Complications associated with the use of flow-diverting devices for cerebral aneurysms: a systematic review and meta-analysis

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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 performing 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 mortality 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 embolization 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 studies on the mechanism underlying the occurrence of adverse events are required.

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.

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 performing 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 mortality 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 embolization 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 studies on the mechanism underlying the occurrence of adverse events are required.

Flow-diverting devices (FDDs) are a groundbreaking invention in the treatment of intracranial aneurysms (IAs). Since their inception in 2007, FDDs have revolutionized the treatment of IAs by replacing the earlier endosaccular approach with an endoluminal strategy.44 Currently, parent vessel reconstruction with FDDs is rapidly becoming the preferred endovascular modality for giant and complex IAs.7 In some areas, FDD application has drastically decreased the rate of coil and stent usage.21

Despite the large number of reports on successful treatment of aneurysms with flow diverters, various unpredictable adverse events have also been reported. Moreover, there is a dearth of studies on the complications associated with this technique. To date, the safety issues and complications related to FDDs have not been fully evaluated. Few studies have comprehensively investigated the clinical and technical events in the use of flow diverters for the treatment of IAs. We therefore performed this meta-analysis to evaluate the overall morbidity and mortality rates associated with this endovascular technique. The purpose of this study is to investigate the overall complication rates for different patient cohorts.

Methods

Literature Search

We used the search strategies recommended in the Cochrane Handbook for Systematic Reviews of Interventions. Titles, abstracts, key words, and free text were searched using combinations of the following key words: “intracranial aneurysm*,” “cerebral aneurysm*,” “flow divert*,” “complication*,” “morbidity,” and “mortality.” The Springer, EBSCO, MEDLINE, Cochrane, and PubMed databases were searched using the specified key words. We also manually searched the references of review articles for additional studies. The decision on whether a study should be included was made independently by 2 authors (G.Z. and M.S.). Data were obtained from the included articles by 1 investigator and reviewed for accuracy by a second investigator. At each step, disagreements were settled by the senior author (M.-H.L.).

Inclusion and Exclusion Criteria

This analysis included: 1) studies on at least 15 patients undergoing IA treatment with an FDD; 2) studies with data on periprocedural and delayed complications; and 3) English language studies. In addition, the following were excluded: 1) studies that were not published in full; and 2) editorials, letters, review articles, guidelines, case reports, in vitro studies, and studies on animal experimentation.

Data Extraction

Using a prespecified form of data abstraction, 2 investigators (G.Z. and M.S.) independently evaluated all the studies and abstracted the following information: 1) study characteristics; 2) patient characteristics (number of patients, demographics, and clinical characteristics); 3) eligibility, based on the abovementioned study selection criteria; 4) mortality and morbidity; 5) adverse technical events; 6) treatment devices; and 7) location of the aneurysms. We also categorized adverse procedural events as follows: symptomatic ischemic events, hemorrhagic events, and symptoms derived from mass effect.

Quality Assessment and Statistical Analysis

This meta-analysis was performed using the software package Stata (version 13.0, StataCorp). The pooled data were subjected to a random-effects meta-analysis with 95% confidence intervals (CIs). Dichotomous variables were presented as odds ratios (ORs) with a 95% CI. Significance was set at p < 0.05. To assess the heterogeneity in the results of individual studies, we used the I2 statistic. Funnel plots were used to screen for potential publication bias. The selected cutoff number of 15 patients was based on the assumption that very small study cohorts probably lack statistical power in their outcome analyses. The complications were divided into 3 categories of minor, intermediate, and severe. Minor complications consisted of minor ischemic events (including distal emboli and transient ischemic attack), transient dysphasia, and access site complications without need for transfusion. The intermediate complications comprised visual impairment, dissections, in-stent stenosis (ISS), branch occlusion, poor stent opening, wire perforation, deployment failure, and device migration or poor position. Severe complications consisted of ipsilateral parenchymal hemorrhage, rebleeding, and major stroke.

Results

Study Selection

A total of 587 articles were obtained from the literature search. After screening the abstracts, we selected 153 complete papers that reported data on the complications associated with FDDs for the treatment of IAs in case series. 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 met all the inclusion criteria and were included and reviewed thoroughly (Figs. 1 and 2). No new studies were found by a manual search of the reference list. In total, 3125 patients and 3427 treated aneurysms were included in the analysis (Table 1).

Fig. 1.
Fig. 1.

Flow diagram of the selection of articles.

Fig. 2.
Fig. 2.

Meta-analysis of the reported complication rate of FDDs. A random-effects model was applied. ES = effect size; s.e. = standard error.

TABLE 1.

Characteristics of studies included in the meta-analysis

Authors & YearPts/AnComplication Rate (%)PMR (%)Mortality (%)SiteStatusFDDBranch OcclusionISSPoor Stent OpeningWPICHRe-bleedingMigration/Poor PositionIschemic EventsACR (%)
OverallP/T (%)
Albuquerque et al., 201517/NA29.4 (5/17)5.9 (1/17)5.9 (1/17)0PCU+RPED5.9 (1/17)17.6 (3/17)
Benaissa et al., 201529/2917.2 (5/29)6.9 (2/29)0Recanalized IAUPED, Silk06.9 (2/29)06.9 (2/29)3.4 (1/29)
Berge et al., 201265/7718.6 (12/65)14.3 (9/63)7.8 (5/65)3 (2/64)IAU+RSilk9.3 (6/64)12.3 (9/73)4.7 (3/64)10.9 (7/64)6.3 (4/64)13.6 (9/66)
Briganti et al., 2012273/29510.6 (29/273)11 (30/273)3.7 (10/273)5.9 (16/273)IAUPED, Silk1.1 (3/273)2.2 (6/273)5.5 (15/273)4.8 (13/273)5.1 (14/273)
Briganti et al., 201435/3914.3 (5/35)11.4 (4/35)00IAU+RPED, Silk0000
Briganti et al., 201614/1527 (4/14)021 (3/14)0MCAUPED7.1 (1/14)14.3 (2/14)0027 (4/14)0
Brinjikji et al., 201515/156.7 (1/15)0/146.7 (1/15)IAU+RPED7.1 (1/14)6.7 (1/15)0
Burrows et al., 201593/9528 (26/93)35 (33/93)1 (1/93)1 (1/93)IAU+RPED2.2 (2/93)2.2 (2/93)9 (9/100)3.2 (3/93)12 (12/100)6.5 (6/93)0
Byrne et al., 201070/702.9 (2/70)21 (15/70)4 (2/70)8 (4/70)IAU+RSILK10 (7/70)17 (12/70)01.4 (1/70)20 (14/70)1.4 (1/70)14.3 (10/70)
Caroff et al., 201614/1521 (3/14)14.3 (2/14)0MCAU+RPED, Silk7.1 (1/14)043 (6/14)0
Chalouhi et al., 201312,1440/NA7.5 (3/40)5 (2/40)2.5 (1/40)IAUPED5 (2/40)2.5 (1/40)10 (4/40)
Chalouhi et al., 20141340/NA5 (2/40)00IAUPED2.5 (1/40)2.5 (1/40)0
Chalouhi et al., 20151195/NA8.4 (8/95)OphPED7 (6/95)1.1 (1/95)1.1 (1/95)0
Chalouhi et al., 201515100/NA3 (3/100)000IAU+RPED1 (1/100)2 (2/100)2 (2/100)
Chiu et al., 201598/11910.2 (10/98)7.1 (7/98)00.8 (3/98)IAUPED7.1 (7/98)1 (1/98)8.4 (8/98)0
Colby et al., 201335/4114.3 (5/35)5.7 (2/35)3 (1/35)3 (1/35)IAUPED5.7 (2/35)3 (1/35)3 (1/35)0
Colby et al., 201642/444.5 (2/44)02.3 (1/42)0IAU+RPED Flex2.3 (1/42)2.3 (1/42)
Cruz et al., 201247/NA8.5 (4/47)02.1 (1/47)2.1 (1/47)ACPED8.5 (4/47)0
De Vries et al., 201337/4932.4 (12/37)10.8 (4/37)2.7 (1/37)0IAUSurpass16.2 (6/37)3 (1/37)3 (1/37)2.7 (1/37)5.4 (2/37)5.4 (2/37)
Deutschmann et al., 201212/1216.7 (2/12)16.7 (2/12)00IAU+RPED8.3 (1/12)016.7 (2/12)
Fischer et al., 201288/1016.8 (6/88)3 (3/88)4.5 (4/88)2 (2/88)IAU+RPED02 (2/88)1.1 (1/88)3.4 (3/88)3.4 (3/88)
Fischer et al., 201465/695 (3/65)9.2 (6/65)8 (5/65)IAUPED+Silk6.2 (4/65)1.5 (1/65)07.7 (5/65)6.2 (4/65)6.2 (4/65)
Fischer et al., 2015121/1306.7 (8/121)2.3 (3/130)1.7 (2/121)0.8 (1/121)IAUp64003.3 (4/121)15.7 (19/121)
Gascou et al., 201559/6632.3 (19/59)4.2 (4/96)5.2 (3/59)6.9 (4/59)IAU+RPED3.4 (2/59)18.6 (11/59)3.4 (2/59)3.4 (2/59)11.9 (7/59)
Gawlitza et al., 201617/1841.2 (7/17)000ACU+RPED, Silk, FRED10.5 (2/19)0017.6 (3/17)5.9 (1/17)
Heller et al., 201323/2652 (13/23)00ACPED52 (13/23)0
Iosif et al., 201538/4913.2 (5/38)07.8 (3/38)0IAU+RPED13.2 (5/38)0
Kim et al., 201423/2447.8 (11/23)8.7 (2/23)00Cav/ParaUPED8 (2/23)8 (2/23)4 (1/23)8 (2/23)8 (2/23)0
Kocer et al., 201433/373 (1/33)3 (1/33)00IAUFRED6.1 (2/33)
Lanzino et al., 201221/2228.6 (6/21)14.3 (3/21)ParaUPED4.5 (1/21)4.5 (1/21)0
Levitt et al., 201323/NA8.7 (2/23)26.1(6/23)00IAUPED8.7 (2/23)008.7 (2/23)13 (3/23)13 (3/23)
Lin et al., 201526/2619.2 (5/26)11.5 (3/26)11.5 (3/26)IARPED7.7 (2/26)3.8 (1/26)07.7 (2/26)46.2 (12/26)
Lubicz et al., 201029/3438 (10/26)11.5 (3/26)4 (1/26)IAUSilk30.7 (8/26)3.8 (1/26)3.8 (1/26)11.5 (3/26)0
Lubicz et al., 201120/2710 (2/20)36 (9/25)5 (1/20)IAUPED5 (1/20)10 (2/20)10 (1/20)0
Lubicz et al., 201558/7015 (8/54)7 (4/58)5.5 (3/54)0IAU+RSilk12 (7/58)57 (33/58)10.3 (6/58)
Di Maria et al, 201577/957.8 (6/77)1.3 (1/77)3.9 (3/77)0OphUPED1.3 (1/77)2.6 (2/77)035.1 (27/77)
Martínez-Galdámez et al., 201525/NA12 (3/25)12 (3/25)0ACU+RPED024 (6/25)4 (1/25)4 (1/25)04 (1/25)8 (2/25)
Martínez-Galdámez et al., 201630/3013.3 (4/30)06.7 (2/30)0IAUPED Flex006.7 (2/30)0
McAuliffe et al., 20124854/579.3 (5/54)7.4 (4/54)00IAUPED3.5 (2/54)1.9 (1/54)01.9 (1/54)05.6 (3/54)
McAuliffe et al., 20124711/1127.2 (3/11)27.2 (3/11)018.2 (2/11)IARPED9.1 (1/11)9.1 (1/11)9.1 (1/11)18.2 (2/11)9.1 (1/11)027.2 (3/11)
Meckel et al., 201310/1060 (6/10)40 (4/10)VBJU+RPED+Silk40 (4/10)70 (7/10)
Möhlenbruch et al., 201529/3413.8 (4/29)3.4 (1/29)3.4 (1/29)0IAU+RFRED3.8 (1/26)10.3 (3/29)34.5 (10/29)
Monteith et al., 201424/244.2 (1/24)4.2 (1/24)IA+EAUPED8.3 (2/24)
Nelson et al., 201131/319.7 (3/31)3.2 (1/31)6.5 (2/31)0IAUPED3.2 (1/31)6.9 (2/29)51.6 (16/31)
O’Kelly et al., 201397/974.4 (4/97)3.1 (3/97)6.3 (6/97)IAUPED4.1 (4/97)3.1 (3/97)2.1 (2/97)5.1 (5/97)
Piano et al., 2013101/10420 (20/100)11 (11/101)03 (3/101)IAU+RPED+Silk5 (5/101)3 (3/101)1 (1/101)4 (4/101)14 (14/101)
Pierot, 201651/5117.6 (9/51)15.7 (8/51)2 (1/51)0IAU+RWEB17.7 (9/51)09.8 (5/51)3.9 (2/51)5.9 (3/51)
Pistocchi et al., 201226/3014.8 (4/27)3.7 (1/27)3.7 (1/27)0ACU+RPED+Silk3.7 (1/27)3.7 (1/27)07.4 (2/27)23.3 (7/30)
Puffer et al., 201444/NA36 (16/44)36 (16/44)00CavUPED+Silk+Surpass2 (1/44)2 (1/44)16 (7/44)9 (4/44)0
Saatci et al., 2012191/25114.1 (27/191)1 (2/191)0.5 (1/191)IAU+RPED0.5 (1/191)4.2 (8/191)1 (2/191)0.5 (1/191)2.1 (4/191)5.8 (11/191)
Saleme et al., 201432/378 (3/37)8 (3/37)9.4 (3/32)0ACU+RPED3.1 (1/32)3.1 (1/32)009.4 (3/32)50 (7/14)
Shankar et al., 201692/1038.7 (8/92)4.3 (4/92)5.4 (5/92)2.2 (2/92)IAU+RSilk2.2 (2/92)13 (12/92)4.3 (4/92)15.1 (13/92)23.3 (21/92)
Tähtinen et al., 201224/2416.7 (4/24)13 (3/24)4.2 (1/24)0IAU+RSilk4.2 (1/24)16.7 (4/24)
Tanweer et al., 201441/432.3 (1/41)2.3 (1/41)0CCUPED2.3 (1/41)2.4 (1/41)
Vedantam et al., 201549/NA14.3 (7/49)4.1 (2/49)6.1 (3/49)0OphUPED6.1 (3/49)2 (1/49)20.4 (10/49)
Wagner et al., 201222/2627 (6/22)005 (1/22)ACUSilk4.5 (1/22)18.1 (4/22)4.5 (1/22)4.5 (1/22)9.1 (2/22)
Wakhloo et al., 2015165/19012 (18/150)13 (21/161)6 (9/150)2.7 (4/165)AC+PCU+RSurpass2.7 (4/161)3.7 (6/165)19.4 (39/190)3.1 (5/190)2.5 (4/161)2.5 (4/165)2.1 (4/190)3.7 (6/165)21.8 (36/165)
Yoon et al., 201411/1245.5 (5/11)9.1 (1/11)9.1 (1/11)ACRPED9.1 (1/11)09.1 (1/11)9.1 (1/11)
Zhang et al., 201645/NA8.9 (4/45)4.4 (2/45)0IAUTubridge4.4 (2/45)008.9 (4/45)0
Zhou et al., 201428/2803.6 (1/28)0IAUTubridge003.6 (1/28)0000064.3 (18/28)

AC = anterior circulation; ACR = adjunctive coiling ratio; Cav = cavernous; CC = cavernous carotid; EA = extracranial aneurysm; FRED = Flow Re-Direction Endoluminal Device; ICH = intracranial hemorrhage; NA, — = data not available; Oph = ophthalmic; p64 = p64 flow modulation device; Para = paraclinoid; PC = posterior circulation; PMR = permanent morbidity rate; P/T = procedural/technical; Pts/An = patients/aneurysms; R = ruptured; Surpass = Surpass flow diverter; U = unruptured; VBJ = vertebrobasilar junction; WEB = Woven EndoBridge; WP = wire perforation.

Complication Rates

The overall complication rate was 17.0% (95% CI 13.6%–20.5%). The incidence of procedural technical complications was 9.4% (95% CI 6.6%–12.2%). The specific causes of the technical events were poor stent opening (in 8.6% of the cases, 95% CI 4.6%–12.7%) and wire perforation (in 3.8% of the cases, 95% CI 0.73%–6.87%; Table 1). Adverse events were classified and the rates were 14.8% for severe complications, 69.1% for intermediate adverse events, and 16.1% for minor complications (Table 2). The overall complication rate was found to be associated with the rupture status of the aneurysm (Table 3). The complication rate for unruptured IAs was 14.6% (95% CI 9.8%–19.4%), which was significantly lower than that for ruptured IAs (30.6%, p < 0.05). A significantly higher overall complication rate was found in the case of ruptured IAs than unruptured IAs (OR 2.3, 95% CI 1.2–4.3). Figure 3 summarizes the complication rates associated with commonly used devices: the Pipeline embolization device (PED; Covidien) was associated with a slightly lower complication rate than the Silk flow-diverter stent (Balt Extrusion; 16.0% vs 18.1%, Table 4). Our present findings indicate the overall complication rate in posterior circulation IAs was 44.7%, which was significantly higher than that for anterior circulation IAs (23.7%, 95% CI 15.4%–31.9%; Table 5). The neurological morbidity rate was 4.5% (95% CI 3.2%–5.8%). The specific causes were ischemia (7.5%, 95% CI 4.9%–10.2%), rebleeding (1.8%, 95% CI 0.5%–3.2%), and intracranial hemorrhages (2.9%, 95% CI 1.9%–3.9%). The permanent morbidity rate and mortality rates were 3.7% (95% CI 2.5%–4.9%) and 2.8% (95% CI 1.2%–4.4%), respectively. Analyses of complications and FDDs were associated with substantial heterogeneity (I2 > 50%), suggesting unexplained differences in study populations and procedures (Fig. 4).

TABLE 2.

Summary of complication and mortality rates of FDDs stratified by different categories

Complication% Type of Device% (Total) of All Complications
PED (n = 1570)Silk (n = 360)FRED (n = 62)Surpass (n = 202)Multiple Devices (n = 614)Other Devices (n = 317)
Minor3.7 (58)0.2 (1)4.8 (3)5.9 (12)2 (12)3.2 (10)16.1 (96/596)
Intermediate13.7 (215)15 (54)034.7 (70)5.7 (35)12 (38)69.1 (412/596)
Severe3.1 (49)2.2 (8)4.8 (3)4 (8)2.4 (15)1.6 (5)14.8 (88/596)
Death1.8 (29)2.8 (10)02 (4)4.6 (28)0.3 (1)
TABLE 3.

Overall complication rates obtained for different types of SAH

SAH TypeRate (%)95% CI
Only unruptured IAs14.69.8–19.4
Only ruptured IAs30.6
Unruptured & ruptured IAs17.416.8–22.5
Fig. 3.
Fig. 3.

Forest plot of complication rates comparing different types of FDDs. FRED = Flow Re-Direction Endoluminal Device; WEB = Woven EndoBridge.

TABLE 4.

Overall complication rate obtained with commonly used FDDs at last follow-up

FDDComplication Rate (%)95% CI
PED16.011.2–20.8
Silk18.17.4–28.8
FRED8.4
Surpass22.2
PED Flex29.4
p646.7
Tubridge4.45
TABLE 5.

Relation between overall complication rate and aneurysm location

SiteRate (%)95% CI
Anterior circulation23.715.4–31.9
MCA24
 Ophthalmic segment8.1
 Supraclinoid segment21.5
 Cavernous carotid25.1
Posterior circulation44.7
Vertebrobasilar junction60
Fig. 4.
Fig. 4.

Funnel plot of the reported rate of complications. Publication biases are evident.

Discussion

In this paper, we report findings from the largest meta-analysis conducted to date of complications related to FDD treatment for IAs. Although some heterogeneity was found in the results of the studies that were included, the current published data suggest that aneurysms treated with FDDs have a low complication rate. There is a dearth of studies on the safety and morbidity related to this technique, so the information added by this study will be valuable.

In several recent data analyses, the morbidity and mortality rates were reported as 2.8%–14.1% and 0%–3.7%, respectively, with a permanent morbidity rate of 1.3%–6.3%.7,83 Our study has several merits compared with the previously published articles. First, because our study includes all available studies in this important field, it presents a complete overview of all available evidence on the adverse events in FDD strategies. We were able to include a larger number of studies due to the rapid growth of the field. We are therefore able to provide the most conclusive overview currently available. Second, we divided the complications into 3 categories of minor, intermediate, and severe. The presented systematic review and results of the meta-analysis investigating the relationship between FDD placement and adverse events is the most comprehensive assessment of this relationship to date. Our findings demonstrated an overall complication rate of 17%, with a permanent morbidity rate of 3.7% and a mortality rate of 2.8%.

Delayed complications associated with the implantation of FDDs have tempered enthusiasm for their widespread use.18 Rupture of aneurysms after FDD treatment is rare (1.8%). This probably reflects the balance between complete aneurysm thrombus formation and thrombosis-mediated inflammatory disruption of the aneurysmal wall.30 Xiang et al.78 also suggest that stagnant aneurysmal flow and excessively low wall shear stress may promote wall degradation via the inflammatory pathway.

Current reports24 have not shown any evidence suggesting that FDDs may induce a pressure change that could lead to rupture of the aneurysm. Moreover, Schneiders et al.68 argue that the wall of the still-perfused aneurysm has to endure hemodynamic stress caused by the cardiac pulse wave, which again might contribute to rupture in a later phase. In our analysis, the reported incidence of delayed ruptures is slightly higher with the Silk FDD than with the PED (3.6% vs 3.3%).

The complication rate for unruptured aneurysms (14.6%) was significantly lower than that for ruptured IAs (30.6%, p < 0.05). This result indicated that the aneurysm is not immediately protected after treatment by FDDs, which often leads to complete occlusion in 3–12 months. Patients need antiplatelet medication after FDD insertion, potentially increasing the rebleeding risk for ruptured aneurysms. Thus, the use of FDDs in the acute subarachnoid hemorrhage (SAH) stage poses a major clinical challenge. Larger case series are needed to define the safety role of FDD application in these kinds of clinical situations.25,54

In our analysis, the overall ratio of adjunctive coiling was 12.3%. The safety and efficacy of PED placement have to be compared with that of conventional endovascular therapy. Our previous study compared the PED with coil embolization and stent-assisted coiling (SAC), and demonstrated that PED placement did not show a significant difference in morbidity and mortality between the two techniques.83 The complications of coiling and SAC are essentially limited to thromboembolic events and aneurysmal rupture, and the total event rates ranged between 3% and 21%. Most of the complications in the series were asymptomatic, and permanent morbidity rates ranged between 0% and 10%.60,65,70,71,75 However, SAC of acutely ruptured aneurysms is associated with significantly higher complication rates (5%–25% vs 0%–16%) than unruptured aneurysms.12,42,75 Mortality rates ranged from 0% to 4.6% and 0% to 20% in ruptured cases.51,75 Major concerns with coiling are coil prolapse into the parent vessel and coil penetration, which is estimated to be 2.5%.72 Procedure-related complications were comparable in the SAC group and the coiling-alone group.34 Delayed (30-day) ISS or occlusion following SAC was reported to be 3.4%–5.8%.26,50

At present, the time frame for complete occlusion of an aneurysm is unknown. To prevent complications, aneurysm occlusions need to be stabilized as soon as possible. The process of aneurysm occlusion after FDD placement is also linked in part to the antiplatelet regimen administered.73

Potential occlusion of the side branches or perforating arteries carries the risk of secondary ischemic complications. Further, overlap of FDDs potentially increases the risk of arterial branch or perforator occlusion and may be responsible for ischemic complications.76 The branch occlusion rate was found to be 4.9% (95% CI 3.2%–6.6%). Only a few studies have examined the effect of FDDs on side branches. Yavuz et al.79 reported that perforators from the middle cerebral artery (MCA) or those from the basilar artery (BA) usually remain patent after FDD placement. However, occlusions may still occur. A previous report found an alarmingly high correlation between perforator infarction and posterior location of IAs. Most side branch occlusion events have been reported to occur in patients who were treated with more than 2 flow diverters or stents.58 Although covering the arterial branch with an FDD may lead to gradual occlusion over time, the vascular territory it supplies could be fed by collateral arterial connections, and most patients were asymptomatic.62

Migration or poor position rate was 5.8% (95% CI 3.7%–8.0%) in the analysis. Fischer et al.28 demonstrated that implantation of an undersized device carries a potential risk of an endoleak-like phenomenon.29 A compliant balloon could be used if the deployed FDD shows poor wall apposition. Moreover, Lubicz et al.41 recommended a stent diameter that is 0.25–0.5 mm larger than the distal parent vessel diameter. Foreshortening of up to 60% of the flow diverter is possible during implantation, but careful size and length selection is important.37,82 Stent placement across a fusiform aneurysm must be performed with more vigilance, as stent anchorage relies on a small surface area for contact with the parent artery.64

De Vries et al.24 considered patients with stenosis after device implantation to be at high risk of in-stent thrombosis on discontinuation of clopidogrel. Cohen et al. reported that ISS was observed in 38% of the cases in which the Silk device was used and 39% of the cases in which PEDs were used. ISS was asymptomatic in 12 of 13 patients.18 No exact duration of treatment, or the best combination for prophylactic platelet inhibition drugs, has been established, which has highlighted the need for better evidence for tailoring antiplatelet therapy.16 An ISS rate of 10.1% was found in our analysis.

In the case of posterior circulation aneurysms, Meckel et al.49 suggested that FDD strategies are associated with significant risk and therefore should be reserved for cases in which alternative approaches are deemed unsafe or ineffective. Our present findings indicate the overall complication rate in posterior circulation aneurysms was 44.7%, which was significantly higher than that for anterior circulation IAs (23.7%).

Our study has several limitations that should be considered. First, the prevalence of risk factors and clinical presentations may differ across participants of various studies, so there is a possibility of a confounding bias. Given this, the overall quality of evidence of this systematic review could be considered as low. We have tried to minimize the effect of such a bias by selecting larger case series with 15 or more patients. Second, most of the selected studies were retrospective. Documentation of complications was collected from medical charts. It is likely that minor complications that did not require event reporting or operative intervention were not taken into account in the published literature.

Conclusions

According to the preliminary series, the complication and mortality rates associated with the use of FDDs appears to be satisfactory, specifically in the context of complex aneurysms. However, the mechanism of delayed rupture after flow diversion must be analyzed so that the appropriate perioperative medication and optimal method for implantation can be determined. More studies, including randomized trials, are needed to provide accurate data on the safety of the flow diversion technique.

Acknowledgments

This study was supported by grants from the National Natural Science Foundation of China (nos. 81471760 and 81671655). Dr. Li is the guarantor of integrity for the entire study.

Disclosures

The authors report no conflict of interest concerning the materials or methods used in this study or the findings specified in this paper.

Author Contributions

Conception and design: Li. Acquisition of data: Zhou, Su. Analysis and interpretation of data: Zhou, Su. Drafting the article: Zhou, Su. Critically revising the article: Li, Yin. Reviewed submitted version of manuscript: Li, Yin. Approved the final version of the manuscript on behalf of all authors: Li. Statistical analysis: Zhou, Su. Administrative/technical/material support: Yin. Study supervision: Li.

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  • 80

    Yoon JWSiddiqui AHDumont TMLevy EIHopkins LNLanzino G: Feasibility and safety of Pipeline Embolization Device in patients with ruptured carotid blister aneurysms. Neurosurgery 75:4194292014

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    Zhang YZhou YYang PLiu JXu YHong B: Comparison of the flow diverter and stent-assisted coiling in large and giant aneurysms: safety and efficacy based on a propensity score-matched analysis. Eur Radiol 26:236923772016

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    Zhou GSu MZhu YQLi MH: Efficacy of flow-diverting devices for cerebral aneurysms: a systematic review and meta-analysis. World Neurosurg 85:2522622016

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    Zhou GZhu YQSu MGao KDLi MH: Flow-diverting devices versus coil embolization for intracranial aneurysms: a systematic literature review and meta-analysis. World Neurosurg 88:6406452016

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  • 84

    Zhou YYang PFFang YBXu YHong BZhao WY: A novel flow-diverting device (Tubridge) for the treatment of 28 large or giant intracranial aneurysms: a single-center experience. AJNR Am J Neuroradiol 35:232623332014

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Article Information

Correspondence Ming-Hua Li, Department of Diagnostic and Interventional Radiology, Shanghai Jiao Tong University Affiliated Sixth People’s Hospital, 600 Yi Shan Rd., Shanghai 200233, China. email: liminghuayx@126.com.

INCLUDE WHEN CITING DOI: 10.3171/2017.3.FOCUS16450.

Disclosures The authors report no conflict of interest concerning the materials or methods used in this study or the findings specified in this paper.

© AANS, except where prohibited by US copyright law.

Headings

Figures

  • View in gallery

    Flow diagram of the selection of articles.

  • View in gallery

    Meta-analysis of the reported complication rate of FDDs. A random-effects model was applied. ES = effect size; s.e. = standard error.

  • View in gallery

    Forest plot of complication rates comparing different types of FDDs. FRED = Flow Re-Direction Endoluminal Device; WEB = Woven EndoBridge.

  • View in gallery

    Funnel plot of the reported rate of complications. Publication biases are evident.

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