Expert opinion of the Heart Rhythm Association of the Polish Cardiac Society and the Polish Neurological Society on evidence-driven implementation of implantable loop recorders in Poland.

Implantable loop recorders (ILR) are considered increasingly helpful in diagnosing cardio-neurological conditions, especially if arrhythmic events are of high clinical importance but are unlikely to be captured by standard methods of electrocardiogram recording due to the low frequency of events and short duration of a single event. The compelling evidence from randomized trials and observational studies strongly supports ILR utilization in patients after cryptogenic stroke or transient ischemic attack and in patients with recurrent transient loss of consciousness of unknown origin. These two groups of patients are expected to gain the most from initiating ILR-driven clinically effective management strategies. Stroke or transient ischemic attack survivors with detected subclinical atrial fibrillation can be switched from antiplatelets to anticoagulants, whilst patients with recurrent syncope may avoid severe injuries and/or substantial impairment of their quality of life. This joint opinion of the Heart Rhythm Association of the Polish Cardiac Society and experts from the Polish Neurological Society summarizes the up-to-date rationale for using ILR in everyday clinical practice and describes the road map for implementing this technology in Poland. Special emphasis is placed on the most recent guidelines issued by both cardiological and neurological scientific societies.

External quality monitoring facilitates improvement in already well-performing stroke units: insights from RES-Q Poland.

INTRODUCTION: The Registry of Stroke Care Quality (RES-Q) is used in Poland for quality monitoring by numerous hospitals participating in the Angels Initiative. Our aim was to assess the degree of improvement in highly stroke-oriented centres that report cases to the RES-Q each year. MATERIAL AND METHODS: This retrospective analysis included Polish stroke units that from January 2017 to December 2020 contributed to the RES-Q at least 25 patients annually. RESULTS: Seventeen out of 180 Polish stroke units reported patients each year (2017, n = 1,691; 2018, n = 2,986; 2019, n = 3,750; 2020, n = 3,975). The percentage of ischaemic stroke patients treated with alteplase remained stable (26%, 29%, 30% and 28%, respectively). The door-to-needle time progressively decreased, from a median 49 minutes to 32 minutes. The percentage of patients treated ≤ 60 minutes and ≤ 45 minutes significantly increased (from 68% to 86% and from 43% to 70%, respectively), with no change observed between 2019 and 2020. Despite a general improvement in dysphagia screening (81%, 91%, 98% and 99%), screening performed within the first 24h from admission became less frequent (78%, 76%, 69% and 65%). In-hospital mortality significantly increased (11%, 11%, 13% and 15%), while the proportion of patients discharged home remained stable. CONCLUSIONS: Quality-oriented projects facilitate the improvement of stroke care, even in centres demonstrating good baseline performance. Polish stroke units that consistently reported cases to the RES-Q demonstrated improvement in terms of door-to- -needle time and dysphagia screening. However, there is still a need to shorten the time to dysphagia screening, and carefully monitor stroke unit mortality following the COVID-19 pandemic.

High neutrophil-to-lymphocyte ratio (NLR) predicts poor response to intravenous thrombolysis in white Caucasian stroke patients.

OBJECTIVES: Our aim was to investigate usefulness of the neutrophil-to-lymphocyte ratio (NLR) for predicting poor response to intravenous rtPA in white Caucasian ischemic stroke patients treated within 4.5 hours from the onset. MATERIALS AND METHODS: This retrospective analysis included all consecutive acute ischemic stroke patients (N = 344) treated with rtPA in a tertiary stroke center from 2011 to 2017. NLR was calculated from complete blood counts obtained on admission. The patients were classified into NLR terciles (T1 <1.75, T2<2.97, T3≥2.97). Significant neurological improvement was defined as an 8-point reduction in the NIHSS score or reaching the score of 0 to 1. RESULTS: Compared to NLR T1, patients from NLR T3 were significantly older, more often disabled before stroke, and had longer onset-to-needle time. They less often achieved neurological improvement at day 7 (38% vs 59% p=0.002) and had higher 90-day mortality (27% vs 13%, p=0.020), with no differences in neurological improvement at 24 hours, occurrence of sICH and 7-day mortality. Each additional 4 units of NLR decreased unadjusted and adjusted odds for achieving favorable outcome at day 7 (OR 0.65, 95% CI: 0.46-0.92; aOR 0.62, 95% CI: 0.39-1.00), and increased the odds for death at 3 months (OR 1.60, 95% CI: 1.15-2.24; aOR 1.82, 95% CI:1.14-2.92) CONCLUSIONS: High NLR can predict poor response to intravenous rtPA in Caucasian patients with acute ischemic stroke, especially in terms of not achieving significant neurological improvement at day 7 and death at day 90. It encourages attempts to incorporate NLR in already validated scores.

Effects of blood pressure and tranexamic acid in spontaneous intracerebral haemorrhage: a secondary analysis of a large randomised controlled trial.

Background: Tranexamic acid reduced haematoma expansion and early death, but did not improve functional outcome in the tranexamic acid for hyperacute spontaneous intracerebral haemorrhage-2 (TICH-2) trial. In a predefined subgroup, there was a statistically significant interaction between prerandomisation baseline systolic blood pressure (SBP) and the effect of tranexamic acid on functional outcome (p=0.019). Methods: TICH-2 was an international prospective double-blind placebo-controlled randomised trial evaluating intravenous tranexamic acid in patients with acute spontaneous intracerebral haemorrhage (ICH). Prerandomisation baseline SBP was split into predefined ≤170 and >170 mm Hg groups. The primary outcome at day 90 was the modified Rankin Scale (mRS), a measure of dependency, analysed using ordinal logistic regression. Haematoma expansion was defined as an increase in haematoma volume of >33% or >6 mL from baseline to 24 hours. Data are OR or common OR (cOR) with 95% CIs, with significance at p<0.05. Results: Of 2325 participants in TICH-2, 1152 had baseline SBP≤170 mm Hg and were older, had larger lobar haematomas and were randomised later than 1173 with baseline SBP>170 mm Hg. Tranexamic acid was associated with a favourable shift in mRS at day 90 in those with baseline SBP≤170 mm Hg (cOR 0.73, 95% CI 0.59 to 0.91, p=0.005), but not in those with baseline SBP>170 mm Hg (cOR 1.05, 95% CI 0.85 to 1.30, p=0.63). In those with baseline SBP≤170 mm Hg, tranexamic acid reduced haematoma expansion (OR 0.62, 95% CI 0.47 to 0.82, p=0.001), but not in those with baseline SBP>170 mm Hg (OR 1.02, 95% CI 0.77 to 1.35, p=0.90). Conclusions: Tranexamic acid was associated with improved clinical and radiological outcomes in ICH patients with baseline SBP≤170 mm Hg. Further research is needed to establish whether certain subgroups may benefit from tranexamic acid in acute ICH. Trial registration number: ISRCTN93732214.

Reliability of the modified Rankin Scale in clinical practice of stroke units and rehabilitation wards.

Introduction: The Modified Rankin Scale (mRS) is the most common tool to quantify post-stroke disability in everyday practice and by certified raters in clinical trials. However, interobserver variability may affect reliability of retrospective observational studies, including clinical registries. Our aim was to assess real-life consistency between neurologists and physical and rehabilitation medicine physicians using mRS to rate post-stroke disability of patients transferred directly from stroke unit (SU) to rehabilitation ward (RW). Methods: This is a retrospective analysis of 132 consecutive acute stroke patients transferred from single tertiary SU to RW located in the same hospital in Poland. Patients were assessed by one rater from each department at the day of transfer. We distinguished between physicians previously certified in using mRS for clinical trials and not-certified physicians using mRS in everyday practice. Results: mRS at discharge from SU and on admission to RW was recorded for 105 of 132 patients. The overall agreement was 70.5% (kappa 0.55). Similar agreement was observed in the subset of 30 patients rated by certified physicians in both departments (70.0%, kappa 0.57) and in the subset of 61 patients rated by a pair of certified neurologist and not-certified rehabilitation physician (73.8%, kappa 0.58). Conclusions: Everyday consistency between raters from SU and RW in using mRS is modest as in previous validation studies. However, it may be considered sufficient for the purpose of observational studies or stroke registries. It emphasizes the need for easily accessible training in conventional mRS or implementation of specialized tools with predefined questions.

Mexiletine for recurrent ventricular tachycardia in adult patients with structural heart disease and implantable cardioverter defibrillator: an EHRA systematic review.

The aim of the study was to systematically review evidence on the effectiveness and safety of oral mexiletine administered in monotherapy or in combination with other antiarrhythmic drugs for recurrent ventricular arrhythmia (ventricular tachycardia/ventricular fibrillation, VT/VF) in adult patients with structural heart disease (SHD) and implantable cardioverter defibrillators (ICDs). We systematically searched MEDLINE, Embase, and CENTRAL databases from inception to 27 August 2021 for prospective and retrospective studies investigating mexiletine in the target population. The main outcome was the reduction of ICD therapy. The main safety outcome was the presence of any serious adverse events (SAEs) leading to mexiletine discontinuation. Study quality was assessed using the Cochrane risk of bias tool or the Newcastle-Ottawa scale. Four studies comprising 86 mexiletine recipients were included in the review. We also obtained individual data of 50 patients from two studies. Ischaemic cardiomyopathy (ICM) was present in 86% of patients. The quality of included studies was moderate/low. A narrative review was undertaken as studies varied widely in terms of study population and treatment. Across studies, mexiletine treatment (with or without amiodarone) seemed to consistently reduce the number of ICD therapies especially in a population where catheter ablation (CA) was unsuccessful or contraindicated. In ICM patients deemed eligible for CA, mexiletine seemed to be inferior to CA. Mexiletine was discontinued in 14% of cases, mainly for gastrointestinal or neurological SAE. Mexiletine seems to be an option for the long-term treatment of recurrent VT/VF in adult patients with SHD, especially ICM, and ICD in whom CA was unsuccessful or not suitable.

Reliability of prehospital diagnosis of acute cerebrovascular accident.

INTRODUCTION: Early and correct suspicion of an acute cerebrovascular accident (CVA) is necessary to minimise the time to reperfusion treatment. Our aim was to evaluate the reliability of a prehospital diagnosis of stroke or transient ischaemic attack made by healthcare professionals referring patients directly to a neurological Emergency Department (ED). MATERIAL AND METHODS: This retrospective analysis included all consecutive patients referred between 1 January and 31 December 2014 by ambulance physicians, paramedics or outpatient physicians to the neurological ED providing care for the 300-350,000 inhabitants of a highly urbanised area. We calculated sensitivity and positive predictive value (PPV) with 95% confidence intervals (95% CI) for each group of healthcare professionals, and compared the proportions of undetected CVAs. RESULTS: Of 802 patients referred with a prehospital diagnosis of CVA, 544 were confirmed. Additional 95 CVA cases were referred with a diagnosis other than CVA. The highest sensitivity for detection of any CVA was among ambulance physicians (96%; 95% CI 92-98%), followed by paramedics (85%; 95% CI 80-90%; p < 0.001) and outpatient physicians (74%; 95% CI 70-79%; p < 0.001). PPV for stroke was 83% (95% CI 77-87%) among ambulance physicians, 73% (95% CI 65-80%) among paramedics, and 56% (95% CI 47-64%) among outpatient physicians. CONCLUSIONS: Ambulance physicians are highly sensitive in diagnosing any CVA, and are correct in 8 out of 10 cases. The inferior performance of paramedics and outpatient physicians indicates the need for regular stroke training for paramedics and the implementation of two-way communication with the stroke team to identify potential candidates for reperfusion therapy before arrival at the ED.

Brief Consent Methods Enable Rapid Enrollment in Acute Stroke Trial: Results From the TICH-2 Randomized Controlled Trial.

BACKGROUND: Seeking consent rapidly in acute stroke trials is crucial as interventions are time sensitive. We explored the association between consent pathways and time to enrollment in the TICH-2 (Tranexamic Acid in Intracerebral Haemorrhage-2) randomized controlled trial. METHODS: Consent was provided by patients or by a relative or an independent doctor in incapacitated patients, using a 1-stage (full written consent) or 2-stage (initial brief consent followed by full written consent post-randomization) approach. The computed tomography-to-randomization time according to consent pathways was compared using the Kruskal-Wallis test. Multivariable logistic regression was performed to identify variables associated with onset-to-randomization time of ≤3 hours. RESULTS: Of 2325 patients, 817 (35%) gave self-consent using 1-stage (557; 68%) or 2-stage consent (260; 32%). For 1507 (65%), consent was provided by a relative (1 stage, 996 [66%]; 2 stage, 323 [21%]) or a doctor (all 2-stage, 188 [12%]). One patient did not record prerandomization consent, with written consent obtained subsequently. The median (interquartile range) computed tomography-to-randomization time was 55 (38-93) minutes for doctor consent, 55 (37-95) minutes for 2-stage patient, 69 (43-110) minutes for 2-stage relative, 75 (48-124) minutes for 1-stage patient, and 90 (56-155) minutes for 1-stage relative consents (P<0.001). Two-stage consent was associated with onset-to-randomization time of ≤3 hours compared with 1-stage consent (adjusted odds ratio, 1.9 [95% CI, 1.5-2.4]). Doctor consent increased the odds (adjusted odds ratio, 2.3 [1.5-3.5]) while relative consent reduced the odds of randomization ≤3 hours (adjusted odds ratio, 0.10 [0.03-0.34]) compared with patient consent. Only 2 of 771 patients (0.3%) in the 2-stage pathways withdrew consent when full consent was sought later. Two-stage consent process did not result in higher withdrawal rates or loss to follow-up. CONCLUSIONS: The use of initial brief consent was associated with shorter times to enrollment, while maintaining good participant retention. Seeking written consent from relatives was associated with significant delays. REGISTRATION: URL: https://www.isrctn.com; Unique identifier: ISRCTN93732214.

Effectiveness and safety of a single freeze strategy of cryoballoon ablation of atrial fibrillation: an EHRA systematic review and meta-analysis.

To conduct a systematic review and meta-analysis to compare the effectiveness and safety of cryoballoon ablation of atrial fibrillation (AF) performed using a single freeze strategy in comparison to an empiric double ('bonus') freeze strategy. We systematically searched MEDLINE, EMBASE, and CENTRAL databases from inception to 12 July 2020, for prospective and retrospective studies of patients undergoing cryoballoon for paroxysmal or persistent AF comparing a single vs. bonus freeze strategy. The main outcome was atrial arrhythmia-free survival and eligible studies required at least 12 months of follow-up; the primary safety outcome was a composite of all complications. Study quality was assessed using the Cochrane risk of bias tool and the Newcastle-Ottawa Scale. Thirteen studies (3 randomized controlled trials and 10 observational studies) comprising 3163 patients were eligible for inclusion (64% males, 71.5% paroxysmal AF, mean CHA2DS2-VASc score 1.3 ± 0.9). There was no significant difference in pooled effectiveness between single freeze strategy compared to double freeze strategy [relative risk (RR) 1.03; 95% confidence interval (CI): 0.98-1.07; I2 = 0%]. Single freeze procedures were associated with a significantly lower adverse event rate (RR 0.72; 95% CI: 0.53-0.98; I2 = 0%) and shorter average procedure time (90 ± 27 min vs. 121 ± 36 min, P < 0.001). A trend for lower risk of persistent phrenic nerve palsy was observed (RR 0.61; 95% CI: 0.37-1.01; I2 = 0%). The quality of included studies was moderate/good, with no evidence of significant publication bias. Single freeze strategy for cryoballoon of AF is as effective as an empiric double ('bonus') freeze strategy while appearing safer and probably quicker (PROSPERO registration number CRD42020158696).

Outcomes in Antiplatelet-Associated Intracerebral Hemorrhage in the TICH-2 Randomized Controlled Trial.

Background Antiplatelet therapy increases the risk of hematoma expansion in intracerebral hemorrhage (ICH) while the effect on functional outcome is uncertain. Methods and Results This is an exploratory analysis of the TICH-2 (Tranexamic Acid in Intracerebral Hemorrhage-2) double-blind, randomized, placebo-controlled trial, which studied the efficacy of tranexamic acid in patients with spontaneous ICH within 8 hours of onset. Multivariable logistic regression and ordinal regression were performed to explore the relationship between pre-ICH antiplatelet therapy, and 24-hour hematoma expansion and day 90 modified Rankin Scale score, as well as the effect of tranexamic acid. Of 2325 patients, 611 (26.3%) had pre-ICH antiplatelet therapy. They were older (mean age, 75.7 versus 66.5 years), more likely to have ischemic heart disease (25.4% versus 2.7%), ischemic stroke (36.2% versus 6.3%), intraventricular hemorrhage (40.2% versus 27.5%), and larger baseline hematoma volume (mean, 28.1 versus 22.6 mL) than the no-antiplatelet group. Pre-ICH antiplatelet therapy was associated with a significantly increased risk of hematoma expansion (adjusted odds ratio [OR], 1.28; 95% CI, 1.01-1.63), a shift toward unfavorable outcome in modified Rankin Scale (adjusted common OR, 1.58; 95% CI, 1.32-1.91) and a higher risk of death at day 90 (adjusted OR, 1.63; 95% CI, 1.25-2.11). Tranexamic acid reduced the risk of hematoma expansion in the overall patients with ICH (adjusted OR, 0.76; 95% CI, 0.62-0.93) and antiplatelet subgroup (adjusted OR, 0.61; 95% CI, 0.41-0.91) with no significant interaction between pre-ICH antiplatelet therapy and tranexamic acid (P interaction=0.248). Conclusions Antiplatelet therapy is independently associated with hematoma expansion and unfavorable functional outcome. Tranexamic acid reduced hematoma expansion regardless of prior antiplatelet therapy use. Registration URL: https://www.isrctn.com; Unique identifier: ISRCTN93732214.

Safety and early outcomes after intravenous thrombolysis in acute ischemic stroke patients with prestroke disability.

BACKGROUND: There are limited data on intravenous thrombolysis treatment in ischemic stroke patients with prestroke disability. AIM: We aimed to evaluate safety and outcomes of intravenous thrombolysis treatment in stroke patients with prestroke disability. METHODS: We analyzed 88,094 patients treated with intravenous thrombolysis, recorded in the Safe Implementation of Treatments in Stroke (SITS) International Thrombolysis Register between January 2003 and December 2017, with available NIHSS data at stroke-onset and after 24 h. Of them, 4566 patients (5.2%) had prestroke disability, defined as a modified Rankin Scale score of 3-5. Safety outcome measures included Symptomatic Intracerebral Hemorrhage, any type of parenchymal hematoma on 24 h imaging scans irrespective of clinical symptoms, and death within seven days. Early outcome measures were 24-h NIHSS improvement (≥4 from baseline to 24 h). RESULTS: Patients with prestroke disability were older, had more severe strokes, and more comorbidities than patients without prestroke disability. When comparing patients with prestroke disability with patients without prestroke disability, there was however no significant increase in adjusted odds for symptomatic intracerebral hemorrhage (adjusted odds ratio 0.83 (95% CI 0.60-1.15) (absolute difference in proportion 1.17% vs. 1.27%)) or for parenchymal hemorrhage (adjusted odds ratio 0.96 (0.83-1.11) (7.51% vs. 6.34%)). The prestroke disability group had a significantly lower-adjusted odds ratio for a 24-h NIHSS improvement (adjusted odds ratio 0.79 (0.73-0.85) (45.95% vs. 48.45%)) and a higher adjusted odds ratio for seven-day mortality (aOR 1.40 (1.21-1.61) (10.40% vs. 4.93%)). CONCLUSIONS: Intravenous thrombolysis in acute ischemic stroke patients with prestroke disability was not associated with an increased risk of symptomatic intracerebral hemorrhage or parenchymal hemorrhage. Prestroke disability was however associated with a higher risk of early mortality compared to patients without prestroke disability.

Sex-related differences among ischaemic stroke patients treated with intravenous thrombolysis in Poland.

AIM OF STUDY: We investigated sex differences i n i schaemic s troke p atients t reated w ith i ntravenous a lteplase. CLINICAL RATIONALE FOR STUDY: We suggest that it is necessary to improve care for women with atrial fibrillation. Our data suggests that closer evaluation of treatment for ischaemic stroke in men and women is needed, preferably in the form of a prospective study. MATERIALS AND METHODS: This was a multicentre analysis of 1,830 ischaemic stroke patients treated with alteplase from 2004 to 2012. Data was prospectively collected in the Safe Implementation of Treatments in Stroke (SITS) registry. The main outcome measures were symptomatic intracerebral haemorrhage (sICH) within 36 hours of treatment, three months of functional independence, and mortality. RESULTS: Women were significantly older (mean age 71.3 vs 66.2 years; p < 0.01), more often suffered from hypertension (78.3% vs 70.1%; p < 0.01) and cardio-embolic strokes (34.7% vs 27.1%; p < 0.01), and presented heavier baseline deficits. There were no differences in sICH, but after three months fewer women were functionally independent (46.5% vs 53.3%; p < 0.01) and women had higher mortality (26.0% vs 19.7%; p < 0.01). CONCLUSIONS: Of the ischaemic stroke patients treated with intravenous thrombolysis, women had worse long-term outcomes than men. This discrepancy may be explained by the older age and higher proportion of cardio-embolic strokes with more severe baseline deficits. However, multiple logistic analysis did not show that sex itself had an impact on the greater mortality in women after a stroke, or on the poorer prognosis.

Dabigatran initiation in patients with non-valvular AF and first acute ischaemic stroke: a retrospective observational study from the SITS registry.

BACKGROUND AND OBJECTIVE: The optimal timing for initiation of dabigatran after acute ischaemic stroke (AIS) is not established. We aimed to evaluate initiation timing and clinical outcomes of dabigatran in AIS patients with non-valvular atrial fibrillation (NVAF). DESIGN: Retrospective study based on prospectively collected data in SITS (Safe Implementation of Treatment in Stroke) Thrombolysis and Thrombectomy Registry from July 2014 to July 2018. PARTICIPANTS: European NVAF patients (≥18 years) hospitalised after first-ever ischaemic stroke. SETTING: A multinational, observational monitoring register. INTERVENTION: Dabigatran initiation within 3 months after the ischaemic stroke. PRIMARY AND SECONDARY OUTCOMES: The primary outcome was time from first-ever ischaemic stroke (index event) to dabigatran initiation. Additional outcomes included physicians' reasons for delaying dabigatran initiation beyond acute hospital discharge and outcomes within 3 months of index event. METHODS: We identified patients with NVAF who received dabigatran within 3 months of the index event. We performed descriptive statistics for baseline and demographic data and clinical outcomes after dabigatran initiation. RESULTS: In total, 1489 patients with NVAF received dabigatran after AIS treated with thrombolysis and/or thrombectomy. Of these, 1240 had available initiation time. At baseline, median age was 75 years; 53% of patients were women, 15% were receiving an oral anticoagulant, 29% acetylsalicylic acid and 4% clopidogrel. Most patients (82%) initiated dabigatran within 14 days after the index event. Patients initiating earlier had lower stroke severity from median NIHSS 8 (IQR 6-13) if initiated within 7 days to NIHSS 15 (9-19) if initiated between 28 days and 3 months. Most common reasons for delaying initiation were haemorrhagic transformation or intracranial haemorrhage, stroke severity and infarct size. Few thrombotic/haemorrhagic events occurred within 3 months after the index event (20 of 926 patients, 2.2% with the available data). CONCLUSIONS: Our findings, together with previous observational studies, indicate that dabigatran initiated within the first days after an AIS is safe in patients treated with intravenous thrombolysis, endovascular thrombectomy or both. TRIAL REGISTRATION NUMBER: SITS Thrombolysis and Thrombectomy Registry (NCT03258645).

Educational needs among physicians treating patients with atrial fibrillation: lessons for Poland from the European Society of Cardiology international educational needs assessment study.

INTRODUCTION: A study by the European Society of Cardiology assessing international educational needs has identified educational and organizational barriers preventing the implementation of optimal therapy of atrial fibrillation (AF) across European countries. OBJECTIVES: Our aim was to investigate educational and organizational barriers in the implementation of guideline­recommended AF care that are specific to physicians and health-care system in Poland. PATIENTS AND METHODS: An internet­based survey was conducted to assess education, skills, and confidence in managing patients with AF among European cardiologists, neurologists, and family physicians (FPs) from 6 countries. RESULTS: Out of 571 respondents, the Polish sample included 90 physicians (16%): 44 cardiologists (15%), 21 neurologists (16%), and 25 FPs (18%). Polish physicians generally reported skills and confidence similar to those presented by their foreign colleagues, but there was high uncertainty concerning skills and confidence in the identification and pathophysiological classification of AF. Also, FPs reported low confidence in applying CHA2DS2­VASc and HAS­BLED scores to clinical practice. The need for access to long­term heart rhythm monitoring including implantable loop recorders was highlighted. There was a general dissatisfaction with the cooperation among Polish physicians, which was significantly higher than in other countries. CONCLUSIONS: The number of substantial educational gaps among physicians from Poland and other European countries is low. Nonetheless, educational programs tailored for different specialist groups separately to improve competence are warranted. There is a clear need for improvement of communication among different specialists treating patients with AF in Poland.

Tranexamic acid to improve functional status in adults with spontaneous intracerebral haemorrhage: the TICH-2 RCT.

BACKGROUND: Tranexamic acid reduces death due to bleeding after trauma and postpartum haemorrhage. OBJECTIVE: The aim of the study was to assess if tranexamic acid is safe, reduces haematoma expansion and improves outcomes in adults with spontaneous intracerebral haemorrhage (ICH). DESIGN: The TICH-2 (Tranexamic acid for hyperacute primary IntraCerebral Haemorrhage) study was a pragmatic, Phase III, prospective, double-blind, randomised placebo-controlled trial. SETTING: Acute stroke services at 124 hospitals in 12 countries (Denmark, Georgia, Hungary, Ireland, Italy, Malaysia, Poland, Spain, Sweden, Switzerland, Turkey and the UK). PARTICIPANTS: Adult patients (aged ≥ 18 years) with ICH within 8 hours of onset. EXCLUSION CRITERIA: Exclusion criteria were ICH secondary to anticoagulation, thrombolysis, trauma or a known underlying structural abnormality; patients for whom tranexamic acid was thought to be contraindicated; prestroke dependence (i.e. patients with a modified Rankin Scale [mRS] score > 4); life expectancy < 3 months; and a Glasgow Coma Scale score of < 5. INTERVENTIONS: Participants, allocated by randomisation, received 1 g of an intravenous tranexamic acid bolus followed by an 8-hour 1-g infusion or matching placebo (i.e. 0.9% saline). MAIN OUTCOME MEASURE: The primary outcome was functional status (death or dependency) at day 90, which was measured by the shift in the mRS score, using ordinal logistic regression, with adjustment for stratification and minimisation criteria. RESULTS: A total of 2325 participants (tranexamic acid, n = 1161; placebo, n = 1164) were recruited from 124 hospitals in 12 countries between 2013 and 2017. Treatment groups were well balanced at baseline. The primary outcome was determined for 2307 participants (tranexamic acid, n = 1152; placebo, n = 1155). There was no statistically significant difference between the treatment groups for the primary outcome of functional status at day 90 [adjusted odds ratio (aOR) 0.88, 95% confidence interval (CI) 0.76 to 1.03; p = 0.11]. Although there were fewer deaths by day 7 in the tranexamic acid group (aOR 0.73, 95% CI 0.53 to 0.99; p = 0.041), there was no difference in case fatality at 90 days (adjusted hazard ratio 0.92, 95% CI 0.77 to 1.10; p = 0.37). Fewer patients experienced serious adverse events (SAEs) after treatment with tranexamic acid than with placebo by days 2 (p = 0.027), 7 (p = 0.020) and 90 (p = 0.039). There was no increase in thromboembolic events or seizures. LIMITATIONS: Despite attempts to enrol patients rapidly, the majority of participants were enrolled and treated > 4.5 hours after stroke onset. Pragmatic inclusion criteria led to a heterogeneous population of participants, some of whom had very large strokes. Although 12 countries enrolled participants, the majority (82.1%) were from the UK. CONCLUSIONS: Tranexamic acid did not affect a patient's functional status at 90 days after ICH, despite there being significant modest reductions in early death (by 7 days), haematoma expansion and SAEs, which is consistent with an antifibrinolytic effect. Tranexamic acid was safe, with no increase in thromboembolic events. FUTURE WORK: Future work should focus on enrolling and treating patients early after stroke and identify which participants are most likely to benefit from haemostatic therapy. Large randomised trials are needed. TRIAL REGISTRATION: Current Controlled Trials ISRCTN93732214. FUNDING: This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 35. See the NIHR Journals Library website for further project information. The project was also funded by the Pragmatic Trials, UK, funding call and the Swiss Heart Foundation in Switzerland.

BACKGROUND: Stroke caused by bleeding in the brain [i.e. an intracerebral haemorrhage (ICH)] is a medical emergency. Around one-third of such strokes are complicated by continuing bleeding, which usually occurs within the first few hours after trauma and childbirth, and is associated with death or severe disability. Tranexamic acid is a drug that is seen to reduce death from bleeding after trauma and childbirth. METHODS: The study enrolled adults within 8 hours of an ICH into this large randomised trial. Half of the participants were given an injection of tranexamic acid and the other half placebo (in the form of salt water). The main aim of the trial was to measure changes in recovery by a telephone questionnaire on how much the person was able to do or needed help with 90 days after the stroke (i.e. functional status). Other measures included amount of brain bleeding, complications after stroke (serious adverse events), drug side effects and death within 7 days of stroke. RESULTS: A total of 2325 participants from 124 hospitals in 12 countries were enrolled between 2013 and 2017. Participants treated with tranexamic acid had no significant difference in functional status 90 days after stroke. There were small but significant reductions in brain bleeding, death in the first 7 days and complications after stroke, and tranexamic acid was safe with no increased side effects. CONCLUSION: Treatment with tranexamic acid did not result in a significant improvement in recovery at 90 days (i.e. functional status), despite small reductions in the number of early deaths, amount of brain bleeding and the number of complications. Larger trials are needed to confirm if these small benefits observed after treatment with tranexamic acid can significantly improve functional status after stroke due to bleeding in the brain (ICH).

Statement by a Working Group conceived by the Polish National Consultants in Cardiology and Neurology addressing the use of implantable cardiac monitors in patients after ischaemic embolic stroke of undetermined source.

INTRODUCTION: Stroke remains one of the main causes of death and the most common cause of long-term disability in adults. Embolic strokes of undetermined source (ESUS) amount to a significant proportion of all ischaemic strokes. Detection of atrial fibrillation (AF) in this group of patients would allow for a major therapeutic decision to switch from antiplatelets to oral anticoagulants and therefore significantly reduce the risk of recurrence. STATE OF THE ART: Current technology allows long-term continuous ECG monitoring with different systems, including implantable cardiac monitors (ICM). However, in Poland lack of reimbursement does not allow their use in everyday clinical practice. CLINICAL IMPLICATIONS: This is a statement by a Working Group conceived by the Polish National Consultants in Cardiology and Neurology addressing the use of ICM in patients after ischaemic embolic strokes of undetermined source. The aim was to develop reasonable and comprehensive guidance on how to select and manage candidates for ICM in order to obtain the maximum benefit for Polish public health. FUTURE DIRECTIONS: This expert opinion is not intended as a guideline but it provides advice as to how to optimise the potential use of ICM in patients after ESUS in the Polish setting.

Recurrent Stroke With Rivaroxaban Compared With Aspirin According to Predictors of Atrial Fibrillation: Secondary Analysis of the NAVIGATE ESUS Randomized Clinical Trial.

Importance: The NAVIGATE ESUS randomized clinical trial found that 15 mg of rivaroxaban per day does not reduce stroke compared with aspirin in patients with embolic stroke of undetermined source (ESUS); however, it substantially reduces stroke risk in patients with atrial fibrillation (AF). Objective: To analyze whether rivaroxaban is associated with a reduction of recurrent stroke among patients with ESUS who have an increased risk of AF. Design, Setting, and Participants: Participants were stratified by predictors of AF, including left atrial diameter, frequency of premature atrial contractions, and HAVOC score, a validated scheme using clinical features. Treatment interactions with these predictors were assessed. Participants were enrolled between December 2014 and September 2017, and analysis began March 2018. Intervention: Rivaroxaban treatment vs aspirin. Main Outcomes and Measures: Risk of ischemic stroke. Results: Among 7112 patients with a mean (SD) age of 67 (9.8) years, the mean (SD) HAVOC score was 2.6 (1.8), the mean (SD) left atrial diameter was 3.8 (1.4) cm (n = 4022), and the median (interquartile range) daily frequency of premature atrial contractions was 48 (13-222). Detection of AF during follow-up increased for each tertile of HAVOC score: 2.3% (score, 0-2), 3.0% (score, 3), and 5.8% (score, >3); however, neither tertiles of the HAVOC score nor premature atrial contractions frequency impacted the association of rivaroxaban with recurrent ischemic stroke (P for interaction = .67 and .96, respectively). Atrial fibrillation annual incidence increased for each tertile of left atrial diameter (2.0%, 3.6%, and 5.2%) and for each tertile of premature atrial contractions frequency (1.3%, 2.9%, and 7.0%). Among the predefined subgroup of patients with a left atrial diameter of more than 4.6 cm (9% of overall population), the risk of ischemic stroke was lower among the rivaroxaban group (1.7% per year) compared with the aspirin group (6.5% per year) (hazard ratio, 0.26; 95% CI, 0.07-0.94; P for interaction = .02). Conclusions and Relevance: The HAVOC score, left atrial diameter, and premature atrial contraction frequency predicted subsequent clinical AF. Rivaroxaban was associated with a reduced risk of recurrent stroke among patients with ESUS and moderate or severe left atrial enlargement; however, this needs to be independently confirmed before influencing clinical practice.

Stroke and TIA mimics in patients referred to a neurological emergency department by non-ambulance physicians, ambulance physicians and paramedics.

INTRODUCTION: Our aim was to compare the structure and management of conditions mimicking acute cerebrovascular events (ACE) defined as stroke or transient ischaemic attack between patients referred directly to a neurological emergency department (ED) by non-ambulance physicians, ambulance physicians and paramedics. METHODS: This is a retrospective study of 802 consecutive patients referred to a Polish urban neurological ED with a prehospital suspicion of ACE between January and December 2014. RESULTS: After proper neurological assessment, ACE was excluded in 258 (32.2%) patients. The ratios of neurological to non--neurological ACE mimics were similar across all groups (35:93 for non-ambulance physicians, 22:39 for ambulance physicians, and 28:39 for paramedics). The most frequent conditions mimicking ACE were vertigo (14.0%), headache (9.7%), seizures (7.0%), blood hypertension (7.0%), electrolyte and metabolic disturbances (5.4%), infections (4.7%) and syncope (4.3%). There were no major differences between patients with ACE-mimics referred by ambulance physicians and referred by paramedics in terms of demographic, previous medical history, extent of diagnostic workup, final diagnosis or further management (neurological admission in 42.6% and 28.4% of cases). However, the characteristics and management of ACE mimics referred by non-ambulance physicians were slightly different, including a lower need for hospital admission (neurological admission in 21.5% of cases). CONCLUSIONS: There seem to be no major differences in the structure, early diagnostic approach or management of ACE mimics between referrals from ambulance physicians and ambulance paramedics, which provides reassurance to healthcare systems that rely solely on paramedics. Mimics referred by non ambulance physicians appear different in structure and are less resource-consuming.