BACKGROUND: Although the introduction of flow-diverter devices (FDDs) has aroused great enthusiasm, the level of evidence supporting their use has not been systematically evaluated. OBJECTIVE: To report a systematic review of medical literature up to May 2012 on FDDs to assess the morbidity, case fatality rate, and efficacy of FDDs for intracranial aneurysms. METHODS: The literature was searched by using MEDLINE, Embase, and all Evidence-Based Medicine in the OVID database. Eligibility criteria were studies including at least 10 patients, reporting duration of follow-up and number of patients lost to follow-up, and documenting the rate of aneurysm occlusion and death and neurological complications. The endpoints were angiographic success, early and late mortality, and neurological morbidity. RESULTS: Fifteen studies were analyzed consisting of 897 patients with 1018 aneurysms. The mean value of methodological quality score was 14.4 using the STROBE score. The early mortality rate was 2.8% (95% confidence interval [CI]: 1.7-3.8; I(2) = 93.4%) and the late mortality rate was 1.3% (95% CI: 0.2-2.3; I(2) = 36.9%). The early neurological morbidity rate was 7.3% (95% CI: 5.7-9; I(2) = 91.8%) and the late morbidity rate was 2.6% (95% CI: 1.1-4; I(2) = 81.3%). The Egger test for early and late morbidity and aneurysm occlusion was <0.001. CONCLUSION: With the available data from the studies, both heterogeneity and publication biases imply that the current clinical use of FDDs is not supported by high-quality evidence. In the absence of reliable evidence, the use of FDDs in patients eligible for more conventional treatments should be restricted to controlled clinical trials.
BACKGROUND: Although the introduction of flow-diverter devices (FDDs) has aroused great enthusiasm, the level of evidence supporting their use has not been systematically evaluated. OBJECTIVE: To report a systematic review of medical literature up to May 2012 on FDDs to assess the morbidity, case fatality rate, and efficacy of FDDs for intracranial aneurysms. METHODS: The literature was searched by using MEDLINE, Embase, and all Evidence-Based Medicine in the OVID database. Eligibility criteria were studies including at least 10 patients, reporting duration of follow-up and number of patients lost to follow-up, and documenting the rate of aneurysm occlusion and death and neurological complications. The endpoints were angiographic success, early and late mortality, and neurological morbidity. RESULTS: Fifteen studies were analyzed consisting of 897 patients with 1018 aneurysms. The mean value of methodological quality score was 14.4 using the STROBE score. The early mortality rate was 2.8% (95% confidence interval [CI]: 1.7-3.8; I(2) = 93.4%) and the late mortality rate was 1.3% (95% CI: 0.2-2.3; I(2) = 36.9%). The early neurological morbidity rate was 7.3% (95% CI: 5.7-9; I(2) = 91.8%) and the late morbidity rate was 2.6% (95% CI: 1.1-4; I(2) = 81.3%). The Egger test for early and late morbidity and aneurysm occlusion was <0.001. CONCLUSION: With the available data from the studies, both heterogeneity and publication biases imply that the current clinical use of FDDs is not supported by high-quality evidence. In the absence of reliable evidence, the use of FDDs in patients eligible for more conventional treatments should be restricted to controlled clinical trials.
Authors: A Rouchaud; C Ramana; W Brinjikji; Y-H Ding; D Dai; T Gunderson; J Cebral; D F Kallmes; R Kadirvel Journal: AJNR Am J Neuroradiol Date: 2016-07-07 Impact factor: 3.825
Authors: Francesco Briganti; Giuseppe Leone; Mariano Marseglia; Giuseppe Mariniello; Ferdinando Caranci; Arturo Brunetti; Francesco Maiuri Journal: Neuroradiol J Date: 2015-08-27
Authors: Robert J McDonald; Jennifer S McDonald; David F Kallmes; Giuseppe Lanzino; Harry J Cloft Journal: Interv Neuroradiol Date: 2015-02 Impact factor: 1.610
Authors: W Brinjikji; G Lanzino; H J Cloft; A H Siddiqui; E Boccardi; S Cekirge; D Fiorella; R Hanel; P Jabbour; E Levy; D Lopes; P Lylyk; I Szikora; D F Kallmes Journal: AJNR Am J Neuroradiol Date: 2016-04-21 Impact factor: 3.825
Authors: G Foa Torres; F Roca; A Noguera; J Godes; S Petrocelli; I Aznar; S Ales; P Muszynski; R Maehara; M Vicente; J M Pumar Journal: Interv Neuroradiol Date: 2018-05-02 Impact factor: 1.610