BACKGROUND AND PURPOSE: The Pipeline Flex embolisation device with Shield Technology (Pipeline Shield) is a novel flow diverter which reduces intra-vessel thrombogenicity. This study summarises periprocedural outcomes and 6-month follow-up results following its introduction in a tertiary interventional neuroradiology centre. MATERIALS AND METHODS: This prospective, single-arm study assessed 32 aneurysms treated over a 21-month time period from the time of procedure to 6 months post-procedure. Data collected included patient demographics, aneurysm features and intraprocedural and 6-month post-procedural complications. RESULTS: The mean age of the cohort was 58.8 ± Standard Deviation 8.5 years. Twenty-eight aneurysms were treated electively and four acutely. The elective cases received dual antiplatelet therapy post-procedure. The acute cases received single antiplatelet therapy post-procedure. Of the target aneurysms, 16/32 (50%) were small (<10 mm), 13/32 (41%) were large (10-25 mm) and 3/32 (9%) were giant (≥25 mm). There was no mortality in the series. There were two periprocedural complications (2/32, 6.2%): a stroke and a dissection. There were no post-procedural complications. At 6 months post-procedure, satisfactory occlusion (defined as Raymond-Roy 1 or 2) was achieved in 90.6% and 93.8% by way of magnetic resonance angiography and digital subtraction angiography assessment, respectively. There was no implant migration, no significant intraluminal hyperplasia or in-stent stenosis and no cases of aneurysm recurrence. CONCLUSION: The Pipeline Shield has an excellent 6- month safety profile with an acceptable rate of intraprocedural complications, no post-procedure complications and no mortality in this case series of 32 acute and elective cases.
BACKGROUND AND PURPOSE: The Pipeline Flex embolisation device with Shield Technology (Pipeline Shield) is a novel flow diverter which reduces intra-vessel thrombogenicity. This study summarises periprocedural outcomes and 6-month follow-up results following its introduction in a tertiary interventional neuroradiology centre. MATERIALS AND METHODS: This prospective, single-arm study assessed 32 aneurysms treated over a 21-month time period from the time of procedure to 6 months post-procedure. Data collected included patient demographics, aneurysm features and intraprocedural and 6-month post-procedural complications. RESULTS: The mean age of the cohort was 58.8 ± Standard Deviation 8.5 years. Twenty-eight aneurysms were treated electively and four acutely. The elective cases received dual antiplatelet therapy post-procedure. The acute cases received single antiplatelet therapy post-procedure. Of the target aneurysms, 16/32 (50%) were small (<10 mm), 13/32 (41%) were large (10-25 mm) and 3/32 (9%) were giant (≥25 mm). There was no mortality in the series. There were two periprocedural complications (2/32, 6.2%): a stroke and a dissection. There were no post-procedural complications. At 6 months post-procedure, satisfactory occlusion (defined as Raymond-Roy 1 or 2) was achieved in 90.6% and 93.8% by way of magnetic resonance angiography and digital subtraction angiography assessment, respectively. There was no implant migration, no significant intraluminal hyperplasia or in-stent stenosis and no cases of aneurysm recurrence. CONCLUSION: The Pipeline Shield has an excellent 6- month safety profile with an acceptable rate of intraprocedural complications, no post-procedure complications and no mortality in this case series of 32 acute and elective cases.
Authors: H Luecking; T Engelhorn; S Lang; P Goelitz; S Kloska; K Roessler; A Doerfler Journal: AJNR Am J Neuroradiol Date: 2017-01-19 Impact factor: 3.825
Authors: David F Kallmes; Waleed Brinjikji; Edoardo Boccardi; Elisa Ciceri; Orlando Diaz; Rabih Tawk; Henry Woo; Pascal Jabbour; Felipe Albuquerque; Rene Chapot; Alain Bonafe; Shervin R Dashti; Josser E Delgado Almandoz; Curtis Given; Michael E Kelly; DeWitte T Cross; Gary Duckwiler; Nasser Razack; Ciaran J Powers; Sebastian Fischer; Demetrius Lopes; Mark R Harrigan; Daniel Huddle; Raymond Turner; Osama O Zaidat; Luc Defreyne; Vitor Mendes Pereira; Saruhan Cekirge; David Fiorella; Ricardo A Hanel; Pedro Lylyk; Cameron McDougall; Adnan Siddiqui; Istvan Szikora; Elad Levy Journal: Interv Neurol Date: 2016-05-26
Authors: Mario Martínez-Galdámez; Saleh M Lamin; Konstantinos G Lagios; Thomas Liebig; Elisa F Ciceri; Rene Chapot; Luc Stockx; Swarupsinh Chavda; Christoph Kabbasch; Giuseppe Faragò; Hannes Nordmeyer; Thierry Boulanger; Mariangela Piano; Edoardo P Boccardi Journal: J Neurointerv Surg Date: 2018-09-27 Impact factor: 5.836
Authors: P Bhogal; Hld Makalanda; K Wong; P Keston; J Downer; J C Du Plessis; A Nania; D Simonato; M Fuschi; W Chong; S O'Reilly; I Rennie Journal: Interv Neuroradiol Date: 2021-06-02 Impact factor: 1.764