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1.
Neurosurg Rev ; 46(1): 124, 2023 May 23.
Artigo em Inglês | MEDLINE | ID: mdl-37219634

RESUMO

Despite the importance of functional outcome, only a few scoring systems exist to predict neurologic outcome in meningioma surgery. Therefore, our study aims to identify preoperative risk factors and develop the receiver operating characteristics (ROC) models estimating the risk of a new postoperative neurologic deficit and a decrease in Karnofsky performance status (KPS). A multicentric study was conducted in a cohort of 552 consecutive patients with skull base meningiomas who underwent surgical resection from 2014 to 2019. Data were gathered from clinical, surgical, and pathology records as well as radiological diagnostics. The preoperative predictive factors of functional outcome (neurologic deficit, decrease in KPS) were analyzed in univariate and multivariate stepwise selection analyses. Permanent neurologic deficits were present in 73 (13.2%) patients and a postoperative decrease in KPS in 84 (15.2%). Surgery-related mortality was 1.3%. A ROC model was developed to estimate the probability of a new neurologic deficit (area 0.74; SE 0.0284; 95% Wald confidence limits (0.69; 0.80)) based on meningioma location and diameter. Consequently, a ROC model was developed to predict the probability of a postoperative decrease in KPS (area 0.80; SE 0.0289; 95% Wald confidence limits (0.74; 0.85)) based on the patient's age, meningioma location, diameter, presence of hyperostosis, and dural tail. To ensure an evidence-based therapeutic approach, treatment should be founded on known risk factors, scoring systems, and predictive models. We propose ROC models predicting the functional outcome of skull base meningioma resection based on the age of the patient, meningioma size, and location and the presence of hyperostosis and dural tail.


Assuntos
Hiperostose , Neoplasias Meníngeas , Meningioma , Neoplasias da Base do Crânio , Humanos , Prognóstico , Fatores de Risco , Base do Crânio
2.
Stroke Vasc Neurol ; 8(5): 399-404, 2023 10.
Artigo em Inglês | MEDLINE | ID: mdl-36972920

RESUMO

BACKGROUND AND AIM: In-stent restenosis (ISR) belongs to an infrequent but potentially serious complication after carotid angioplasty and stenting in patients with severe carotid stenosis. Some of these patients might be contraindicated to repeat percutaneous transluminal angioplasty with or without stenting (rePTA/S). The purpose of the study is to compare the safety and effectiveness of carotid endarterectomy with stent removal (CEASR) and rePTA/S in patients with carotid ISR. METHODS: Consecutive patients with carotid ISR (≥80%) were randomly allocated to the CEASR or rePTA/S group. The incidence of restenosis after intervention, stroke, transient ischaemic attack myocardial infarction and death 30 days and 1 year after intervention and restenosis 1 year after intervention between patients in CEASR and rePTA/S groups were statistically evaluated. RESULTS: A total of 31 patients were included in the study; 14 patients (9 males; mean age 66.3±6.6 years) were allocated to CEASR and 17 patients (10 males; mean age 68.8±5.6 years) to the rePTA/S group. The implanted stent in carotid restenosis was successfully removed in all patients in the CEASR group. No clinical vascular event was recorded periproceduraly, 30 days and 1 year after intervention in both groups. Only one patient in the CEASR group had asymptomatic occlusion of the intervened carotid artery within 30 days and one patient died in the rePTA/S group within 1 year after intervention. Restenosis after intervention was significantly greater in the rePTA/S group (mean 20.9%) than in the CEASR group (mean 0%, p=0.04), but all stenoses were <50%. Incidence of 1-year restenosis that was ≥70% did not differ between the rePTA/S and CEASR groups (4 vs 1 patient; p=0.233). CONCLUSION: CEASR seems to be effective and save procedures for patients with carotid ISR and might be considered as a treatment option. TRIAL REGISTRATION NUMBER: NCT05390983.


Assuntos
Reestenose Coronária , Endarterectomia das Carótidas , Masculino , Humanos , Pessoa de Meia-Idade , Idoso , Endarterectomia das Carótidas/efeitos adversos , Constrição Patológica , Fatores de Risco , Resultado do Tratamento , Artérias Carótidas , Angioplastia , Stents
3.
J Neurointerv Surg ; 15(5): 439-445, 2023 May.
Artigo em Inglês | MEDLINE | ID: mdl-35428739

RESUMO

BACKGROUND: Despite all the gains that have been achieved with endovascular mechanical thrombectomy revascularization and intravenous thrombolysis logistics since 2015, there is still a subgroup of patients with salvageable brain tissue for whom persistent emergent large vessel occlusion portends a catastrophic outcome. OBJECTIVE: To test the safety and efficacy of emergent microsurgical intervention in patients with acute ischemic stroke and symptomatic middle cerebral artery occlusion after failure of mechanical thrombectomy. METHODS: A prospective two-center cohort study was conducted. Patients with acute ischemic stroke and middle cerebral artery occlusion for whom recanalization failed at center 1 were randomly allocated to the microsurgical intervention group (MSIG) or control group 1 (CG1). All similar patients at center 2 were included in the control group 2 (CG2) with no surgical intervention. Microsurgical embolectomy and/or extracranial-intracranial bypass was performed in all MSIG patients at center 1. RESULTS: A total of 47 patients were enrolled in the study: 22 at center 1 (12 allocated to the MSIG and 10 to the CG1) and 25 patients at center 2 (CG2). MSIG group patients showed a better clinical outcome on day 90 after the stroke, where a modified Rankin Scale score of 0-2 was reached in 7 (58.3%) of 12 patients compared with 1/10 (10.0%) patients in the CG1 and 3/12 (12.0%) in the CG2. CONCLUSIONS: This study demonstrated the potential for existing microsurgical techniques to provide good outcomes in 58% of microsurgically treated patients as a third-tier option.


Assuntos
Isquemia Encefálica , Procedimentos Endovasculares , AVC Isquêmico , Acidente Vascular Cerebral , Humanos , Estudos Prospectivos , Infarto da Artéria Cerebral Média , Estudos de Coortes , Artéria Carótida Interna/cirurgia , Trombectomia/efeitos adversos , Trombectomia/métodos , Resultado do Tratamento , Acidente Vascular Cerebral/diagnóstico por imagem , Acidente Vascular Cerebral/cirurgia , Isquemia Encefálica/diagnóstico por imagem , Isquemia Encefálica/cirurgia , Estudos Retrospectivos , Procedimentos Endovasculares/métodos
4.
Sci Rep ; 12(1): 14631, 2022 08 27.
Artigo em Inglês | MEDLINE | ID: mdl-36030282

RESUMO

Reflecting the first wave COVID-19 pandemic in Central Europe (i.e. March 16th-April 15th, 2020) the neurosurgical community witnessed a general diminution in the incidence of emergency neurosurgical cases, which was impelled by a reduced number of traumatic brain injuries (TBI), spine conditions, and chronic subdural hematomas (CSDH). This appeared to be associated with restrictions imposed on mobility within countries but also to possible delayed patient introduction and interdisciplinary medical counseling. In response to one year of COVID-19 experience, also mapping the third wave of COVID-19 in 2021 (i.e. March 16 to April 15, 2021), we aimed to reevaluate the current prevalence and outcomes for emergency non-elective neurosurgical cases in COVID-19-negative patients across Austria and the Czech Republic. The primary analysis was focused on incidence and 30-day mortality in emergency neurosurgical cases compared to four preceding years (2017-2020). A total of 5077 neurosurgical emergency cases were reviewed. The year 2021 compared to the years 2017-2019 was not significantly related to any increased odds of 30 day mortality in Austria or in the Czech Republic. Recently, there was a significant propensity toward increased incidence rates of emergency non-elective neurosurgical cases during the third COVID-19 pandemic wave in Austria, driven by their lower incidence during the first COVID-19 wave in 2020. Selected neurosurgical conditions commonly associated with traumatic etiologies including TBI, and CSDH roughly reverted to similar incidence rates from the previous non-COVID-19 years. Further resisting the major deleterious effects of the continuing COVID-19 pandemic, it is edifying to notice that the neurosurgical community´s demeanor to the recent third pandemic culmination keeps the very high standards of non-elective neurosurgical care alongside with low periprocedural morbidity. This also reflects the current state of health care quality in the Czech Republic and Austria.


Assuntos
COVID-19 , Hematoma Subdural Crônico , Europa (Continente) , Humanos , Procedimentos Neurocirúrgicos , Pandemias
5.
Clin Neurophysiol ; 138: 221-230, 2022 06.
Artigo em Inglês | MEDLINE | ID: mdl-35227592

RESUMO

OBJECTIVE: The clinical outcome of surgical extracranial internal carotid artery (eICA) recanalization may be adversely affected by intraoperative ischemia. Median nerve somatosensory evoked potential (SEP) amplitude correlates well with cerebral blood flow. Our study presents the value of intraoperative SEP and selective shunting in the prevention of intraoperative ischemia development during urgent eICA recanalization. METHODS: Prospective recruitment of patients with acute unilateral eICA occlusion. All underwent surgical recanalization with intraoperative monitoring of scalp median SEPs. Preoperative clinical findings, cerebral collaterals, and 3 month functional outcome were evaluated. RESULTS: The cohort consisted of 33 patients. Intraoperative SEP amplitude decreased significantly in 6 (18.2%). An intraluminal shunt was inserted twice (6.1%), surgical complications occurred in 6 (18.2%), intracerebral hemorrhage was not found. Favorable outcome 3 months after surgery according to the modified Rankin scale (mRS 0-2) was achieved in 28 (84.8%), 3 patients died (9.1%). CONCLUSIONS: Intraoperative SEP during urgent eICA recanalization seems to be beneficial. Thanks to the effective measure based on the intraoperative SEP changes, the clinical outcome in four(12.1%) could be positively affected. SIGNIFICANCE: The results suggest that selective shunting based on intraoperative median SEPs may prevent intraoperative ischemia and may improve overall outcome of urgent eICA recanalization.


Assuntos
Isquemia Encefálica , Doenças das Artérias Carótidas , Monitorização Neurofisiológica Intraoperatória , Isquemia Encefálica/prevenção & controle , Doenças das Artérias Carótidas/cirurgia , Artéria Carótida Interna/cirurgia , Potenciais Somatossensoriais Evocados/fisiologia , Humanos , Estudos Prospectivos
6.
JACC Cardiovasc Imaging ; 15(2): 181-189, 2022 02.
Artigo em Inglês | MEDLINE | ID: mdl-34419390

RESUMO

OBJECTIVES: This paper sought to evaluate the occurrence of decompression sickness (DCS) after the application of a patent foramen ovale (PFO) screening and risk stratification strategy. BACKGROUND: PFO is associated with an increased risk of DCS. Recently, transcatheter closure was reported to reduce DCS occurrence in divers with a high-grade shunt. However, to date, there are no data regarding the effectiveness of any PFO screening and risk stratification strategy for divers. METHODS: A total of 829 consecutive divers (age 35.4 ± 10.0 years, 81.5% men) were screened for PFO by means of transcranial color-coded sonography in the DIVE-PFO (Decompression Illness Prevention in Divers with a Patent Foramen Ovale) registry. Divers with a high-grade PFO were offered either catheter-based PFO closure (the closure group) or advised conservative diving (high grades). Divers with a low-grade shunt were advised conservative diving (low grades), whereas those with no PFO continued unrestricted diving (controls). A telephone follow-up was performed. To study the effect of the screening and risk stratification strategy, DCS occurrence before enrollment and during the follow-up was compared. RESULTS: Follow-up was available for 748 (90%) divers. Seven hundred and 2 divers continued diving and were included in the analysis (mean follow-up 6.5 ± 3.5 years). The DCS incidence decreased significantly in all groups, except the controls. During follow-up, there were no DCS events in the closure group; DCS incidence was similar to the controls in the low-grade group (HR: 3.965; 95% CI: 0.558-28.18; P = 0.169) but remained higher in the high-grade group (HR: 26.170; 95% CI: 5.797-118.160; P < 0.0001). CONCLUSIONS: The screening and risk stratification strategy using transcranial color-coded sonography was associated with a decrease in DCS occurrence in divers with PFO. Catheter-based PFO closure was associated with a DCS occurrence similar to the controls; the conservative strategy had a similar effect in the low-grade group, but in the high-grade group the DCS incidence remained higher than in all other groups.


Assuntos
Doença da Descompressão , Forame Oval Patente , Adulto , Doença da Descompressão/diagnóstico por imagem , Doença da Descompressão/epidemiologia , Doença da Descompressão/etiologia , Feminino , Forame Oval Patente/complicações , Forame Oval Patente/diagnóstico por imagem , Forame Oval Patente/epidemiologia , Humanos , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Sistema de Registros , Medição de Risco
7.
Sci Rep ; 11(1): 6171, 2021 03 17.
Artigo em Inglês | MEDLINE | ID: mdl-33731753

RESUMO

The world currently faces the novel severe acute respiratory syndrome coronavirus 2 pandemic. Little is known about the effects of a pandemic on non-elective neurosurgical practices, which have continued under modified conditions to reduce the spread of COVID-19. This knowledge might be critical for the ongoing second coronavirus wave and potential restrictions on health care. We aimed to determine the incidence and 30-day mortality rate of various non-elective neurosurgical procedures during the COVID-19 pandemic. A retrospective, multi-centre observational cohort study among neurosurgical centres within Austria, the Czech Republic, and Switzerland was performed. Incidence of neurosurgical emergencies and related 30-day mortality rates were determined for a period reflecting the peak pandemic of the first wave in all participating countries (i.e. March 16th-April 15th, 2020), and compared to the same period in prior years (2017, 2018, and 2019). A total of 4,752 emergency neurosurgical cases were reviewed over a 4-year period. In 2020, during the COVID-19 pandemic, there was a general decline in the incidence of non-elective neurosurgical cases, which was driven by a reduced number of traumatic brain injuries, spine conditions, and chronic subdural hematomas. Thirty-day mortality did not significantly increase overall or for any of the conditions examined during the peak of the pandemic. The neurosurgical community in these three European countries observed a decrease in the incidence of some neurosurgical emergencies with 30-day mortality rates comparable to previous years (2017-2019). Lower incidence of neurosurgical cases is likely related to restrictions placed on mobility within countries, but may also involve delayed patient presentation.


Assuntos
COVID-19/mortalidade , Procedimentos Neurocirúrgicos/mortalidade , Procedimentos Neurocirúrgicos/tendências , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Criança , Pré-Escolar , Europa (Continente) , Feminino , Humanos , Lactente , Recém-Nascido , Masculino , Pessoa de Meia-Idade , Neurocirurgia/métodos , Pandemias/estatística & dados numéricos , Estudos Retrospectivos , Adulto Jovem
8.
J Neurol Surg A Cent Eur Neurosurg ; 82(6): 505-511, 2021 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-33583008

RESUMO

OBJECTIVES: The impact of a change in hemodynamics on cognitive skills in patients with asymptomatic carotid stenosis (ACS) after carotid endarterectomy (CEA) remains unclear. The aim of this study was to evaluate the results of CEA for ACS at 1 year by assessing the changes in anterior, middle, and posterior cerebral artery blood flow in tandem with changes in cognitive efficiency. METHODS: Flow volume in cerebral arteries using quantitative magnetic resonance angiography was measured in a group of 14 males and 5 females before and at 1 year after CEA for ACS. Cognitive efficiency was assessed by Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). The values of flow volume were processed using simple ratio (SR) and were used for covariance analyses with changes in cognitive skills after CEA. RESULTS: A significant improvement in cognitive efficiency indexes of immediate memory and visuospatial perception at 1 year after CEA for ACS was observed. Simultaneously, a significant deterioration of speech index was noted. During the analysis of association between flow and cognition, the highest correlation could be seen between the middle cerebral artery (MCA) flow and the visuospatial perception. A change in posterior cerebral artery (PCA) flow was associated with an increase in immediate memory index and anterior cerebral artery (ACA) flow change with the speech index. CONCLUSION: Convergence of data supporting the association between revascularization and cognitive improvement were added in a small, single-center cohort of ACS patients undergoing CEA. No significant differences in cognition were seen between preoperative findings and at 1 year after CEA. Visuospatial perception improvement was linked to flow change in MCA, immediate memory improvement to flow change in PCA, and speech index change to flow change in ACA. Methodical limitations of this small study preclude formulating larger generalizations. Hemodynamic factors in CEA should be assessed in a larger-scale study.


Assuntos
Estenose das Carótidas , Endarterectomia das Carótidas , Estenose das Carótidas/diagnóstico por imagem , Estenose das Carótidas/cirurgia , Circulação Cerebrovascular , Cognição , Constrição Patológica , Feminino , Hemodinâmica , Humanos , Masculino
9.
Clin Neurophysiol ; 132(2): 372-381, 2021 02.
Artigo em Inglês | MEDLINE | ID: mdl-33450560

RESUMO

OBJECTIVE: Changes in the N20/P25 amplitude of somatosensory evoked potentials (SEP) of the median nerve have been found to correlate with those in cortical regional cerebral blood flow (rCBF). Our study presents the use of median nerve SEP amplitude in predicting the clinical outcome of urgent surgical internal carotid artery (ICA) recanalization. METHODS: A total of 27 patients suffering an acute ischemic stroke (AIS) with extracranial ICA occlusion within 24 h were prospectively recruited. The primary preoperative endpoints included the SEP amplitude absolute value (SEP-amp) and the SEP amplitude side-to-side ratio (SEP-ratio). Clinical outcome at 3 months postoperatively was assessed using the modified Rankin scale (mRS-3M). RESULTS: The positive predictive values (PPVs) for SEP-amp and SEP-ratio were 95.5% and 100%, respectively, with the negative predictive values (NPVs) being 60.0% and 100%, respectively. The SEP-ratio correlated fully with mRS-3M. CONCLUSION: The median SEP side-to-side N20/P25 amplitude ratio seems to be a very strong positive and negative predictor of the clinical outcome of urgent recanalization of an extracranial ICA occlusion. SIGNIFICANCE: The results suggest that cortical evoked activity may help in selection patient for surgical recanalization and predict clinical recovery after an acute ischemic stroke.


Assuntos
Artéria Carótida Interna/fisiopatologia , Potenciais Somatossensoriais Evocados , AVC Isquêmico/diagnóstico , Procedimentos Cirúrgicos Vasculares/efeitos adversos , Idoso , Idoso de 80 Anos ou mais , Artéria Carótida Interna/cirurgia , Feminino , Humanos , AVC Isquêmico/cirurgia , Masculino , Complicações Pós-Operatórias/epidemiologia , Prognóstico , Procedimentos Cirúrgicos Vasculares/métodos
10.
Ultraschall Med ; 42(1): 65-74, 2021 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-32340045

RESUMO

PURPOSE: Cerebral blood flow volume is an important factor for the accurate diagnosis of neurovascular diseases and treatment indication. This study aims to assess correlations of blood flow volume measurements in cervical and intracranial arteries between duplex sonography and quantitative magnetic resonance angiography (qMRA). MATERIALS AND METHODS: Consecutive patients with suspicion of cerebral vascular pathology underwent qMRA and duplex sonography of cervical and intracranial arteries with measurement of blood flow volume in bilateral common (CCA), internal (ICA) and external carotid arteries, vertebral and basilar arteries, middle, anterior, posterior cerebral and posterior communicating arteries using 2 different ultrasound machines. Ten patients underwent all examinations twice. Correlations between blood flow volume measurements were evaluated using Spearman's correlation coefficient and inter-class correlation coefficient (ICC). RESULTS: In total, 21 subjects (15 males, mean age: 56.3 ± 6.2 years) were included in the study. Duplex sonography inter-investigator correlation was excellent (ICC = 0.972, p < 0.0001) as well as intra-investigator correlations of both qMRA and duplex sonography (ICC ˃ 0.990, p < 0.0001). Mostly high correlations were recorded between qMRA and duplex sonography in particular cervical arteries but only low to moderate correlations were obtained for intracranial arteries. The mean differences between blood flow volume measurements were 10.9 ±â€Š8.1 % in the CCA and its branches when using qMRA and 15.0 ±â€Š11.9 % when using duplex sonography, 13.5 ±â€Š11.8 %/35.4 ±â€Š34.2 % in the ICA siphon and its branches when using qMRA/duplex sonography, and 24.1 ±â€Š19.7 %/44.9 ± 44.0 % in both vertebral arteries and the basilar artery when using qMRA/duplex sonography. CONCLUSION: Duplex sonography as well as qMRA allow for highly reproducible measurement of blood flow volume in cervical and intracranial arteries in routine clinical practice.


Assuntos
Circulação Cerebrovascular , Angiografia por Ressonância Magnética , Ultrassonografia , Artérias , Velocidade do Fluxo Sanguíneo , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos
11.
Arch Med Sci ; 16(5): 1247-1249, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32864017
14.
J Cardiol ; 74(6): 519-523, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31255461

RESUMO

BACKGROUND: Patent foramen ovale (PFO), male sex, age, and body mass index (BMI) were all identified as potential risk factors of decompression sickness (DCS). It has been debated whether PFO might cause unprovoked DCS (i.e. without violation of decompression procedure) due to paradoxical embolization of venous gas emboli. To date, there are no data on the incidence or risk factors of unprovoked DCS. This study sought to evaluate the risk factors of unprovoked DCS in recreational divers. METHODS: A total of 489 consecutive divers were screened for PFO between January 2006 and January 2014 by means of transcranial Doppler. All patients were prospectively included in the study registry. Survival analysis techniques were used to assess for risk factors for unprovoked DCS. Age, sex, BMI, PFO presence, and grade were analyzed. The total sum of dives was used as a measure of time. RESULTS: The group performed a total of 169,411 dives (mean 346±636). Thirty-six (7%) of the divers suffered from an unprovoked DCS. The frequency of PFO was 97.2% in divers with a history of unprovoked DCS and 35.5% in controls (p<0.001). There was no difference in sex, age, BMI, or total number of dives between the respective groups. In the adjusted Cox proportional hazards model, PFO grade 3 was a major risk factor for unprovoked DCS; there was a slight protective effect of increasing age. CONCLUSIONS: We demonstrated that a high-grade PFO was a major risk factor for unprovoked DCS in recreational scuba divers.


Assuntos
Doença da Descompressão/etiologia , Mergulho/efeitos adversos , Forame Oval Patente/complicações , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Modelos de Riscos Proporcionais , Estudos Prospectivos , Sistema de Registros , Fatores de Risco
15.
Oper Neurosurg (Hagerstown) ; 17(2): E54-E55, 2019 Aug 01.
Artigo em Inglês | MEDLINE | ID: mdl-30715551

RESUMO

This video shows an urgent microsurgical embolectomy of the inferior division of the left middle cerebral artery in a patient treated by intravenous thrombolysis (IVT). Patient was eligible for endovascular mechanical thrombectomy1; however, the interventional radiologist was not comfortable performing the procedure given prior unsuccessful attempts to remove a calcified cerebral embolus.2 A 75-yr-old female presented with an acute ischemic stroke with isolated aphasia (NIHSS 9). Using the drip-and-ship concept, IVT (0.9 mg/kg rt-PA) was administered in a regional hospital. Fifty-five minutes after a complete recovery following IVT, multiple transient ischemic attacks of aphasia were observed. While the patient was a candidate for mechanical thrombectomy based on CT perfusion imaging, given the unsuccessful reports in the literature and the interventional radiologist's experience, the decision was made to offer microsurgical embolectomy of the calcified cerebral embolus.3 Informed consent for the procedure was obtained directly from the patient. Calcified, crumbly embolus was removed from a 5 mm longitudinal arteriotomy. The arteriotomy was sutured with interrupted 10-0 suture. Initial flow after the embolectomy was 6.5 mL/min. Upon inspection, a distal kink was found in the M2 and after repositioning, flow improved to 35 mL/min. Postoperative CT angiography documented complete recanalization. The clinical findings completely resolved (NIHSS 0) within 12 hr and remained unchanged at 3 mo and 1 yr. Informed consent was obtained from the patient for use of media for educational and publication purposes.

17.
Trials ; 18(1): 25, 2017 01 17.
Artigo em Inglês | MEDLINE | ID: mdl-28095924

RESUMO

BACKGROUND: Carotid endarterectomy (CEA) is a beneficial procedure for selected patients with an internal carotid artery (ICA) stenosis. Surgical risk of CEA varies from between 2 and 15%. The aim of the study is to demonstrate the safety and effectiveness of sonolysis (continual transcranial Doppler monitoring, TCD) using a 2-MHz diagnostic probe with maximal diagnostic energy on the reduction of the incidence of stroke, transient ischemic attack (TIA) and brain infarction detected using magnetic resonance imaging (MRI) by the activation of the endogenous fibrinolytic system during CEA. METHODS/DESIGN: Design: a multicenter, randomized, double-blind, sham-controlled trial. SCOPE: international, multicenter trial for patients with at least 70% symptomatic or asymptomatic ICA stenosis undergoing CEA. INCLUSION CRITERIA: patients with symptomatic or asymptomatic ICA stenosis of at least 70% are candidates for CEA; a sufficient temporal bone window for TCD; aged 40-85 years, functionally independent; provision of signed informed consent. Randomization: consecutive patients will be assigned to the sonolysis or control (sham procedure) group by computer-generated 1:1 randomization. Prestudy calculations showed that a minimum of 704 patients in each group is needed to reach a significant difference with an alpha value of 0.05 (two-tailed) and a beta value of 0.8 assuming that 10% would be lost to follow-up or refuse to participate in the study (estimated 39 endpoints). ENDPOINTS: the primary endpoint is the incidence of stroke or TIA during 30 days after CEA and the incidence of new ischemic lesions on brain MRI performed 24 h after CEA in the sonolysis and control groups. Secondary endpoints are occurrence of death, any stroke, or myocardial infarction within 30 days, changes in cognitive functions 1 year post procedure related to pretreatment scores, and number of new lesions and occurrence of new lesions ≥0.5 mL on post-procedural brain MRI. ANALYSIS: descriptive statistics and linear/logistic multiple regression models will be performed. Clinical relevance will be measured as relative risk reduction, absolute risk reduction and the number needed to treat. DISCUSSION: Reduction of the periprocedural complications of CEA using sonolysis as a widely available and cheap method may significantly increase the safety of CEA and extend the indication criteria for CEA. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02398734 . Registered on 20 March 2015.


Assuntos
Artéria Carótida Interna/cirurgia , Estenose das Carótidas/cirurgia , Infarto Cerebral/prevenção & controle , Endarterectomia das Carótidas , Fibrinólise , Terapia por Ultrassom/métodos , Ultrassonografia Doppler Transcraniana , Adulto , Idoso , Idoso de 80 Anos ou mais , Artéria Carótida Interna/diagnóstico por imagem , Estenose das Carótidas/sangue , Estenose das Carótidas/complicações , Estenose das Carótidas/diagnóstico por imagem , Infarto Cerebral/diagnóstico por imagem , Infarto Cerebral/etiologia , Protocolos Clínicos , República Tcheca , Método Duplo-Cego , Endarterectomia das Carótidas/efeitos adversos , Feminino , Humanos , Imageamento por Ressonância Magnética , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Projetos de Pesquisa , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
20.
JACC Cardiovasc Interv ; 7(4): 403-8, 2014 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-24630875

RESUMO

OBJECTIVES: This study sought to evaluate the effect of catheter-based patent foramen ovale (PFO) closure on the occurrence of arterial bubbles after simulated dives. BACKGROUND: PFO is a risk factor of decompression sickness in divers due to paradoxical embolization of bubbles. To date, the effectiveness of catheter-based PFO closure in the reduction of arterial bubbles has not been demonstrated. METHODS: A total of 47 divers (age 35.4 ± 8.6 years, 81% men) with a PFO (PFO group) or treated with a catheter-based PFO closure (closure group) were enrolled in this case-controlled observational trial. All divers were examined after a simulated dive in a hyperbaric chamber: 34 divers (19 in the PFO group, 15 in the closure group) performed a dive to 18 m for 80 min, and 13 divers (8 in the PFO group, 5 in the closure group) performed a dive to 50 m for 20 min. Within 60 min after surfacing, the presence of venous and arterial bubbles was assessed by transthoracic echocardiography and transcranial color-coded sonography, respectively. RESULTS: After the 18-m dive, venous bubbles were detected in 74% of divers in the PFO group versus 80% in the closure group (p = 1.0), and arterial bubbles were detected in 32% versus 0%, respectively (p = 0.02). After the 50-m dive, venous bubbles were detected in 88% versus 100%, respectively (p = 1.0), and arterial bubbles were detected in 88% versus 0%, respectively (p < 0.01). CONCLUSIONS: No difference was observed in the occurrence of venous bubbles between the PFO and closure groups, but the catheter-based PFO closure led to complete elimination of arterial bubbles after simulated dives. (Nitrogen Bubble Detection After Simulated Dives in Divers With PFO and After PFO Closure; NCT01854281).


Assuntos
Cateterismo Cardíaco , Doença da Descompressão/prevenção & controle , Mergulho/efeitos adversos , Embolia Aérea/prevenção & controle , Forame Oval Patente/terapia , Adulto , Cateterismo Cardíaco/instrumentação , Estudos de Casos e Controles , Doença da Descompressão/diagnóstico por imagem , Doença da Descompressão/etiologia , Ecocardiografia Transesofagiana , Embolia Aérea/diagnóstico por imagem , Embolia Aérea/etiologia , Feminino , Forame Oval Patente/diagnóstico por imagem , Humanos , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Fatores de Risco , Dispositivo para Oclusão Septal , Fatores de Tempo , Resultado do Tratamento , Ultrassonografia Doppler Transcraniana
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