A Direct Aspiration First Pass Technique in Japanese Real-World Clinical Setting

Abstract BACKGROUND It is debatable whether mechanical thrombectomy has benefits in a real-world setting outside the more rigid and selective clinical trial environment. OBJECTIVE To evaluate clinical outcomes, efficacy, and safety of mechanical thrombectomy in single-center retrospective cohort case series. METHODS We reviewed prospectively collected data from our large-vessel occlusion stroke database to identify patients undergoing mechanical thrombectomy using Penumbra catheters (Penumbra, Almeida, California) as first-line devices. The primary outcomes were the modified Rankin Scale score at 90 d and recanalization rate. The secondary outcomes included the rates of hemorrhagic complications and mortality. RESULTS The entire study population included 298 patients. Thrombolysis in Cerebral Infarction Scale ≥2b was achieved in 86.6% of patients. Fifty-five patients (18.5%) were outside the 6 hr time window and 82 patients (27.5%) were over 80-yr old. The posterior circulation thrombectomy rate was 12.4%. At 90 d from onset, 49.3% of patients had favorable outcomes. The parenchymal hemorrhage type 2 (PH2) and subarachnoid hemorrhage rates were 2.3% and 11.7%, respectively. In multivariate analyses, cerebral blood flow/cerebral blood volume mismatch (odds ratio [OR] = 9.418; 95% confidence interval [CI], 3.680-27.726; P < .0001), onset to recanalization time (OR = 0.995; 95% CI, 0.991-0.998; P = .0003), and hemorrhagic complications including PH2 and subarachnoid hemorrhage (OR = 0.186; 95% CI, 0.070-0.455; P = .0002) were associated with favorable outcomes. CONCLUSION A direct aspiration first pass technique with an adjunctive device demonstrated high recanalization rates in old Japanese patients. Our patient cohort may reflect the application of endovascular techniques in acute ischemic stroke treatment in a real-world setting.

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Early Outcomes of a Synthetic Cartilage Implant for Treatment of Hallux Rigidus: A Series of 87 Patients

Foot & Ankle Orthopaedics ◽

10.1177/2473011420s00151 ◽

2020 ◽

Vol 5 (4) ◽

pp. 2473011420S0015

Author(s):

Michael A. Campbell

Keyword(s):

Real World ◽

Case Series ◽

Hallux Rigidus ◽

Time Interval ◽

Pivotal Trial ◽

Human Cartilage ◽

First Metatarsophalangeal Joint ◽

Real World Setting ◽

Positive Results

Category: Midfoot/Forefoot; Bunion Introduction/Purpose: Arthritis of the first metatarsophalangeal joint (MTPJ), or hallux rigidus, is the most common arthritic condition of the foot, affecting 1 in 40 people over 50 years of age. One surgical option is the implantation of a synthetic polyvinyl alcohol hydrogel implant that has water content, tensile strength, and biomechanical properties similar to those of healthy human cartilage. This implant is supported by positive outcomes in a Level 1 clinical trial out to over 5 years follow-up. The objective of this case series was to determine if the positive results seen in the pivotal trial could be recreated in a ‘real world’ setting. Methods: All patients implanted with a synthetic cartilage implant by a single surgeon between September 2016 and December 2018 were retrospectively reviewed. Consecutive adult patients diagnosed with hallux rigidus that failed nonoperative treatment were included in the analysis. Patient demographics, complications, Foot and Ankle Ability Measures (FAAM), and a 10-point visual analog score (VAS) were collected from the chart review. Results: A total of 87 patients were available for review during the time interval of interest with a mean length of follow-up of 38.7 weeks (range, 2-125). The average patient age was 56.6 years (range, 21-80). Two (2.3%) patients were converted to fusion. The first at 71 weeks and the second at 73 weeks following the initial surgery. Six (6.9%) patients experienced some complications: 3 cases of synovitis treated with corticosteroid injection; 1 case of sesamoiditis; 1 case of neuritis; and 1 insufficiency fracture at the plantar aspect of the MTPJ with implant subsidence. Patients had mean FAAM ADL and VAS scores of 81.2 (range 21-100) and 0.6 (range, 0-3), respectively, at final follow-up. Conclusion: This retrospective review is one of the first presentations of outcomes for a synthetic cartilage implant in a ‘real world’ setting. Patients experienced excellent pain relief, good functional outcomes, and a satisfactory survival rate. This case series confirms the positive results seen in the original pivotal trial for this device.

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Clinical observations of acute onset of myopic optic neuropathy in a real-world setting

International Journal of Ophthalmology ◽

10.18240/ijo.2021.03.21 ◽

2021 ◽

Vol 14 (3) ◽

pp. 461-467

Author(s):

Li Liao ◽

◽

Fang Fang ◽

Xiao-Hua Zhu ◽

◽

...

Keyword(s):

Clinical Features ◽

Optic Neuropathy ◽

Real World ◽

Vision Loss ◽

Case Series ◽

Acute Onset ◽

Glucocorticoid Therapy ◽

Glucocorticoid Treatment ◽

Real World Setting ◽

Systemic Glucocorticoid

AIM: To describe the clinical features of acute myopic onset of optic neuropathy and observe the effects of retrobulbar and systemic glucocorticoid therapy in a real-world setting. METHODS: A retrospective observational case series included 18 patients with a clinical diagnosis of acute onset of myopic optic neuropathy in a real-world setting. While the patients were using retrobulbar and systemic glucocorticoid therapy, various imaging examination data were analysed, and the clinical features of myopic optic neuropathy were summarized for 6mo to 2y. RESULTS: The included group of patients with acute onset of myopic optic neuropathy consisted mostly of females (n=11). The visual field (VF) showed abnormalities in bilateral eyes, including the spread of physiological blind spots, central and paracentral dark spots, and centripetal peripheral VF reduction; but central vision with no subjective changes. The visual evoked potential (VEP) was abnormal in all eyes with vision loss. The best corrected visual acuity (BCVA) was improved from 1.04±0.63 to 0.47±0.57 (logMAR) after glucocorticoid treatment (P<0.05). In patients with a short course (within 1wk), recovery was fast and achieved the same BCVA as recorded before the onset within 6d. However, in patients with the long course (1 to 2wk), recovery was slow and did not achieve the BCVA recorded before the onset within 10d. The changes of intraocular pressure (IOP) were not obvious before and after treatment (18.68±5.30 vs 19.55±5.34 mm Hg, P>0.05). There was no recurrence during long-term follow-up observation. CONCLUSION: The acute onset of myopic optic neuropathy is characterized by BCVA and VF abnormalities in bilateral eyes. Retrobulbar and systemic glucocorticoid therapy is effective.

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Surgical aspects of thoracic aortic aneurysms: A case series from a real-world setting

Annals of Medicine and Surgery ◽

10.1016/j.amsu.2021.103099 ◽

2021 ◽

pp. 103099

Author(s):

Aniss Seghrouchni ◽

Noureddine Atmani ◽

Younes Moutakiallah ◽

Youssef El Bekkali ◽

Mahdi Ait Houssa

Keyword(s):

Real World ◽

Case Series ◽

Aortic Aneurysms ◽

Thoracic Aortic Aneurysms ◽

Real World Setting ◽

Surgical Aspects

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Abstract WP45: Subarachnoid Hemorrhage After Mechanical Thrombectomy With a Direct Aspiration First Pass Technique

Stroke ◽

10.1161/str.50.suppl_1.wp45 ◽

2019 ◽

Vol 50 (Suppl_1) ◽

Author(s):

Yser Orabi ◽

Mohamad Anadani ◽

Ali Alawieh ◽

Alejandro M.Spiotta

Keyword(s):

Subarachnoid Hemorrhage ◽

Mechanical Thrombectomy ◽

First Pass

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1003. BIC/FTC/TAF Maintains Viral Suppression in Patients with Documented M184V/I Mutations: A Real World Experience

Open Forum Infectious Diseases ◽

10.1093/ofid/ofaa439.1189 ◽

2020 ◽

Vol 7 (Supplement_1) ◽

pp. S530-S530

Author(s):

Nicholas Chamberlain ◽

James B Brock ◽

Leandro A Mena

Keyword(s):

Real World ◽

Viral Suppression ◽

Group Analysis ◽

Case Series ◽

Common Mutation ◽

Research Support ◽

Adherence To Medication ◽

Sustained Viral Suppression ◽

Real World Setting ◽

Level Resistance

Abstract Background The M184V/I mutation is a common mutation in treatment-experienced patients with HIV and confers high-level resistance to lamivudine and emtricitabine. Our objective is to assess the effectiveness of bictegravir (BIC)/emtricitabine (FTC)/tenofovir alafenamide (TAF) in a real-world setting in achieving and maintaining viral suppression in patients with documented M184V/I mutations. Methods This case series is comprised of treatment-experienced HIV-positive patients with documented historical or newly-identified M184V/I mutations who were placed on BIC/FTC/TAF as a switch strategy or as therapy for patients who had failed a prior regimen. Patients with any resistance to tenofovir or bictegravir were excluded. Our primary outcome was sustained viral suppression at 12 months after initiation of BIC/FTC/TAF. Results We included 33 patients (94% black, 52% male, median age 49, range 36-63) with an M184V/I mutation. The majority (91%) showed sustained viral suppression at 12 months of treatment. Non-adherence to medication was the common factor in all three cases of treatment failure. One patient developed an R263K mutation while on therapy, which conferred low-level resistance to bictegravir. There were no other instances of newly-acquired resistance to any of the components of BIC/FTC/TAF. Conclusion Our results demonstrate high success rates of BIC/FTC/ATF in achieving and maintaining viral suppression in patients with documented M184V/I mutations who adhere to medications in a real-world setting with a single instance of new treatment-emergent resistance to bictegravir. These findings are congruent with reported sub-group analysis in clinical trial data and support the use of BIC/FTC/TAF in patients with M184V/I mutations. Disclosures Leandro A. Mena, MD, MPH, Binx Health (Grant/Research Support)Evofem (Grant/Research Support)Gilead Science (Consultant, Grant/Research Support, Speaker’s Bureau)GSK (Grant/Research Support)Janssen (Grant/Research Support)Merck (Consultant, Grant/Research Support)Roche Molecular (Consultant, Grant/Research Support)SpeedDx (Grant/Research Support)ViiV Healthcare (Consultant, Grant/Research Support, Speaker’s Bureau)

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Endovascular Treatment of Acute Ischemic Stroke With the Penumbra System in Routine Practice: COMPLETE Registry Results

Stroke ◽

10.1161/strokeaha.121.034268 ◽

2021 ◽

Author(s):

Osama O. Zaidat ◽

Johanna T. Fifi ◽

Ashish Nanda ◽

Benjamin Atchie ◽

Keith Woodward ◽

...

Keyword(s):

Ischemic Stroke ◽

Cerebral Infarction ◽

Acute Ischemic Stroke ◽

Real World ◽

Mechanical Thrombectomy ◽

Modified Rankin Scale ◽

Large Vessel Occlusion ◽

Vessel Occlusion ◽

Real World Setting ◽

All Cause Mortality

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 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.

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Clot Composition Analysis as a Diagnostic Tool to Gain Insight into Ischemic Stroke Etiology: A Systematic Review

Journal of Stroke ◽

10.5853/jos.2021.02306 ◽

2021 ◽

Vol 23 (3) ◽

pp. 327-342

Author(s):

Alicia Aliena-Valero ◽

Júlia Baixauli-Martín ◽

Germán Torregrosa ◽

José I. Tembl ◽

Juan B. Salom

Keyword(s):

Cohort Studies ◽

Systematic Reviews ◽

Diagnostic Tool ◽

Mechanical Thrombectomy ◽

Size Structure ◽

Case Reports ◽

Case Series ◽

Composition Analysis ◽

Stroke Treatment ◽

Stroke Etiology

Mechanical thrombectomy renders the occluding clot available for analysis. Insights into thrombus composition could help establish the stroke cause. We aimed to investigate the value of clot composition analysis as a complementary diagnostic tool in determining the etiology of large vessel occlusion (LVO) ischemic strokes (International Prospective Register of Systematic Reviews [PROSPERO] registration # CRD42020199436). Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, we ran searches on Medline (using the PubMed interface) and Web of Science for studies reporting analyses of thrombi retrieved from LVO stroke patients subjected to mechanical thrombectomy (January 1, 2006 to September 21, 2020). The PubMed search was updated weekly up to February 22, 2021. Reference lists of included studies and relevant reviews were hand-searched. From 1,714 identified studies, 134 eligible studies (97 cohort studies, 31 case reports, and six case series) were included in the qualitative synthesis. Physical, histopathological, biological, and microbiological analyses provided information about the gross appearance, mechanical properties, structure, and composition of the thrombi. There were non-unanimous associations of thrombus size, structure, and composition (mainly proportions of fibrin and blood formed elements) with the Trial of Org 10172 in Acute Stroke Treatment (TOAST) etiology and underlying pathologies, and similarities between cryptogenic thrombi and those of known TOAST etiology. Individual thrombus analysis contributed to the diagnosis, mainly in atypical cases. Although cohort studies report an abundance of quantitative rates of main thrombus components, a definite clot signature for accurate diagnosis of stroke etiology is still lacking. Nevertheless, the qualitative examination of the embolus remains an invaluable tool for diagnosing individual cases, particularly regarding atypical stroke causes.

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