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1.
Stroke ; 53(3): 769-778, 2022 03.
Artigo em Inglês | MEDLINE | ID: mdl-34547927

RESUMO

BACKGROUND AND PURPOSE: The purpose of the COMPLETE (International Acute Ischemic Stroke Registry With the Penumbra System Aspiration Including the 3D Revascularization Device) registry was to evaluate the generalizability of the safety and efficacy of the Penumbra System (Penumbra, Inc, Alameda) in a real-world setting. METHODS: COMPLETE was a global, prospective, postmarket, multicenter registry. Patients with large vessel occlusion-acute ischemic stroke who underwent mechanical thrombectomy using the Penumbra System with or without the 3D Revascularization Device as frontline approach were enrolled at 42 centers (29 United States, 13 Europe) from July 2018 to October 2019. Primary efficacy end points were successful postprocedure angiographic revascularization (modified Thrombolysis in Cerebral Infarction ≥2b) and 90-day functional outcome (modified Rankin Scale score 0-2). The primary safety end point was 90-day all-cause mortality. An imaging core lab determined modified Thrombolysis in Cerebral Infarction scores, Alberta Stroke Program Early CT Scores, clot location, and occurrence of intracranial hemorrhage at 24 hours. Independent medical reviewers adjudicated safety end points. RESULTS: Six hundred fifty patients were enrolled (median age 70 years, 54.0% female, 49.2% given intravenous recombinant tissue-type plasminogen activator before thrombectomy). Rate of modified Thrombolysis in Cerebral Infarction 2b to 3 postprocedure was 87.8% (95% CI, 85.3%-90.4%). First pass and postprocedure rates of modified Thrombolysis in Cerebral Infarction 2c to 3 were 41.5% and 66.2%, respectively. At 90 days, 55.8% (95% CI, 51.9%-59.7%) had modified Rankin Scale score 0 to 2, and all-cause mortality was 15.5% (95% CI, 12.8%-18.3%). CONCLUSIONS: Using Penumbra System for frontline mechanical thrombectomy treatment of patients with large vessel occlusion-acute ischemic stroke in a real-world setting was associated with angiographic, clinical, and safety outcomes that were comparable to prior randomized clinical trials with stringent site and operator selection criteria. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03464565.


Assuntos
Angiografia Cerebral , AVC Isquêmico , Trombólise Mecânica , Sistema de Registros , Idoso , Idoso de 80 Anos ou mais , Feminino , Seguimentos , Humanos , AVC Isquêmico/diagnóstico por imagem , AVC Isquêmico/cirurgia , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos
2.
Ophthalmology ; 128(6): 857-865, 2021 06.
Artigo em Inglês | MEDLINE | ID: mdl-33166551

RESUMO

PURPOSE: To report 3-year outcomes of the HORIZON study comparing cataract surgery (CS) with Hydrus Microstent (Ivantis, Inc) implantation versus CS alone. DESIGN: Multicenter randomized clinical trial. PARTICIPANTS: Five hundred fifty-six eyes from 556 patients with cataract and primary open-angle glaucoma (POAG) treated with 1 or more glaucoma medication, washed out diurnal intraocular pressure (IOP) of 22 to 34 mmHg, and no prior incisional glaucoma surgery. METHODS: After phacoemulsification, eyes were randomized 2:1 to receive a Hydrus Microstent or no stent. Follow-up included comprehensive eye examinations through 3 years. MAIN OUTCOME MEASURES: Outcome measures included IOP, medical therapy, reoperation rates, visual acuity, adverse events, and changes in corneal endothelial cell counts. RESULTS: Three hundred sixty-nine eyes were randomized to microstent treatment and 187 to CS only. Preoperative IOP, medication use, washed-out diurnal IOP, and glaucoma severity did not differ between the two treatment groups. At 3 years, IOP was 16.7 ± 3.1 mmHg in the microstent group and 17.0 ± 3.4 mmHg in the CS group (P = 0.85). The number of glaucoma medications was 0.4 ± 0.8 in the microstent group and 0.8 ± 1.0 in the CS group (P < 0.001), and 73% of microstent group eyes were medication free compared with 48% in the CS group (P < 0.001). The microstent group included a higher proportion of eyes with IOP of 18 mmHg or less without medications compared with the CS group (56.2% vs. 34.6%; P < 0.001), as well as IOP reduction of at least 20%, 30%, or 40% compared with CS alone. The cumulative probability of incisional glaucoma surgery was lower in the microstent group (0.6% vs. 3.9%; hazard ratio, 0.156; 95% confidence interval, 0.031-0.773; P = 0.020). No difference was found in postoperative corneal endothelial cell loss between groups. No procedure- or device-related serious adverse events resulting in vision loss occurred in either group. CONCLUSIONS: Combined CS and microstent placement for mild to moderate POAG is safe, more effective in lowering IOP with fewer medications, and less likely to result in further incisional glaucoma filtration surgery than CS alone at 3 years.


Assuntos
Catarata/complicações , Cirurgia Filtrante/métodos , Glaucoma de Ângulo Aberto/cirurgia , Pressão Intraocular/fisiologia , Facoemulsificação/métodos , Stents , Acuidade Visual , Seguimentos , Glaucoma de Ângulo Aberto/complicações , Glaucoma de Ângulo Aberto/fisiopatologia , Humanos , Estudos Prospectivos , Desenho de Prótese , Ensaios Clínicos Controlados Aleatórios como Assunto , Fatores de Tempo , Resultado do Tratamento
3.
Neurosurg Focus ; 42(4): E7, 2017 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-28366056

RESUMO

Recent randomized controlled trials have demonstrated the superiority of endovascular treatment (ET) over medical management in the treatment of acute ischemic stroke patients with anterior circulation emergent large vessel occlusions (ELVOs). Due to such accumulating evidence, expanding ET has become of paramount importance. Advancements in modern technology have enabled the use of mobile stroke units, telestroke networks, mobile neuroendovascular teams, and smartphone applications that shorten the time window to treatment and, thus, make patients more amenable to ET. Additionally, modifying stroke-screening tools to make them more accessible to first responders and the creation of stroke registries can provide further opportunities for ET.


Assuntos
Procedimentos Endovasculares/métodos , Fibrinolíticos/uso terapêutico , Acidente Vascular Cerebral/terapia , Ativador de Plasminogênio Tecidual/uso terapêutico , Isquemia Encefálica/complicações , Humanos , Injeções Intraventriculares , Índice de Gravidade de Doença , Acidente Vascular Cerebral/etiologia
4.
Clin Ophthalmol ; 17: 3899-3913, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-38111854

RESUMO

Topical glaucoma medications have favorable safety and efficacy, but their use is limited by factors such as side effects, nonadherence, costs, ocular surface disease, intraocular pressure fluctuations, diminished quality of life, and the inherent difficulty of penetrating the corneal surface. Although traditionally these limitations have been accepted as an inevitable part of glaucoma treatment, a rapidly-evolving arena of minimally invasive surgical and laser interventions has initiated the beginnings of a reevaluation of the glaucoma treatment paradigm. This reevaluation encompasses an overall shift away from the reactive, topical-medication-first default and a shift toward earlier intervention with laser or surgical therapies such as selective laser trabeculoplasty, sustained-release drug delivery, and micro-invasive glaucoma surgery. Aside from favorable safety, these interventions may have clinically important attributes such as consistent IOP control, cost-effectiveness, independence from patient adherence, prevention of disease progression, and improved quality of life.

5.
Clin Ophthalmol ; 16: 1225-1234, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35493971

RESUMO

Purpose: To report 12-month efficacy outcomes of 360° canaloplasty and 180° trabeculotomy using the OMNI surgical system in combination with phacoemulsification in patients with mild-moderate open-angle glaucoma (OAG) and visually significant cataract. Setting: Fifteen multi-subspecialty ophthalmology practices and surgery centers located in 14 US states. Design: Prospective, multicenter, IRB approved study of patients treated with canaloplasty (360°) and trabeculotomy (180°). Eligible patients had cataract and mild-moderate OAG with intraocular pressure (IOP) ≤33 mmHg on 1 to 4 hypotensive medications. Unmedicated post-washout mean diurnal IOP (DIOP) ≥21 and ≤36 mmHg. Methods: Medication washout preoperatively and prior to month 12 DIOP. Effectiveness outcomes were IOP and IOP lowering medication use. Safety outcomes included adverse events and secondary surgical interventions (SSIs). Evaluations at 1, 3, 6, and 12 months. Results: A total of 149 subjects underwent surgery and 120 were included in the final effectiveness analysis. Mean (standard deviation) unmedicated diurnal IOP was reduced from 23.8 (3.1) mmHg at baseline to 15.6 (4.0) at month 12 (-35%) and medications (before washout) were reduced from 1.8 (0.9) at baseline to 0.4 (0.9) at month 12 (-80%). At month 12, 84.2% of eyes achieved IOP reductions >20% from baseline, 80% of eyes were medication-free, and 76% of eyes achieved IOP between 6-18 mmHg inclusive. Adverse events were uncommon. Most were mild and self-limited including transient hyphema (9 of 149; 6%) and transient IOP elevations (3 of 149; 2.0%). No eyes required SSIs or experienced loss of VA that was attributable to the device or procedure. Conclusion: Canaloplasty and trabeculotomy performed with the OMNI surgical system at the time of phacoemulsification significantly reduces unmedicated mean diurnal IOP and medication use 12 months postoperatively, with an excellent safety profile. This procedure should be considered for eyes with mild-moderate OAG to reduce IOP, medication burden, or both.

6.
J Glaucoma ; 31(5): 335-339, 2022 05 01.
Artigo em Inglês | MEDLINE | ID: mdl-35249988

RESUMO

PRCIS: Designed with novel features to facilitate implantation and improve safety, the Ahmed ClearPath (ACP) glaucoma drainage device (GDD) provided intraocular pressure (IOP) reduction comparable with other GDDs in eyes with refractory glaucoma in a multicenter retrospective study. PURPOSE: To present clinical outcomes with a novel valveless GDD (ACP, New World Medical). The 250 and 350 mm2 models feature a contoured plate for optimal globe apposition, anteriorized suture points to facilitate suturing to the globe, and a prethreaded 4-0 polypropylene ripcord suture. METHODS: This was a multicenter retrospective analysis of eyes with medically and/or surgically uncontrolled glaucoma implanted with the 250 or 350 mm2 ACP either as a standalone procedure or in combination with other procedures. Pre-, intra-, and postoperative data through 6 months were collected. RESULTS: A total of 104 eyes (100 subjects) received the ACP by 10 US surgeons, 63.5% of which had primary open-angle glaucoma and 62.5% had severe glaucoma. Mean baseline IOP was 26.3 (9.0) mm Hg and mean medication use was 3.9 (1.3). Through 6 months' follow-up, mean IOP ranged from 13.6 to 16.7 mm Hg and mean medication use from 0.9 to 1.9 medications (P<0.0001 at all timepoints for each outcome measure). At 6 months, mean IOP was 13.7 mm Hg (-13.0 mm Hg, 43.0%, P<0.0001) and mean medication use was 1.9 medications per eye (-2.1, 47.7%, P<0.0001). Common adverse events included anterior chamber inflammation (16.3%), hyphema (15.4%), and hypotony (6.7%). CONCLUSION: The new ACP appears to be safe and efficacious as a standalone procedure or in combination with other procedures for uncontrolled glaucoma, and may be considered as a GDD option for patients in whom its unique design may facilitate the implantation process.


Assuntos
Doença da Artéria Coronariana , Implantes para Drenagem de Glaucoma , Glaucoma de Ângulo Aberto , Glaucoma , Hipotensão Ocular , Angiografia Coronária , Doença da Artéria Coronariana/etiologia , Doença da Artéria Coronariana/cirurgia , Seguimentos , Glaucoma/etiologia , Glaucoma/cirurgia , Implantes para Drenagem de Glaucoma/efeitos adversos , Glaucoma de Ângulo Aberto/diagnóstico , Glaucoma de Ângulo Aberto/etiologia , Glaucoma de Ângulo Aberto/cirurgia , Humanos , Pressão Intraocular , Hipotensão Ocular/cirurgia , Implantação de Prótese , Estudos Retrospectivos , Resultado do Tratamento , Acuidade Visual
7.
Clin Ophthalmol ; 15: 3231-3240, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34376967

RESUMO

PURPOSE: To examine effectiveness outcomes stratified by preoperative disease burden in the pivotal trial of iStent inject ® with cataract surgery (INJ) vs cataract surgery alone (CS). MATERIALS AND METHODS: Prospective, 3:1 randomized, single-masked, concurrently-controlled, multicenter trial enrolling 505 subjects with cataract and mild-to-moderate primary open-angle glaucoma who underwent iStent inject implantation with phacoemulsification or phacoemulsification alone, and were followed for 2 years including annual medication washouts. Post hoc stratification was completed for baseline mean diurnal intraocular pressure (BL DIOP; Low-DIOP <25mmHg, Mid-DIOP ≥25 to <30 mmHg, High-DIOP ≥30mmHg) and preoperative medication burden (Low-Med 1 medication, Mid-Med 2 medications, High-Med ≥3 medications). RESULTS: The 24-month primary and secondary effectiveness endpoints were met, with significant treatment-over-control differences in percent of eyes achieving ≥20% unmedicated DIOP reduction and in unmedicated DIOP reduction, respectively. In subgroup analyses, the proportions of INJ eyes achieving the primary endpoint remained steady across all BL DIOP (75.4%, 77.1%, 74.4% in Low/Mid/High-DIOP strata, respectively) and preoperative medication levels (76.8%, 70.8%, 79.7% in Low/Mid/High-Med strata, respectively); meanwhile, the proportions of CS eyes diminished with higher BL DIOP (64.5%, 63.6%, 33.3%, respectively) and more medications (69.0%, 63.3%, 29.4%, respectively). Regarding secondary effectiveness, postoperative DIOP reduction increased with higher BL DIOP in INJ eyes (6.2mmHg, 7.8mmHg, 9.8mmHg, respectively) but plateaued in CS eyes (5.2mmHg, 5.8mmHg, 5.4mmHg, respectively). INJ eyes also had consistent DIOP reduction regardless of preoperative medication burden (6.8mmHg, 6.7mmHg, 7.8mmHg, respectively), while DIOP reduction diminished with more medications in CS eyes (6.1mmHg, 5.0mmHg, 3.3mmHg, respectively). Safety was favorable, comparable to phacoemulsification alone. CONCLUSION: Significant IOP reductions occurred across all levels of BL DIOP and preoperative medication burden in iStent inject eyes. DIOP reductions increased with higher BL DIOP and remained stable across all levels of preoperative medication burden, suggesting the device's potential utility in more medically challenging cases.

8.
Am J Ophthalmol ; 229: 220-229, 2021 09.
Artigo em Inglês | MEDLINE | ID: mdl-33737036

RESUMO

OBJECTIVE: To assess quality of life (QOL) as measured by patient-reported outcomes (PRO) within the iStent inject® pivotal trial. DESIGN: Randomized controlled trial analysis of secondary outcomes. METHODS: The Vision Function Questionnaire (VFQ-25) and Ocular Surface Disease Index (OSDI) questionnaire were administered at baseline and at months 1, 6, 12, and 24. PRO responders were defined as patients reaching improvement based on minimally important differences. RESULTS: A total of 505 patients were randomized (386 iStent inject® [Glaukos], 119 surgery alone). The iStent inject® group exhibited a greater percentage of PRO responders across all follow-up visits over 24 months, averaging 58.0% vs 45.8%; P < .05 for VFQ-25 composite scores and 56.7% vs 48.9%; P < .05 for OSDI composite scores. Odds of being a responder in the iStent inject® group was 60% (P < .05) higher for the VFQ-25 and 32% (P > .05) higher for the ODSI. Driving (49.0% vs 28.8%; P < .05), ocular pain (59.3% vs 47.2%; P < .05), and general vision (71.8% vs 60.0%; P < .05) were the VFQ-25 subscales responsible for differences between treatment groups. At month 24, 76.5% of VFQ-25 responders and 62.5% of nonresponders were medication free regardless of treatment group (P < .05). CONCLUSIONS: Exploratory analysis suggests that by reducing medication dependence, implantation with the micro-scale iStent inject® device with cataract surgery may improve QOL vs cataract surgery alone over 24 months, with improvements influenced by ocular symptoms and vision-related activities.


Assuntos
Catarata , Implantes para Drenagem de Glaucoma , Glaucoma de Ângulo Aberto , Glaucoma de Ângulo Aberto/terapia , Humanos , Pressão Intraocular , Qualidade de Vida , Stents , Tonometria Ocular
9.
Clin Ophthalmol ; 15: 481-489, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33603325

RESUMO

PURPOSE: To report interim 6-month safety and efficacy outcomes of 360° canaloplasty and 180° trabeculotomy using the OMNI® Surgical System concomitantly with phacoemulsification in patients with open-angle glaucoma (OAG). SETTING: Fifteen multi-subspecialty ophthalmology practices and surgery centers located in 14 states (Alabama, Arizona, Arkansas, Florida, Georgia, Iowa, Kansas, Montana, Nebraska, North Dakota, Oklahoma, Pennsylvania, Texas, and Wisconsin). DESIGN: Prospective, multicenter, IRB approved study of patients treated with canaloplasty (360°) and trabeculotomy (180°). Eligible patients had cataract and mild-moderate OAG with intraocular pressure (IOP) ≤33 mmHg on 1 to 4 hypotensive medications. METHODS: Medication washout prior to baseline diurnal IOP (Goldmann). Effectiveness outcomes included mean IOP and medications. Safety outcomes included adverse events (AE), best corrected visual acuity (BCVA) and secondary surgical interventions (SSI). Analysis includes descriptive statistics and t-tests evaluating change from baseline. RESULTS: A total of 137 patients were enrolled and treated. Mean diurnal IOP after washout was 23.8 ± 3.1 mmHg at baseline. At month 6, 78% (104/134) were medication free with IOP of 14.2 mmHg, a mean reduction of 9.0 mmHg (38%). 100% (104/104) had a ≥ 20% reduction in IOP and 86% (89/104) had IOP ≥6 and ≤18 mmHg. The mean number of medications at screening was 1.8 ± 0.9 and 0.6 ± 1.0 at month 6. AE included transient hyphema (4.6%) and IOP elevation ≥10 mmHg (2%). There were no AE for loss of BCVA or recurring hyphema. There were no SSI. CONCLUSION: Canaloplasty followed with trabeculotomy and performed concomitantly with phacoemulsification has favorable intra and perioperative safety, significantly reduces IOP and anti-glaucoma medications through 6 months in eyes with mild-moderate OAG.

10.
Surv Ophthalmol ; 65(5): 581-588, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32135174

RESUMO

I review the background of laser floater treatment and address the differences between the old technology and the new technology of YAG lasers. I also review some recent publications and discuss the importance of careful patient selection, some of the adverse events, and patient outcomes.


Assuntos
Oftalmopatias/cirurgia , Terapia a Laser/métodos , Lasers de Estado Sólido/uso terapêutico , Acuidade Visual , Vitrectomia/métodos , Corpo Vítreo/cirurgia , Humanos
11.
J Cataract Refract Surg ; 46(8): 1165-1171, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32358417

RESUMO

PURPOSE: To compare reduction in intraocular pressure (IOP) and IOP-lowering medication in eyes undergoing excisional goniotomy with Kahook Dual Blade (KDB) vs iStent microbypass implantation, both combined with phacoemulsification, in eyes with mild to moderate open-angle glaucoma (OAG). SETTING: Nine practices in the United States. DESIGN: Prospective, randomized, active-controlled, parallel-group clinical trial. METHODS: Eyes were randomized to KDB-Phaco or iStent-Phaco group. Demographics, corrected distance visual acuity, IOP, IOP-lowering medications, and adverse events were collected at baseline and at day 1, week 1, and months 1, 3, 6, and 12 postoperatively. The primary outcome measure was the proportion of eyes at 12 months with IOP reduction of 20% or greater or IOP medication reduction of 1 or more compared with baseline. RESULTS: For this study, 164 eyes of 164 patients were analyzed (82 in each group). Mean IOP was reduced at 12 months compared with baseline from 18.5 (standard of error 0.4) to 15.4 (0.4) mm Hg in the KDB-Phaco group and from 18.5 (0.3) to 16.1 (0.4) mm Hg in the iStent-Phaco group (P = .24). Mean IOP-lowering medications were reduced from 1.3 (0.1) to 0.3 (0.1) in the KDB-Phaco group and from 1.4 (0.1) to 0.4 (0.1) in the iStent-Phaco group (P = .17). Among study completers, the primary outcome was attained in 74 (93.7%) of 79 patients of KDB-Phaco eyes and 65 (83.3%) of 78 patients of iStent-Phaco eyes (P = .04). Both procedures had similar safety profiles. CONCLUSIONS: Both procedures lowered both IOP and the need for IOP-lowering medications effectively and safely in eyes with mild to moderate OAG and cataract. Significantly, more KDB-Phaco eyes than iStent-Phaco eyes met the primary outcome of 20% or greater IOP reduction or 1 or more medication reduction at 12 months.


Assuntos
Glaucoma de Ângulo Aberto , Trabeculectomia , Glaucoma de Ângulo Aberto/cirurgia , Humanos , Pressão Intraocular , Estudos Prospectivos , Estudos Retrospectivos , Stents , Malha Trabecular
12.
J Neurointerv Surg ; 11(3): 241-245, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-30415226

RESUMO

BACKGROUND: Accurate assessment of the prevalence of large vessel occlusion (LVO) in patients presenting with acute ischemic stroke (AIS) is critical for optimal resource allocation in neurovascular intervention. OBJECTIVE: To perform a systematic review of the literature in order to identify the proportion of patients with AIS presenting with LVO on image analysis. METHODS: A systematic review was performed according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines in order to identify studies reporting LVO rates for patients presenting with AIS. Studies that included patients younger than 18 years, were non-clinical, or did not report LVO rates in the context of a consecutive AIS series were excluded. Characteristics regarding presentation, diagnosis, and LVO classification were recorded for each paper. RESULTS: Sixteen studies, spanning a total of 11 763 patients assessed for stroke, were included in the qualitative synthesis. The majority (10/16) of articles reported LVO rates exceeding 30% in patients presenting with AIS. There was substantial variability in the LVO definitions used, with nine unique classification schemes among the 16 studies. The mean prevalence of LVO was 31.1% across all studies, and 29.3% when weighted by the number of patients included in each study. CONCLUSIONS: Despite the wide variability in LVO classification, the majority of studies in the last 10 years report a high prevalence of LVO in patients presenting with AIS. These rates of LVO may have implications for the volume of patients with AIS who may benefit from endovascular therapy.


Assuntos
Isquemia Encefálica/diagnóstico , Isquemia Encefálica/epidemiologia , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/epidemiologia , Isquemia Encefálica/terapia , Humanos , Prevalência , Estudos Prospectivos , Estudos Retrospectivos , Acidente Vascular Cerebral/terapia
13.
J Cataract Refract Surg ; 45(2): 204-212, 2019 02.
Artigo em Inglês | MEDLINE | ID: mdl-30367938

RESUMO

PURPOSE: To assess the efficacy and safety of a sustained-release intracanalicular dexamethasone insert for the treatment of postoperative ocular inflammation and pain in patients having cataract surgery. SETTING: Twenty-one United States sites. DESIGN: Prospective multicenter randomized parallel-arm double-masked vehicle-controlled phase 3 study. METHODS: Patients with planned clear corneal cataract surgery were randomized (1:1) to receive dexamethasone insert or placebo, and the treatment was placed in the canaliculus of the eye immediately after surgery (Day 1). The primary efficacy endpoints were complete absence of anterior chamber cells at Day 14 and complete absence of pain at Day 8. RESULTS: The study comprised 438 adult patients (216 in the treatment arm and 222 in the placebo arm). At Day 14, significantly more patients had an absence of anterior chamber cells in the dexamethasone insert arm compared with placebo (52.3% versus 31.1%; P < .0001). At Day 8, significantly more patients had an absence of ocular pain in the dexamethasone insert arm compared with placebo (79.6% versus 61.3%; P < .0001). The dexamethasone insert arm showed no increase compared with placebo in incidence of all adverse events or ocular adverse events. Twice as many placebo patients required rescue therapy, compared with treated patients at Day 14. CONCLUSIONS: Both primary endpoints were successfully met. In addition, patients receiving the dexamethasone insert experienced a decrease in inflammation after surgery as early as Day 4 through Day 45, and a decrease in pain as early as one day after surgery (Day 2) through Day 45. The dexamethasone insert was well-tolerated, and the adverse events profile was similar to placebo.


Assuntos
Extração de Catarata/efeitos adversos , Dexametasona/administração & dosagem , Dor Ocular/tratamento farmacológico , Complicações Pós-Operatórias/tratamento farmacológico , Uveíte Anterior/tratamento farmacológico , Acuidade Visual , Idoso , Preparações de Ação Retardada , Método Duplo-Cego , Feminino , Seguimentos , Glucocorticoides/administração & dosagem , Humanos , Masculino , Soluções Oftálmicas/administração & dosagem , Estudos Prospectivos , Resultado do Tratamento , Uveíte Anterior/etiologia
14.
Ophthalmic Surg Lasers Imaging Retina ; 49(10): 806-811, 2018 10 01.
Artigo em Inglês | MEDLINE | ID: mdl-30395668

RESUMO

Vitrectomy is an effective treatment for visually disabling vitreous opacities (floaters) but carries significant surgical risk. Nd:YAG laser vitreolysis using newer technology has been shown safe and effective in treating symptomatic Weiss ring vitreous floaters. These Weiss rings, as well as amorphous opacities in the mid- to posterior vitreous, can be impossible to visualize or treat using conventional YAG lasers. In the cases presented here, undetected symptomatic amorphous type posterior vitreous floaters were confirmed with assistance of a novel optical coherence tomography application and successfully treated using a YAG laser optimized for vitreolysis. These cases suggest that with proper technology and technique, laser vitreolysis may be safer and more effective than previously recognized. [Ophthalmic Surg Lasers Imaging Retina. 2018;49:806-811.].


Assuntos
Oftalmopatias/cirurgia , Terapia a Laser/métodos , Lasers de Estado Sólido/uso terapêutico , Cirurgia Assistida por Computador/métodos , Tomografia de Coerência Óptica/métodos , Vitrectomia/métodos , Corpo Vítreo/cirurgia , Oftalmopatias/diagnóstico , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Acuidade Visual , Corpo Vítreo/patologia
15.
World Neurosurg ; 120: e68-e71, 2018 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-30055364

RESUMO

BACKGROUND: The exact mechanism, incidence, and risk factors for cerebral vasospasm after traumatic intracranial hemorrhage (ICH) continue to be poorly characterized. The incidence of post-traumatic vasospasm (PTV) varies depending on the detection modality. OBJECTIVE: We aimed to shed light on the predictors, associations, and true incidence of cerebral vasospasm after traumatic ICH using digital subtraction angiography (DSA) as the gold standard. METHODS: We examined a prospectively maintained database of traumatic brain injury (TBI) patients to identify patients with ICH secondary to TBI enrolled between 2002 and 2015 at our trauma center. Patients with TBI-associated ICH and evidence of elevated velocities on transcranial Doppler and computed tomography angiograms, confirmed with DSA were included. The diagnostic cerebral angiograms were evaluated by 2 blinded neurointerventionalists for cerebral vasospasm. Statistical analyses were conducted to determine predictors of PTV. RESULTS: Twenty patients with ICH secondary to TBI and evidence of vasospasm underwent DSAs. Seven patients (7/20; 35%) with traumatic ICH developed cerebral vasospasm and of those, 1 developed delayed cerebral ischemia (1/7; 14%). Of these 7 patients, 6 presented with subarachnoid hemorrhage (6/7; 85%). Vasospasm was substantially more common in patients with a Glasgow Coma Scale <9 (P = 0.017) than in all other groups. CONCLUSIONS: PTV as demonstrated by DCA may be more common than previously reported. Patients who exhibit PTV were more likely to have a Glasgow Coma Scale <9. This subgroup of patients may benefit from more systematic screening for the development of PTV, and earlier monitoring for signs of delayed cerebral ischemia.


Assuntos
Hemorragia Encefálica Traumática/epidemiologia , Hemorragia Cerebral Traumática/epidemiologia , Hemorragia Cerebral Intraventricular/epidemiologia , Escala de Coma de Glasgow , Hematoma Subdural/epidemiologia , Hemorragia Subaracnoídea Traumática/epidemiologia , Vasoespasmo Intracraniano/epidemiologia , Adulto , Angiografia Digital , Hemorragia Encefálica Traumática/diagnóstico por imagem , Hemorragia Encefálica Traumática/fisiopatologia , Angiografia Cerebral , Hemorragia Cerebral Traumática/diagnóstico por imagem , Hemorragia Cerebral Traumática/fisiopatologia , Hemorragia Cerebral Intraventricular/diagnóstico por imagem , Hemorragia Cerebral Intraventricular/fisiopatologia , Angiografia por Tomografia Computadorizada , Bases de Dados Factuais , Feminino , Hematoma Subdural/diagnóstico por imagem , Hematoma Subdural/fisiopatologia , Humanos , Hemorragia Intracraniana Traumática/diagnóstico por imagem , Hemorragia Intracraniana Traumática/epidemiologia , Hemorragia Intracraniana Traumática/fisiopatologia , Masculino , Medição de Risco , Fatores de Risco , Hemorragia Subaracnoídea Traumática/diagnóstico por imagem , Hemorragia Subaracnoídea Traumática/fisiopatologia , Ultrassonografia Doppler Transcraniana , Vasoespasmo Intracraniano/diagnóstico por imagem
16.
Neurosurgery ; 80(4): 646-654, 2017 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-28362925

RESUMO

Bilateral carotid cavernous fistulas are rare entities that can cause debilitating symptoms and can lead to more severe consequences if left untreated. Therefore, the recognition and adequate treatment of these pathologies is very important. We present 2 cases of bilateral carotid cavernous fistulas that arose as a result of cavernous sinus thrombosis. We review the literature and discuss the pathophysiology, symptomatology, management, and treatment of bilateral carotid cavernous fistulas. Within our own cases, treatment of the patients was varied. The patient in case 1 was successfully treated with endovascular therapy after a failed trial of anticoagulation. The patient in case 2 demonstrated resolution of bilateral carotid cavernous fistulas after anticoagulation therapy. Case 2 highlights the fact that certain cases of bilateral carotid cavernous fistulas due to cavernous sinus thrombosis may benefit from extensive anticoagulation therapy. If anticoagulation therapy is unsuccessful, endovascular therapy may prove beneficial in resolving the fistulous shunt.


Assuntos
Fístula Carótido-Cavernosa/etiologia , Trombose do Corpo Cavernoso/complicações , Embolização Terapêutica , Procedimentos Endovasculares , Idoso , Anticoagulantes/uso terapêutico , Cloridrato de Bendamustina , Fístula Carótido-Cavernosa/tratamento farmacológico , Fístula Carótido-Cavernosa/cirurgia , Trombose do Corpo Cavernoso/tratamento farmacológico , Trombose do Corpo Cavernoso/cirurgia , Humanos , Masculino , Pessoa de Meia-Idade
18.
Interv Neuroradiol ; 22(2): 236-9, 2016 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-26769735

RESUMO

With the increased reliance on the Pipeline embolization device (PED) for the treatment of complex intracranial aneurysms, our experience in managing intraoperative complications and challenges continues to accumulate amid a scarcity of reports on rescue strategies and innovative techniques. We describe the case of a 50-year-old woman who presented for elective repeat embolization of a right posterior communicating artery aneurysm with some residual aneurysmal filling. During the procedure the patient developed severe vasospasm due to vessel irritation and this led us to proceed to deploy the PED through a biaxial construct composed of the 6 French Envoy MPD DA XB, and the Marksman catheters. The biaxial construct in select patients may provide the required stability while eliminating the need for an intermediate catheter, minimizing embolic risk, and allowing for less irritation to the vessel. Larger studies are required for further validation.


Assuntos
Embolização Terapêutica/instrumentação , Aneurisma Intracraniano/terapia , Angiografia Digital , Cateterismo , Catéteres , Angiografia Cerebral , Embolização Terapêutica/métodos , Feminino , Humanos , Complicações Intraoperatórias/terapia , Angiografia por Ressonância Magnética , Pessoa de Meia-Idade , Artéria Cerebral Posterior , Stents , Vasoespasmo Intracraniano/etiologia , Vasoespasmo Intracraniano/terapia
19.
Interv Neurol ; 4(3-4): 130-7, 2016 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-27051409

RESUMO

BACKGROUND: Developmental venous anomalies (DVAs) are variations of normal transmedullary veins draining white and gray matter. In the vast majority of cases, DVAs are diagnosed incidentally and should be considered as benign entities. In extremely rare circumstances, DVAs may become symptomatic due to mechanical or flow-related etiologies. Thrombosis of the collector vein of a DVA is a rare type of a flow-related complication with only 29 cases reported in the literature, the majority of which are supratentorial. Infratentorial thrombosed DVAs are thus extremely rare and the few cases reported have typically caused symptoms due to venous ischemic infarctions. SUMMARY: We report a case of an infratentorial DVA with a thrombosed drainage vein in a patient with nonhemorrhagic, noninfarcted venous congestive edema, which was successfully treated with high-dose glucocorticoids and short-term anticoagulation. We review the pertinent venous anatomy of the posterior fossa as well as the literature of symptomatic infratentorial thrombosed DVAs. KEY MESSAGE: The presented case of an infratentorial thrombosed DVA with cerebellar and pontine venous congestive edema is extremely rare. A working knowledge of posterior fossa venous anatomy and possible pathomechanisms responsible for the rarely symptomatic lesion will aid in the timely and efficacious treatment of such lesions.

20.
World Neurosurg ; 92: 581.e1-581.e5, 2016 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-27338210

RESUMO

BACKGROUND: Visual loss can be encountered in the immediate, early, or even delayed postoperative period after resection of skull base meningiomas involving the optic apparatus. Various mechanisms for visual loss can include mechanical injury, vascular insult, optic nerve and chiasm edema, and vasospasm of the blood supply to the visual apparatus. CASE DESCRIPTION: In this article, we describe a patient who developed unilateral visual worsening in the early postoperative period after skull base resection of a sphenoclinoidocavernous meningioma that was compressing the ipsilateral optic nerve. After implementing hyperdynamic therapy and high-dose corticosteroids, catheter angiography showed severe vasospasm of the ipsilateral ophthalmic artery with delayed filling of the choroidal blush. Intra-arterial chemical angioplasty with verapamil was administered that resulted in angiographic improvement and clinical restoration of vision back to preoperative baseline. Vision remained stable in the postoperative course and continued to improve after discharge from the hospital. CONCLUSIONS: To our knowledge, this is the first report of successful reversal of postoperative unilateral visual loss related to vasospasm after resection of a skull base sphenoclinoidocavernous meningioma. This may be a useful strategy to diagnose and treat possible vasospasm-induced visual loss after resection of skull base meningiomas involving the optic apparatus.


Assuntos
Procedimentos Neurocirúrgicos/efeitos adversos , Complicações Pós-Operatórias/tratamento farmacológico , Vasodilatadores/uso terapêutico , Vasoespasmo Intracraniano/tratamento farmacológico , Verapamil/uso terapêutico , Baixa Visão/tratamento farmacológico , Corticosteroides/uso terapêutico , Feminino , Humanos , Angiografia por Ressonância Magnética , Imageamento por Ressonância Magnética , Neoplasias Meníngeas/diagnóstico por imagem , Neoplasias Meníngeas/terapia , Meningioma/diagnóstico por imagem , Meningioma/terapia , Pessoa de Meia-Idade , Complicações Pós-Operatórias/etiologia , Base do Crânio/cirurgia , Osso Esfenoide/cirurgia , Resultado do Tratamento , Vasoespasmo Intracraniano/etiologia , Baixa Visão/etiologia
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