Roberto Sterzi

Endovascular Treatment for Acute Ischemic Stroke

BACKGROUND In patients with ischemic stroke, endovascular treatment results in a higher rate of recanalization of the affected cerebral artery than systemic intravenous thrombolytic therapy. However, comparison of the clinical efficacy of the two approaches is needed. METHODS We randomly assigned 362 patients with acute ischemic stroke, within 4.5 hours after onset, to endovascular therapy (intraarterial thrombolysis with recombinant tissue plasminogen activator [t-PA], mechanical clot disruption or retrieval, or a combination of these approaches) or intravenous t-PA. Treatments were to be given as soon as possible after randomization. The primary outcome was survival free of disability (defined as a modified Rankin score of 0 or 1 on a scale of 0 to 6, with 0 indicating no symptoms, 1 no clinically significant disability despite symptoms, and 6 death) at 3 months. RESULTS A total of 181 patients were assigned to receive endovascular therapy, and 181 intravenous t-PA. The median time from stroke onset to the start of treatment was 3.75 hours for endovascular therapy and 2.75 hours for intravenous t-PA (P<0.001). At 3 months, 55 patients in the endovascular-therapy group (30.4%) and 63 in the intravenous t-PA group (34.8%) were alive without disability (odds ratio adjusted for age, sex, stroke severity, and atrial fibrillation status at baseline, 0.71; 95% confidence interval, 0.44 to 1.14; P=0.16). Fatal or nonfatal symptomatic intracranial hemorrhage within 7 days occurred in 6% of the patients in each group, and there were no significant differences between groups in the rates of other serious adverse events or the case fatality rate. CONCLUSIONS The results of this trial in patients with acute ischemic stroke indicate that endovascular therapy is not superior to standard treatment with intravenous t-PA. (Funded by the Italian Medicines Agency, ClinicalTrials.gov number, NCT00640367.).

Stroke-unit care for acute stroke patients: an observational follow-up study

BACKGROUND Large numbers of stroke patients arrive at hospital at a very early stage, and effective treatments for the acute phase of the disease are available. However, evidence that patients with acute stroke benefit from stroke-unit care is scarce. Our aim was to determine whether admission to a stroke unit, rather than a conventional ward, affected the outcome of patients with acute stroke. METHODS We did an observational follow-up study of 11 572 acute stroke patients hospitalised within 48 h of the onset of symptoms either in a stroke unit (n=4936) or in a conventional ward (6636). Patients were identified retrospectively from discharge records from 260 Italian hospitals. The primary outcome was mortality or disability (Rankin score greater than two), assessed prospectively by independent, masked assessors 2 years after admission. Analyses were adjusted for patient characteristics and clustered at the hospital level. FINDINGS Overall, 1576 patients died in hospital; 2169 died during the follow-up period. 347 patients were lost to follow-up. Compared with conventional-ward care, stroke-unit care was associated with a reduced probability of death or being disabled at the end of follow-up (odds ratio 0.81, 95% CI 0.72-0.91; p=0.0001). The potential benefit was significant across all age ranges and clinical characteristics, except for unconsciousness. No specific elements of setting, organisation, or process of care were associated with outcome. INTERPRETATION Admission to a stroke-unit ward with dedicated beds and staff within 48 h of onset should be recommended for all patients with acute stroke.

Debunking 7 Myths That Hamper the Realization of Randomized Controlled Trials on Intra-Arterial Thrombolysis for Acute Ischemic Stroke

Background and Purpose— Although intravenous (IV) thrombolysis is the standard treatment for patients with ischemic stroke occurring within 3 hours from symptom onset, a few interventional neuroradiologists have been treating this category of patients by an intra-arterial (IA) route for >25 years. However, evidence is still required to support the clinical feeling that IA treatment, which needs longer time and greater complexity, leads to a better outcome. Therefore, the objective of the present review was to analyze beliefs and myths underlying the selection of patients for IA thrombolysis. Methods and Results— We identified and debunked the following myths on IA thrombolysis: (1) IA thrombolysis works better than IV because it achieves higher recanalization rates; (2) IA thrombolysis works better than IV after the 3-hour window; (3) IA thrombolysis works better than IV in vertebrobasilar stroke; (4) carotid duplex, transcranial doppler, CT angiography, or MRA should be used to screen for major vessel occlusion treatable with IA thrombolysis; (5) to be treated with IA thrombolysis, patients should be selected with diffusion/perfusion MRI; (6) IA thrombolysis should be used as a “rescue” therapy for IV thrombolysis; and (7) the efficacy of IA thrombolysis depends on the thrombolytic agent or the device used. Conclusion— Evidence on acute stroke management with IA thrombolysis is scant. Therefore, neither clinicians nor patients have enough information to make truly informed decisions about the most appropriate treatment. Only randomized controlled trials can clear uncertainties about the possible superiority of IA over IV thrombolysis. Regretfully, case series on IA treatment have limited the organization of such trials and have only favored the spread of myths.

Drug abuse and intracranial hemorrhage

The rate of strokes among amphetamine and cocaine abusers is increasing. The exact mechanism remains unclear. Many factors could be involved including vasospasm, cerebral vasculitis, enhanced platelet aggregation, cardioembolism, and hypertensive surges. Around 40% of patients have pre-existing lesions (aneurysms, artero-venous malformations). Cerebral angiographic examination is recommended in cases of cocaine-related intracerebral hemorrhage, especially if the hemorrhage is lobar or intraventricular.

The neurologist in the emergency department. An Italian nationwide epidemiological survey

A nationwide survey has been undertaken to evaluate the resources and the activities of Italian hospital neurology units (NU) in the emergency setting. NU are widely disseminated throughout the entire country and 220 (84%) are located in hospitals with an emergency room (ER). Complete data about hospital setting, structural and functional characteristics of each NU and clinical activities were obtained from 159 (72.3%). Each NU has, on average, 25 beds (7% bedside monitoring), 7 neurologists and 17 nurses. A neuroscience department is present in 25% of the hospitals. The ER is the source of 71% of the 148,040 annual admissions and of 57% of the 577,279 annual neurological consultations. Stroke is the most common cause of admission (29%), followed by epilepsy/headache and transient ischaemic attacks. Head trauma prevails in hospitals with no neurosurgical units. Cerebrovascular disorders are the main cause of neurological consultations (28%), followed by headache (22%), dizziness (13%), head trauma (13%), impairment of consciousness (12%) and epilepsy (9%). Only 36% of NU have a 24-h/day, 7 days/week on-duty neurologist and 28% have a stroke unit. The burden of neurological activities is unrelated to the geographical area and hospital’s complexity (size, structural and functional context, ER organisation, presence of stroke units, neurosurgery units or 24/7 neurological service).

Wake-up stroke and TIA due to paradoxical embolism during long obstructive sleep apnoeas: a cross-sectional study

Background and purpose Long obstructive sleep apnoeas (LOSAs) can cause brain ischaemia through paradoxical embolism since they can lead to right to left shunting (RLSh) but this has never been assessed as a risk factor for stroke. We investigated whether the combination of LOSA and RLSh is associated with ischaemic stroke or transient ischaemic attack (TIA) on waking (wake-up stroke). Methods We prospectively considered patients aged over 18 years, admitted to 13 stroke units for acute ischaemic stroke or TIA. Patients had to be able to give consent, to specify whether the event occurred on waking, and to cooperate sufficiently to undergo contrast transcranial Doppler examination and cardiorespiratory sleep study within 10 days of the onset of symptoms. Single LOSA events, lasting 20 s or more, were considered a possible harbinger of RLSh. Results Between April 2008 and March 2010, 335 patients (109 women; 61 TIA, mean age 64 years) were enrolled; 202 (60%) had at least one LOSA and 116 (35%) a RLSh; 69 (21%) had both. There were significantly more wake-up strokes/TIAs in subjects with RLSh plus LOSA than those without this association (27/69 vs 70/266; OR 1.91, controlled for age, sex, hypertension, diabetes, atrial fibrillation, antithrombotic therapy; 95% CI 1.08 to 3.38; p=0.03). No other risk factor was associated with an increase in the incidence of events on waking. Conclusions The study suggests that the combination of LOSA and RLSh could be a new major, potentially treatable risk factor for cerebrovascular ischaemic events.

Stroke Unit care in Italy. Results from PROSIT (Project on Stroke Services in Italy). A nationwide study

The future challenge for improving stroke patients’ outcome will be to implement new Stroke Units (SUs) worldwide. However the best SU model remains uncertain. The aim of this study was to evaluate the number of SUs and the quality characteristics of acute stroke care in Italy. We conducted a SU survey in Italy, interviewing the directors of the hospital wards that discharged at least 50 acute stroke patients a year. A SU was defined as an acute ward area with stroke-dedicated beds and staff. To compare the quality of care provided in SUs with that in general wards (GWs) we investigated the characteristics of five domains: hospital setting, unit setting, staffing, process of care and diagnostic investigations. We identified 68 SUs and 677 GWs. Multivariate logistic regression analyses demonstrated that SUs compared to GWs had higher quality scores in unit setting (ROC area=0.9721), staffing (ROC area=0.8760) and care organisation (ROC area=0.7984). The hospital setting (ROC area=0.7033) and the availability of rapid diagnostic investigations (ROC area=0.7164) had lower power in discriminating SU from GW. In Italy in 2003/04 only 9% of the hospital services had organised SU care. The study demonstrated that SUs admitted more than 100 patients per year, had more monitoring equipment and staffing time, and practised multidisciplinary meetings and early mobilisation. The utility of these structural and performance characteristics needs validation from outcome studies.

Thrombolysis for acute ischemic stroke: the patient's point of view.

Background: The use of thrombolytic therapy for acute ischemic stroke is still controversial. A major problem is balancing the improvement in functional ability against the risk of early death from cerebral hemorrhage. Our aim was to assess whether patients who have had a stroke, and their proxies, would give consent to thrombolysis if this therapy were introduced into clinical practice for acute ischemic stroke in Italy. Methods: A 10-item questionnaire was administered by personnel not directly involved in the care of patients in 12 Italian hospitals. Interviews were carried out with at least 10 consecutive stroke inpatients per center in the postacute phase and to their proxies. Results: There were 685 responders (377 female), median age 58 years (range 18–98); 332 were patients and 353 proxies. Responders were representative of the Italian population as a whole as regards mean age and sex, education and marital status; 59% of responders (95% confidence interval 55–62%) would agree to thrombolysis in the case of stroke. There was more uncertainty among proxies than patients, especially when the decision had to be taken for a relative (41 vs. 17% could not decide, p < 0.001). The preference for thrombolysis was higher among more educated people (p = 0.001) and was not influenced by sex, age and marital status. Overall, 81% of responders would prefer to risk dying rather than remain severely disabled. Conclusion: Thrombolytic therapy is feasible in Italy as there is ample willingness to trade off a better functional outcome with a higher risk of death. Education is the main sociodemographic determinant of independent decision-making, as only those with an adequate cultural level are able to discriminate between one treatment option and another. The proxy’s uncertainty about how to interpret a patient’s preference regarding consent to thrombolytic therapy should be tackled, since proxies play a key role in making patients’ preferences known in case of incompetence after an acute stroke.

Assessment of Regional Acute Stroke Unit Care in Italy: The PROSIT Study

Background/Objectives: The aim of this study was to survey acute in-hospital stroke services in seven Italian regions. Methods: Regional hospital discharge registers were searched to identify hospital services that record at least 50 acute stroke discharges per year and the doctors in charge of these services were interviewed. Results: Only 31 (7%) out of 447 services could be classified as stroke units (SUs). Of these, only 9 (29%) were found to have vital function monitoring systems available for all patients. The most striking differences between SUs and mixed stroke services emerged when comparing staff/patient ratios in the two types of unit. Conclusions: There are still not enough SUs in Italy, and fewer than 10% of stroke patients can be admitted to such units.

Stroke units and general wards in seven Italian regions: the PROSIT Study

PROSIT (research PROject on Stroke services in ITaly) is a study performed to evaluate number and work organisation of acute in-hospital services (stroke units, SU) and general wards (GW), in seven Italian regions (Liguria, Lombardia, Lazio, Veneto, Friuli-Venezia-Giulia, Emilia Romagna, Toscana), which have a population of 29 169 811 inhabitants and a relative ratio of 225/100 000 hospitalisations for acute stroke. The registers of hospital discharges from January to December 1999 were looked at identify to services recording at least 50 acute stroke discharges (DRG14) per year. A structured questionnaire investigating stroke service characteristics was submitted to the doctors in charge of the identified units and completed in the presence of an external observer between October 2000 and February 2001. SUs were identified as units with dedicated beds (at least 80%) and team (at least 1 physician and 1 nurse) for acute stroke patients. SUs are still uncommon in many Italian regions because only, as 7% of the wards evaluated were found to be a SU and less than 10% of acute stroke patients resulted to be admitted to a SU. Great heterogeneity was found between the different regions surveyed. The most striking differences between SUs and GW were related to the staffing and care organisation, with higher number/patients ratio in SUs as far as physicians and nurses, speech therapists and social workers were concerned.