The Barrel vascular reconstruction device for endovascular coiling of wide-necked intracranial aneurysms: a multicenter, prospective, post-marketing study

Abstract

Background and purpose: The Barrel vascular reconstruction device (Barrel VRD) is a novel stent with design features that allow endovascular coiling of wide-necked bifurcation aneurysms while preserving adjacent branches, without necessitating dual stent implantation. This study aimed to assess the safety and effectiveness of the Barrel VRD at 12-month follow-up.

Materials and methods: The Barrel VRD trial is a prospective, multicenter, observational post-marketing registry evaluating the use of the Barrel VRD for treatment of wide-necked bifurcation aneurysms. The primary effectiveness endpoint was successful aneurysm treatment measured by digital subtraction angiography with a Raymond-Roy occlusion grade of 1 or 2 in the absence of retreatment, parent artery stenosis (>50%), or target aneurysm rupture at 12 months. The primary safety endpoint was the absence of neurological death or major stroke at 12 months.

Results: Twenty patients were enrolled from December 2013 to December 2014. The device was implanted in 19 patients with 19 aneurysms (8 middle cerebral artery, 4 anterior communicating artery, 1 internal carotid artery terminus, 4 basilar artery aneurysms; mean dome height 5.7±1.91 mm; mean neck length 4.8±1.35 mm, mean dome-to-neck ratio 1.6±2.0). Coiling was performed in all cases. The primary effectiveness endpoint was achieved in 78.9% of subjects (15/19; 12 complete occlusions, 3 neck remnants), and the primary safety endpoint was 5.3% (1/19).

Conclusions: This prospective study demonstrates that the Barrel VRD device resulted in ~80% occlusion rates and ~5% rates of neurological complications at 1 year after endovascular treatment of wide-necked bifurcation intracranial aneurysms. REGISTERED CLINICAL TRIAL: NCT02125097;Results.

Keywords: aneurysm; device; stent; technology.

Conflict of interest statement

Competing interests: BG: None. RB: Consultancy for Stryker, Medtronic, Microvention, Balt, and Penumbra. FT: Consultancy for Stryker, Medtronic, and Codman. JB: None. MP: Consultancy for Stryker, Medtronic, Microvention, Balt, and Penumbra.

© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Figures

Figure 1

The Barrel vascular reconstruction device (VRD) is intended for use with detachable coils for endovascular therapy of wide-necked intracranial aneurysms originating on vessel bifurcation.

Figure 2

Sizing the Barrel vascular reconstruction device (VRD): 1, aneurysm neck size; 2, neck height; 3, neck span. The neck height corresponds to the ideal radius of the Barrel VRD when fully deployed at the level of the six equatorial radio-opaque markers.

Figure 3

Patient with left unruptured internal carotid artery bifurcation aneurysm. (A) Subtracted angiogram of internal carotid artery shows a wide-necked terminus carotid aneurysm. (B) Non-subtracted image shows Barrel vascular reconstruction device (VRD). The six markers of the cage covering aneurysmal neck are shown. (C) Non-subtracted image shows the placement of a second microcatheter through struts into the aneurysm fundus. (D) Non-subtracted image at the end of coiling. (E) Subtracted angiograms of the internal carotid artery at the end of the procedure show small neck remnant and one in-stent thromboembolic event. (F) Subtracted angiogram of internal carotid artery at 12-month follow-up shows near-complete occlusion with neck remnant that is stable in size.

Figure 4

Patient with wide-necked basilar tip aneurysm. (A) Subtracted angiogram of left vertebral artery shows small basilar tip aneurysm with 4 mm neck. (B, C) Non-subtracted image after placement of Barrel vascular reconstruction device (VRD). (D, E) Subtracted and non-subtracted angiograms of vertebral artery at procedure end show complete obliteration of neck remnant. (F) Angiogram at 12-month follow-up shows complete aneurysm occlusion.