Examining a sentiment algorithm on session patient records in an eating disorder treatment setting: a preliminary study.

Background: Clinicians collect session therapy notes within patient session records. Session records contain valuable information about patients' treatment progress. Sentiment analysis is a tool to extract emotional tones and states from text input and could be used to evaluate patients' sentiment during treatment over time. This preliminary study aims to investigate the validity of automated sentiment analysis on session patient records within an eating disorder (ED) treatment context against the performance of human raters. Methods: A total of 460 patient session records from eight participants diagnosed with an ED were evaluated on their overall sentiment by an automated sentiment analysis and two human raters separately. The inter-rater agreement (IRR) between the automated analysis and human raters and IRR among the human raters was analyzed by calculating the intra-class correlation (ICC) under a continuous interpretation and weighted Cohen's kappa under a categorical interpretation. Furthermore, differences regarding positive and negative matches between the human raters and the automated analysis were examined in closer detail. Results: The ICC showed a moderate automated-human agreement (ICC = 0.55), and the weighted Cohen's kappa showed a fair automated-human (k = 0.29) and substantial human-human agreement (k = 0.68) for the evaluation of overall sentiment. Furthermore, the automated analysis lacked words specific to an ED context. Discussion/conclusion: The automated sentiment analysis performed worse in discerning sentiment from session patient records compared to human raters and cannot be used within practice in its current state if the benchmark is considered adequate enough. Nevertheless, the automated sentiment analysis does show potential in extracting sentiment from session records. The automated analysis should be further developed by including context-specific ED words, and a more solid benchmark, such as patients' own mood, should be established to compare the performance of the automated analysis to.

Intravenous Thrombolysis Before Endovascular Treatment in Posterior Circulation Occlusions: A MR CLEAN Registry Study.

BACKGROUND: The effectiveness of intravenous thrombolysis (IVT) before endovascular treatment (EVT) has been investigated in randomized trials and meta-analyses. These studies mainly concerned anterior circulation occlusions. We aimed to investigate clinical, technical, and safety outcomes of IVT before EVT in posterior circulation occlusions in a nationwide registry. METHODS: Patients were included from the MR CLEAN Registry (Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands), a nationwide, prospective, multicenter registry of patients with acute ischemic stroke due to a large intracranial vessel occlusion receiving EVT between 2014 and 2019. All patients with a posterior circulation occlusion were included. Primary outcome was a shift toward better functional outcome on the modified Rankin Scale at 90 days. Secondary outcomes were favorable functional outcome (modified Rankin Scale scores, 0-3), occurrence of symptomatic intracranial hemorrhages, successful reperfusion (extended Thrombolysis in Cerebral Ischemia ≥2B), first-attempt successful reperfusion, and mortality at 90 days. Regression analyses with adjustments based on univariable analyses and literature were applied. RESULTS: A total of 248 patients were included, who received either IVT (n=125) or no IVT (n=123) before EVT. Results show no differences in a shift on the modified Rankin Scale (adjusted common odds ratio, 1.04 [95% CI, 0.61-1.76]). Although symptomatic intracranial hemorrhages occurred more often in the IVT group (4.8% versus 2.4%), regression analysis did not show a significant difference (adjusted odds ratio, 1.65 [95% CI, 0.33-8.35]). Successful reperfusion, favorable functional outcome, first-attempt successful reperfusion, and mortality did not differ between patients treated with and without IVT. CONCLUSIONS: We found no significant differences in clinical, technical, and safety outcomes between patients with a large vessel occlusion in the posterior circulation treated with or without IVT before EVT. Our results are in line with the literature on the anterior circulation.

Exploring mental health dynamics during eating disorder treatment: A psychometric network study with panel data.

To explore mental health associations during eating disorder (ED) treatment. Based on the dual-continua model of mental health, general and ED-specific psychopathology, as well as emotional, psychological, and social well-being were considered as mental health domains.Network analyses with panel data were applied to explore within- (temporal and contemporaneous networks) and between-person effects in a sample of 1250 female ED patients during 12 months of outpatient treatment. The associations between the domains and their centrality were examined. Autoregressive and cross-lagged effects were also estimated.ED psychopathology was the most central domain in the temporal network. ED psychopathology changes predicted further ED psychopathology changes and small changes in the other domains. Weak bi-directional associations were found between changes in the well-being domains and general psychopathology. In contrast to the temporal network, ED psychopathology was the least central and psychological well-being the most central domain in the contemporaneous and between-subjects networks. This suggests a central role of psychological well-being for experiencing mental health within time points.ED psychopathology may change relatively independent from other mental health domains. Well-being domains may be considered as more stable aspects of mental health.

A roadmap for applying machine learning when working with privacy-sensitive data: predicting non-response to treatment for eating disorders.

OBJECTIVES: Applying machine-learning methodology to clinical data could present a promising avenue for predicting outcomes in patients receiving treatment for psychiatric disorders. However, preserving privacy when working with patient data remains a critical concern. METHODS: In showcasing how machine-learning can be used to build a clinically relevant prediction model on clinical data, we apply two commonly used machine-learning algorithms (Random Forest and least absolute shrinkage and selection operator) to routine outcome monitoring data collected from 593 patients with eating disorders to predict absence of reliable improvement 12 months after entering outpatient treatment. RESULTS: An RF model trained on data collected at baseline and after three months made 31.3% fewer errors in predicting lack of reliable improvement at 12 months, in comparison with chance. Adding data from a six-month follow-up resulted in only marginal improvements to accuracy. CONCLUSION: We were able to build and validate a model that could aid clinicians and researchers in more accurately predicting treatment response in patients with EDs. We also demonstrated how this could be done without compromising privacy. ML presents a promising approach to developing accurate prediction models for psychiatric disorders such as ED.

Endovascular treatment versus no endovascular treatment after 6-24 h in patients with ischaemic stroke and collateral flow on CT angiography (MR CLEAN-LATE) in the Netherlands: a multicentre, open-label, blinded-endpoint, randomised, controlled, phase 3 trial.

BACKGROUND: Endovascular treatment for anterior circulation ischaemic stroke is effective and safe within a 6 h window. MR CLEAN-LATE aimed to assess efficacy and safety of endovascular treatment for patients treated in the late window (6-24 h from symptom onset or last seen well) selected on the basis of the presence of collateral flow on CT angiography (CTA). METHODS: MR CLEAN-LATE was a multicentre, open-label, blinded-endpoint, randomised, controlled, phase 3 trial done in 18 stroke intervention centres in the Netherlands. Patients aged 18 years or older with ischaemic stroke, presenting in the late window with an anterior circulation large-vessel occlusion and collateral flow on CTA, and a neurological deficit score of at least 2 on the National Institutes of Health Stroke Scale were included. Patients who were eligible for late-window endovascular treatment were treated according to national guidelines (based on clinical and perfusion imaging criteria derived from the DAWN and DEFUSE-3 trials) and excluded from MR CLEAN-LATE enrolment. Patients were randomly assigned (1:1) to receive endovascular treatment or no endovascular treatment (control), in addition to best medical treatment. Randomisation was web based, with block sizes ranging from eight to 20, and stratified by centre. The primary outcome was the modified Rankin Scale (mRS) score at 90 days after randomisation. Safety outcomes included all-cause mortality at 90 days after randomisation and symptomatic intracranial haemorrhage. All randomly assigned patients who provided deferred consent or died before consent could be obtained comprised the modified intention-to-treat population, in which the primary and safety outcomes were assessed. Analyses were adjusted for predefined confounders. Treatment effect was estimated with ordinal logistic regression and reported as an adjusted common odds ratio (OR) with a 95% CI. This trial was registered with the ISRCTN, ISRCTN19922220. FINDINGS: Between Feb 2, 2018, and Jan 27, 2022, 535 patients were randomly assigned, and 502 (94%) patients provided deferred consent or died before consent was obtained (255 in the endovascular treatment group and 247 in the control group; 261 [52%] females). The median mRS score at 90 days was lower in the endovascular treatment group than in the control group (3 [IQR 2-5] vs 4 [2-6]), and we observed a shift towards better outcomes on the mRS for the endovascular treatment group (adjusted common OR 1·67 [95% CI 1·20-2·32]). All-cause mortality did not differ significantly between groups (62 [24%] of 255 patients vs 74 [30%] of 247 patients; adjusted OR 0·72 [95% CI 0·44-1·18]). Symptomatic intracranial haemorrhage occurred more often in the endovascular treatment group than in the control group (17 [7%] vs four [2%]; adjusted OR 4·59 [95% CI 1·49-14·10]). INTERPRETATION: In this study, endovascular treatment was efficacious and safe for patients with ischaemic stroke caused by an anterior circulation large-vessel occlusion who presented 6-24 h from onset or last seen well, and who were selected on the basis of the presence of collateral flow on CTA. Selection of patients for endovascular treatment in the late window could be primarily based on the presence of collateral flow. FUNDING: Collaboration for New Treatments of Acute Stroke consortium, Dutch Heart Foundation, Stryker, Medtronic, Cerenovus, Top Sector Life Sciences & Health, and the Netherlands Brain Foundation.

Intraspecific variation in growth response to drought stress across geographic locations and genetic groups in Coffea canephora.

Uganda lies within the drier end of the natural distribution range of Coffea canephora and contains unexplored genetic material that could be drought-adapted and useful for developing climate-resilient varieties. Using water treatment: (i) ample and (ii) restricted-water, the response of 148 genotypes were studied comprising wild, feral and cultivated C. canephora. Biomass allocation, standing leaf area and leaf area growth data were collected. Linear mixed effect models and PCA were used to the analyze effect of water treatment on genotypes from different: (i) cultivation status, (ii) genetic groups and (iii) locations. We also assessed the relationship between drought tolerance for relative growth rate in leaf area (RGRA), total number of leaves (TNL), total leaf area (TLA) and total leaf dry weight (TLDW) of genotypes at final harvest. Restricted-water reduced RGRA across genetic groups (3.2-32.5%) and locations (7.1-36.7%) but not cultivation status. For TNL, TLA and TLDW, genotypes that performed well in ample-water performed worse under restricted-water, indicating growth-tolerance trade-off. Drought tolerance in RGRA and TNL were negatively correlated with wetness index suggesting some degree of adaptation to local climate. Findings indicate a growth-tolerance trade-off within this tropical tree species and drought tolerance of Uganda's C. canephora is somewhat associated with local climate.

Modelling trajectories of change in psychopathology and well-being during eating disorder outpatient treatment.

Objective: There are considerable differences in how eating disorder (ED) patients respond to treatment. This study aimed to identify change trajectories of mental health during treatment. Method: Longitudinal data of 442 patients was used with five time points during a year of outpatient treatment. ED psychopathology and well-being were used as primary measures. A series of latent growth mixture models were applied to model trajectories of change. Results: Three latent classes were found for ED psychopathology and well-being. For ED psychopathology, a high baseline severity and slow recovery class (55.9% of the patients), a high baseline severity followed by a substantial recovery class (19.9%) and a moderate baseline severity and no significant recovery class (24.2%) were found. For well-being, a low baseline followed by a slow growth class (44.6%), a low baseline and substantial growth class (9.5%) and a moderate and stable well-being class (45.9%) was found. General psychopathology, early symptom change, hope for recovery, intrinsic motivation and the ED type were predictive of class membership in either ED psychopathology or well-being. Conclusions: This study shows variability in ED psychopathology and well-being change trajectories, modelled in meaningful latent recovery classes. These results may have clinical implications, such as adjusting patients' treatment based on change trajectories.

Editor's Choice - Two Year Results of the Randomised DISCOVER Trial Comparing Covered Versus Bare Metal Stents in the Common Iliac Artery.

OBJECTIVE: It has been suggested that covered stents (CS) may lower restenosis rates compared with bare metal stents (BMS) after endovascular treatment of the common iliac artery. This trial aimed to provide additional evidence on the efficacy of CS vs. BMS in the common iliac artery. METHODS: This multicentre, randomised, single blind controlled superiority trial compared balloon expandable CS and balloon expandable BMS for advanced atherosclerotic lesions in the common iliac artery; this was defined as a stenosis > 3 cm in length or occlusion. The primary end point was freedom from binary restenosis after two years of follow up. The study was conducted according to the principles of the Declaration of Helsinki (version: October 2008) and registered with the Dutch Trial register (NTR3381). RESULTS: One hundred and seventy-four limbs were included between 2012 and 2019 with 87 limbs in each group. Six patients crossed over from the BMS group to the CS group but were analysed according to an intention to treat principle. Freedom from binary restenosis after two years of follow up was 84.7% (95% CI 76.7 - 92.7%) in the BMS group and 89.1% (95% CI 82.4 - 95.8%) in the CS group (p = .40). Freedom from occlusion was 95.0% (95% CI 90.3 - 95.7%) in the BMS group and 96.4% (95% CI 92.5 - 100%) in the CS group (p = .66). Freedom from target lesion revascularisation was 91.1% (95% CI 84.8 - 97.3%) and 95.2% (95% CI 90.7 -99.7%), respectively (p = .31). Technical success, complications, haemodynamic success, and clinical success were also comparable between both groups. Per-protocol analysis did not affect the outcomes of the study. CONCLUSION: No difference was found between balloon expandable CS and BMS for treating advanced atherosclerotic lesions of the common iliac artery.

Influence of the interventionist's experience on outcomes of endovascular thrombectomy in acute ischemic stroke: results from the MR CLEAN Registry.

BACKGROUND: The relationship between the interventionist's experience and outcomes of endovascular thrombectomy (EVT) for acute ischemic stroke of the anterior circulation, is unclear. OBJECTIVE: To assess the effect of the interventionist's level of experience on clinical, imaging, and workflow outcomes. Secondly, to determine which of the three experience definitions is most strongly associated with these outcome measures. METHODS: We analysed data from 2700 patients, included in the MR CLEAN Registry. We defined interventionist's experience as the number of procedures performed in the year preceding the intervention (EXPfreq), total number of procedures performed (EXPno), and years of experience (EXPyears). Our outcomes were the baseline-adjusted National Institutes of Health Stroke Scale (NIHSS) score at 24-48 hours post-EVT, recanalization (extended Thrombolysis in Cerebral Infarction (eTICI) score ≥2B), and procedural duration. We used multilevel regression models with interventionists as random intercept. For EXPfreq and EXPno results were expressed per 10 procedures. RESULTS: Increased EXPfreq was associated with lower 24-48 hour NIHSS scores (adjusted (a)ß:-0.46, 95% CI -0.70 to -0.21). EXPno and EXPyears were not associated with short-term neurological outcomes. Increased EXPfreq and EXPno were both associated with recanalization (aOR=1.20, 95% CI 1.11 to 1.31 and aOR=1.08, 95% CI 1.04 to 1.12, respectively), and increased EXPfreq, EXPno, and EXPyears were all associated with shorter procedure times (aß:-3.08, 95% CI-4.32 to -1.84; aß:-1.34, 95% CI-1.84 to -0.85; and aß:-0.79, 95% CI-1.45 to -0.13, respectively). CONCLUSIONS: Higher levels of interventionist's experience are associated with better outcomes after EVT, in particular when experience is defined as the number of patients treated in the preceding year. Every 20 procedures more per year is associated with approximately one NIHSS score point decrease, an increased probability for recanalization (aOR=1.44), and a 6-minute shorter procedure time.

Benefit of successful reperfusion achieved by endovascular thrombectomy for patients with ischemic stroke and moderate pre-stroke disability (mRS 3): results from the MR CLEAN Registry.

BACKGROUND: Pre-stroke dependent patients (modified Rankin Scale score (mRS) ≥3) were excluded from most trials on endovascular treatment (EVT) for acute ischemic stroke (AIS) in the anterior circulation. Therefore, little evidence exists for EVT in those patients. We aimed to investigate the safety and benefit of EVT in pre-stroke patients with mRS score 3. METHODS: We used data from the Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic stroke in the Netherlands (MR CLEAN) Registry. All patients treated with EVT for anterior circulation AIS with pre-stroke mRS 3 were included. We assessed causes for dependence and compared patients with successful reperfusion (defined as expanded Thrombolysis in Cerebral Ischemia scale (eTICI) 2b-3) to patients without successful reperfusion. We used regression analyses with pre-specified adjustments. Our primary outcome was 90-day mRS 0-3 (functional improvement or return to baseline). RESULTS: A total of 192 patients were included, of whom 82 (43%) had eTICI <2b and 108 (56%) eTICI ≥2b. The median age was 80 years (IQR 73-87). Fifty-one of the 192 patients (27%) suffered from previous stroke and 36/192 (19%) had cardiopulmonary disease. Patients with eTICI ≥2b more often returned to their baseline functional state or improved (n=26 (26%) vs n=15 (19%); adjusted odds ratio (aOR) 2.91 (95% CI 1.08 to 7.82)) and had lower mortality rates (n=49 (49%) vs n=50 (64%); aOR 0.42 (95% CI 0.19 to 0.93)) compared with patients with eTICI <2b. CONCLUSIONS: Although patients with AIS with pre-stroke mRS 3 comprise a heterogenous group of disability causes, we observed improved outcomes when patients achieved successful reperfusion after EVT.

Initial Single-Center Experience With the Knickerbocker Technique During Thoracic Endovascular Aortic Repair to Block Retrograde False Lumen Flow in Patients With Type B Aortic Dissection.

OBJECTIVE: Effectiveness of thoracic endovascular aortic repair in type B aortic dissection is impaired by persistent retrograde false lumen flow via distal re-entry tears. Controlled, stentgraft-assisted balloon dilatation of the true lumen at its lower end, or Knickerbocker technique, may block retrograde false lumen flow and consequently improve effectiveness by inducing immediate thrombosis along the entire descending thoracic aorta. MATERIALS AND METHODS: A single-center retrospective analysis was performed for all consecutive patients with aortic dissection treated with the Knickerbocker technique to block retrograde false lumen flow. RESULTS: Eleven patients were included for analysis. Intraoperative control angiography showed successful occlusion of the false lumen at the level of balloon dilatation in 9 out of 11 patients (82%). There was one perioperative mortality (9%), due to stroke. There were 2 early reinterventions, due to retroperitoneal bleeding and due to chyle leakage in the neck after left subclavian artery bypass. Median clinical follow-up duration was 6 (interquartile range [IQR] 2-11] months. There were 2 deaths during follow-up, one at 2 months after TEVAR from unknown cause of death, and one after 11 months due to rupture of an ascending aortic pseudoaneurysm. The Knickerbocker technique led to positive aortic remodeling. At 3 months follow-up, 100% of patients showed complete false lumen thrombosis in the thoracic aorta proximal to the level of balloon dilatation, with decreasing false lumen diameters (100%) and stable (44%) or decreasing (56%) total aortic diameters. In most patients, the false lumen distal to the stentgraft (i.e. at visceral level) remained patent (11% false lumen thrombosis rate), leading to ≥2 mm dilatation at this level (78% of patients) and in the infrarenal abdominal aorta (56% of patients) at 3 months postoperatively. No distal stent-graft-induced new entry tears were noticed during follow-up. CONCLUSION: The Knickerbocker technique is feasible and effective, leading to positive aortic remodeling of the aorta covered by stentgraft in all of a small cohort of patients. CLINICAL IMPACT: Persistent, retrograde false lumen perfusion from distal re-entries following thoracic endovascular aortic repair (TEVAR) for Stanford type B aortic dissection, may lead to progressive, aneurysmal dilatation. Controlled, stent graft-assisted balloon dilatation of the true lumen in the distal descending aorta (i.e. Knickerbocker technique) during TEVAR effectively excludes the false lumen from persistent flow resulting in positive aortic remodeling in our small cohort of patients, and hence potentially eliminates the risk of late post-dissection aneurysm formation in the descending thoracic aorta.

Endovascular repair of a ruptured, extremely tortuous, descending thoracic aorta aneurysm with aortic coarctation.

We have presented a case of a ruptured descending aortic aneurysm that was accompanied by extreme tortuosity and a pseudocoarctation at the level of the ligamentum arteriosum. We performed successful endovascular repair, covering the left subclavian artery, using a transapical-to-femoral artery (through-and-through) guidewire technique to overcome the tortuosity, with the option to perform balloon angioplasty in the case of an increased gradient over the coarctation. In the present case report, we have underlined the role of close collaborations with aortic expertise centers.

Circle of Willis variation and outcome after intra-arterial treatment.

Background: Intra-arterial treatment (IAT) improves outcomes in acute ischaemic stroke. Presence of collaterals increases likelihood of good outcome. We investigated whether variations in the circle of Willis (CoW) and contributing carotid arteries influence outcome in patients who had a stroke treated with IAT. Methods: CT angiography data on patients who had an acute stroke treated with IAT were retrospectively collected. CoW was regarded complete if the contralateral A1 segment, anterior communicating artery and ipsilateral posterior communicating artery were fully developed, and the P1 segment was visible. Carotid artery contribution was studied with a self-developed carotid artery score ranging from 0 to 2 depending on the number of arteries supplying the occluded side of the CoW. Good clinical outcome was defined as modified Rankin Score ≤2 and measured at discharge and 3 months. We calculated risk ratios for the relation between completeness of the CoW, carotid score and good outcome, and performed a trend analysis for good outcome according to the carotid score. Results: 126 patients were included for analysis. Patients with a complete and incomplete CoW had a comparable risk for good outcome at discharge and 3 months. A higher carotid score was associated with a higher likelihood of good clinical outcome (p for trend 0.24 at discharge and 0.05 at 3 months). Conclusion: In patients with acute ischaemic stroke treated with IAT, chances of good clinical outcome tended to improve with number of carotid arteries supplying the cerebral circulation. Completeness of the CoW was not related to clinical outcome.

RETALT: review of technologies and overview of design changes.

RETALT (RETro propulsion Assisted Landing Technologies) is a project funded in the frame of the European Union Horizon 2020 program, that is studying critical key technologies for the vertical landing of launcher configurations with the aid of retro propulsion. In particular Aerodynamics, Aerothermodynamics, Flight Dynamics and Guidance Navigation and Control (GNC), Structures, Mechanisms, Thrust Vector Control and Thermal Protection Systems are investigated in detail in the project. This paper provides an overview of the technological achievements in these different technological areas, with emphasis on the interaction between them. Design changes made to the RETALT1 configuration are laid out in detail. The novel approach of using interstage segments as aerodynamic control surfaces proved to be challenging from the aerodynamics, flight dynamics, mechanical and structural points of view. For this reason, planar fins were introduced as aerodynamic control surfaces in the new base line configuration for RETALT1. The paper concludes with a summary of future steps to be made in the RETALT project to reach the targeted Technology Readiness Level (TRL) of the different key technologies.

CIRSE Standards of Practice on Bronchial Artery Embolisation.

This CIRSE Standards of Practice document is aimed at interventional radiologists and provides best practices for performing bronchial artery embolisation to effectively treat haemoptysis. It has been developed by an expert writing group established by the CIRSE Standards of Practice Committee.

Safety and efficacy of aspirin, unfractionated heparin, both, or neither during endovascular stroke treatment (MR CLEAN-MED): an open-label, multicentre, randomised controlled trial.

BACKGROUND: Aspirin and unfractionated heparin are often used during endovascular stroke treatment to improve reperfusion and outcomes. However, the effects and risks of anti-thrombotics for this indication are unknown. We therefore aimed to assess the safety and efficacy of intravenous aspirin, unfractionated heparin, both, or neither started during endovascular treatment in patients with ischaemic stroke. METHODS: We did an open-label, multicentre, randomised controlled trial with a 2 × 3 factorial design in 15 centres in the Netherlands. We enrolled adult patients (ie, ≥18 years) with ischaemic stroke due to an intracranial large-vessel occlusion in the anterior circulation in whom endovascular treatment could be initiated within 6 h of symptom onset. Eligible patients had a score of 2 or more on the National Institutes of Health Stroke Scale, and a CT or MRI ruling out intracranial haemorrhage. Randomisation was done using a web-based procedure with permuted blocks and stratified by centre. Patients were randomly assigned (1:1) to receive either periprocedural intravenous aspirin (300 mg bolus) or no aspirin, and randomly assigned (1:1:1) to receive moderate-dose unfractionated heparin (5000 IU bolus followed by 1250 IU/h for 6 h), low-dose unfractionated heparin (5000 IU bolus followed by 500 IU/h for 6 h), or no unfractionated heparin. The primary outcome was the score on the modified Rankin Scale at 90 days. Symptomatic intracranial haemorrhage was the main safety outcome. Analyses were based on intention to treat, and treatment effects were expressed as odds ratios (ORs) or common ORs, with adjustment for baseline prognostic factors. This trial is registered with the International Standard Randomised Controlled Trial Number, ISRCTN76741621. FINDINGS: Between Jan 22, 2018, and Jan 27, 2021, we randomly assigned 663 patients; of whom, 628 (95%) provided deferred consent or died before consent could be asked and were included in the modified intention-to-treat population. On Feb 4, 2021, after unblinding and analysis of the data, the trial steering committee permanently stopped patient recruitment and the trial was stopped for safety concerns. The risk of symptomatic intracranial haemorrhage was higher in patients allocated to receive aspirin than in those not receiving aspirin (43 [14%] of 310 vs 23 [7%] of 318; adjusted OR 1·95 [95% CI 1·13-3·35]) as well as in patients allocated to receive unfractionated heparin than in those not receiving unfractionated heparin (44 [13%] of 332 vs 22 [7%] of 296; 1·98 [1·14-3·46]). Both aspirin (adjusted common OR 0·91 [95% CI 0·69-1·21]) and unfractionated heparin (0·81 [0·61-1·08]) led to a non-significant shift towards worse modified Rankin Scale scores. INTERPRETATION: Periprocedural intravenous aspirin and unfractionated heparin during endovascular stroke treatment are both associated with an increased risk of symptomatic intracranial haemorrhage without evidence for a beneficial effect on functional outcome. FUNDING: The Collaboration for New Treatments of Acute Stroke consortium, the Brain Foundation Netherlands, the Ministry of Economic Affairs, Stryker, Medtronic, Cerenovus, and the Dutch Heart Foundation.

Improvements in Endovascular Treatment for Acute Ischemic Stroke: A Longitudinal Study in the MR CLEAN Registry.

BACKGROUND: We evaluated data from all patients in the Netherlands who underwent endovascular treatment for acute ischemic stroke in the past 3.5 years, to identify nationwide trends in time to treatment and procedural success, and assess their effect on clinical outcomes. METHODS: We included patients with proximal occlusions of the anterior circulation from the second and first cohorts of the MR CLEAN (Multicenter Randomized Clinical trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands) Registry (March 2014 to June 2016; June 2016 to November 2017, respectively). We compared workflow times and rates of successful reperfusion (defined as an extended Thrombolysis in Cerebral Infarction score of 2B-3) between cohorts and chronological quartiles (all included patients stratified in chronological quartiles of intervention dates to create equally sized groups over the study period). Multivariable ordinal logistic regression was used to assess differences in the primary outcome (ordinal modified Rankin Scale at 90 days). RESULTS: Baseline characteristics were similar between cohorts (second cohort n=1692, first cohort n=1488) except for higher age, poorer collaterals, and less signs of early ischemia on computed tomography in the second cohort. Time from stroke onset to groin puncture and reperfusion were shorter in the second cohort (median 185 versus 210 minutes; P<0.001 and 236 versus 270 minutes; P<0.001, respectively). Successful reperfusion was achieved more often in the second than in the first cohort (72% versus 66%; P<0.001). Functional outcome significantly improved (adjusted common odds ratio 1.23 [95% CI, 1.07-1.40]). This effect was attenuated by adjustment for time from onset to reperfusion (adjusted common odds ratio, 1.12 [95% CI, 0.98-1.28]) and successful reperfusion (adjusted common odds ratio, 1.13 [95% CI, 0.99-1.30]). Outcomes were consistent in the analysis per chronological quartile. CONCLUSIONS: Clinical outcomes after endovascular treatment for acute ischemic stroke in routine clinical practice have improved over the past years, likely resulting from improved workflow times and higher successful reperfusion rates.

Long-term patency of surgical left subclavian artery revascularization.

OBJECTIVE: Little is known regarding the long-term patency rates of surgical left subclavian artery (LSA) revascularization, especially when performed concomitant to thoracic endovascular aortic repair and without arterial occlusive disease. Our aim is to contribute to the existing evidence by reporting the patency rates at mid- and long-term follow-up after surgical LSA revascularization. METHODS: This observational, retrospective, single-center cohort study included 90 eligible patients who underwent a left common carotid artery to LSA bypass (72%) or transposition (28%) from December 31, 2017 to January 1, 2000. Data regarding demographics, medical history, intraoperative characteristics, and outcomes regarding bypass graft or transposition patency, severe stenosis, or occlusion were assessed at discharge, 3 months, 1 year, and maximum follow-up using consecutive follow-up computed tomography scans. RESULTS: In our predominantly male (74%) cohort with a mean age of 66 years (standard deviation, ±12 years), LSA revascularization was mostly performed concomitant to or adjacent to thoracic endovascular aneurysm repair procedures (98%) with the primary indication for surgery being degenerative or saccular aneurysmatic aortic disease (50%), subacute or acute type B aortic dissection (17%), post-dissection aortic aneurysm (16%), type B intramural hematoma (6%), and other indications (11%). Ninety-seven percent of our left common carotid artery to LSA bypasses were performed using a central, supraclavicular approach, and the other 3% were performed using an infraclavicular approach to the LSA. Median diameter of the bypass was 6 mm (range, 6-12 mm). We found two occlusions at 7.7 and 12.9 months follow-up and four severe stenoses at 21.2, 35.4, 38.3, and 46.7 months follow-up, respectively. Estimated freedom from occlusion was 97% ± 2% and freedom from severe stenosis was 90% ± 4% at both midterm (5 years) and long-term (10 years) follow-up, with a median follow-up duration of 42.2 months for occlusion (25th-75th percentile, 15.4-67.4 months) and 41.9 months (25th-75th percentile, 15.4-67.4 months) for severe stenosis. CONCLUSIONS: Open surgical LSA revascularization may be considered the gold standard to preserve antegrade LSA flow in the context of debranching for thoracic endovascular aneurysm repair or open surgical aortic arch repair, with excellent patency rates at mid-term and long-term follow-up.

Impact of the lockdown on acute stroke treatments during the first surge of the COVID-19 outbreak in the Netherlands.

INTRODUCTION: We investigated the impact of the Corona Virus Disease 2019 (COVID-19) pandemic and the resulting lockdown on reperfusion treatments and door-to-treatment times during the first surge in Dutch comprehensive stroke centers. Furthermore, we studied the association between COVID-19-status and treatment times. METHODS: We included all patients receiving reperfusion treatment in 17 Dutch stroke centers from May 11th, 2017, until May 11th, 2020. We collected baseline characteristics, National Institutes of Health Stroke Scale (NIHSS) at admission, onset-to-door time (ODT), door-to-needle time (DNT), door-to-groin time (DGT) and COVID-19-status at admission. Parameters during the lockdown (March 15th, 2020 until May 11th, 2020) were compared with those in the same period in 2019, and between groups stratified by COVID-19-status. We used nationwide data and extrapolated our findings to the increasing trend of EVT numbers since May 2017. RESULTS: A decline of 14% was seen in reperfusion treatments during lockdown, with a decline in both IVT and EVT delivery. DGT increased by 12 min (50 to 62 min, p-value of < 0.001). Furthermore, median NIHSS-scores were higher in COVID-19 - suspected or positive patients (7 to 11, p-value of 0.004), door-to-treatment times did not differ significantly when stratified for COVID-19-status. CONCLUSIONS: During the first surge of the COVID-19 pandemic, a decline in acute reperfusion treatments and a delay in DGT was seen, which indicates a target for attention. It also appeared that COVID-19-positive or -suspected patients had more severe neurologic symptoms, whereas their EVT-workflow was not affected.

Biliopancreatic and biliary leak after pancreatoduodenectomy treated by percutaneous transhepatic biliary drainage.

BACKGROUND: Complementary to percutaneous intra-abdominal drainage, percutaneous transhepatic biliary drainage (PTBD) might ameliorate healing of pancreatic fistula and biliary leakage after pancreatoduodenectomy by diversion of bile from the site of leakage. This study evaluated technical and clinical outcomes of PTBD for this indication. METHODS: All patients undergoing PTBD for leakage after pancreatoduodenectomy were retrospectively evaluated in two tertiary pancreatic centers (2014-2019). Technical success was defined as external biliary drainage. Clinical success was defined as discharge with a resolved leak, without additional surgical interventions for anastomotic leakage other than percutaneous intra-abdominal drainage. RESULTS: Following 822 pancreatoduodenectomies, 65 patients (8%) underwent PTBD. Indications were leakage of the pancreaticojejunostomy (n = 25; 38%), hepaticojejunostomy (n = 15; 23%) and of both (n = 25; 38%). PTBD was technically successful in 64 patients (98%) with drain revision in 40 patients (63%). Clinical success occurred in 60 patients (94%). Leakage resolved after median 33 days (IQR 21-60). PTBD related complications occurred in 23 patients (35%), including cholangitis (n = 14; 21%), hemobilia (n = 7; 11%) and PTBD related bleeding requiring re-intervention (n = 4; 6%). In hospital mortality was 3% (n = 2). CONCLUSION: Although drain revisions and complications are common, PTBD is highly feasible and appears to be effective in the treatment of biliopancreatic leakage after pancreatoduodenectomy.