Otavio Frederico De Toledo
Current Organizations / Institutes
The organizations/institutes from the scholar's latest article
Research Subjects
Otavio Frederico De Toledo has a total of 102 co-authors. Here are the top co-authors by number of shared publications:
- Ricardo A. Hanel
Neurosurgery, Baptist Medical Center Jacksonville, Jacksonville, Florida, USA
12 shared publications - Salvador F. Gutierrez-Aguirre
Lyerly Neurosurgery, Baptist Medical Center Downtown, Jacksonville, Florida, USA
11 shared publications - Amin Aghaebrahim
Neurological Institute, Lyerley Neurosurgery, Baptist Medical Center Jacksonville, Jacksonville, Florida, USA
7 shared publications Eric Sauvageau
Lyerly Neurosurgery
5 shared publications- Eric Sauvageau
Lyerly Neurosurgery, Baptist Medical Center Downtown, Jacksonville, Florida, USA
5 shared publications Amin Aghaebrahim
Lyerly Neurosurgery
4 shared publications
Latest Publications
- 3 December 2025
- Published by BMJ in Journal of NeuroInterventional Surgery
- Vol. 18 (11) , 2153-2159
Delayed aneurysm rupture after flow-diverter deployment in unruptured aneurysms: a systematic review and meta-analysis
Background: Delayed aneurysm rupture (DAR) is a potentially devastating complication after flow-diverters (FD) deployment and their exact mechanisms are still unclear. The purpose of this meta-analysis is to synthesize the latest evidence on DAR after FD treatment and identify predictive factors. Methods: A systematic review and meta-analysis were conducted according to established protocols. Searches were conducted in PubMed, Scopus, Web of Science, and Embase databases up to June 2024 using variations of “aneurysm “and “delayed aneurysm rupture” terms. Original studies reporting DAR and including more than five patients were included. All analyses were conducted in R software (version 4.4.2), employing the “meta” and “tableone” packages. Results: 64 studies with 9820 patients were included, large aneurysm size (OR=1.08, 95% CI (1.02, 1.14), P value=0.008), intra-aneurysmal thrombus (OR=1.05, 95% CI (1.01, 1.09), P value=0.010) and posterior circulation location (OR=1.02, 95% CI (1.00, 1.04), P value=0.014) were significant risk factors for DAR. The pooled prevalence of DAR was 1.40%, with a rate of 1.18% after removing outliers. DAR occurred within 30 days in 66.7% of cases, with a mortality rate of 73.3% at discharge. Conclusion: DAR following flow diversion treatment is an uncommon but devastating complication and remains a limitation of the technique. It is influenced by factors such as large aneurysm size, intra-aneurysmal thrombosis, and posterior circulation involvement. The first 30 days post-procedure represent a particularly high-risk period. Despite advancements in FD technology, significant gaps remain, highlighting the need for further research to improve risk assessment and treatment strategies.
- 3 December 2025
- Published by BMJ in Journal of NeuroInterventional Surgery
- Vol. 18 (11) , 2153-2159
Delayed aneurysm rupture after flow-diverter deployment in unruptured aneurysms: a systematic review and meta-analysis
Background: Delayed aneurysm rupture (DAR) is a potentially devastating complication after flow-diverters (FD) deployment and their exact mechanisms are still unclear. The purpose of this meta-analysis is to synthesize the latest evidence on DAR after FD treatment and identify predictive factors. Methods: A systematic review and meta-analysis were conducted according to established protocols. Searches were conducted in PubMed, Scopus, Web of Science, and Embase databases up to June 2024 using variations of “aneurysm “and “delayed aneurysm rupture” terms. Original studies reporting DAR and including more than five patients were included. All analyses were conducted in R software (version 4.4.2), employing the “meta” and “tableone” packages. Results: 64 studies with 9820 patients were included, large aneurysm size (OR=1.08, 95% CI (1.02, 1.14), P value=0.008), intra-aneurysmal thrombus (OR=1.05, 95% CI (1.01, 1.09), P value=0.010) and posterior circulation location (OR=1.02, 95% CI (1.00, 1.04), P value=0.014) were significant risk factors for DAR. The pooled prevalence of DAR was 1.40%, with a rate of 1.18% after removing outliers. DAR occurred within 30 days in 66.7% of cases, with a mortality rate of 73.3% at discharge. Conclusion: DAR following flow diversion treatment is an uncommon but devastating complication and remains a limitation of the technique. It is influenced by factors such as large aneurysm size, intra-aneurysmal thrombosis, and posterior circulation involvement. The first 30 days post-procedure represent a particularly high-risk period. Despite advancements in FD technology, significant gaps remain, highlighting the need for further research to improve risk assessment and treatment strategies.
- 15 July 2025
- Published by SAGE Publications in The Neurohospitalist
- Vol. 16 (1) , 28-35
Clot Migration after Tenecteplase (TNK): A Potential Cause of Neurological Deterioration in Stroke Patients
Background: Tenecteplase (TNK) has been increasingly adopted as an alternative to alteplase (tPA) for ischemic stroke due to its ease of administration and pharmacologic advantages. However, recent studies suggest TNK may be associated with a higher incidence of clot migration, potentially contributing to early neurologic deterioration. Objective: To describe the incidence and clinical impact of clot migration following TNK administration in acute ischemic stroke patients. Methods: We retrospectively reviewed consecutive patients treated with TNK at our Comprehensive Stroke Center between May and August 2023. Clot migration was defined as a change in thrombus position without full distal reperfusion. Neurologic deterioration was defined as an NIHSS increase ≥4 or new-onset deficit. All patients underwent pre- and post-TNK vascular imaging. Results: Among 53 patients treated with TNK, 12 (22.6%) experienced neurological deterioration. Clot migration was identified in 4 patients (8.3%) among those with confirmed vessel occlusion on baseline imaging (n = 48). All exhibited new occlusions in anatomically compatible sites and clinical worsening shortly after TNK. One patient required mechanical thrombectomy; the remaining 3 had distal occlusions or low NIHSS scores. At discharge, two patients had good outcomes (mRS ≤2), and two had poor outcomes (mRS >2). Conclusion: Clot migration may contribute to early neurologic deterioration following TNK, particularly in posterior circulation strokes. Outcomes appear to depend on final clot location and clinical severity. As TNK becomes more widely used, increased awareness and early vascular imaging are critical for recognizing this phenomenon and guiding management.
- 15 July 2025
- Published by SAGE Publications in The Neurohospitalist
- Vol. 16 (1) , 28-35
Clot Migration after Tenecteplase (TNK): A Potential Cause of Neurological Deterioration in Stroke Patients
Background: Tenecteplase (TNK) has been increasingly adopted as an alternative to alteplase (tPA) for ischemic stroke due to its ease of administration and pharmacologic advantages. However, recent studies suggest TNK may be associated with a higher incidence of clot migration, potentially contributing to early neurologic deterioration. Objective: To describe the incidence and clinical impact of clot migration following TNK administration in acute ischemic stroke patients. Methods: We retrospectively reviewed consecutive patients treated with TNK at our Comprehensive Stroke Center between May and August 2023. Clot migration was defined as a change in thrombus position without full distal reperfusion. Neurologic deterioration was defined as an NIHSS increase ≥4 or new-onset deficit. All patients underwent pre- and post-TNK vascular imaging. Results: Among 53 patients treated with TNK, 12 (22.6%) experienced neurological deterioration. Clot migration was identified in 4 patients (8.3%) among those with confirmed vessel occlusion on baseline imaging (n = 48). All exhibited new occlusions in anatomically compatible sites and clinical worsening shortly after TNK. One patient required mechanical thrombectomy; the remaining 3 had distal occlusions or low NIHSS scores. At discharge, two patients had good outcomes (mRS ≤2), and two had poor outcomes (mRS >2). Conclusion: Clot migration may contribute to early neurologic deterioration following TNK, particularly in posterior circulation strokes. Outcomes appear to depend on final clot location and clinical severity. As TNK becomes more widely used, increased awareness and early vascular imaging are critical for recognizing this phenomenon and guiding management.
- Open Access
- 10 July 2025
- Published by Wolters Kluwer Health in Neurosurgery
- Vol. 98 (2) , 464-473
The Silk Vista Baby Study: A Multicenter Aneurysm Report From North America and Europe
BACKGROUND AND OBJECTIVES: The Silk Vista Baby (SVB) flow diverter (FD) stent (Balt SAS) is the first device designed for treating distally located brain aneurysms. It can be delivered through a 0.017-inch ID microcatheter, enabling access to small, distal vessels. The aim of this study was to evaluate the effectiveness, safety, technical success, occlusion rate, and clinical outcomes of the SVB device. METHODS: This retrospective, multicenter study included data from 18 centers from November 2023 to September 2024. Procedures were performed by experienced neurointerventionalists following institutional standards of care. Outcomes analyzed included effectiveness, safety, and aneurysm occlusion rates. Descriptive analyses and Pearson χ 2 or Independent t -Test were used for statistical evaluation. RESULTS: A total of 95 patients, mean age 55.4 years, were included. A total of 31% of aneurysms were ruptured at admission. Most (58.3%) were located in the anterior circulation, and 45% had previous treatment, mainly coiling (69.4%). Complication rates were higher for ruptured aneurysms (24.1%) compared with unruptured ones (9.2%). Two deaths occurred, 1 (1.1%) related to the procedure. At discharge, 87% of patients had modified Rankin Scale ≤2. The latest follow-up showed overall complete/near-complete occlusion rates of 76.1%, with 81.14% for ruptured and 73.43% for unruptured aneurysms. Technical success was higher in unruptured cases (100% vs 93.1%). CONCLUSION: Our case series demonstrated the efficacy of the SVB with a high rate of technical success. The occlusion rates for ruptured cases are comparable with those of other FDs. However, the rates are lower for unruptured cases. This discrepancy is likely due to the characteristics of the aneurysms, particularly in the presence of side branches in bifurcation lesions. The SVB safety profile is similar to other FDs in unruptured cases, while the ruptured group presented more complications.
- 10 July 2025
- Published by Wolters Kluwer Health in Neurosurgery
- Vol. 98 (2) , 464-473
Open AccessThe Silk Vista Baby Study: A Multicenter Aneurysm Report From North America and Europe
BACKGROUND AND OBJECTIVES: The Silk Vista Baby (SVB) flow diverter (FD) stent (Balt SAS) is the first device designed for treating distally located brain aneurysms. It can be delivered through a 0.017-inch ID microcatheter, enabling access to small, distal vessels. The aim of this study was to evaluate the effectiveness, safety, technical success, occlusion rate, and clinical outcomes of the SVB device. METHODS: This retrospective, multicenter study included data from 18 centers from November 2023 to September 2024. Procedures were performed by experienced neurointerventionalists following institutional standards of care. Outcomes analyzed included effectiveness, safety, and aneurysm occlusion rates. Descriptive analyses and Pearson χ 2 or Independent t -Test were used for statistical evaluation. RESULTS: A total of 95 patients, mean age 55.4 years, were included. A total of 31% of aneurysms were ruptured at admission. Most (58.3%) were located in the anterior circulation, and 45% had previous treatment, mainly coiling (69.4%). Complication rates were higher for ruptured aneurysms (24.1%) compared with unruptured ones (9.2%). Two deaths occurred, 1 (1.1%) related to the procedure. At discharge, 87% of patients had modified Rankin Scale ≤2. The latest follow-up showed overall complete/near-complete occlusion rates of 76.1%, with 81.14% for ruptured and 73.43% for unruptured aneurysms. Technical success was higher in unruptured cases (100% vs 93.1%). CONCLUSION: Our case series demonstrated the efficacy of the SVB with a high rate of technical success. The occlusion rates for ruptured cases are comparable with those of other FDs. However, the rates are lower for unruptured cases. This discrepancy is likely due to the characteristics of the aneurysms, particularly in the presence of side branches in bifurcation lesions. The SVB safety profile is similar to other FDs in unruptured cases, while the ruptured group presented more complications.
- 2 June 2025
- Published by BMJ in Journal of NeuroInterventional Surgery
- Vol. 18 (4) , 1113-1118
Use of new aspiration thrombectomy delivery catheter: a multicenter experience
Background and objectives: Large-bore aspiration catheters have demonstrated better recanalization times and higher first-pass effects in large vessel occlusions. However, vessel tortuosity and branching vessels can hinder navigability, potentially increasing the ‘ledge effect’, procedural times, and the risk of vessel injury. Recently, a newly designed delivery catheter (Carrier Delivery Catheter (CDC), Balt, France) has been introduced to the US market. This paper aims to report our combined experience with this catheter in a real-life clinical setting. Methods: This is a retrospective, multicenter study based on a prospectively maintained database of patients with ischemic stroke who underwent mechanical thrombectomy between February 2024 and January 2025. All consecutive patients who underwent mechanical thrombectomy in which a CDC was used were included. Results: A total of 43 patients from three centers in the USA were included. The mean age was 69.74 years, and most of the patients were male (60.5%). The CDC delivered the aspiration catheter to the clot in all cases. The mean National Institutes of Health Stroke Scale (NIHSS) score was 18, and the mean time between puncture to clot access was 18.14 min. No vessel dissection or perforation was reported, and 4.6% of symptomatic hemorrhagic complications were reported. None of the complications were adjudicated to be directly related to the use of the Carrier. Conclusion: Our case series shows that the CDC is a useful and reliable tool as a delivery catheter for treating vessel occlusions in both the anterior and posterior circulation. This study serves as proof of concept and may provide a foundation for future prospective analyses of this innovative delivery system.
- 2 June 2025
- Published by BMJ in Journal of NeuroInterventional Surgery
- Vol. 18 (4) , 1113-1118
Use of new aspiration thrombectomy delivery catheter: a multicenter experience
Background and objectives: Large-bore aspiration catheters have demonstrated better recanalization times and higher first-pass effects in large vessel occlusions. However, vessel tortuosity and branching vessels can hinder navigability, potentially increasing the ‘ledge effect’, procedural times, and the risk of vessel injury. Recently, a newly designed delivery catheter (Carrier Delivery Catheter (CDC), Balt, France) has been introduced to the US market. This paper aims to report our combined experience with this catheter in a real-life clinical setting. Methods: This is a retrospective, multicenter study based on a prospectively maintained database of patients with ischemic stroke who underwent mechanical thrombectomy between February 2024 and January 2025. All consecutive patients who underwent mechanical thrombectomy in which a CDC was used were included. Results: A total of 43 patients from three centers in the USA were included. The mean age was 69.74 years, and most of the patients were male (60.5%). The CDC delivered the aspiration catheter to the clot in all cases. The mean National Institutes of Health Stroke Scale (NIHSS) score was 18, and the mean time between puncture to clot access was 18.14 min. No vessel dissection or perforation was reported, and 4.6% of symptomatic hemorrhagic complications were reported. None of the complications were adjudicated to be directly related to the use of the Carrier. Conclusion: Our case series shows that the CDC is a useful and reliable tool as a delivery catheter for treating vessel occlusions in both the anterior and posterior circulation. This study serves as proof of concept and may provide a foundation for future prospective analyses of this innovative delivery system.
- 3 January 2025
- Published by BMJ in Journal of NeuroInterventional Surgery
- Vol. 18 (8) , 1838
Artisse intrasaccular device for intracranial aneurysm treatment: a technical video case
The Artisse intrasaccular device (Medtronic) offers a novel treatment option for unruptured and ruptured wide-neck bifurcating intracranial aneurysms.1 2The Artisse device features enhancements including a distal tip for dome protection, platinum band markers for improved visibility, and a bilayer high-density platinum core nitinol mesh basket for enhanced flexibility and visibility when compared with previous devices.2–7 Data from case series demonstrate the procedural safety and efficacy of the Artisse device.1 2 This versatile flared-shape intrasaccular device can be used alongside products such as the Rebar microcatheter 18 and Navien.2 In Europe, an adequate occlusion rate of 78% at 12 months and 79.2% at 36 months follow-up has been shown.3 8 This video documents the embolization of a wide-neck unruptured anterior communicating artery aneurysm using the Artisse device, where Sim&Size was used for proper sizing (video 1).4 9 The procedure was uneventful, achieving successful device deployment with no parent vessel compromise. Video 1 Artisse intrasaccular device for intracranial aneurysm treatment—first in the USA:
- 3 January 2025
- Published by BMJ in Journal of NeuroInterventional Surgery
- Vol. 18 (8) , 1838
Artisse intrasaccular device for intracranial aneurysm treatment: a technical video case
The Artisse intrasaccular device (Medtronic) offers a novel treatment option for unruptured and ruptured wide-neck bifurcating intracranial aneurysms.1 2The Artisse device features enhancements including a distal tip for dome protection, platinum band markers for improved visibility, and a bilayer high-density platinum core nitinol mesh basket for enhanced flexibility and visibility when compared with previous devices.2–7 Data from case series demonstrate the procedural safety and efficacy of the Artisse device.1 2 This versatile flared-shape intrasaccular device can be used alongside products such as the Rebar microcatheter 18 and Navien.2 In Europe, an adequate occlusion rate of 78% at 12 months and 79.2% at 36 months follow-up has been shown.3 8 This video documents the embolization of a wide-neck unruptured anterior communicating artery aneurysm using the Artisse device, where Sim&Size was used for proper sizing (video 1).4 9 The procedure was uneventful, achieving successful device deployment with no parent vessel compromise. Video 1 Artisse intrasaccular device for intracranial aneurysm treatment—first in the USA:
- Open Access
- 1 October 2024
- Published by Oxford University Press (OUP) in Journal of Surgical Case Reports
- Vol. 2024 (10) , rjae585
Recurrent syncope during mastication
Steal syndrome is characterized by the disruption of blood flow from specific vascular territories due to perfusion via collateral vessels bypassing an obstructed artery segment. In the neurovascular setting, this can lead to entities such as subclavian steal syndrome or the less prevalent double steal phenomenon, primarily associated with atherosclerosis. We present a case of an early 80s patient with cerebrovascular insufficiency who exhibited neurological deficits during mastication. The angiographic evaluation showed occlusion at the origins of the left common carotid and of the brachiocephalic trunk. This configuration caused the left vertebral artery to be the only vessel filling anterograde. The flow in the right vertebral artery is retrograde, filling the subclavian and the right common carotid artery. Endovascular revascularization of the brachiocephalic trunk was successfully performed using a Gore Viabahn VBX Balloon Expandable Stent (W.L. Gore & Associates, Flagstaff, AZ, USA), leading to symptom resolution.
- 1 October 2024
- Published by Oxford University Press (OUP) in Journal of Surgical Case Reports
- Vol. 2024 (10) , rjae585
Open AccessRecurrent syncope during mastication
Steal syndrome is characterized by the disruption of blood flow from specific vascular territories due to perfusion via collateral vessels bypassing an obstructed artery segment. In the neurovascular setting, this can lead to entities such as subclavian steal syndrome or the less prevalent double steal phenomenon, primarily associated with atherosclerosis. We present a case of an early 80s patient with cerebrovascular insufficiency who exhibited neurological deficits during mastication. The angiographic evaluation showed occlusion at the origins of the left common carotid and of the brachiocephalic trunk. This configuration caused the left vertebral artery to be the only vessel filling anterograde. The flow in the right vertebral artery is retrograde, filling the subclavian and the right common carotid artery. Endovascular revascularization of the brachiocephalic trunk was successfully performed using a Gore Viabahn VBX Balloon Expandable Stent (W.L. Gore & Associates, Flagstaff, AZ, USA), leading to symptom resolution.
- 1 October 2024
- Published by BMJ in Journal of NeuroInterventional Surgery
- Vol. 17 (12) , 1362-1367
Braids and beyond: a comprehensive study on pipeline device braid stability from PREMIER data
Background The pipeline embolization device (PED) has been increasingly used to treat brain aneurysms; however, concerns have been raised about braid stability with newer drawn filled tubing technology devices. Objective To evaluate braid stability of PED early generations using data from the PREMIER trial. Methods All consecutive intracranial aneurysms treated with PED (Classic and Flex) within the PREMIER trial were reviewed for braid stability (fish mouthing, foreshortening, braid bump, braid collapsing). Immediate postprocedure cone-beam CT and angiography were compared with 1- and 2- years' follow-up. Analyses included safety, measured with the modified Rankin Scale (mRS) score, including +1 mRS point and a good clinical outcome (mRS score 0–2), vessel stenosis ≥50%, effectiveness measured with Raymond-Roy Scale, and re-treatment rates. Results 133/141 aneurysms had a complete dataset. 8/133 (6%) aneurysms showed braid deformations. Inter-reader agreement was excellent (κ=0.83). Braid deformations were statistically significantly associated with in-stent vessel stenosis >50% (P=0.029), without impact on effectiveness or safety. Fish mouthing was found in 1/133 (0.75%) at 1 year, causing >50% vessel stenosis. Foreshortening occurred in 6/133 (4.5%), and braid bump in 1/133 (0.75%) associated with severe in-stent stenosis. Four other cases (3.0%) of asymptomatic in-stent stenosis due to neointimal hyperplasia were seen without braid changes. No new braid stability deformations were found at the 2-year follow-up. Conclusion Our study demonstrates excellent braid stability among patients treated with the PED Classic and Flex in the PREMIER trial. Within the uncommon braid changes observed, none affected the PED safety or efficacy. Trial registration number NCT02186561.
- 1 October 2024
- Published by BMJ in Journal of NeuroInterventional Surgery
- Vol. 17 (12) , 1362-1367
Braids and beyond: a comprehensive study on pipeline device braid stability from PREMIER data
Background The pipeline embolization device (PED) has been increasingly used to treat brain aneurysms; however, concerns have been raised about braid stability with newer drawn filled tubing technology devices. Objective To evaluate braid stability of PED early generations using data from the PREMIER trial. Methods All consecutive intracranial aneurysms treated with PED (Classic and Flex) within the PREMIER trial were reviewed for braid stability (fish mouthing, foreshortening, braid bump, braid collapsing). Immediate postprocedure cone-beam CT and angiography were compared with 1- and 2- years' follow-up. Analyses included safety, measured with the modified Rankin Scale (mRS) score, including +1 mRS point and a good clinical outcome (mRS score 0–2), vessel stenosis ≥50%, effectiveness measured with Raymond-Roy Scale, and re-treatment rates. Results 133/141 aneurysms had a complete dataset. 8/133 (6%) aneurysms showed braid deformations. Inter-reader agreement was excellent (κ=0.83). Braid deformations were statistically significantly associated with in-stent vessel stenosis >50% (P=0.029), without impact on effectiveness or safety. Fish mouthing was found in 1/133 (0.75%) at 1 year, causing >50% vessel stenosis. Foreshortening occurred in 6/133 (4.5%), and braid bump in 1/133 (0.75%) associated with severe in-stent stenosis. Four other cases (3.0%) of asymptomatic in-stent stenosis due to neointimal hyperplasia were seen without braid changes. No new braid stability deformations were found at the 2-year follow-up. Conclusion Our study demonstrates excellent braid stability among patients treated with the PED Classic and Flex in the PREMIER trial. Within the uncommon braid changes observed, none affected the PED safety or efficacy. Trial registration number NCT02186561.
- 29 August 2024
- Published by Wolters Kluwer Health in Operative Neurosurgery
- Vol. 28 (5) , 741-742
Ruptured Perinidal Aneurysm Clipping and Spinal Arteriovenous Malformation Resection: 2-Dimensional Operative Video
- 29 August 2024
- Published by Wolters Kluwer Health in Operative Neurosurgery
- Vol. 28 (5) , 741-742
Ruptured Perinidal Aneurysm Clipping and Spinal Arteriovenous Malformation Resection: 2-Dimensional Operative Video
- 28 June 2024
- Published by Elsevier in Clinical Neurology and Neurosurgery
- Vol. 244, 108396
Are ventriculopleural shunts the second option for treating hydrocephalus? A meta-analysis of 543 patients
- 28 June 2024
- Published by Elsevier in Clinical Neurology and Neurosurgery
- Vol. 244, 108396
Are ventriculopleural shunts the second option for treating hydrocephalus? A meta-analysis of 543 patients
- 21 June 2024
- Published by BMJ in Journal of NeuroInterventional Surgery
- Vol. 17 (4) , 405-409
Multicenter early United States feasibility study and periprocedural safety of LVIS EVO for the treatment of unruptured intracranial aneurysms
Background Stent development has focused recently on low-profile, self-expandable stents compatible with 0.0165 inch microcatheters. The LVIS EVO is the second-generation version of the Low-Profile Visualized Intraluminal Support (LVIS) with improved visibility and resheathability. The LVIS EVO underwent a limited premarket release (PMR) in December 2023. This study aims to report the early safety and feasibility experience with the LVIS EVO stent for the treatment of intracranial aneurysms in the United States (US). Methods This was a multicenter, retrospective, observational study evaluating patients who underwent treatment of an intracranial aneurysm with an LVIS EVO stent after the limited PMR. All physicians who had placed an LVIS EVO stent were asked to input their cases after institutional review board approval was obtained. The data were then sent to a single center for analysis. Any patient aged 18 years or older who underwent treatment of an intracranial aneurysm with a LVIS EVO stent in the US was included from the initial PMR in December 2023 until April 2024. Patient age (or ≤90 years old), sex, preoperative modified Rankin Scale (mRS), aneurysm location, aneurysm measurements, and information about preoperative antiplatelet management were all collected. Data on periprocedural complications, 30-day mortality, discharge mRS, and length of stay were also collected. Results Some 53 patients with 55 aneurysms underwent treatment with the LVIS EVO stent at 15 institutions. All aneurysms were unruptured. The most common location was the anterior communicating artery (35%) followed by the middle cerebral artery bifurcation (31%). All patients were on dual antiplatelet therapy. The average aneurysm size was 5.2 mm with a neck size of 3.7 mm. The smallest distal parent vessel size was 1.2 mm and 36% of stents were deployed in distal parent vessels Conclusions The LVIS EVO is a braided, self-expanding, retrievable stent with enhanced visibility and smaller cell size. The drawn filled tube (DFT) technology results in improved visibility of the stent, allowing for more controlled stent positioning and visualization of vessel wall apposition. All cases in our series had complete neck coverage and good wall apposition. There were no thromboembolic or hemorrhagic complications.
- 21 June 2024
- Published by BMJ in Journal of NeuroInterventional Surgery
- Vol. 17 (4) , 405-409
Multicenter early United States feasibility study and periprocedural safety of LVIS EVO for the treatment of unruptured intracranial aneurysms
Background Stent development has focused recently on low-profile, self-expandable stents compatible with 0.0165 inch microcatheters. The LVIS EVO is the second-generation version of the Low-Profile Visualized Intraluminal Support (LVIS) with improved visibility and resheathability. The LVIS EVO underwent a limited premarket release (PMR) in December 2023. This study aims to report the early safety and feasibility experience with the LVIS EVO stent for the treatment of intracranial aneurysms in the United States (US). Methods This was a multicenter, retrospective, observational study evaluating patients who underwent treatment of an intracranial aneurysm with an LVIS EVO stent after the limited PMR. All physicians who had placed an LVIS EVO stent were asked to input their cases after institutional review board approval was obtained. The data were then sent to a single center for analysis. Any patient aged 18 years or older who underwent treatment of an intracranial aneurysm with a LVIS EVO stent in the US was included from the initial PMR in December 2023 until April 2024. Patient age (or ≤90 years old), sex, preoperative modified Rankin Scale (mRS), aneurysm location, aneurysm measurements, and information about preoperative antiplatelet management were all collected. Data on periprocedural complications, 30-day mortality, discharge mRS, and length of stay were also collected. Results Some 53 patients with 55 aneurysms underwent treatment with the LVIS EVO stent at 15 institutions. All aneurysms were unruptured. The most common location was the anterior communicating artery (35%) followed by the middle cerebral artery bifurcation (31%). All patients were on dual antiplatelet therapy. The average aneurysm size was 5.2 mm with a neck size of 3.7 mm. The smallest distal parent vessel size was 1.2 mm and 36% of stents were deployed in distal parent vessels Conclusions The LVIS EVO is a braided, self-expanding, retrievable stent with enhanced visibility and smaller cell size. The drawn filled tube (DFT) technology results in improved visibility of the stent, allowing for more controlled stent positioning and visualization of vessel wall apposition. All cases in our series had complete neck coverage and good wall apposition. There were no thromboembolic or hemorrhagic complications.