Midterm Results on Pipeline Vantage Embolization Device (MR-PVED): First Reported Experience in Asia

Abstract

Objectives

The purpose of this study is to evaluate the safety and efficacy in consecutive patients treated with Pipeline Vantage flow diverter in an Asian population before the partial recall, as well as their outcomes in both unruptured and ruptured cohorts.

Materials and Methods

This was a retrospective study conducted at a single center. Consecutive patients treated with Pipeline Vantage for intracranial aneurysms between August 2022 and July 2024, regardless of their rupture status, were systematically reviewed. There was no aneurysm size or location exclusion criteria. New adverse neurological events noted during hospitalization or the follow-up period were recorded as clinical safety outcomes. Radiological performance, including the degree of aneurysm occlusion, in-stent stenosis (ISS) and their braid deformation patterns were analyzed.

Statistical Analysis

Data were analyzed based on the intention-to-treat population. Categorical variables were presented as numbers with percentages, and continuous variables were summarized using mean and standard deviation (SD).

Results

A total of 31 patients with 36 aneurysms were identified. The average maximum aneurysm dimension was 5.7 mm. Four cases (12.9%) were presented as acute aneurysm rupture. Adjunctive coiling of the aneurysm was performed in eight cases (26%). At a mean of 12.4 months, the morbidity rate was 6.5%, and no mortality was observed. All the new adverse neurological events belonged to ischemic complications. Adequate aneurysm occlusion was achieved at 77.8%. ISS was observed in four cases (12.9%) while the rate of braid changes was noted to be 6.5%.

Conclusion

This is the first-ever study reporting the performance of Pipeline Vantage in Asia. The occlusion rate and safety outcomes were similar to those in recent studies. However, the relatively high incidence of ISS or braid deformation remains a concern.

Keywords

aneurysm - braid deformation - flow diverter - in-stent stenosis - Pipeline Vantage

Introduction

Flow diverter devices have been widely used for the treatment of wide-neck intracranial aneurysms by acting as endoluminal implants for vessel reconstruction.[1] Their use has been extended for other indications, including acutely ruptured cases, particularly blister or dissecting aneurysms.[2] [3] [4] [5] Being one of the most commonly used flow diverters, Pipeline Embolization Devices (Medtronic) have undergone several refinements since its first approval from the U.S. Food and Drug Administration (FDA) in 2011.[6] The latest (fourth) generation of Pipeline flow diverters (Pipeline Vantage Embolization Device with Shield Technology) was designed to further improve aneurysm occlusion and promote implant endothelialization by having a higher pore density, while retaining the synthetic phosphorylcholine polymer coating to reduce stent thrombogenicity as in its preceding generation (Pipeline Shield).[7]

Pipeline Vantage consists of either 48 (for 2.50–3.50 mm braids) or 64 (for 4.00–6.00 mm braids) cobalt chromium wires with platinum on the inside of each wire (drawn filled tube configuration). The 48-wire variant is compatible with 0.021 inch microcatheter delivery system, which allows easier distal access, whereas the 64-wire variant contains an additional 16 solid cobalt chromium wires, which provide increased radial force and improved opening of its distal end. The stainless-steel single-core pusher wire is also built more robustly to gain more pushability and stability. Another improvement is the significantly thinner expanded polytetrafluoroethylene sleeves, which offer faster distal braid release during deployment and allow more precise distal device placement. It was also reported to have improved wall apposition and ease of resheathing, in comparison to the previous generations.[8] Early clinical outcomes were equally promising, with a good aneurysm occlusion rate and a satisfactory safety profile similar to those in previously published flow diverter device studies.[9] However, a 64-wire series of Pipeline Vantage (compatible with 0.027-inch microcatheter) was recalled in January 2025 by the FDA due to incomplete wall apposition and/or braid deformation observed in some of their devices as revealed by the manufacturer's INSPIRE-A registry.

The purpose of this study is to evaluate the safety and efficacy in consecutive patients treated with Pipeline Vantage in an Asian population before the recall, as well as their outcomes in both unruptured and ruptured cohorts.

Materials and Methods

Study Design

This was a retrospective study conducted at a single center. Consecutive patients treated with Pipeline Vantage between August 2022 and July 2024 were systematically reviewed. The inclusion criteria were all patients who underwent Pipeline Vantage placement for intracranial aneurysm treatment, regardless of their rupture status or any prior intervention. There were no aneurysm size or location exclusion criteria. All cases were discussed, and the management plan was agreed upon among neurovascular team members. There were several clinical and anatomical indications for considering flow diversion over clipping or primary coiling, including wide-neck saccular aneurysms, unfavorable dome-to-neck ratio, complex dissecting or blister aneurysms, and patient-specific preference or factors.

Demographic and clinical data, aneurysm characteristics and location, number and size of Pipeline Vantage used, as well as technical aspects of stent deployment such as concomitant coil embolization and postdeployment balloon angioplasty were collected.

Procedures

All patients were loaded on dual antiplatelet therapy (DAPT) prior to flow diverter placement. In cases with acutely ruptured aneurysms, DAPT was usually given 3 hours before implant deployment, or, rarely, Integrilin (eptifibatide) administration immediately before deployment. Platelet resistance testing (Aspirin Reactivity Unit and P2Y12 inhibition) with VerifyNow (Werfen, Spain) was performed whenever possible. The Pipeline Vantage placement was performed under general anesthesia using a transfemoral or transradial arterial approach with a triaxial system, including a guiding catheter, an intermediate catheter, and a 0.021- or 0.027-inch microcatheter. Adjunctive coiling was performed in cases with large aneurysms to promote aneurysm occlusion, in which either a jailing technique or coiling first, followed by flow diverter deployment, was adopted. Wall apposition and braid deformation were immediately assessed by the operating team intraprocedurally based on the rotational angiogram to decide on the need for any balloon angioplasty. All patients were put on maintenance DAPT for at least 3 months, followed by long-term single antiplatelet therapy, unless serious hemorrhagic events occurred.

Outcome Measures

New adverse neurological events noted during hospitalization or the follow-up period were recorded as clinical safety outcomes. Digital subtraction angiography (DSA), cone-beam computed tomography angiography (CTA), and magnetic resonance angiography (MRA) were used alone or in combination as follow-up imaging modalities, but usually the first posttreatment follow-up imaging was scheduled at approximately 6 months postprocedure using DSA. Angiographic follow-up images were independently evaluated by neurointerventionists. In-stent stenosis (ISS) was categorized as none, mild (less than 25%), moderate (25–75%), and severe (greater than 75%), or completely occluded, whereas the degree of aneurysm occlusion was assessed using the Raymond–Roy occlusion rate (RROC).[10] RROC I was regarded as complete aneurysm occlusion, whereas adequate occlusion was defined as either RROC I or II. Other braid deformation patterns were reported according to the recent F2B2 definition (foreshortening, fish-mouthing, braid bump deformation, and braid collapse), which was endorsed by multiple international societies and published in 2024.[11]

Statistical Analysis

Data were analyzed based on the intention-to-treat population. Categorical variables were presented as numbers with percentages, and continuous variables were summarized using mean and standard deviation (SD).

Results

Patient and Disease Characteristics

In the 2-year study period, a total of 31 patients with 36 aneurysms were treated with Pipeline Vantage. The mean age was 61.3 years (range 41–77 years), and 83.9% of patients were female. The supraclinoid segment of the internal carotid artery (ICA) was the most common location (10/36, 27.8%), while 4/36 aneurysms (11.1%) were located in the posterior circulation. The majority (91.7%) of the aneurysms were saccular in morphology, while the remaining three cases were dissecting aneurysms that presented with acute rupture. The average largest aneurysm dimension was 5.7 (SD 4.3) mm with a mean neck width of 4 (SD 2.2) mm. Four patients (12.9%) presented with acute subarachnoid hemorrhage (SAH), and all were treated in emergency setting. Half of them were presented as good-grade SAH. Detailed patient and aneurysm characteristics are shown in [Table 1].

Table 1 Baseline patient and aneurysm characteristics

Characteristic	Frequency
Demographics, n = 31
Age, mean (IQR)	61.3 (52–71)
Female, n (%)	26 (83.9)
Aneurysm characteristics, n = 36
Aneurysm rupture status
Acutely ruptured, n (%)	4 (11.1)
Previously treated, n (%)	11 (30.6)
Aneurysm size
Maximum diameter (mm), mean (IQR)	5.7 (3–6)
Small (<10 mm), n (%)	30 (83.3)
Large (10–25 mm), n (%)	6 (16.7)
Neck width (mm), mean (IQR)	4 (2.5–4.3)
Aneurysm location, n (%)
ICA—cavernous segment	2 (5.6)
ICA—paraophthalmic segment	7 (19.4)
ICA—supraclinoid segment	10 (27.8)
ICA—posterior communicating artery segment	8 (22.2)
ICA—anterior choroidal artery	1 (2.8)
ICA—terminal segment	2 (5.6)
Anterior cerebral artery	2 (5.6)
Vertebral artery	2 (5.6)
Posterior inferior cerebellar artery	2 (5.6)
Aneurysm morphology, n (%)
Saccular	33 (91.7)
Dissecting	3 (8.3)

Abbreviation: IQR, interquartile range.

Treatment

The procedure characteristics are listed in [Table 2]. Pipeline Vantage was successfully deployed in all procedures. A single stent was used in the vast majority of cases (93.5%), while double stents were deployed in the remaining two cases with recently ruptured dissecting aneurysms to enhance implant coverage in view of large aneurysm size and inadequate contrast stasis following the first stent. Adjunctive embolization with detachable coils was performed in 8/31 patients (25.8%). There was 100% success in deployment. However, 6/31 patients (19.4%) underwent additional in-stent balloon angioplasty in the same session to improve wall apposition. Periprocedural thrombus formation was observed in only 1/31 case (3.2%), and it resolved after Integrilin administration.

Table 2 Procedural characteristics

Parameter	Frequency, n (%)
Vascular access
Transfemoral	25 (80.6)
Transradial	6 (19.4)
Multiple stents	2 (6.5)
Adjunctive devices used
Coil embolization	8 (25.8)
In-stent balloon angioplasty	6 (19.4)

Clinical Outcome

During a mean clinical follow-up period of 16.6 months, the morbidity rate was 6.5%, and no mortality was observed ([Table 3]). Among the two patients with new adverse neurological events, all were ischemic complications. One of them experienced clinical deterioration with an modified rankin scale (mRS) shift due to the distal embolic complication.

Table 3 Outcomes

Outcome	Frequency
	Unruptured (N = 27)	Ruptured (N = 4)	Total (N = 31)
Neurological adverse events	1 (3.7%)	1 (25%)	2 (6.5%)
Mortality	0 (0)	0 (0)	0 (0)
Aneurysm occlusion
RROC I	23 (85.2%)	2 (50%)	25 (69.4%)
RROC II	2 (7.4%)	1 (25%)	3 (8.3%)
RROC III	7 (25.9%)	1 (25%)	8 (22.2%)
In-stent stenosis
Mild (<25%)	2 (7.4%)	0 (0)	2 (6.5%)
Moderate (25–75%)	1 (3.7%)	0 (0)	1 (3.2%)
Severe (>75%)	1 (3.7%)	0 (0)	1 (3.2%)
Braid deformation
Fish-mouthing	1 (3.7%)	0 (0)	1 (3.2%)
Braid bump deformation	1 (3.7%)	0 (0)	1 (3.2%)

Abbreviation: RROC, Raymond–Roy occlusion rate.

One ischemic complication was retinal branch artery occlusion in a patient with an acutely ruptured right dissecting terminal ICA aneurysm with double Pipeline Vantage deployed (both stents not covering the ophthalmic artery), resulting in deterioration in visual acuity and visual field defect. Another case was a giant cavernous ICA aneurysm presented with diplopia, and flow diverter along with adjunctive coiling under jailing technique was planned for her. However, stretching of the detachable coil was encountered after stent deployment, and the stretched part was anchored to the side wall of ICA with other intracranial stents (Solitaire FR). Unfortunately, a distal embolic event occurred, and hemorrhagic transformation happened after intravenous thrombolytic therapy. Both adverse events were regarded as procedure-related rather than device-related.

Radiological Outcome

All our treated patients were available for angiographic follow-up at a mean of 12.4 months, with digital subtraction angiogram being the most widely used modality (54.8%), followed by cone-beam CTA (29%). Complete aneurysm occlusion rate (RROC I) was achieved in 69.4%, while neck remnant rate (RROC II) was 8.3%. That made the adequate occlusion rate (RROC I/II) reach 77.8%. Of the remaining 8/36 aneurysms (22.2%) that showed an aneurysm remnant at 6 months, all demonstrated a reduction in size.

There were four cases (12.9%) of ISS. Of these, half of them demonstrated moderate to severe stenosis requiring retreatment, either balloon angioplasty or intracranial stenting, despite all four patients being asymptomatic.

Regarding braid deformation, there were two cases (6.5%) with braid changes observed, and all of them belonged to the Pipeline Vantage 027 group. One was fish-mouthing with 25% reduction of braid diameter, another was braid bump deformation at mid-segment ([Fig. 1]). None of these braid changes causes any clinical manifestation.

Fig. 1 Two cases of braid changes: (A) Fish-mouthing over a proximal stent end, and (B) braid bump deformation over the mid-portion of the stent.

Discussion

Aneurysm Occlusion

The pooled analysis of the three benchmark studies on previous generations of Pipeline showed complete occlusion rates of 75% at 6 months and 86% at 1 year.[12] This novel generation of Pipeline Vantage was refined with a higher pore density to promote early endothelial coverage, and hence to further improve aneurysm occlusion rates. De Villiers et al reported that the aneurysm occlusion rate reached up to 82% at 6 months in this new generation, which was seemingly more promising than its predecessors.[8] In our study with longer-term follow-up at a mean of 12.4 months, an adequate occlusion rate of 77.8% was achieved, which was comparable with other Pipeline Vantage studies.

It was suggested by Goertz et al that older patient age and vessel originating from the aneurysm sac were independent predictors of incomplete aneurysm occlusion.[13] Our study corroborated the same findings that five out of our eight residual aneurysms (62.5%) had a vessel (most commonly fetal posterior-communicating artery) incorporated at the aneurysm sac. However, our sample size of residual aneurysms was not large enough to perform statistical analysis.

Procedure-Related Complications

Ischemic complications are the leading cause of procedural morbidity after flow diverter treatment, primarily due to thromboembolism and perforator infarction.[14] [15] In a registry study of the preceding generation Pipeline Shield, Trivelato et al reported major neurologic complications in 7%.[16] Several recent publications on Pipeline Vantage also revealed a neurologic complication rate ranging from 3.3% to 6.6% in unruptured cases.[17] [18] The procedure-related complication rate was even higher in its ruptured cohort, reaching up to 33% by Booth et al, and 40% by Sciacca et al.[9] [19] The overall complication rate on neurological adverse events in our study was 6.5%, which was attributed mainly by its inherent procedural risk rather than the intrinsic properties of the Pipeline Vantage device itself, and it was comparable to other flow-diverter series.

Notably, there were no intracranial hemorrhagic complications in our series, even with DAPT use in ruptured cases. The more flexible structure of Pipeline Vantage and its delivery system may be one of the possible reasons to prevent vessel or aneurysm perforation.[20]

Device-Related Safety

In-Stent Stenosis

The promotion of early endothelial coverage introduced by the higher pore density of Pipeline Vantage may improve aneurysm occlusion and mitigate thromboembolic events, but it may also result in excessive neointimal hyperplasia and then ISS.[18] The reported ISS rate of Pipeline Vantage ranged from 4.2% to 13.8%.[9] [19] [20] On the flip side, the cobalt chromium wires in the Vantage implant are designed to have a smaller diameter than those in the previous versions of the device, resulting in a reduced overall thickness profile of the device.[7] This may theoretically reduce the incidence of ISS. Our rate of ISS was 12.9%, which belongs to high side among those in the reported series. It was noted that most of our cases of ISS (3/4, 75%) happened in long-flow diverters (longer than 20 mm in length) or small ones (less than 2.5 mm in diameter). A potential mechanism may be a higher degree of vessel diameter discrepancy between the distal and proximal ends of a long implant, which results in higher wall shear stress in the oversized distal segment and may induce a greater inflammatory response.[21] A recent systematic review and meta-analysis by Abramyan et al has identified other high-risk aneurysm characteristics, such as posterior circulation, fusiform or recently ruptured status, that were associated with an increased risk of ISS after flow diverter treatment, but a clear correlation of these risk factors was not demonstrated in our series.[22]

Braid Deformation

To our knowledge, this is the first study addressing braid deformation patterns on Pipeline Vantage using the standardized F2B2 reporting format. A clearly defined nomenclature on angiographic appearance of stent struts provided a common language for future studies to make a fair comparison and help enable research and development on specific technical aspects of flow diverters.

According to the U.S. initial experience, during the deployment of the proximal Pipeline Vantage stent end, avoiding delivering too much forward loading and instead allowing the device to slowly unsheath itself will generally result in satisfactory opening of the proximal end.[23] Notwithstanding the nuances, Pipeline Vantage 027 devices were recalled globally in early 2025 due to reports of incomplete wall apposition and/or braid deformation, reaching 12.1%,[24] according to the INSPIRE-A registry, which was a prospective, single-arm, multicenter, global registry for the real-world use of over 400 Pipeline Vantage devices.[25] Our two cases (8.3%) of braid changes in the Pipeline Vantage 027 cohort aligned well with the deformities highlighted in the recall notices. On the other hand, there were no cases of incomplete wall apposition observed in our study, but this may be attributed to the relatively frequent (19.4%) in-stent balloon angioplasty rate.

Strengths and Limitations

To the best of our knowledge, this was the first published experience with the new Pipeline Vantage embolization device with Shield Technology on the Asian population. We have also analyzed the braid deformation issue according to the latest F2B2 consensus. Up-to-date literature review in recently published studies on Pipeline Vantage, on its effectiveness and safety profile, was also included.

Furthermore, our radiological outcomes were relatively complete because a significant proportion (96.8%) of patients had completed their follow-up imaging at least 6 months after the procedure. Our patients were followed up angiographically for a relatively longer period compared with other studies, reaching an average of 12.4 months, hence midterms radiological outcome could be obtained.

Nonetheless, this study has several limitations. First of all, the inherent bias of retrospective studies includes patient selection and data collection. Second, the study has no control group, and no direct comparison of results with other flow diverters is therefore possible. Third, there was no evaluation of the angiographic results by core imaging laboratories, although they were all independently adjudicated by experienced neurointerventionists, and braid deformation patterns were graded in a standardized and well-defined manner.

Despite the fact that Pipeline Vantage 027 devices were still under quarantine at the time of writing, it is hoped that this study could provide additional, especially midterm angiographic information on the device performance for existing patients with Pipeline Vantage implanted, and guide future improvement on current issues such as ISS and braid deformation in the coming refinement.

Conclusion

This study on the Asian population demonstrated a similar safety and efficacy profile for Pipeline Vantage as shown in other studies, while braid deformation and ISS remained the key challenges for future generation devices to address.

Conflict of Interest

None declared.

Authors' Contributions

S.K.C., the corresponding author, was responsible for study design, data collection, and manuscript writing. The other coauthors were responsible for supervision.

Ethical Approval

This study was approved by the hospital's Research and Ethics Committee.

• References

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Publication History

Article published online:
13 February 2026