The pCONus Device for Treatment of Complex Wide-Neck Anterior Communicating Artery Aneurysms

doi:10.1016/j.wneu.2017.02.045

World Neurosurgery

Volume 101, May 2017, Pages 498-505

https://doi.org/10.1016/j.wneu.2017.02.045 Get rights and content

Background and Purpose

Anterior communicating artery (AcomA) aneurysms with a wide neck are often not feasible for endovascular coiling. Emerging devices for neck protection, such as the pCONus stent, are promising for endovascular treatment of challenging intracranial aneurysms. We report the preliminary results with pCONus in the treatment of wide-neck AcomA aneurysms.

Methods

All consecutive patients harboring AcomA aneurysms treated with pCONus in 3 European centers were retrospectively reviewed.

Results

Thirty-six patients (mean age, 61 years) harboring 36 saccular AcomA aneurysms (mean dome size, 7.3 mm; mean neck size, 5.4 mm) were included, of which 7 were treated in the setting of subarachnoid hemorrhage. A procedural angiographic complication was reported in 3 patients without clinical impact at 3 months. Five patients presented a postoperative neurological deficit without angiographic complication. Procedure-related permanent morbidity and mortality rates were 11% (3/33) and 0 at 3 months, respectively. Postoperative angiographic results showed a complete aneurysm occlusion in 56% (20/36), a neck remnant in 25% (9/36), and an aneurysm remnant in 19% (7/36) of cases. Four patients were retreated after early angiographic follow-up (mean, 3.2 months). Twenty-two patients were followed (mean, 12.9 months), and a complete aneurysm occlusion was observed in 59% of patients (13/22), and a neck remnant in 41% (9/22). There was no in-stent stenosis or jailed branch occlusion. Recanalization rate was 9%.

Conclusions

The pCONus device allows endovascular coiling of wide-necked AcomA aneurysms.

Introduction

The anterior communicating artery (AcomA) is one of the most frequent locations of intracranial aneurysms,1, 2, 3 and endovascular coiling of these aneurysms could not be feasible in the setting of large and/or wide neck.4, 5 Balloon remodeling and stent-assisted coiling allow the endovascular treatment of wide-neck AcomA aneurysms,6, 7, 8 but seems associated with a higher procedure-related morbidity and mortality, especially in cases of double intracranial stenting.⁸ At present, there is a need of a safe endovascular approach in these aneurysms with unfavorable anatomy. A new device, the pCONus (phenox GmbH, Bochum, Germany) has recently been developed to improve the safety of treatment of intracranial bifurcation aneurysms with a wide neck.6, 9, 10 To our knowledge no study assesses the safety and efficacy of pCONus for AcomA aneurysms.

We reported the immediate and 1-year clinical and anatomic post-treatment results of consecutive patients harboring wide-neck AcomA aneurysms treated with the pCONus device.¹⁰

Section snippets

Patients

We retrospectively analyzed the results of consecutive patients who had the pCONus stent-assisted coiling for AcomA aneurysms between June 2012 and December 2015 in 3 European centers (Lyon and Besançon, France; Stuttgart, Germany). The inclusion was done in the acute ruptured phase, or the recanalized or unruptured status. Decision of the pCONus stent-assisted coiling strategy was made at the discretion of the operator. All patients were informed of the procedure, respective to the

Results

During the study period, 36 patients harboring 36 saccular AcomA aneurysms were treated with pCONus. They were 16 women and 20 men ranging in age from 34–83 years (mean, 61 years). Seven (19%) patients were treated at the acute phase of rupture, 24 (67%) patients harbored unruptured aneurysm, and 5 (14%) were recanalyzed aneurysm (all of these 5 aneurysms were previously treated with an endovascular approach).

Baseline aneurysm characteristics were dome sizes ranged from 3–15.1 mm (mean, 7.3 mm)

Clinical Results

Our preliminary series of 36 patients showed that pCONus stent-assisted coiling of AcomA aneurysms with complex anatomy and/or wide-neck was feasible. Postoperative neurological deficit was observed in 5 patients; however, only 3 permanent neurological complications were observed and no patient died from complication directly related to the procedure. Thus, pCONus intracranial stenting presented no mortality and the permanent morbidity rate at 90 days was 11%. Recently published studies6, 10

Conclusions

However, our preliminary evaluation of this new endovascular approach for the treatment of AcomA aneurysms with unfavorable anatomy shows that the pCONus device can be a feasible option for such complex lesions.

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Single-center experience in the endovascular treatment of wide-necked intracranial aneurysms with a bridging intra-/extra-aneurysm implant (pCONus)
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Coil occlusion of wide-neck bifurcation aneurysms assisted by a novel intra- to extra-aneurysmatic neck-bridging device (pCONus): initial experience
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Endovascular embolization of wide-necked bifurcation aneurysms with the use of pCONus device: A systematic review and meta-analysis
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Citation Excerpt :
A summary of these results is shown in Table 2. Six studies were included into subgroup analysis of immediate treatment results: 4 studies with both ruptured (n = 19) and unruptured aneurysms (n = 77) [5,7,12,14], one study only with ruptured aneurysms (n = 21) [8] and one study with only unruptured aneurysms (n = 19) [13]. The subgroup analysis showed that complete occlusion (RROC I) rate immediately after the procedure was less frequently observed in ruptured aneurysms which was seen in 46.8% (95% CI: 32.8–63.1) of cases when compared to unruptured aneurysms, seen in 54.3% (95% CI: 29.9–74.4) (Table 2) of cases, but the difference was not statistically significant (p = 0.478).
The following study aimed to summarize the overall safety and efficacy of the pCONus device in the treatment of wide-necked bifurcation aneurysms.
Major electronic medical databases were thoroughly searched to identify relevant studies. Data regarding the type of included studies, type of aneurysm and its location, treatment results measured in Raymond-Roy Occlusion Class (RROC) and its complications, as well as patients' neurological outcome at the discharge were extracted from the eligible studies and included in the meta-analysis. The subgroup analyses dependent on the aneurysm rupture status were also conducted.
A total of 8 studies (198 patients with 200 aneurysms) were included in this meta-analysis. The most common localization of the treated aneurysms was the middle cerebral artery with its pooled prevalence estimate (PPE) of 44.5%. Immediately after the procedure, RROC I (complete obliteration of the aneurysm) was observed in 46.8%, RROC II in 32.9%, while RROC III (residual aneurysm) in 20.3% of the patients. In a short-term follow-up, PPE of RROC I was 55.0%, RROC II 29.0%, and RROC III 16.1%. The PPE of intraprocedural complications was 17.3%, the most frequent were thromboembolic events, which were observed in 12.1% of all procedures. Poor neurological outcome at the discharge was noted with PPE of 9.6%.
The effectiveness and safety of wide-necked bifurcation aneurysm treatment utilizing the pCONus device is moderate. There is still a need for a consensus regarding the effective antiplatelet regimen in furtherance of diminishing the rate of thromboembolic events.
The pCONus2 Neck-Bridging Device: Early Clinical Experience and Immediate Angiographic Results
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Citation Excerpt :
At the distal end of the stent structure are 6 polyamide fibers that form a cross and provide extra support to the coil ball mass. Several studies have addressed the use of the pCONus1.11-20 The second-generation pCONus2 device features further design improvements aimed at improving functionality and ease of use.
Treating wide-necked aneurysms is challenging for the interventional neuroradiologist. Recently, numerous devices dedicated to the treatment of these aneurysms have become available. We report our early experience using the pCONus2 device and present the technical success rate, clinical outcomes, and immediate angiographic occlusion rates.
We performed a retrospective review of prospectively collected data to identify patients treated with the pCONus2 device between February 2015 and February 2017.
We identified 12 patients (10 females) treated with the pCONus2 device. The average patient age was 56.6 ± 15.8 years (range, 13–71 years). The average aneurysm dome width was 8.83 ± 5.3 mm (range, 3.8–20 mm), the average dome height was 7.23 ± 4.06 mm (range, 3.36–15 mm), and the average neck width was 5.88 ± 2.92 mm (range, 2.77–11 mm). The angulation of the aneurysm to the parent vessel varied between 0 and 78° (mean, 32.2°). Ten aneurysms were located in the anterior circulation, and 2 were in the posterior circulation. Immediate posttreatment angiography showed 11 aneurysms with modified Raymond–Roy classification (mRRC) grade I occlusion and 1 aneurysm with mRRC grade II occlusion. There were no deaths or hemorrhagic complications. Three patients developed small thrombi during treatment, all of whom were successfully treated with glycoprotein IIb/IIIa antagonists. Early angiographic follow-up data for 6 patients showed adequate aneurysm occlusion in 5 patients and aneurysm recanalization in 1 patient.
The early results on the use of the pCONus2 device suggest that it can be useful for treating wide-necked aneurysms; however, larger studies with longer-term follow-up data are needed.
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2018, Intracranial Aneurysms
The anterior communicating artery (Acomm) is one of the most common locations for intracranial aneurysm (IA) formation, especially ruptured IAs. These lesions may vary greatly in anatomy and in complexity, and this combination of tortuous proximal anatomy, multiple branching and perforating arteries, and relatively small aneurysm sizes along with the potential for profound neurological and neuropsychological deficits secondary to vascular injury make AComm aneurysms a treatment challenge for even the most experienced of practitioners. Numerous microsurgical and endovascular techniques have been used to treat Acomm aneurysms, and there is no standard algorithm to follow. In this chapter, we will review the many endovascular and microsurgical treatment options as well as the nuances that may guide treatment choice.
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Intra-procedural complications, success rate, and need for retreatment of endovascular treatments in anterior communicating artery aneurysms: a systematic review and meta-analysis
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: Paul Emile Labeyrie, Benjamin Gory, Elisa Pomero, Alessandra Biondi, Roberto Riva, Francis Turjman do not have any conflict of interest; Marta Aguilar-Perez is a consultant for phenox GmbH; and Hans Henkes is a co-founder and shareholder of phenox GmbH.

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Original ArticleThe pCONus Device for Treatment of Complex Wide-Neck Anterior Communicating Artery Aneurysms

Background and Purpose

Methods

Results

Conclusions

Introduction

Section snippets

Patients

Results

Clinical Results

Conclusions

Morphological and clinical risk factors for the rupture of anterior communicating artery aneurysms: Clinical article

J Neurosurg

Natural history of unruptured intracranial aneurysms: a long-term follow-up study

J Neurosurg

Factors affecting formation and rupture of intracranial saccular aneurysms

Neurosurg Rev

Endovascular treatment of 404 intracranial aneurysms treated with Nexus detachable coils: short-term results from a prospective, consecutive, European multicenter study

Acta Neurochir (Wien)

Endovascular treatment of wide-neck anterior communicating artery aneurysms using WEB-DL and WEB-SL: short-term results in a multicenter study

AJNR Am J Neuroradiol

Single-center experience in the endovascular treatment of wide-necked intracranial aneurysms with a bridging intra-/extra-aneurysm implant (pCONus)

J Neurointerv Surg

Solitaire AB stent-assisted coiling of wide-necked intracranial aneurysms: mid-term results from the SOLARE study

Neurosurgery

“Y” and “X” Stent-assisted coiling of complex and wide-neck intracranial bifurcation aneurysms

Am J Neuroradiol

Coil occlusion of wide-neck bifurcation aneurysms assisted by a novel intra- to extra-aneurysmatic neck-bridging device (pCONus): initial experience

Am J Neuroradiol

Original Article
The pCONus Device for Treatment of Complex Wide-Neck Anterior Communicating Artery Aneurysms