Current evidence on novel devices for the treatment of intracranial wide-neck aneurysms—Contour and Neqstent: a narrative review

Introduction

The complexities of the treatment of intracranial aneurysms (IAs) have led to the development of a variety of techniques, with an ever-changing balance in achieving the aim of becoming less invasive, whilst maintaining a high efficacy and safety.

The journey and evolution of the endovascular treatment of IAs has accelerated and rocketed during the last 25 years, particularly since the overwhelming evidence of its relative safety to open surgery in the International Subarachnoid Aneurysm Trial (ISAT) study (1). Alongside the benefit of not requiring open surgery and the associated risks such as seizures and post-operative infection, endovascular embolisation has been shown to improve outcomes for patients due to the decreased morbidity and mortality rates (2). One major concern of endovascular techniques, compared to open surgical techniques such as clipping, is the rate of aneurysm recurrence. One study following the rate of aneurysm recurrence 9 years post-surgical clipping noted only 2.9% regrowth (3). Whereas a recent meta-analysis highlighted an 18% retreatment rate (recurrence) in the endovascular treatment group (4). There has been a quest to refine endovascular techniques due to their overall benefits, with the aim of reducing recurrence rates post treatment.

The earliest endovascular techniques involved simple, and balloon assisted coiling. The ATENA (unruptured aneurysms) and CLARITY (ruptured aneurysms) studies demonstrate the results of a large series of IAs treated with simple and balloon assisted coiling. In the ATENA study, the rate of thromboembolic complications was lower in the balloon assisted coiling group (5.4% vs. 6.2%), whilst the rate of thromboembolic complications was similar in the CLARITY study (12.7% coiling vs. 11.3% remodelling) (5). The rate of intra-operative rupture was 3.2% in the balloon remodelling group in ATENA vs. 2.2% in the coiling group, whilst the rate of rupture was 1.4% in the balloon remodelling group in CLARITY vs. 0.6% in the coiling group.

Whilst the efficacy of these described coiling techniques is generalised across narrow and wide-necked aneurysms, the results are positive. The CLARITY series demonstrated an adequate occlusion rate of 94.9% for balloon remodelling and 88.5% for simple coiling (P=0.02).

The advent of intrasaccular devices in the last decade came about to improve the treatment of aneurysms, particularly wide-neck aneurysms. The technique of simple coiling requires formation of a safe coil mass without prolapse into the parent artery, which would be time-consuming. The use of balloon remodelling would reduce the time needed for placing the coils, however, would require time for balloon navigation and in some cases complex manoeuvres, particularly in complex neck anatomy. The use of intrasaccular devices such as woven endoluminal bridge (WEB) has been found to reduce procedure time by an average of 27 minutes and fluoroscopy doses by 363–2,086 µGym2 (P=0.006) (6).

Intrasaccular devices were generated as a method to achieve this, with particular use in the management of wide-neck and bifurcation IAs (1).

Wide-neck aneurysms have a neck width ≥4 mm, dome to neck ratio <2 or both features together (7). Classically, aneurysms were managed via simple coiling methods, with particular efficacy in unruptured aneurysms (2). However due to the difficulty of coiling in complex aneurysm anatomy and morphology and with 70–80% complete occlusion achieved and despite better short-term results with second-generation hydrocoils, simple coiling has become less favourable (8). Increasing long-term durability can be attempted via treatment with adjunctive stent or flow divertor, but this technique carries high immediate treatment risks, as well as the need for long-term antiplatelet medication, which is less favourable in younger patients (1).

Flow diverters offer a higher 85–90% complete occlusion rate, hence in conjunction with the improvement of imaging modalities, these were explored further. This technique diverts blood away from the aneurysm to decrease pressure and reduce the risk of rupture (9). The prospective cohort study ‘DIVERSION’ running from 2012 to 2014 studying 398 patients, described a 1.2% mortality rate 12 months post flow divertor treatment, highlighting promising outcomes for patients from this technique (10) Some of their disadvantages include a long learning curve due to their complexity, high expense and their unfavourable nature for bifurcation IAs or IAs in the posterior circulation (2). Alongside this, they still require the long-term use of dual antiplatelet therapy Their use in ruptured aneurysms is still limited in practice due to the requirement of dual antiplatelet therapy, with increased morbidity and mortality in the immediate post subarachnoid haemorrhage (SAH) recovery phase. Additionally, they do not offer immediate occlusion of aneurysms, which increases the risk of aneurysm rebleed, particularly in the absence of or only partial aneurysm dome coiling. A series of 44 patients treated with ruptured aneurysms treated with flow diverters demonstrated a rebleed rate of 11% and a mortality rate of 18% (11).

The advent of new flow diverter technology with ‘coating’ has increased the safety of this technique. Of particular interest, a recent retrospective study into the P64 mw hydrophilic polymer coating (HPC) by Hellstern et al. demonstrated a post-procedural or delayed complication rate of 9/102 patients (8.8%) under a single antiplatelet (prasugrel) for 6 months, then switched to aspirin for life, therefore reducing the need for dual antiplatelets for the initial 6-month post-treatment period (12).

A further multicentre case series by Khanafer et al. demonstrated a 4.7% flow diverter dependent complication rate in a series of 84 patients with the same device under a single antiplatelet (13). This latest technology and subsequent research raise the potential for changing the dynamics of endovascular treatment of IAs, particularly acutely ruptured aneurysms.

A new wave of techniques for managing IAs has been developing for several years within the intrasaccular flow disruptors group. These were the first group of devices shown to be of benefit for treating wide-neck bifurcation IAs, a subtype many previous methods were not shown to have as high success rates when treating. WEB was originally designed as a dual layered device, and subsequently became available as a single layered model. It is a barrel shaped nitinol-based device, placed within the aneurysm (14). This occupies the aneurysm space, diverting blood flow away from the aneurysm and promoting aneurysm thrombosis. The WEBCAST study of 51 patients in 10 neurointerventional centres across Europe had a 94.1% success rate with the use of WEB, with a 17.6% thromboembolic event occurring. At 6 months there was a 56.1% complete occlusion rate, and 29.3% had a remnant neck, highlighting their promising short-term use (15). Subsequent results from the WEBCAST2 study with 55 patients, and only using the WEB single layer model, had a 2% mortality rate at 1 year, with complete occlusion in 54% of patients and 26% neck remnant (16). The results of these trials showed good potential of intrasaccular devices in the management of complex wide-neck aneurysms and has boosted research groups and industry to develop further different iterations of these devices to build upon this work.

Two such intrasaccular devices are Contour (Stryker, Freemont, CA, USA) and Neqstent (Stryker, Freemont, CA, USA). In this paper we will explore the construct of each device, alongside their technique of deployment. We will also compare the efficacy and safety of each device with each other, and pre-existing intrasaccular devices to determine limitations which still require addressing to improve mortality and morbidity for patients. We present this article in accordance with the Narrative Review reporting checklist (available at https://jni.amegroups.com/article/view/10.21037/jni-25-35/rc).

Methods

A PubMed search was completed with the terms Contour, Neqstent and intrasaccular devices. The initial trial data for devices extending from 2010 till the current present as well as the most recent meta-analyses were chosen for this review (Table 1).

Contour

Contour is a mesh radio-opaque device, composed of a dual layer of 144 wires consisting of platinum opaque markers with nitinol drawn filled tube (DFT) (17). In contrast to other intrasaccular devices on the market, such as WEB which occupy the entire aneurysm, Contour is deployed at the aneurysm neck alone, where it adapts to the lower portion of the aneurysm and occludes the neck. The advantage of this design is that the high occlusion rate can be maintained, whilst also reducing the complex manipulation required within the aneurysm. Figure 1 demonstrates the device and its structure. The device is available in five sizes, with diameters 5, 7, 9, 11 and 14 mm. The 5, 7 and 9 mm diameter devices require a 0.021” microcatheter for deployment, and the 11 and 14 mm devices require a 0.027” microcatheter. This allows to treat aneurysms 2.0–10.5 mm wide, with neck width ranging from 2.0–10.0 mm (17). Figure 2 shows an example of an aneurysm treated with Contour with long-term follow-up. Commonly patients will be started on single antiplatelets in the form of aspirin or dual antiplatelets with the addition of P2Y12 inhibitors due to the high-density component of the device protruding slightly into the bifurcation and parent artery, but they can be stopped after a short course of treatment (6–8 weeks) (18). This differs to treatment with stents and flow divertors which require dual antiplatelet therapy long term due to their parent vessel component and associated thromboembolic complications.

Figure 1 The Contour is a Nitinol micro-braided dual layered planar mesh implant containing a platinum core wire for visualisation. (A,B) The varying degree of angulation possible by the device, dependent on the applied force during deployment. This widens the scope of aneurysms that can be treated according to the varying aneurysm neck and dome morphology.

Figure 2 Example case of Contour-treated aneurysm with stable 2-year follow-up. (A,B) 3D demonstration and DSA of a small wide-neck basilar tip aneurysm with a maximum neck diameter of 3.23 mm. (C) DSA image of detached Contour device in the basilar tip aneurysm. (D) 2-year follow-up DSA image of completely occluded aneurysm treated with Contour. 3D, three-dimensional; DSA, digital subtraction angiography.

The CERUS Study was the first prospective multicentre single arm study investigating Contour, which monitored 32 patients with the implant [34 with intention-to-treat (ITT)] (19). The average width of the aneurysms studied was 6.3 mm (±2.4mm), with an average height of 7.1 mm (±3.4 mm), and a mean neck width of 4.3 mm (±1.4 mm). Of the 34 patients in the ITT group, 13 of the aneurysms were located in the anterior communicating artery. They monitored the patients to determine successful occlusion 6 months post treatment, and any stroke or non-accidental death after 30 days as their primary endpoints. As seen in early trials of WEB (WEBCAST and WEBCAST 2), CERUS showed similar complete occlusion rate of 47% at 6 months, compared to 56.1% in WEBCAST and 54% in WEBCAST2, in addition to relatively high thromboembolic complication rate of 11% in the Cerus ITT group compared to 17.7% in WEBCAST and 14.5% in WEBCAST2 (15,16). Similar to subsequent WEB trials and retrospective patient series, the balance of occlusion rates and complication rates improve, especially as experience and insight into aneurysm suitability for these devices improves. An updated meta-analysis on the safety and effectiveness of Contour neurovascular system demonstrated an adequate occlusion rate of 85% across 206 aneurysms treated in 192 patients. The thromboembolic rate was 6%, whilst functional independence rate was 96% (20). A WEB meta-analysis consisting of 767 patients showed mid-term adequate occlusion rates of 86.6%, and 4% thromboembolic complication rates whilst functional independence rate 94.3% (21). A table in the appendix details comparison between WEB, Contour and Neqstent (Table S1).

A subsequent multi-centre cohort study across 10 European neurovascular centres studied the outcomes in 279 aneurysms (median age 60 years) treated with Contour. The middle cerebral artery (26.5%) and anterior communicating artery (26.2%) were the most common aneurysm sites, with the 7 mm Contour device used most often (39%) (22). They reported that adequate occlusion was achieved in 91.5% of aneurysms, with thromboembolic events noted in 6.8% of patients. However, a limitation to this study was the lack of blinding when assessing outcomes which may have skewed results recorded. This issue has been highlighted in a systematic review of 23 studies by Müller et al., which shows that the number of studies with low bias and sufficient randomisation is very small (23).

A subsequent study retrospectively reviewing patients who received treatment using Contour in combination with platinum coils demonstrated an immediate complete occlusion in 62.5% of patients (24). This technique may further reduce the recurrence of aneurysms, particularly larger aneurysms as it may provide a scaffold and mechanism to stabilise the Contour at the neck in addition to promoting quicker thrombosis in the aneurysm dome, a method which has been described as COCOJAMBO. Although they deemed the method to be a safe for use, with a smaller sample size of only eight patients, further evidence was still required. Figure 3 demonstrates an example of a large aneurysm that was treated with Contour 14, which recurred and required further endovascular treatment.

Figure 3 Example case of a recurrent Contour-treated aneurysm. (A) 3D image of a large wide-neck ACOM aneurysm with a maximum aneurysm dome width of 9.5 mm. (B,C) Subtracted and un-subtracted angiographic images demonstrated the detached Contour device at the neck of the ACOM aneurysm. (D) CT angiographic image demonstrating a significant recurrence involving the Contour-treated ACOM aneurysm with displacement of the device. (E,F) DSA image demonstrating a large aneurysm recurrence which was treated with flow diversion and coiling. 3D, three-dimensional; ACOM, anterior communicating artery; CT, computed tomography; DSA, digital subtraction angiography.

More evidence is still required regarding long term outcomes in patients after Contour use to treat IAs. The NECC trial (Contour Neurovascular System for IA repair) in the United States (US) has now finished recruiting 220 patients and we await the results from this study (25).

The safety of the device was one of the primary end points in the CERUS study, noting non-disabling thromboembolic events, one unexplained SAH, and one patient experienced a stroke (19). The long-term safety of intrasaccular devices can be superior to stent and flow diversion techniques due to the lack of a substantive parent artery component. Flow diversion was designed to interfere with blood flow at the aneurysm neck through the parent artery, however this increases the risk of thromboembolic events, whereas Contour disrupts flow from within the sac, reducing said risk (1). Due to the routine use of dual antiplatelets post procedure when flow diverters are used, it is difficult to directly compare the two methods. However, as highlighted earlier, the use of coated devices such as P64 HPC with single antiplatelets can dramatically change this dynamic.

The use of Contour in ruptured aneurysms is yet to be established or further studied. As the device is only a neck flow disruptor and does not occupy the aneurysm fully, there may be hesitance by operators to use the device in such clinical scenarios. As evidenced by a large meta-analysis by Günkan et al., immediate occlusion rates achieved with Contour was 53%, but with 93% adequate occlusion at follow-up, which is reassuring for long-term efficacy, but may be of less assurance in the immediate post-treatment phase in ruptured aneurysms (26).

The safety profile of Contour is evidenced by the average thromboembolic risk of approximately 6% in the aforementioned large meta-analysis. In our experience, the risks associated with device deployment can be reduced by ensuring the use of a tri-axial system to increase stability. Additionally, the thromboembolic risks can be alleviated by the routine use of short-term antiplatelets (single or dual; dependent on aneurysm morphology and final device position).

Aneurysm recurrences associated with Contour often present as progressive ‘dogears’ as presented in Figure 3. These recurrences can be treated with further coiling and flow diversion/stenting. If significant enough, then definitive treatment with open surgery and clipping may be considered.

The initial success of the CERUS Contour device has demonstrated further technical advancement in this field. There are still reservations over the economic costs. As the device has similar efficacy and safety results to WEB, the Contour potentially increases the portfolio of complex wide-neck aneurysms that can be treated with intrasaccular devices, with the requirement of a stent and with possible provision of better long-term results when compared with coiling.

Neqstent

Neqstent is another intrasaccular device which was designed to reduce the requirement of antiplatelet therapy, whilst also treating challenging aneurysms that require coiling (27). Available in four sizes, diameters 7, 9, 11 and 14 mm, Neqstent can be used to manage aneurysms with neck widths ranging from 3.0–10.0 mm. This dual-layered coil-assisted flow diverter consisting of 64 wires (67% of surface area coverage of Contour) was designed to encompass a platinum core wire, to allow for visualisation, within a nitinol mesh. Similar to Contour, Neqstent is also deployed at the aneurysm neck alone, hence only the width of the neck is required to choose the appropriate device for treatment. The main difference between Contour and Neqstent, is that a coiling microcatheter can be entered through the wire mesh of the Neqstent, allowing coils to be deployed in the aneurysm dome. The biggest advantage to this, is better coiling packing density with the protection of the parent vessel in wide-neck aneurysms without needing a balloon, in addition to providing better long-term stability due to the flow diverting property of the device. Additionally, the device can be carefully moved to change its position along the aneurysm dome or neck after a certain degree of coiling to allow further coiling or to modify its position away from the neck if there is initial impingement on the aneurysm neck and bifurcation branches. Figure 4 demonstrates an example of device deployment and its use in aneurysm coiling. The device is pushed after a few coils have been deployed to provide a coil mass further coiling and subsequently clearing off the aneurysm neck.

Figure 4 Graphic example of Neqstent deployment with coiling through a microcatheter which has been navigated through the device wires in (A), and jailed alongside the device in (B-D) demonstration of coiling the aneurysm dome whilst the Neqstent provides protection of coil prolapse into the parent artery. (E-G) Angiographic demonstration of a completely coiled wide-neck aneurysm with assistance of Neqstent.

The Coil-Assisted Flow Diversion Safety and Performance Study (CAFI) was the first multicentre trial investigating outcomes in 38 patients where Neqstent assisted coiling was performed (28). The device was implanted in 36 patients, with follow-up available for 33 patients. Immediately after treatment, 25% of patients in the per protocol group had complete occlusion, and at 6 months this increased to 77.8% which was higher than the CERUS, WEBCAST and WEBCAST2 studies. The primary safety endpoint of symptomatic thromboembolic events was met in 4 patients. Two of these were deemed unrelated to the device as were past the observation period, and they suggested one of the other two patients may have had a stroke due to the device implantation (2.6% morbidity). The non-randomisation and the non-exclusion of patients into the trial may affect the reliability of the results despite the improved occlusion rates.

A prior single centred study in Barcelona, Spain performed a retrospective analysis on patients treated with Contour/Neqstent with coiling. Of the 13 patients with successful treatment and therefore included in the results, nine received Neqstent, and the other five received the Contour neurovascular system (29). In the Neqstent group, the neck width ranged from 1.4 to 7.2 mm. They reported no morbidity or mortality relating to the operation, although one patient in the Neqstent group did experience an ischaemic stroke and therefore deployment failed and the Neqstent was removed. Complete occlusion was achieved in 92.3%, but the study sample was too small and there was no sub-analysis as to the proportion of complete occlusion in the Neqstent group versus Contour group, so it is difficult to draw conclusions. A further 2024 retrospective single-arm study followed 20 patients (age 44–78 years) for 6 months post-treatment (30). They deemed the primary safety end point to be any neurological deficit after the procedure, and a measure of the modified Rankin score (mRS) at 6 months. The average neck size was 5.6 mm, with the majority of the aneurysms being located in the middle cerebral artery (6/20) or anterior communicating artery (6/20); 90% of the patients had complete occlusion immediately post-embolisation. Of the 20 patients, 17 were followed up for 6 months, with 88.2% having complete occlusion, and only 1 patient (5%) experiencing treatment-related morbidity at follow up. These results further highlighted the positive occlusion rates associated with Neqstent treatment for wide-neck aneurysms. Figure 5 demonstrates an example case of Neqstent assisted coiling with 2-year follow-up.

Figure 5 Sample case of the treatment of a ruptured basilar tip aneurysm. (A) Non-contrast CT head demonstrating acute subarachnoid haemorrhage within the basal cisterns and sylvian fissures. (B,C) 3D and DSA representation of a large wide-neck basilar tip aneurysm. (D,E) Angiographic demonstration of deployment of an 11 mm Neqstent with an adjacent coiling catheter and subsequent complete coiling of the basilar tip aneurysm with no coil prolapse and no need for balloon protection. (F) 2-year follow-up DSA demonstrating ongoing complete occlusion of the previously ruptured basilar tip aneurysm. 3D, three-dimensional; DSA, digital subtraction angiography.

With a mean procedure time of 129 minutes, the procedure takes on average longer to perform than using Contour (28). A meta-analysis of Neqstent safety deemed the device to be comparable to or safer than previous stent-assisted coil occlusion of IAs (31). Larger studies with a greater patient population are required to better outline the immediate and long-term complications associated with Neqstent use, despite their overall promising occlusion results.

The adverse events and complication rates of Neqstent appear to be within expected endovascular embolization ranges. As this paper demonstrates and from early experience, this is between 2.6–5%. It should be highlighted that the aneurysms treated in these groups are large and complex and would otherwise require complex manoeuvres such as double balloon assisted coiling or Y-stenting and coiling, or otherwise flow diversion, which would increase procedure complexity and the associated risk.

We noted from our experience that thromboembolic complications often occur when the device is too close to a branch, affecting haemodynamic flow and therefore risks thrombus formation. Since then, our practice has been to not detach early and monitor for 5–10 minutes. If there’s any concern regarding thrombus formation across the Neqstent interface, then IV anti-platelet or antithrombolytic medication can be administered. Further manipulation of the device can be performed by carefully pushing the Neqstent and flattening it, therefore increasing the gap with the affected branch. This can be performed safely as the push is against a secure coil mass. Additionally, the use of short-term (3–6 weeks) antiplatelet medication (single or dual; dependent on aneurysm location and morphology) is encouraged to reduce the thromboembolic risk).

Whilst the Neqstent recurrences are less than Contour, they appear in a similar fashion with progression of dogears and migration of the device in coils into the aneurysm, leaving wide-neck, shallow recurrences. These can either be follow-up if remain stable or are insignificant, or treated with flow diversion and further coiling if significant, particularly in previously ruptured aneurysms.

Based on the encouraging results, it is apparent that Neqstent has shown promising results, particularly with complete occlusion rates 6 months post treatment and continue to reduce the need for postoperative antiplatelet therapy. Its simple size, design and deployment nature require less training to use, and provides an effective method to treat wide-neck aneurysms, without requiring a parent artery component. Long term studies, with larger sample sizes are required to reliably assess long-term efficacy and safety outcomes.

Limitations

Limitations still include the lack of multicentre studies with large sample sizes, more universal guidelines for intra-operative antiplatelet use, and whether antiplatelets are required intraoperatively for both ruptured and unruptured IAs. Furthermore, although there have been studies retrospectively exploring the use of Contour and Neqstent, randomised studies directly comparing different intrasaccular devices or with other endovascular techniques and their long-term safety and efficacy would be beneficial.

Conclusions

In summary, the exciting developments within the field of intrasaccular devices is elucidated by the initial success in trials and further studies using Contour and Neqstent. The efficacy outcomes across trials and retrospective trials demonstrate similar efficacy and safety results to WEB, increasing the range of different intrasaccular options for aneurysms with different morphologies and sizes.

Acknowledgments

None.

Footnote

Provenance and Peer Review: This article was commissioned by the Guest Editors (Tufail Patankar, Ricardo Hanel and Jeremy Lynch) for the series “Intracranial Aneurysms Current Status and Future Prospects” published in Journal of Neurointervention. The article has undergone external peer review.

Reporting Checklist: The authors have completed the Narrative Review reporting checklist. Available at https://jni.amegroups.com/article/view/10.21037/jni-25-35/rc

Peer Review File: Available at https://jni.amegroups.com/article/view/10.21037/jni-25-35/prf

Funding: None.

Conflicts of Interest: Both authors have completed the ICMJE uniform disclosure form (available at https://jni.amegroups.com/article/view/10.21037/jni-25-35/coif). The series “Intracranial Aneurysms Current Status and Future Prospects” was commissioned by the editorial office without any funding or sponsorship. F.I.I. reports consultant for Stryker and Medtronic, payments from Stryker, and support from Stryker and Medtronic. Stryker had no input or insight whatsoever into this manuscript or knowledge of his intention to publish this review. The authors have no other conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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