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Relative health-related quality of life after treatment of unruptured intracranial aneurysms: long-term outcomes and influencing factors.

ABSTRACT: Health-related quality of life (HRQOL) is an important clinical outcome parameter. Its analysis is particularly meaningful to patients with minor functional impairment. The main goal of this study was to assess long-term data of HRQOL and their variables for patients undergoing treatment for unruptured intracranial aneurysms (UIAs). Therefore, a cross-sectional study of HRQOL (SF-36 questionnaire) was conducted in patients treated for UIA using a telephone survey assessing numerous medical and sociodemographic variables. A total of 96 patients with a follow up longer than 36 months post-treatment were included. HRQOL results were compared with the German reference population. Uni- and multivariate analyses were performed to detect variables with an impact on outcome. After a mean follow up of 57.75 ± 13.56 months, patients with treated UIAs showed a significant decrease in the mental health domains 'role emotional' and 'social functioning' and the 'mental health component score' (MHCS) compared with the age- and sex-matched reference population. Overall, 47% of the patients showed a clinically and psychosocially relevant decrease compared with the mean MHCS of the reference population. Multivariate analysis suggests that mainly the treatment modality (coiling versus clipping) and additional remaining untreated UIAs negatively impacted mental HRQOL. In conclusion, the partly significant losses in HRQOL identify the necessity for less-wearing treatment strategies and a better prediction of risk of UIA rupture. Our results indicate that certain factors in the guidance and management of patients undergoing endovascular treatment may negatively affect their mental HRQOL. The relevance of additional UIAs remaining untreated on HRQOL is a new finding that should be considered in the counseling of patients with multiple UIAs.

SUBMITTER: Dammann P

PROVIDER: S-EPMC6410394 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Relative health-related quality of life after treatment of unruptured intracranial aneurysms: long-term outcomes and influencing factors.

Dammann Philipp P Wittek Paula P Darkwah Oppong Marvin M Hütter Bernd-Otto BO Jabbarli Ramazan R Wrede Karsten K Wanke Isabel I Mönninghoff Christoph C Kaier Klaus K Frank Benedikt B Müller Oliver O Kleinschnitz Christoph C Forsting Michael M Sure Ulrich U

Therapeutic advances in neurological disorders 20190308

Health-related quality of life (HRQOL) is an important clinical outcome parameter. Its analysis is particularly meaningful to patients with minor functional impairment. The main goal of this study was to assess long-term data of HRQOL and their variables for patients undergoing treatment for unruptured intracranial aneurysms (UIAs). Therefore, a cross-sectional study of HRQOL (SF-36 questionnaire) was conducted in patients treated for UIA using a telephone survey assessing numerous medical and s ...[more]

PMID: 30886649

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Project description:IntroductionUnruptured intracranial aneurysms (UIA) are common in the adult population, but only a relatively small proportion will rupture. It is therefore essential to have accurate estimates of rupture risk to target treatment towards those who stand to benefit and avoid exposing patients to the risks of unnecessary treatment. The best available UIA natural history data are the PHASES study. However, this has never been validated and given the known heterogeneity in the populations, methods and biases of the constituent studies, there is a need to do so. There are also many potential predictors not considered in PHASES that require evaluation, and the estimated rupture risk is largely based on short-term follow-up (mostly 1 year). The aims of this study are to: (1) test the accuracy of PHASES in a UK population, (2) evaluate additional predictors of rupture and (3) assess long-term UIA rupture rates.Methods and analysisThe Risk of Aneurysm Rupture study is a longitudinal multicentre study that will identify patients with known UIA seen in neurosurgery units. Patients will have baseline demographics and aneurysm characteristics collected by their neurosurgery unit and then a single aggregated national cohort will be linked to databases of hospital admissions and deaths to identify all patients who may have subsequently suffered a subarachnoid haemorrhage. All matched admissions and deaths will be checked against medical records to confirm the diagnosis of aneurysmal subarachnoid haemorrhage. The target sample size is 20 000 patients. The primary outcome will be aneurysm rupture resulting in hospital admission or death. Cox regression models will be built to test each of the study's aims.Ethics and disseminationEthical approval has been given by South Central Hampshire A Research Ethics Committee (21SC0064) and Confidentiality Advisory Group support (21CAG0033) provided under Section 251 of the NHS Act 2006. The results will be disseminated in peer-reviewed journals.Trial registration numberISRCTN17658526.

Project description:Importance:Unruptured intracranial aneurysms (UIAs) are relatively common in the general population and are being increasingly diagnosed; a significant proportion are tiny (≤3 mm) aneurysms. There is significant heterogeneity in practice and lack of clear guidelines on the management of incidental, tiny UIAs. It is important to quantify the implications of different management strategies in terms of health benefits to patients. Objective:To evaluate the effectiveness of routine treatment (aneurysm coiling) vs 3 strategies for imaging surveillance compared with no preventive treatment or routine follow-up of tiny UIAs. Design, Setting, and Participants:A decision-analytic model-based comparative effectiveness analysis was conducted from May 1 to June 30, 2017, using inputs from the medical literature. PubMed searches were performed to identify relevant literature for all key model inputs, each of which was derived from the clinical study with the most robust data and greatest applicability. Analysis included 10 000 iterations simulating adult patients with incidental detections of UIAs 3 mm or smaller and no history of subarachnoid hemorrhage. Interventions:The following 5 management strategies for tiny UIAs were evaluated: annual magnetic resonance angiography (MRA) screening, biennial MRA screening, MRA screening every 5 years, aneurysm coiling and follow-up, and no treatment or preventive follow-up. Main Outcomes and Measures:A Markov decision model for lifetime rupture was constructed from a societal perspective per 10 000 patients with incidental, tiny UIAs. Outcomes were assessed in terms of quality-adjusted life-years. Probabilistic, 1-way, and 2-way sensitivity analyses were performed. Results:In this analysis of 10 000 iterations simulating adult patients with a mean age of 50 years, the base-case calculation shows that the management strategy of no treatment or preventive follow-up has the highest health benefit (mean [SD] quality-adjusted life-years, 19.40 [0.31]). Among the management strategies that incorporate follow-up imaging, MRA every 5 years is the best strategy with the next highest effectiveness (mean [SD] quality-adjusted life-years, 18.05 [0.62]). The conclusion remains robust in probabilistic and 1-way sensitivity analyses. No routine follow-up remains the optimal strategy when the annual growth rate and risk of rupture of growing aneurysms are varied. When the annual risk of rupture of nongrowing UIAs is less than 1.7% (0.23% in base case scenario), no follow-up is the optimal strategy. If annual risk of rupture is more than 1.7%, coiling should be performed directly. Conclusions and Relevance:Given the current literature, no preventive treatment or imaging follow-up is the most effective strategy in patients with aneurysms that are 3 mm or smaller, resulting in better health outcomes. More aggressive imaging surveillance for aneurysm growth or preventive treatment should be reserved for patients with a high risk of rupture. Given these findings, it is important to critically evaluate the appropriateness of current clinical practices, and potentially determine specific guidelines to reflect the most effective management strategy for patients with incidental, tiny UIAs.

Project description:Background and purposeThis study arose from a need to systematically evaluate the clinical and angiographic outcomes of intracranial aneurysms treated with modified coils. We report the procedural safety and clinical outcomes in a prospective randomized controlled trial of endovascular coiling for ruptured and unruptured intracranial aneurysms, comparing polymer-loaded Cerecyte coils with bare platinum coils in 23 centers worldwide.Materials and methodsFive hundred patients between 18 and 70 years of age with a ruptured or unruptured target aneurysm planning to undergo endovascular coiling were randomized to receive Cerecyte or bare platinum coils. Analysis was by intention to treat.ResultsTwo hundred forty-nine patients were allocated to Cerecyte coils and 251 to bare platinum coils. Baseline characteristics were balanced. For ruptured aneurysms, in-hospital mortality was 2/114 (1.8%) with Cerecyte versus 0/119 (0%) bare platinum coils. There were 8 (3.4%) adverse procedural events resulting in neurological deterioration: 5/114 (4.4%) with Cerecyte versus 3/119 (2.5%) with bare platinum coils (P = .22). The 6-month mRS score of ≤2 was not significantly different in 103/109 (94.5%) patients with Cerecyte and 110/112 (98.2%) patients with bare platinum coils. Poor outcome (mRS score of ≥3 or death) was 6/109 (5.5%) with Cerecyte versus 2/112 (1.8%) with bare platinum coils (P = .070). For UIAs, there was no in-hospital mortality. There were 7 (2.7%) adverse procedural events with neurological deterioration, 5/133 (3.8%) with Cerecyte versus 2/131 (1.5%) with bare platinum coils (P = .13). There was a 6-month mRS score of ≤2 in 114/119 (95.8%) patients with Cerecyte versus 123/123 (100%) patients with bare platinum coils. There was poor outcome (mRS ≥3 and 1 death) in 5/119 (4.2%) patients with Cerecyte versus 0/123 (0%) patients with bare platinum coils (P = .011).ConclusionsThere was a statistical excess of poor outcomes in the Cerecyte arm at discharge in the ruptured aneurysm group and at 6-month follow-up in the unruptured group. Overall adverse clinical outcomes and in-hospital mortality were exceptionally low in both groups.

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Relative health-related quality of life after treatment of unruptured intracranial aneurysms: long-term outcomes and influencing factors.

Publications

Relative health-related quality of life after treatment of unruptured intracranial aneurysms: long-term outcomes and influencing factors.

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