Review some factors related to neurological functional recovery outcome in the treatment of acute ischemic stroke by the solitaire device

Objectives: To review some factors related to neurological functional recovery outcome in the treatment of acute ischemic stroke by the solitaire device. Subjects and methods: A prospective study and case series were conducted on 104 patients at People’s Hospital 115 from 4 - 2014 to 9 - 2016.

Journal of military phrmaco-medicine nO7-2017 REVIEW SOME FACTORS RELATED TO NEUROLOGICAL FUNCTIONAL RECOVERY OUTCOME IN THE TREATMENT OF ACUTE ISCHEMIC STROKE BY THE SOLITAIRE DEVICE Vu Viet Lanh*; Phan Viet Nga** SUMMARY Objectives: To review some factors related to neurological functional recovery outcome in the treatment of acute ischemic stroke by the solitaire device Subjects and methods: A prospective study and case series were conducted on 104 patients at People’s Hospital 115 from - 2014 to - 2016 Results: The age group greater than or equal 70 had worse neurological functional outcome (23.5%) than the group less 70 years old (55.2%), statistically significant difference (p < 0.03) The good recanalization group had better neurological functional outcomes (59.7%) than that without good recanalization (22.2%), the difference was statistically significant (p < 0.05) The group of severe stroke patients (NIHSS > 15) with better neurological functional outcomes (39.7%) was less than that at the mild and moderate level (NIHSS ≤ 15), statistically significant difference (p < 0.05) The symptomatic incranial hemorrhage patients with bad neurological functional outcome (mRS - 6) (100%) were higher than those with asymptomatic incranial hemorrhage (42.9%), statistically significant difference (p < 0.05) Conclusions: Such factors as revascularization, severe stroke levels, symptomatic incranial hemorrhage related to neurological functional recovery outcome * Keywords: Acute ischemic stroke; Revascularization; Neurological functional recovery outcome INTRODUCTION Stroke is a common disease in the world as well as Vietnam It is the third most common cause of death after heart disease and cancer and is the single reason for permenant disability More than 700,000 new strokes occur each year in the United States alone, accounting for more than 45 billion dollars in medical expenses, rehabilitation costs, and loss of employment [3] Stroke is a pathological process Therein, the cerebral artery is narrowed or occluded The circulating blood volume is severely reduced, the function of area of the brain is disordered [1] A cerebral infarction can occur for a few minutes as the circulating blood volume is reduced so it is rapid revascularization and restoration of circulation In 1996, Food and Drug Administration (FDA) approved the administration of intravenous (IV) recombinant tissue plasminogen activator (rt-PA) within hours of symptoms onset for the treatment of patients with acute ischemic stroke * Thaibinh General Hospital ** 103 Military Hospital Corresponding author: Phan Viet Nga (dr.vietnga@gmail.com) Date received: 11/07/2017 Date accepted: 08/08/2017 121 Journal of military parmaco-medicine n07-2017 Due to the time limitation and contraindications to intravenous tissue-type plasminogen activator (IV tPA), < 10% of patients with stroke receive the treatment, even in wellorganized stroke networks Furthermore, IV tPA recanalizes only 40% of large vessel occlusions in patients with acute stroke during the first hours after administration with even lower rates of revascularization for proximal arterial occlusions such as the terminal internal carotid artery Thus, faster and more effective approaches to reperfusion are needed [4] Clinical results have shown that mechanical devices for clot removal provide an alternative treatment option to patients with stroke who are ineligible for thrombolytic therapy The solitaire device has received US Food and Drug Administration clearance for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease In Vietnam, this approach has been deployed in some hospitals and received good results Therefore, we have studied this topic to aim: Review some factors related to neurological functional recovery outcome in the treatment of acute ischemic stroke by the solitaire device SUBJECTS AND METHODS Subjects We conducted a prospective study to evaluate all consecutive patients with ischemic stroke, who were treated from April, 2014 to September, 2016 at People’s Hospital 115 Patients had received Solitaire device as the first-choice 122 device to restore blood flow Patients had a intracranial and terminus internal carotid artery (ICA), first and second segments of the middle cerebral artery (MCA), basilar artery (BA) and first segment posterior cerebral artery (PCA), patients were refractory to intrarvenous IV tPA or the patient had contraindications for systemic thrombolysis within hours from onset stroke symptoms * Inclusion criteria: - No hemorrhage image on CT-scanner or MRI - From the onset of stroke symptoms to treatment ≤ hours - Patients have proximal vessel large arterial occlusion: Intracranial and terminus internal carotid artery (ICA), first and second segments of the middle cerebral artery (MCA), basilar artery (BA) and first segment posterior cerebral artery (PCA) - Patients visit the hospital > 4.5 hours after the onset of stroke symptoms or ineligibility for or failure to respond to intravenous rt-PA - Patients and their families agree to treat * Exclusion criteria: - The exact time of onset stroke symptoms is unknown - Systolic blood pressure ≥ 185 mmHg or diastolic blood pressure ≥ 110 mmHg is uncompensated - Platelet below 100,000/mm3 Hematocit below 25% - Blood glucose < 50 mg/dL (2.8 mmol/L) or > 400 mg/dL (22.2 mmol/L) Journal of military phrmaco-medicine nO7-2017 - Activated partial thromboplastin time (aPTT) > 50 seconds Anticoagulation with IRN (International Normal Ratio) > 3.0 or administration of heparin within the early 48 hours - Ischemic infarction occurs in more than a third of the middle cerebral artery territory on CT-scanner Methods Prospective study and case series RESULTS AND DISCUSSIONS Age Table 1: Age factor related to the neurological functional revovery outcome mRS - Age mRS - Number (n = 52) Rate (%) Number (n = 52) Rate (%) < 70 48 55.2 39 44.8 ≥ 70 23.5 13 76.5 OR 95%CI p 4.00 (1.2 - 13.2) 0.03 The age group greater than or equal 70 had worse neurological functional outcome (23.5%) than the group less 70 years old (55.2%), statistically significant difference (p < 0.03) According to the medical literature, age was a constant risk factor The higher age it is, the more the accumulation of risk factors is (vessel disease, atherosclerosis…) In the studies, the elderly had worse neurological functional revovery outcome than the younger [6] However, there is currently no evidence of high levels of (A-level) confidence in the relationship between age and benefit of the intervention The main cause may be the limited number of elderly patients in the intervention studies Recanalirization Table 2: Recanalization related to neurological functional recovery outcome mRS - mRS - TICI Number (n = 52) Rate (%) Number (n = 52) Rate (%) 15 27 39.7 41 60.3 OR 95% CI p 3.45 0.007 (1.46 - 8.15) The number of severity stroke patients (NIHSS > 15) had worse neurological functional outcome (39.7%) than those at mid and moderate level (NIHSS ≤ 15), statistically significant deference (p < 0.05) Currently, there are many scales to review severe stroke levels Therein, the NIHSS scale has high specificity and sensitivity, severe stroke levels is directly associated with high NIHSS score [10] The NIHSS score scale was capable of predicting neurological recovery in acute stroke patients Patients with NIHSS score > 15 are at risk of disability and poor neurological recovery [5] Symptomatic incranial hemorrhage Table 4: Symptomatic incranial hemorrhage related to neurological functional recovery outcome mRS - Symptomatic incranial hemorrhage mRS - Number (n = 52) Rate (%) Number (n = 52) Rate (%) OR 95% CI p No 52 57,1 39 42.9 0.42 > 0.05 Yes 0.0 13 100.0 (0.33 - 0.54) In the study, the symptomatic incranial hemorrhage patients group without good neurological functional outcome (mRS - 6) (100%) was higher than that with asymptomatic incranial hemorrhage patients group (42.9%), statistically significant difference (p < 0.05) According to Saver and Lanberg (2007), symptomatic incranial hemorrhage was the most serious complications leading to high mortality and disability after intravenous thrombolytic and intervention therapy [8, 9] 124 Journal of military phrmaco-medicine nO7-2017 Multivariate regression statistical analysis Table 5: Multivariate regression statistical analysis of risk factors related to neurological function recovery outcome Factors < 70 Age ≥ 70 15 Multivariate regression statistical analysis showed that factors related to neurological functional recovery outcome include age group, revascularization, symptomatic incranial hemorrhage, severe stroke leves) Besides, no good revascularization group (TICI - 2A), symptomatic incranial hemorrhage group, severity stroke group (NIHSS > 15) associated with impaired neurological functional rehabilitation (mRS - 6) CONCLUSIONS - Simple variable statistical analysis: + The risk factors related to good neurological functional outcome: the age group less than 70, good revascularization (TICI ≥ 2B), mid and moderate stroke (NIHSS ≤ 15) + The risk factors related to no good neurological functional outcome: the age group greater than 70, no good revascularization (TICI -2A), severity stroke (NIHSS > 15) and symptomatic incranial hemorrhage - Multivariate regression statistical analysis revealed that factors related to neurological functional recovery outcome are age group, revascularization, symptomatic incranial hemorrhage, severe stroke levels); no good revascularization group (TICI - 2A), symptomatic incranial hemorrhage group, severity stroke group (NIHSS > 15) associated with impaired neurological functional rehabilitation (mRS - 6) REFERENCES Nguyễn Văn Chương Thực hành thần kinh tập III: Bệnh học thần kinh Nhà xuất Y học 2005, tr.7-73 Phạm Nguyên Bình Đánh giá tính an tồn hiệu phương pháp lấy huyết khối dụng cụ học solitaire bệnh nhân đột quỵ nhồi máu não Luận văn Thạc sỹ Y học Trường Đại học Y Dược Thành phố Hồ Chí Minh 2013 Perry P Ng, Randall T Higashida, Sean P Cullen et al Intraarterial thrombolysis trials 125 Journal of military parmaco-medicine n07-2017 in acute ischemic stroke J Vasc Interv Radiol 2004, 15, S77-S85 Antoni Davalos, Victor Mendes Peria, Rene Chapot et al Retrospective multicenter study of solitaire FR for revascularization in the treatment of acute ischemic stroke Stroke 2012, 43 Marian Muchada, Marta Rubiera Baseline National Institutes of Health Stroke Scale adjusted time window for intravenous tisue type plasminogen activator in acute ischemic stroke Stroke 2014, 45, pp.1059-1063 Messeguer E., Labreuche J., Olive J.M et al Determinants of outcome and safety of intervenous tr-PA therapy in the older: a clinical registry study and systematic review Age and Ageing 2008, 37, pp.107-111 126 Rha J.H, Shaver J.L The impact of recanalization on ischemic stroke outcome: a meta - analysis Stroke 2007, 38, pp.976-973 Maarten G Lansberg, Gregory W Albers Christine Symptomatic intracerebral hemorrhage following thrombolytic therapy for acute ischemic stroke: A review of the risk fators Cerebrovasc Dis 2007, 24, pp.1-10 Jeffrey L Saver Intra-arterial fibrinolysis for acute ischemic stroke: The massage of Melts Stroke 2007, 38, pp.2627-2628 10 Maurizio Paciaroni, Giancarlo Agnelli, Francesco Corea et al Early hemorrhage transformation of brain infarction: rate, predictive factors and influence on clinical outcome Results of a prospective multicenter study Stroke 2008, 39, pp.2249-2256  ... results Therefore, we have studied this topic to aim: Review some factors related to neurological functional recovery outcome in the treatment of acute ischemic stroke by the solitaire device. .. thrombolytic therapy for acute ischemic stroke: A review of the risk fators Cerebrovasc Dis 2007, 24, pp.1-10 Jeffrey L Saver Intra-arterial fibrinolysis for acute ischemic stroke: The massage of Melts Stroke. .. factor The higher age it is, the more the accumulation of risk factors is (vessel disease, atherosclerosis…) In the studies, the elderly had worse neurological functional revovery outcome than the