scholarly journals Safety profile of an 8F femoral arteriotomy closure using the Angio-Seal device in thrombolysed acute stroke patients undergoing thrombectomy

2018 ◽  
Vol 24 (5) ◽  
pp. 540-545
Author(s):  
James Wareham ◽  
Sebastian Luppe ◽  
Adam Youssef ◽  
Robert Crossley ◽  
Alex Mortimer

Background The relationship between bridging thrombolysis and femoral access site complications after mechanical thrombectomy remains contested. Use of a closure device could minimise bleeding complications. This study aimed to elucidate the rate of access site complications in a cohort of patients treated using an 8F groin sheath with subsequent closure using the Angio-Seal to assess safety and the impact of bridging thrombolysis on access site complication rate. Methods All patients with large vessel occlusive stroke treated between 2014 and 2017 with thrombectomy with or without bridging thrombolysis were reviewed. A prospectively acquired departmental database was used to obtain baseline data, and the radiology information and haematology reporting systems were used to record imaging or transfusion relating to subsequent access site complications. Results Seventy-five patients treated with thrombectomy alone were compared to 70 patients treated with prior intravenous thrombolysis. All had an 8F femoral sheath placed for arterial access, and all underwent attempted haemostasis with an 8F Angio-Seal. Two patients (1.14%) suffered Angio-Seal device failure necessitating manual pressure. One patient (0.6%) suffered a small femoral pseudo-aneurysm. No retroperitoneal haemorrhage, haematoma requiring transfusion, ipsilateral deep-vein thrombosis or ipsilateral acute limb ischaemia was encountered. There was no significant difference in the rate of haemorrhagic, ischaemic or infective complications between those treated with bridging thrombolysis or thrombectomy alone. Conclusion Use of the Angio-Seal closure device for 8F femoral access is safe in acute stroke patients. Intravenous thrombolysis prior to endovascular thrombectomy does not significantly alter femoral access site complication rate if this approach is used.

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
Z Ruzsa ◽  
A Csavajda ◽  
M Deak ◽  
P Sotonyi ◽  
O.F Bertrand ◽  
...  

Abstract Background Traditional access for the treatment of femoral artery lesions is the femoral artery (FA) approach, but radial (RA) and pedal access (PA) is an alternative access site. The aim of the study was to compare the success rate, complication rate of different access sites for the treatment of superfitial artery stenosis in a randomized study Methods 180 consecutive patients were randomized in a prospective study to treat symptomatic superficial femoral stenosis, via RA, FA and PA. Primary endpoint: technical success, rate of major and minor access site complications. Secondary endpoints: major adverse events (MAE), procedural factors, cross-over rate, and duration of hospitalization. Results Technical success was achieved in 96.6%, 100% and 100% patients in RA, FA and PA group (p=ns). Secondary access site was used in 30%, 3.3% and 30% in the RA, FA and PA access group (p<0.01). Stent implantation was done in the femoral artery in 26.6%, 58.3% and 71.6% cases in RA, FA and PA group (p<0.01). CTO recanalization was performed in 34/36 (100%), 30/30 (100%) and 45/45 (100%) cases successfully in RA, FA and PA group (p=ns). Contrast consumption, fluoroscopy and procedure time was not statistically different, but the X Ray dose was significantly lower in PA than in the RA and FA access group (63.1 vs 162 vs 153 Dyn). The cumulative rate of access site complications in the RA, FA and PA group was 3.3% (0% major and 3.3% minor), 15% (3.3% major and 11.6% minor) and 3.3% (0% major and 3.3% minor) (p<0.01), respectively. The cumulative incidence of MAE's at 6 months in the RA, FA and PA group was 8.3% vs 13.3% and 18.3%. (p<0.05) Conclusion Femoral artery intervention can be safely and effectively performed using radial, femoral and pedal access, but radial and pedal access is associated with less access site complication rate. Pedal access is associated with less X Ray dose than radial and femoral access. Funding Acknowledgement Type of funding source: None


2020 ◽  
Vol 13 (1) ◽  
pp. 91-95 ◽  
Author(s):  
Yangchun Li ◽  
Stephanie H Chen ◽  
Alejandro M Spiotta ◽  
Pascal Jabbour ◽  
Michael R Levitt ◽  
...  

BackgroundCurrently, there are no large-scale studies in the neurointerventional literature comparing safety between transradial (TRA) and transfemoral (TFA) approaches for flow diversion procedures. This study aims to assess complication rates in a large multicenter registry for TRA versus TFA flow diversion.MethodsWe retrospectively analyzed flow diversion cases for cerebral aneurysms from 14 institutions from 2010 to 2019. Pooled analysis of proportions was calculated using weighted analysis with 95% CI to account for results from multiple centers. Access site complication rate and overall complication rate were compared between the two approaches.ResultsA total of 2,285 patients who underwent flow diversion were analyzed, with 134 (5.86%) treated with TRA and 2151 (94.14%) via TFA. The two groups shared similar patient and aneurysm characteristics. Crossover from TRA to TFA was documented in 12 (8.63%) patients. There were no access site complications in the TRA group. There was a significantly higher access site complication rate in the TFA cohort as compared with TRA (2.48%, 95% CI 2.40% to 2.57%, vs 0%; p=0.039). One death resulted from a femoral access site complication. The overall complications rate was also higher in the TFA group (9.02%, 95% CI 8.15% to 9.89%) compared with the TRA group (3.73%, 95% CI 3.13% to 4.28%; p=0.035).ConclusionTRA may be a safer approach for flow diversion to treat cerebral aneurysms at a wide range of locations. Both access site complication rate and overall complication rate were lower for TRA flow diversion compared with TFA in this large series.


Author(s):  
Juha-Pekka Pienimäki ◽  
Jyrki Ollikainen ◽  
Niko Sillanpää ◽  
Sara Protto

Abstract Purpose Mechanical thrombectomy (MT) is the first-line treatment in acute stroke patients presenting with large vessel occlusion (LVO). The efficacy of intravenous thrombolysis (IVT) prior to MT is being contested. The objective of this study was to evaluate the efficacy of MT without IVT in patients with no contraindications to IVT presenting directly to a tertiary stroke center with acute anterior circulation LVO. Materials and Methods We collected the data of 106 acute stroke patients who underwent MT in a single high-volume stroke center. Patients with anterior circulation LVO eligible for IVT and directly admitted to our institution who subsequently underwent MT were included. We recorded baseline clinical, laboratory, procedural, and imaging variables and technical, imaging, and clinical outcomes. The effect of intravenous thrombolysis on 3-month clinical outcome (mRS) was analyzed with univariate tests and binary and ordinal logistic regression analysis. Results Fifty-eight out of the 106 patients received IVT + MT. These patients had 2.6-fold higher odds of poorer clinical outcome in mRS shift analysis (p = 0.01) compared to MT-only patients who had excellent 3-month clinical outcome (mRS 0–1) three times more often (p = 0.009). There were no significant differences between the groups in process times, mTICI, or number of hemorrhagic complications. A trend of less distal embolization and higher number of device passes was observed among the MT-only patients. Conclusions MT without prior IVT was associated with an improved overall three-month clinical outcome in acute anterior circulation LVO patients.


Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Simone B. Duss ◽  
Anne-Kathrin Brill ◽  
Sébastien Baillieul ◽  
Thomas Horvath ◽  
Frédéric Zubler ◽  
...  

Abstract Background Sleep-disordered breathing (SDB) is highly prevalent in acute ischaemic stroke and is associated with worse functional outcome and increased risk of recurrence. Recent meta-analyses suggest the possibility of beneficial effects of nocturnal ventilatory treatments (continuous positive airway pressure (CPAP) or adaptive servo-ventilation (ASV)) in stroke patients with SDB. The evidence for a favourable effect of early SDB treatment in acute stroke patients remains, however, uncertain. Methods eSATIS is an open-label, multicentre (6 centres in 4 countries), interventional, randomized controlled trial in patients with acute ischaemic stroke and significant SDB. Primary outcome of the study is the impact of immediate SDB treatment with non-invasive ASV on infarct progression measured with magnetic resonance imaging in the first 3 months after stroke. Secondary outcomes are the effects of immediate SDB treatment vs non-treatment on clinical outcome (independence in daily functioning, new cardio-/cerebrovascular events including death, cognition) and physiological parameters (blood pressure, endothelial functioning/arterial stiffness). After respiratory polygraphy in the first night after stroke, patients are classified as having significant SDB (apnoea-hypopnoea index (AHI) > 20/h) or no SDB (AHI < 5/h). Patients with significant SDB are randomized to treatment (ASV+ group) or no treatment (ASV− group) from the second night after stroke. In all patients, clinical, physiological and magnetic resonance imaging studies are performed between day 1 (visit 1) and days 4–7 (visit 4) and repeated at day 90 ± 7 (visit 6) after stroke. Discussion The trial will give information on the feasibility and efficacy of ASV treatment in patients with acute stroke and SDB and allows assessing the impact of SDB on stroke outcome. Diagnosing and treating SDB during the acute phase of stroke is not yet current medical practice. Evidence in favour of ASV treatment from a randomized multicentre trial may lead to a change in stroke care and to improved outcomes. Trial registration ClinicalTrials.gov NCT02554487, retrospectively registered on 16 September 2015 (actual study start date, 13 August 2015), and www.kofam.ch (SNCTP000001521).


Stroke ◽  
2021 ◽  
Vol 52 (Suppl_1) ◽  
Author(s):  
Betty A McGee ◽  
Melissa Stephenson

Background and Purpose: Thrombolytic therapy is a key link in the stroke chain of survival. Data suggests that four components are vital in decreasing door to thrombolytic administration in acute stroke patients eligible for treatment. Analysis of system data, pre and post implementation of a Door to Needle Project, afforded the opportunity to assess. Hypothesis: We assessed the hypothesis that commitment, collaboration, communication, and consistency (referred to as Four C’s) are vital in improving door to thrombolytic administration time in ischemic stroke patients. Methods: In this quantitative study, we utilized case data collected by a quality improvement team serving five emergency departments within a healthcare system. We retrospectively reviewed times of thrombolytic administration from admission to the emergency department in acute ischemic stroke patients. Cases were included based on eligibility criteria from American Heart Association’s Get With the Guidelines. Times from 2019 were compared with times through April 2020, before and after implementation of the project, which had multidisciplinary process interventions that reinforced the Four C’s. Results: The data revealed a 13.5 % reduction in median administration time. Cases assessed from 2019 had a median time of 52 minutes from door to thrombolytic administration, 95% CI [47.0, 59.0], n = 52. Cases assessed through April 2020 had a median time of 45 minutes from door to thrombolytic administration, 95% CI [39.0, 57.5], n = 18. Comparing cases through April 2020 to those of 2019, there were improvements of 38.1% fewer cases for administration in greater than 60 minutes and 27.8% fewer cases for administration in greater than 45 minutes. Conclusion: The hypothesis that Four C’s are vital in improving door to thrombolytic administration was validated by a decrease in median administration time as well as a reduction in cases exceeding targeted administration times. The impact to clinical outcomes is significant as improving administration time directly impacts the amount of tissue saved. Ongoing initiatives encompassing the Four C’s, within a Cerebrovascular System of Care, are essential in optimizing outcomes in acute stroke patients.


Stroke ◽  
2021 ◽  
Vol 52 (Suppl_1) ◽  
Author(s):  
Nicolle W Davis ◽  
Meghan Bailey ◽  
Natalie Buchwald ◽  
Amreen Farooqui ◽  
Anna Khanna

Background/Objective: There is growing importance on discovering factors that delay time to intervention for acute ischemic stroke (AIS) patients, as rapid intervention remains essential for better patient outcomes. The management of these patients involves a multidisciplinary effort and quality improvement initiatives to safely increase treatment with intravenous thrombolytic (IV tPa). The objective of this pilot is to evaluate factors of acute stroke care in the emergency department (ED) and the impact they have on IV tPa administration. Methods: A sample of 89 acute ischemic stroke patients that received IV tPa from a single academic medical institution was selected for retrospective analysis. System characteristics (presence of a stroke nurse and time of day) and patient characteristics (mode of arrival and National Institutes of Health Stroke Scale score (NIHSS) on arrival) were analyzed using descriptive statistics and multiple regression to address the study question. Results: The mean door to needle time is 53.74 minutes ( + 38.06) with 74.2% of patients arriving to the ED via emergency medical services (EMS) and 25.8% having a stroke nurse present during IV tPa administration. Mode of arrival ( p = .001) and having a stroke nurse present ( p = .022) are significant predictors of door to needle time in the emergency department (ED). Conclusion: While many factors can influence door to needle times in the ED, we did not find NIHSS on arrival or time of day to be significant factors. Patients arriving to the ED by personal vehicle will have a significant delay in IV tPa administration, therefore emphasizing the importance of using EMS. Perhaps more importantly, collaborative efforts including the addition of a specialized stroke nurse significantly decreased time to IV tPa administration for AIS patients. With this dedicated role, accelerated triage and more effective management of AIS patients is accomplished, leading to decreased intervention times and potentially improving patient outcomes.


Author(s):  
Joshua S Catapano ◽  
Andrew Ducruet ◽  
Felipe C Albuquerque ◽  
Ashutosh Jadhav

Introduction : The transradial artery (TRA) approach for neuroendovascular procedures has been demonstrated as a safe and effective alternative to the transfemoral artery (TFA) approach. The present study compares the efficiency and periprocedural outcomes of the TRA and TFA approach for acute stroke interventions in patients receiving intravenous alteplase. Methods : The study was designed as a retrospective analysis of patients who underwent acute mechanical thrombectomy at a large cerebrovascular center between January 2014 and March 2021. Intervention cohorts (TRA and TFA) were compared on baseline characteristics, periprocedural efficiency/efficacy, and in‐hospital outcomes. Results : A total of 314 patients underwent acute mechanical thrombectomy following IV tPA via TRA (6.7%, 21/314) or TFA (93.3%, 293/314) approach. The overall complication rate appeared higher in TFA (6.8%, 20/314) compared to TRA (4.8%,1/21) patients. Access site complications were present in 4.1%(12/293) of TFA patients and 0.0%(0/21) of TRA patients. The average length of stay (days ± standard deviation) was significantly greater in TFA (8.8 ± 8.5) vs. TRA (4.8 ± 2.9) patients (P = 0.02). Linear regression analysis found femoral access (p = 0.046), Medicaid (p = 0.004) insurance, and discharge NIHSS >10 (p = 0.045) as predictors of increased length of stay. However, when time to initial physical/occupation session was added to the model, access site was no longer significant. Conclusions : The TRA (vs. TFA) approach for acute stroke interventions following IV tPA administration may potentially reduce periprocedural complications and hospital length of stay. The reduction in length of stay with TRA access appears to be associated with earlier initiation of therapies.


2021 ◽  
pp. 152660282110385
Author(s):  
Zoltán Ruzsa ◽  
Ádám Csavajda ◽  
István Hizoh ◽  
Mónika Deák ◽  
Péter Sótonyi ◽  
...  

Background The aim of this randomized study was to compare the success and complication rates of different access sites for the treatment of superficial artery stenosis. Methods and Results A total of 180 consecutive patients were randomized in a prospective study to treat symptomatic superficial femoral artery stenosis via radial (RA), femoral (FA), or pedal artery (PA) access. Technical success was achieved in 96.7%, 100%, and 100% of the patients in the RA, FA, and PA groups, respectively (p=0.33). Secondary access sites were used in 30%, 3.3%, and 30% of the patients in the RA, FA, and PA access groups, respectively (p=0.0002). Recanalization for chronic total occlusion was performed in 34/36 (94.4%), 30/30 (100%), and 46/46 (100%) patients in the RA, FA, and PA groups, respectively (p=0.17). The X-ray dose was significantly lower in the PA group than that in the RA and FA access groups (63.1 vs 162 vs 153 Dyn, p=0.0004). The cumulative rates of access site complications in the RA, FA, and PA groups were 3.3% (0% major and 3.3% minor), 16.7% (3.3% major and 13.3% minor), and 3.3% (3.3% major and 0% minor) (p=0.0085), respectively. The cumulative incidence of MACEs at 6 months in the RA, FA, and PA groups was 5%, 6.7%, and 1.7%, respectively. The cumulative incidence of MALEs at 6 months in the RA, FA, and PA groups was 20%, 16.7%, and 9.2%, respectively (p=0.54). Conclusion Femoral artery intervention can be safely and effectively performed using radial, femoral, and pedal access, but radial and pedal access is associated with a lower access site complication rate and hospitalization. Pedal access is associated with a lower X-ray dose than that with radial and femoral access.


Sign in / Sign up

Export Citation Format

Share Document