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1.
J Neurointerv Surg ; 15(3): 209-213, 2023 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-35232752

RESUMO

BACKGROUND: Few studies have explored the association between stroke thrombectomy (ST) volume and hospital accreditation with clinical outcomes. OBJECTIVE: To assess the association of ST case volume and accreditation status with in-hospital mortality and home discharge disposition using the national Medicare Provider Analysis and Review (MEDPAR) database. METHODS: Rates of hospital mortality, home discharge disposition, and hospital stay were compared between accredited and non-accredited hospitals using 2017-2018 MEDPAR data. The association of annual ST case volume with mortality and home disposition was determined using Pearson's correlation. Median rate of mortality and number of ST cases at hospitals within the central quartiles were estimated. RESULTS: A total of 29 355 cases were performed over 2 years at 847 US centers. Of these, 354 were accredited. There were no significant differences between accredited and non-accredited centers for hospital mortality (14.8% vs 14.5%, p=0.34) and home discharge (12.1% vs 12.0%, p=0.78). A significant positive correlation was observed between thrombectomy volume and home discharge (r=0.88; 95% CI 0.58 to 0.97, p=0.001). A significant negative relationship was found between thrombectomy volume and mortality (r=-0.86; 95% CI -0.97 to -0.49, p=0.002). Within the central quartiles, the median number of ST cases at hospitals with mortality was 24/year, and the median number of ST cases at hospitals with home discharge rate was 23/year. CONCLUSION: A higher volume of ST cases was associated with lower mortality and higher home discharge rate. No significant differences in mortality and discharge disposition were found between accredited and non-accredited hospitals.


Assuntos
Mortalidade Hospitalar , Alta do Paciente , Acidente Vascular Cerebral , Trombectomia , Idoso , Humanos , Acreditação , Hospitais , Medicare , Acidente Vascular Cerebral/cirurgia , Estados Unidos/epidemiologia
2.
J Neurointerv Surg ; 14(4): 390-396, 2022 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-34039682

RESUMO

BACKGROUND: Most conventional 0.088 inch guide catheters cannot safely navigate intracranial vasculature. The objective of this study is to evaluate the safety of stroke thrombectomy using a novel 0.088 inch guide catheter designed for intracranial navigation. METHODS: This is a multicenter retrospective study, which included patients over 18 years old who underwent thrombectomy for anterior circulation large vessel occlusions. Technical outcomes for patients treated using the TracStar Large Distal Platform (TracStar LDP) or earlier generation TRX LDP were compared with a matched cohort of patients treated with other commonly used guide catheters. The primary outcome measure was device-related complications. Secondary outcome measures included guide catheter failure and time between groin puncture and clot engagement. RESULTS: Each study arm included 45 patients. The TracStar group was non-inferior to the control group with regard to device-related complications (6.8% vs 8.9%), and the average time to clot engagement was 8.89 min shorter (14.29 vs 23.18 min; p=0.0017). There were no statistically significant differences with regard to other technical outcomes, including time to recanalization (modified Thrombolysis In Cerebral Infarction (mTICI) ≥2B). The TracStar was successfully advanced into the intracranial internal carotid artery in 33 cases (73.33%); in three cases (6.67%), it was swapped for an alternate catheter. Successful reperfusion (mTICI 2B-3) was achieved in 95.56% of cases. Ninety-day follow-up data were available for 86.67% of patients, among whom 46.15% had an modified Rankin Score of 0-2%, and 10.26% were deceased. CONCLUSIONS: Tracstar LDP is safe for use during stroke thrombectomy and was associated with decreased time to clot engagement. Intracranial access was regularly achieved.


Assuntos
Isquemia Encefálica , Acidente Vascular Cerebral , Adulto , Isquemia Encefálica/complicações , Catéteres/efeitos adversos , Humanos , Estudos Retrospectivos , Acidente Vascular Cerebral/diagnóstico por imagem , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/cirurgia , Tecnologia , Trombectomia/efeitos adversos , Resultado do Tratamento
3.
J Neurointerv Surg ; 14(2): 143-148, 2022 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-33722961

RESUMO

BACKGROUND: Stent-assisted coiling of wide-necked intracranial aneurysms (IAs) using the Neuroform Atlas Stent System (Atlas) has shown promising results. OBJECTIVE: To present the primary efficacy and safety results of the ATLAS Investigational Device Exemption (IDE) trial in a cohort of patients with posterior circulation IAs. METHODS: The ATLAS trial is a prospective, multicenter, single-arm, open-label study of unruptured, wide-necked, IAs treated with the Atlas stent and adjunctive coiling. This study reports the results of patients with posterior circulation IAs. The primary efficacy endpoint was complete aneurysm occlusion (Raymond-Roy (RR) class I) on 12-month angiography, in the absence of re-treatment or parent artery stenosis >50%. The primary safety endpoint was any major ipsilateral stroke or neurological death within 12 months. Adjudication of the primary endpoints was performed by an imaging core laboratory and a Clinical Events Committee. RESULTS: The ATLAS trial enrolled and treated 116 patients at 25 medical centers with unruptured, wide-necked, posterior circulation IAs (mean age 60.2±10.5 years, 81.0% (94/116) female). Stents were placed in all patients with 100% technical success rate. A total of 95/116 (81.9%) patients had complete angiographic follow-up at 12 months, of whom 81 (85.3%) had complete aneurysm occlusion (RR class I). The primary effectiveness outcome was achieved in 76.7% (95% CI 67.0% to 86.5%) of patients. Overall, major ipsilateral stroke and secondary persistent neurological deficit occurred in 4.3% (5/116) and 1.7% (2/116) of patients, respectively. CONCLUSIONS: In the ATLAS IDE posterior circulation cohort, the Neuroform Atlas Stent System with adjunctive coiling demonstrated high rates of technical and safety performance. Trial registration number https://clinicaltrials.gov/ct2/show/NCT02340585.


Assuntos
Embolização Terapêutica , Aneurisma Intracraniano , Idoso , Angiografia Cerebral , Feminino , Humanos , Aneurisma Intracraniano/diagnóstico por imagem , Aneurisma Intracraniano/cirurgia , Pessoa de Meia-Idade , Estudos Prospectivos , Estudos Retrospectivos , Stents , Resultado do Tratamento
4.
J Neurointerv Surg ; 14(3): 280-285, 2022 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-33858971

RESUMO

BACKGROUND: The use of a balloon-guide catheter (BGC) in acute stroke treatment has been widely adopted after demonstrating optimized procedure metrics and outcomes. Initial technical constraints of previous devices included catheter stiffness and smaller inner diameters. We aim to evaluate the performance and safety of the Walrus BGC, a variable stiffness catheter with a large bore 0.087 inch inner diameter (ID), via the the WICkED study (Walrus Large Bore guide Catheter Impact on reCanalization first pass Effect anD outcomes). METHODS: This is a retrospective, site adjudicated, multicenter study on consecutive patients with large vessel occlusion treated with the Walrus BGC. Baseline characteristics, procedural outcomes and functional outcomes were analyzed. RESULTS: A total of 338 patients met the inclusion criteria. The Walrus was successfully tracked into distal vasculature and allowed therapeutic device delivery in all but 3 cases (0.9%). Large aspiration catheters ≥0.070 inch ID were used in 71.9% of cases. Stent retriever thrombectomy was used as the first-line modality in 59.2% and thromboaspiration in 40.8% of cases. The successful recanalization rate (modified treatment in cerebral ischemia (mTICI) 2b/3) was 94.4%, with 64.8% of the patients achieving mTICI 2b/3 after the first pass. The Walrus-related adverse event rate was 0.6%, corresponding to two vessel dissections. Functional independence was 50% (126/252) and mortality 25% (63/252). Unfavorable outcomes were more likely in older patients, who had unsuccessful reperfusion, longer procedure times, and a higher mean number of passes. CONCLUSION: In acute ischemic stroke patients presenting with large vessel occlusion, the Walrus BGC demonstrated excellent navigability and safety profile, allowed the accommodation of leading large bore aspiration catheters, and demonstrated high vessel recanalization rates.


Assuntos
Isquemia Encefálica , AVC Isquêmico , Acidente Vascular Cerebral , Idoso , Animais , Isquemia Encefálica/diagnóstico por imagem , Isquemia Encefálica/cirurgia , Catéteres , Humanos , Estudos Retrospectivos , Stents , Acidente Vascular Cerebral/diagnóstico por imagem , Acidente Vascular Cerebral/cirurgia , Trombectomia/métodos , Resultado do Tratamento , Morsas
5.
J Neurointerv Surg ; 14(6): 577-584, 2022 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-34282038

RESUMO

OBJECTIVE: To evaluate the safety and effectiveness of the Flow Redirection Endoluminal Device (FRED) flow diverter in support of an application for Food and Drug Administration approval in the USA. METHODS: 145 patients were enrolled in a prospective, single-arm multicenter trial. Patients with aneurysms of unfavorable morphology for traditional endovascular therapies (large, wide-necked, fusiform, etc) were included. The trial was designed to demonstrate non-inferiority in both safety and effectiveness, comparing trial results with performance goals (PGs) established from peer-reviewed published literature. The primary safety endpoint was death or major stroke (National Institutes of Health Stroke Scale score ≥4 points) within 30 days of the procedure, or any major ipsilateral stroke or neurological death within the first year. The primary effectiveness endpoint was complete occlusion of the target aneurysm with ≤50% stenosis of the parent artery at 12 months after treatment, and in which an alternative treatment of the target intracranial aneurysm had not been performed. RESULTS: 145 patients underwent attempted placement of a FRED device, and one or more devices were placed in all 145 patients. 135/145 (93%) had a single device placed. Core laboratory adjudication deemed 106 (73.1%) of the aneurysms large or giant. A safety endpoint was experienced by 9/145 (6.2%) patients, successfully achieving the safety PG of <15%. The effectiveness PG of >46% aneurysm occlusion was also achieved, with the effectiveness endpoint being met in 80/139 (57.6%) CONCLUSION: As compared with historically derived performance benchmarks, the FRED flow diverter is both safe and effective for the treatment of appropriately selected intracranial aneurysms. CLINICAL REGISTRATION NUMBER: NCT01801007.


Assuntos
Embolização Terapêutica , Procedimentos Endovasculares , Aneurisma Intracraniano , Acidente Vascular Cerebral , Embolização Terapêutica/métodos , Procedimentos Endovasculares/métodos , Humanos , Aneurisma Intracraniano/diagnóstico por imagem , Aneurisma Intracraniano/cirurgia , Estudos Prospectivos , Stents , Acidente Vascular Cerebral/terapia , Resultado do Tratamento
6.
J Neurointerv Surg ; 13(10): 930-934, 2021 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-33298509

RESUMO

BACKGROUND: No randomized trial of intracranial aneurysm coiling has compared long-term efficacy of polymer-modified coils to bare metal coils (BMCs). We report 5-year results comparing Matrix2 coils to BMCs. The primary objective was to compare the rates of target aneurysm recurrence (TAR) at 12 months. Secondary objectives included angiographic outcomes at TAR or 12 months and TAR at 5 years. METHODS: A total of 626 patients were randomized to BMCs or Matrix2 coils. Detailed methods and 1-year results have been published previously. RESULTS: Of 580 patients eligible for 5-year follow-up, 431 (74.3%) completed follow-up or reached TAR. Matrix2 coils were non-inferior to BMCs (P=0.8) but did not confer any benefit. Core lab reported post-treatment residual aneurysm filling (Raymond III) correlated with TAR (P<0.0001) and with aneurysm hemorrhage after treatment (P<0.008). Repeat aneurysmal hemorrhage after treatment, but before hospital discharge, occurred in three patients treated for acutely ruptured aneurysms. Additionally, two patients treated for unruptured aneurysms experienced a first hemorrhage during follow-up. All five hemorrhages resulted from aneurysms with Raymond III residual aneurysm filling persisting after initial treatment. After 5 years follow-up, 2/626 (0.3%) patients are known to have had target aneurysm rupture following hospital discharge. The annualized rate of delayed hemorrhage after coiling was 2/398/5=0.001 (0.1%) per year for unruptured aneurysms and 0 for ruptured aneurysms. CONCLUSIONS: After 5 years Matrix2 coils were non-inferior to BMCs but no benefit was demonstrated. Post-treatment residual angiographic aneurysm filling (Raymond III) is strongly associated with TAR (P<0.0001) and post-treatment aneurysmal hemorrhage (P=0.008).


Assuntos
Aneurisma Roto , Embolização Terapêutica , Aneurisma Intracraniano , Aneurisma Roto/terapia , Embolização Terapêutica/efeitos adversos , Humanos , Aneurisma Intracraniano/diagnóstico por imagem , Aneurisma Intracraniano/terapia , Resultado do Tratamento
7.
J Neurointerv Surg ; 12(3): 289-297, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-31530655

RESUMO

INTRODUCTION: The endovascular stent-assisted coiling approach for the treatment of cerebral aneurysms is evolving rapidly with the availability of new stent devices. It remains unknown how each type of stent affects the safety and efficacy of the stent-coiling procedure. METHODS: This study compared the outcomes of endovascular coiling of cerebral aneurysms using Neuroform (NEU), Enterprise (EP), and Low-profile Visualized Intraluminal Support (LVIS) stents. Patient characteristics, treatment details and angiographic results using the Raymond-Roy grade scale (RRGS), and procedural complications were analyzed in our study. RESULTS: Our study included 659 patients with 670 cerebral aneurysms treated with stent-assisted coiling (NEU, n=182; EP, n=158; LVIS, n=330) that were retrospectively collected from six academic centers. Patient characteristics included mean age 56.3±12.1 years old, female prevalence 73.9%, and aneurysm rupture on initial presentation of 18.8%. We found differences in complete occlusion on baseline imaging, defined as RRGS I, among the three stents: LVIS 64.4%, 210/326; NEU 56.2%, 95/169; EP 47.6%, 68/143; P=0.008. The difference of complete occlusion on 10.5 months (mean) and 8 months (median) angiographic follow-up remained significant: LVIS 84%, 251/299; NEU 78%, 117/150; EP 67%, 83/123; P=0.004. There were 7% (47/670) intra-procedural complications and 11.5% (73/632) post-procedural-related complications in our cohort. Furthermore, procedure-related complications were higher in the braided-stents vs laser-cut, P=0.002. CONCLUSIONS: There was a great variability in techniques and choice of stent type for stent-assisted coiling among the participating centers. The type of stent was associated with immediate and long-term angiographic outcomes. Randomized prospective trials comparing the different types of stents are warranted.


Assuntos
Aneurisma Roto/diagnóstico por imagem , Aneurisma Roto/terapia , Angiografia Cerebral/tendências , Aneurisma Intracraniano/diagnóstico por imagem , Aneurisma Intracraniano/terapia , Stents/tendências , Adulto , Idoso , Angiografia Cerebral/métodos , Estudos de Coortes , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Estudos Retrospectivos , Stents/efeitos adversos , Resultado do Tratamento
8.
J Neurointerv Surg ; 11(8): 801-806, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-30670625

RESUMO

BACKGROUND AND OBJECTIVE: Stent-assisted coil embolization is a well-established treatment of intracranial wide-necked aneurysms. The Neuroform Atlas Stent System is a new generation microstent designed to enhance coil support, conformability, deliverability, and improve deployment accuracy. We present the 1-year efficacy and angiographic results of the Humanitarian Device Exemption (HDE) cohort from the Atlas Investigational Device Exemption (IDE) clinical trial. METHOD: The Atlas IDE trial is a prospective, multicenter, single-arm, open-label study of unruptured wide-necked intracranial aneurysms treated with the Neuroform Atlas stent and approved coils. The primary efficacy endpoint was the rate of 12-month complete aneurysm angiographic occlusion (Raymond class I) without target aneurysm retreatment or significant parent artery stenosis (>50%) at the target location. The primary safety endpoint was the rate of major ipsilateral stroke or neurological death within 12 months. Imaging core laboratory and Clinical EventsCommittee adjudicated the primary endpoints. RESULTS: 30 patients were enrolled at eight US centers, with 27 patients completing the 12-month angiographic follow-up. The mean age was 59.4±11.8 years and 24/30 patients (80%) were women. The mean aneurysm size was 5.3±1.7 mm and the dome:neck ratio was 1.1±0.2. Procedural technical success of Neuroform Atlas Stent deployment was 100%. 27 patients completed 12-month angiographic follow-up and 30 patients completed their 6-month follow-up. When applying the last observation carried forward method, the primary efficacy endpoint was observed in 26/30 patients (86.7%, 95% CI 69.3% to 96.2%) compared with 25/27 patients (92.6%, 95% CI 75.7% to 99.1%) who completed the 12-month angiographic follow-up. The primary safety endpoint of stroke occurred in one patient (3.3%), who made a complete clinical recovery at discharge. There were no neurological deaths. CONCLUSION: The Neuroform Atlas stent in conjunction with coils demonstrated a high rate of complete aneurysm occlusion at 12-month angiographic follow-up, with an improved safety profile in the HDE cohort. CLINICAL TRIALGOV REGISTRATION NUMBER: NCT0234058;Results.


Assuntos
Ensaios de Uso Compassivo/instrumentação , Ensaios de Uso Compassivo/tendências , Aneurisma Intracraniano/diagnóstico por imagem , Aneurisma Intracraniano/cirurgia , Stents Metálicos Autoexpansíveis , Adulto , Idoso , Prótese Vascular/tendências , Angiografia Cerebral/métodos , Angiografia Cerebral/tendências , Estudos de Coortes , Ensaios de Uso Compassivo/métodos , Embolização Terapêutica/instrumentação , Embolização Terapêutica/métodos , Embolização Terapêutica/tendências , Feminino , Humanos , Aneurisma Intracraniano/terapia , Masculino , Pessoa de Meia-Idade , Alta do Paciente/tendências , Estudos Prospectivos , Retratamento/tendências , Resultado do Tratamento
9.
World Neurosurg ; 123: e693-e699, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-30576811

RESUMO

BACKGROUND: The optimal management of intracranial arterial stenosis is unclear, particularly in patients who have failed medical management. We report a multicenter real-world experience of endovascular recanalization of intracranial atherosclerotic stenosis refractory to aggressive medical therapy. METHODS: Retrospective multicenter case series of consecutive endovascularly treated patients presenting with symptomatic (transient ischemic attack [TIA] or stroke) intracranial stenosis who had failed medical therapy. Patients were divided into 2 groups: patients with recurrent TIA or stroke despite medical management (group 1) versus patients presenting with a stroke and worsening symptoms (progressive or crescendo stroke) despite medical management (group 2). RESULTS: A total of 101 patients were treated in 8 stroke centers from August 2009 to May 2017. Sixty-nine presented with recurrent TIA or stroke and 32 with stroke and worsening symptoms. Successful recanalization was achieved in 84% of patients. Periprocedural stroke occurred in 3 patients and 2 had a recurrent ischemic stroke at the 90-day follow-up. Symptomatic intraparenchymal hemorrhage secondary to reperfusion injury occurred in 3 patients and 1 had a hemorrhagic stroke after discharge. There were 2 periprocedural perforations that resulted in death. At 90 days, 86% of patients (64/74) did not have a recurrence of stroke and the 90-day cumulative ischemic stroke rate was 6.7% with 90-day mortality of 11.2%. The 90-day favorable outcome (modified Rankin Scale score, ≤2) rate was 77.5%. CONCLUSIONS: Endovascular recanalization of unstable intracranial atherosclerotic stenosis in patients who have failed medical therapy is feasible. Future randomized trials need to determine if recanalization is of any value for this population.


Assuntos
Procedimentos Endovasculares/métodos , Arteriosclerose Intracraniana/cirurgia , Ataque Isquêmico Transitório/cirurgia , Acidente Vascular Cerebral/cirurgia , Doença Crônica , Constrição Patológica/tratamento farmacológico , Constrição Patológica/cirurgia , Feminino , Humanos , Arteriosclerose Intracraniana/tratamento farmacológico , Ataque Isquêmico Transitório/etiologia , Masculino , Pessoa de Meia-Idade , Recidiva , Reoperação/estatística & dados numéricos , Reperfusão/métodos , Estudos Retrospectivos , Acidente Vascular Cerebral/etiologia , Resultado do Tratamento
10.
J Neurointerv Surg ; 11(4): 357-361, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30297543

RESUMO

INTRODUCTION: The LVIS stent system (LVIS and LVIS Junior) is a self-expanding, retrievable, microstent system indicated for the treatment of wide-necked cerebral aneurysms (WNAs). The present pivotal study was performed to evaluate the safety and effectiveness of this device. METHODS: The US LVIS pivotal trial was a prospective, multicenter, single-arm, interventional study conducted at 21 US centers. The study enrolled 153 adults with WNAs of the anterior and posterior circulations. The study was conducted under good clinical practices and included independent adjudication of all adverse events. The primary effectiveness endpoint was defined as successful aneurysm treatment with the LVIS System as evidenced by complete (100%) aneurysm occlusion at 12 months on conventional angiography without retreatment and without significant (≥50%) stenosis of the treated artery at 12 months as determined by an independent core laboratory. The primary safety endpoint was defined as the rate of stroke or death within 30 days, or ipsilateral stroke or neurologic death with 12 months. RESULTS: One hundred and fifty-three patients enrolled at 21 investigational sites underwent attempted LVIS-assisted coil embolization. The mean age was 58.3±10.5 years and the majority of the participants (110/153, 71.9%) were female. Fifty-seven aneurysms (57/153, 37.3%) arose from the anterior cerebral artery, 43 (43/153, 28.1%) from the internal carotid artery, 17 (17/153, 11.1%) from the middle cerebral artery, 27 (27/153, 17.6%) from the basilar artery, six (6/153,3.9 %) from the PCA, and two from the vertebral artery. A single aneurysm arose from the superior cerebellar artery. The mean aneurysm dome height was 6.0±2.2 mm and mean width 5.5±2.3 mm. Mean neck width was 4.2±1.4 mm. A total of 22 participants presented for re-treatment of a previously ruptured (>30 days prior to treatment) target aneurysm. The primary effectiveness endpoint was observed in 70.6% (108/153) in the intent to treat population (ITT). Of the evaluable participants with follow-up 12-month angiography, 79.1 % (110/139) demonstrated complete occlusion- 92.1% (128/139) in this population demonstrated ≥95% occlusion and 95% demonstrated ≥90% occlusion (132/139). Eight participants (5.2%, 8/153) had at least one primary safety event in the ITT population. CONCLUSION: The LVIS stent system allows safe and highly effective coil embolization of WNAs. CLINICAL REGISTRATION NUMBER: NCT01793792.


Assuntos
Procedimentos Endovasculares/métodos , Aneurisma Intracraniano/diagnóstico por imagem , Aneurisma Intracraniano/terapia , Stents Metálicos Autoexpansíveis , Adulto , Idoso , Embolização Terapêutica/efeitos adversos , Embolização Terapêutica/métodos , Procedimentos Endovasculares/efeitos adversos , Feminino , Seguimentos , Humanos , Aneurisma Intracraniano/epidemiologia , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Stents Metálicos Autoexpansíveis/efeitos adversos , Resultado do Tratamento , Estados Unidos/epidemiologia
12.
J Neurointerv Surg ; 10(Suppl 1): i4-i7, 2018 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-30037944

RESUMO

BACKGROUND: The development of new revascularization devices has improved recanalization rates and time, but not clinical outcomes. We report a prospectively collected clinical experience with a new technique utilizing a direct aspiration first pass technique with large bore aspiration catheter as the primary method for vessel recanalization. METHODS: 98 prospectively identified acute ischemic stroke patients with 100 occluded large cerebral vessels at six institutions were included in the study. The ADAPT technique was utilized in all patients. Procedural and clinical data were captured for analysis. RESULTS: The aspiration component of the ADAPT technique alone was successful in achieving Thrombolysis in Cerebral Infarction (TICI) 2b or 3 revascularization in 78% of cases. The additional use of stent retrievers improved the TICI 2b/3 revascularization rate to 95%. The average time from groin puncture to at least TICI 2b recanalization was 37 min. A 5MAX demonstrated similar success to a 5MAX ACE in achieving TICI 2b/3 revascularization alone (75% vs 82%, p=0.43). Patients presented with an admitting median National Institutes of Health Stroke Scale (NIHSS) score of 17.0 (12.0-21.0) and improved to a median NIHSS score at discharge of 7.3 (1.0-11.0). Ninety day functional outcomes were 40% (modified Rankin Scale (mRS) 0-2) and 20% (mRS 6). There were two procedural complications and no symptomatic intracerebral hemorrhages. DISCUSSION: The ADAPT technique is a fast, safe, simple, and effective method that has facilitated our approach to acute ischemic stroke thrombectomy by utilizing the latest generation of large bore aspiration catheters to achieve previously unparalleled angiographic outcomes.


Assuntos
Isquemia Encefálica/cirurgia , Cateterismo Periférico/métodos , Acidente Vascular Cerebral/cirurgia , Trombectomia/métodos , Idoso , Idoso de 80 Anos ou mais , Isquemia Encefálica/diagnóstico , Isquemia Encefálica/epidemiologia , Cateterismo Periférico/tendências , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Paracentese/métodos , Paracentese/tendências , Alta do Paciente/tendências , Estudos Prospectivos , Stents/tendências , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/epidemiologia , Trombectomia/tendências , Resultado do Tratamento
13.
J Neurointerv Surg ; 10(Suppl 1): i20-i25, 2018 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-30037948

RESUMO

BACKGROUND: The development of new revascularization devices has improved recanalization rates and time but not clinical outcomes. We report our initial results with a new technique utilizing a direct aspiration first pass technique with a large bore aspiration catheter as the primary method for vessel recanalization. METHODS: A retrospective evaluation of a prospectively captured database of 37 patients at six institutions was performed on patients where the ADAPT technique was utilized. The data represent the initial experience with this technique. RESULTS: The ADAPT technique alone was successful in 28 of 37 (75%) cases although six cases had large downstream emboli that required additional aspiration. Nine cases required the additional use of a stent retriever and one case required the addition of a Penumbra aspiration separator to achieve recanalization. The average time from groin puncture to at least Thrombolysis in Cerebral Ischemia (TICI) 2b recanalization was 28.1 min, and all cases were successfully revascularized. TICI 3 recanalization was achieved 65% of the time. On average, patients presented with an admitting National Institutes of Health Stroke Scale (NIHSS) score of 16.3 and improved to an NIHSS score of 4.2 by the time of hospital discharge. There was one procedural complication. DISCUSSION: This initial experience highlights the fact that the importance of the technique with which new stroke thrombectomy devices are used may be as crucial as the device itself. The ADAPT technique is a simple and effective approach to acute ischemic stroke thrombectomy. Utilizing the latest generation of large bore aspiration catheters in this fashion has allowed us to achieve excellent clinical and angiographic outcomes.


Assuntos
Isquemia Encefálica/diagnóstico por imagem , Isquemia Encefálica/cirurgia , Acidente Vascular Cerebral/diagnóstico por imagem , Acidente Vascular Cerebral/cirurgia , Trombectomia/métodos , Adulto , Idoso , Idoso de 80 Anos ou mais , Cateterismo Periférico/métodos , Catéteres/tendências , Feminino , Hospitalização/tendências , Humanos , Masculino , Pessoa de Meia-Idade , Paracentese/instrumentação , Paracentese/métodos , Alta do Paciente/tendências , Estudos Prospectivos , Estudos Retrospectivos , Stents/tendências , Trombectomia/instrumentação , Resultado do Tratamento
14.
J Neurointerv Surg ; 10(12): 1209-1217, 2018 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-29666180

RESUMO

INTRODUCTION: Completed randomized trials on endovascular thrombectomy (ET) did not independently assess the efficacy of ET in the elderly (≥80 years old) who were often excluded or under-represented in trials. There were also inconsistent criteria for patient selection in this population across the different trials. This work evaluates outcomes after ET for acute ischemic stroke (AIS) in the elderly at a high volume stroke center. METHODS: We reviewed all cases of AIS that underwent a direct aspiration first pass technique (ADAPT) thrombectomy for large vessel occlusions between March 2013 and October 2017 while comparing outcomes in the elderly with younger counterparts. We also reviewed AIS cases in elderly patients undergoing medical management who were matched to the ET counterparts by demographics, comorbidities, baseline deficits, and stroke severity. RESULTS: Of 560 patients undergoing ET for AIS, 108 patients were in the elderly group (≥80 years of age), and had a significantly lower likelihood of functional independence (defined as a modified Rankin Scale score of 0-2) at 90 days compared with younger patients (20.5% vs 44.4%, P<0.001), and higher mortality rates (34.3% vs 20%, P<0.001). When compared with patients undergoing medical management, elderly patients did not have a significant improvement in rates of good outcomes (20.5% vs 19.5%, P>0.05), and had significantly higher rates of hemorrhage (40.7% vs 9.3%, P<0.001). We also identified baseline stroke severity and the incidence of hemorrhage as two independent predictors of outcome in the elderly patients. CONCLUSIONS: ET in the elderly did not show a similar benefit to younger patients when compared with medical management. These findings emphasize the need for more optimal selection criteria for the elderly population to improve the risk to benefit ratio of ET.


Assuntos
Isquemia Encefálica/diagnóstico , Isquemia Encefálica/cirurgia , Seleção de Pacientes , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/cirurgia , Trombectomia/métodos , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Estudos Retrospectivos , Trombectomia/tendências , Resultado do Tratamento
16.
J Neurointerv Surg ; 10(10): 953-957, 2018 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-29463619

RESUMO

BACKGROUND AND OBJECTIVE: Acute ischemic stroke is a potentially devastating condition and leading cause of morbidity and mortality, affecting an estimated 800 000 people per year in the USA. The natural history of untreated or unrevascularized large vessel occlusions in acute stroke patients results in mortality rates approaching 30%, with only 25% achieving good neurologic outcomes at 90 days. Recently, data have demonstrated that early endovascular recanalization of large vessel occlusions results in better outcomes than medical therapy alone. However, the majority of patients in these studies were treated with a stent retriever based approach. The purpose of COMPASS is to evaluate whether patients treated with a direct aspiration first pass (ADAPT) approach have non-inferior functional outcomes to those treated with a stent retriever as the firstline (SRFL) approach. MATERIALS AND METHODS: All patients who meet the inclusion and exclusion criteria and consent to participate will be enrolled at participating centers. Treatment will be randomly assigned by a central web based system in a 1:1 manner to treatment with either ADAPT or SRFL thrombectomy. Statistical methodology is prespecified with details available in the statistical analysis plan. RESULTS: The trial recently completed enrollment, and data collection/verification is ongoing. The final results will be made available on completion of enrollment and follow-up. CONCLUSIONS: This paper details the design of the COMPASS trial, a randomized, blinded adjudicator, concurrent, controlled trial of patients treated with either ADAPT or SRFL approaches in order to evaluate whether ADAPT results in non-inferior functional outcome. TRIAL REGISTRATION NUMBER: NCT02466893, Results.


Assuntos
Isquemia Encefálica/cirurgia , Procedimentos Endovasculares/métodos , Stents , Acidente Vascular Cerebral/cirurgia , Trombectomia/métodos , Idoso , Isquemia Encefálica/diagnóstico , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Método Simples-Cego , Acidente Vascular Cerebral/diagnóstico , Sucção/métodos , Resultado do Tratamento
17.
J Neurointerv Surg ; 10(7): 708-716, 2018 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-29463620

RESUMO

Infectious intracranial aneurysms (IIAs) are a rare cerebrovascular complication of systemic infections induced by microbial infiltration and degradation of the arterial vessel wall. Studies on the epidemiology and management of IIAs are limited to case reports and retrospective single-center studies, and report a large variability in epidemiological features, management, and outcomes due to the limited sample size. We conducted a systematic review of all published papers on IIAs in the English literature using MEDLINE and SCOPUS database from January 1950 to June 2017. A total of 288 publications describing 1191 patients with IIA (1398 aneurysms) were included and reviewed for epidemiological features, disease features, treatment and outcome. All patients were merged into a single cohort and summary data are presented. The majority of reported IIAs are distally located, relatively small (<5 mm), involve the anterior circulation, are associated with a relatively high rate of rupture, and demonstrate a propensity to multiplicity of aneurysms. Sensitive diagnosis of IIAs requires digital subtraction angiography and not CT angiography or MR angiography. Treatment of ruptured, symptomatic, or enlarging IIAs has evolved over the last 50 years. Endovascular therapy is associated with a high success rate and low morbidity compared with microsurgical and medical management. A treatment algorithm for the management of patients with IIA in various contexts is proposed and the need for prospective multicenter studies is emphasized.


Assuntos
Aneurisma Infectado/epidemiologia , Aneurisma Infectado/terapia , Aneurisma Intracraniano/epidemiologia , Aneurisma Intracraniano/terapia , Adulto , Idoso , Aneurisma Infectado/diagnóstico por imagem , Angiografia Digital/tendências , Angiografia Cerebral/tendências , Angiografia por Tomografia Computadorizada/tendências , Feminino , Humanos , Aneurisma Intracraniano/diagnóstico por imagem , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Estudos Retrospectivos , Sepse/diagnóstico por imagem , Sepse/epidemiologia , Sepse/terapia , Resultado do Tratamento
18.
J Neurointerv Surg ; 10(11): 1074-1078, 2018 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-29478029

RESUMO

BACKGROUND: Blood blister aneurysms (BBA) are a rare subset of intracranial aneurysms that represent a therapeutic challenge from both a surgical and endovascular perspective. OBJECTIVE: To report multicenter experience with flow diversion exclusively for BBA, located at non-branching segments along the anteromedial wall of the supraclinoidal internal carotid artery (ICA). METHODS: Consecutive cases of BBA located at non-branching segments along the anteromedial wall of the supraclinoidal ICA treated with flow diversion were included in the final analysis. RESULTS: 49 patients with 51 BBA of the ICA treated with devices to achieve the flow diversion effect were identified. 43 patients with 45 BBA of the ICA were treated with the pipeline embolization device and were included in the final analysis. Angiographic follow-up data were available for 30 patients (32 aneurysms in total); 87.5% of aneurysms (28/32) showed complete obliteration, 9.4% (3/32) showed reduced filling, and 3.1% (1/32) persistent filling. There was no difference between the size of aneurysm (≤2 mm vs >2 mm) or the use of adjunct coiling and complete occlusion of the aneurysm on follow-up (P=0.354 and P=0.865, respectively). Clinical follow-up data were available for 38 of 43 patients. 68% of patients (26/38) had a good clinical outcome (modified Rankin scale score of 0-2) at 3 months. There were 7 (16%) immediate procedural and 2 (5%) delayed complications, with 1 case of fatal delayed re-rupture after the initial treatment. CONCLUSIONS: Our data support the use of a flow diversion technique as a safe and effective therapeutic modality for BBA of the supraclinoid ICA.


Assuntos
Artéria Carótida Interna/diagnóstico por imagem , Artéria Carótida Interna/cirurgia , Aneurisma Intracraniano/diagnóstico por imagem , Aneurisma Intracraniano/cirurgia , Stents Metálicos Autoexpansíveis , Adulto , Idoso , Angiografia Cerebral/métodos , Embolização Terapêutica/métodos , Procedimentos Endovasculares/métodos , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Stents Metálicos Autoexpansíveis/tendências , Resultado do Tratamento
19.
J Neurointerv Surg ; 10(3): 213-220, 2018 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-28465405

RESUMO

INTRODUCTION: In acute ischemic stroke (AIS), extending mechanical thrombectomy procedural times beyond 60 min has previously been associated with an increased complication rate and poorer outcomes. OBJECTIVE: After improvements in thrombectomy methods, to reassess whether this relationship holds true with a more contemporary thrombectomy approach: a direct aspiration first pass technique (ADAPT). METHODS: We retrospectively studied a database of patients with AIS who underwent ADAPT thrombectomy for large vessel occlusions. Patients were dichotomized into two groups: 'early recan', in which recanalization (recan) was achieved in ≤35 min, and 'late recan', in which procedures extended beyond 35 min. RESULTS: 197 patients (47.7% women, mean age 66.3 years) were identified. We determined that after 35 min, a poor outcome was more likely than a good (modified Rankin Scale (mRS) score 0-2) outcome. The baseline National Institutes of Health Stroke Scale (NIHSS) score was similar between 'early recan' (n=122) (14.7±6.9) and 'late recan' patients (n=75) (15.9±7.2). Among 'early recan' patients, recanalization was achieved in 17.8±8.8 min compared with 70±39.8 min in 'late recan' patients. The likelihood of achieving a good outcome was higher in the 'early recan' group (65.2%) than in the 'late recan' group (38.2%; p<0.001). Patients in the 'late recan' group had a higher likelihood of postprocedural hemorrhage, specifically parenchymal hematoma type 2, than those in the 'early recan' group. Logistic regression analysis showed that baseline NIHSS, recanalization time, and atrial fibrillation had a significant impact on 90-day outcomes. CONCLUSIONS: Our findings suggest that extending ADAPT thrombectomy procedure times beyond 35 min increases the likelihood of complications such as intracerebral hemorrhage while reducing the likelihood of a good outcome.


Assuntos
Isquemia Encefálica/diagnóstico por imagem , Isquemia Encefálica/cirurgia , Acidente Vascular Cerebral/diagnóstico por imagem , Acidente Vascular Cerebral/cirurgia , Trombectomia/normas , Tempo para o Tratamento/normas , Idoso , Idoso de 80 Anos ou mais , Hemorragia Cerebral/diagnóstico por imagem , Hemorragia Cerebral/etiologia , Hemorragia Cerebral/prevenção & controle , Bases de Dados Factuais , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Trombectomia/efeitos adversos , Trombectomia/métodos , Fatores de Tempo , Resultado do Tratamento
20.
J Neurointerv Surg ; 10(8): 735-740, 2018 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-29222394

RESUMO

INTRODUCTION: In acute ischemic stroke (AIS), posterior circulation large vessel occlusions (LVOs) have been associated with poorer outcomes compared with anterior circulation LVOs. The outcomes of anterior versus posterior circulation thrombectomy for LVOs were compared at a high volume center employing a direct aspiration first pass technique (ADAPT). METHODS: We retrospectively studied a database of AIS cases that underwent ADAPT thrombectomy for LVOs. Cases were grouped by anatomical location of thrombectomy (posterior vs anterior circulation), and analysis was performed on both entire sample size. RESULTS: A total of 436 AIS patients (50.2% women, mean age 67.3 years) underwent ADAPT thrombectomy for LVO during the study period, of whom 13% of had posterior circulation thrombectomy. Patients with posterior circulation thrombectomy did not show a significant difference in preprocedural variables, including age, baseline National Institutes of Health Stroke Scale (NIHSS), and onset to groin time, compared with anterior circulation (P>0.05). There were also no differences in procedural variables between the two groups. Patients in the posterior group were found to have a similar likelihood of good outcome (modified Rankin Scale score 0-2) at 90 days compared with the anterior group (42.9% vs 43.2%, respectively), and a small but not significant increase in mortality at 90 days. Multilogistic regression analysis showed that the anatomical location (anterior vs posterior) was not an independent predictor of good outcome or mortality after thrombectomy. Prominent predictors of outcome/mortality included age, female gender, procedure time, and baseline NIHSS. CONCLUSIONS: Our findings demonstrate that when patients are carefully selected for thrombectomy, those with posterior circulation LVOs can achieve similar outcomes compared with anterior circulation thrombectomy, indicating comparable safety and efficacy profiles.


Assuntos
Infarto Encefálico/diagnóstico por imagem , Infarto Encefálico/terapia , Trombectomia/métodos , Trombectomia/tendências , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Estudos Retrospectivos , Acidente Vascular Cerebral/diagnóstico por imagem , Acidente Vascular Cerebral/terapia , Resultado do Tratamento
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