Ischemic stroke affects over 400,000 people in the

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1 Utilization and Outcome of Thrombolytic Therapy for Acute Ischemic Stroke: The St. John Hospital Code Stroke Experience Sule Salami, MD, Anuradha Kolluru, MD, Saif Al-Najafi, MD, Carrie Stover, MSN, NP, Alice Mar, BA, Susan Szpunar, PhD, and Shyam Moudgil, MD ABSTRACT Objective: To examine the impact of an acute stroke protocol on care of acute ischemic stroke patients. Methods: A retrospective chart review was conducted of adult patients with acute ischemic stroke for the 1 year preceding and following the initiation of a code stroke team. We collected data on demographic and clinical characteristics, laboratory values, use of tpa, and in-hospital outcomes. The 2 time periods were compared using chi-square analysis, Student s t test, and logistic regression. Results: 186 patients were included: 66 in the pre-protocol period and 120 post-protocol. Overall, 51.2% of subjects were female, 66.5% were age 41 to 80 years, 31.1% were over age 80, and 2.4% were age 40 years or younger. Patients in the pre-protocol period were more likely to have ever smoked (p = 0.007) and to have COPD/asthma (p = 0.04). The use of tpa between the 2 periods was not significantly different: 25.8% pre-protocol vs. 27.5% post-protocol (p = 0.8). Neither inpatient nor short-term outcomes differed significantly between periods. Overall, individuals who had a previous cerebrovascular accident (CVA) were less likely to get tpa (OR, 0.38 [p = 0.02]). Multivariate analysis confirmed that the only significant predictor of tpa use was previous CVA. Individuals who received tpa were more likely to die (OR, 6.6 [p < 0.001]). Conclusion: Our rate of tpa use, already above the national average, remained steady after the institution of a code stroke team. More research is required to understand physician utilization of tpa and its effect on outcomes. Ischemic stroke affects over 400,000 people in the United States annually and is the third leading cause of death in this country [1]. Tissue plasminogen activator (tpa) is the only approved treatment for acute ischemic stroke [2]. Despite its effectiveness in improving neurological outcomes, the majority of patients with ischemic stroke are not treated with tpa, largely because they arrive after the recommended time limit for administration of the medication in patients who are eligible [3 7]. Other reasons for the low utilization rate that have been put forward include lack of public awareness about stroke symptoms, reluctance of neurologists to be involved in acute stroke therapy, resistance of emergency physicians to utilize thrombolytic therapy in ischemic stroke, and poor coordination of services when a patient arrives with stroke symptoms [8,9]. St. John Hospital and Medical Center sought to improve the care of their patients with acute stroke and took the necessary steps to become a certified primary stroke center, which included the development of a code stroke team and the establishment of a written care protocol. In February 2009, the code stroke protocol was initiated. In this paper, we report on the impact of the protocol on utilization of tpa and shortterm outcomes in eligible acute ischemic stroke patients. Methods Setting St. John Hospital and Medical Center in Detroit, Michigan, is a community-based 804-bed, level 2 trauma center that admits approximately 25,000 patients per year and has about 88,535 annual emergency department (ED) visits per year. This institution has several residency programs including internal medicine, family medicine, emergency medicine, surgery, obstetrics/gynecology, podiatry, and pathology but no neurology residency program. There are 13 neurologists, 1 interventional neurologist and 1 neurointerventional radiologist that participate in covering the code stroke team. Discharge facilities include extended care facilities, acute inpatient rehabilitation centers and hospice level care. From the St. John Hospital and Medical Center, Detroit, MI. Vol. 18, No. 4 April 2011 JCOM 165

2 Stroke PROTOCOL Table 1. Patient Characteristics Characteristic Preprotocol Postprotocol P Value Age, yr 0.58 < % 3.3% % 63.3% > % 33.3% Male 48.5% 49.2% 0.93 Race 0.29 White 43.9% 53.3% Black 53.0% 45.8% Other 3.0% 0.8% Smoking Current 24.2% 31.1% Never 22.6% 39.6% Former 53.2% 29.2% Alcohol use Frequent 4.9% 12.3% Occasional 6.6% 15.1% Abstinent 88.5% 72.6% COPD or asthma 21.2% 10.0% Care Protocol According to the protocol, any patient with possible stroke in the ED or on the floor is seen by the emergency medicine physician or rapid response resident, who evaluates the patient using the National Institutes of Health (NIH) Stroke Scale and activates the code stroke team if symptom onset is less than 8 hours (Figure). Emergent computed tomography (CT) and perfusion CT scans of the head are expected to be completed within 25 minutes. In some cases, perfusion CT is omitted due to clinical presentation or the presence of renal insufficiency or failure. Our protocol for acute ischemic strokes involves the use of intravenous tpa in eligible patients who present within 4.5 hours of symptom onset, and a combined approach of intravenous tpa and endovascular therapy is considered if the patient presents within 4.5 hours and a proximal intracranial lesion is identified. Intra-arterial tpa/endovascular therapy is considered if the radiologic studies shows a proximal intracranial lesion and the patient presents after 4.5 hours but within 8 hours. The multidisciplinary code stroke team includes a neurologist, an interventional neurologist if needed, a nurse, and radiology, pharmacy, and laboratory personnel. The team is available 24 hours a day, 7 days a week. Data Collection Our study population was all patients who had presented to the hospital with acute ischemic stroke or inpatients that developed acute ischemia on the floor between February 2008 and February To obtain our study sample, we first identified patients in the hospital database 18 years or older with an end diagnosis of stroke. We reviewed the charts of these patients and excluded those who were misdiagnosed as having stroke, those with symptom onset > 8 hours, and those in whom the specific duration of symptoms could not be ascertained. We collected patient demographic information including age-group (< 40 years, years, and > 80 years), sex, place of residence prior to admission, and use of tobacco, alcohol, or illicit substances. Presence or absence of comorbidities, triage vitals, laboratory findings at admission including serum calcium levels and random urine drug screen, NIH stroke scale at admission, as well as length of stay were obtained. Utilization and type of intervention were also noted. Inhospital outcomes were classified as requiring straight admission to the intensive care unit (ICU) from the ED, requiring rapid response therapy or ICU reevaluation if initially transferred to the floor, cardiopulmonary arrest requiring a code to be called, death while in the hospital, or stable throughout the admission. Since as per protocol all patients who received tpa are required to be observed in the ICU for 24 hours, these patients were classified as stable throughout admission. If they stayed in the ICU beyond 24 hours, they were included in the ICU admission category. With regard to disposition, patients were classified as discharge to home, acute inpatient rehabilitation, or skilled nursing facility. Since discharge to hospice implies imminent death, this group of patients was included in the category of in-house death. Analysis We compared utilization and outcomes in patients from the pre-protocol period (15 February February 2009) and the post-protocol initiation period (15 February February 2010). We analyzed the data using chi-square test, Student s t test, and logistic regression. Results There were 186 patients with acute ischemic stroke 66 in the pre-protocol period and 120 in the post-protocol period. All of the patients presented through the ED. Overall, 95 of the patients (51%) were female. 93 (50%) were Caucasian, 90 (48.4%) were African American, and 3 (1.6%) were other category. 122 (66%) were in the 41 to 80 years age-group (Table 1). A majority of patients did not receive acute intervention. There were 17 recipients (25.8%) in the pre-protocol period and 33 (27.5%) in the post-protocol period. Of the 50 patients, 42 received intravenous tpa, 8 received some form of endovascular intervention, while 1 received both. The reasons for nontreatment are listed in Table 2. The most common reasons were rapid improvement, no 166 JCOM April 2011 Vol. 18, No. 4

3 Patient arrives in the emergency department within 8 hours of stroke symptom onset (or awoke with symptoms) OR Stroke symptoms identified within 8 hours of onset in a hospitalized patient ED Physician / Rapid Response Perform NIH Stroke Scale Order STAT CT of brain with perfusion (to be completed within 25 minutes of arrival) ED Nurse / Floor Nurse IV access (2) large bore 12 lead EKG Labs drawn and sent STAT (if not done in last 24 hours) Vital signs and neuro check Activate Code Stroke Neurology on-call alerted via hospital messaging system System also notifies radiology STAT CT Scan of the Brain and CT Perfusion of the Brain (completed within 25 minutes of arrival) Results discussed with neurologist Neurologist notifies neurovascular on call if needed IV tpa Candidate? Yes No Initiate IV tpa protocol Document reason Re-eval in 50 min. If no improvement, notify neurologist Neurology and Neuroendovascular physicians discuss need for neurovascular treatment. If patient going to Specials Lab (Interventional Radiology) for neurovascular treatment: Activate Specials team via hospital messaging system Figure. Patient care protocol for suspected acute ischemic stroke. Vol. 18, No. 4 April 2011 JCOM 167

4 Stroke PROTOCOL Table 2. Reasons for Nonadministration of tpa Pre- Reason protocol, n Rapid improvement in symptoms No documented reason Very low or very high presenting NIH stroke score Patient/family refusal 1 1 Uncontrolled hypertension 5 3 Advanced age 1 1 Seizure at presentation 0 5 Missed/uncertain diagnosis at 2 3 presentation Loss of consciousness at presentation 0 1 History of subarachnoid hemorrage 0 3 History of previous ischemic 2 2 stroke Gastrointestinal bleed 1 3 High INR on coumadin 0 4 Head trauma 0 1 Complete infarction on CT 0 2 perfusion Iodine allergy 0 1 CT perfusion not read secondary 0 1 to computer malfunction Stroke team not informed 0 1 Postprotocol, n documented reason, and very low or very high presenting NIH score. The NIH stroke scale score was more consistently documented in patients who received tpa, ranging from 1 to 34 (mean, 10). Post hoc analysis showed that the NIH score was 19±4.4 in patients that died versus 9.1±7.7 in those that survived (P = 0.001). Of the 186 patients, 83.3% (155 out of 186) were stable throughout the admission, while 12.4% (16 out of 186) required ICU admission. Of those patients who required ICU admission, 7 died. There was no difference in the in- hospital outcomes between the pre and post stroke protocol periods (Table 3). In-hospital mortality overall was 8.1% (n = 15) with further analysis revealing that patients who received tpa were more likely to die (odds ratio [OR], 6.6, p < 0.001) irrespective of the time period (that is, pre or post code stroke initiation). Mortality was slightly higher in the older than 80 Table 3. In-hospital Outcomes and Disposition Pre-protocol Post-protocol In-hospital (P = 0.686) Stable throughout admission ICU admission 4 12 Deceased 5 10 Total Disposition (p = 0.703) Home Nursing home 8 15 Inpatient rehabilitation Total Table 4. Length of Stay (p = 0.299) Days Pre-protocol Post-protocol Total < 5 18 (27.3%) 46 (38.3%) 64 (34.4%) (53%) 52 (43.3%) 87 (46.8%) (13.6%) 11 (9.2%) 20 (10.8%) 15 4 (6.1%) 11 (9.2%) 15 (8%) Total years group at 8.5% (5 out of 54). Mortality was 8.3% (10 out of 122) in the 41 to 80 age-group, while no patient in the less than 40 years group died. Over the 2-year period, 54.3% (101 out of 186) of patients went home with or without home health, with 25.3% (47 out of 186) going to acute inpatient rehabilitation, and 12.4% going to the nursing home. No statistically significant differences were found. A large majority of the patients stayed in the hospital less than 10 days (81.2% versus 18.8%). Eight percent of patients stayed in the hospital for 15 days or more. There was no statistical difference between groups (Table 4). Interestingly, no patients with a long stay died. The highest mortality rate was for patients having a length of stay of less than 5 days. Discussion Nationwide, the rate of tpa use is about 3% to 8.5% [8]. The rate of utilization at our hospital at baseline prior to the initiation of the code stroke protocol was more than 3 times the national rate. This may be related to the fact that we are a teaching institution with fellows and residents within the hospital on a constant basis. The complex variety of exclusion criteria in our patients indicates a need for neurological expertise. 168 JCOM April 2011 Vol. 18, No. 4

5 Despite the fact that there was no statistical increase in utilization of tpa after the initiation of the code stroke team, there is still much work required to ensure that the 72.5% (87 out 120 patients in the post code stroke period) are better managed and given the best chance of avoiding disability. This is currently being achieved by monthly meetings by the neuroscience department to track utilization as well as reasons for non-administration of the drug. Though not the intention of the study, one of the most alarming findings of this study is the 912 patients who were excluded from the study for various reasons, including but not limited to presentation greater than 8 hours after the onset of symptoms. This issue needs to be addressed. Our institution is dedicated to educating patients to recognize the early symptoms of stroke as time wasted equals brain tissue loss. Sadly but expectedly, there was a slightly higher mortality rate in the older than 80 age-group with no death recorded in the younger than 40 age-group. The patients that received tpa were 6 times more likely to die. The reason for this may be related to the finding of a higher NIH score in these patients at presentation, meaning that these patients were probably sicker than those that survived. This, we believe, raises the question of a cut-off NIH stroke score beyond which it is unsafe to administer tpa. Unexpected deterioration after acute stroke treatment has been so rare that it may be necessary to re-evaluate our protocol of mandatory 24-hour ICU observation post tpa administration. A low-risk monitoring unit outside the ICU would open ICU beds and use fewer resources. The benefit of tpa as shown in large trials has always been in the 30- and 90- day follow-up periods when the functional status of the patients who received tpa has been shown to be statistically better than those that did not get tpa [2,5]. Our study was not designed to look at longerterm outcomes. Rather, we sought to examine the impact of our stroke protocol and to optimize utilization of tpa. The favorable health outcomes seen in patients treated with tpa support our pursuit of this goal. Limitations of this study are many and include its retrospective nature, small number of patients, absence of NIH stroke scale on all acute ischemic stroke patients irrespective of administration of tpa, and lack of standardized methods to compare benchmarks for percentage of treated acute stroke patients at different institutions. Important outcome parameters such as baseline, 30-, and 90-day functional status were not available through electronic chart review. In conclusion, the need for continued education programs in the community cannot be overemphasized. This, coupled with the presence of a dedicated code stroke team and a well-defined protocol, will increase utilization of acute intervention in acute ischemic stroke. Acknowledgements: We would like to express our appreciation to Dr. Saravolatz, our Chief of Medicine, who guided us throughout this study; the medical records department, for our frequent last-minute requests for charts to be pulled, and to the ever hardworking librarians, especially Karin Werner, who is ever willing to assist with literature review. Corresponding author: Sule Salami, MD, St. John Hospital and Medical Center, Moross Rd., Detroit, MI 48236, References 1. Lloyd-Jones D, Adams R, Carnethon M, et al. Heart disease and stroke statistics update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation Jan 27;119(3): e Tissue plasminogen activator for acute ischemic stroke. The National Institute of Neurological Disorders and Stroke rt-pa Stroke Study Group. N Eng J Med 1995;333: Barber PA, Zhang J, Demchuk A, et al. Why are stroke patients excluded from tpa therapy? Neurology 2001;56: Smith EE, Abdullah AR, Petkovska I, et al. Poor outcomes in patients who do not receive intravenous tissue plasminogen activator because of mild or improving ischemic stroke. Stroke 2005;36: Hacke W, Kaste M, Bluhmki E, et al. Thrombolysis with alteplase 3 to 4.5 hours after acute ischemic stroke. N Engl J Med 2008;359: Smith WS, Sung G, Starkman S, et al. Safety and efficacy of mechanical embolectomy in acute ischemic stroke; results of the MERCI Trial. Stroke 2005; 36: Del Zoppo GJ, Saver JL, Jauch EC, Adams HP Jr; American Heart Association Stroke Council. Expansion of the time window for treatment of acute ischemic stroke with intravenous tissue plasminogen activator: a science advisory from the American Heart Association/American Stroke Association. Stroke 2009;40: Reeves MJ, Arora S, Broderick JP, et al. Acute stroke care in the US: results from 4 pilot prototypes of the Paul Coverdell National Acute Stroke Registry. Stroke 2005;36: Rymer MM, Thrutchley DE. Organizing regional networks to increase acute stroke intervention. Neuro Research 2005;27(1 suppl): Copyright 2011 by Turner White Communications Inc., Wayne, PA. All rights reserved. Vol. 18, No. 4 April 2011 JCOM 169

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