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1.
J Vasc Surg ; 75(1): 363-371.e2, 2022 01.
Artigo em Inglês | MEDLINE | ID: mdl-34182024

RESUMO

OBJECTIVE: Mechanisms of procedural stroke after carotid endarterectomy (CEA) or carotid artery stenting are surprisingly underresearched. However, understanding the underlying mechanism could (1) assist in balancing the choice for revascularization vs conservative therapy, (2) assist in choosing either open or endovascular techniques, and (3) assist in taking appropriate periprocedural measures to further decrease procedural stroke rate. The purpose of this study was to overview mechanisms of procedural stroke after carotid revascularization and establish reporting standards to facilitate more granular investigation and individual patient data meta-analysis in the future. METHODS: A systematic review was conducted according to the PRISMA statement. RESULTS: The limited evidence in the literature was heterogeneous and of low quality. Thus, no formal data meta-analysis could be performed. Procedural stroke was classified as hemorrhagic or ischemic; the latter was subclassified as hemodynamic, embolic (carotid embolic or cardioembolic) or carotid occlusion derived, using a combination of clinical inference and imaging data. Most events occurred in the first 24 hours after the procedure and were related to hypoperfusion (pooled incidence 10.2% [95% confidence interval (CI), 3.0-17.5] vs 13.9% [95% CI, 0.0-60.9] after CEA vs carotid artery stenting events, respectively) or atheroembolism (28.9% [95% CI, 10.9-47.0]) vs 34.3 [95% CI, 0.0-91.5]). After the first 24 hours, hemorrhagic stroke (11.6 [95% CI, 5.7-17.4] vs 9.0 [95% CI, 1.3-16.7]) or thrombotic occlusion (18.4 [95% CI, 0.9-35.8] vs 14.8 [95% CI, 0.0-30.5]) became more likely. CONCLUSIONS: Although procedural stroke incidence and etiology may have changed over the last decades owing to technical improvements and improvements in perioperative monitoring and quality control, the lack of literature data limits further statements. To simplify and enhance future reporting, procedural stroke analysis and classification should be documented preemptively in research settings. We propose a standardized form enclosing reporting standards for procedural stroke with a systematic approach to inference of the most likely etiology, for prospective use in registries and randomized controlled trials on carotid revascularization.


Assuntos
Estenose das Carótidas/cirurgia , Endarterectomia das Carótidas/efeitos adversos , Complicações Pós-Operatórias/epidemiologia , Projetos de Pesquisa/normas , Acidente Vascular Cerebral/epidemiologia , Artérias Carótidas/cirurgia , Endarterectomia das Carótidas/instrumentação , Humanos , Incidência , Complicações Pós-Operatórias/etiologia , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Sistema de Registros/normas , Fatores de Risco , Stents/efeitos adversos , Acidente Vascular Cerebral/etiologia , Resultado do Tratamento
3.
J Neurointerv Surg ; 13(6): 524-529, 2021 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-32934139

RESUMO

BACKGROUND: The dual-layer nitinol CASPER stent was designed to prevent plaque prolapse into its strut and periprocedural stroke. OBJECTIVE: To conduct a clinical trial for government approval of the device in patients at either high or normal risk for carotid endarterectomy (CEA). METHODS: Eligible patients had ≥50% symptomatic stenosis or ≥80% asymptomatic stenosis according to the North American Symptomatic Carotid Endarterectomy Trial methods (peak systolic velocity 130 and 230 cm/s on ultrasonography, respectively). The primary endpoint was the lack of major adverse events (MAEs), defined as death, stroke, and myocardial infarction within 30 days, and ipsilateral stroke within 1 year. The performance goal was set at 90.5%. MAE rates were also compared between the CEA high- and normal-risk groups. RESULTS: 140 carotid artery stenting procedures, including 40% of patients at high risk and 60% at normal risk for CEA, were performed in 13 institutes. MAEs occurred in two cases (one intraprocedural and one postprocedural stroke), and the MAE rate was 1.4%. The non-MAE rate was 98.6% according to Kaplan-Meier analysis, which was superior to the previously set performance goal. The deployment success, target lesion revascularization (TLR), in-stent restenosis, and cerebrovascular event rates were 99.3%, 2.4%, 8.5%, and 7.2%, respectively. The MAE rate in patients with normal CEA risk was 1.2%, which was similar to the high-risk CEA group, with no significant difference due to the small number of MAEs. CONCLUSIONS: The MAE rate following use of the CASPER stent was low (1.4%). The MAE, deployment success, TLR, in-stenosis, and cerebrovascular event rates were similar to those of previous reports.


Assuntos
Artérias Carótidas/cirurgia , Estenose das Carótidas/epidemiologia , Estenose das Carótidas/cirurgia , Endarterectomia das Carótidas/instrumentação , Endarterectomia das Carótidas/tendências , Stents Metálicos Autoexpansíveis/tendências , Idoso , Idoso de 80 Anos ou mais , Endarterectomia das Carótidas/efeitos adversos , Feminino , Humanos , Japão/epidemiologia , Masculino , Pessoa de Meia-Idade , Fatores de Risco , Stents Metálicos Autoexpansíveis/efeitos adversos , Fatores de Tempo , Resultado do Tratamento
4.
Vascular ; 28(5): 505-512, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32356684

RESUMO

OBJECTIVES: Carotid cross-clamping during endarterectomy exposes the patient to intraoperative neurological deficits due to embolism or cerebral hypoperfusion. To prevent further cerebrovascular incidents, resorting to shunt is frequently recommended. However, since this method is also considered a stroke risk factor, the use is still controversial. This study aims to shed some light on the best approach regarding the use of shunt in symptomatic cerebral malperfusion after carotid artery cross-clamping. METHODS: From January 2012 to January 2018, 79 patients from a tertiary referral hospital who underwent carotid endarterectomy with regional anesthesia for carotid artery stenosis and manifested post-clamping neurologic deficits were prospectively gathered. Shunt use was left to the decision of the surgeon and performed in 31.6% (25) of the patients. Demographics, comorbidities, imaging tests, and clinical/intraoperative features were evaluated. For data assessment, univariate analysis was performed. RESULTS: Regarding 30-day stroke, 30-day postoperative complications (stroke, surgical hematoma, hyperperfusion syndrome), and cranial nerve injury, no significant differences were found (P = 0.301, P = 0.460, and P = 0.301, respectively) between resource to shunt and non-shunt. Clamping and surgery times were significantly higher in the shunt group (P < 0.001 and P = 0.0001, respectively). CONCLUSIONS: Selective-shunting did not demonstrate superiority for patients who developed focal deficits regarding stroke or other postoperative complications. However, due to the limitations of this study, the benefit of shunting cannot be excluded. Further randomized trials are recommended for precise results on this matter with current sparse clinical evidence.


Assuntos
Anestesia por Condução , Estenose das Carótidas/cirurgia , Circulação Cerebrovascular , Endarterectomia das Carótidas/instrumentação , Idoso , Idoso de 80 Anos ou mais , Anestesia por Condução/efeitos adversos , Estenose das Carótidas/diagnóstico por imagem , Estenose das Carótidas/mortalidade , Estenose das Carótidas/fisiopatologia , Traumatismos dos Nervos Cranianos/etiologia , Endarterectomia das Carótidas/efeitos adversos , Endarterectomia das Carótidas/mortalidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Sistema de Registros , Fatores de Risco , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/fisiopatologia , Fatores de Tempo , Resultado do Tratamento
5.
Ann Vasc Surg ; 67: 557-562, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32243906

RESUMO

Lesion manipulation during internal carotid artery (ICA) surgical dissection is the most crucial stage of carotid endarterectomy (CEA); a friable part of the carotid plaque or a thrombus may detach from the arterial wall, leading to cerebral embolism. Proximal protection devices used in carotid artery stenting reverse the blood flow to the brain eliminating, at least after their deployment, the chance of cerebral embolism. Based on the working principle of these devices, we propose a new approach to CEA making use of a flow-reversal technique, and we report its successful application in 2 high-risk patients with a soft and friable type 4 ICA plaque: a 62-year-old male patient presenting with crescendo transient ischemic attacks and a 61-year-old male patient presenting with a major stroke. Both were operated in the acute period. Once the reverse flow has been established, the surgeon can freely manipulate the carotid and perform a fast blunt dissection without the risk that the disturbance of the arterial wall may lead to cerebral embolism. A video recording of the procedure has been made and presented with this article. Despite the various limitations, including increased clamping time, transient intolerance to reverse flow, and increased blood loss, this technique may improve clinical outcomes, especially in symptomatic patients with friable plaque. A clinical trial is warranted to further study the results of the flow-reversal CEA.


Assuntos
Artéria Carótida Interna/cirurgia , Estenose das Carótidas/cirurgia , Infarto Cerebral/prevenção & controle , Dispositivos de Proteção Embólica , Endarterectomia das Carótidas/instrumentação , Embolia Intracraniana/prevenção & controle , Artéria Carótida Interna/diagnóstico por imagem , Artéria Carótida Interna/fisiopatologia , Estenose das Carótidas/complicações , Estenose das Carótidas/diagnóstico por imagem , Estenose das Carótidas/fisiopatologia , Infarto Cerebral/diagnóstico por imagem , Infarto Cerebral/etiologia , Endarterectomia das Carótidas/efeitos adversos , Humanos , Embolia Intracraniana/diagnóstico por imagem , Embolia Intracraniana/etiologia , Masculino , Pessoa de Meia-Idade , Desenho de Prótese , Fluxo Sanguíneo Regional , Fatores de Risco , Resultado do Tratamento
6.
J Vasc Surg ; 72(4): 1395-1404, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32145991

RESUMO

OBJECTIVE: Three procedures are currently available to treat atherosclerotic carotid artery stenosis: carotid endarterectomy (CEA), transfemoral carotid artery stenting (TF-CAS), and transcarotid artery revascularization (TCAR). Although there is considerable debate evaluating each of these in a head-to-head comparison to determine superiority, little has been mentioned concerning the specific anatomic criteria that make one more appropriate. We conducted a study to define anatomic criteria in relation to inclusion and exclusion criteria and relative contraindications. METHODS: A retrospective review was conducted of 448 carotid arteries from 224 consecutive patients who underwent a neck and head computed tomography arteriography (CTA) scan before carotid intervention for significant carotid artery stenosis. Occlusion of the internal carotid artery (ICA) occurred in 15, yielding 433 arteries for analysis. Anatomic data were collected from CTA images and demographic and comorbidities from chart review. Eligibility for CEA, TF-CAS, and TCAR was defined on the basis of anatomy, not by comorbidity. RESULTS: CTA analysis revealed that 92 of 433 arteries (21%) were ineligible for CEA because of carotid lesions extending cephalad to the second cervical vertebra. Overall, 26 arteries (6.0%) were not eligible for any type of carotid artery stent because of small ICA diameter (n = 11), heavy circumferential calcium (n = 14), or combination (n = 1). An additional 126 arteries were ineligible for TF-CAS on the basis of a hostile aortic arch (n = 115) or severe distal ICA tortuosity (n = 11), yielding 281 arteries (64.9%) that were eligible. In addition to the 26 arteries ineligible for any carotid stent, TCAR was contraindicated in 39 because of a clavicle to bifurcation distance <5 cm (n = 17), common carotid artery diameter <6 mm (n = 3), or significant plaque at the TCAR sheath access site (n = 20), yielding 368 arteries (85.0%) that were eligible for TCAR. CONCLUSIONS: A significant proportion of patients who present with carotid artery stenosis have anatomy that makes one or more carotid interventions contraindicated or less desirable. Anatomic factors should play a key role in selecting the most appropriate procedure to treat carotid artery stenosis. Determination of superiority for one procedure over another should be tempered until anatomic criteria have been assessed to select the best procedural options for each patient.


Assuntos
Artérias Carótidas/anatomia & histologia , Estenose das Carótidas/cirurgia , Tomada de Decisão Clínica , Placa Aterosclerótica/cirurgia , Idoso , Idoso de 80 Anos ou mais , Implante de Prótese Vascular/instrumentação , Implante de Prótese Vascular/normas , Implante de Prótese Vascular/estatística & dados numéricos , Artérias Carótidas/diagnóstico por imagem , Artérias Carótidas/cirurgia , Estenose das Carótidas/etiologia , Angiografia por Tomografia Computadorizada , Endarterectomia das Carótidas/instrumentação , Endarterectomia das Carótidas/normas , Endarterectomia das Carótidas/estatística & dados numéricos , Procedimentos Endovasculares/instrumentação , Procedimentos Endovasculares/normas , Procedimentos Endovasculares/estatística & dados numéricos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Placa Aterosclerótica/complicações , Estudos Retrospectivos , Stents
7.
J. vasc. bras ; 19: e20190027, 2020. tab, graf
Artigo em Português | LILACS | ID: biblio-1091015

RESUMO

Resumo Contexto A espectroscopia próxima ao infravermelho (NIRS) é uma técnica não invasiva que detecta as alterações hemodinâmicas teciduais. A NIRS pode monitorar de forma contínua as informações fisiológicas vasculares intracranianas. Por ser portátil, ela pode ser utilizada à beira do leito e no centro cirúrgico. Objetivos Avaliar as possíveis alterações hemodinâmicas cerebrais durante a endarterectomia em pacientes com estenoses maiores que 70% utilizando NIRS. Métodos Foram avaliados 10 voluntários portadores de doença carotídea aterosclerótica com indicação de endarterectomia. Após a seleção dos pacientes, que responderam um questionário com dados epidemiológicos e informações referentes à presença de comorbidades, a doença foi confirmada por métodos diagnósticos. No procedimento cirúrgico, utilizou-se a NIRS para monitorização. Foram avaliadas as variáveis saturação de oxigênio (SatO2), hemoglobina total (HbT), hemoglobina reduzida (HbR) e hemoglobina oxigenada (HbO) nos três tempos cirúrgicos pré-, trans e pós-clampeamento carotídeo. Utilizou-se p < 0,05 como nível de significância. Resultados A avaliação dos resultados obtidos por meio das medidas registradas pela NIRS permite afirmar que HbR e SatO2 variam ao longo das etapas da cirurgia. Durante o clampeamento, a variável HbR mostra valores mais elevados que nas outras duas etapas da cirurgia. Por outro lado, a variável SatO2 mostra redução durante o clampeamento. Conclusões A NIRS é um método viável e aplicável de monitorização intracerebral, não invasivo e em tempo real, durante a endarterectomia carotídea, capaz de medir de forma precisa as mudanças das condições hemodinâmicas capilares intracerebrais.


Abstract Backgrounds Near-infrared spectroscopy (NIRS) is non-invasive technique that detects hemodynamic alterations in tissues. It enables continuous monitoring of intracerebral vascular physiologic information. Due to its portable nature, NIRS may be used bedside or in the operating room. Objectives To evaluate use of NIRS for intraoperative monitoring of the brain hemodynamic response, during carotid endarterectomy. Methods 10 patients with atherosclerotic carotid disease scheduled for endarterectomy were evaluated. After patients had been selected, they answered a questionnaire on epidemiological data and information about comorbidities and then carotid disease was confirmed with diagnostic methods. NRIS monitoring was used during the surgical procedure. The variables analyzed before, during and after carotid clamping were oxygen saturation (SatO2), total hemoglobin (THb), reduced hemoglobin (RHb), and oxyhemoglobin (OHb). A p value of <0.05 was considered statistically significant. Results The results obtained from NIRS show that RHb and SatO2 vary during the different stages of surgery. RHb levels are higher during clamping, when compared with the other two surgical stages. On the other hand, SatO2 is lower during clamping. Conclusions During carotid endarterectomy, NIRS is a feasible, real-time, and non-invasive intracranial monitoring method that accurately and reliably measures the changes in intracerebral capillary hemodynamic conditions.


Assuntos
Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Idoso , Monitorização Intraoperatória/instrumentação , Endarterectomia das Carótidas/instrumentação , Espectroscopia de Luz Próxima ao Infravermelho/métodos , Doenças das Artérias Carótidas/cirurgia , Estudos Transversais , Estudos Prospectivos , Cérebro/irrigação sanguínea , Monitorização Hemodinâmica/instrumentação , Período Intraoperatório
9.
Eur J Vasc Endovasc Surg ; 58(6): 805-812, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31653610

RESUMO

OBJECTIVES: The metabolic syndrome (MetS) is a cluster of risk factors for cardiovascular disease. The effect of MetS on clinical outcome in patients with cerebrovascular disease remains largely unknown because conflicting results have been published. This study aimed to determine the influence of MetS on the occurrence of restenosis after carotid endarterectomy (CEA). METHODS: All patients who underwent CEA between June 2003 and December 2014 in two tertiary academic referral centres in The Netherlands were included. MetS was defined if three or more of the following criteria were present: hypertension, obesity, high fasting serum blood glucose, high serum triglycerides, or low serum high density lipoprotein cholesterol. The primary outcome measure was the occurrence of ipsilateral restenosis after index surgery. The secondary outcome measure was (all cause) mortality during follow up. For the primary analysis, missing data were multiply imputed using multivariable imputation by chained equations. A Cox proportional hazards model was used to perform an adjusted analysis on the multiply imputed data sets. RESULTS: A total of 1668 CEA procedures (in 1577 patients) were performed. The presence or absence of MetS could not be determined in 263 patients because of missing data. There was no significant difference in freedom from restenosis in the MetS group vs. the no-MetS group (hazard ratio [HR], 1.10; 95% confidence interval [CI] 0.98-1.23; p = .10) or in all cause mortality (HR 1.20; 95% CI 0.94-1.54; p = .14). CONCLUSION: This study shows that MetS does not predict restenosis after CEA. Also, the presence of MetS did not influence patient survival negatively.


Assuntos
Estenose das Carótidas/cirurgia , Endarterectomia das Carótidas/efeitos adversos , Síndrome Metabólica/epidemiologia , Idoso , Estenose das Carótidas/epidemiologia , Comorbidade , Endarterectomia das Carótidas/instrumentação , Feminino , Seguimentos , Humanos , Estimativa de Kaplan-Meier , Masculino , Síndrome Metabólica/complicações , Pessoa de Meia-Idade , Países Baixos/epidemiologia , Estudos Prospectivos , Recidiva , Medição de Risco , Fatores de Risco , Stents , Fatores de Tempo , Resultado do Tratamento
10.
J Vasc Surg ; 70(5): 1488-1498, 2019 11.
Artigo em Inglês | MEDLINE | ID: mdl-31416653

RESUMO

OBJECTIVE: We sought to analyze the association between last neurologic event and the risk of stroke or death among patients treated with carotid endarterectomy (CEA) or carotid artery stenting (CAS) under routine conditions in Germany. METHODS: Secondary data analysis was performed based on the German statutory quality assurance database for carotid procedures. A total of 144,347 patients treated by CEA and 14,794 patients treated by CAS were included in the analysis. Primary outcome was any in-hospital stroke or death. To analyze the association between the last neurologic event and outcome, multilevel multivariable regression analysis was performed. RESULTS: In patients treated by CEA, raw risk for any in-hospital stroke or death was 2.0% (2923/144,347), with a risk of 1.4% in asymptomatic and 3.0% in symptomatic patients. In patients treated by CAS, raw risk for any in-hospital stroke or death was 3.6% (538/14,794), with a risk of 1.7% in asymptomatic and 6.1% in symptomatic patients. Regression analysis revealed that increasing severity of last neurologic event was significantly associated with an increasing risk of any in-hospital stroke or death in patients treated by both CEA and CAS (P < .004). However, the risk of any stroke or death did not significantly differ between asymptomatic patients and patients with amaurosis fugax before CEA or CAS (P = .219 for CEA, P = .124 for CAS). CONCLUSIONS: Increasing severity of last neurologic event is associated with an increasing risk of any in-hospital stroke or death in patients treated by CEA and CAS. The risk of any stroke or death did not differ between asymptomatic patients and patients with amaurosis fugax.


Assuntos
Amaurose Fugaz/epidemiologia , Estenose das Carótidas/cirurgia , Endarterectomia das Carótidas/efeitos adversos , Complicações Pós-Operatórias/epidemiologia , Acidente Vascular Cerebral/epidemiologia , Idoso , Amaurose Fugaz/diagnóstico , Amaurose Fugaz/etiologia , Doenças Assintomáticas , Estenose das Carótidas/complicações , Estenose das Carótidas/mortalidade , Bases de Dados Factuais/estatística & dados numéricos , Endarterectomia das Carótidas/instrumentação , Endarterectomia das Carótidas/métodos , Feminino , Alemanha/epidemiologia , Mortalidade Hospitalar , Humanos , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/etiologia , Medição de Risco , Fatores de Risco , Índice de Gravidade de Doença , Stents/efeitos adversos , Acidente Vascular Cerebral/etiologia , Resultado do Tratamento
11.
Int Angiol ; 38(4): 326-333, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31203597

RESUMO

BACKGROUND: Renal insufficiency and allergy to iodine contrast are relative contraindications to carotid artery stenting (CAS). The primary aim of this pilot study was to evaluate the feasibility and safety of the CAS assisted by 3D fusion of previously performed computed tomography (CTA) and magnetic resonance angiography (MRA) images and DynaCT, the secondary aim was to determine if 3D fusion decreases radiation exposure and the amount of contrast needed during the procedure. METHODS: Retrospective review of patients who underwent CAS between October 1st, 2012 and November 30th, 2014 was performed. CTA-assisted fusion was used in group A (CAS/CTA), MRA-assisted fusion in group B (CAS/MRA) and group C (control group) underwent CAS without fusion. No patient in the study had renal dysfunction, risk factors of contrast-induced nephropathy or insulin-dependent diabetes. Primary outcome was perioperative stroke or death, secondary outcome included technical success, radiation dose, exposure time and volume of contrast used. Statistical analysis was performed with Student's t-test, using the permutation methods. Level of significance was set at P<0.05. RESULTS: Fifty-seven patients (32 female, mean age: 69.4 years, range 61 to 82 years), underwent CAS (group A: 10 patients, group B: 10 patients, group C: 37 patients). Technical success was 100%. There was no 30-day mortality or stroke and there were no general, neurological or local complications. Mean contrast volume was significantly less in groups A and B, than in group C (15±5 mL and 16±4 mL vs. 51±16 mL, group A vs. C: t(43.35)=11.85; P<0.0001; group B vs. C: t(44.94)=12.23; P<0.00001). Radiation exposure time and dose were not statistically different between groups (group A vs. C: t(45)=0.95, P=0.3497 and t(45)=0.3, P=0.7694, respectively; group B vs. C: t(45)=0.93, P=0.3455 and t(45)=0.92, P=0.3644, respectively). CONCLUSIONS: Carotid stenting with 3D fusion in this pilot study was safe and feasible. 3D fusion techniques using either CTA or MRA allowed a significant reduction of contrast volume but did not reduce radiation dose or exposure time. Larger prospective studies of CAS with 3D fusion imaging in patients with renal insufficiency or mild allergy to contrast are warranted.


Assuntos
Doenças das Artérias Carótidas/cirurgia , Meios de Contraste/administração & dosagem , Endarterectomia das Carótidas/instrumentação , Imageamento Tridimensional , Stents , Idoso , Idoso de 80 Anos ou mais , Doenças das Artérias Carótidas/diagnóstico por imagem , Doenças das Artérias Carótidas/mortalidade , Endarterectomia das Carótidas/efeitos adversos , Feminino , Humanos , Angiografia por Ressonância Magnética , Masculino , Pessoa de Meia-Idade , Projetos Piloto , Doses de Radiação , Exposição à Radiação/efeitos adversos , Radiografia Intervencionista/efeitos adversos , Estudos Retrospectivos , Tomografia Computadorizada por Raios X , Resultado do Tratamento
12.
J Cardiovasc Surg (Torino) ; 60(5): 599-611, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31089086

RESUMO

BACKGROUND: Synthetic vascular material use, particularly polytetrafluoroethylene- (PTFE) -based, can be associated with bleeding, which may increase operative time and blood loss. None of the commercially available sealants designed to ensure hemostasis combine bioresorption, high viscosity, hydrophobicity, and compliance with the underlying tissue and on-demand activation. METHODS: A study was designed to assess the biocompatibility and in-vivo performance and bioresorption of a new synthetic on-demand light-activated poly(glycerol-sebacate) acrylate- (PGSA) -based SETALIUM™ Vascular Sealant (TISSIUM, Paris, France) in three large animal studies of open vascular carotid and aortic surgery. The pre-clinical results were then translated into a clinical setting in a prospective, single-arm multicenter study in patients requiring carotid endarterectomy using an ePTFE patch. RESULTS: The biocompatibility testing showed that the PGSA-based SETALIUM™ Vascular Sealant did not induce any significant toxic reaction at a standard clinical dose nor at doses up to 40 times the equivalent intended clinical dose. The PGSA-based sealant was shown to be non-pyrogenic, non-sensitizing, non-irritant, non-clastogenic, and non-mutagenic. The animal studies showed excellent performance and safety results, with clinically significant hemostasis achieved in 100% of the animals in both carotid and aorta studies and excellent local tolerance. Histopathology and morphometric analyses showed surface-based gradual and sustained bioresorption of the PGSA-based sealant up to 86% at 12 months. In the clinical study, the application of the PGSA-based sealant resulted in good performance and safety, with immediate hemostasis achieved in 84% of the cases and no adverse event related to the sealant reported through the one-year follow-up. CONCLUSIONS: The new synthetic on-demand light activated PGSA-based SETALIUM™ Vascular Sealant investigated in our studies demonstrated good biocompatibility, sustained and gradual surface based bioresorption, and acceptable safety profile in animal studies. In addition, the first in-human use showed that the sealant is a safe and effective alternative to achieve fast and controlled hemostasis in vascular carotid reconstructions. A larger randomized controlled study will allow further validation of these encouraging preliminary results.


Assuntos
Acrilatos/administração & dosagem , Angioplastia/efeitos adversos , Aorta Torácica/cirurgia , Artérias Carótidas/cirurgia , Decanoatos/administração & dosagem , Endarterectomia das Carótidas/efeitos adversos , Glicerol/análogos & derivados , Hemorragia/prevenção & controle , Técnicas Hemostáticas , Polímeros/administração & dosagem , Adesivos Teciduais/administração & dosagem , Acrilatos/efeitos adversos , Idoso , Idoso de 80 Anos ou mais , Angioplastia/instrumentação , Animais , Decanoatos/efeitos adversos , Endarterectomia das Carótidas/instrumentação , Feminino , Glicerol/administração & dosagem , Glicerol/efeitos adversos , Técnicas Hemostáticas/efeitos adversos , Humanos , Masculino , Teste de Materiais , Pessoa de Meia-Idade , Modelos Animais , Polímeros/efeitos adversos , Estudos Prospectivos , Carneiro Doméstico , Fatores de Tempo , Adesivos Teciduais/efeitos adversos , Resultado do Tratamento
13.
World Neurosurg ; 123: 17-22, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-30481633

RESUMO

OBJECTIVE: To resolve problems with retraction instruments in order to obtain shallow and flat operative field in procedures such as carotid endarterectomy, we developed a new malleable tin alloy omnidirectional retraction supporting (ORS) ring. METHODS: The new ORS ring has an ellipse-shaped (major axis: 275 mm; minor axis: 192 mm) bar frame (4 mm × 6 mm). The bar has 22 equidistant outward protrusions (length, 12 mm; diameter, 2.5 mm). The frame is made of tin alloy with approximately 1% silver, which provides sufficient malleability to fit different cervical surgical approaches. Rubber bands ending with hooks are attached around the protrusions. The new ORS ring can be placed closer to the skin surface, and skin incision edges are horizontally retracted by the hooks attached in the desired direction. The hooks are repositioned in a stepwise fashion at deeper layers of the surgical wound following dissection for carotid artery exposure. RESULTS: The tin alloy ORS ring was used in 30 carotid endarterectomies. As this ring could be closely positioned in all cases, the real depth of the operative fields (with all instruments in place) was reduced by the omnidirectional horizontal retraction without interference with surgical manipulations. Working on the distal internal carotid artery, such as putting a tacking suture in place and arteriotomy closure, could be easily performed. CONCLUSIONS: The newly developed malleable tin alloy ORS ring can be a valuable instrument for the easy performance of surgery for cervical carotid lesions. Considering its advantages, it is better than conventional retractors and existing stainless steel ORS rings.


Assuntos
Doenças das Artérias Carótidas/cirurgia , Artéria Carótida Primitiva/cirurgia , Artéria Carótida Interna/cirurgia , Endarterectomia das Carótidas/instrumentação , Ligas , Desenho de Equipamento , Humanos , Instrumentos Cirúrgicos , Estanho
14.
Oper Neurosurg (Hagerstown) ; 16(6): 707-716, 2019 06 01.
Artigo em Inglês | MEDLINE | ID: mdl-30508178

RESUMO

BACKGROUND: The exoscope has been reported as a novel neurosurgical instrumentation in clinical practice. OBJECTIVE: To investigate the possibility that ORBEYE (OE), a novel instrument that excludes eyepiece lenses and allows for microsurgery by observation of the 4K3D monitor, could replace microscopes. METHODS: We report 22 clinical cases by 5 experienced neurosurgeons and the comparative results of training 10 residents. An observation study with questionnaire survey was conducted on usability. Twelve items including image quality, eyestrain, and function of the arm were evaluated. RESULTS: The following 22 clinical procedures were conducted: surgery for intracranial hemorrhage (n = 2) and brain tumor (n = 8), laminectomy (n = 3), aneurysm clipping (n = 3), vascular anastomosis (n = 2), carotid endarterectomy (n = 2), and nerve decompression (n = 1). No complications were observed. The fluorescent study, including indocyanine-green and 5-aminolevunic acid, allowed for clear depiction on the 4K monitor. The surgeon could operate in a comfortable posture. Similar to the microscope, it was possible to change the optical and viewing axes with the OE, but the OE was switched to the microscope or endoscope in hematoma removal and pituitary surgery. Residents judged that eyestrain was strong (P = .0096). Experienced neurosurgeons acting as assistants judged that the scope arm's range of movement was narrow (P = .0204). Sixty percent of residents judged that the OE was superior to the microscope. CONCLUSION: Although based on limited experience, it was not possible to substitute the microscope with the OE in all operations; however, the OE surpasses the microscope in terms of ergonomic features.


Assuntos
Astenopia , Ergonomia , Microcirurgia/instrumentação , Procedimentos Neurocirúrgicos/instrumentação , Postura , Adolescente , Adulto , Idoso , Ácido Aminolevulínico , Atitude do Pessoal de Saúde , Neoplasias Encefálicas/cirurgia , Revascularização Cerebral/instrumentação , Revascularização Cerebral/métodos , Criança , Corantes , Neoplasias dos Nervos Cranianos/cirurgia , Descompressão Cirúrgica/instrumentação , Descompressão Cirúrgica/métodos , Endarterectomia das Carótidas/instrumentação , Endarterectomia das Carótidas/métodos , Feminino , Humanos , Verde de Indocianina , Internato e Residência , Aneurisma Intracraniano/cirurgia , Hemorragias Intracranianas/cirurgia , Laminectomia/instrumentação , Laminectomia/métodos , Masculino , Neoplasias Meníngeas/cirurgia , Meningioma/cirurgia , Microcirurgia/métodos , Pessoa de Meia-Idade , Neurilemoma/cirurgia , Procedimentos Neurocirúrgicos/métodos , Fármacos Fotossensibilizantes
15.
Ann Vasc Surg ; 57: 177-186, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-30500638

RESUMO

BACKGROUND: The purpose of this study is to determinate the cost-effectiveness of carotid endarterectomy (CEA) versus transfemoral stenting (TFS) and transcervical stenting (TCS) in a short- and long-term basis in symptomatic and asymptomatic patients. METHODS: From January 2003 to December 2014, patients from the vascular department, with symptomatic or asymptomatic carotid stenosis, who were clinically and anatomically suitable for TFS, TCS, or CEA, were included. Prospective cost data for each individual procedure and complication during follow-up were obtained from the diagnosis-related group. The quality-adjusted life years (QALYs) and incremental cost-effectiveness ratios were estimated. Analysis of data was by treatment received. All statistical tests were two-sided. The significance level was 5%. RESULTS: A total of 349 patients were enrolled: 61 for CEA (17.5%), 159 for TFS (45.5%), and 129 for TCS (37%). A total of 220 (63%) patients were symptomatic and 129 (37%) were asymptomatic. The median procedural cost and overall cost were lower on CEA (5499€ and 5595€, respectively). However, QALYs, for symptomatic patients, were better on TCS (7.3), whereas for asymptomatic patients, QALYs were better on CEA (9.6). Cost-effectiveness for symptomatic patients was better with TCS (803€/QALY), and for asymptomatic patients, it was with CEA (654€/QALY). CONCLUSIONS: TFS and TCS were associated with clinical outcomes equivalent to CEA on both symptomatic and asymptomatic patients. Cost-effectiveness ratios for symptomatic patients were better on TCS, whereas the CEA showed the best results in asymptomatic patients.


Assuntos
Estenose das Carótidas/economia , Estenose das Carótidas/cirurgia , Endarterectomia das Carótidas/instrumentação , Procedimentos Endovasculares/economia , Custos Hospitalares , Avaliação de Processos e Resultados em Cuidados de Saúde/economia , Idoso , Idoso de 80 Anos ou mais , Doenças Assintomáticas , Estenose das Carótidas/complicações , Análise Custo-Benefício , Endarterectomia das Carótidas/efeitos adversos , Procedimentos Endovasculares/efeitos adversos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Modelos Econômicos , Estudos Prospectivos , Qualidade de Vida , Anos de Vida Ajustados por Qualidade de Vida , Espanha , Stents/economia , Fatores de Tempo , Resultado do Tratamento
16.
Ann Vasc Surg ; 53: 273.e1-273.e5, 2018 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-30092422

RESUMO

Carotid endarterectomy (CEA) requires complete control of the blood backflow. An anomalous ascending pharyngeal artery (AphA) has been reported to result in incomplete control of the blood flow during CEA. Here, we present a case of symptomatic right internal carotid stenosis for which CEA was performed. An anomalous AphA was confirmed based on its origin from the distal internal carotid artery (ICA) on 3-dimensional rotational angiography (3DRA). The anomalous AphA arose near the distal end of the plaque, and the origin of the AphA was located in the dorsal wall of the ICA, hidden from the surgical view. The origin of the AphA was detected with rotation of the ICA within the carotid sheath (CS). Intraoperatively, the blood flow from the AphA was completely controlled with clamping of the origin of the AphA. We emphasize the importance of the 3DRA to detect an anomalous AphA and propose the use of the CS as an anchor to rotate the ICA for optimizing the surgical view behind the ICA. This simple surgical technique facilitates to detect and clamp an anomalous AphA arising from the ICA.


Assuntos
Artérias/anormalidades , Artéria Carótida Interna/cirurgia , Estenose das Carótidas/cirurgia , Endarterectomia das Carótidas/instrumentação , Faringe/irrigação sanguínea , Dispositivos de Acesso Vascular , Malformações Vasculares , Idoso , Artérias/diagnóstico por imagem , Artérias/fisiopatologia , Artérias/cirurgia , Velocidade do Fluxo Sanguíneo , Artéria Carótida Interna/diagnóstico por imagem , Artéria Carótida Interna/fisiopatologia , Estenose das Carótidas/diagnóstico por imagem , Estenose das Carótidas/fisiopatologia , Angiografia Cerebral/métodos , Angiografia por Tomografia Computadorizada , Feminino , Humanos , Ligadura , Fluxo Sanguíneo Regional , Resultado do Tratamento , Malformações Vasculares/diagnóstico por imagem , Malformações Vasculares/fisiopatologia
17.
Angiol Sosud Khir ; 24(2): 123-137, 2018.
Artigo em Russo | MEDLINE | ID: mdl-29924783

RESUMO

BACKGROUND: It is known that namely long-term presence of suture material as the only foreign body in autologous conditions may lead to restenosis in the remote period. Such hypothesis was put forward based on good results of reconstructive cardiovascular operations in case of using absorbable suture material. OBJECTIVE: Our study was aimed at comparative analysis of remote results of using absorbable suture material polydioxanone and non-absorbable suture material polypropylene in eversion carotid endarterectomy. PATIENTS AND METHODS: Over the period from 2002 to 2007, at the Department of Vascular Surgery of the Institute of Surgery named after A.V. Vishnevsky performed a total of 408 carotid reconstructions according to the eversion technique. The study was based on comparative analysis of the remote results of this procedure in two groups of patients: the first group consisted of 121 patients in whom replantation of the internal carotid artery into the common carotid artery was performed using absorbable suture material polydioxanone with the metric sizes 5-0 and 6-0 and the second group comprising 135 patients in whom similar manipulations were performed using non-absorbable suture material polypropylene with the metric size 6-0. In the course of the study it turned out that the remote results might also be influenced by the metric size of polydioxanone, therefore the first group was further subdivided into subgroups: polydioxanone 5-0 - 79 patients and polydioxanone 6-0 - 42 patients. RESULTS: At baseline, with statistically significant differences by the gender, incidence of unstable atherosclerotic plaque, diameter of the ipsilateral internal carotid artery ≤4 mm, the groups of patients turned out to be in the remote period statistically significantly comparable by such parameters as frequency of the development of a pseudoaneurysm, restenosis of the internal carotid artery, ipsilateral stroke, restenosis-associated stroke, and by survival. However, when comparing the subgroup of patients wherein polydioxanone 6-0 was used and the second group with the initially statistically significant differences by incidence of unstable atherosclerotic plaque and myocardial infarction, in the remote period there was a statistically significant decrease in the incidence rate of restenosis of the internal carotid artery in the first case. CONCLUSIONS: The obtained findings suggested that the absorbable suture material polydioxanone with the metric size 6-0 might be considered as quite a substantiated alternative to the used in cardiovascular surgery non-absorbable suture material polypropylene. Polydioxanone with the metric size 6-0 made it possible to remove or considerably decrease the incidence rate of the development of restenosis of the internal carotid artery after eversion carotid endarterectomy.


Assuntos
Artérias Carótidas/cirurgia , Estenose das Carótidas/cirurgia , Endarterectomia das Carótidas , Oclusão de Enxerto Vascular , Polidioxanona/uso terapêutico , Polipropilenos/uso terapêutico , Complicações Pós-Operatórias , Suturas/efeitos adversos , Idoso , Artérias Carótidas/diagnóstico por imagem , Artérias Carótidas/patologia , Endarterectomia das Carótidas/efeitos adversos , Endarterectomia das Carótidas/instrumentação , Endarterectomia das Carótidas/métodos , Feminino , Oclusão de Enxerto Vascular/diagnóstico , Oclusão de Enxerto Vascular/epidemiologia , Oclusão de Enxerto Vascular/etiologia , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Avaliação de Processos e Resultados em Cuidados de Saúde , Complicações Pós-Operatórias/classificação , Complicações Pós-Operatórias/diagnóstico , Complicações Pós-Operatórias/etiologia , Procedimentos de Cirurgia Plástica/efeitos adversos , Procedimentos de Cirurgia Plástica/instrumentação , Procedimentos de Cirurgia Plástica/métodos
18.
J Neurointerv Surg ; 10(12): 1149-1154, 2018 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-29674483

RESUMO

BACKGROUND AND PURPOSE: Carotid artery stenting is an alternative to endarterectomy for the treatment of symptomatic carotid stenosis but was associated with a higher risk of procedural stroke or death in randomized controlled trials (RCTs). Technical aspects of treatment may partly explain these results. The purpose of this analysis was to investigate the influence of technical aspects such as stent design or the use of protection devices, as well as clinical variables, on procedural risk. METHODS: We pooled data of 1557 individual patients receiving stent treatment in three large RCTs comparing stenting versus endarterectomy for symptomatic carotid stenosis. The primary outcome event was any procedural stroke or death occurring within 30 days after stenting. RESULTS: Procedural stroke or death occurred significantly more often with the use of open-cell stents (61/595 patients, 10.3%) than with closed-cell stents (58/962 patients, 6.0%; RR 1.76; 95% CI 1.23 to 2.52; P=0.002). Procedural stroke or death occurred in 76/950 patients (8.0%) treated with protection devices (predominantly distal filters) and in 43/607 (7.1%) treated without protection devices (RR 1.10; 95% CI 0.71 to 1.70; P=0.67). Clinical variables predicting the primary outcome event were age, severity of the qualifying event, history of prior stroke, and level of disability at baseline. The effect of stent design remained similar after adjustment for these variables. CONCLUSIONS: In symptomatic carotid stenosis, the use of stents with a closed-cell design is independently associated with a lower risk of procedural stroke or death compared with open-cell stents. Filter-type protection devices do not appear to reduce procedural risk.


Assuntos
Estenose das Carótidas/cirurgia , Endarterectomia das Carótidas/instrumentação , Endarterectomia das Carótidas/normas , Desenho de Equipamento/normas , Equipamentos de Proteção/normas , Stents/normas , Idoso , Artérias Carótidas/patologia , Artérias Carótidas/cirurgia , Estenose das Carótidas/diagnóstico , Análise de Dados , Endarterectomia das Carótidas/efeitos adversos , Desenho de Equipamento/efeitos adversos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Stents/efeitos adversos , Acidente Vascular Cerebral/etiologia , Resultado do Tratamento
19.
J Neurointerv Surg ; 10(4): 351-354, 2018 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-28701298

RESUMO

BACKGROUND: The revascularization of carotid stenosis can increase ipsilateral cerebral blood flow (CBF). Occasionally, elevated CBF is also evident on the contralateral side, but this phenomenon is poorly understood. OBJECTIVE: To analyze retrospectively the relationship between a contralateral CBF increase and several clinical and radiologic features. MATERIALS AND METHODS: We retrospectively analyzed 40 patients with unilateral cervical carotid stenosis treated by carotid artery stenting (CAS). Using 123I-iodamphetamine single-photon emission computed tomography (SPECT); we compared pre- and postoperative hemispheric CBF on both sides. We investigated the influence of the following five factors on the increase of the contralateral hemispheric CBF: stenosis grade (≥50% or <50%, according to the North American Symptomatic Carotid Endarterectomy Trial criteria); age; the presence of anterior and posterior communicating arteries; postoperative hyperperfusion on the stenotic side; and the presence of cerebral steal phenomenon during preoperative acetazolamide-challenge SPECT. RESULTS: Following unilateral CAS, mean hemispheric CBF increased significantly on both sides: from 33.4±5.6 (mean ± SD) to 38.7±7.8 mL/min on the operated side (paired t test, p<0.001) and f35.4±5.4 to 39.2±7.2 mL/min on the contralateral side (p<0.001). In a general linear model, stenosis grade (≥50%) alone was significantly correlated with the increase of the CBF on the contralateral side (p=0.03). CONCLUSION: Revascularization by CAS for unilateral carotid stenosis can increase hemispheric CBF on both sides. Increase of the contralateral CBF is correlated with stenosis grade (≥50%).


Assuntos
Estenose das Carótidas/diagnóstico por imagem , Estenose das Carótidas/cirurgia , Circulação Cerebrovascular/fisiologia , Endarterectomia das Carótidas/métodos , Stents , Idoso , Artérias Carótidas/diagnóstico por imagem , Artérias Carótidas/cirurgia , Endarterectomia das Carótidas/instrumentação , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Tomografia Computadorizada de Emissão de Fóton Único/métodos , Procedimentos Cirúrgicos Vasculares/instrumentação , Procedimentos Cirúrgicos Vasculares/métodos
20.
Ann Vasc Surg ; 39: 209-215, 2017 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-27666808

RESUMO

BACKGROUND: In selected populations, carotid endarterectomy (CEA) reduces long-term stroke risk. Studies have shown increased risk of restenosis with use of a collagen-impregnated Dacron patch compared to a polytetrafluorethylene patch. There is concern that collagen impregnation may initiate thrombosis or promote restenosis due to platelet activation. We performed a retrospective analysis of our CEA experience with routine patching using knitted Dacron patches with (Hemashield) and without (Sauvage) collagen impregnation. METHODS: Our database was queried for all CEAs between January 2006 and December 2010. Seven surgeons performed 655 CEAs. Patients were excluded if no patch was used (n = 1), a primary CEA was performed before study period or by other surgeons (n = 11), or the patch type was indeterminable (n = 38). Demographics, clinical data, and outcomes were compared between the collagen-impregnated (C, Hemashield) group and non-collagen-impregnated (NC, Sauvage) group. RESULTS: A total of 605 CEAs were analyzed (395 C and 210 NC). Demographics were similar except for coronary artery disease (C 54.3% vs. NC 41.6%, P = 0.003). There was no statistically significant difference in 30-day (C 99.7% vs. NC 99.5%, P > 0.99) or 5-year survival (C 80.0% vs. NC 83.7%, P = 0.26) or 30-day stroke rate (C 0.3% vs. NC 1.0%, P = 0.28). No late ipsilateral strokes occurred during 5-year follow-up. The 5-year freedom from restenosis >30% (C 85.3% vs. NC 86.4%, P = 0.33), restenosis >50% (C 94.5% vs. NC 95.5%, P = 0.44), and restenosis >70% (C 98.6% vs. NC 98.9%, P = 0.73) were similar. Two patients underwent carotid stenting for restenosis >70%. Two patients (both in the C group) developed occlusion of the carotid artery. CONCLUSIONS: The thrombosis and restenosis rates in the 2 groups were similar. This suggests that collagen-impregnated patches do not initiate thrombosis or increase restenosis rates after CEA.


Assuntos
Angioplastia/instrumentação , Artéria Carótida Interna/cirurgia , Estenose das Carótidas/cirurgia , Colágeno/administração & dosagem , Endarterectomia das Carótidas/instrumentação , Técnicas Hemostáticas/instrumentação , Polietilenotereftalatos , Idoso , Idoso de 80 Anos ou mais , Angioplastia/efeitos adversos , Artéria Carótida Interna/diagnóstico por imagem , Estenose das Carótidas/diagnóstico por imagem , Colágeno/efeitos adversos , Bases de Dados Factuais , Intervalo Livre de Doença , Endarterectomia das Carótidas/efeitos adversos , Desenho de Equipamento , Feminino , Técnicas Hemostáticas/efeitos adversos , Humanos , Estimativa de Kaplan-Meier , Masculino , Recidiva , Estudos Retrospectivos , Fatores de Risco , Trombose/etiologia , Fatores de Tempo , Resultado do Tratamento
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