학술논문
A PROSPECTIVE MULTICENTRE REGISTRY OF PATIENTS TREATED FOR UNRUPTURED INTRACRANIAL ANEURYSMS WITH THE DERIVO FLOW DIVERTER: PROCEDURAL SAFETY AND CORE-LAB ADJUDICATED ANGIOGRAPHIC BASELINE RESULTS
340
340
Document Type
Academic Journal
Author
Source
Clinical Neuroradiology. September 2019, Vol. 29 Issue S1, pS95, 2 p.
Subject
Language
English
ISSN
1869-1439
Abstract
References (1.) Brinjikji W, et al. Endovascular treatment of intracranial aneurysms with flow diverters: a meta-analysis. Stroke. 2013;44(2:442-7. (2.) Becske T, et al. Pipeline for uncoilable or failed aneurysms: 3-year [...]
Hintergrund: The study objective is to examine the safety and efficacy of the Derivo flow-diverter (Acandis, Germany) for the treatment of unruptured intracranial aneurysms. Methoden: A prospective multicentre, observational, single arm, uncontrolled registry trial was conducted at 12 centres in Germany and Poland. Patients aged 18 to 75 years with untreated unruptured intracranial aneurysms were eligible. Additional coiling was allowed as clinically required. Angiographic images at baseline were reviewed by an independent imaging core laboratory. Primary end point is clinical outcome at 18 months follow-up. Ergebnisse: Patient inclusion was started in April, 2013, and was stopped in January, 2018, after enrolment of104 patients. Seven patients were excluded for missing data. Ninety-seven patients were analysed on an intention-to-treat basis. Mean age was 54.1 (range 18-86), 73 (75%) were female. Modified Rankin score at presentation was 0 in 74 (75%), and 1 in 24 (25%). Eighty-three (86%) of aneurysms were located in the anterior circulation, 12 (12%) in the posterior circulation. Seventy-seven (79%) of aneurysms treated were saccular, 21 (21%) were fusiform. Median diameter was 9.0 mm (5.4-13.5). All flow-diverter (FD) treatments were performed under dual anti-platelet therapy. Additional coiling occurred in 51 (52%). On average 1.2 FD were placed per patient. Technical complications were observed in 9 (9%) patients. Clinical complications were reported in 10 (10%) cases. Modified Rankin scores at discharge were 0 in 81 (83%), 1 in 14 (14%), 2 in 2 (2%), and 4 in 1 (1%), respectively. Diskussion: With a morbidity rate of 3% and a mortality rate of 0, the results of our observational trial compare favourably with FD treatment reported in the literature. Brinjikji reported results from a metaanalysis (n = 1451) with a morbidity rate of 5% and a mortality rate of 4% for FD treatment of intracranial aneurysms (1). In a prospective registry on FD treatment with the Pipeline device (n = 108) Becske et al. observed morbidity and mortality rates of 5.6% and 2.7% respectively. Fazit: Our data suggests that aneurysm treatment with the Derivo FD has a safety profile comparable to other FD available on the market.
Hintergrund: The study objective is to examine the safety and efficacy of the Derivo flow-diverter (Acandis, Germany) for the treatment of unruptured intracranial aneurysms. Methoden: A prospective multicentre, observational, single arm, uncontrolled registry trial was conducted at 12 centres in Germany and Poland. Patients aged 18 to 75 years with untreated unruptured intracranial aneurysms were eligible. Additional coiling was allowed as clinically required. Angiographic images at baseline were reviewed by an independent imaging core laboratory. Primary end point is clinical outcome at 18 months follow-up. Ergebnisse: Patient inclusion was started in April, 2013, and was stopped in January, 2018, after enrolment of104 patients. Seven patients were excluded for missing data. Ninety-seven patients were analysed on an intention-to-treat basis. Mean age was 54.1 (range 18-86), 73 (75%) were female. Modified Rankin score at presentation was 0 in 74 (75%), and 1 in 24 (25%). Eighty-three (86%) of aneurysms were located in the anterior circulation, 12 (12%) in the posterior circulation. Seventy-seven (79%) of aneurysms treated were saccular, 21 (21%) were fusiform. Median diameter was 9.0 mm (5.4-13.5). All flow-diverter (FD) treatments were performed under dual anti-platelet therapy. Additional coiling occurred in 51 (52%). On average 1.2 FD were placed per patient. Technical complications were observed in 9 (9%) patients. Clinical complications were reported in 10 (10%) cases. Modified Rankin scores at discharge were 0 in 81 (83%), 1 in 14 (14%), 2 in 2 (2%), and 4 in 1 (1%), respectively. Diskussion: With a morbidity rate of 3% and a mortality rate of 0, the results of our observational trial compare favourably with FD treatment reported in the literature. Brinjikji reported results from a metaanalysis (n = 1451) with a morbidity rate of 5% and a mortality rate of 4% for FD treatment of intracranial aneurysms (1). In a prospective registry on FD treatment with the Pipeline device (n = 108) Becske et al. observed morbidity and mortality rates of 5.6% and 2.7% respectively. Fazit: Our data suggests that aneurysm treatment with the Derivo FD has a safety profile comparable to other FD available on the market.