American Heart Association

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The ARISTOPHANES Study: Real-World Evidence About Oral Anticoagulants

Lina Palaiodimou, MD

Lip GYH, Keshishian A, Li X, Hamilton M, Masseria C, Gupta K, et al. Effectiveness and Safety of Oral Anticoagulants Among Nonvalvular Atrial Fibrillation Patients: The ARISTOPHANES Study. Stroke. 2018

The ARISTOPHANES study is a large retrospective observational study with real-world data pooled from 5 data sources in the United States, in order to compare stroke/systemic embolism (SE) and major bleeding (MB) among nonvalvular atrial fibrillation patients treated with either non-vitamin K antagonist oral anticoagulants (NOACs) or warfarin.

The researchers of this study collected data about a total of 321182 patients with a diagnosis of AF, who had an active medical and pharmacy health plan enrollment and were prescribed treatment with either NOAC or warfarin according to pharmacy claims. Exclusion criteria were the following: evidence of valvular heart disease, venous thromboembolism, previous oral anticoagulant treatment, transient AF due to treatable causes (pericarditis, hyperthyroidism, thyrotoxicity), heart valve replacement or transplant, pregnancy and recent surgical operations. Demographic data, Charlson Comorbidity Index score, baseline bleeding and stroke/SE history, comorbidities, baseline comedication and dose of NOAC were recorded about all patients. In contrast, reason for lose-dose NOAC prescription, creatinine clearance, international normalized ratio (INR) measurements in warfarin-treatment group and patient adherence data were not available. The outcome measures were time to stroke (either ischemic or hemorrhagic) or systemic embolism and time to major bleeding, either gastrointestinal or intracranial or at other key sites (eyes, pericardium, urinary tract, joints). Identification of these events were based just on hospitalization incidence with stroke/SE or MB as the principal diagnosis according to International Classification of Diseases, Ninth Revision (ICD-9). Mortality due to all-causes was also evaluated, but just for the patients enlisted in only one out of five data sources. Patients were followed up each for a different period, according to drug discontinuation date, switch to another drug date, death, end of medical and pharmacy health plan enrollment, or end of study period, whichever occurred first. In the conducted sensitivity analysis, the follow-up period was restricted to 1 year, to better achieve balance between the cohorts.

By |January 11th, 2019|clinical, health care, outcomes, policy|0 Comments
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AHA Scientific Statement on Intracranial Endovascular Procedures and the Evidence Behind Them

Gurmeen Kaur, MBBS
@kaurgurmeen

Eskey CJ, Meyers PM, Nguyen TN, Ansari SA, Jayaraman M, McDougall CG, et al. Indications for the Performance of Intracranial Endovascular Neurointerventional Procedures: A Scientific Statement From the American Heart Association. Circulation. 2018

Endovascular intracranial procedures have seen significant advances over the past 3-4 years as reflected in all the recent stroke thrombectomy trials. Given that the last scientific review by the American Heart Association was in 2009, this Scientific Statement document updates the review of outcomes data for the efficacy and safety of these procedures and provides new recommendations for the use of these therapies.

A highly selected writing group did a computerized search of the National Library of Medicine database of literature (PubMed) from July 2007 to January 2016 to come up with these recommendations.

By |July 2nd, 2018|clinical, health care, treatment|0 Comments
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Utility Weighted Modified Rankin Scale and the Future of Patient-Centered Outcomes in Stroke Research

Kevin S. Attenhofer, MD

Dijkland SA, Voormolen DC, Venema E, Roozenbeek B, Polinder S, Haagsma JA, et al. Utility-Weighted Modified Rankin Scale as Primary Outcome in Stroke Trials: A Simulation Study. Stroke. 2018

As stroke neurologists, we are all intimately familiar with the modified Rankin Scale (mRS) as a measure of degree of disability. It is a common outcome measure in stroke research and can be statistically analyzed as a simple dichotomization or ordinal shift (among other options). The dichotomized outcome takes varied and complex neurological outcomes and simplifies them down to nominal variables of “good” or “bad.” This is statistically more straightforward, but does result in some outcome information being discarded. The ordinal shift retains more of this information, but typically requires larger sample size to maintain adequate power. Even when well powered, however, the mRS still has a disproportionate focus on motor function when compared to other neurological domains, such as cognition or patient metrics such as quality of life.

By |April 25th, 2018|clinical, health care, outcomes, policy|0 Comments
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Insights from Modeling Stroke Systems of Care in Philadelphia

Neal S. Parikh, MD
@NealSParikhMD

Mullen MT, Pajerowski W, Messe SR, Mechem CC, Jia J, Abboud M, et al. Geographic Modeling to Quantify the Impact of Primary and Comprehensive Stroke Center Destination Policies. Stroke. 2018

Dr. Mullen and colleagues performed a geographic modeling study to understand the implications of several pre-hospital triage strategies on transport times. The rationale for this and related studies is that optimizing stroke systems of care requires accounting for regional and local constraints. Because most of the U.S. population lives in urban areas, investigating urban stroke systems of care is worthwhile.

Philadelphia has only one EMS provider. So, the researchers were able to use EMS data to identify and geocode all ambulance-transported patients with possible stroke and then use a maps application programming interface (API) to estimate travel times. They also had actual travel times as reported by EMS.

By |March 21st, 2018|clinical, health care, outcomes, policy|0 Comments
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The PLUMBER Study Yields an Important Piece of the Stroke Systems of Care Puzzle

Neal S. Parikh, MD 
@NealSParikhMD

Dozois A, Hampton L, Kingston CW, Lambert G, Porcelli TJ, Sorenson D, et al. PLUMBER Study (Prevalence of Large Vessel Occlusion Strokes in Mecklenburg County Emergency Response). Stroke. 2017

Optimizing access to endovascular therapy has become a public health priority. While various national guidelines seek to shape acute stroke EMS triage practices broadly, regulatory bodies have also acknowledged the need to tailor protocols to local and regional environments.

In deciding whether to triage an individual patient with suspected stroke to an endovascular center instead of a primary stroke center, EMS may consider factors such as relative travel distances, stroke severity, and the likelihood of a large vessel occlusion (LVO).

LVO screening tools have inherent imprecision, and the positive predictive value, of course, depends on the prevalence of LVO. For this reason, knowing the prevalence of LVO among acute ischemic stroke 9-1-1 dispatches is of importance. Further, at an organizational level, the accuracy and precision of LVO detection in the field has upstream implications for case load at endovascular and non-endovascular centers. The importance of these considerations varies by locale.

By |December 4th, 2017|clinical, health care, outcomes, policy|0 Comments
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Cost Effectiveness and Analysis of Mechanical Thrombectomy for Acute Ischemic Stroke

Sami Al Kasab, MD

Sevick LK, Ghali S, Hill MD, Danthurebandara V, Lorenzetti DL, Noseworthy T, et al. Systematic Review of the Cost and Cost-Effectiveness of Rapid Endovascular Therapy for Acute Ischemic Stroke. Stroke. 2017

Stroke remains one of the most devastating neurological illnesses and the leading cause of long-term disability in the U.S. It’s projected that the total cost of stroke from 2005 to 2050 will be $1.52 trillion for non-Hispanic whites, $313 billion for Hispanics, and $379 billion for African Americans. Until 2015, intravenous alteplase (rtPA) was the only proven treatment for acute ischemic stroke. In 2015, a series of five randomized controlled trials demonstrated the effectiveness of mechanical thrombectomy for patients presenting with acute ischemic stroke due to anterior circulation large vessel occlusion within 6 hours of symptom onset.

In this study, Sevick et al perform a systematic review to evaluate cost effectiveness of endovascular therapy (EVT) for acute ischemic stroke. The authors also aim to synthesize all the publicly available economic literature regarding EVT.

By |November 20th, 2017|clinical, health care, outcomes, policy|0 Comments
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Benchmarking Telestroke Proficiency

Abbas Kharal, MD, MPH, and Richa Sharma, MD, MPH

Jagolino-Cole AL, Bozorgui S, Ankrom CM, Bambhroliya AB, Cossey TD, Trevino AD, et al. Benchmarking Telestroke Proficiency: Page-to-Needle Time Among Neurovascular Fellows and Attendings. Stroke. 2017

Telestroke management is built into the curriculum of many vascular neurology fellowships and affords fellows (NVF) the opportunity to achieve proficiency in this modality. This study demonstrates that the page-to-needle time, or PTNT, is higher among NVFs compared to NVAs. As a result, the authors are suggesting that PTNT is a metric of proficiency. Given lower PTNT among NVAs compared to NVFs, there is an assumption that further training may decrease PTNT and, transitively, increase proficiency. As such, there may be a benefit in greater emphasis of dedicated telestroke training during fellowship.

There is an inherent truth in the logic that additional training can result in decreased PTNT just by sheer procedural repetition to learn the logistics of data-gathering by the phone, video, and imaging from an outside institution. However, perhaps the process is also faster for NVAs compared to fellows due to the attendings’ greater body of experiences seeing numerous patients with each stroke syndrome, treating them acutely, and then following the clinical course in the rehabilitation and subacute phase. Thus, proximal care of stroke patients longitudinally may aide in faster decision-making for remote, telestroke patients. Given that most vascular neurology fellowships are only one clinical year, it is thus critical that telestroke training does not supersede rotations, which require direct patient contact throughout the spectrum of the disease, since it is this contact which informs the decision-making process in the practice of telestroke.

By |November 17th, 2017|clinical, health care, outcomes, policy|0 Comments
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Beyond Drip and Ship: The Role of Baseline Vascular Imaging for Referring Hospitals in Acute Ischemic Stroke Triage for the Endovascular Era

Danny R. Rose, Jr. MD

Boulouis G, Siddiqui K, Lauer A, Charidimou A, Regenhardt R, Viswanathan A, et al.  Immediate Vascular Imaging Needed for Efficient Triage of Patients With Acute Ischemic Stroke Initially Admitted to Nonthrombectomy Centers. Stroke. 2017

The landmark publication of multiple positive endovascular thrombectomy (EVT) trials in 2015 was a pivotal moment for treatment of acute ischemic stroke. The most significant development in acute stroke treatment in the nearly twenty years since the FDA approval of tissue plasminogen activator in 1996 has led to much discussion with respect to improving stroke systems of care to be able to provide this treatment to as many eligible patients as possible. Reflecting this new development in acute stroke treatment, the American Heart Association released a focused update to their guidelines on acute stroke treatment that recommended endovascular therapy be offered to patients who present within 6 hours of last known normal and have a favorable imaging profile and a National Institutes of Health Stroke Scale (NIHSS) of 6 or greater.

Just as the time-sensitive nature of intravenous thrombolytic administration led to the development of prehospital stroke scales and the stroke alert process, the most effective way to triage and treat patients with suspected emergent large vessel occlusions (LVO) amenable to endovascular treatment is a topic of ongoing research and debate. An important facet of this discussion concerns the most effective method to triage and transfer patients with suspected LVO to a thrombectomy-capable stroke center. A cohort by Sarraj et al. presented at the 2017 International Stroke Conference showed comparably good outcomes for patients transferred to thrombectomy-capable centers as compared to patients who presented directly to the facility, suggesting that the “drip and ship” transfer paradigm can be successfully augmented to accommodate endovascular therapy.

By |September 18th, 2017|clinical, health care, outcomes, policy|0 Comments
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Low socioeconomic status across age spectrum associated with higher incidence of stroke in adulthood


Low socioeconomic status is associated with a higher incidence risk of stroke in multiple populations worldwide. Although differences in the prevalence and severity of vascular risk factors likely contribute to this disparity, these risks may also be modified by negative socioeconomically driven influences throughout an individual’s lifespan. Becher et al. sought to investigate this further by conducting a case-control study to investigate the contribution of socioeconomic, genetic, and infectious risk factors during childhood, adolescence, and adulthood with respect to the risk of ischemic stroke in adulthood.
The study was nested in a population-based stroke registry in the city of Ludwigshafen, a city in South-West Germany with about 160,000 inhabitants. Patients of Caucasian race-ethnicity ages 18-80 with first-ever ischemic stroke treated at the only stroke unit within the city were compared to age and sex matched controls who were randomly selected from the general population. Patients with prior stroke, myocardial infarction within the last 90 days, dementia or severe communication barriers were excluded. 

Variables that were studied included anthropometric measures, medical history, smoking status, alcohol intake, diet, physical activity and medications. Socioeconomic measures were separated by age group (childhood, up to age 14; adolescence, age 15-25; adulthood,> age 25). Childhood socioeconomic conditions included parents’ occupation (divided into academic, non-academic white collar, blue collar and unskilled labor) during subjects’ childhood as well as living, familial, material and self-estimated financial conditions. For adolescence, highest school degree and professional education was used.  Last, profession, marital status and periods of unemployment were used as conditions for adulthood. Risk scores were calculated prior to analysis by summing scores according to weights chosen a priori based on previous work. Principal component analysis was also performed, as well as classification into tertiles of the summed scores based on distribution in controls. Odds ratio estimates were determined using both univariate and multivariate analyses, with the latter adjusted for known risk factors for stroke and the other life periods. 

A total of 470 subjects agreed to participate in the study and were compared to 809 controls. For childhood conditions, a higher number of siblings (OR=1.48[1.12-1.96]), lack of an own toilet (OR=1.52[1.12-2.05]), and estimated lower family income (OR=2.9[2.18-3.87]) were independently  associated with stroke in multivariate analysis. Lack of vocational training in adolescence (OR=1.93[1.03-3.63]) was independently associated with stroke.  In adulthood, single, divorced or windowed persons (OR=1.63[1.20-2.22]), greater than 6 months of unemployment (OR=1.52[1.05-2.19]) and unskilled last profession (OR=1.99[1.11-3.60]) were independently associated with stroke. In the fully adjusted model (adjusting for age, sex, medical and lifestyle risk factors, and the other life stages), low socioeconomic conditions during childhood (OR=1.77[1.20-2.60]) and adulthood (OR=1.74[1.16-2.60]) were independently associated with stroke risk. Interestingly, adjustment for medical risk factors attenuated the socioeconomic effect in childhood whereas lifestyle risk factors reduced the effect during adolescence and adulthood. When analyzed by stroke subtype, less favorable childhood socioeconomic conditions were associated with a strong risk of large artery stroke (OR=2.13[1.24-3.67]) that was not found for other etiologies of stroke or life stages. 

This study provides an intriguing insight into the impact of various socioeconomic conditions during each stage of life on stroke risk during adulthood. The relatively large number of patients and variety of factors assessed contribute to the strength of the study, although the lack of knowledge about the precise way that socioeconomic conditions affect health makes confounding factors difficult to assess and control. The attenuation of childhood risk after adjustment for medical factors suggests that factors in childhood may be causally linked to the development of known medical risk factors for stroke later in life, and the attenuation of adult risk after adjustment for lifestyle factors suggests that their effects may be independent of medical risk factors. Further study looking at associations with childhood socioeconomic conditions and medical risk factors for stroke could provide further clarity on this issue. The association of low socioeconomic conditions in childhood with large artery strokes may be related to this relationship, as there are many commonalities between medical risk factors for atherogenesis and stroke. The authors’ hypothesis related to chronic systemic inflammation could be further investigated using high-sensitivity CRP values either in a similarly designed study or, ideally, a longitudinal cohort that would track these values over time.   

The racial and geographical homogeneity of the study population limits its generalizability.  Conducting and reviewing similar studies with racially diverse populations in a variety of locations could be helpful in identifying common factors, as there is likely important variation in diet and environmental exposures between low socioeconomic status groups in different regions worldwide. This study and similar studies will be vital in expanding our understanding of how social conditions contribute to stroke risk.

By |January 7th, 2016|health care, outcomes, policy|0 Comments
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Randomized trial shows telephone-based comprehensive caregiver education and support can help mood and quality of life for caregivers of stroke survivors

Danny R. Rose, Jr., MD

Bakas T, Austin JK, Habermann B, Jessup NM, McLennon SM, Mitchell PH, et al. Telephone Assessment and Skill-Building Kit for Stroke Caregivers: A Randomized Controlled Clinical Trial. Stroke. 2015

The myriad of challenges that caregivers of stroke survivors face is an under-recognized consequence of stroke that has significant implications on quality of life for both the caregiver and patient. A 2014 American Heart Association scientific statement reviewed the available scientific literature regarding caregiver interventions and recommended individualized programs that combine skill-building with psycho-educational strategies. The variation in studies cited in that report reflect the current lack of evidence with respect to the most effective and feasible approach to implement such an intervention. Bakas et al. sought to investigate the efficacy of the revised Telephone Assessment and Skill-Building Kit (TASK II, a multifaceted caregiver intervention program) by conducting a randomized controlled clinical trial comparing TASK II to a more traditional program, Support and Referral (ISR) strategy, to determine if a more comprehensive intervention improved caregivers’ mood and quality of life. 

A total of 254 stroke caregivers were randomized to either the TASK II group (n=123) or to the ISR comparison group (n=131). Caregivers were deemed appropriate for inclusion if they were the primary caregiver, 21 years of age or older, anticipated providing care for at least one year and were able to participate in the telephone calls and interviews. Caregivers and stroke survivors were excluded if they had severe cognitive issues, severe mental illness or had been hospitalized for alcohol or drug abuse. Demographics between the two groups were similar. Caregivers were primarily women (78.0%, TASK II; 78.6% ISR), about half spouses (48.4%, TASK II; 46.6%, ISR), predominantly White (70.7%, TASK II; 72.1%, ISR), and ranged in age from 22 to 87 years.

Both groups received an information pamphlet from the American Heart Association. Caregivers randomized to the TASK II intervention group also received a resource guide including a checklist addressing caregiver needs regarding finding information, providing physical and instrumental care as well as managing the survivor’s emotions and behaviors. The resource guide also included skill building information for screening for depressive symptoms, maintaining realistic expectations, communicating with healthcare providers as well as stress management for the caregiver and stroke survivor. Both groups received 8 weekly calls from a nurse with a booster call at 12 weeks. Calls to the caregivers in the TASK II group focused on identifying and prioritizing their needs and concerns and using the resources in the resource guide with skill-building strategies. Calls to caregivers in the ISR group focused on providing support through active listening strategies. Baseline data were collected within 8 weeks after the stroke survivor was discharged, and follow-up data were collected at 8 weeks (post-intervention), 12 weeks and at 24 and 52 weeks. Caregiver outcomes were assessed using validated questionnaires on depressive symptoms (Patient Health Questionnaire Depressive Symptom Scale, PHQ-9), changes in social functioning, subjective well-being, and physical health (Bakas Caregiving Outcomes Scale, BCOS), and Unhealthy Days, measured by summing two items asking caregivers to estimate the number of days in the past 30 days that their own physical and/or mental health had been poor.

At baseline, approximately half of the caregivers in each group reported mild to severe depressive symptoms (defined as PHQ-9 ≥ 5). For that subgroup, caregivers in the TASK II group reported a greater reduction in depressive symptoms from baseline to 8 weeks compared to the ISR group (mean difference -2.6, p= 0.013) The effect was also found when comparing baseline to 24 weeks (mean difference -1.9, p=0.041) and baseline to 52 weeks (mean difference -3.0, p=0.041). This subgroup also had a significant improvement in life changes compared to ISR participants from baseline to 12 weeks. This difference was not present for the cohort as a whole for either endpoint. Caregivers in the TASK II group also had a greater reduction in unhealthy days from baseline to 8 weeks compared to the ISR group (mean difference -2.9, p=0.025).

This study represents an important step in the continued effort to design and revise evidence-based programs to provide targeted caretaker support. Based on this study, it appears that caretakers with baseline depressive symptoms are a particularly vulnerable subset that tend to benefit from caregiver interventions in general and do better with interventions targeted at identifying needs and building problem solving skills. It is also worth noting that this represents the first telephone-based intervention showing durable results up to one year for any group of caretakers, and is much more feasible compared to interventions focusing on in-person counseling. Further research on a larger scale resulting from the incorporation of this and similar caregiver well-being intervention strategies into existing stroke systems of care will likely continue to improve our understanding of the most efficient and effective way to provide targeted interventions to improve caretaker well-being
.

By |December 22nd, 2015|health care, policy|0 Comments
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