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Erratum. The second-generation eCLIPs Endovascular Clip System: initial experience

Thomas R. Marotta

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Erratum

Thomas R. Marotta

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Physiological remodeling of bifurcation aneurysms: preclinical results of the eCLIPs device

Thomas R. Marotta, Howard A. Riina, Ian McDougall, Donald R. Ricci, and Monika Killer-Oberpfalzer

OBJECTIVE

Intracranial bifurcation aneurysms are complex lesions for which current therapy, including simple coiling, balloon- or stent-assisted coiling, coil retention, or intrasaccular devices, is inadequate. Thromboembolic complications due to a large burden of intraluminal metal, impedance of access to side branches, and a high recurrence rate, due largely to the unmitigated high-pressure flow into the aneurysm (water hammer effect), are among the limitations imposed by current therapy. The authors describe herein a novel device, eCLIPs, and its use in a preclinical laboratory study that suggests the device's design and functional features may overcome many of these limitations.

METHODS

A preclinical model of wide-necked bifurcation aneurysms in rabbits was used to assess functional features and efficacy of aneurysm occlusion by the eCLIPs device.

RESULTS

The eCLIPs device, in bridging the aneurysm neck, allows coil retention, disrupts flow away from the aneurysm, leaves the main vessel and side branches unencumbered by intraluminal metal, and serves as a platform for endothelial growth across the neck, excluding the aneurysm from the circulation.

CONCLUSIONS

The eCLIPs device permits physiological remodeling of the bifurcation.

Open access

Calcium pyrophosphate dihydrate crystal deposition disease and retro-odontoid pseudotumor rupture managed via posterior occipital cervical instrumented fusion: illustrative case

Armaan K. Malhotra, Aayush R. Malhotra, Alexander P. Landry, Arjun Balachandar, William Guest, Aditya Bharatha, Thomas R. Marotta, and Christopher D. Witiw

BACKGROUND

Craniocervical junction and subaxial cervical spinal manifestations of calcium pyrophosphate deposition disease are rarely encountered. The authors presented a severe case of retro-odontoid pseudotumor rupture causing rapid quadriparesis and an acute comatose state with subsequent radiographic and clinical improvement after posterior occipital cervical fusion.

OBSERVATIONS

The authors surveyed the literature and outlined multiple described operative management strategies for compressive cervical and craniocervical junction calcium pyrophosphate deposition disease manifestations ranging from neck pain to paresthesia, weakness, myelopathy, quadriparesis, and cranial neuropathies. In this report, radiographic features of cervical and craniocervical junction calcium pyrophosphate deposition disease were explored. Several previously described surgical strategies were compiled, including patient characteristics and outcomes.

LESSONS

With this case report, the authors presented for the first time an isolated posterior occipital cervical fusion for treatment of a compressive retro-odontoid pseudotumor with rupture into the brainstem. They demonstrated rapid clinical and radiographic resolution after stabilization of cranial cervical junction only 12 weeks postsurgery.

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A novel endovascular clip system for the treatment of intracranial aneurysms: technology, concept, and initial experimental results

Laboratory investigation

Thomas R. Marotta, Thorsteinn Gunnarsson, Ian Penn, Donald R. Ricci, Ian Mcdougall, Alexei Marko, Gyasi Bourne, and Leodante Da Costa

Object

The authors describe a novel device for the endovascular treatment of intracranial aneurysms, the endovascular clip system (eCLIPs). Descriptions of the device and its delivery system as well as the results of flow model tests and the treatment of experimental aneurysms are provided.

Methods

The eCLIPs comprises a flexible hybrid implantable device (an anchor and a covered leaf) and a balloon catheter delivery system, designed to be positioned and activated in the parent vessel in such a way that the covered portion will abut the aneurysm neck. The eCLIPs was subjected to testing in glass, elastomeric, and cadaveric flow models to determine its navigability, orientation, and activation compared with commercially available stents. In a second experiment, 8 carotid artery sidewall aneurysms in swine were treated using eCLIPs. The degree of occlusion was observed on angiography immediately following and 30 days after device activation, and a histological analysis was performed at 30 days.

Results

The device could navigate tortuous glass models and human cadaveric vessels. Compared with commercially available stents, the eCLIPs performed well. It could be navigated, oriented, and activated easily and reliably. With regard to the 8 porcine experimental aneurysms, immediate postactivation angiograms confirmed complete occlusion of 4 lesions and near occlusion of the other 4. Angiographic follow-up at 30 days postactivation showed occlusion of all 8 aneurysms and patency of all parent vessels. Histopathological analysis revealed aneurysm healing, with smooth-muscle cells growing across the lesion neck to allow reendothelialization.

Conclusions

Aneurysm occlusion with a single extrasaccular endovascular device has potential advantages. The authors believe that eCLIPs may prove to be a useful tool in the endovascular treatment of cerebral aneurysms. The system should reduce risks associated with coiling, procedure time, costs, and radiation exposure. The device satisfactorily occluded 8 experimental sidewall aneurysms. The observed healing pattern is similar to that seen after microsurgical clipping.

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Safety of Embolic Materials

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The second-generation eCLIPs Endovascular Clip System: initial experience

Albert H. Chiu, Joost De Vries, Cian J. O'Kelly, Howard Riina, Ian McDougall, Jonathan Tippett, Martina Wan, Airton Leonardo de Oliveira Manoel, and Thomas R. Marotta

OBJECTIVE

Treatment of wide-necked intracranial aneurysms is associated with higher recanalization and complication rates; however, the most commonly used methods are not specifically designed to work in bifurcation lesions. To address these issues, the authors describe the evolution in the design and use of the eCLIPs (Endovascular Clip System) device, a novel hybrid stent-like assist device with flow diverter properties that was first described in 2008.

METHODS

A registry was established covering 13 international centers at which patients were treated with the second-generation eCLIPs device. Aneurysm morphology and rupture status, device neck coverage, coil retention, and procedural and late morbidity and mortality were recorded. For those patients who had undergone successful implantation more than 6 months earlier, the final imaging and clinical follow-up results and need for re-treatment were recorded.

RESULTS

Thirty-three patients were treated between June 2013 and September 2015. Twenty-five (76%) patients had successful placement of an eCLIPs device; 23 (92%) of these 25 patients had complete data. Eight cases of nondeployment occurred during the 1st year of use, consistent with a learning curve; no failures of deployment occurred thereafter. Two periprocedural transient ischemic attacks and 2 asymptomatic thrombotic events occurred. Twenty-one (91%) of 23 patients underwent follow-up at an average of 8 months (range 3–18 months); 9 (42.9%) of these 21 patients demonstrated an improvement in Raymond grade at follow-up; no cases of worsening Raymond grade were recorded, and 17 (81.0%) patients sustained a modified Raymond-Roy Classification class of I or II angiographic result at follow-up. Two delayed ruptures were recorded, both in previously coiled, symptomatic giant aneurysms where the device was used as a part of a salvage strategy.

CONCLUSIONS

The second-generation eCLIPs device is a viable treatment option for bifurcation aneurysms. The aneurysm occlusion rates in this initial clinical series are comparable to the initial experience with other bifurcation support devices.

Free access

Vertebral artery aneurysms and the risk of cord infarction following spinal artery coverage during flow diversion

Adam A. Dmytriw, Anish Kapadia, Alejandro Enriquez-Marulanda, Carmen Parra-Fariñas, Anna Luisa Kühn, Patrick J. Nicholson, Muhammad Waqas, Leonardo Renieri, Caterina Michelozzi, Paul M. Foreman, Kevin Phan, I-Hsiao Yang, Vincent M. Tutino, Christopher S. Ogilvy, Ivan Radovanovic, Mark R. Harrigan, Adnan H. Siddiqui, Elad I. Levy, Nicola Limbucci, Christophe Cognard, Timo Krings, Vitor Mendes Pereira, Ajith J. Thomas, Thomas R. Marotta, and Christoph J. Griessenauer

OBJECTIVE

Coverage of the anterior spinal artery (ASA) ostia is a source of considerable consternation regarding flow diversion (FD) in vertebral artery (VA) aneurysms due to cord supply. The authors sought to assess the association between coverage of the ASA, posterior spinal artery (PSA), or lateral spinal artery (LSA) ostia when placing flow diverters in distal VAs and clinical outcomes, with emphasis on cord infarction.

METHODS

A multicenter retrospective study of 7 institutions in which VA aneurysms were treated with FD between 2011 and 2019 was performed. The authors evaluated the risk of ASA and PSA/LSA occlusion, associated thromboembolic complication, complications overall, aneurysm occlusion status, and functional outcome.

RESULTS

Sixty patients with 63 VA and posterior inferior cerebellar artery aneurysms treated with FD were identified. The median aneurysm diameter was 7 mm and fusiform type was the commonest morphology (42.9%). During a procedure, 1 (61.7%) or 2 (33.3%) flow diverters were placed. Complete occlusion was achieved in 71.9%. Symptomatic thromboembolic complications occurred in 7.4% of cases and intracranial hemorrhage in 10.0% of cases. The ASA and PSA/LSA were identified in 51 (80.9%) and 35 (55.6%) complications and covered by the flow diverter in 29 (56.9%) and 13 (37.1%) of the procedures, respectively. Patency after flow diverter coverage on last follow-up was 89.2% for ASA and 100% for PSA/LSA, not significantly different between covered and noncovered groups (p = 0.5 and p > 0.99, respectively). No complications arose from coverage.

CONCLUSIONS

FD aneurysm treatment in the posterior circulation with coverage of ASA or PSA/LSA was not associated with higher rates of occlusion of these branches or any instances of cord infarction.

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Pipeline embolization of posterior circulation aneurysms: a multicenter study of 131 aneurysms

Christoph J. Griessenauer, Christopher S. Ogilvy, Nimer Adeeb, Adam A. Dmytriw, Paul M. Foreman, Hussain Shallwani, Nicola Limbucci, Salvatore Mangiafico, Ashish Kumar, Caterina Michelozzi, Timo Krings, Vitor Mendes Pereira, Charles C. Matouk, Mark R. Harrigan, Hakeem J. Shakir, Adnan H. Siddiqui, Elad I. Levy, Leonardo Renieri, Thomas R. Marotta, Christophe Cognard, and Ajith J. Thomas

OBJECTIVE

Flow diversion for posterior circulation aneurysms performed using the Pipeline embolization device (PED) constitutes an increasingly common off-label use for otherwise untreatable aneurysms. The safety and efficacy of this treatment modality has not been assessed in a multicenter study.

METHODS

A retrospective review of prospectively maintained databases at 8 academic institutions was performed for the years 2009 to 2016 to identify patients with posterior circulation aneurysms treated with PED placement.

RESULTS

A total of 129 consecutive patients underwent 129 procedures to treat 131 aneurysms; 29 dissecting, 53 fusiform, and 49 saccular lesions were included. At a median follow-up of 11 months, complete and near-complete occlusion was recorded in 78.1%. Dissecting aneurysms had the highest occlusion rate and fusiform the lowest. Major complications were most frequent in fusiform aneurysms, whereas minor complications occurred most commonly in saccular aneurysms. In patients with saccular aneurysms, clopidogrel responders had a lower complication rate than did clopidogrel nonresponders. The majority of dissecting aneurysms were treated in the immediate or acute phase following subarachnoid hemorrhage, a circumstance that contributed to the highest mortality rate in those aneurysms.

CONCLUSIONS

In the largest series to date, fusiform aneurysms were found to have the lowest occlusion rate and the highest frequency of major complications. Dissecting aneurysms, frequently treated in the setting of subarachnoid hemorrhage, occluded most often and had a low complication rate. Saccular aneurysms were associated with predominantly minor complications, particularly in clopidogrel nonresponders.

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Association of preprocedural antiplatelet use with decreased thromboembolic complications for intracranial aneurysms undergoing intrasaccular flow disruption

Jose Danilo Bengzon Diestro, Nimer Adeeb, Basel Musmar, Hamza Salim, Assala Aslan, Nicole M. Cancelliere, Rachel M. McLellan, Oktay Algin, Sherief Ghozy, Sovann V. Lay, Adrien Guenego, Leonardo Renieri, Joseph Carnevale, Guillaume Saliou, Panagiotis Mastorakos, Kareem El Naamani, Eimad Shotar, Kevin Premat, Markus Möhlenbruch, Michael Kral, Joshua D. Bernstock, Omer Doron, Charlotte Chung, Mohamed M. Salem, Ivan Lylyk, Paul M. Foreman, Jay A. Vachhani, Hamza Shaikh, Vedran Župančić, Muhammad U. Hafeez, Joshua Catapano, Muhammad Waqas, Mohamed K. Ibrahim, Marwa A. Mohammed, Cetin Imamoglu, Ahmet Bayrak, James D. Rabinov, Yifan Ren, Clemens M. Schirmer, Mariangela Piano, Anna L. Kühn, Caterina Michelozzi, Stéphanie Elens, Robert M. Starke, Ameer E. Hassan, Mark Ogilvie, Anh Nguyen, Jesse Jones, Waleed Brinjikji, Marie T. Nawka, Marios Psychogios, Christian Ulfert, Bryan Pukenas, Jan-Karl Burkhardt, Thien Huynh, Juan Carlos Martinez-Gutierrez, Muhammed Amir Essibayi, Sunil A. Sheth, Gary Spiegel, Rabih G. Tawk, Boris Lubicz, Pietro Panni, Ajit S. Puri, Guglielmo Pero, Erez Nossek, Eytan Raz, Monika Killer-Oberpfalzer, Christoph J. Griessenauer, Hamed Asadi, Adnan Siddiqui, Allan L. Brook, David Altschul, Julian Spears, Thomas R. Marotta, Andrew F. Ducruet, Felipe C. Albuquerque, Robert W. Regenhardt, Christopher J. Stapleton, Peter Kan, Vladimir Kalousek, Pedro Lylyk, Srikanth Boddu, Jared Knopman, Mohammad A. Aziz-Sultan, Stavropoula I. Tjoumakaris, Pascal M. Jabbour, Frédéric Clarençon, Nicola Limbucci, Hugo H. Cuellar-Saenz, Vitor Mendes Pereira, Aman B. Patel, and Adam A. Dmytriw

OBJECTIVE

This study was conducted to investigate the impact of antiplatelet administration in the periprocedural period on the occurrence of thromboembolic complications (TECs) in patients undergoing treatment using the Woven EndoBridge (WEB) device for intracranial wide-necked bifurcation aneurysms. The primary objective was to assess whether the use of antiplatelets in the pre- and postprocedural phases reduces the likelihood of developing TECs, considering various covariates.

METHODS

A retrospective multicenter observational study was conducted within the WorldWideWEB Consortium and comprised 38 academic centers with endovascular treatment capabilities. Univariable and multivariable logistic regression analyses were performed to determine the association between antiplatelet use and TECs, adjusting for covariates. Missing predictor data were addressed using multiple imputation.

RESULTS

The study comprised two cohorts: one addressing general thromboembolic events and consisting of 1412 patients, among whom 103 experienced TECs, and another focusing on symptomatic thromboembolic events and comprising 1395 patients, of whom 50 experienced symptomatic TECs. Preprocedural antiplatelet use was associated with a reduced likelihood of overall TECs (OR 0.32, 95% CI 0.19–0.53, p < 0.001) and symptomatic TECs (OR 0.49, 95% CI 0.25–0.95, p = 0.036), whereas postprocedural antiplatelet use showed no significant association with TECs. The study also revealed additional predictors of TECs, including stent use (overall: OR 4.96, 95% CI 2.38–10.3, p < 0.001; symptomatic: OR 3.24, 95% CI 1.26–8.36, p = 0.015), WEB single-layer sphere (SLS) type (overall: OR 0.18, 95% CI 0.04–0.74, p = 0.017), and posterior circulation aneurysm location (symptomatic: OR 18.43, 95% CI 1.48–230, p = 0.024).

CONCLUSIONS

The findings of this study suggest that the preprocedural administration of antiplatelets is associated with a reduced likelihood of TECs in patients undergoing treatment with the WEB device for wide-necked bifurcation aneurysms. However, postprocedural antiplatelet use did not show a significant impact on TEC occurrence.