Browsing by Subject "endovascular"

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  • CLOTBUST-ER Trial Investigators; Alexandrov, Andrei V.; Tsivgoulis, Georgios; Köhrmann, Martin; Soinne, Lauri; Schellinger, Peter D. (2019)
    Background: Results of our recently published phase III randomized clinical trial of ultrasound-enhanced thrombolysis (sonothrombolysis) using an operator-independent, high frequency ultrasound device revealed heterogeneity of patient recruitment among centers. Methods: We performed a post hoc analysis after excluding subjects that were recruited at centers reporting a decline in the balance of randomization between sonothrombolysis and concurrent endovascular trials. Results: From a total of 676 participants randomized in the CLOTBUST-ER trial we identified 52 patients from 7 centers with perceived equipoise shift in favor of endovascular treatment. Post hoc sensitivity analysis in the intention-to-treat population adjusted for age, National Institutes of Health Scale score at baseline, time from stroke onset to tPA bolus and baseline serum glucose showed a significant (p <0.01) interaction of perceived endovascular equipoise shift on the association between sonothrombolysis and 3 month functional outcome [adjusted common odds ratio (cOR) in centers with perceived endovascular equipoise shift: 0.22, 95% CI 0.06-0.75; p = 0.02; adjusted cOR for centers without endovascular equipoise shift: 1.20, 95% CI 0.89-1.62; p = 0.24)]. After excluding centers with perceived endovascular equipoise shift, patients randomized to sonothrombolysis had higher odds of 3 month functional independence (mRS scores 0-2) compared with patients treated with tPA only (adjusted OR: 1.53; 95% CI 1.01-2.31; p = 0.04). Conclusion: Our experience in CLOTBUST-ER indicates that increasing implementation of endovascular therapies across major academic stroke centers raises significant challenges for clinical trials aiming to test noninterventional or adjuvant reperfusion strategies.
  • Wahlgren, Nils; Moreira, Tiago; Michel, Patrik; Steiner, Thorsten; Jansen, Olav; Cognard, Christophe; Mattle, Heinrich P.; van Zwam, Wim; Holmin, Staffan; Tatlisumak, Turgut; Petersson, Jesper; Caso, Valeria; Hacke, Werner; Mazighi, Mikael; Arnold, Marcel; Fischer, Urs; Szikora, Istvan; Pierot, Laurent; Fiehler, Jens; Gralla, Jan; Fazekas, Franz; Lees, Kennedy R.; ESO-KSU; ESO; ESMINT; ESNR; EAN (2016)
    The original version of this consensus statement on mechanical thrombectomy was approved at the European Stroke Organisation (ESO)-Karolinska Stroke Update conference in Stockholm, 16-18 November 2014. The statement has later, during 2015, been updated with new clinical trials data in accordance with a decision made at the conference. Revisions have been made at a face-to-face meeting during the ESO Winter School in Berne in February, through email exchanges and the final version has then been approved by each society. The recommendations are identical to the original version with evidence level upgraded by 20 February 2015 and confirmed by 15 May 2015. The purpose of the ESO-Karolinska Stroke Update meetings is to provide updates on recent stroke therapy research and to discuss how the results may be implemented into clinical routine. Selected topics are discussed at consensus sessions, for which a consensus statement is prepared and discussed by the participants at the meeting. The statements are advisory to the ESO guidelines committee. This consensus statement includes recommendations on mechanical thrombectomy after acute stroke. The statement is supported by ESO, European Society of Minimally Invasive Neurological Therapy (ESMINT), European Society of Neuroradiology (ESNR), and European Academy of Neurology (EAN).
  • Tolonen, Matti; Lemma, Aurora; Vikatmaa, Pirkka; Peltola, Erno; Mentula, Panu; Björkman, Patrick; Leppäniemi, Ari; Sallinen, Ville (2021)
    BACKGROUND Acute mesenteric ischemia (AMI) is a disease with high mortality and requires a multidisciplinary approach for effective management. A pathway and care bundle were developed and implemented with the objective to reduce mortality. The aim of this retrospective comparative study was to analyze the effects of the pathway on patient management and outcome. METHODS All consecutive patients operated in a secondary and tertiary referral center because of occlusive arterial AMI were identified between 2014 and April 2020. The pathway aimed to increase overall awareness, and hasten and improve diagnostics and management. Patients treated before implementation of the pathway (pregroup, years 2014-2017) were compared with patients treated using the pathway (postgroup, May 2018 to April 2020). Univariate and multivariate analyses were used to compare the groups. RESULTS There were 78 patients in the pregroup and 67 patients in the postgroup with comparable baseline characteristics and disease acuity. The postgroup was more often diagnosed with contrast-enhanced computed tomography (58 [74%] vs. 63 [94%], p = 0.001) and had shorter mean in-hospital delay to operating room (7 hours [interquartile range, 3.5-12.5] vs. 3 hours [interquartile range, 2-11], p = 0.023). Revascularization was done more often in the postgroup (53 [68%] vs. 56 [84%], p = 0.030) especially using endovascular treatment (26 [33%] vs. 43 [64%], p < 0.001). Thirty-day mortality was lower in the postgroup (23 [51%] vs. 17 [25%], p = 0.001). Being managed in the postgroup remained as a protective factor (odds ratio, 0.32; 95% confidence interval, 0.14-0.75; p = 0.008) for 30-day mortality in the multivariate analysis. CONCLUSION Implementing a pathway and care bundle resulted in enhanced regional and in-hospital awareness of AMI, more appropriate computed tomography imaging, shorter in-hospital delays, increased number of revascularizations, and, hence, lower mortality.