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Abstract

Objectives

The aim of this study is to investigate and delineate the reliability and efficacy of the new Pipeline Vantage (PV). The flow diverter device was recently introduced presenting the innovative shield technology.

Methods

This retrospective study included 21 patients with 22 unruptured intracranial aneurysms, all of whom were treated with the PV device at our institution between January 2022 and January 2023. Patient demographics, aneurysm morphology and location, periprocedural strategies, treatment approaches, and occlusion status at follow-up (up to one year) were retrospectively analyzed.

Results

Nineteen of the aneurysms (86.36%) were treated solely with the PV device and three (13.63%) were treated in combination with coil embolization. Two patients (9.52%) were expired, one related to a subarachnoid hemorrhage occurred during treatment and the second one after a successful treatment on follow-up, due to the existence of concomitant disease, not related to the aneurysm itself. The mean time of follow-up on the treated aneurysms was 7.4 months. In 81.81% (18 aneurysms) of the cases presented, a complete aneurysm obliteration was achieved on the last follow-up imaging.

Conclusions

In this initial experience, the PV flow diverter demonstrated favorable short- and mid-term outcomes in the treatment of intracranial aneurysms. While the overall complication profile was acceptable, the occurrence of a periprocedural mortality reflects the inherent procedural risks of neurointervention, even under meticulous technique. However, short-term results should be balanced with caution and supported by robust research to demonstrate the long-term safety and efficacy of the device.

Advances in knowledge

PV the successor of the novel Pipeline device showed promising short-term results.

Keywords

Pipeline embolization device intracranial aneurysm endovascular treatment flow diversion vantage flow diverter

Introduction

In the field of intracranial aneurysm treatment, endovascular approaches—particularly the use of flow diverter (FD) devices—are currently considered first-line options by most neurointerventionalists.

The ability to successfully treat an intracranial aneurysm in many different anatomic localizations by the endovascular route has already been confirmed by many researchers working in this field.^1,2

The efficacy of the devices led to the explosion in the application of FDs and subsequently their modifications leading to their ubiquitous use in endovascular therapy. Plenty of different types of FDs are in clinical use constructed from different materials with different device peculiarities.^3,4 Despite their different properties, the primary indication in clinical practice is identical. Although the FDs seem to be a problem solver in plenty of different situations, the excitement should be balanced with caution as they also have some drawbacks. Possible complications such as incomplete occlusion, parent arterial thrombosis, early and delayed hemorrhages, in-stent stenosis and/or perforator occlusions, mostly due to their high percentages of metal surface area coverage.⁵ Another important anatomical consideration is that the tortuous anatomy of distal vessels markedly foreshortened the FD on deployment.^6,7

Contrary to the other surgical and endovascular techniques, achieving immediate obliteration of the aneurysms, the ability of the FD devices will achieve aneurysm occlusion at longer time periods. Comprehensive meta-analyses and pooled studies have demonstrated that FD devices result in progressive aneurysm occlusion over time, with complete occlusion observed in approximately 76% of cases at six months and up to 86% at one-year follow-up.^1,8 There is a relatively new FD device introduced in the field in recent years and the first clinical experiences have already been presented in the literature.^9–12 This fourth-generation device, Pipeline Vantage (PV), features Shield Technology™, a phosphorylcholine surface modification that aims to reduce thrombogenicity and enhance biocompatibility. It also incorporates improved fluoroscopic visibility, increased mesh density, and enhanced conformability, which may collectively contribute to better wall apposition and procedural control compared to previous generations.¹²

The aim of this study with a small cohort is to determine and illustrate the performance and efficacy of the newly introduced FD device the PV with the Shield Technology.

Material and method

Participants

This retrospective study was reviewed and approved by the institutional ethics committee (Approval No: I06-416-23). All patients provided written informed consent prior to treatment. No identifiable patient data other than age and gender were recorded due to ethical considerations, and all patients were over 18 years of age.

A total of 21 consecutive patients with 22 unruptured intracranial aneurysms treated with the newly introduced flow diverter, the PV Embolization Device (Medtronic Neurovascular, Irvine, CA), between January 2022 and January 2023, were included in this study. Patients treated with other techniques or devices were excluded.

Data were collected retrospectively and included: patient age, sex, aneurysm size and location, number of aneurysms, aneurysm occlusion status at follow-up, clinical outcomes, modified Rankin Scale (mRS) scores (initial/follow-up), antiplatelet regimens, and procedure-related complications. All patients were selected consecutively from our institutional database, and the methodology was designed to ensure reproducibility by clearly describing imaging protocols, treatment procedures, and follow-up criteria.

This study was conducted in accordance with the ethical principles of the Declaration of Helsinki (1975), as revised in 2024.

The reporting of this study conforms to the Strengthening the Reporting of Observational Studies in Epidemiology guidelines.¹³

Device characteristics and performance

The PV device can be delivered through a .021” (0.53 mm) or .027” (0.68 mm) microcatheter system, as specified by the manufacturer's instructions. Precise apposition of the device to the vessel wall is one of the leading edges preventing endoleak, increasing the possibility of the aneurysm to rupture relating with the in-advent conformability. In this fashion, maneuvers described in the previous literature were used during the device deployments.^14,15 Another factor to consider for the success of the procedure is the predictability of the device behavior on deployment and the possibility of foreshortening on tortuous anatomy. Along these lines, the devices’ performances and characteristics were rated by the performing physicians, with 5 to 40 years of experience, according to the conformability of the device to the vessel wall, ease of device deployment and precise of landing to the target zone.

Preoperative assessment, endovascular technique, and posttreatment imaging follow-up

Patients diagnosed with an intracranial aneurysm at a diagnostic work-up were introduced to our endovascular unit by their referring clinicians. These cases were scheduled for a routine diagnostic angiographic imaging, via a retrograde femoral access, assisted by a bi-plane angiography device (Siemens Healthcare GmbH, Erlangen, Germany). Routine intracranial imaging projections as well as the 3D rotational images were obtained in all patients, in order to preplan the intended working projections and determine the device sizing.

Following this stage, the eligible patients for the treatment were discussed in a multidisciplinary team meeting, seeking a consensus and prepared for their definitive treatment in an elective fashion. All patients underwent general anesthesia with a four-channel BIS™ complete monitoring system (Medtronic Inc., Minneapolis, MN, USA) attached on their heads to monitor the intracranial statuses better and instantaneously. Postprocedural imaging was tailored according to clinical need. Dyna cone-beam (CT) was selectively performed in cases requiring further evaluation of flow diverter positioning or wall apposition. As part of the institutional discharge protocol, all patients underwent noncontrast cranial CT prior to discharge to rule out any hemorrhagic or ischemic complications. Routine posttreatment MRI was not performed unless neurologically indicated, as nonspecific diffusion-weighted changes may be observed even after diagnostic cerebral angiography, which are often clinically silent.¹⁶

Imaging follow-up evaluations were conducted using the modified Cekirge–Saatci Classification (mCSC), an extension of the original classification system proposed by Cekirge and Saatci, designed to more accurately reflect aneurysm occlusion and branch vessel patency following flow diverter treatment.^17,18 Class 4, which pertains to immediate postprocedural imaging findings, was not applicable in this study as it was not the focus of our analysis. Similarly, Class 5 and its subclass 5A, which require imaging from at least two time points beyond one year, could not be applied due to limited long-term follow-up. The mCSC utilized in this study is presented in Table 1.

Table 1.

Modified Cekirge–Saatci classification.

Class	Description	Commentary
1	Complete aneurysm occlusion	Applied to aneurysms without incorporated branches.
1A	With full patency of the incorporated branch	The incorporated branch remains fully patent.
1B	With reduced caliber of the incorporated branch	The branch is patent but demonstrates a reduced lumen.
1C	With no anterograde filling of the incorporated branch	The branch is occluded or shows no forward flow.
2	Residual neck filling	Minimal contrast opacification is observed at the neck of the aneurysm.
3	Residual aneurysm filling	Aneurysm sac continues to fill without dimensional change, regardless of branch incorporation.
3A	Stable residual filling in a sidewall aneurysm (no incorporated branch)	Residual filling is stable or decreasing in size on follow-up angiograms; no branch involvement.
3C	With documented growth	The aneurysm shows interval growth on follow-up angiograms, independent of branch involvement.
4	Aneurysm filling (immediate postoperative findings)	Used only for immediate postprocedural imaging.
4A	With contrast stagnation within the sac	Delayed washout of contrast within the aneurysm sac is observed.
4B	Without contrast stagnation	Rapid washout of contrast, suggesting continued active flow.
5	Residual filling with aneurysm remodeling (with incorporated branch)	Aneurysms harboring an incorporated branch show progressive or stable reduction in sac size during follow-up imaging.
5A	Progressive remodeling	Follow-up imaging demonstrates gradual size reduction over time. At least two imaging assessments (≥6 months apart and >1 year from index procedure) are required.*

*Note: In exceptional cases, Class 5A may be assigned on the first follow-up if contrast dynamics indicate branch redirection without sac opacification.

Angiographic imaging was obtained by either CTA or MRA modality for the initial evaluation, decided for either the third or sixth month. DSA control imaging was also performed in 6–12 months. If a complete aneurysm obliteration is documented in the control DSA, then patients would be scheduled for the annual MRA follow-up. No further DSA imaging follow-up would be required unless clinically suggested. Unless a total aneurysm occlusion was documented, an annual MRA/CTA or DSA imaging will be obtained in order to determine a retreatment decision.

Blood thinning medication and the protocol

Given the metallic properties of the FD, dual antiplatelet therapy is required to reduce the risk of thromboembolism. The drug regimens were tailored according to patients’ thrombocyte aggregation test results, and anatomic localizations of their aneurysms. This is done in order to ensure therapeutic inhibition and mitigate the risk of thrombotic/hemorrhagic complications. Different drug protocols were prescribed to the patients firstly according to the aneurysm localizations. For the patients with their aneurysms located on the ICA territory, presenting vessel diameters greater than 4.25 mm; (1) patients with an ADP aggregation value between 40% and 70% have double antiplatelet therapy with aspirin 100 mg and prasugrel 10 mg daily for 1–3 months followed by single therapy with prasugrel 10 mg for 6–12 months, (2) patients with an ADP aggregation value between 70% and 90% have both aspirin 100 mg and prasugrel 10 mg daily for 1 month followed by prasugrel 10 mg only for 6–12 months. (3) Patients with an ADP aggregation value > 90% will receive single therapy with prasugrel 10 mg for 6–12 months. Furthermore three different categories of patients were divided, with their aneurysms located either on bifurcation points or on the posterior circulation and on smaller caliber distal arterial territories; (1) patients with an ADP aggregation value between 40% and 70% have both aspirin 100 mg and prasugrel 10 mg daily for 3–6 months followed by only prasugrel 10 mg for 6–12 months, (2) patients with an ADP aggregation value between 70% and 90% have both aspirin 100 mg and prasugrel 10 mg daily for three months followed by prasugrel only 10 mg for 6–12 months. (3) Patients with an ADP aggregation value > 90% have both aspirin 100 mg and prasugrel 10 mg for one month followed by prasugrel only, 10 mg for 6–12 months. After completing the initial dual antiplatelet therapy regimen, all patients were prescribed 100 mg of aspirin daily for five years or lifelong use, depending on clinical factors. This strategy was based on the assumption that sufficient endothelialization occurs over time, making long-term use of potent agents such as prasugrel unnecessary.

Clinical outcome and follow-up

Post procedure initial neurologic outcomes were evaluated by the entire team including the anesthesiologists, neurosurgeons and interventionists. Following the multidisciplinary assessment all patients were scheduled for an appointment with their treating clinicians on the first, third, sixth, and 12th months with annual clinical control thereafter.

To estimate and understand the importance of complications related to the techniques used at this study, both Society of Interventional Radiology adverse event classification and Clavien-Dindo classification grading were used.^19,20

Statistical analysis

All statistical analyses were performed using Statistical Package for the Social Sciences, version 20 (IBM, Armok, NY). Descriptive data for age are presented as average standard deviation (±), whereas categorical data representing the number of participants (angiographies) are indicated as percentage (%). Student's t test was used in this study to compare ages in different gender groups. For the descriptive statistics average, standard deviation (±), median, minimum, and maximum values were used whole numbers and percentages were used for discrete data. The relationship among the categorical variables were analyzed using Pearson's Chi-Squared Test. Student's t test was used for the data that showed a normal distribution and Mann–Whitney U test was used for those that did not. For results with p < .05, we assessed the statistical significance of the findings.

Results

Demographic data of the patients and the anatomic localizations of the aneurysms

There were 21 patients (14 female, seven male) with 22 aneurysms in this study and the mean ages of the patients were 59.52 years (41–85 years). The PV embolization devices were used solely in 19 (86.36%) aneurysms and in combination with coil embolization in three (13.63%) of the aneurysms. The decision to use adjunctive coiling in these cases was made at the discretion of the operator, based on aneurysm size, morphology, and intraprocedural hemodynamic considerations. Telescopic stenting technique was performed in three of the aneurysms (13.63%), located on the internal carotid (two patients) and distal middle cerebral arteries (one patient) (Table 2).

Table 2.

Summary of patients and complications.

Age (years)	59.52 (41–85)
Patients	21
Total embolizations	22
Average control period	7.4 ± 2.9 month
Coil embolization	(3) 13,63%
Telescopic stenting technique	(3) 13,63%
Complications during procedure	(3) 13.63%
Complication after procedure	(1) 4,54%

Four aneurysms (18.18%) were located on the anterior communicating arteries. Eleven aneurysms (50%) were located on the internal carotid arteries (22.72% left sided, 18.18% right sided, 4.54% bilateral). 13.63% of the aneurysms were located on the middle cerebral artery bifurcations (two right sided and one left sided). The remaining four aneurysms (18.18%), interpreted in this cohort were located on the distal middle cerebral artery (4.54%), distal anterior cerebral artery (4.54%), terminal basilar artery (4.54%), and posterior cerebral artery (4.54%) (Table 3).

Table 3.

Aneurysm localizations.

Location of aneurysms	Percentage
Anterior circulation	19 (86.36%)
Acom	4 (18.18%)
ICA	10 (45.45%)
Left	5 (22.72%)
Right	3 (13.63%)
Bilateral	1 (9.09%)
DACA	1 left (4.54%)
MCA	4 (18.18%)
Left	1 (4.54%)
Right	2 (9.09%)
Distal m2-m3	1 (4.54%)
Posterior circulation	3 (13.63%)
Basiler	1 (4.54%)
PCA	1 left (4.54%)
Pcom (ostium)	1 right (4.54%)

Acom: anterior choroidal artery; ICA: internal carotid artery; DACA: distal anterior cerebral artery; MCA: middle cerebral artery; Basiler: basiler artery; PCA: posterior cerebral artery; Pcom: posterior choroidal artery.

Procedure related angiographic and clinical findings and consequences

The average size of the aneurysms measured 11.05 mm (± 9.98 mm) × 5.29 mm (± 1.70 mm), on the 4D DSA images obtained during the procedures. All patients in this cohort were treated with an antiplatelet regimen of prasugrel (10 mg) and aspirin (100 mg). The patients’ platelet aggregation values were obtained with the laboratory results, prior to the treatment. Operators observed satisfactory results regarding the conformability, vessel wall apposition, deployment characteristics and tractability of the devices in all cases.

A total of three complications (14.28%) associated with the endovascular procedures were recorded (Table 3). The first was an 85-year-old male with a 25 × 25 mm ACOM aneurysm and an initial mRS score of 2, who experienced intraprocedural rupture during distal catheterization of the anterior cerebral artery. The patient died in the intensive care unit four days after the procedure. The second complication occurred in a 45-year-old female with a right ICA aneurysm, who was diagnosed with an asymptomatic focal dissection in the distal right ICA on the six-month follow-up CTA. This finding was likely related to the guiding sheath used during the procedure and did not result in any neurological symptoms during the follow-up. The third recorded complication was a minor infarction in a 45-year-old male patient, which occurred a few weeks after discharge and was attributed to the inadvertent discontinuation of antiplatelet therapy. The infarct was detected on imaging, and the patient was discharged without sequelae after the reinitiation of antiplatelet treatment.

A femoral access-site hematoma with spontaneous resolution was observed in one patient but was not included in Table 3, as it required no intervention and had no clinical impact. Another patient died due to cardiac arrest one month after successful aneurysm treatment; however, this event was deemed unrelated to the procedure or the aneurysm itself.

Excluding the patients with an mRS score of 6, all other patients maintained a stable clinical status throughout follow-up, with a final mRS score of 0 (Table 4).

Table 4.

Patients with complications.

Age (y)/Sex	Aneurysm Localization	Complications	Follow-ups until the first year (third month, sixth month, first year)	Result
45 y/M	Left ICA	Minor infarction after the procedure due to the discontinuation of the antiaggregants	Transient ischemic symptoms weeks after successful procedure	Total occlusion of the aneurysm at first year with CTA—sequellae free
85 y/M	Acom	Ex as a result of bleeding during the catheterization	-	Patient with an initial mRS score of 2 rupturing during the distal catheterization of the anterior cerebral artery died at intensive care unit 4 days after the procedure
45 y/F	Right ICA	Focal asymptomatic dissection	Diagnosed at 6^th month follow-up CTA in the distal right ICA	Recovered without sequellae

Acom: anterior choroidal artery; ICA: internal carotid artery; CTA: computed tomography angiography; M: male; F: female, y year.

Follow-up imaging

All patients were controlled with CTA, DSA or MRA in the third, sixth, and/or first year. Two patients (9.52%) were expired during this period and lost to follow-up; therefore, the final cohort consisted of 19 (90.47%) patients including follow-up imaging data with a mean of 7.4 months (3–12 months). Eighteen aneurysms (81.81%) across 17 patients demonstrated complete occlusion. Among these, the incorporated branches—when present—remained fully patent, indicating that these cases correspond to either Class 1 or Class 1A. One internal carotid artery aneurysm (4.54%) exhibited residual neck filling and was classified as Class 2. Additionally, one middle cerebral artery aneurysm (4.54%) demonstrated residual aneurysm filling without dimensional change, consistent with Class 3. These angiographic outcomes were categorized according to the mCSC criteria (Figures 1 and 2).

Figure 1.

Images of a fusiform distal left MCA aneurysm. (A, B, C) 3D rotational angiographic and initial working projection images used during the treatment. (D) Images of the stents in a telescopic fashion to treat the fusiform aneurysm. (E, F) First year control DSA images.

Figure 2.

Images of a residual Acom aneurysm obtained before, during, and after treatment with the Pipeline Vantage flow diverter. (A) Residual aneurysm diagnosed at MRA images two years after a coil embolization session of an Acom aneurysm. (B) DSA images obtained before endovascular treatment of the aneurysm. (C) Native images after implantation of bilateral Vantage stents. (D) Control MRA images obtained six months after the treatment. Note: No aneurysm filling seen at last follow up.

Discussion

In the present study, we present our experience with the new FD the PV Embolization Device in a small cohort; in order to study in detail and understand both its performance and efficacy. At one- year follow-up, vast majority of the patients had achieved the study's primary effectiveness endpoint of complete aneurysm occlusion. The results have demonstrated that the safety and the ability to preclude the aneurysms is effective and satisfactory as its predecessor, with easier deployment properties minimizing the possibility of device malposition.

Flow diverter stents were initially developed for the treatment of difficult-to-treat aneurysms, such as large, giant, fusiform, or blister-type aneurysms.²¹ Although, parent artery sacrifice can be an appropriate option in some of these cases (aneurysms located at ICA terminus, distal middle cerebral artery (MCA) and vertebrobasilar junctions), different techniques have been introduced such as the telescoping technique for these wide necked or fusiform aneurysms.^22–25 We have optioned to use the telescopic stenting technique in two giant ICA and one distal MCA fusiform aneurysms and treated them successfully without any complications.

The number of female patients was predominant in the published literature on flow diverter treatments; accordingly, the demographic distribution in our cohort was consistent with previously reported data. The use of flow diverter devices has been most common for anterior circulation aneurysms and can be combined with coil deployment in selected cases.^3–5,26 In our series, more than 90% of aneurysms were located in the anterior circulation and 13.63% of the patients—mostly with giant aneurysms—were treated with adjunctive coiling, which is in line with earlier-generation Pipeline reports and also consistent with recent studies on the PV device.^{2–5,12,26–29}

There is currently no consensus regarding the utility of preoperative platelet aggregation testing in flow diverter procedures, and published studies have shown mixed or inconclusive results regarding its impact on clinical outcomes.^25,30 Even though there are conflicting data regarding the preoperative testing of the platelet aggregation, our institution protocol consists of a dedicated antiaggregation regimen tailored through the results of the platelet aggregation tests of the patients. We prefer to have full control of our patients during the follow-up protocol and we believe that this patient based tailored protocol helps us reach our intent. As such, patients in this cohort neither experienced any neurologic nor any hemorrhagic events. The only patient experiencing a minor infarct was attributed to the discontinuation of the prescribed antiplatelet medication, in the two weeks following a successful treatment. However, the patient's condition was ameliorated after restarting the medication.

Previous data including the aneurysm treatments with the implementation of flow diverter devices, showed encouraging conclusions with up to 100% aneurysm occlusion rates in long term follow-up.²⁷

Overall, 19 of the patients had follow-up data available at a mean of 7.4 months, during which an aneurysm occlusion rate of 81.81% was achieved in this cohort. The short- and mid-term efficacy of flow diverter devices has been demonstrated in previous studies, showing satisfactory aneurysm occlusion rates.^2–5,26,28

Our findings are in line with these earlier results and also comparable to recently published data on the fourth-generation PV device, which similarly reports high rates of complete or near-complete occlusion within the first six to seven months of follow-up.^12,29

There are some limitations of this study, mainly due to its retrospective character. Additionally, it is a single center study with a limited number of patients. Thirdly, there is no control group involving other flow diverter stents or techniques. Finally, the duration of mean follow-up times is very short as the device's release is relatively recent; however, further studies with long term follow-up results of the device in addition to mortality and morbidity rates will be essential.

Conclusion

In conclusion, the new Pipeline FD device Vantage has shown a satisfying performance treating intracranial aneurysms in this study. More prospective studies, with higher patient numbers, are needed to fully assess and determine its therapeutic effects and benefits on excluding intracranial aneurysms.

Footnotes

Acknowledgments

The authors would like to express their sincere appreciation to the multidisciplinary team at Ankara University Faculty of Medicine for their dedicated efforts in the diagnosis, treatment, and follow-up of the patients included in this study.

ORCID iDs

Emre Can Çelebioğlu

Emre Utkan Büyükceran

Ethical considerations

This study was approved by the Ankara University Clinical Research Ethics Board on July 11th, 2023 (Approval No: I06-416-23), and was conducted in accordance with the ethical principles of the 1964 Declaration of Helsinki and its later amendments.

Author contributions

ECÇ: project development, data collection, manuscript writing, data analysis and interpretation, literature search, and study design; SB: project development, critical review, supervision, and resources; ŞK: study design and data collection; FDE: study design and resources; MY: study design, literature search, and data analysis; EB: manuscript editing and writing; MZ: data collection; EB: data collection and manuscript editing; İD: manuscript editing and critical review; HT: critical review and supervision; MAÜ: manuscript editing and resources; and E.U B: design and editing-writing.

Funding

The authors received no financial support for the research, authorship, and/or publication of this article.

Declaration of conflicting interests

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Data availability statement

All data generated or analyzed during this study are included in this published article. Additional data are available from the corresponding author upon reasonable request.

Patient consent

Written Informed Consent was obtained from all participants prior to inclusion in the study.

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Efficacy and performance of the new pipeline vantage flow diverter stent with shield technology: Short-term results of a single-center experience

Abstract

Objectives

Methods

Results

Conclusions

Advances in knowledge

Keywords

Introduction

Material and method

Participants

Device characteristics and performance

Preoperative assessment, endovascular technique, and posttreatment imaging follow-up

Blood thinning medication and the protocol

Clinical outcome and follow-up

Statistical analysis

Results

Demographic data of the patients and the anatomic localizations of the aneurysms

Procedure related angiographic and clinical findings and consequences

Follow-up imaging

Discussion

Conclusion

Footnotes

Acknowledgments

ORCID iDs

Ethical considerations

Author contributions

Funding

Declaration of conflicting interests

Data availability statement

Patient consent

References