Elsevier

World Neurosurgery

Volume 99, March 2017, Pages 605-609
World Neurosurgery

Original Article
PulseRider for Treatment of Wide-Neck Bifurcation Intracranial Aneurysms: 6-Month Results

https://doi.org/10.1016/j.wneu.2016.12.065Get rights and content

Background/Objective

PulseRider is a new endovascular stent dedicated to treat bifurcation intracranial aneurysms with a wide neck. Our purpose was to evaluate 6-month clinical and anatomic results of the device when used to facilitate endovascular coiling of wide-neck bifurcation aneurysms.

Methods

Unruptured intracranial aneurysms coiled with PulseRider, in 6 European centers and 1 U.S. center, were retrospectively reviewed from June 2014 to October 2015. Immediate and 6-month results were evaluated independently by using the Raymond classification scale. Recanalization was defined as worsening, and progressive thrombosis was defined as improvement on the Raymond scale.

Results

Nineteen patients (10 women, 9 men; mean age, 63 years) harboring 19 bifurcation aneurysms (mean dome size, 8.8 mm; mean neck size, 5.8 mm) were included. Immediate angiographic outcome showed 11 complete aneurysm occlusions, 6 neck remnants, and 2 residual aneurysms. Follow-up at 6 months, obtained in all patients, included 12 complete aneurysm occlusions (63.1%), 6 neck remnants (31.6%), and 1 residual aneurysm (5.3%). Adequate occlusion (defined as complete occlusion and neck remnant combined) was observed in 94.7%. Progressive thrombosis was observed in 2 cases (10.6%) and recanalization in 1 case (5.3%). There was no in-stent stenosis or jailed branch occlusion. No bleeding was observed during the follow-up period. Permanent morbidity rate was 5.3% (1/19), and the mortality rate was 0% at 6 months.

Conclusions

The PulseRider allows endovascular treatment of wide-neck bifurcation intracranial aneurysms. Larger series are needed to confirm our preliminary results.

Introduction

In the setting of wide-necked intracranial aneurysms, balloon-assisted and stent-assisted coiling has widened the indications of endovascular treatment.1, 2 However, management of these aneurysms, especially middle cerebral artery (MCA) aneurysms, remains a matter of debate, and many institutions still use surgical clipping as the first therapeutic option. To date, with the advent of new endovascular tools, the majority of wide-necked aneurysms can be managed by endovascular approach. Three endovascular devices have been developed specifically for the treatment of such aneurysms arising at bifurcations: WEB, pCONus, and PulseRider. The WEB (Sequent Medical, Aliso Viejo, California, USA) is an intrasaccular braided-wire flow-disruptor.3, 4, 5 The pCONus (Phenox GmbH, Bochum, Germany) is a new stentlike, self-expanding nitinol implant with 4 distal petals that support the coil mass of a wide-neck lesion within the aneurysmal sac.6, 7, 8 The PulseRider (Pulsar Vascular, Los Gatos, California, USA) is a retrievable self-expanding nitinol implant bridging the aneurysm neck while retaining coils within the aneurysm. To date, 3 small series were reported on intracranial aneurysms treated with PulseRider, but anatomic follow-up was reported in only 3 patients.9, 10, 11 The aim of our study was to evaluate 6-month anatomic results in the treatment of wide-neck bifurcation aneurysms with PulseRider.

Section snippets

Methods

From June 2014 to October 2015, the clinical and angiographic outcomes of consecutive patients treated at 1 U.S. center (Charleston, South Carolina, USA) and 6 European (Lyon and Besançon, France; Firenze and Treviso, Italy; Recklinghausen, Germany; Salzburg, Austria) institutions with the PulseRider device for intracranial aneurysms were retrospectively analyzed. The decision to assist coiling with the PulseRider was made at the discretion of the senior operator. All patients were informed of

Results

A total of 19 patients (10 women and 9 men; mean age, 63 years) with 19 unruptured bifurcation aneurysms were included. One aneurysm was previously treated by coiling. Aneurysm locations and measurements are summarized in Table 1. The mean dome size was 8.8 mm (range, 3–17 mm), and mean neck size was 5.8 mm (range, 2.3–14 mm). In all cases, the aneurysm was treated with a single PulseRider without any other endovascular device except coils.

Discussion

To date, our study represents the largest series of patients with wide-necked bifurcation aneurysms treated by the PulseRider stent-assisted coiling. We reported recently immediate clinical and anatomic outcomes.10 We assess here the 6-month anatomic results of patients managed by the endovascular approach with the PulseRider.

As previously reported in our preliminary series of 15 patients,10 initial adequate occlusion was achieved in the majority of cases (89.5%) despite unfavorable anatomic

Conclusions

Endovascular therapy of wide-neck bifurcation intracranial aneurysms with PulseRider allows treatment with a high rate of adequate aneurysm occlusion at 6 months. The risk of aneurysm recanalization was low at 6 months.

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    This new design is expected to decrease the risk of periprocedural risk by simpler techniques and to reduce thromboembolic complications owing to less metal burden compared with using 2 circumferential stents. Although recent case series with 6-month or 12-month follow-up have shown a safe and effective profile of PulseRider,12,14,16-19 long-term results beyond 12 months remain unknown. In this series, there were no intraprocedural or postprocedural complications related to the PulseRider.

  • Current Status of the PulseRider in the Treatment of Bifurcation Aneurysms: A Systematic Review

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    There was 1 recanalization reported in 1 of the multicenter case series within the 6-month follow-up. A summary of the results of these studies is shown in Table 2.8-10 This systematic review suggests that the PulseRider has a safe and effective profile at short-term follow-up.

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Conflict of interest statement: Alejandro M. Spiotta's affiliations are as follows: Penumbra Consulting, honorarium, speaker bureau; Pulsar Vascular Consulting, honorarium, speaker bureau; Microvention Consulting, honorarium, speaker bureau, research; and Stryker Consulting, honorarium, speaker bureau. None of the other authors have conflicts of interest.

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