Treatment pathways, resource use, and costs of endovascular coiling versus surgical clipping after aSAH.

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.

Retreatment of ruptured cerebral aneurysms in patients randomized by coiling or clipping in the International Subarachnoid Aneurysm Trial (ISAT).

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.

International subarachnoid aneurysm trial (ISAT) of neurosurgical clipping versus endovascular coiling in 2143 patients with ruptured intracranial aneurysms: a randomised comparison of effects on survival, dependency, seizures, rebleeding, subgroups, and aneurysm occlusion.

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.

Early experience in the treatment of intra-cranial aneurysms by endovascular flow diversion: a multicentre prospective study.

INTRODUCTION: Flow diversion is a new approach to the endovascular treatment of intracranial aneurysms which uses a high density mesh stent to induce sac thrombosis. These devices have been designed for the treatment of complex shaped and large size aneurysms. So far published safety and efficacy data on this approach is sparse. MATERIAL AND METHODS: Over 8 months, standardized clinical and angiographic data were collected on 70 patients treated with a flow diverter device (SILK flow diverter (SFD)) in 18 centres worldwide. Treatment and early follow up details were audited centrally. SFDs were deployed alone in 57 (81%) or with endosaccular coils in 10 (14%) aneurysms, which included: 44 (63%) saccular, 26 (37%) fusiform shapes and 18 (26%) small, 37 (53%) large, 15 (21%) giant sizes. Treatment outcome data up to 30 days were reported for all patients, with clinical (50 patients) and imaging (49 patients) follow up (median 119 days) data available. RESULTS: Difficulties in SFD deployment were reported in 15 (21%) and parent artery thrombosis in 8 (11%) procedures. Procedural complications caused stroke in 1 and serious extracranial bleeding in 3 patients; 2 of whom developed fatal pneumonias. Delayed worsening of symptoms occurred in 5 patients (3 transient, 1 permanent neurological deficit, and 1 death) and fatal aneurysm bleeding in 1 patient. Overall permanent morbidity rates were 2 (4%) and mortality 4 (8%). Statistical analysis revealed no significant association between complications and variables related to treated aneurysm morphology or rupture status. CONCLUSION: This series is the largest reporting outcome of the new treatment approach and provides data for future study design. Procedural difficulties in SFD deployment were frequent and anti-thrombosis prophylaxis appears to reduce the resulting clinical sequelae, but at the cost of morbidity due to extracranial bleeding. Delayed morbidity appears to be a consequence of the new approach and warrants care in selecting patients for treatment and future larger studies.

The costs and prognostic characteristics of ischaemic neurological deficit due to subarachnoid haemorrhage in the United Kingdom. Evidence from the MRC International Subarachnoid Aneurysm Trial.

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.