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Complications Associated with the Use of Flow-Diverting Devices for Cerebral Aneurysms: a Systematic Review and Meta-Analysis

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Complications Associated with the Use of Flow-Diverting Devices for Cerebral Aneurysms: a Systematic Review and Meta-Analysis NEUROSURGICAL FOCUS Neurosurg Focus 42 (6):E17, 2017 Complications associated with the use of flow-diverting devices for cerebral aneurysms: a systematic review and meta-analysis Geng Zhou, PhD,1 Ming Su, MD,2 Yan-Ling Yin, MD,3 and Ming-Hua Li, PhD1 1Department of Diagnostic and Interventional Radiology, Shanghai Jiao Tong University Affiliated Sixth People’s Hospital, Shanghai; 2Shandong Academy of Chinese Medicine, Lixia, Jinan; and 3Department of Anesthesiology, The Military General Hospital of Beijing PLA, Beijing, China OBJECTIVE The objective of this study was to review the literature on the use of flow-diverting devices (FDDs) to treat intracranial aneurysms (IAs) and to investigate the safety and complications related to FDD treatment for IAs by perform- ing a meta-analysis of published studies. METHODS A systematic electronic database search was conducted using the Springer, EBSCO, PubMed, Medline, and Cochrane databases on all accessible articles published up to January 2016, with no restriction on the publication year. Abstracts, full-text manuscripts, and the reference lists of retrieved articles were analyzed. Random-effects meta- analysis was used to pool the complication rates across studies. RESULTS Sixty studies were included, which involved retrospectively collected data on 3125 patients. The use of FDDs was associated with an overall complication rate of 17.0% (95% confidence interval [CI] 13.6%–20.5%) and a low mortal- ity rate of 2.8% (95% CI 1.2%–4.4%). The neurological morbidity rate was 4.5% (95% CI 3.2%–5.8%). No significant difference in the complication or mortality rate was observed between 2 commonly used devices (the Pipeline emboliza- tion device and the Silk flow-diverter device). A significantly higher overall complication rate was found in the case of ruptured IAs than in unruptured IA (odds ratio 2.3, 95% CI 1.2–4.3). CONCLUSIONS The use of FDDs in the treatment of IAs yielded satisfactory results with regard to complications and the mortality rate. The risk of complications should be considered when deciding on treatment with FDDs. Further stud- ies on the mechanism underlying the occurrence of adverse events are required. https://thejns.org/doi/abs/10.3171/2017.3.FOCUS16450 KEY WORDS intracranial aneurysm; flow-diverting device; complication; delayed rupture LOW-DIVERTING devices (FDDs) are a groundbreak- cations related to FDDs have not been fully evaluated. Few ing invention in the treatment of intracranial aneu- studies have comprehensively investigated the clinical and rysms (IAs). Since their inception in 2007, FDDs technical events in the use of flow diverters for the treat- Fhave revolutionized the treatment of IAs by replacing the ment of IAs. We therefore performed this meta-analysis to earlier endosaccular approach with an endoluminal strat- evaluate the overall morbidity and mortality rates associ- egy. 44 Currently, parent vessel reconstruction with FDDs is ated with this endovascular technique. The purpose of this rapidly becoming the preferred endovascular modality for study is to investigate the overall complication rates for giant and complex IAs.7 In some areas, FDD application different patient cohorts. has drastically decreased the rate of coil and stent usage.21 Despite the large number of reports on successful treat- Methods ment of aneurysms with flow diverters, various unpredict- able adverse events have also been reported. Moreover, Literature Search there is a dearth of studies on the complications associated We used the search strategies recommended in the Co- with this technique. To date, the safety issues and compli- chrane Handbook for Systematic Reviews of Interventions. ABBREVIATIONS BA = basilar artery; CI = confidence interval; FDD = flow-diverting device; IA = intracranial aneurysm; ISS = in-stent stenosis; MCA = middle cerebral artery; OR = odds ratio; PED = Pipeline embolization device; SAC = stent-assisted coiling; SAH = subarachnoid hemorrhage. SUBMITTED October 30, 2016. ACCEPTED March 28, 2017. INCLUDE WHEN CITING DOI: 10.3171/2017.3.FOCUS16450. ©AANS, 2017 Neurosurg Focus Volume 42 • June 2017 1 Unauthenticated | Downloaded 10/05/21 09:18 PM UTC G. Zhou et al. FIG. 1. Flow diagram of the selection of articles. Titles, abstracts, key words, and free text were searched us- eligibility, based on the abovementioned study selection ing combinations of the following key words: “intracranial criteria; 4) mortality and morbidity; 5) adverse technical aneurysm*,” “cerebral aneurysm*,” “flow divert*,” “com- events; 6) treatment devices; and 7) location of the an- plication*,” “morbidity,” and “mortality.” The Springer, eurysms. We also categorized adverse procedural events EBSCO, MEDLINE, Cochrane, and PubMed databases as follows: symptomatic ischemic events, hemorrhagic were searched using the specified key words. We also events, and symptoms derived from mass effect. manually searched the references of review articles for ad- ditional studies. The decision on whether a study should Quality Assessment and Statistical Analysis be included was made independently by 2 authors (G.Z. This meta-analysis was performed using the software and M.S.). Data were obtained from the included articles package Stata (version 13.0, StataCorp). The pooled data by 1 investigator and reviewed for accuracy by a second were subjected to a random-effects meta-analysis with investigator. At each step, disagreements were settled by 95% confidence intervals (CIs). Dichotomous variables the senior author (M.-H.L.). were presented as odds ratios (ORs) with a 95% CI. Signifi- cance was set at p < 0.05. To assess the heterogeneity in the Inclusion and Exclusion Criteria results of individual studies, we used the I2 statistic. Fun- This analysis included: 1) studies on at least 15 patients nel plots were used to screen for potential publication bias. undergoing IA treatment with an FDD; 2) studies with The selected cutoff number of 15 patients was based on data on periprocedural and delayed complications; and 3) the assumption that very small study cohorts probably lack English language studies. In addition, the following were statistical power in their outcome analyses. The complica- excluded: 1) studies that were not published in full; and 2) tions were divided into 3 categories of minor, intermediate, editorials, letters, review articles, guidelines, case reports, and severe. Minor complications consisted of minor ische- in vitro studies, and studies on animal experimentation. mic events (including distal emboli and transient ischemic attack), transient dysphasia, and access site complications Data Extraction without need for transfusion. The intermediate complica- Using a prespecified form of data abstraction, 2 in- tions comprised visual impairment, dissections, in-stent vestigators (G.Z. and M.S.) independently evaluated all stenosis (ISS), branch occlusion, poor stent opening, wire the studies and abstracted the following information: 1) perforation, deployment failure, and device migration or study characteristics; 2) patient characteristics (number poor position. Severe complications consisted of ipsilateral of patients, demographics, and clinical characteristics); 3) parenchymal hemorrhage, rebleeding, and major stroke. 2 Neurosurg Focus Volume 42 • June 2017 Unauthenticated | Downloaded 10/05/21 09:18 PM UTC Complications of flow-diverting devices FIG. 2. Meta-analysis of the reported complication rate of FDDs. A random-effects model was applied. ES = effect size; s.e. = standard error. Results ries. Finally, a total of 60 articles1–6, 8–11, 13–15, 17, 19, 20, 22–25, 27–29, 31–33, 35–40, 42, 43, 45–48, 52, 53, 55–57, 59, 61, 63, 66, 67, 69, 73–77, 80, 81,84 Study Selection met all the inclusion criteria and were included and reviewed thor- A total of 587 articles were obtained from the litera- oughly (Figs. 1 and 2). No new studies were found by a ture search. After screening the abstracts, we selected 153 manual search of the reference list. In total, 3125 patients complete papers that reported data on the complications and 3427 treated aneurysms were included in the analysis associated with FDDs for the treatment of IAs in case se- (Table 1). Neurosurg Focus Volume 42 • June 2017 3 Unauthenticated | Downloaded 10/05/21 09:18 PM UTC G. Zhou et al. 4 TABLE 1. Characteristics of studies included in the meta-analysis Complication Rate Poor Migration/ (%) PMR Mortality Branch Stent Re- Poor Ischemic ACR Authors & Year Pts/An Overall P/T (%) (%) (%) Site Status FDD Occlusion ISS Opening WP ICH bleeding Position Events (%) Albuquerque 17/NA 29.4 5.9 5.9 0 PC U+R PED 5.9 17.6 et al., 2015 (5/17) (1/17) (1/17) (1/17) (3/17) Benaissa et 29/29 17.2 — 6.9 0 Recana- U PED, Silk 0 6.9 0 6.9 3.4 al., 2015 (5/29) (2/29) lized IA (2/29) (2/29) (1/29) Berge et al., 65/77 18.6 14.3 7.8 3 IA U+R Silk 9.3 12.3 4.7 10.9 6.3 13.6 2012 (12/65) (9/63) (5/65) (2/64) (6/64) (9/73) (3/64) (7/64) (4/64) (9/66) Briganti et al., 273/295 10.6 11 3.7 5.9 IA U PED, Silk 1.1 2.2 5.5 4.8 5.1 2012 (29/273) (30/273) (10/273) (16/273) (3/273) (6/273) (15/273) (13/273) (14/273) Briganti et al., 35/39 14.3 11.4 0 0 IA U+R PED, Silk 0 0 0 0 2014 (5/35) (4/35) Briganti et al., 14/15 27 0 21 0 MCA U PED 7.1 14.3 0 0 27 0 2016 (4/14) (3/14) (1/14) (2/14) (4/14) Brinjikji et al., 15/15 6.7 — 0/14 6.7 IA U+R PED 7.1 6.7 0 2015 (1/15) (1/15) (1/14) (1/15) Burrows et al., 93/95 28 35 1 1 IA U+R PED 2.2 2.2 9 3.2 12 6.5 0 2015 (26/93) (33/93) (1/93) (1/93) (2/93) (2/93) (9/100) (3/93) (12/100) (6/93) Byrne et al., 70/70
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