Vigilance Aid Use and Aircraft Carrier Landing Performance in Pilots of Tactical Aircraft

2020 ◽  
Vol 91 (6) ◽  
pp. 518-524
Author(s):  
Craig S. Schallhorn
Keyword(s):  
Primary Outcome ◽  
Linear Regression Analysis ◽  
Secondary Outcome ◽  
Outcome Analysis ◽  
Multivariate Linear Regression Analysis ◽  
Operational Environment ◽  
Aircraft Carrier ◽  
Mixed Effect ◽  
Flight Operations ◽  
Objective Evidence

BACKGROUND: Fatigue is a well-known hazard in aviation. In military fighter communities, policies have evolved to allow for in-flight use of pharmacological vigilance aids to counteract the negative effects of fatigue. With limited objective evidence supporting the role of these medications in continuous flight operations, the present study seeks to evaluate whether use of modafinil is associated with pilot aircraft carrier landing performance.METHODS: A retrospective, observational study was completed following carrier-based flight operations in support of Operation Inherent Resolve. All graded landing passes were included in the analysis. Mixed-effect multivariate linear regression analysis was utilized for the primary outcome of landing signal officer grade of landing performance following combat sorties for events with reported in-flight use of modafinil.RESULTS: A total of 1122 sorties were flown by 79 different pilots with an average landing pass grade of 3.86. The primary outcome of modafinil use in-flight was not generally associated with landing performance. In a subset analysis of more senior ranked aviators, modafinil use appeared to offer a relative performance improvement back to baseline (+0.19). Secondary outcome analysis revealed landing performance was associated with advanced landing technologies (+0.25), sorties later in deployment (+0.05 per 30 d), total career carrier landings (+0.03 per 100 traps), and longer mission duration (-0.04 per hour).DISCUSSION: In the context of evidence supporting subjective benefits of vigilance aid use by aircrew, the results of this study provide ample objective support to the controlled use of modafinil in the operational environment.Schallhorn CS. Vigilance aid use and aircraft carrier landing performance in pilots of tactical aircraft. Aerosp Med Hum Perform. 2020; 91(6):518–524.

scholarly journals Nephrotoxicity of concomitant piperacillin/tazobactam and teicoplanin compared with monotherapy

2020 ◽  
Vol 76 (1) ◽  
pp. 212-219
Author(s):  
J D Workum ◽  
C Kramers ◽  
E Kolwijck ◽  
J A Schouten ◽  
S N de Wildt ◽  
...  
Keyword(s):  
Renal Function ◽  
Serum Creatinine ◽  
Retrospective Cohort ◽  
Primary Outcome ◽  
Linear Regression Analysis ◽  
Kidney Injury ◽  
Secondary Outcome ◽  
Multivariate Linear Regression Analysis ◽  
Single Centre ◽  
Health Records

Abstract Objectives Piperacillin/tazobactam combined with vancomycin has been associated with a decline in renal function when compared with monotherapy. Teicoplanin is a glycopeptide similar to vancomycin. We investigated whether piperacillin/tazobactam combined with teicoplanin is associated with a decline in renal function as well. Methods We conducted a single-centre retrospective cohort study with data from our electronic health records from 9 August 2013 to 15 November 2019, including all adult patients that received either piperacillin/tazobactam, teicoplanin or piperacillin/tazobactam + teicoplanin. The incidence of acute kidney injury (AKI) at 48–72 h served as the primary outcome, whereas change in serum creatinine served as a secondary outcome. Results Of the 4202 included patients, 3188 (75.9%) received piperacillin/tazobactam, 791 (18.8%) received teicoplanin and 223 (5.3%) received piperacillin/tazobactam + teicoplanin. The incidence of AKI at 48–72 h after commencement of antibiotic therapy was 5.4% for piperacillin/tazobactam, 3.4% for teicoplanin and 11.7% for piperacillin/tazobactam + teicoplanin (P < 0.001). However, mean serum creatinine at 48–72 h was slightly higher in the piperacillin/tazobactam + teicoplanin group therapy compared with baseline [+1.61% (95% CI –2.25 to 5.70)], indicating a slight decrease in renal function, and decreased for piperacillin/tazobactam [–1.98% (95% CI –2.73 to –1.22)] and teicoplanin [–8.01% (95% CI –9.54 to –6.45)]. After correcting for significant confounders in a multivariate linear regression analysis, these patterns remained. Conclusions Our study suggests that piperacillin/tazobactam + teicoplanin is associated with a higher prevalence of AKI compared with monotherapy. However, as the overall decline in renal function with piperacillin/tazobactam + teicoplanin is very small, its clinical relevance is likely limited. Therefore, piperacillin/tazobactam + teicoplanin can probably be safely combined.

scholarly journals Can changes in spending on health and social care explain the recent mortality trends in Scotland? A protocol for an observational study

BMJ Open ◽  
2020 ◽  
Vol 10 (7) ◽  
pp. e036025
Author(s):  
Christina Wraw ◽  
Jon Minton ◽  
Rory Mitchell ◽  
Grant M A Wyper ◽  
Clare Campbell ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Social Care ◽  
Linear Regression Analysis ◽  
Mortality Rates ◽  
Secondary Outcome ◽  
Service Research ◽  
Mortality Trends ◽  
Data Set ◽  
Health And Social Care ◽  
The Absolute

IntroductionThere have been steady reductions in mortality rates in the majority of high-income countries, including Scotland, since 1945. However, reductions in mortality rates have slowed down since 2012–2014 in these nations; and have reversed in some cases. Deaths among those aged 55+ explain a large amount of these changing mortality trends in Scotland. Increased pressures on health and social care services have been suggested as one factor explaining these changes. This paper outlines a protocol for the approach to testing the extent to which health and social care pressures can explain recent mortality trends in Scotland. Although a slower rate of mortality improvements have affected people of all ages, certain ages have been more negatively affected than the others. The current analyses will be run by age-band to test if the service pressure-mortality link varies across age-group.Methods and analysisThis will be an observational ecological study based on the Scottish population. The exposures of interest will be the absolute (primary outcome) and percentage (secondary outcome) change in real terms per capita spending on social and healthcare services between 2011 and 2017. The outcome of interest will be the absolute (primary outcome) and percentage (secondary outcome) change in age-standardised mortality rate between 2012 and 2018 for men and women separately. The units of analysis will be the 32 local authorities and the 14 territorial health boards. The analyses will be run for both all age-groups combined and for the following age bands: <1, 1–15, 16–44, 45–64, 65–74, 75–84 and 85+.A series of descriptive analyses will summarise the distribution of health and social care expenditure and mortality trends between 2011 and 2018. Linear regression analysis will be used to investigate the direct association between health care spending and mortality rates.Ethics and disseminationThe data used in this study will be publicly available and aggregated and will not be individually identifiable; therefore, ethical committee approval is not needed. This work will not result in the creation of a new data set. On completion, the study will be stored within the National Health Service research governance system. All of the results will be published once they have been shared with partner agencies.

Effect of pectasol-c modified citrus pectin (P-MCP) treatment (tx) on PSA dynamics in non- metastatic biochemically relapsed prostate cancer (BRPC) patients (pts): Primary outcome analysis of a prospective phase II study.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e16609-e16609 ◽  
Author(s):  
Daniel Keizman ◽  
Moshe A. Frenkel ◽  
Avivit Peer ◽  
Eli Rosenbaum ◽  
David Margel ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Primary Outcome ◽  
Serum Testosterone ◽  
Secondary Outcome ◽  
Outcome Analysis ◽  
Carbohydrate Binding ◽  
Full Cohort ◽  
Cancer Pathogenesis ◽  
Prospective Phase

e16609 Background: 30% of pts with localized PC will have a biochemical relapse post local tx. Their optimal tx remains elusive. While androgen deprivation therapy is effective in reducing PSA level, its long-term benefit remain undefined, and it is associated with significant toxicities. Thus, evaluation of new non-toxic compounds in this pt population is warranted. P-MCP is a competitive inhibitor of galectin-3, a carbohydrate-binding protein, known to be involved in cancer pathogenesis. Pre-clinical data suggest that P-MCP is active in PC, and in two previous smaller clinical trials in biochemically relapsed prostate cancer (BRPC) pts, a PSA response/stabilization rate of 57%-75% was noted. In the present study, we aimed to evaluate the safety and PSA dynamics of P-MCP tx in BRPC pts. Methods: non-castrate non-metastatic BRPC pts were enrolled in a prospective phase 2 study of oral P-MCP tx, at 4.8 grams X 3/day for 6 months (mos). Eligible pts had 3 consecutive rise of PSA, without any tx in the previous 3 mos, a normal level of serum testosterone, and negative scans. The primary outcome was the rate of pts without disease progression (DP) (clinically, biochemically with stabilization/decrease of PSA or improvement of PSA doubling time = PSADT, and radiologically) at 6 mos. A Sample size of ≥ 50 pts provided 85% power to assess a decrease in DP rate from 80% (natural history) to 40% (P-MCP tx) at 6 mos. Pts that did not progress at 6 mos, were treated for subsequent 12 mos (secondary outcome of long term effect). Herein we report the results of the primary outcome analysis. Results: 53 pts were enrolled. Median age was 74 years. Tx of the primary tumor consisted of surgery in 13% (n = 7), radiation in 60% (n = 32), and both in 26% (n = 14). No pt had tx related grade 3/4 toxicity. One pt withdrew his consent after 1 mos. At present, 46 pts completed 6 mos of tx, and were analyzed for the primary outcome. Among them, 20% (n = 9) had grade 1 toxicity (all gas and bloating ). The primary outcome was met in 76% (n = 35), that did not progress at 6 mos of tx. Of these, 59% (n = 27) had a stabilization/decrease of PSA, 70% (n = 32) had an improvement (increase) of PSADT, and all had no metastases on scans at 6 mos. DP at 6 mos was noted in 24% (n = 11: PSA only in 20%, n = 9; PSA and scans in 4%, n = 2). Full cohort data (additional 6 pts that will complete 6 mos of tx) will be available by June 2019. Conclusions: The present study suggests the safety and potential benefit of P-MCP tx on progression of BRPC. Clinical trial information: NCT01681823.

Abstract 1122‐000133: ANA Catheter System, Combined With a Stent Retriever in Acute Ischemic Stroke Trial (SOLONDA)

2021 ◽  
Vol 1 (S1) ◽  
Author(s):  
Marc Ribo ◽  
Manuel Requena ◽  
Alejandro Tomasello ◽  
David Hernandez ◽  
Maria Angeles De Miquel ◽  
...  
Keyword(s):  
Functional Outcome ◽  
Primary Outcome ◽  
Rescue Therapy ◽  
Data Safety Monitoring Board ◽  
Trial Steering Committee ◽  
High Rate ◽  
Secondary Outcome ◽  
Outcome Analysis ◽  
Symptomatic Intracerebral Hemorrhage ◽  
First Pass

Introduction : The ANA™ (Anaconda Biomed) thrombectomy system is a novel stroke thrombectomy device comprising a self‐expanding funnel designed to reduce clot fragmentation by locally restricting flow while becoming as wide as the lodging artery. Once deployed, ANA allows distal aspiration in combination with a stentretriever (SR) to mobilize the clot into the funnel where it remains copped during extraction. We investigate safety and efficacy of ANA™ in a first‐in‐man study. Methods : The SOLONDA study was prospective, multicenter (9 centers in Spain) with blinded assessment of the primary outcome by an independent core lab. Patients with an acute occlusion of terminal internal carotid artery (TICA), M1 or M2 segments of the middle cerebral artery (MCA) admitted within 8 hours from symptom onset were eligible. The primary endpoint was successful reperfusion, defined as mTICI≥2b in the target vessel with ≤3 passes of the ANA device in combination with a SR, without the use of rescue therapy in the intention to treat population. Primary predefined analysis was non‐inferiority as compared to performance endpoint observed in HERMES (71.1%). Secondary outcome measures included per‐pass reperfusion scores, symptomatic intracerebral hemorrhage (sICH), NIHSS at day 5, and mRS at 90 days. After enrollment of 74 patients, an interim analysis was conducted. The trial Steering Committee decided to terminate recruitment due to overwhelming evidence that safety and performance objectives were reached. Results : Mean age was 71.6 (SD 8.9) years, 46.6% women and median NIHSS on admission 14 (IQR 10–19). Sites of primary occlusion were: TICA 10 (13.7%), M1‐MCA 37 (50.7%) and M2‐MCA in 26 (35.6%) patients. The independent imaging corelab determined that successful reperfusion within 3 passes without rescue therapy was achieved in 60/72 (83.3%) with a rate of complete reperfusion (TICI 2c‐3) of 60% (43/72 patients). After non‐inferiority was confirmed (p<0.01), the ANA device also showed superiority in the primary outcome analysis (p = 0.02). Median procedural time from first angiogram to recanalization or final angiogram was 38(±28) minutes. First pass successful recanalization rate was 56% with a rate of first pass complete recanalization of 39%. Rescue therapy to obtain a mTICI≥2b was needed in 12/72 (17%) patients. At 90 days, the rate of favorable functional outcome was 57.5% and the rate of excellent functional outcome (mRS 0–1) 45.2%. The rate of severe adverse device‐related effects as adjudicated by the data safety monitoring board was 1.4% (one patient suffered an arterial dissection). Conclusions : In this first‐in‐man clinical experience, the ANA device achieved a high rate of complete recanalization with a good safety profile and favourable 90 days clinical outcomes. ClinicalTrials.gov Identifier: NCT04095767

scholarly journals Effectiveness of Extra Corporeal Removal Methods in the Management of Paraquat Poisoning: A Retrospective Analysis

2021 ◽  
Author(s):  
Balaji Srid ◽  
Jemima Pappu Raj ◽  
Vijayanarayana Kunhikatta ◽  
K Shivashankar ◽  
Athira Balakrishnan ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Treatment Strategies ◽  
Medical Problem ◽  
Asia Pacific ◽  
Secondary Outcome ◽  
Outcome Analysis ◽  
Secondary Complications ◽  
Paraquat Poisoning ◽  
The Mean ◽  
Treatment Analysis

Abstract Paraquat poisoning is a major medical problem in many parts of Asia, Pacific nations, and America. An increased rate of morbidity and mortality is associated with paraquat poisoning due to the absence of a definite antidote. The objective of this study is to assess the effectiveness of various treatment strategies with the outcome in paraquat poisoning. In this study the mean age of 206 patients were 28.14±11.35 years. Majority of the patient population were males (63.6%). Extra Corporeal Removal treatment (ECR) (45.6%) method was given majorly to the patients. Primary outcome analysis with respect to various ECR methods revealed that hemoperfusion (43.9%) showed better results compared to other ECR methods. Secondary outcome such as the ICU days (4.66±3.43), ventilator days (0.63±1.61), and secondary complications (7.6%) was comparatively less in the group treated with hemoperfusion. The treatment analysis revealed ECR of Paraquat by hemoperfusion ensured better clinical outcomes in terms of primary and secondary outcomes.

scholarly journals Detecting Oropharyngeal and Esophageal Emptying by Submental Ultrasonography and High-Resolution Impedance Manometry: Intubated vs. Non-Intubated Video-Assisted Thoracoscopic Surgery

Diagnostics ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. 1079
Author(s):  
Chih-Jun Lai ◽  
Jin-Shing Chen ◽  
Shih-I Ho ◽  
Zhi-Yin Lu ◽  
Yi-Ju Huang ◽  
...  
Keyword(s):  
High Resolution ◽  
Primary Outcome ◽  
Thoracoscopic Surgery ◽  
Oral Intake ◽  
Secondary Outcome ◽  
Video Assisted ◽  
Objective Evidence ◽  
Esophageal Emptying ◽  
Time Required ◽  
Video Assisted Thoracoscopic Surgery

Postoperative swallowing, affected by general anesthesia and intubation, plays an important part in airway and oral intake safety regarding effective oropharyngeal and esophageal emptying. However, objective evidence is limited. This study aimed to determine the time required from emergence to effective oropharyngeal and esophageal emptying in patients undergoing non-intubated (N) or tracheal-intubated (I) video-assisted thoracoscopic surgery (VATS). Hyoid bone displacement (HBD) by submental ultrasonography and high-resolution impedance manometry (HRIM) measurements were used to assess oropharyngeal and esophageal emptying. HRIM was performed every 10 min after emergence, up to 10 times. The primary outcome was to determine whether intubation affects the time required from effective oropharyngeal to esophageal emptying. The secondary outcome was to verify if HBD is comparable to preoperative data indicating effective oropharyngeal emptying. Thirty-two patients suitable for non-intubated VATS were recruited. Our results showed that comparable HBDs were achieved in all patients after emergence. Effective esophageal emptying was achieved at the first HRIM measurement in 11 N group patients and 2 I group patients (p = 0.002) and was achieved in all N (100%) and 13 I group patients (81%) within 100 min (p = 0.23). HBD and HRIM are warranted for detecting postoperative oropharyngeal and esophageal emptying.

Rationale, baseline characteristics and methodology of the non-interventional VIVA study in postmenopausal osteoporosis

2014 ◽  
Vol 23 (01) ◽  
pp. 49-55
Author(s):  
L. C. Hofbauer ◽  
D. Felsenberg ◽  
M. Amling ◽  
A. Kurth ◽  
P. Hadji
Keyword(s):  
Quality Of Life ◽  
Postmenopausal Osteoporosis ◽  
Primary Outcome ◽  
Osteoporosis Treatment ◽  
Secondary Outcome ◽  
Matched Pairs ◽  
Fracture History ◽  
Baseline Characteristics ◽  
Study Inclusion

SummaryIt is important to understand compliance and persistence with medication use in the clinical practice of osteoporosis treatment. The purpose of this work is to describe the “intravenous ibandronate versus oral alendronate” (VIVA) study, a non-interventional trial to assess the compliance and persistence of osteopenic postmenopausal women with treatment via weekly oral alendronate or intravenous ibandronate (Bonviva®) every three months.4477 patients receiving ibandronate 3 mg i. v. quarterly and 1491 patients receiving alendronate 70 mg orally weekly were included in the study. Matched pairs of 901 subjects in each group were also generated. Matching was performed on the basis of age, body mass index, fracture history at study inclusion, prior treatment with bisphosphonates and the number of concomitant disorders. Secondary outcome measures of osteoporosis related fractures, mobility restriction and pain, analgesia, quality of life questionnaires as well as attitudes to medications were assessed. The primary outcome parameters of compliance and persistence will be tracked in these subjects.At baseline, the entire collectives differed significantly on body weight (less in ibandronate group), duration since osteo - porosis diagnosis (longer in ibandronate), and incidence of prior osteoporotic fracture (higher in ibandronate group). The matched-pairs differed only on mobility restriction and quality of life (both worse in ibandronate group).The results from the VIVA study trial will provide scientific rationale for clinical recommendations in the pharmacological treatment of postmenopausal osteoporosis.

Patient Tolerability of Bowel Preparation is Associated with Polyp Detection Rate During Colonoscopy

2014 ◽  
Vol 23 (2) ◽  
pp. 135-140 ◽  
Author(s):  
Edward W. Holt ◽  
Kidist K. Yimam ◽  
Hanley Ma ◽  
Richard E. Shaw ◽  
Richard A. Sundberg ◽  
...  
Keyword(s):  
Bowel Preparation ◽  
Primary Outcome ◽  
Secondary Outcome ◽  
Polyp Detection ◽  
Cross Sectional ◽  
Quality Outcomes ◽  
Negative Experience ◽  
Polyp Detection Rate ◽  
Patient Reported ◽  
Bowel Prep

Background & Aims: A number of factors have been identified that influence the yield of screeningcolonoscopy. The perceived tolerability of bowel preparation has not been studied as a predictor of quality outcomes in colonoscopy. We aimed to characterize the association between patient-perceived tolerability of bowel preparation and polyp detection during colonoscopy.Methods: We performed a cross-sectional cohort study of 413 consecutive adult patients presenting foroutpatient colonoscopy at two outpatient endoscopy centers at our institution. We developed a standardized questionnaire to assess the patient's experience with bowel preparation. Bowel preparation quality was measured using the validated Ottawa scale and colonoscopic findings were recorded for each patient. The primary outcome was polyp detection and the secondary outcome was the quality of bowel preparation.Results: Patient-reported clarity of effluent during bowel preparation correlated poorly with Ottawa score during colonoscopy, k=0.15. Female gender was an independent risk factor for a poorly tolerated bowel prep (OR 3.93, 95% CI 2.30 - 6.72, p<0.001). Report of a poorly tolerated bowel prep was independently associated with the primary outcome, polyp detection (OR 0.39, 95% CI 0.18 - 0.84, p=0.02) and also with the secondary outcome, lower quality bowel preparation (OR 2.39, 95% CI 1.17 - 4.9, p=0.02).Conclusions: A patient-perceived negative experience with bowel preparation independently predicted both a lower quality bowel preparation and a lower rate of polyp of detection. Assessment of the tolerability of bowel preparation before colonoscopy may be a clinically useful predictor of quality outcomes during colonoscopy.

scholarly journals 57. Evaluating the Utility of a Penicillin Allergy Reconciliation Program within an Infectious Diseases Consult Population in a Community Health System

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S49-S50
Author(s):  
Bruce M Jones ◽  
Emily Plauche ◽  
Susan E Smith ◽  
Christopher M Bland
Keyword(s):  
Infectious Diseases ◽  
Health System ◽  
Community Health ◽  
Intervention Program ◽  
Primary Outcome ◽  
Panel Member ◽  
Penicillin Allergy ◽  
Secondary Outcome ◽  
Research Support ◽  
Research Grant

Abstract Background Penicillin allergy reconciliation is an important aspect of antimicrobial stewardship with ~10% of the population reporting a penicillin allergy. Our facility utilizes a Penicillin Allergy Reconciliation Program (PARP) led by an Infectious Diseases (ID) Pharmacist and pharmacy students to identify patients with penicillin allergies to reconcile and intervene when necessary. Information is collected by interview, electronic medical record (EMR) review, prescription outpatient fill history. This study evaluated reconciliations with and without a PARP in patients in a community health system. Methods This was a retrospective study that compared reconciliations performed on adult patients admitted at least once in 2019 with a self-reported penicillin allergy and ID physician consult at a hospital with a PARP (Institution 1) and one without a formal evaluation and intervention program (Institution 2) within the same community health system with same ID physicians. The primary outcome was documented reconciliation of a patient’s penicillin allergy during an inpatient visit in 2019. Reconciliation was defined as an edit or clarification (updating the severity, reaction, or comments section, as well as deleting) to a patient’s penicillin allergy in the EMR. The secondary outcome evaluated the percentage of total and ID consult patients with a penicillin allergy. Results There were 245 patients who met criteria and were included in the study, 113 from Institution 1 and 132 from Institution 2. For the primary outcome, there were 82 (72.6%) reconciliations at Institution 1 and 15 (11.4%) reconciliations at Institution 2 (p &lt; 0.001). Interventions at Institution 1 and 2 resulted in 74 EMR updates and 8 removals and 14 EMR updates and 1 removal, respectively. Reconciliation was performed on the same visit as the ID consult in 59/82 patients (72%) at Institution 1 and 11/15 patients (73.3%) at Institution 2. All reconciliations at Institution 2 were made by pharmacist (10) or nurses (5). For the secondary outcome, 10.9% of patients with an ID consult and 12.6% of all patients admitted in 2019 had a penicillin allergy (p=0.027). Conclusion A PARP led by an ID pharmacist and students was an effective method to perform penicillin allergy reconciliations, even in the presence of active ID consultation. Disclosures Bruce M. Jones, PharmD, BCPS, ALK-Abello (Research Grant or Support)Allergan/Abbvie (Speaker’s Bureau) Christopher M. Bland, PharMD, FCCP, FIDSA, BCPS, ALK Abello, Inc. (Grant/Research Support)Biomerieux (Consultant)Merck (Consultant, Grant/Research Support, Advisor or Review Panel member, Speaker’s Bureau)Tetraphase (Speaker’s Bureau)

Comparative study of intracranial access in thrombectomy using next generation 0.088 inch guide catheter technology

2021 ◽  
pp. neurintsurg-2021-017341
Author(s):  
Devin V Bageac ◽  
Blake S Gershon ◽  
Jan Vargas ◽  
Maxim Mokin ◽  
Zeguang Ren ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Control Group ◽  
Anterior Circulation ◽  
Guide Catheter ◽  
Catheter Failure ◽  
Catheter Technology ◽  
Intracranial Vasculature

BackgroundMost 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.MethodsThis 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.ResultsEach 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.ConclusionsTracstar LDP is safe for use during stroke thrombectomy and was associated with decreased time to clot engagement. Intracranial access was regularly achieved.

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