Markus Möhlenbruch

Effect of Conscious Sedation vs General Anesthesia on Early Neurological Improvement Among Patients With Ischemic Stroke Undergoing Endovascular Thrombectomy: A Randomized Clinical Trial

Importance Optimal management of sedation and airway during thrombectomy for acute ischemic stroke is controversial due to lack of evidence from randomized trials. Objective To assess whether conscious sedation is superior to general anesthesia for early neurological improvement among patients receiving stroke thrombectomy. Design, Setting, and Participants SIESTA (Sedation vs Intubation for Endovascular Stroke Treatment), a single-center, randomized, parallel-group, open-label treatment trial with blinded outcome evaluation conducted at Heidelberg University Hospital in Germany (April 2014-February 2016) included 150 patients with acute ischemic stroke in the anterior circulation, higher National Institutes of Health Stroke Scale (NIHSS) score (>10), and isolated/combined occlusion at any level of the internal carotid or middle cerebral artery. Intervention Patients were randomly assigned to an intubated general anesthesia group (n = 73) or a nonintubated conscious sedation group (n = 77) during stroke thrombectomy. Main Outcomes and Measures Primary outcome was early neurological improvement on the NIHSS after 24 hours (0-42 [none to most severe neurological deficits; a 4-point difference considered clinically relevant]). Secondary outcomes were functional outcome by modified Rankin Scale (mRS) after 3 months (0-6 [symptom free to dead]), mortality, and peri-interventional parameters of feasibility and safety. Results Among 150 patients (60 women [40%]; mean age, 71.5 years; median NIHSS score, 17), primary outcome was not significantly different between the general anesthesia group (mean NIHSS score, 16.8 at admission vs 13.6 after 24 hours; difference, -3.2 points [95% CI, -5.6 to -0.8]) vs the conscious sedation group (mean NIHSS score, 17.2 at admission vs 13.6 after 24 hour; difference, -3.6 points [95% CI, -5.5 to -1.7]); mean difference between groups, -0.4 (95% CI, -3.4 to 2.7; P = .82). Of 47 prespecified secondary outcomes analyzed, 41 showed no significant differences. In the general anesthesia vs the conscious sedation group, substantial patient movement was less frequent (0% vs 9.1%; difference, 9.1%; P = .008), but postinterventional complications were more frequent for hypothermia (32.9% vs 9.1%; P < .001), delayed extubation (49.3% vs 6.5%; P < .001), and pneumonia (13.7% vs 3.9%; P = .03). More patients were functionally independent (unadjusted mRS score, 0 to 2 after 3 months [37.0% in the general anesthesia group vs 18.2% in the conscious sedation group P = .01]). There were no differences in mortality at 3 months (24.7% in both groups). Conclusions and Relevance Among patients with acute ischemic stroke in the anterior circulation undergoing thrombectomy, conscious sedation vs general anesthesia did not result in greater improvement in neurological status at 24 hours. The study findings do not support an advantage for the use of conscious sedation. Trial Registration clinicaltrials.gov Identifier: NCT02126085.

Emergency Cervical Internal Carotid Artery Stenting in Combination with Intracranial Thrombectomy in Acute Stroke

BACKGROUND AND PURPOSE: In past years, thrombectomy has become a widely used procedure in interventional neuroradiology for the treatment of acute intracranial occlusions. However, in 10–20% of patients, there are additional occlusions or stenotic lesions of the ipsilateral cervical internal carotid artery. The purpose of this study was to evaluate the feasibility of emergency carotid artery stent placement in combination with intracranial thrombectomy and the clinical outcome of the treated patients. MATERIALS AND METHODS: We analyzed clinical and angiographic data of patients who underwent emergency cervical ICA stent placement and intracranial thrombectomy with stent-retriever devices in our institution between November 2009 and July 2012. Recanalization was assessed according to the Thrombolysis in Cerebral-Infarction score. Clinical outcome was evaluated at discharge (NIHSS) and after 3 months (mRS). RESULTS: Overall, 24 patients were treated. The mean age was 67.2 years; mean occlusion time, 230.2 minutes. On admission, the median NIHSS score was 18. In all patients, the Thrombolysis in Cerebral Infarction score was zero before the procedure. Stent implantation was feasible in all cases. In 15 patients (62.5%), a Thrombolysis in Cerebral Infarction score ≥ 2b could be achieved. Six patients (25%) improved ≥10 NIHSS points between admission and discharge. After 90 days, the median mRS score was 3.0. Seven patients (29.2%) had a good clinical outcome (mRS 0–2), and 4 patients (16.6%) died, 1 due to fatal intracranial hemorrhage. Overall, symptomatic intracranial hemorrhage occurred in 4 patients (16.6%). CONCLUSIONS: Emergency ICA stent implantation was technically feasible in all patients, and the intracranial recanalization Thrombolysis in Cerebral Infarction score of ≥2b was reached in a high number of patients. Clinical outcome and mortality seem to be acceptable for a cohort with severe stroke. However, a high rate of symptomatic intracranial hemorrhage occurred in our study.

Mechanical thrombectomy with stent retrievers in acute basilar artery occlusion.

BACKGROUND AND PURPOSE: Basilar artery occlusion remains one of the most devastating subtypes of ischemic stroke. The prognosis is poor if early recanalization is not achieved. The purpose of this study was to evaluate the safety and technical feasibility of self-expanding retrievable stents in the endovascular treatment of acute basilar artery occlusion. MATERIALS AND METHODS: Twenty-four patients with acute basilar artery occlusion were treated with Solitaire FR or Revive SE devices between December 2009 and May 2012. Additional treatment included intravenous and/or intra-arterial thrombolysis (21/24) and percutaneous transluminal angioplasty/permanent stent placement (7/24). Recanalization was assessed by means of the TICI score. Clinical outcome was determined at discharge (NIHSS), and at 3 months (mRS). RESULTS: Median NIHSS score on admission was 24; median duration of symptoms was 254 minutes. Successful recanalization (TICI 2b +3) by thrombectomy only was achieved in 18 patients (75%). Intracranial stent deployment after thrombectomy caused by underlying atherosclerotic stenosis was performed in 7 patients. If these patients with intracranial stent placement are included, successful recanalization was achieved in 21 of 24 patients (87.5%). NIHSS improvement ≥10 points was reached in 54% of patients (n = 13/24). Mortality during the first 3 months was 29% (7/24). After 3 months, 8 patients (33%) had a favorable clinical outcome (mRS 0–2). CONCLUSIONS: In our series, application of self-expanding retrievable stents in acute basilar artery occlusion resulted in a high recanalization rate without procedural complications and good clinical outcome in one-third of patients.

Sedation vs. Intubation for Endovascular Stroke TreAtment (SIESTA) - a randomized monocentric trial.

Background The optimal peri-interventional management of sedation and airway for endovascular stroke treatment (EST) appears to be a crucial factor for treatment success. According to retrospective studies, the widely favored general anesthesia with intubation seems to be associated with poor functional outcome compared to a slightly sedated non-intubated condition (conscious sedation). Method SIESTA is a monocentric, prospective, randomized parallel-group, open-label treatment trial with blinded endpoint evaluation (PROBE design). The study compares the non-intubated with the intubated state in patients receiving endovascular treatment of acute ischemic anterior circulation stroke. The primary endpoint is early neurological improvement as by National Institutes of Health Stroke Scale (NIHSS) after 24 h (difference between NIHSS on admission and NIHSS after 24 h). Secondary endpoints include: functional outcome after three-months as by modified Rankin Scale (mRS), mortality, parameters of ventilation and critical care, feasibility, and safety, i.e. complications related to endovascular stroke treatment. Conclusion The aims of this study are to prospectively clarify whether the non-intubated state of conscious sedation is feasible, safe, and superior with regard to early neurological improvement compared to the intubated state of general anesthesia in patients receiving acute endovascular stroke treatment.

First-line lesional aspiration in acute stroke thrombectomy using a novel intermediate catheter: Initial experiences with the SOFIA

Introduction Five randomized controlled trials (RCTs) on endovascular therapy (EVT) of stroke have proven a clinical benefit over conservative treatment or IV-thrombolysis alone. Lesional clot aspiration with a dedicated system can achieve revascularization without an additional retriever (a direct-aspiration first-pass technique, ADAPT), and the SOFIA has been shown to be both safe and efficacious in a multicentric retrospective study. We have evaluated a subset of these data acquired in two major stroke centers with regard to using the SOFIA for first-line lesional aspiration. Methods Thirty patients with large-vessel occlusions treated with first-line lesional aspiration were identified. Procedural data, clot length, reperfusion success (mTICI), procedural timings, complications, and clinical status at admission, discharge and at 90 days were analyzed. Results The median baseline NIHSS was 16. IV thrombolysis was administered in 15/30 patients. Ninety-three percent of occlusions were in the anterior circulation. TICI ≥ 2b was achieved in 90% of multimodality treatments; lesional aspiration was successful in 67% within a median time of 20 minutes. The highest first-attempt success rate was in MCA occlusions (median time to recanalization 10 minutes). There were no device-related events. Symptomatic intracerebral hemorrhage (sICH) occurred in 10%, but never with sole lesional aspiration. Embolization to new territories was recorded in 1/30 (3%). Median discharge NIHSS was 7; 30% were mRS ≤ 2 at discharge and 43% at 90-day follow-up. Conclusions Lesional aspiration with SOFIA is in line with published data. The SOFIA may be used as a first-line device, aiming at fast recanalization by sole aspiration with good safety and efficacy. If unsuccessful, it converts into part of a stent retriever-based multimodality treatment.

Stress mediators and immune dysfunction in patients with acute cerebrovascular diseases.

Background Post-stroke immune depression contributes to the development of infections which are major complications after stroke. Previous experimental and clinical studies suggested that humoral stress mediators induce immune dysfunction. However, prospective clinical studies testing this concept are missing and no data exists for other cerebrovascular diseases including intracerebral hemorrhage (ICH) and TIA. Methods We performed a prospective clinical study investigating 166 patients with TIA, ischemic and hemorrhagic stroke. We measured a broad panel of stress mediators, leukocyte subpopulations, cytokines and infection markers from hospital admission to day 7 and on follow-up after 2–3 months. Multivariate regression analyses detected independent predictors of immune dysfunction and bacterial infections. ROC curves were used to test the diagnostic value of these parameters. Results Only severe ischemic strokes and ICH increased some catecholamine metabolites, ACTH and cortisol levels. Immunodysfunction was eminent already on hospital admission after large brain lesions with lymphocytopenia as a key feature. None of the stress mediators was an independent predictor of lymphocytopenia or infections. However, lymphocytopenia on hospital admission was detected as an independent explanatory variable of later infections. NIHSSS and lymphocytopenia on admission were excellent predictors of infection. Conclusions Our results question the present pathophysiological concept of stress-hormone mediated immunodysfunction after stroke. Early lymphocytopenia was identified as an early independent predictor of post-stroke infections. Absence of lymphocytopenia may serve as a negative predictive marker for stratification for early antibiotic treatment.

Initial experience with a new distal intermediate and aspiration catheter in the treatment of acute ischemic stroke: clinical safety and efficacy

Purpose To describe our initial experience with the novel 5 F SOFIA (Soft Torqueable catheter Optimized For Intracranial Access) intermediate and aspiration catheter for endovascular treatment of patients with acute ischemic stroke. Methods A retrospective review was performed in three centers of prospectively collected data of all stroke patients who underwent endovascular therapy using the SOFIA catheter. Patients were enrolled between November 2013 and December 2014. The primary endpoint of the study was accessibility of the thrombus with the SOFIA catheter. As a secondary endpoint, the study assessed recanalization success (Thrombolysis In Cerebral Infarction (TICI) ≥2b). Clinical presentation on admission and discharge was also documented. In addition, catheter- and procedure-related complications (particularly thromboembolic complications) were recorded. Results The SOFIA catheter was used in 115 acute stroke procedures. In 110 cases (96%) the catheter could be advanced to the occlusion site. After mechanical thrombectomy, successful recanalization (TICI ≥2b) was documented in 86.9%. There were no complications related to positioning of the catheter. Distal thrombus migration into a new vascular territory occurred in three patients following thrombectomy with a stent retriever (2.6%). The mean NIH Stroke Scale (NIHSS) score on admission was 16.8±6 and at discharge the mean NIHSS score was 8.2±7.7. Sixteen patients died. Conclusions The SOFIA catheter is a safe and efficient catheter for endovascular stroke therapy.

Prevalence of atrial fibrillation and association of previous antithrombotic treatment in patients with cerebral microbleeds.

Cerebral microbleeds (CMBs) are associated with an increased risk of intracerebral hemorrhage. The impact of oral anticoagulation (OAC) on CMBs is not well characterized. Our aim was to assess the prevalence of CMBs in stroke and transient ischaemic attack (TIA) patients with atrial fibrillation (AF) and to analyze the implications of previous treatment with OAC.

Asymmetry of deep medullary veins on susceptibility weighted MRI in patients with acute MCA stroke is associated with poor outcome

Background and Purpose Due to its sensitivity to deoxyhemoglobin, susceptibility weighted imaging (SWI) enables the visualization of deep medullary veins (DMV) in patients with acute stroke, which are difficult to depict under physiological circumstances. This study assesses the asymmetric appearance of prominent DMV as an independent predictor for stroke severity and outcome. Materials and Methods SWI of 86 patients with acute middle cerebral artery (MCA) stroke were included. A scoring system from 0 (no visible DMV) to 3 (very prominent DMV) was applied for both hemispheres separately. A difference of scores between ipsi- and contralateral side was defined as asymmetric (AMV+). Occurrence of AMV+ was correlated with the National Institute of Health Stroke Scale (NIHSS) Score on admission and discharge, as well as the modified Rankin Scale (mRS) at discharge. Ordinal regression analysis was used to evaluate NIHSS and mRS as predictors of stroke severity, clinical course of disease and outcome. Results 55 patients displayed AMV+ while 31 did not show an asymmetry (AMV–). Median NIHSS on admission was 17 (11–21) in the AMV+ group and 9 (5–15) in the AMV– group (p = 0.001). On discharge median NIHSS was 11 (5–20) for AMV+ and 5 (2–14) for AMV– (p = 0.005). The median mRS at discharge was 4 (3–5) in the AMV+ group and 3 (1–4) in AMV– (p = 0.001). Odds ratio was 3.19 (95% CI: 1.24–8.21) for AMV+ to achieve a higher mRS than AMV– (p = 0.016). Conclusion The asymmetric appearance of DMV on SWI is a fast and easily evaluable parameter for the prediction of stroke severity and can be used as an additional imaging parameter in patients with acute MCA stroke.

Improved Clinical Outcome after Acute Basilar Artery Occlusion since the Introduction of Endovascular Thrombectomy Devices

Background: Thrombectomy devices are increasingly used for intra-arterial recanalization therapy in stroke. We analyzed whether the use of these devices modified the outcome of patients with acute basilar occlusion (BAO) at our institution. Methods: Between 1998 and 2012, one hundred forty-seven consecutive patients with acute BAO received recanalization therapy. In July 2009, for the first time, a thrombectomy device was used and hence the cohort was split into two chronological groups: BAO-1 (before July 2009) and BAO-2 (after July 2009). All patients were treated at a dedicated neurological ICU following institutional standard operating procedures. A good clinical outcome was defined as a modified Rankin scale score of 0-2 after 3 months. Univariate and multivariate analyses were applied using outcome parameters as dependent variables and baseline variables with a significant p value in univariate tests as independent variables. Results: One hundred eleven patients (BAO-1) were treated before and 36 were treated after July 2009 (BAO-2). Patients in the BAO-1 and BAO-2 groups had similar neurological deficits on admission as expressed by the Glasgow Coma Scale (BAO-1: median 4, IQR 5, vs. BAO-2: median 4.5, IQR 8, p = 0.41) and the proportion of patients who were presented intubated and ventilated was similar in both groups as well (49.5 vs. 47.7%, p = 0.85). Bridging concepts with intravenous recombinant tissue plasminogen activator (rtPA) were applied in 18.9% (BAO-1) versus 63.9% (BAO-2, p < 0.001) of cases, whereas glycoprotein IIb/IIIa antagonists were used significantly more frequently in the BAO-1 cohort (57.7 vs. 33.3%, p = 0.034). Thrombectomies were performed in 20 patients (55.5%) of the BAO-2 group but in none of the BAO-1 cohort. Complete recanalization (TICI 3) was achieved in 45.1% (BAO-1) versus 66.7% (BAO-2, p = 0.062) of patients. A good clinical outcome was observed in 13.5% of the BAO-1 group and 30.6% of the BAO-2 cohort (p = 0.026); mortality was 57.7% in the earlier group and 36.1% in the later group (p = 0.034). The frequency of symptomatic intracranial hemorrhage was similar in both groups (8.1% BAO-1 vs. 2.8% BAO-2, p = 0.45). Treatment in the BAO-2 cohort was an independent predictor of good clinical outcome (OR 2.56; 95% CI 1.01-6.78) and mortality (OR 0.36; 95% CI 0.15-0.86) in an adjusted logistic regression model. Conclusion: Our results show improved outcomes in patients in the BAO-2 cohort. The treatment approach in this group was an independent predictor of both good outcome and mortality. Especially in patients with BAO - where endovascular treatment strategies are common clinical practice - bridging protocols with rtPA and modern thrombectomy devices should be used more frequently.