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1.
Neurosurgery ; 88(2): 252-260, 2021 01 13.
Artigo em Inglês | MEDLINE | ID: mdl-33073847

RESUMO

BACKGROUND: Previous analyses of the International Subarachnoid Aneurysm Trial (ISAT) cohort have reported on clinical outcomes after treatment of a ruptured intracranial aneurysm with either neurosurgical clipping or endovascular coiling. OBJECTIVE: To evaluate the long-term quality-adjusted life years (QALYs) gained of endovascular coiling compare to neurosurgical clipping in the UK cohort of ISAT. METHODS: Between September 12, 1994 and May 1, 2002, patients with ruptured intracranial aneurysms who were assumed treatment equipoise were randomly allocated to either neurosurgical clipping or endovascular coiling. We followed-up 1644 patients in 22 UK neurosurgical centers for a minimum of 10 yr. Health-related quality of life (HRQoL) was collected through yearly questionnaires, measured by utilities calculated from the EQ-5D-3L. We compared HRQoL between the 2 treatment groups over a period of 10 yr. In all, 1-yr, 5-yr, and 10-yr QALYs were estimated by combining utility and survival information. RESULTS: Higher average utility values were found in the endovascular group throughout the follow-up period, with mean differences between groups statistically significant in most years. The 10-yr QALYs were estimated to be 6.68 (95% CI: 6.45-6.90) in the coiling group and 6.32 (95% CI: 6.10-6.55) in the clipping group, respectively, a significant mean difference of 0.36 (95% CI: 0.04-0.66). A third of this mean QALYs gain was estimated to derive solely from HRQoL differences. CONCLUSION: HRQoL after treatment of a ruptured intracranial aneurysm was better after endovascular coiling compared to neurosurgical clipping, which contributed significantly to the QALYs gained over a 10-yr period.


Assuntos
Aneurisma Roto/cirurgia , Procedimentos Endovasculares/métodos , Aneurisma Intracraniano/cirurgia , Procedimentos Neurocirúrgicos/métodos , Qualidade de Vida , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Procedimentos Endovasculares/instrumentação , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Procedimentos Neurocirúrgicos/instrumentação , Inquéritos e Questionários , Resultado do Tratamento , Reino Unido , Adulto Jovem
2.
Stroke ; 51(5): 1600-1603, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-32208844

RESUMO

Background and Purpose- ISAT (International Subarachnoid Aneurysm Trial) demonstrated that 1 year after aneurysmal subarachnoid hemorrhage, coiling resulted in a significantly better clinical outcome than clipping. After 5 years, this difference did not reach statistical significance, but mortality was still higher in the clipping group. Here, we present additional analyses, reporting outcome after excluding pretreatment deaths. Methods- Outcome measures were death with or without dependency at 1 and 5 years after treatment, after exclusion of all pretreatment deaths. Treatment differences were assessed using relative risks (RRs). With sensitivity and exploratory analyses, the relation between treatment delay and outcome was analyzed. Results- After exclusion of pretreatment deaths, at 1-year follow-up coiling was favorable over clipping for death or dependency (RR, 0.77 [95% CI, 0.67-0.89]) but not for death alone (RR, 0.88 [95% CI, 0.66-1.19]). After 5 years, no significant differences were observed, neither for death or dependency (RR, 0.88 [95% CI, 0.77-1.02]) nor for death alone (RR, 0.82 [95% CI, 0.64-1.05]). Sensitivity analyses showed a similar picture. In good-grade patients, coiling remained favorable over clipping in the long-term. Time between randomization and treatment was significantly longer in the clipping arm (mean 1.7 versus 1.1 days; P<0.0001), during which 17 patients died because of rebleeding versus 6 pretreatment deaths in the endovascular arm (RR, 2.81 [95% CI, 1.11-7.11]). Conclusions- These additional analyses support the conclusion of ISAT that at 1-year follow-up after aneurysmal subarachnoid hemorrhage coiling has a better outcome than clipping. After 5 years, with pretreatment mortality excluded, the difference between coiling and clipping is not significant. The high number of pretreatment deaths in the clipping group highlights the importance of urgent aneurysm treatment to prevent early rebleeding.


Assuntos
Aneurisma Roto/cirurgia , Procedimentos Endovasculares/métodos , Aneurisma Intracraniano/cirurgia , Procedimentos Neurocirúrgicos/métodos , Hemorragia Subaracnóidea/cirurgia , Tempo para o Tratamento/estatística & dados numéricos , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Instrumentos Cirúrgicos , Resultado do Tratamento
4.
Lancet ; 385(9969): 691-7, 2015 Feb 21.
Artigo em Inglês | MEDLINE | ID: mdl-25465111

RESUMO

BACKGROUND: Previous analyses of the International Subarachnoid Aneurysm Trial (ISAT) cohort have reported on the risks of recurrent subarachnoid haemorrhage and death or dependency for a minimum of 5 years and up to a maximum of 14 years after treatment of a ruptured intracranial aneurysm with either neurosurgical clipping or endovascular coiling. At 1 year there was a 7% absolute and a 24% relative risk reduction of death and dependency in the coiling group compared with the clipping group, but the medium-term results showed the increased need for re-treatment of the target aneurysm in the patients given coiling. We report the long-term follow-up of patients in this UK cohort. METHODS: In ISAT, patients were randomly allocated to either neurosurgical clipping or endovascular coiling after a subarachnoid haemorrhage, assuming treatment equipoise, between Sept 12, 1994, and May 1, 2002. We followed up 1644 patients in 22 UK neurosurgical centres for death and clinical outcomes for 10·0-18·5 years. We assessed dependency as self-reported modified Rankin scale score obtained through yearly questionnaires. Data for recurrent aneurysms and rebleeding events were collected from questionnaires and from hospital and general practitioner records. The Office for National Statistics supplied data on deaths. This study is registered, number ISRCTN49866681. FINDINGS: At 10 years, 674 (83%) of 809 patients allocated endovascular coiling and 657 (79%) of 835 patients allocated neurosurgical clipping were alive (odds ratio [OR] 1·35, 95% CI 1·06-1·73). Of 1003 individuals who returned a questionnaire at 10 years, 435 (82%) patients treated with endovascular coiling and 370 (78%) patients treated with neurosurgical clipping were independent (modified Rankin scale score 0-2; OR 1·25; 95% CI 0·92-1·71). Patients in the endovascular treatment group were more likely to be alive and independent at 10 years than were patients in the neurosurgery group (OR 1·34, 95% CI 1·07-1·67). 33 patients had a recurrent subarachnoid haemorrhage more than 1 year after their initial haemorrhage (17 from the target aneurysm). INTERPRETATION: Although rates of increased dependency alone did not differ between groups, the probability of death or dependency was significantly greater in the neurosurgical group than in the endovascular group. Rebleeding was more likely after endovascular coiling than after neurosurgical clipping, but the risk was small and the probability of disability-free survival was significantly greater in the endovascular group than in the neurosurgical group at 10 years. FUNDING: UK Medical Research Council.


Assuntos
Aneurisma Roto/terapia , Embolização Terapêutica/métodos , Aneurisma Intracraniano/terapia , Procedimentos Neurocirúrgicos/métodos , Hemorragia Subaracnóidea/terapia , Aneurisma Roto/mortalidade , Intervalo Livre de Doença , Embolização Terapêutica/mortalidade , Feminino , Humanos , Aneurisma Intracraniano/mortalidade , Masculino , Procedimentos Neurocirúrgicos/mortalidade , Hemorragia Subaracnóidea/mortalidade , Inquéritos e Questionários , Resultado do Tratamento , Reino Unido
6.
J Neurosurg ; 118(1): 3-12, 2013 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-23039145

RESUMO

OBJECT: In randomized clinical trials of subarachnoid hemorrhage (SAH) in which the primary clinical outcomes are ordinal, it has been common practice to dichotomize the ordinal outcome scale into favorable versus unfavorable outcome. Using this strategy may increase sample sizes by reducing statistical power. Authors of the present study used SAH clinical trial data to determine if a sliding dichotomy would improve statistical power. METHODS: Available individual patient data from tirilazad (3552 patients), clazosentan (the Clazosentan to Overcome Neurological Ischemia and Infarction Occurring After Subarachnoid Hemorrhage trial [CONSCIOUS-1], 413 patients), and subarachnoid aneurysm trials (the International Subarachnoid Aneurysm Trial [ISAT], 2089 patients) were analyzed. Treatment effect sizes were examined using conventional fixed dichotomy, sliding dichotomy (logical or median split methods), or proportional odds modeling. Whether sliding dichotomy affected the difference in outcomes between the several age and neurological grade groups was also evaluated. RESULTS: In the tirilazad data, there was no significant effect of treatment on outcome (fixed dichotomy: OR = 0.92, 95% CI 0.80-1.07; and sliding dichotomy: OR = 1.02, 95% CI 0.87-1.19). Sliding dichotomy reversed and increased the difference in outcome in favor of the placebo over clazosentan (fixed dichotomy: OR = 1.06, 95% CI 0.65-1.74; and sliding dichotomy: OR = 0.85, 95% CI 0.52-1.39). In the ISAT data, sliding dichotomy produced identical odds ratios compared with fixed dichotomy (fixed dichotomy vs sliding dichotomy, respectively: OR = 0.67, 95% CI 0.55-0.82 vs OR = 0.67, 95% CI 0.53-0.85). When considering the tirilazad and CONSCIOUS-1 groups based on age or World Federation of Neurosurgical Societies grade, no consistent effects of sliding dichotomy compared with fixed dichotomy were observed. CONCLUSIONS: There were differences among fixed dichotomy, sliding dichotomy, and proportional odds models in the magnitude and precision of odds ratios, but these differences were not as substantial as those seen when these methods were used in other conditions such as head injury. This finding suggests the need for different outcome scales for SAH.


Assuntos
Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Estatística como Assunto/métodos , Hemorragia Subaracnóidea/terapia , Vasoespasmo Intracraniano/terapia , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Fármacos Neuroprotetores/uso terapêutico , Pregnatrienos/uso terapêutico , Hemorragia Subaracnóidea/tratamento farmacológico , Hemorragia Subaracnóidea/cirurgia , Resultado do Tratamento , Vasoespasmo Intracraniano/tratamento farmacológico , Vasoespasmo Intracraniano/cirurgia
7.
BMC Med Res Methodol ; 10: 86, 2010 Sep 29.
Artigo em Inglês | MEDLINE | ID: mdl-20920243

RESUMO

BACKGROUND: Aneurysmal subarachnoid haemorrhage (aSAH) is a devastating event with a frequently disabling outcome. Our aim was to develop a prognostic model to predict an ordinal clinical outcome at two months in patients with aSAH. METHODS: We studied patients enrolled in the International Subarachnoid Aneurysm Trial (ISAT), a randomized multicentre trial to compare coiling and clipping in aSAH patients.Several models were explored to estimate a patient's outcome according to the modified Rankin Scale (mRS) at two months after aSAH. Our final model was validated internally with bootstrapping techniques. RESULTS: The study population comprised of 2,128 patients of whom 159 patients died within 2 months (8%). Multivariable proportional odds analysis identified World Federation of Neurosurgical Societies (WFNS) grade as the most important predictor, followed by age, sex, lumen size of the aneurysm, Fisher grade, vasospasm on angiography, and treatment modality. The model discriminated moderately between those with poor and good mRS scores (c statistic = 0.65), with minor optimism according to bootstrap re-sampling (optimism corrected c statistic = 0.64). CONCLUSION: We presented a calibrated and internally validated ordinal prognostic model to predict two month mRS in aSAH patients who survived the early stage up till a treatment decision. Although generalizability of the model is limited due to the selected population in which it was developed, this model could eventually be used to support clinical decision making after external validation. TRIAL REGISTRATION: International Standard Randomised Controlled Trial, Number ISRCTN49866681.


Assuntos
Médicos de Família/psicologia , Polimedicação , Adulto , Bélgica , Pesquisa sobre Serviços de Saúde , Humanos , Entrevistas como Assunto , Pessoa de Meia-Idade , População Rural , População Urbana
8.
Stroke ; 41(8): 1743-7, 2010 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-20616321

RESUMO

BACKGROUND AND PURPOSE: The International Subarachnoid Aneurysm Trial (ISAT) reported lower rates of death and disability with endovascular versus neurosurgical treatment of ruptured intracranial aneurysms. However, assessment of functional outcome was limited to the modified Rankin Scale, which is known to be insensitive to cognitive function. A neuropsychological substudy (N-ISAT) was therefore done in all recruits from 8 ISAT centers in the United Kingdom. METHODS: Detailed neuropsychological assessment was performed at a 12-month follow-up visit. Impairment was defined as performance below the 5th percentile of the study population on at least 2 tests in >or=2 major cognitive domains. Analysis was restricted to patients who were not known to be otherwise disabled according to the modified Rankin Scale (ie, modified Rankin Scale 0 to 2). RESULTS: Of 836 patients randomized in ISAT in the 8 UK centers (411 allocated endovascular treatment versus 425 neurosurgery), 224 were dead or disabled before 12-month follow-up (78 allocated endovascular treatment versus 135 neurosurgery). Of the remaining 612 patients eligible for neuropsychological assessment, 137 (65 allocated endovascular treatment versus 72 neurosurgery) did not attend. Of the 474 nondisabled patients who were assessed, 152 (32.1%) had cognitive impairment. Patients with cognitive impairment had reduced self-reported health-related quality of life (P<0.001) in both treatment groups, but cognitive impairment was less common in those allocated endovascular treatment (70 of 262 versus 82 of 212 allocated neurosurgery, OR=0.58, 95% CI 0.38 to 0.87, P=0.0055). The incidence of epilepsy was also lower in the N-ISAT endovascular group (7 versus 18, OR=0.30, 0.11 to 0.77, P=0.005) but was independent of the effect on cognitive function. CONCLUSIONS: Cognitive impairment occurred in approximately one third of patients who were not otherwise disabled according to the modified Rankin Scale in N-ISAT and was more frequent in the neurosurgery group. These results have implications for management of ruptured intracranial aneurysms and more generally for interpretation of the outcomes of clinical trials that use the modified Rankin Scale.


Assuntos
Aneurisma Roto/terapia , Cognição/fisiologia , Embolização Terapêutica , Aneurisma Intracraniano/terapia , Adulto , Idoso , Distribuição de Qui-Quadrado , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Testes Neuropsicológicos , Razão de Chances , Resultado do Tratamento , Reino Unido
10.
Stroke ; 40(6): 1969-72, 2009 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-19390079

RESUMO

BACKGROUND AND PURPOSE: Antiplatelets are frequently used during or after endovascular coiling of aneurysm in patients with subarachnoid hemorrhage (SAH). This strategy is based on uncontrolled case series including also patients with unruptured aneurysms or other lesions. We collected data on effectiveness of antiplatelets in patients with SAH. METHODS: All 43 participating centers in the International Subarachnoid Aneurysm Trial (ISAT) were sent a questionnaire whether they never, sometimes, or always prescribed antiplatelets during or after coiling. Based on individual patient data, the relative risks (RRs) of coiling versus clipping were calculated separately for patients treated in hospitals with standard prescription during or after coiling versus patients treated in hospitals with no standard prescription of antiplatelets. We calculated ratios of RRs for standard versus not standard prescription of antiplatelets during coiling and for standard versus not standard prescription after coiling. RESULTS: Nineteen centers responded, representing 1422 (66%) of the 2143 ISAT patients. Antiplatelets were standard prescribed during coiling in 2 responding centers (8% of coiled patients) and after coiling in 6 centers (24%). For poor outcome at 2 months of coiling versus clipping the RR was 0.82 (95% CI: 0.45 to 1.49) in hospitals with a policy of antiplatelet prescription during coiling versus 0.66 (95% CI: 0.55 to 0.78) in those without such policy (ratio of RR's 1.24, P=0.56). The ratio of RRs for 1-year outcome was 1.01 (P=0.89) for antiplatelet use during coiling and 1.00 (P=0.77) for use after coiling. CONCLUSIONS: The results of this study do not support the assumption that antiplatelets during or after endovascular coiling improve outcome in patients with SAH.


Assuntos
Procedimentos Neurocirúrgicos , Inibidores da Agregação Plaquetária/uso terapêutico , Hemorragia Subaracnóidea/sangue , Hemorragia Subaracnóidea/cirurgia , Procedimentos Cirúrgicos Vasculares , Aspirina/uso terapêutico , Coleta de Dados , Feminino , Humanos , Complicações Intraoperatórias/sangue , Complicações Intraoperatórias/prevenção & controle , Masculino , Pessoa de Meia-Idade , Risco , Stents , Instrumentos Cirúrgicos , Resultado do Tratamento
11.
Lancet Neurol ; 8(5): 427-33, 2009 May.
Artigo em Inglês | MEDLINE | ID: mdl-19329361

RESUMO

BACKGROUND: Our aim was to assess the long-term risks of death, disability, and rebleeding in patients randomly assigned to clipping or endovascular coiling after rupture of an intracranial aneurysm in the follow-up of the International Subarachnoid Aneurysm Trial (ISAT). METHODS: 2143 patients with ruptured intracranial aneurysms were enrolled between 1994 and 2002 at 43 neurosurgical centres and randomly assigned to clipping or coiling. Clinical outcomes at 1 year have been previously reported. All UK and some non-UK centres continued long-term follow-up of 2004 patients enrolled in the original cohort. Annual follow-up has been done for a minimum of 6 years and a maximum of 14 years (mean follow-up 9 years). All deaths and rebleeding events were recorded. Analysis of rebleeding was by allocation and by treatment received. ISAT is registered, number ISRCTN49866681. FINDINGS: 24 rebleeds had occurred more than 1 year after treatment. Of these, 13 were from the treated aneurysm (ten in the coiling group and three in the clipping group; log rank p=0.06 by intention-to-treat analysis). There were 8447 person-years of follow-up in the coiling group and 8177 person-years of follow-up in the clipping group. Four rebleeds occurred from a pre-existing aneurysm and six from new aneurysms. At 5 years, 11% (112 of 1046) of the patients in the endovascular group and 14% (144 of 1041) of the patients in the neurosurgical group had died (log-rank p=0.03). The risk of death at 5 years was significantly lower in the coiling group than in the clipping group (relative risk 0.77, 95% CI 0.61-0.98; p=0.03), but the proportion of survivors at 5 years who were independent did not differ between the two groups: endovascular 83% (626 of 755) and neurosurgical 82% (584 of 713). The standardised mortality rate, conditional on survival at 1 year, was increased for patients treated for ruptured aneurysms compared with the general population (1.57, 95% CI 1.32-1.82; p<0.0001). INTERPRETATION: There was an increased risk of recurrent bleeding from a coiled aneurysm compared with a clipped aneurysm, but the risks were small. The risk of death at 5 years was significantly lower in the coiled group than it was in the clipped group. The standardised mortality rate for patients treated for ruptured aneurysms was increased compared with the general population. FUNDING: UK Medical Research Council.


Assuntos
Aneurisma Roto/terapia , Embolização Terapêutica , Aneurisma Intracraniano/mortalidade , Aneurisma Intracraniano/terapia , Hemorragia Subaracnóidea/terapia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Aneurisma Roto/mortalidade , Aneurisma Roto/cirurgia , Embolização Terapêutica/mortalidade , Feminino , Seguimentos , Humanos , Aneurisma Intracraniano/cirurgia , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Probabilidade , Recidiva , Fatores de Risco , Hemorragia Subaracnóidea/etiologia , Hemorragia Subaracnóidea/mortalidade , Hemorragia Subaracnóidea/cirurgia , Análise de Sobrevida , Resultado do Tratamento , Adulto Jovem
12.
J Neurol ; 256(3): 364-73, 2009 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-19221850

RESUMO

BACKGROUND: Delayed ischaemic neurological deficit (DID) following subarachnoid haemorrhage from aneurysm rupture (aSAH) is a serious complication and a major cause of mortality and morbidity. No empirical estimates of resource use and costs of patients with delayed ischaemic deficit compared to those without have been reported to date. METHODS: A detailed cost analysis of the UK National Health Service health care costs of DID was performed using resource use data from the International Subarachnoid Aneurysm Trial (ISAT) over the 24 months following haemorrhage. Resource use categories included direct health care and employment-related costs. A prognostic model of baseline predictors of DID and overall total health care costs was also constructed. RESULTS: Mean (standard deviation) total health care costs at 24 months follow-up were estimated to be pound sterling 28175 (pound sterling 26773) in the DID group and pound sterling 18805 (pound sterling 17287) in the no DID group, a significant difference (95 % confidence interval) of pound sterling 9370 (pound sterling 6880 to pound sterling 12516). This cost difference was driven by statistically significant differences on imaging and investigations, longer length of stay and higher cost of complications and adverse events experienced by patients with DID. Patients with DID also spent on average 62 days less in paid employment than patients without this complication. The prognostic model found CT Fisher grading, WFNS grade, aneurysm location and time from aSAH to intervention statistically significant baseline predictors of delayed ischaemic deficit. CONCLUSION: Patients who developed DID incurred substantially higher costs and a significantly slower resumption of employment than patients without at 24 months follow-up after aSAH.


Assuntos
Isquemia Encefálica/diagnóstico , Isquemia Encefálica/economia , Hemorragia Subaracnóidea/complicações , Adulto , Idoso , Encéfalo/patologia , Isquemia Encefálica/etiologia , Angiografia Cerebral , Emprego , Feminino , Seguimentos , Custos de Cuidados de Saúde , Humanos , Masculino , Pessoa de Meia-Idade , Modelos Teóricos , Prognóstico , Estudos Prospectivos , Índice de Gravidade de Doença , Hemorragia Subaracnóidea/patologia , Fatores de Tempo , Tomografia Computadorizada por Raios X , Reino Unido
13.
Stroke ; 39(10): 2720-6, 2008 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-18669898

RESUMO

BACKGROUND AND PURPOSE: It is often thought that elderly patients in particular would benefit from endovascular aneurysm treatment. The aim of this analysis was therefore to compare the efficacy and safety of endovascular coiling (EVT) with neurosurgical clipping (NST) in the subgroup of elderly SAH patients in the International Subarachnoid Aneurysm Trial (ISAT). METHODS: In the ISAT cohort 278 SAH patients, 65 years or older, were enrolled. The patients were randomly allocated EVT (n=138) or NST (n=140). The primary outcome was the proportion of patients with a modified Rankin scale score of 0 to 2 (independent survival) at 1 year after the SAH. The rates of procedural complications and adverse events were also recorded. RESULTS: 83 of 138 (60.1%) patients allocated EVT were independent compared to 78 of 140 (56.1%) allocated NST (N.S.). 36 of 50 (72.0%) patients with internal carotid and posterior communicating artery aneurysms allocated EVT were independent compared to 26 of 50 (52.0%) allocated NST (P<0.05). 10 of 22 (45.5%) patients with middle cerebral artery aneurysms allocated EVT were independent compared to 13 of 15 (86.7%) allocated NST (P<0.05). The epilepsy frequency was 0.7% in the EVT group compared to 12.9% in the NST group (P<0.001). CONCLUSIONS: In good grade elderly SAH patients with small anterior circulation aneurysms, EVT should probably be the favored treatment for ruptured internal carotid and posterior communicating artery aneurysms, whereas elderly patients with ruptured middle cerebral artery aneurysms appear to benefit from NST. EVT resulted in a lower epilepsy frequency than NST.


Assuntos
Aneurisma Roto/cirurgia , Aneurisma Intracraniano/cirurgia , Neurocirurgia/instrumentação , Procedimentos Neurocirúrgicos/instrumentação , Hemorragia Subaracnóidea/cirurgia , Instrumentos Cirúrgicos , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Complicações Pós-Operatórias/epidemiologia , Instrumentos Cirúrgicos/efeitos adversos , Resultado do Tratamento
14.
Stroke ; 39(1): 111-9, 2008 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-18048858

RESUMO

BACKGROUND AND PURPOSE: The International Subarachnoid Aneurysm Trial (ISAT) reported that endovascular coiling yields better clinical outcomes than surgical clipping at 1 year. The high cost of the consumables associated with the endovascular coiling procedure (particularly the coils) led health care purchasers to conclude that coiling was a more costly procedure overall. To examine this assumption and provide evidence for future policy, accurate and comprehensive data are required on the overall resource usage and cost of each strategy. METHODS: We provide detailed results of patient treatment pathways, resource utilization, and costs up to 24 months postrandomization for endovascular and neurosurgical treatment of aSAH. We report data on costs related to initial and subsequent procedures (ward days, ITU, equipment, staff, consumables, etc), adverse events, complications, and follow up. The data are based on a subsample of all patients randomized in ISAT, containing all patients across 22 UK centers (n=1644). RESULTS: There was a nonsignificant difference - pound 1740 (- pound 3582 to pound 32) in the total 12-month cost of treatment in favor of endovascular treatment. Endovascular patients had higher costs than neurosurgical patients for the initial procedure, for the number and length of stay of subsequent procedures, and for follow-up angiograms. These were more than offset by lower costs related to length of stay for the initial procedure. In the following 12- to 24-month period, costs for subsequent procedures, angiograms, complications, and adverse events were greater for the endovascular patients, reducing the difference in total per patient cost to - pound 1228 (- pound 3199 to pound 786) over the first 24 months of follow-up. CONCLUSIONS: No significant difference in costs between the endovascular and neurosurgery groups existed at 12- or 24-month follow up.


Assuntos
Embolização Terapêutica/economia , Custos de Cuidados de Saúde/estatística & dados numéricos , Procedimentos Neurocirúrgicos/economia , Hemorragia Subaracnóidea/cirurgia , Procedimentos Cirúrgicos Vasculares/economia , Angiografia/economia , Custos e Análise de Custo , Procedimentos Clínicos , Embolização Terapêutica/efeitos adversos , Seguimentos , Recursos em Saúde/economia , Humanos , Tempo de Internação/economia , Procedimentos Neurocirúrgicos/efeitos adversos , Procedimentos Neurocirúrgicos/métodos , Complicações Pós-Operatórias/economia , Complicações Pós-Operatórias/etiologia , Hemorragia Subaracnóidea/economia , Instrumentos Cirúrgicos/efeitos adversos , Instrumentos Cirúrgicos/economia , Reino Unido , Procedimentos Cirúrgicos Vasculares/efeitos adversos , Procedimentos Cirúrgicos Vasculares/métodos
15.
Stroke ; 38(5): 1538-44, 2007 May.
Artigo em Inglês | MEDLINE | ID: mdl-17395870

RESUMO

BACKGROUND AND PURPOSE: Because the long-term security of endovascular treatments remains uncertain, a follow-up study of the patients treated in the International Subarachnoid Aneurysm Trial was performed to compare the frequency, timing, and consequences of aneurysm recurrence. METHODS: Patient data were reclassified by actual treatment performed. Aneurysm and patient characteristics, including occlusion grades, time and type of retreatment, and clinical outcomes, were compared. The relationship between these variables and late retreatment as a surrogate for recurrence was analyzed by means of the Cox proportional hazards model. RESULTS: Retreatment was performed in 191 of 1096 (17.4%) patients after primary endovascular coiling (EVT) and in 39 of 1012 patients (3.8%) after neurosurgical clipping. After EVT, 97 (8.8%) patients were retreated early and 94 (9.0%) late, 7 (0.6%) after rebleeding and 87 (8.3%) without. The mean time to late retreatment was 20.7 months. After neurosurgical clipping, 30 (2.9%) patients were retreated early and 9 (0.85%) late, 3 (0.3%) after rebleeding and 6 (0.6%) without. The mean time to late retreatment was 5.7 months. The hazard ratio (HR) for retreatment after EVT was 6.9 (95% CI=3.4 to 14.1) after adjustment for age (P=0.001, HR=0.97, 95% CI=0.95 to 0.98), lumen size (P=0.006, HR=1.1, 95% CI=1.03 to 1.18), and incomplete occlusion (P<0.001, HR=7.6, 95% CI=3.3 to 17.5). CONCLUSIONS: Late retreatment was 6.9 times more likely after EVT. Younger age, larger lumen size, and incomplete occlusion were risk factors for late retreatment after EVT. After neurosurgical clipping, retreatments were earlier; whereas EVT retreatments continued to be performed throughout the follow-up period. Short-term follow-up imaging is therefore insufficient to detect recurrences after EVT.


Assuntos
Aneurisma Roto/terapia , Embolização Terapêutica , Aneurisma Intracraniano/terapia , Grampeamento Cirúrgico , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Aneurisma Roto/epidemiologia , Feminino , Seguimentos , Humanos , Incidência , Aneurisma Intracraniano/epidemiologia , Masculino , Pessoa de Meia-Idade , Recidiva , Reoperação , Instrumentos Cirúrgicos
16.
Stroke ; 36(12): 2654-9, 2005 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-16269648

RESUMO

BACKGROUND AND PURPOSE: Because neck recurrence after endovascular treatment of intracranial aneurysms (IAs) is not uncommon, surveillance to assess long-term stability of occlusion is clearly important. This study evaluated unenhanced and contrast-enhanced transcranial color-coded duplex sonography (TCCS) in detecting refilling of IAs treated with detachable coils. METHODS: Patients with coiled IAs were imaged before and after contrast enhancement. The results were compared with those of a surveillance digital subtraction angiogram (DSA). The operator was blinded to the results of the DSA. Aneurysms were classed as either occluded or with residual flow and quantified as minor, moderate, or extensive. There were 208 studies performed in 4 neurosurgical centers. Of those, 141 studies received ultrasonic contrast enhancement with Levovist, and 68 had an additional enhanced study with SonoVue. RESULTS: We excluded 44 studies. Of the 164 unenhanced studies, TCCS correctly identified 52 of 67 cases defined as completely occluded by DSA (sensitivity 78%; specificity 77%), 13 of 50 aneurysms with minor refilling (sensitivity 26%; specificity 88%), 15 of 27 aneurysms with moderate refilling (sensitivity 56%; specificity 95%), and 9 of 20 aneurysms with extensive refilling (sensitivity 45%; specificity 100%). TCCS correctly identified an additional 10 aneurysms with minor refilling after Levovist enhancement and 3 with SonoVue. Both SonoVue and Levovist enhancement identified an additional 1 aneurysm with moderate refilling and 3 with extensive refilling. CONCLUSIONS: TCCS could be used to selectively monitor IAs, which would reduce the requirement for long-term invasive monitoring. The detection of neck refilling is improved with contrast enhancement.


Assuntos
Embolização Terapêutica/instrumentação , Aumento da Imagem/métodos , Aneurisma Intracraniano/diagnóstico por imagem , Aneurisma Intracraniano/terapia , Ultrassonografia Doppler Dupla , Ultrassonografia Doppler Transcraniana , Adulto , Idoso , Idoso de 80 Anos ou mais , Prótese Vascular , Meios de Contraste , Embolização Terapêutica/métodos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Recidiva , Sensibilidade e Especificidade
17.
Lancet ; 366(9488): 809-17, 2005.
Artigo em Inglês | MEDLINE | ID: mdl-16139655

RESUMO

BACKGROUND: Two types of treatment are being used for patients with ruptured intracranial aneurysms: endovascular detachable-coil treatment or craniotomy and clipping. We undertook a randomised, multicentre trial to compare these treatments in patients who were suitable for either treatment because the relative safety and efficacy of these approaches had not been established. Here we present clinical outcomes 1 year after treatment. METHODS: 2143 patients with ruptured intracranial aneurysms, who were admitted to 42 neurosurgical centres, mainly in the UK and Europe, took part in the trial. They were randomly assigned to neurosurgical clipping (n=1070) or endovascular coiling (n=1073). The primary outcome was death or dependence at 1 year (defined by a modified Rankin scale of 3-6). Secondary outcomes included rebleeding from the treated aneurysm and risk of seizures. Long-term follow up continues. Analysis was in accordance with the randomised treatment. FINDINGS: We report the 1-year outcomes for 1063 of 1073 patients allocated to endovascular treatment, and 1055 of 1070 patients allocated to neurosurgical treatment. 250 (23.5%) of 1063 patients allocated to endovascular treatment were dead or dependent at 1 year, compared with 326 (30.9%) of 1055 patients allocated to neurosurgery, an absolute risk reduction of 7.4% (95% CI 3.6-11.2, p=0.0001). The early survival advantage was maintained for up to 7 years and was significant (log rank p=0.03). The risk of epilepsy was substantially lower in patients allocated to endovascular treatment, but the risk of late rebleeding was higher. INTERPRETATION: In patients with ruptured intracranial aneurysms suitable for both treatments, endovascular coiling is more likely to result in independent survival at 1 year than neurosurgical clipping; the survival benefit continues for at least 7 years. The risk of late rebleeding is low, but is more common after endovascular coiling than after neurosurgical clipping.


Assuntos
Aneurisma Roto/terapia , Embolização Terapêutica , Aneurisma Intracraniano/terapia , Procedimentos Neurocirúrgicos , Atividades Cotidianas , Adulto , Idoso , Aneurisma Roto/mortalidade , Aneurisma Roto/cirurgia , Embolização Terapêutica/efeitos adversos , Seguimentos , Humanos , Aneurisma Intracraniano/mortalidade , Aneurisma Intracraniano/cirurgia , Pessoa de Meia-Idade , Procedimentos Neurocirúrgicos/efeitos adversos , Qualidade de Vida , Recidiva , Hemorragia Subaracnóidea/cirurgia , Hemorragia Subaracnóidea/terapia , Taxa de Sobrevida , Resultado do Tratamento
18.
Br J Neurosurg ; 19(4): 338-44, 2005 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-16455541

RESUMO

The base of the skull can be affected by a variety of tumours requiring a wide range of treatment modalities. In formulating a management plan, histological diagnosis can play an essential role. Existing methods of skull base biopsy, especially in the anatomically critical parasellar region, include either prolonged open skull base approaches or image-guided needle biopsies. The latter methods can be time-consuming and cannot reliably avoid surrounding critical neurovascular structures. The experience with an endoscopic, transnasal biopsy of parasellar tumours in selected patients is presented. A preliminary series of 11 patients harbouring parasellar lesions with some degree of extension to the sphenoid or maxillary sinus underwent endoscopic, transnasal biopsy. The procedure was diagnostic in all cases. There was no operative mortality and minimal morbidity only recorded. The biopsy results affected the patients' management and, based on these results, major skull base surgery was avoided in four cases. Direct endoscopic visualization prompted avoidance of a vascular catastrophe of an atypical vascular lesion. The endoscopic, transnasal biopsy appears to offer a number of advantages over existing methods in selected patients. It is minimally invasive as it employs the use of natural osseous corridors. Tissue sampling under direct visualization minimizes the risks of negative biopsies or damage to critical neurovascular structures. The use of additional imaging employed by image-guided needle biopsies in not necessary. When planning treatment of parasellar tumours, the endoscopic, transnasal route should be considered.


Assuntos
Cavidade Nasal , Neuroendoscopia/métodos , Neoplasias da Base do Crânio/patologia , Adulto , Idoso , Biópsia/métodos , Feminino , Humanos , Imageamento por Ressonância Magnética , Masculino , Seio Maxilar/patologia , Pessoa de Meia-Idade , Invasividade Neoplásica/patologia , Neuroendoscópios , Sela Túrcica , Seio Esfenoidal/patologia
19.
J Neurosurg ; 99(5): 843-7, 2003 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-14609163

RESUMO

OBJECT: The aim of this study was to evaluate the efficacy of a treatment combination of coil embolization and clot evacuation in patients presenting with an intracerebral hematoma (ICH) caused by the rupture of an aneurysm. METHODS: Twenty-seven patients were prospectively recruited in this study between 1996 and 2000. Endovascular treatment of the putative ruptured aneurysm was performed as soon as practical after diagnosis and before surgical evacuation of the ICH. The Glasgow Outcome Scale (GOS) was used during follow up. Despite admission World Federation of Neurosurgical Societies grades of IV or V in 25 patients (92%), 13 (48%) recovered well with GOS scores of 1 or 2, whereas six patients (21%) died. CONCLUSIONS: The combined result of a favorable outcome in 48% of the patients and a mortality rate of 21% indicates that this treatment may be a valuable alternative for this patient group and warrants further study.


Assuntos
Aneurisma Roto/terapia , Hemorragia Cerebral/terapia , Drenagem/métodos , Embolização Terapêutica/métodos , Hematoma/terapia , Aneurisma Intracraniano/terapia , Adulto , Idoso , Idoso de 80 Anos ou mais , Aneurisma Roto/complicações , Aneurisma Roto/diagnóstico por imagem , Angiografia Cerebral , Hemorragia Cerebral/diagnóstico por imagem , Hemorragia Cerebral/etiologia , Terapia Combinada/métodos , Feminino , Escala de Resultado de Glasgow , Hematoma/diagnóstico por imagem , Hematoma/etiologia , Humanos , Aneurisma Intracraniano/complicações , Aneurisma Intracraniano/diagnóstico por imagem , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Tomografia Computadorizada por Raios X
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