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Prospective study on embolization of intracranial aneurysms with the pipeline device: the PREMIER study 1 year results
Hanel, Ricardo A; Kallmes, David F; Lopes, Demetrius Klee; Nelson, Peter Kim; Siddiqui, Adnan; Jabbour, Pascal; Pereira, Vitor M; Szikora István, Istvan; Zaidat, Osama O; Bettegowda, Chetan; Colby, Geoffrey P; Mokin, Maxim; Schirmer, Clemens; Hellinger, Frank R; Given Ii, Curtis; Krings, Timo; Taussky, Philipp; Toth, Gabor; Fraser, Justin F; Chen, Michael; Priest, Ryan; Kan, Peter; Fiorella, David; Frei, Don; Aagaard-Kienitz, Beverly; Diaz, Orlando; Malek, Adel M; Cawley, C Michael; Puri, Ajit S
BACKGROUND:Preliminary clinical studies on the safety and efficacy of the pipeline embolization device (PED) for the treatment of small/medium aneurysms have demonstrated high occlusion rates with low complications. OBJECTIVE:To evaluate the safety and effectiveness of the PED for treatment of wide necked small and medium intracranial aneurysms. METHODS:PREMIER is a prospective, multicenter, single arm trial. Patients were treated with the PED for unruptured wide necked aneurysms, measuring ≤12 mm along the internal carotid artery or vertebral artery, between July 2014 and November 2015. At 1 year post-procedure, the primary effectiveness endpoint was complete occlusion (Raymond grade 1) without major parent vessel stenosis (≤50%) or retreatment, and the primary safety endpoint was major stroke in the territory supplied by the treated artery or neurologic death. RESULTS:A total of 141 patients were treated with PEDs (mean age 54.6±11.3 years, 87.9% (124/141) women). Mean aneurysm size was 5.0±1.92 mm, and 84.4% (119/141) measured <7 mm. PED placement was successful in 99.3% (140/141) of patients. Mean number of PEDs implanted per patient was 1.1±0.26; a single PED was used in 92.9% (131/141) of patients. At 1 year, 97.9% (138/141) of patients underwent follow-up angiography with 76.8% (106/138) of patients having met the study's primary effectiveness endpoint. The combined major morbidity and mortality rate was 2.1% (3/140). CONCLUSIONS:Treatment of wide necked small/medium aneurysms with the PED results in high rates of complete occlusion without significant parent vessel stenosis and low rates of permanent neurologic complications. TRIAL REGISTRATION/BACKGROUND:NCT02186561.
PMID: 31308197
ISSN: 1759-8486
CID: 3977722
Endovascular Reconstruction of Intracranial Aneurysms with the Pipeline Embolization Device in Pediatric Patients: A Single-Center Series
Shirani, Peyman; Mirbagheri, Saeedeh; Shapiro, Maksim; Raz, Eytan; Mowla, Ashkan; Semsarieh, Bita; Riina, Howard A; Nelson, Peter K
Background/UNASSIGNED:Pediatric intracranial aneurysms tend to differ in etiology, size, and location from their adult counterparts, and they are often less amenable to microsurgical clip reconstruction techniques. Endovascular treatment with detachable coils is an accepted treatment technique for pediatric patients, though high recurrence rates have been reported with coil embolization of large and giant aneurysms in this population. While the Pipeline Embolization Device (PED) is FDA-approved for adult intracranial aneurysms, the use of PEDs in pediatric patients is considered off-label. Case Descriptions/UNASSIGNED:We present 3 cases of pediatric intracranial aneurysms in a 5-year-old male, a 12-year-old male, and a 12-year-old female who presented with symptoms including seizure, headache, and blurred vision. The 2 male patients were found to have intradural vertebral artery saccular aneurysms, while the female patient had a paraophthalmic right internal carotid complex aneurysm. After endovascular reconstruction of the aneurysms with PEDs, follow-up angiography showed complete occlusion of the previous aneurysms with no residual aneurysm filling in all 3 cases. Conclusion/UNASSIGNED:While further investigation is needed, the evidence presented here supports the conclusion that the PED can be an effective and viable treatment strategy in the pediatric population.
PMCID:7253861
PMID: 32508891
ISSN: 1664-9737
CID: 4474242
Radial Artery Access for Treatment of Posterior Circulation Aneurysms Using the Pipeline Embolization Device: Case Series
Raz, Eytan; Shapiro, Maksim; Buciuc, Razvan; Nelson, Peter Kim; Nossek, Erez
BACKGROUND:The treatment of selected wide-neck and fusiform posterior circulation aneurysms is challenging for clipping as well as for endovascular route. OBJECTIVE:To describe an endovascular approach for vertebral artery aneurysm treatment using transradial access (TRA) instead of the conventional transfemoral access. METHODS:We collected cases from two institutions in which TRA was used for posterior circulation Pipeline Embolization Device (Medtronic, Dublin, Ireland) deployment. RESULTS:A total of four patients were treated. TRA was useful in the setting of extreme vessel tortuosity. We utilized 5F Terumo Glidesheath (Terumo Medical, Somerset, New Jersey), intermediate catheter, and a 027 microcatheter for Pipeline deployment. TRA was not associated with any access or deployment difficulties. CONCLUSIONS:Early experience suggests that TRA for Pipeline Embolization Device placement for posterior circulation aneurysm is a safe and efficient alternative to standard transfemoral access. While this approach was initially applied to patients with vascular anatomy that may not allow for safe femoral access or navigation, experience so far argues for considering a radial approach towards some posterior circulation aneurysm treatment.
PMID: 30668769
ISSN: 2332-4260
CID: 3610522
MR-based protocol for metabolically-based evaluation of tissue viability during recanalization therapy: Initial experience [Meeting Abstract]
Boada, F E; Qian, Y; Baete, S; Raz, E; Shapiro, M; Nelson, P K; Ishida, K
Objectives: To demonstrate the development and use of an acute imaging protocol for the metabolic assessment of tissue viability during acute stroke.
Method(s): The DAWN and DEFUSE 3 trials (1,2) have demonstrated that there is much to gain from the use of physiologically based guidelines to extend the use of mechanical recanalization. Literature reports provide strong data supporting the use of brain tissue sodium concentration (TSC) as a biomarker for identifying physiologically non-viable tissue during evolving brain ischemia (3,4). Testing this hypothesis in vivo, in humans, have been previously hampered by acquisition times that were long for routine clinical use. Recent developments in MRI data acquisition and hardware make it possible to acquire the data to provide the aforementioned assessment in under 5 minutes at a level of signal-to-noise ratio (SNR) and spatial resolution compatible with physiologically driven MRI scans such as diffusion weighted imaging and perfusion imaging. This was achieved using an Ultra-Short-Echo Time sequence with optimal acquisition throughput (TPI, TE/TR 0.3/100 ms, p 0.2). Signal excitation/reception was performed using a patient-friendly double-tuned (1H/23Na) birdcage coil (Quality Electrodynamics Inc., Mayfield Heights, Ohio). The protocol was implemented on a MAGNETOM Skyra 3 Tesla scanner at NYU's Tisch hospital. The scanner is located adjacent (20 feet) to the neuro interventional suite where patients are recanalized. Subject's anesthesia was maintained (FabiusMRI, DraegerInc., Telford, PA) and physiological status continuously monitored using MRI-compatible equipment (Expression MR400, Phillips Healthcare, Andover, MA).
Result(s): After phantom validation and healthy volunteer studies to determine the quantitative performance of the data acquisition techniques the protocol was used on post-endovascular thrombectomy subjects (n 3), immediately upon procedure completion and under its own IRB approved protocol. During these studies, the use of the proposed methodology was found to be compatible with the clinical care of the subjects. Specifically, performing the required scans was not found to interfere with the subject's post-recanalization care. Tissue sodium concentration data were, likewise, found to meet the required levels of SNR to provide the quantitative assessment mentioned above. A representative data set from one of these sessions is shown in figure 1. This mechanically-recanalized patient had an area of non-salvaged tissue in the left parietal lobe that is clearly depicted on the 23Na MRI scan. The TSC in this area was 76 mM at the time of the scan. (Figure presented)
Conclusion(s): This work demonstrates that state-of-the-art MRI methodology can be used to provide a clinically viable imaging protocol for evaluating the use of sodium MRI as a quantitative biomarker for identifying physiologically viable tissue during evolving brain ischemia
EMBASE:629097757
ISSN: 1559-7016
CID: 4070532
Multicenter Study of Pipeline Flex for Intracranial Aneurysms
Brasiliense, Leonardo B C; Aguilar-Salinas, Pedro; Lopes, Demetrius K; Nogueira, Danilo; DeSousa, Keith; Nelson, Peter K; Moran, Christopher J; Mazur, Marcus D; Taussky, Philipp; Park, Min S; Dabus, Guilherme; Linfante, Italo; Chaudry, Imran; Turner, Ray D; Spiotta, Alex M; Turk, Aquilla S; Siddiqui, Adnan H; Levy, Elad I; Hopkins, L Nelson; Arthur, Adam S; Nickele, Christopher; Gonsales, Douglas; Sauvageau, Eric; Hanel, Ricardo A
Background/UNASSIGNED:The Pipeline Flex (PED Flex; Medtronic, Dublin, Ireland) was designed to facilitate deployment and navigation compared to its previous iteration to reduce the rate of technical events and complications. OBJECTIVE:To assess the neurological morbidity and mortality rates of the PED Flex at 30 d. Methods/UNASSIGNED:Information from 9 neurovascular centers was retrospectively obtained between July 2014 and March 2016. Data included patient/aneurysm characteristics, periprocedural events, clinical, and angiographic outcomes. Multivariate logistic regression was performed to determine predictors of unfavorable clinical outcome (modified Rankin Scale [mRS]Â >Â 2). Results/UNASSIGNED:A total of 205 patients harboring 223 aneurysms were analyzed. The 30-d neurological morbidity and mortality rates were 1.9% (4/205) and 0.5% (1/205), respectively. The rate of intraprocedural events without neurological morbidity was 6.8% (14/205), consisting of intraprocedural ischemic events in 9 patients (4.5%) and hemorrhage in 5 (2.4%). Other technical events included difficulty capturing the delivery wire in 1 case (0.5%) and device migration after deployment in another case (0.5%). Favorable clinical outcome (mRS 0-2) was achieved in 186 patients (94.4%) at discharge and in 140 patients (94.5%) at 30 d. We did not find predictors of clinical outcomes on multivariate analysis. Conclusion/UNASSIGNED:The 30-d rates of neurological morbidity and mortality in this multicenter cohort using the PED Flex for the treatment of intracranial aneurysms were low, 1.9% (4/205) and 0.5% (1/205), respectively. In addition, technical events related to device deployment were also low, most likely due to the latest modifications in the delivery system.
PMID: 30239959
ISSN: 1524-4040
CID: 3301872
Spinal dural fistula and anterior spinal artery supply from the same segmental artery: Case report of volumetric T2 MRI diagnosis and rational endovascular treatment
Shapiro, Maksim; Kister, Ilya; Raz, Eytan; Loh, John; Young, Matthew; Goldman-Yassen, Adam; Chancellor, Breehan; Nelson, Peter Kim
Spinal dural fistulas (SDAVFs) occasionally arise from the same segmental artery as the radiculomedullary branch to the anterior spinal artery. In such cases, selective fistula embolization that does not endanger the anterior spinal artery is not possible, and surgical fistula disconnection is recommended. We present an exceptional case in which rational embolization strategy of SDAVF was feasible because of separate origins from a common segmental artery pedicle of the ventral radiculomedullary artery and the dorsal radicular artery branch supplying the fistula.
PMID: 31072249
ISSN: 2385-2011
CID: 3885202
Balloon-assisted tracking technique to overcome intracranial stenosis during thrombectomy for stroke
Burkhardt, Jan-Karl; Shapiro, Maksim; Tanweer, Omar; Litao, Miguel; Chancellor, Breehan; Raz, Eytan; Riina, Howard A; Nelson, Peter Kim
Anatomical vessel obstacles such as an intracranial stenosis in stroke are challenging and may lead to delayed clot access for thrombectomy. We describe a simple and effective technique to overcome the step-off between the intermediate catheter and an intracranial vessel stenosis during thrombectomy. The patient presented with acute embolic left middle cerebral artery occlusion and a favorable penumbral pattern. Clot access was made challenging by focal stenosis in the ipsilateral cavernous segment. The balloon-assisted tracking technique was effective in traversing the step-off to enable TICI 3 aspiration thrombectomy. This simple and effective technique should be kept in mind during stroke procedures where a proximal stenotic obstacle complicates access to the site of occlusion.
PMID: 30580285
ISSN: 1759-8486
CID: 3680242
Infection risk in endovascular neurointerventions: a comparative analysis of 549 cases with and without prophylactic antibiotic use
Burkhardt, Jan-Karl; Tanweer, Omar; Litao, Miguel; Sharma, Pankaj; Raz, Eytan; Shapiro, Maksim; Nelson, Peter Kim; Riina, Howard A
OBJECTIVEA systematic analysis on the utility of prophylactic antibiotics for neuroendovascular procedures has not been performed. At the authors' institution there is a unique setup to address this question, with some attending physicians using prophylactic antibiotics (cefazolin or vancomycin) for all of their neurointerventions while others generally do not.METHODSThe authors performed a retrospective review of the last 549 neurointerventional procedures in 484 patients at Tisch Hospital, NYU Langone Medical Center. Clinical and radiological data were collected for analysis, including presence of prophylactic antibiotic use, local or systemic infection, infection laboratory values, and treatment. Overall, 306 aneurysms, 117 arteriovenous malformations/arteriovenous fistulas, 86 tumors, and 40 vessel stenosis/dissections were treated with coiling (n = 109), Pipeline embolization device (n = 197), embolization (n = 203), or stenting (n = 40).RESULTSAntibiotic prophylaxis was used in 265 of 549 cases (48%). There was no significant difference between patients with or without antibiotic prophylaxis in sex (p = 0.48), presence of multiple interventions (p = 0.67), diseases treated (p = 0.11), or intervention device placed (p = 0.55). The mean age of patients in the antibiotic prophylaxis group (53.4 years) was significantly lower than that of the patients without prophylaxis (57.1 years; p = 0.014). Two mild local groin infections (0.36%) and no systemic infections (0%) were identified in this cohort, with one case in each group (1/265 [0.38%] vs 1/284 [0.35%]). Both patients recovered completely with local drainage (n = 1) and oral antibiotic treatment (n = 1).CONCLUSIONSThe risk of infection associated with endovascular neurointerventions with or without prophylactic antibiotic use was very low in this cohort. The data suggest that the routine use of antibiotic prophylaxis seems unnecessary and that to prevent antibiotic resistance and reduce costs antibiotic prophylaxis should be reserved for selected patients deemed to be at increased infection risk.
PMID: 30738405
ISSN: 1933-0693
CID: 3632542
Indication and technique for using the Pipeline embolization device to treat intracranial aneurysms [Editorial]
Burkhardt, J -K; Tanweer, O; Nelson, P K; Riina, H A
EMBASE:2001869501
ISSN: 0022-3085
CID: 3833902
Balloon-assisted tracking technique to overcome intracranial stenosis during thrombectomy for stroke
Burkhardt, Jan-Karl; Shapiro, Maksim; Tanweer, Omar; Litao, Miguel; Chancellor, Breehan; Raz, Eytan; Riina, Howard A; Nelson, Peter Kim
Anatomical vessel obstacles such as an intracranial stenosis in stroke are challenging and may lead to delayed clot access for thrombectomy. We describe a simple and effective technique to overcome the step-off between the intermediate catheter and an intracranial vessel stenosis during thrombectomy. The patient presented with acute embolic left middle cerebral artery occlusion and a favorable penumbral pattern. Clot access was made challenging by focal stenosis in the ipsilateral cavernous segment. The balloon-assisted tracking technique was effective in traversing the step-off to enable TICI 3 aspiration thrombectomy. This simple and effective technique should be kept in mind during stroke procedures where a proximal stenotic obstacle complicates access to the site of occlusion.
PMID: 30567225
ISSN: 1757-790x
CID: 3556662