sac volume and diameter were 140.7 mL (95% CI, 126.6-154.9 mL) and 61.0 mm (95% CI, 59.7-62.3 mm). The adjusted mean percentage change in normalized volume at 1 year was -28.8% (95% CI, -35.3 to -22.3%; P < .001). The adjusted mean change in sac diameter at 1 year was -5.9 mm (95% CI, -7.5 to -4.4 mm; P < .001). At 1 year, 81.8% of patients (95% CI, 64.5%-93.0%) achieved a ≥10% decrease in normalized volume and 57.6% of patients (95% CI, 39.2%-74.5%) achieved a ≥5 mm decrease in diameter. No device- or study procedure-related major adverse events occurred through 1 year after the procedure. CONCLUSIONS: Treatment of AAA sacs with SMP devices during EVAR resulted in significant sac volume and diameter regression at 1 year with an acceptable safety profile in this prospective study.


Assuntos
Aneurisma da Aorta Abdominal , Implante de Prótese Vascular , Procedimentos Endovasculares , Masculino , Humanos , Feminino , Prótese Vascular , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Abdominal/cirurgia , Aneurisma da Aorta Abdominal/etiologia , Estudos Prospectivos , Implante de Prótese Vascular/efeitos adversos , Correção Endovascular de Aneurisma , Seguimentos , Resultado do Tratamento , Procedimentos Endovasculares/efeitos adversos , Estudos Retrospectivos , Endoleak/diagnóstico por imagem , Endoleak/etiologia , Endoleak/cirurgia , Fatores de Risco
2.
J Vasc Surg Cases Innov Tech ; 9(3): 101241, 2023 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-37496654

RESUMO

Preprocedural image analysis and intraprocedural techniques to fully treat infrarenal abdominal aortic aneurysm sacs outside of the endograft with shape memory polymer (SMP) devices during endovascular aneurysm repair were developed. Prospective, multicenter, single-arm studies were performed. SMP is a porous, self-expanding polyurethane polymer material. Target lumen volumes (aortic flow lumen volume minus endograft volume) were estimated from the preprocedural imaging studies and endograft dimensions. SMP was delivered immediately after endograft deployment via a 6F sheath jailed in a bowed position in the sac. Technical success was achieved in all cases, defined as implanting enough fully expanded SMP volume to treat the actual target lumen volume.

3.
J Vasc Surg ; 78(4): 929-935.e1, 2023 10.
Artigo em Inglês | MEDLINE | ID: mdl-37330148

RESUMO

OBJECTIVE: There is no proven therapy to reduce growth rates of small- to medium-sized abdominal aortic aneurysms (AAAs). Ex vivo and animal studies have demonstrated that a novel stabilizing agent, 1,2,3,4,6-pentagalloyl glucose (PGG), delivered locally to the aneurysm sac, can bind to elastin and collagen to re-establish strength and resist enzymatic degradation. We aimed to demonstrate that a one-time administration of PGG solution to the aneurysm wall is safe and potentially effective to slow the growth of small- to medium-sized AAAs. METHODS: Patients with small- to medium-sized infrarenal AAAs (maximum diameter <5.5 cm) were recruited. Via transfemoral access, a 14F or 16F dual-balloon delivery catheter was introduced into the aneurysm sac. A single, 3-minute, localized endoluminal infusion of PGG was delivered via a 'weeping' balloon to the aneurysm wall. Independent core laboratory measurements of maximum aneurysm sac diameter and sac volume measurements based on computed tomography angiography (CTA) were used for assessments at 1, 6, 12, 24, and 36 months. The primary endpoints were technical success and safety (major adverse events at 30 days). The secondary endpoint was growth stabilization, defined as freedom from aneurysm sac enlargement (diameter increase >5 mm per year or volume increase of >10% per year). RESULTS: Twenty patients (19 male) were enrolled at five centers from May 2019 to June 2022 (mean age, 67.8 years; range, 50-87 years). All procedures were technically successful. The safety profile was consistent with standard interventional procedures. Four patients demonstrated transient elevations of liver enzymes levels that returned to normal by 30 days with no clinical symptoms. Through November 2022, follow-up CTA data is available on the first 11 patients. The average changes in maximum aneurysm diameter from baseline to 6, 12, 24, and 36 months were 0.2 mm, 1.1 mm, 1.2 mm, and 0.8 mm, respectively, and the average changes in volume were 2.0%, 9.6%, 18.1%, and 11.6%, respectively. At 12 months, none of the aneurysms showed growth >5.0 mm, and three had volume growth >10%. CONCLUSIONS: The early results of this first-in-human, small cohort study demonstrated that a single, localized PGG administration to patients with small- to medium-sized infrarenal AAAs is safe. Longer term follow-up on all 20 treated patients is needed to better assess the potential impact on aneurysm growth.


Assuntos
Aneurisma da Aorta Abdominal , Implante de Prótese Vascular , Procedimentos Endovasculares , Humanos , Masculino , Idoso , Projetos Piloto , Estudos de Coortes , Aorta Abdominal , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Abdominal/cirurgia , Aneurisma da Aorta Abdominal/etiologia , Tomografia Computadorizada por Raios X , Implante de Prótese Vascular/efeitos adversos , Procedimentos Endovasculares/efeitos adversos , Resultado do Tratamento , Prótese Vascular , Desenho de Prótese
4.
Vascular ; : 17085381231177851, 2023 May 22.
Artigo em Inglês | MEDLINE | ID: mdl-37218283

RESUMO

OBJECTIVES: Porous, radiolucent, shape memory polymer is a new technology available in discrete peripheral vascular embolization devices. Shape memory polymers can exist in two stable shapes; crimped for catheter delivery and expanded for vessel embolization. The expanded shape memory polymer in these new devices is hemostatic, and the porous polymeric scaffold has been shown to support tissue ingrowth and eventually bioabsorbs in preclinical animal studies. This report describes clinical experience with this novel material in vascular plug devices. METHODS: a prospective, single-arm, safety study at a single center in New Zealand with longer term follow-up via retrospective imaging review. The study device was a pushable shape memory polymer vascular plug with a distal nitinol anchor coil and a proximal radiopaque marker. RESULTS: Ten male patients were each implanted with a single shape memory polymer vascular plug. Three inferior mesenteric arteries and an accessory renal artery were embolized during endovascular aneurysm repair. An internal iliac artery was treated prior to the open surgical repair of aorto-iliac aneurysms. An internal iliac artery and a subclavian artery were embolized to treat/prophylactically address potential endoleaks. A profunda branch was embolized prior to tumor resection, and two testicular veins were embolized to treat varicoceles. Acute technical success of target vessel embolization was achieved in all implantation cases. Patients were followed for 30 days as part of the study, and no serious adverse events with a relationship to the study device occurred. No recurrent clinical symptoms attributable to treated vessel embolization or recanalization were documented. There was no evidence of recanalization on retrospective review of follow-up imaging through a mean of 22.2 months (range, <1-44 months) post-procedure. CONCLUSIONS: Shape memory polymer vascular embolization devices were safe and effective over the follow-up period of this small safety study. Further experience and longer term follow-up will assess further applicability.

5.
J Vasc Surg Venous Lymphat Disord ; 9(5): 1200-1208, 2021 09.
Artigo em Inglês | MEDLINE | ID: mdl-33359385

RESUMO

OBJECTIVE: Definitive treatment techniques for symptomatic deep venous reflux have been relegated to complex and invasive open surgery which is rarely performed today. The BlueLeaf System provides an endovenous method for the formation of deep venous valves without an implant, avoiding the complications associated with permanent foreign materials. The system has the adaptability to form valves within the femoral and popliteal veins at multiple levels in a single procedure. The aim was to determine the midterm safety and efficacy of this novel device in an early feasibility study. METHODS: Feasibility of endovenous deep venous valve formation was assessed in patients with chronic venous insufficiency (Clinical, Etiologic, Anatomic, Pathophysiologic [CEAP] 4-6). Follow-up was completed through 1 year, assessing vein patency and reflux time (RT) with duplex ultrasound examination. Venous clinical improvement was evaluated using the revised Venous Clinical Severity Scale. RESULTS: Of the 14 patients, 13 (93%) had successful formation of at least one monocuspid valve, with a mean number of 1.4 valves (range, 0-3 valves) per patient. There were no device-related serious adverse events during the index procedure. There were no deep venous thromboses reported at any time point, including 10 patients through the 1-year follow-up. In patients with at least one valve formed, site reported duplex ultrasound examination measured the average RT in the popliteal vein below valve formations, was 3.0 ± 1.0 seconds at baseline, 3.9 ± 3.1 seconds at 30 days, and 3.6 ± 2.1 seconds at 360 days. The revised Venous Clinical Severity Scale improved in all 13 successfully treated patients, decreasing from 15.0 ± 6.0 at baseline to 11.6 ± 5.5 at 30 days, 10.7 ± 5.3 at 210 days, and 9.4 ± 5.0 at 360 days (P = .0002; baseline to 360 days). Among the five patients with an ulcer who reached the 360-day follow-up visit, all (100%) healed at least one ulcer. Two patients (40%) healed all ulcers and three patients (60%) had a decrease in ulcers number but remained at C6 at 360 days. The five patients with a total of nine active ulcers at baseline had four active ulcers at 360 days. CONCLUSIONS: The BlueLeaf System holds promise as a minimally invasive means to safely form fully autogenous deep venous valves. Reconstructed deep veins remained patent, without deep venous thrombosis and symptomatic improvement was consistently observed; however, a decrease in the RT was not. Incremental device design improvements have been undertaken to improve valve function. The results of these iterations await further clinical evaluation.


Assuntos
Procedimentos Endovasculares/instrumentação , Veia Femoral/cirurgia , Veia Poplítea/cirurgia , Insuficiência Venosa/cirurgia , Idoso , Estudos de Viabilidade , Feminino , Veia Femoral/diagnóstico por imagem , Humanos , Masculino , Veia Poplítea/diagnóstico por imagem , Estudos Prospectivos , Ultrassonografia Doppler Dupla , Grau de Desobstrução Vascular
8.
Open Forum Infect Dis ; 6(12): ofz453, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31850388

RESUMO

BACKGROUND: Aerococcus urinae is a Gram-positive coccus that is increasingly recognized as a urinary pathogen since the introduction of mass spectrometry for identification of bacteria. We report a case of abdominal aortitis (with aneurysm) caused by A urinae in a male with recurrent urinary tract infections and recently treated A urinae bacteremia. A 63-year-old gentleman with a history of A urinae urosepsis 7 weeks prior, presented to the Emergency Department with thoracolumbar back pain radiating bilaterally into the groin. Radiological and surgical findings were consistent with infective infrarenal aortitis with aneurysm. METHODS: The patient successfully underwent open surgical debridement and reconstruction of the infrarenal aorta with autologous vein graft. RESULTS: Aerococcus urinae was isolated from excised tissue. The patient completed a 4-week course of intravenous antimicrobial therapy. CONCLUSIONS: Aurinae is a urinary pathogen with the ability to cause severe invasive disease including endovascular infections.

9.
J Vasc Interv Radiol ; 30(1): 61-68, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-30527650

RESUMO

PURPOSE: A prospective, single-center, single-arm feasibility study evaluated procedural and short-term performance of the Advance Enforcer 35 focal-force percutaneous transluminal angioplasty (PTA) balloon catheter in treating stenoses of mature native arteriovenous (AV) hemodialysis access circuits. MATERIALS AND METHODS: Twenty-eight patients undergoing treatment for stenosis of a mature native AV hemodialysis access circuit were enrolled at a single institution. Angiographic assessments of the study lesion were required at baseline and after the procedure. Adjunctive procedures for significant residual stenosis were permitted, and patients had clinical and imaging follow-up for as long as 6 months. RESULTS: Treatment with the study balloon was effective in reducing the average percent diameter stenosis of the treated lesion from 66.3% (range, 43.8%-93.3%) before the procedure to 23.7% (range, -6.7% to 51.4%) after the procedure. The average inflation pressure required was 12.3 atm. Only 1 patient required an adjunctive procedure, and all patients could resume normal dialysis following the study procedure. At 3 months, 62.0% of study lesions remained patent, and the 6-month patency rate was 25.1%. Two adverse events associated with the study procedure were reported: access-site hematoma and forearm pain (3.6% each). CONCLUSIONS: The results demonstrate safety of the study balloon in treating AV access stenosis. Nominal-diameter angioplasty was achieved at relatively low pressure in most study patients without the use of adjunctive procedures, and resumption of normal dialysis was achieved for all patients.


Assuntos
Angioplastia com Balão/instrumentação , Derivação Arteriovenosa Cirúrgica/efeitos adversos , Oclusão de Enxerto Vascular/terapia , Diálise Renal , Dispositivos de Acesso Vascular , Adulto , Idoso , Angiografia , Angioplastia com Balão/efeitos adversos , Desenho de Equipamento , Estudos de Viabilidade , Feminino , Oclusão de Enxerto Vascular/diagnóstico por imagem , Oclusão de Enxerto Vascular/etiologia , Oclusão de Enxerto Vascular/fisiopatologia , Humanos , Masculino , Pessoa de Meia-Idade , Nova Zelândia , Estudos Prospectivos , Fatores de Tempo , Tomografia de Coerência Óptica , Resultado do Tratamento , Grau de Desobstrução Vascular
10.
Circ Res ; 120(2): 341-353, 2017 Jan 20.
Artigo em Inglês | MEDLINE | ID: mdl-27899403

RESUMO

RATIONALE: Abdominal aortic aneurysm (AAA) is a complex disease with both genetic and environmental risk factors. Together, 6 previously identified risk loci only explain a small proportion of the heritability of AAA. OBJECTIVE: To identify additional AAA risk loci using data from all available genome-wide association studies. METHODS AND RESULTS: Through a meta-analysis of 6 genome-wide association study data sets and a validation study totaling 10 204 cases and 107 766 controls, we identified 4 new AAA risk loci: 1q32.3 (SMYD2), 13q12.11 (LINC00540), 20q13.12 (near PCIF1/MMP9/ZNF335), and 21q22.2 (ERG). In various database searches, we observed no new associations between the lead AAA single nucleotide polymorphisms and coronary artery disease, blood pressure, lipids, or diabetes mellitus. Network analyses identified ERG, IL6R, and LDLR as modifiers of MMP9, with a direct interaction between ERG and MMP9. CONCLUSIONS: The 4 new risk loci for AAA seem to be specific for AAA compared with other cardiovascular diseases and related traits suggesting that traditional cardiovascular risk factor management may only have limited value in preventing the progression of aneurysmal disease.


Assuntos
Aneurisma da Aorta Abdominal/diagnóstico , Aneurisma da Aorta Abdominal/genética , Loci Gênicos/genética , Predisposição Genética para Doença/genética , Estudo de Associação Genômica Ampla/métodos , Aneurisma da Aorta Abdominal/epidemiologia , Predisposição Genética para Doença/epidemiologia , Variação Genética/genética , Estudo de Associação Genômica Ampla/tendências , Humanos
11.
J Vasc Surg ; 64(5): 1262-1269, 2016 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-27776696

RESUMO

OBJECTIVE: The purpose of this study was to determine the long-term effectiveness of endovascular aneurysm sealing (EVAS) in the treatment of complex aortoiliac aneurysms with preservation of hypogastric artery flow. METHODS: We reviewed all patients with abdominal aortic aneurysms (AAAs) and common iliac aneurysms (CIAs) enrolled and treated in prospective studies of EVAS using the Nellix endograft (Endologix, Irvine, Calif) at two centers from 2008 to 2014. Patients with 1 year or more of computed tomography follow-up underwent quantitative morphometric assessment by two independent vascular radiologists blinded to clinical outcome results. Hypogastric patency and CIA diameter changes over time were assessed and compared in three treatment groups: totally excluded CIA, partially excluded CIA, and untreated CIA. RESULTS: Among 125 patients with EVAS, 68 patients (mean age, 75 ± 8 years; 79% men) had both AAA (mean diameter, 55.8 ± 2.0 mm) and CIA (median diameter, 23.4; interquartile range, 21.3-27.0 mm), with bilateral CIAs in 33 patients. Treatment of 101 CIAs included complete CIA exclusion in 40 (39.6%), partial CIA exclusion in 33 (32.7%), and no CIA treatment in 28 (27.7%), with successful AAA exclusion in all patients. Internal iliac flow was preserved in all 122 hypogastric arteries that were patent before treatment (14 hypogastric arteries were occluded at baseline). During the 5-year follow-up period (median follow-up, 24.7 months; range, 11.5-61.7 months), three patients required secondary treatment with hypogastric occlusion and graft extension to the external iliac. Thus, internal iliac flow was maintained in 98% of at-risk hypogastric arteries. There were no aneurysm-related clinical events, except for the three secondary treatments. Totally excluded iliac aneurysms did not change in diameter over time (P = .85), whereas untreated CIAs enlarged at a rate of 0.16 mm/y (95% confidence interval, 0.09-0.23; P < .0001). Partially excluded CIAs enlarged at a higher rate of 0.59 mm/y (95% confidence interval, 0.47-0.71; P < .0001). Enlargement ≥3 mm occurred only in partially treated CIAs larger than 3 cm. CONCLUSIONS: EVAS was effective in treating aortoiliac aneurysms with preservation of internal iliac patency in most cases. Complete CIA exclusion prevented aneurysm enlargement over time, whereas partial exclusion did not prevent continued CIA enlargement, particularly in larger aneurysms.


Assuntos
Aneurisma da Aorta Abdominal/cirurgia , Implante de Prótese Vascular/instrumentação , Prótese Vascular , Procedimentos Endovasculares/instrumentação , Aneurisma Ilíaco/cirurgia , Pelve/irrigação sanguínea , Stents , Idoso , Idoso de 80 Anos ou mais , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Abdominal/fisiopatologia , Aortografia/métodos , Implante de Prótese Vascular/efeitos adversos , Ensaios Clínicos como Assunto , Angiografia por Tomografia Computadorizada , Procedimentos Endovasculares/efeitos adversos , Feminino , Humanos , Aneurisma Ilíaco/diagnóstico por imagem , Aneurisma Ilíaco/fisiopatologia , Letônia , Masculino , Tomografia Computadorizada Multidetectores , Nova Zelândia , Variações Dependentes do Observador , Complicações Pós-Operatórias/etiologia , Desenho de Prótese , Fluxo Sanguíneo Regional , Reprodutibilidade dos Testes , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Ultrassonografia Doppler em Cores , Grau de Desobstrução Vascular
12.
Risk Anal ; 36(3): 437-49, 2016 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-27002672

RESUMO

A farm-to-consumption quantitative microbiological risk assessment (QMRA) for Salmonella in pigs in the European Union has been developed for the European Food Safety Authority. The primary aim of the QMRA was to assess the impact of hypothetical reductions of slaughter-pig prevalence and the impact of control measures on the risk of human Salmonella infection. A key consideration during the QMRA development was the characterization of variability between E.U. Member States (MSs), and therefore a generic MS model was developed that accounts for differences in pig production, slaughterhouse practices, and consumption patterns. To demonstrate the parameterization of the model, four case study MSs were selected that illustrate the variability in production of pork meat and products across MSs. For the case study MSs the average probability of illness was estimated to be between 1 in 100,000 and 1 in 10 million servings given consumption of one of the three product types considered (pork cuts, minced meat, and fermented ready-to-eat sausages). Further analyses of the farm-to-consumption QMRA suggest that the vast majority of human risk derives from infected pigs with a high concentration of Salmonella in their feces (≥10(4) CFU/g). Therefore, it is concluded that interventions should be focused on either decreasing the level of Salmonella in the feces of infected pigs, the introduction of a control step at the abattoir to reduce the transfer of feces to the exterior of the pig, or a control step to reduce the level of Salmonella on the carcass post-evisceration.


Assuntos
Medição de Risco/métodos , Intoxicação Alimentar por Salmonella/prevenção & controle , Salmonelose Animal/transmissão , Suínos/microbiologia , Criação de Animais Domésticos , Animais , Simulação por Computador , Surtos de Doenças/prevenção & controle , União Europeia , Fazendas , Contaminação de Alimentos/análise , Manipulação de Alimentos , Microbiologia de Alimentos , Inocuidade dos Alimentos , Humanos , Produtos da Carne/microbiologia , Modelos Teóricos , Método de Monte Carlo , Controle de Qualidade , Carne Vermelha/microbiologia , Doenças dos Suínos/microbiologia
13.
Risk Anal ; 36(3): 546-60, 2016 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-27002673

RESUMO

As part of the evidence base for the development of national control plans for Salmonella spp. in pigs for E.U. Member States, a quantitative microbiological risk assessment was funded to support the scientific opinion required by the EC from the European Food Safety Authority. The main aim of the risk assessment was to assess the effectiveness of interventions implemented on-farm and at the abattoir in reducing human cases of pig meat-borne salmonellosis, and how the effects of these interventions may vary across E.U. Member States. Two case study Member States have been chosen to assess the effect of the interventions investigated. Reducing both breeding herd and slaughter pig prevalence were effective in achieving reductions in the number of expected human illnesses in both case study Member States. However, there is scarce evidence to suggest which specific on-farm interventions could achieve consistent reductions in either breeding herd or slaughter pig prevalence. Hypothetical reductions in feed contamination rates were important in reducing slaughter pig prevalence for the case study Member State where prevalence of infection was already low, but not for the high-prevalence case study. The most significant reductions were achieved by a 1- or 2-log decrease of Salmonella contamination of the carcass post-evisceration; a 1-log decrease in average contamination produced a 90% reduction in human illness. The intervention analyses suggest that abattoir intervention may be the most effective way to reduce human exposure to Salmonella spp. However, a combined farm/abattoir approach would likely have cumulative benefits. On-farm intervention is probably most effective at the breeding-herd level for high-prevalence Member States; once infection in the breeding herd has been reduced to a low enough level, then feed and biosecurity measures would become increasingly more effective.


Assuntos
Medição de Risco/métodos , Intoxicação Alimentar por Salmonella/prevenção & controle , Salmonelose Animal/epidemiologia , Salmonelose Animal/prevenção & controle , Matadouros , Algoritmos , Animais , União Europeia , Fazendas , Contaminação de Alimentos/análise , Microbiologia de Alimentos , Inocuidade dos Alimentos , Humanos , Carne/microbiologia , Prevalência , Probabilidade , Salmonella , Salmonelose Animal/transmissão , Suínos , Doenças dos Suínos/epidemiologia
14.
Risk Anal ; 36(3): 531-45, 2016 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-26857423

RESUMO

In response to the European Food Safety Authority's wish to assess the reduction of human cases of salmonellosis by implementing control measures at different points in the farm-to-consumption chain for pork products, a quantitative microbiological risk assessment (QMRA) was developed. The model simulated the occurrence of Salmonella from the farm to consumption of pork cuts, minced meat, and fermented ready-to-eat sausage, respectively, and a dose-response model was used to estimate the probability of illness at consumption. The QMRA has a generic structure with a defined set of variables, whose values are changed according to the E.U. member state (MS) of interest. In this article we demonstrate the use of the QMRA in four MSs, representing different types of countries. The predicted probability of illness from the QMRA was between 1 in 100,000 and 1 in 10 million per serving across all three product types. Fermented ready-to-eat sausage imposed the highest probability of illness per serving in all countries, whereas the risks per serving of minced meat and pork chops were similar within each MS. For each of the products, the risk varied by a factor of 100 between the four MSs. The influence of lack of information for different variables was assessed by rerunning the model with alternative, more extreme, values. Out of the large number of uncertain variables, only a few of them have a strong influence on the probability of illness, in particular those describing the preparation at home and consumption.


Assuntos
Medição de Risco/métodos , Salmonelose Animal/diagnóstico , Salmonelose Animal/transmissão , Matadouros , Algoritmos , Animais , Simulação por Computador , União Europeia , Fazendas , Contaminação de Alimentos/análise , Manipulação de Alimentos , Microbiologia de Alimentos , Inocuidade dos Alimentos , Humanos , Produtos da Carne/microbiologia , Modelos Estatísticos , Probabilidade , Carne Vermelha/microbiologia , Risco , Salmonella , Intoxicação Alimentar por Salmonella , Suínos
15.
Risk Anal ; 36(3): 461-81, 2016 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-25715888

RESUMO

The burden of Salmonella entering pig slaughterhouses across the European Union is considered a primary food safety concern. To assist E.U. member states with the development of national control plans, we have developed a farm transmission model applicable to all member states. It is an individual-based stochastic susceptible-infected model that takes into account four different sources of infection of pigs (sows, feed, external contaminants such as rodents, and new stock) and various management practices linked to Salmonella transmission/protection (housing, flooring, feed, all-in-all-out production). A novel development within the model is the assessment of dynamic shedding rates. The results of the model, parameterized for two case study member states (one high and one low prevalence) suggest that breeding herd prevalence is a strong indicator of slaughter pig prevalence. Until a member state's' breeding herd prevalence is brought below 10%, the sow will be the dominant source of infection to pigs raised for meat production; below this level of breeding herd prevalence, feed becomes the dominant force of infection.


Assuntos
Carne Vermelha/microbiologia , Intoxicação Alimentar por Salmonella/transmissão , Salmonelose Animal/epidemiologia , Salmonelose Animal/transmissão , Criação de Animais Domésticos , Animais , União Europeia , Fazendas , Fezes , Feminino , Microbiologia de Alimentos , Humanos , Linfonodos/microbiologia , Modelos Estatísticos , Prevalência , Intoxicação Alimentar por Salmonella/prevenção & controle , Sensibilidade e Especificidade , Suínos , Doenças dos Suínos/epidemiologia
16.
J Vasc Access ; 14(2): 164-9, 2013.
Artigo em Inglês | MEDLINE | ID: mdl-23599134

RESUMO

PURPOSE: The aim of this work was to assess the safety and efficacy of the VWING Vascular Needle Guide to assist in cannulation of difficult or impossible to access fistulae using the buttonhole cannulation technique. METHODS: VWING devices were surgically implanted into patients with difficult to access fistulae. A nondevice site and a device site were used to access the fistula and perform dialysis over a six month period. The device site utilized the buttonhole cannulation technique. The performance of each access site was recorded. RESULTS: VWING devices were implanted in nine patients. A total of 387 cannulations took place over 1367 study days. The device site was successfully used 94% of the time compared to 77% for the nondevice site. Cannulation success was comparable between the device and nondevice sites. Ease of insertion, pain during insertion and complication rates were also comparable. No interventions were required at the device site to maintain access compared with four interventions for the nondevice access site. CONCLUSIONS: The VWING performed as intended by facilitating required repeated access to the vascular system and access for hemodialysis treatment. The study has demonstrated that the VWING is a potential solution for access to difficult to cannulate fistulae.


Assuntos
Derivação Arteriovenosa Cirúrgica , Cateterismo/instrumentação , Diálise Renal , Idoso , Cateterismo/efeitos adversos , Cateterismo/métodos , Desenho de Equipamento , Estudos de Viabilidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Agulhas , Nova Zelândia , Estudos Prospectivos , Fatores de Tempo , Resultado do Tratamento
17.
Hum Mol Genet ; 22(14): 2941-7, 2013 Jul 15.
Artigo em Inglês | MEDLINE | ID: mdl-23535823

RESUMO

Abdominal aortic aneurysm (AAA) is a common human disease with a high estimated heritability (0.7); however, only a small number of associated genetic loci have been reported to date. In contrast, over 100 loci have now been reproducibly associated with either blood lipid profile and/or coronary artery disease (CAD) (both risk factors for AAA) in large-scale meta-analyses. This study employed a staged design to investigate whether the loci for these two phenotypes are also associated with AAA. Validated CAD and dyslipidaemia loci underwent screening using the Otago AAA genome-wide association data set. Putative associations underwent staged secondary validation in 10 additional cohorts. A novel association between the SORT1 (1p13.3) locus and AAA was identified. The rs599839 G allele, which has been previously associated with both dyslipidaemia and CAD, reached genome-wide significance in 11 combined independent cohorts (meta-analysis with 7048 AAA cases and 75 976 controls: G allele OR 0.81, 95% CI 0.76-0.85, P = 7.2 × 10(-14)). Modelling for confounding interactions of concurrent dyslipidaemia, heart disease and other risk factors suggested that this marker is an independent predictor of AAA susceptibility. In conclusion, a genetic marker associated with cardiovascular risk factors, and in particular concurrent vascular disease, appeared to independently contribute to susceptibility for AAA. Given the potential genetic overlap between risk factor and disease phenotypes, the use of well-characterized case-control cohorts allowing for modelling of cardiovascular disease risk confounders will be an important component in the future discovery of genetic markers for conditions such as AAA.


Assuntos
Proteínas Adaptadoras de Transporte Vesicular/genética , Aneurisma da Aorta Abdominal/genética , Cromossomos Humanos Par 1/genética , Polimorfismo de Nucleotídeo Único , Idoso , Idoso de 80 Anos ou mais , Estudos de Coortes , Feminino , Predisposição Genética para Doença , Variação Genética , Humanos , Masculino , Pessoa de Meia-Idade
18.
J Vasc Interv Radiol ; 23(9): 1160-4, 2012 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-22832141

RESUMO

PURPOSE: To compare the outcomes of planned superficial femoral artery (SFA) and common femoral artery (CFA) antegrade punctures in patients undergoing endovascular interventions for infrainguinal occlusive arterial disease in a single center. MATERIALS AND METHODS: Between August 2010 and July 2011, consecutive patients who underwent antegrade puncture of CFA or SFA for infrainguinal occlusive disease were studied. Data including sheath size, rate of closure device usage, and complications relating to the arterial puncture were classified according to Society of Interventional Radiology (SIR) classification and analyzed retrospectively. RESULTS: There were 199 antegrade arterial punctures, of which 28 (14%) were planned SFA punctures, performed in 184 patients. All patients had ultrasound-guided puncture. The sheath size ranged from 4 F to 8 F. In 2 of 28 (7%) SFA punctures, a closure device was deployed compared with 43 of 171 (25%) CFA punctures. Six bleeding complications were noted in the CFA puncture group (6 of 171 [3.5%]), of which 2 required urgent operations (repair of a pseudoaneurysm and evacuation of retroperitoneal hematoma). In comparison, only one minor groin hematoma was noted in the SFA puncture group; this did not require any further treatment. No thromboembolic complications were associated with SFA puncture. CONCLUSIONS: Planned antegrade SFA puncture under ultrasound guidance can be performed safely in selected cases with no added morbidity. Interventionalists should have a low threshold for considering antegrade SFA puncture as a first-line access site, especially in patients with a hostile groin.


Assuntos
Arteriopatias Oclusivas/terapia , Cateterismo Periférico/métodos , Procedimentos Endovasculares , Artéria Femoral , Idoso , Idoso de 80 Anos ou mais , Arteriopatias Oclusivas/diagnóstico por imagem , Cateterismo Periférico/efeitos adversos , Cateterismo Periférico/instrumentação , Artéria Femoral/diagnóstico por imagem , Hematoma/etiologia , Hemorragia/etiologia , Hemorragia/cirurgia , Humanos , Pessoa de Meia-Idade , Nova Zelândia , Punções , Estudos Retrospectivos , Resultado do Tratamento , Ultrassonografia de Intervenção , Dispositivos de Acesso Vascular
19.
Respir Physiol Neurobiol ; 181(2): 234-47, 2012 Apr 30.
Artigo em Inglês | MEDLINE | ID: mdl-22484001

RESUMO

Prenatal nicotine exposure is associated with deficiencies in the ability to respond to life threatening stressors such as hypoxia. Although many of these deficiencies appear to originate from defects in the brainstem respiratory network, the specific effects of prenatal nicotine exposure on the brainstem respiratory network are not well understood. We have tested the effects of prenatal nicotine exposure on the respiratory rhythm using an in vitro mouse brainstem slice preparation containing the pre-Bötzinger Complex, a region of the ventral respiratory group that is the postulated site of inspiratory rhythm generation. We found that nicotine exposure during pre- and early postnatal development led to a lower frequency of baseline fictive respiratory discharges from rhythmic slices and a reduction in the ability of the slice to maintain a respiratory rhythm during exposure to severe hypoxia compared to controls. These impairments of the central respiratory rhythm could potentially affect the ability to survive a period of exposure to severe hypoxia in vivo.


Assuntos
Hipóxia/tratamento farmacológico , Nicotina/efeitos adversos , Agonistas Nicotínicos/efeitos adversos , Periodicidade , Efeitos Tardios da Exposição Pré-Natal/fisiopatologia , Sistema Respiratório/efeitos dos fármacos , Animais , Feminino , Hipóxia/fisiopatologia , Camundongos , Gravidez , Respiração/efeitos dos fármacos , Sistema Respiratório/fisiopatologia
20.
Artigo em Inglês | MEDLINE | ID: mdl-22526113

RESUMO

Previous in vitro and in vivo studies showed that the frequency of rhythmic pyloric network activity in the lobster is modulated directly by oxygen partial pressure (PO(2)). We have extended these results by (1) increasing the period of exposure to low PO(2) and by (2) testing the sensitivity of the pyloric network to changes in PO(2) that are within the narrow range normally experienced by the lobster (1 to 6 kPa). We found that the pyloric network rhythm was indeed altered by changes in PO(2) within the range typically observed in vivo. Furthermore, a previous study showed that the lateral pyloric constrictor motor neuron (LP) contributes to the O(2) sensitivity of the pyloric network. Here, we expanded on this idea by testing the hypothesis that pyloric pacemaker neurons also contribute to pyloric O(2) sensitivity. A 2-h exposure to 1 kPa PO(2), which was twice the period used previously, decreased the frequency of an isolated group of pacemaker neurons, suggesting that changes in the rhythmogenic properties of these cells contribute to pyloric O(2) sensitivity during long-term near-anaerobic (anaerobic threshold, 0.7-1.2 kPa) conditions.


Assuntos
Limiar Anaeróbio , Relógios Biológicos , Sistema Digestório/inervação , Nephropidae/metabolismo , Neurônios/metabolismo , Oxigênio/metabolismo , Periodicidade , Potenciais de Ação , Animais , Nephropidae/anatomia & histologia , Rede Nervosa/metabolismo , Fatores de Tempo
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