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The Trials of tPA

Rachel Forman, MD

Haslett JJ, Genadry L, Zhang X, LaBelle LA, Bederson J, Mocco J, et al. Systematic Review of Malpractice Litigation in the Diagnosis and Treatment of Acute Stroke. Stroke. 2019

When I read the title of this article, the first thing that came to mind was the bleeding risk associated with tPA. After all, we carefully read through the tPA contraindications checklist making sure we will not cause harm to our patients. It turns out that there is a lot more to worry about! 

In the article “Systematic Review of Malpractice Litigation in the Diagnosis and Treatment of Acute Stroke,” Haslett et al. discuss characteristics of malpractice cases related to acute stroke management. 

It was helpful that the authors first defined some legal terms, specifically that “to prove medical malpractice occurred, a plaintiff must show that during the course of treatment, the physician deviated from the standard of care as defined by the medical community, and that caused injury to the patient.”

Infection Impact on Stroke Outcome Beyond Hospital Discharge

Elena Zapata-Arriaza, MD
@ElenaZaps

Boehme AK, Kulick ER, Canning M, Alvord T, Khaksari B, Omran S, et al. Infections Increase the Risk of 30-Day Readmissions Among Stroke Survivors: Analysis of the National Readmission Database. Stroke. 2018;49:2999–3005.

Infection is a most frequent medical complication after stroke. It is well recognized that acute stroke induces both the central nervous system and peripheral inflammatory responses, and, infection during stroke admission increases acute and longer-term inflammatory responses, complicating stroke outcomes. However, up to now, clinical trials with prophylactic aim in infection after stroke have failed. Therefore, stroke and infection develop a negative feedback between them.

Based on the known association between infection and stroke outcomes, the authors performed a weighted analysis of the federally managed 2013 National Readmission Database to assess the relationship between infection during a stroke hospitalization and 30-day readmission (30dRA) among ischemic stroke survivors. The main goal of this paper was to confirm the relation between stroke infection and 30dRA. The novelty of the paper is the identification of stroke associated infection as a predictor of readmission, not only as the most frequent cause of a new hospitalization. The authors employed the International Classification of Disease Ninth Revision [ICD-9] codes to identify ischemic stroke patients with ICD-9 codes present in the first diagnostic position ischemic stroke (referred as primary ischemic stroke patients) and patients with ischemic stroke code at any diagnostic position (referred as all ischemic stroke patients). The primary outcome, 30dRA, was classified as any hospitalization occurring within the 30-day postdischarge window and classified into planned or unplanned readmissions using previously validated ICD-9 codes. Secondary outcomes, 7dRA and 60dRA, were also assessed and were classified as any hospitalization occurring within the 7 days, or 60 days, postdischarge window.

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.

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.

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.

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.

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.

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.

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.

Improving Access to Stroke Care Through Advocacy

AAN Neurology on the Hill

March 1, 2016
On Super Tuesday, March 1, 2016, members of the American Academy of Neurology met with our lawmakers to advocate for an act of congress to increase availability of acute stroke care. We were joined by a delegation of stroke patient advocates from the AHA/ASA.

The bill is called the FAST Act (Senate 1465, House 2799), which stands for Furthering Access to Stroke Telemedicine. Medicare currently only reimburses for telestroke consultation for patients presenting to hospitals in rural areas, and this bill seeks to expand coverage for patients originating in urban and suburban areas as well.

Though telemedicine has clear utility for patients in rural areas, the vast majority of patients fall victim to stroke in urban and suburban areas. Neurologists and stroke centers are more common in these areas, but this is not universally true. Increasing the availability of telestroke consultation could increase the rate and speed of acute ischemic stroke treatment in more areas.

A number of studies have examined safety, outcomes and cost-effectiveness of telestroke. Most of the data regarding telestroke come from studies in rural settings, in which telestroke systems safely and effectively aid in the treatment of stroke.1,2 Additionally, in urban Madrid, implementation of telestroke was associated with higher rates of IV-tPA administration, faster door-to-needle times, and a lower 3-month mRS scores.3 In terms of cost effectiveness, telestroke networks are at least cost-neutral and likely result in societal cost savings.2,4 Telestroke may have additional unique benefits in urban and suburban areas such as refining access to endovascular therapy.

Politically, this bill is considered a “win-win” bill. It is intended to benefit patients through expansion of coverage, yet is nonetheless expected, by AHA/ASA estimates, to generate considerable savings through the reduction of nursing home and long-term care facility use. Additionally, it has true bipartisan support with at least 25 Democrat and 25 Republican co-sponsors in the house. There is, therefore, a real possibility of this expansion becoming codified in law, whether through passage of the FAST Act or incorporation into other health care legislation.

The FAST Act would require Medicare to reimburse hospitals for telestroke regardless of geography, thereby allowing hospitals to build and strengthen the infrastructure for acute stroke care. The benefits are clear and may exceed expectations.

Concerned readers are encouraged to write to their senators and representatives. Members of the American Academy of Neurology can do so through the Action Center on the AAN website.

– Neal S. Parikh, MD

References
1. Stroke. 2014;45:2739-44.
2. Stroke. 2014;45:1876-80. [Review]
3. J Neurol. 2014;261:1768-73.
4. Am J Manag Care. 2013;19:976-85.