Prevalence of stroke, associated risk factors and stroke related physical, mental, and economic burden in the Republic of Georgia.

Introduction: We investigated the prevalence, risk factors and physical, mental, and economic consequences of ischemic Janelidze and hemorrhagic stroke in the population of the Republic of Georgia. Materials and Methods: A population-based, cross-sectional study was conducted among 3036 adults residing in the Imereti Region of Georgia, selected using a multistage, probability proportionate-to-size, cluster sampling technique. Data were collected by medical students, using an interviewer-administered questionnaire. Diagnosis of stroke was confirmed by neurologists based on clinical examination and corroborated by documental evidence. Results: Of the targeted 3036 subjects, 2811 (92.6%) participated, of whom 1223 (43.5%) were women. Mean age of the sample was 49.7 (SD 15.2) years. The overall prevalence of stroke was 8.9%, the prevalence of ischemic stroke - 7.8% (95% CI 6.9-8.9) and of hemorrhagic stroke - 0.7% (95% CI 0.4-1.0). Ischemic stroke was more prevalent in males, while hemorrhagic stroke was more prevalent in females. Age, smoking, hypertension, and diabetes were associated with stroke. Stroke victims were young, many of them in the fifth decade of life. Sixty-five percent of them had a modified Rankin scale of three or greater, 25% were depressed, and 85% suffered cognitive impairment. Discussion: Stroke affected people and their families, experiencing a significant economic burden due to loss of the income and increase in out-of-pocket payment for post-stroke medical care. Conclusion: The stroke prevalence in the Republic of Georgia is higher than in Europe and is associated with a significant physical, mental, and economic burden.

Establishing Stroke Services in the Republic of Georgia.

INTRODUCTION: This article summarizes the medical experience in establishing stroke units and systemic thrombolysis in Georgia, which, like many other post-Soviet countries, still faces problems in organizing stroke care even after 30 years of independence. PATIENTS AND METHODS: We created an example of treating acute stroke with systemic thrombolysis and introduced stroke units in several hospitals in the country, including standardization of the diagnostic and treatment process, consistent evaluation, and monthly feedback to the stroke unit staff. RESULTS: Systemic thrombolysis has become a clinical routine in some large hospitals and is meanwhile reimbursed by the state insurance. The data of consecutive 1,707 stroke patients in 4 major cities demonstrated significant time lost at the prehospital level, due to failure in identifying stroke symptoms, delay in notification, or transportation. The consequent quality reports resulted in a dramatic increase in adherence to the European and national guidelines. A mandatory dysphagia screening and subsequent treatment led to a decrease in pneumonia rates. DISCUSSION: We discuss our experience and suggestions on how to overcome clinical, financial, and ethical problems in establishing a stroke services in a developing country. CONCLUSION: The Georgian example might be useful for doctors in other post-Soviet countries or other parts of the world.

Refined Sphenopalatine Ganglion Stimulator Placement and Intensity Setting to Augment Blood Flow and Neurologic Function.

Background and Purpose- Two large, randomized trials indicated that sphenopalatine ganglion (SPG) stimulation improves final disability outcome in acute anterior circulation patients with ischemic stroke with confirmed cortical involvement. This study evaluated 2 refinements in SPG stimulation treatment technique: (1) SPG electrode placement with real-time optical tracking guidance; and (2) stimulation intensity comfortable tolerance level selection using non-noxious facial physiological markers. Methods- This study was a single, active arm trial at 4 centers, enrolling patients with anterior circulation ischemic stroke, National Institutes of Health Stroke Scale 1 to 6 including arm weakness subitem score ≥1, not receiving recanalization therapies, and within 24 hours of onset. Stimulation level was set based on ipsilateral facial tingling sensation or lacrimation. SPG stimulation effects were assessed by measuring volumetric blood flow in the ipsilateral common carotid artery by ultrasound and grasp and pinch strength in the affected hand before and during stimulation, and by change in National Institutes of Health Stroke Scale from day 1 to 7. Results- Among 50 enrolled patients, age was median 66 years (interquartile range, 60-74), 44% were female, National Institutes of Health Stroke Scale median was 5 (interquartile range, 4-5), and median onset-to-screening time was 18 hours (interquartile range, 9-20). Median implantation skin-to-skin time was 4 minutes (interquartile range, 3-7), and all 50 implants were placed correctly. Comfortable tolerance level was found based on physiological biomarkers in 96% of patients, including 86% in the optimal, low-medium intensity range. SPG stimulation significantly increased common carotid artery peak systolic and end-diastolic blood flow (44%, P<0.0001; and 52%, P<0.0001) and improved pinch strength (42%, P<0.0001) and grasp strength (26%, P<0.0001). Degree of National Institutes of Health Stroke Scale recovery by day 7 was greater than in matched historic controls, median 75% versus 50%, P=0.0003. Conclusions- SPG stimulator placement with real-time optical tracking guidance was fast and accurate, and selection of stimulation intensity levels based on non-noxious facial tingling and lacrimation was feasible in nearly all patients. SPG stimulation led to cervico-cranial blood flow augmentation and improved hand motor function. Clinical Trial Registration- URL: https://www.clinicaltrials.gov. Unique identifier: NCT03551093.

An injectable implant to stimulate the sphenopalatine ganglion for treatment of acute ischaemic stroke up to 24 h from onset (ImpACT-24B): an international, randomised, double-blind, sham-controlled, pivotal trial.

BACKGROUND: Sphenopalatine ganglion stimulation increased cerebral collateral blood flow, stabilised the blood-brain barrier, and reduced infarct size, in preclinical models of acute ischaemic stroke, and showed potential benefit in a pilot randomised trial in humans. The pivotal ImpACT-24B trial aimed to determine whether sphenopalatine ganglion stimulation 8-24 h after acute ischaemic stroke improved functional outcome. METHODS: ImpACT-24B is a randomised, double-blind, sham-controlled, pivotal trial done at 73 centres in 18 countries. It included patients (men aged 40-80 years and women aged 40-85 years) with anterior-circulation acute ischaemic stroke, not undergoing reperfusion therapy. Enrolled patients were randomly assigned via web-based randomisation to receive active sphenopalatine ganglion stimulation (intervention group) or sham stimulation (sham-control group) 8-24 h after stroke onset. Patients, clinical care providers, and all outcome assessors were masked to treatment allocation. The primary efficacy endpoint was the difference between active and sham groups in the proportion of patients whose 3-month level of disability improved above expectations. This endpoint was evaluated in the modified intention-to-treat (mITT) population (defined as all patients who received one active or sham treatment session) and the population with confirmed cortical involvement (CCI) and was analysed using the Hochberg multi-step procedure (significance in both populations if p<0·05 in both, and in one population if p<0·025 in that one). Safety endpoints at 3 months were all serious adverse events (SAEs), SAEs related to implant placement or removal, SAEs related to stimulation, neurological deterioration, and mortality. All patients who underwent an attempted sphenopalatine ganglion stimulator or sham stimulator placement procedure were included in the safety analysis. This trial is registered with ClinicalTrials.gov, number NCT00826059. FINDINGS: Between June 10, 2011, and March 7, 2018, 1078 patients were enrolled and randomly assigned to either the intervention or the sham-control group. 1000 patients received at least one session of sphenopalatine ganglion stimulation or sham stimulation and entered the mITT population (481 [48%] received sphenopalatine ganglion stimulation, 519 [52%] were sham controls), among whom 520 (52%) patients had CCI on imaging. The proportion of patients in the mITT population whose 3-month disability level was better than expected was 49% (234/481) in the intervention group versus 45% (236/519) in the sham-control group (odds ratio 1·14, 95% CI 0·89-1·46; p=0·31). In the CCI population, the proportion was 50% (121/244) in the intervention group versus 40% (110/276) in the sham-control group (1·48, 1·05-2·10; p=0·0258). There was an inverse U-shaped dose-response relationship between attained sphenopalatine ganglion stimulation intensity and the primary outcome in the CCI population: the proportion with favourable outcome increased from 40% to 70% at low-midrange intensity and decreased back to 40% at high intensity stimulation (p=0·0034). There were no differences in mortality or SAEs between the intervention group (n=536) and the sham-control group (n=519) in the safety population. INTERPRETATION: Sphenopalatine ganglion stimulation is safe for patients with acute ischaemic stroke 8-24 h after onset, who are ineligible for thrombolytic therapy. Although not reaching significance, the trial's results support that, among patients with imaging evidence of cortical involvement at presentation, sphenopalatine ganglion stimulation is likely to improve functional outcome. FUNDING: BrainsGate Ltd.