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Anticoagulation in Subclinical Atrial Fibrillation and the Prevention of Stroke

May is National Stroke Awareness Month. This initiative began in May 1989 to promote public awareness and reduce the incidence and associated burden of stroke in the United States.1  Despite ongoing efforts, stroke remains a leading cause of death and long-term disability in the United States.2-4 Every year about 795,000 people in the United States have a stroke.2    

Stroke can be preventable. One of its major risk factors, atrial Fibrillation, affects as many as 2.2 million Americans.  In people over 80 years of age, atrial fibrillation remains the direct cause of 1 in 4 strokes.5-6 There are documented benefits to the administration of direct oral anticoagulants and vitamin K antagonists in new-onset atrial fibrillation (> 24-hour duration).  There is controversy on the use of these agents with asymptomatic, subclinical atrial fibrillation (SCAF), or atrial fibrillation (< 24 hour duration).7-8   Results from a meta-analysis of 50 studies suggested SCAF being commonly detected within in patients after a stroke.9   Studies also report shorter episodes of SCAF associated with a higher likelihood of subsequent longer episodes of SCAF and nearly six times higher risk of clinical atrial fibrillation.10-11

It has been well documented that the use of cardiac implantable electronic devices and wearable monitors leading to increased detection of subclinical atrial fibrillation in patients. It is argued that in efforts to reduce the stroke risk, with the detection of subclinical atrial fibrillation, clinicians may have a window of opportunity in the initiation of anticoagulation. The American Heart Association published a scientific statement on the prevalence, clinical significance, and management of subclinical atrial fibrillation. It also highlighted current gaps in knowledge and areas of controversy around the treatment of subclinical atrial fibrillation.8

With the lack of clearly defined thresholds of atrial fibrillation burden to initiate oral anticoagulation, clinicians are faced with having to weight the clinical benefits and contraindications to anticoagulation therapy for patients with SCAF.8  A population health approach, leveraging the use of the electronic medical record may present alternatives into risk stratification and therapeutic management of direct oral anticoagulants .6 Options such as the use of anticoagulation clinics may need to be explored in the case of oral anticoagulant agents that do not require routine laboratory monitoring.

 Findings from two ongoing clinical trials in patients with Cardiac Implanted Electronic Devices-detected SCAF will inform on the management of SCAF in the prevention of strokes: the ARTESiA (Apixaban for the Reduction of Thrombo-Embolism in Patients With Device-Detected Subclinical Atrial Fibrillation; NCT 01938248)41 and NOAH (Non–Vitamin K Antagonist Oral Anticoagulants in Patients With Atrial High Rate Episodes; NCT 02618577).8  Until then, it will be important for clinicians to continue working, following a patient centered approach. Factors such as patient goals and preferences, adherence, gaps in knowledge, will need to be addressed in order to support a more personalized, therapeutic approach.8

References:

  1. Bush, George. Peters, Gerhard; Woolley, John T. (eds.). “Proclamation 5975—National Stroke Awareness Month, 1989”. The American Presidency Project. University of California at Santa Barbara.
  2. Kochanek KD, Xu JQ, Murphy SL, Arias E. Mortality in the United States, 2013. NCHS Data Brief, No. 178. Hyattsville, MD: National Center for Health Statistics, Centers for Disease Control and Prevention, Department of Health and Human Services; 2014.
  3. Mozzafarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, et al., on behalf of the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics—2016 update: a report from the American Heart Association. Circulation 2016;133(4):e38–360.
  4. Virani SS, Alonso A, Benjamin EJ, Bittencourt MS, Callaway CW, Carson AP, et al. Heart disease and stroke statistics—2020 update: a report from the American Heart Associationexternal icon. Circulation. 2020;141(9):e139–e596.
  5. National Institute of Neurological Disorders and Stroke. Atrial fibrillation and stroke information. 2019. https://www.ninds.nih.gov/Disorders/All-Disorders/Atrial-Fibrillation-and-Stroke-Information-Page
  6. Jame S, Barnes G. Stroke and thromboembolism prevention in atrial fibrillation. Heart. 2020;106(1):10-17. doi:10.1136/heartjnl-2019-314898
  7. Healey JS, Amit G, Field TS. Atrial fibrillation and stroke: how much atrial fibrillation is enough to cause a stroke?. Curr Opin Neurol. 2020;33(1):17-23. doi:10.1097/WCO.0000000000000780
  8. Noseworthy PA, Kaufman ES, Chen LY, Chung MK, Elkind MSV, Joglar JA, Leal MA, McCabe PJ, Pokorney SD, Yao X; on behalf of the American Heart Association Council on Clinical Cardiology Electrocardiography and Arrhythmias Committee; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Cardiovascular and Stroke Nursing; and Stroke Council. Subclinical and device-detected atrial fibrillation: pondering the knowledge gap: a scientific statement from the American Heart Association. Circulation. 2019;140:e944–e963. doi: 10.1161/CIR.0000000000000740.
  9. Sposato LA, Cipriano LE, Saposnik G, Ruíz Vargas E, Riccio PM, Hachinski V. Diagnosis of atrial fibrillation after stroke and transient ischaemic attack: a systematic review and meta-analysis. Lancet Neurol. 2015; 14:377–387. doi: 10.1016/S1474-4422(15)70027-X
  10. Mahajan R, Perera T, Elliott AD, Twomey DJ, Kumar S, Munwar DA, Khokhar KB, Thiyagarajah A, Middeldorp ME, Nalliah CJ, et al.. Subclinical device-detected atrial fibrillation and stroke risk: a systematic review and meta-analysis. Eur Heart J. 2018; 39:1407–1415. doi: 10.1093/eurheartj/ehx731
  11. Swiryn S, Orlov MV, Benditt DG, DiMarco JP, Lloyd-Jones DM, Karst E, Qu F, Slawsky MT, Turkel M, Waldo AL; RATE Registry Investigators. Clinical implications of brief device-detected atrial tachyarrhythmias in a cardiac rhythm management device population: results from the Registry of Atrial Tachycardia and Atrial Fibrillation Episodes. Circulation. 2016; 134:1130–1140. doi: 10.1161/CIRCULATIONAHA.115.020252

“The views, opinions and positions expressed within this blog are those of the author(s) alone and do not represent those of the American Heart Association. The accuracy, completeness and validity of any statements made within this article are not guaranteed. We accept no liability for any errors, omissions or representations. The copyright of this content belongs to the author and any liability with regards to infringement of intellectual property rights remains with them. The Early Career Voice blog is not intended to provide medical advice or treatment. Only your healthcare provider can provide that. The American Heart Association recommends that you consult your healthcare provider regarding your personal health matters. If you think you are having a heart attack, stroke or another emergency, please call 911 immediately.”

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Get with the Guidelines (GWTG) – Stroke Patient Registry Use in Primary and Comprehensive Designated Stroke Centers during COVID-19 Pandemic

This year many of the professional conferences that traditionally took place live have had to change to virtual mode due to the global COVID-19 pandemic and its related social distancing rules.  The International Stroke Conference and Nursing Symposium was no exception. Yet it presented an excellent opportunity for many to attend, especially those who could not have joined the conference in-person had the opportunity to participate virtually.  Healthcare professionals, academicians, researchers, and supporters of stroke prevention were able to join from different places in the world, under different time zones. There were many options for participants to engage and interact in the many discussions and presentations through the online platform.

Earlier I had the opportunity to write about various topics presented during the #ISC21 (you can read them here: “Reducing Disparities through Diversity and Inclusion in Stroke Science, Clinical Trial Enrollment, and Community Engagement”; “Transformation of the GWTG – Stroke Patient Registry to into a National Representative Database of Acute Ischemic Strokes (AIS) in the U.S.”).

Today, I wanted to interview a couple of conference participants who could share with you about their experience attending this virtual conference. I also wanted them to share with you their experience with the GWTG Stroke Registry and the prevention of stroke in the midst of the COVID-19 pandemic. My guests for this post-conference interview are Ms. Jessilyn Pozo, Baptist Health South Florida System-Wide Stroke Program Manager, and Dawntray Radford, Stroke Coordinator for South Miami Hospital (You can follow them for more information here).  This transcript is a lightly edited version of the interview we conducted on webcam, shortly after the 2021 International Stroke Conference.

Catherina: How was your experience at the 2021 International Stroke Conference (ISC) delivered in virtual mode?

Dawntray: The International Stroke Conference was definitely different this year. However, I was appreciative that they (AHA) were able to extend the sessions’ timeframe so that we would be able to take a deeper dive, engage in deeper discussions opposed to the 10-15 minute sessions that we normally would have (in a live conference).  I think I got a lot more information (from the presentations and discussions), especially within the different scheduled presentations.  Therefore, I think there was an added bonus of extending the sessions’ timeframe.

 

Dawntray Radford, BSN, RN Stroke Coordinator South Miami Hospital

 

Jessilyn: This is my second time attending ISC. I went last year to Los Angeles for it. Although I do like the live version more, I liked that we were able to see lectures recorded and delivered on-demand. There were a lot of interesting topics this year, specifically hot topics with Tenecteplase1, which many hospitals are leaning towards converting its use. There were different topics like the nursing care guidelines, and reports from recent studies released.  We were able to take many good notes, and we were able to pause and write down things and keep going with the lectures.  I really enjoyed attending the conference, but I am excited for it to be live next year.

 

 

Jessilyn Pozo, BSN, RN, SCRN BHSF System-Wide Stroke Program Manager Baptist Hospital of Miami

 

Catherina: How would you describe your role in the stroke program at your organization?

Jessilyn: I oversee the stroke program for the Baptist Health system. Baptist Hospital of Miami is our comprehensive center. Dawntray Redford runs the South Miami Hospital stroke program, which is a primary stroke center, certified by the Joint Commission.2  She worked tirelessly to get it certified with no Requests for Improvements (RIFs).  So kudos to her! We are working with West Kendall Baptist Hospital to become a primary stroke center. We are working to have a few of our other entities to be acute stroke ready. We have oversight of the stroke program at each individual entity and as a system to provide standardized great stroke care for all patients.

Catherina: Please tell us Ms. Radford about your role in the stroke program at South Miami Hospital.

Dawntray: We went through our first initial certification as a primary stroke center.  There are a lot of moving parts in the program that we need to monitor.  In addition to providing care, since we are a primary stroke center, there is an urgency of transferring stroke patients to the comprehensive center.  This shows to our community and Emergency Medical Services (EMS) that we have the capabilities of readily identifying the acute stroke patients when they arrive and transferring them out at a target time of sixty minutes. Based on the feedback we received from the certification survey by the Joint Commission, it was very impressive! Because of the national times, the average goal is to push for at least 90 minutes.   The literature suggests and has proven (benefits) from taking about 2 hours to 3 hours to actually have a patient transferred out to an equipped hospital.  Emergency medical services (EMS) had tried to propose to bypass the primary stroke centers and go to the comprehensive one. They did not want these two-to-three-hour delays of the patient transferred because of so many logistics of trying to transfer a patient from one hospital to another system, as we had to go through that transfer process.  With the streamlined process at our Institute, the Miami Neuroscience Institute, we have our own streamlined process and our dedicated transfer center.  We can actually execute our transfers in sixty minutes.  We worked very hard with our internal system of identifying patients before they even arrived to our institution. We are having that proactive approach of readily identifying that patient that has that large vessel occlusion. We already have a transfer center in place before the patient even arrives. This would make our numbers soar to that target timeframe for patients to get excellent stroke care.  During our certification survey, we got compliments on our timeframe, less than the 90-minute-to-120-minutes timeframe, as we probably may be set back a new benchmark for the nation.

Catherina: What are the benefits of the GWTG Stroke Registry at your organizations?

Jessilyn: We are very lucky to have a data analyst team that is driven and just solely dedicated to the management of our stroke data. They are the ones who check on our stroke alert times; make these dashboards with turnaround times that they input in Get With The Guidelines. The Get With The Guidelines Stroke Registry helps us to stay on track.  It keeps us on our toes, making sure that we meet the (stroke) goals.  We aim to provide the care that we need to (deliver to stroke patients) based on the guidelines and the standards.  This (registry data) allows for feedback on how our programs are doing.

Dawntray: The use of The Get With The Guidelines at South Miami Hospital is imperative, especially with the fact that we have different stroke units. The staff at the stroke units would like to see how they are doing as an individual unit, so they know where they need to improve individually as opposed to the hospital as a whole.  Especially with the Emergency Department, their metrics would be different from the metrics of an inpatient unit.   At least with the registry, I could take the different core quality measures and give the appropriate information specific to their unit.  I use the registry 100% to monitor our quality measures and performance improvement measures.

Catherina: What has been your experience with stroke patients seeking stroke care in the midst of the COVID-19 pandemic?

Dawntray:  We definitely have seen a decrease in the volume of care, especially with EMS and the patients that walk in.  Eighty percent of our patients would arrive by their private vehicles. Many patients did not come through EMS during the pandemic.  We noticed at least 50% change in our volume for at least the first two months of the COVID pandemic.  We have also seen an increase in ischemic strokes with clots, with occlusive strokes in patients that were positive for COVID. They developed COVID first.  The developed stroke as a secondary diagnosis.

Jessilyn: From the comprehensive center standpoint, being like the hub of the system, we have seen internal patient transfers from our sister hospitals. These patients were initially admitted for COVID care. They developed an acute ischemic stroke and were transferred over for neuro intervention.  Unfortunately, these have been the trickiest patients. They were on the younger side, ended up being hypercoagulable. Our interventionalists are amazing! However, they do say it is more difficult, they find more clots. It is not just one. They seem to find several clots.  These patients also tend to reocclude, even though they have had a successful thrombectomy. Therefore, I think COVID has really posed quite a challenge in stroke care for all.

Catherina: What suggestions do you have for healthcare professionals in educating patients about the prevention of stroke, especially during this COVID-19 pandemic?

Jessilyn: I think one of the biggest issues in stroke is that as high as it is, 80% of the strokes are preventable. Stroke should probably be out of the top 10 issues that are the cause of mortality in our nation or in the world.  A lot of it has to do with the fact that people do not recognize the symptoms.  It also has to do with getting them in here (hospital) for early treatment.  We have those 24 hours for them to be a possible candidate for stroke care.  A lot of them do not just even recognize the symptoms or the risk factors of stroke.  They do not understand things that they just do in their daily life, that if they were to change one of these minute things, it can help them decrease their risk of stroke and relieve them from possible debilitating life symptoms.

Dawntray: (During the pandemic) we reached out to our marketing department.  We have a Facebook page where we have a post on Fridays.  (We posted) on recognition of the signs of early stroke: FAST: Face, Arm, Speech, Time of recognizing stroke, calling 911.   We also had information on what (symptoms) to look for.  We had a message built in to the post as well, stating that, “we know that you may be afraid to come in, that you want to stay at home, but you choose to be aware of, of not being afraid to seek services, to come in to the hospital where it is safe.”   “We take a lot of preventative measures to protect ourselves and to the community during the pandemic”.   We are just letting them know what the signs and symptoms were and not to be afraid to come in and to seek care (at the hospital).   We are just giving them that comfort that it is safe to come into the hospital.  Because that is what they feel… it was not safe, so they were afraid to come in (during the pandemic).

Catherina: Thank you for the opportunity to interview you and look forward to the next ICS conference.  Anything that you would like to share out there with stroke coordinators, any advice or word of guidance?

Jessilyn: Just hang in there.

Dawntray: You have to be inventive. Just know that a pandemic cannot hinder you from providing the care that you provide every day.   You just have to be creative, find a better way, a different way of still executing what you do on a daily basis.

I would like to thank Ms. Jessilyn Pozo and Ms. Dawntray Redford for sharing their experiences during this 2021 Virtual International Stroke conference as well as their experiences with the GWTG Stroke Registry, Primary and Comprehensive Stroke Program, and stroke prevention during the COVID-19 pandemic. For more information, you can reach them at JessilynP@baptisthealth.net and DawntrayTW@Baptisthealth.net

 

References:

  1. Warach SJ, Dula AN, Milling TJ Jr. Tenecteplase Thrombolysis for Acute Ischemic Stroke. Stroke. 2020;51(11):3440-3451. doi:10.1161/STROKEAHA.120.029749
  2. The Joint Commission. Primary Stroke Center Certification. (2021). Retrieved from https://www.jointcommission.org/accreditation-and-certification/certification/certifications-by-setting/hospital-certifications/stroke-certification/advanced-stroke/primary-stroke-center/
  3. American Heart Association. Get with the Guidelines Stroke Registry. (2021). Retrieved from https://www.heart.org/en/professional/quality-improvement/get-with-the-guidelines/get-with-the-guidelines-stroke

“The views, opinions and positions expressed within this blog are those of the author(s) alone and do not represent those of the American Heart Association. The accuracy, completeness and validity of any statements made within this article are not guaranteed. We accept no liability for any errors, omissions or representations. The copyright of this content belongs to the author and any liability with regards to infringement of intellectual property rights remains with them. The Early Career Voice blog is not intended to provide medical advice or treatment. Only your healthcare provider can provide that. The American Heart Association recommends that you consult your healthcare provider regarding your personal health matters. If you think you are having a heart attack, stroke or another emergency, please call 911 immediately.”

 

 

 

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Effects of COVID-19 on Acute Ischaemic Stroke care: Comparative insights from Get With The Guidelines-Stroke registry

Much like acute myocardial infarctions, the optimal management of acute ischaemic stroke (AIS) is extremely time-sensitive. The foundation of favorable outcomes of AIS lies in the timely presentation and acute intervention by means of either intravenous thrombolysis and mechanical thrombectomy. Especially earlier on during the COVID-19 pandemic, there was a concern regarding a decline in non-COVID acute medical admissions, as well as hospital-based challenges to appropriate and timely delivery of acute stroke care.

A study led by Dr Pratyaksh Srivastava and colleagues, published in Stroke, uses data from the American Heart Association (AHA)’s Get With The Guidelines Stroke (GWTG-Stroke)® registry, to compare characteristics, treatment patterns, and in-hospital outcomes of 81,084 patients over two time periods: before COVID and after the first reported case of COVID-19 (1). The AHA’s GWTG-Stroke registry is a validated and reliable national registry of adults with stroke in the United States (2,3). This blog provides a brief summary of the key findings of this analysis.

The study cohort and comparisons:

81,084 AIS patients were included over a period extending from 01st November 2019 to 29th June 2020, from among 458 participating hospitals with at least one positive COVID-19 patient. They were divided into two groups, according to the first reported case of COVID-19 in the registry. The pre-COVID group consisting of 39,113 patients (01st November 2019 to 3rd February 2020) and the during COVID group, consisting of 41,971 patients (4th February 2020 to 29th June 2020).

The two groups were compared for characteristics, treatment patterns, and outcomes. These analyses were repeated in sensitivity analyses, comparing a later during COVID-19 time period (1st April 2020 to 29th June 2020) to the same pre-COVID-19 time period. There were no differences in general characteristics among patients of the two time periods. 48.8% of the cohort were women. 61.9% were White. 2.7% of patients in the during COVID-19 group had a diagnosis of COVID-19.

Key findings from the study & implications:

There was a 15.3% average reduction of stroke presentations per week in the during-COVID-time period (3rd February 2020 to 24th May 2020) when compared with similar months in 2019. This is perhaps a reflection of general trends (4,5) in the immediate aftermath of the pandemic, partially reflecting an anticipated lack of capacity in overburdened health systems, the effect of shelters in place and social distancing disorders (5), and patients delaying or avoiding seeking medical care due to concerns of contracting COVID-19(6).

Treatment patterns:

Similar rates of acute interventions for AIS were observed in pre-COVID and during-COVID time periods. There were no differences in rates of intravenous alteplase (11.7% vs. 11.4%, p=0.26) or endovascular therapy (10.2% vs. 10.1%, p=0.90) pre- and during COVID respectively.

Furthermore, there were also no additional delays in administering care. Median door to needle times (46 [32-65] minutes vs 46 [33-64] minutes; p= 0.69) and door to endovascular times (86 [53-129] minutes vs 90 [54-134] minutes; p=0.06) were not different between the pre-COVID and during COVID periods respectively. This is crucial and encouraging data, given the time-sensitive nature of acute stroke care and the delays that were anticipated during the COVID-19 period, from having to don personal protective equipment (PPE).

Also, door to computed tomography (CT) time was slightly shorter during the COVID-19 time period (median 35 [14-100] vs 37 [15-111] mins, p<0.001). A significant uptake of telestroke consult was observed during the COVID-19 period as compared with pre-COVID (6.0% vs 7.1%; p <0.0001).

GWTG-Stroke quality measures: 

Slight decreases were observed in rates of timely IV alteplase administration, prescription of antithrombotics at discharge, dysphagia screen, smoking cessation counseling, stroke education, and rehabilitation consideration in the during-COVID-19 group.  Despite this, these quality measures remained above the 85% target, suggesting the maintenance of quality care during the pandemic.

Outcomes:

Adjusted inpatient mortality of AIS was similar between pre- and during COVID-19 periods (4.8% vs. 5.2%; odd ratio 1.05, 95% CI 0.97-1.13), consistent with prior published studies (5,7). Also, in these adjusted models, no significant differences were observed for other outcomes such as symptomatic intracranial hemorrhage among IV alteplase patients, venous thromboembolism or pulmonary embolism during hospitalization.

In terms of patients’ disposition, there were reduced odds of discharge to skilled nursing facility (OR 0.78, 95% CI 0.74-0.82) and of a hospital stay >4 days during COVID-19 time period (OR 0.84, 95% CI 0.81-0.87), and increased odds of discharge to hospice (1.12, 95% CI 1.03- 1.21), and to home (OR 1.12, 95% CI 1.09-1.16) during COVID-19 period. These possibly reflect a hesitancy towards prolonged hospital stays, competing pressures on beds and skilled facilities, and tendency to triage away from high-risk environments.

Sensitivity analyses:

Apart from a slightly longer, and perhaps clinically insignificant, time from door to endovascular treatment in the later during COVID-19 group, findings remained largely similar in sensitivity analyses comparing those presenting in the later COVID-19 time period to those presenting pre-COVID-19.

Limitations:

Given its retrospective, observational nature, this study is limited in its ability to only evaluate, but not infer causality, with descriptive statistics performed being hypothesis generating. Not all data were complete and the observed decline in AIS patients during the pandemic may be due to lags in data entry. Furthermore, these findings may not be generalizable to hospitals that differ from GWTG-Stroke and international cohorts.

Key take-home message:

Despite an observed 15.3 % average decline in AIS presentations during the pandemic, this analysis from the GWTG-Stroke registry demonstrates preserved AIS care quality in the pre- and during COVID-19 time periods with similar door to needle, and door to endovascular times, similar rates of IV alteplase therapy, endovascular therapy, and adjusted in-hospital mortality.

For more latest science on Stroke and Neurology, be sure to register and attend the International Stroke Conference – happening now!

References

  1. Srivastava PK, Zhang S, Xian Y, et al. Acute Ischemic Stroke in Patients With COVID-19: An Analysis From Get With The Guidelines–Stroke. Stroke. 2021;52:00–00. DOI: 10.1161/STROKEAHA.121.034301
  2. Ormseth CH, Sheth KN, Saver JL, Fonarow GC and Schwamm LH. The American Heart Association’s Get With the Guidelines (GWTG)-Stroke development and impact on stroke care. Stroke Vasc Neurol. 2017;2:94-105
  3. Xian Y, Fonarow GC, Reeves MJ, Webb LE, Blevins J, Demyanenko VS, et al. Data quality in the American Heart Association Get With The Guidelines-Stroke (GWTG-Stroke): results from a national data validation audit. Am Heart J. 2012;163:392-8, 398 e1.
  4. Diegoli H, Magalhaes PSC, Martins SCO, Moro CHC, Franca PHC, Safanelli J, Nagel V, Venancio VG, Liberato RB and Longo AL. Decrease in Hospital Admissions for Transient Ischemic Attack, Mild, and Moderate Stroke During the COVID-19 Era. Stroke. 2020;51:2315-2321.
  5. Nguyen-Huynh MN, Tang XN, Vinson DR, Flint AC, Alexander JG, Meighan M, Burnett M,Sidney S and Klingman JG. Acute Stroke Presentation, Care, and Outcomes in Community  Hospitals in Northern California During the COVID-19 Pandemic. Stroke. 2020;51:2918-2924
  6. American College of Emergency Physicians. Public Poll: Emergency Care Concerns Amidst COVID-19 https://wwwemergencyphysiciansorg/article/covid19/public-poll-emergency care-concerns-amidst-covid-19. 2020.
  7. Tejada Meza H, Lambea Gil Á, Sancho Saldaña A, Martínez-Zabaleta M, Garmendia Lopetegui E, López-Cancio Martínez E, et al; NORDICTUS Investigators. Impact of COVID-19 outbreak in reperfusion therapies of acute ischaemic stroke in northwest Spain. Eur J Neurol. 2020;27(12):2491-2498.

 

“The views, opinions and positions expressed within this blog are those of the author(s) alone and do not represent those of the American Heart Association. The accuracy, completeness and validity of any statements made within this article are not guaranteed. We accept no liability for any errors, omissions or representations. The copyright of this content belongs to the author and any liability with regards to infringement of intellectual property rights remains with them. The Early Career Voice blog is not intended to provide medical advice or treatment. Only your healthcare provider can provide that. The American Heart Association recommends that you consult your healthcare provider regarding your personal health matters. If you think you are having a heart attack, stroke or another emergency, please call 911 immediately.”

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Transformation of the GWTG – Stroke Patient Registry to into a National Representative Database of Acute Ischemic Strokes (AIS) in the U.S.

Stroke remains a leading cause of death and disability in the United States.1  Approximately 800,000 people in the United States have a stroke every year.1  Eighty percent of all strokes can be prevented by screening for and treating known risk factors (hypertension, tobacco smoking, and atrial fibrillation).2 Recurrent strokes can also be prevented with proper management of these risk factors.3 Disease surveillance is crucial to the prevention of stroke, particularly in high-risk groups. Blacks and Hispanics report increasing stroke rates.4  Deprived populations within high-income countries are less likely to receive good-quality acute hospital and rehabilitation care than people with higher socioeconomic status.5  Findings from robust surveillance systems can be useful as healthcare providers can make informed decisions in the better medical management of strokes. Policymakers can work towards the development of aggressive campaigns to decrease the incidence of strokes in our communities and associated disparities in ethnic minorities and low-income groups.4,6  We can further estimate progress made towards the reduction and elimination of common risk factors of stroke.

Previously, the Institutes of Medicine recommended the development of surveillance systems in efforts to monitor the incidence and associated disabling burden from cardiovascular disease and strokes.7-8 The CDC’s Division for Heart Disease and Stroke Prevention (DHDSP) supports state, local, and tribal efforts to prevent, manage, and reduce risk factors related to stroke. The CDC has supported the implementation of stroke programs through cooperative agreements at these levels (CDC, 2020).9 However, due to the voluntary nature of these agreements, stroke surveillance data has been limited to only participant states. Therefore, it has been difficult to estimate the burden of a stroke at the national level.

A recent study by Ziaeian and colleagues presented the transformation of The Get With The Guidelines (GWTG) Stroke Patient Registry into a nationally representative database.10  This is the first study that has transformed a patient registry using post-stratification weights to represent a larger population of interest. The ability to translate observations from large registries to a national scale fills a considerable gap in the surveillance of the clinical characteristics, quality of care, and outcomes for Acute Ischemic Strokes (AIS) hospitalizations nationally.10  An acute stroke quality registry that is integrated with a guideline-based support tool can be a powerful tool for measuring and improving the quality of stroke care.11  Here we provide a summary of this recent study.10

Study population: The target population for the post-stratification weighting procedure is the total AIS presenting to U.S. hospitals by year. The NIS defines the AIS burden nationally stratified between the years of 2012 and 2014 and the nine U.S. Census regions – preserving the smallest sampling unit recommended by the NIS sponsors.  The National Inpatient Sample (NIS) is a weighted structured random sample of U.S. hospitalizations to represent national hospital utilization. However, the database does not include detailed clinical data such as stroke severity, laboratory data, medical treatments received, and patient-reported outcomes. The NIS is sponsored by the Agency for Healthcare Research and Quality’s Healthcare Cost and Utilization Project.

GWTG Stroke Patient Registry History: The GWTG – Stroke Patient Registry is a voluntary registry and continuous quality improvement initiative that collects data on patient characteristics, hospital adherence to guidelines and inpatient outcomes.  It was developed as part of a strategic goal of the American Heart Association (AHA) to reduce stroke and its associated risks, and Healthy People 2010 (HP2010) established national goals for stroke prevention and management.  The implementation of the GWTG Stroke registry has led to the implementation of evidence-based care and improved patient outcomes in many hospitals, acute care, and long-term care settings.6

GWTG hospitals comprise a mix of Joint Commission-certified stroke centers, PCNASR hospitals and small and large hospitals in urban and rural settings across the USA and Puerto Rico. Based on previous studies, the population of patients enrolled in GWTG is similar in age and racial makeup to the US population according to the U.S. census 2000.  Medicare beneficiaries linked to the GWTG registry are similar in demographics, comorbidities, and in-hospital outcomes compared with Medicare beneficiaries who are not linked.6,10

Methods: Ziaeian and colleagues integrated two data sources, The National Inpatient Sample (NIS), a structured random sample of U.S. hospitalizations weighted to represent national hospital utilization.10 The AHA-sponsored Get With The Guidelines Program (GWTG) program includes rich clinical data for quality improvement and research analyses.  They transformed these non-representative databases into a representative one with the use of post-stratification weights to rebalance over and underrepresented segments of the U.S. acute ischemic stroke (AIS) population. The approach described in the present paper is a far more robust estimation of the characteristics of stroke presentation and the quality of hospital care nationally.

The NIS lacks detailed clinical data such as stroke severity, laboratory data, medical treatments received, and patient-reported outcomes. It is not nationally representative and inadequate to measure stroke burden and quality of care nationally.  The GWTG-Stroke patient registry captures 58% of all strokes nationally. The GWTG program registries with volunteer hospitals are not proportionally representative of the entire nation.10  Ziaeian and colleagues used the GWTG-Stroke registry from 2012 to 2014 to evaluate post-stratification weighting procedures to represent the entire US AIS population.10

To determine the total number of AIS hospitalizations in the U.S. and marginal population characteristics for post-stratification weights, the investigators used target population counts from the NIS database. The NIS sampled 20% of the administrative discharge records from all participating hospitals (approximately 4300 hospitals) covering 95% of the U.S. population and 94% of all community hospital discharges from 2010 to 2014.  Raking and Bayesian interpolation, two parallel methods to estimate post-stratification survey weights, were used and their distribution was analyzed with histograms and treemaps to provide a perspective on the skewed representation of the GWTG-Stroke raw sample.

Results:  There were an estimated 1,388,296 AIS hospitalizations between 2012 to 2014 in the U.S. For the raking method, anchored characteristics in the weighted GWTG-Stroke sample matched the exact population totals estimated from the NIS. On admission, 49.2% of stroke patients nationally were using antiplatelet medications, 15.5% anticoagulants, 69.1% antihypertensives, 43.6% cholesterol-lowering medications, and 27.4% used diabetic medications. Approximately 48% of patients were discharged home, 40.2% to transitional care facilities, and 4.6% with hospice-related services.

Conclusions and Implications:  This research demonstrated the integration of two valuable data systems to make better population wide clinical estimates of acute ischemic stroke in the U.S., the GWTG Stroke Patient Registry and the NIS.  Their work demonstrates that methods exist to marry existing databases to make more reliable statistical inferences of population health and health services utilization. Understanding the effectiveness of hospital systems at a national and regional level is critical to insure consistency and timeliness in the receipt of evidence-based care. With the expansion of patient registries, the inclusion of clinical outcomes in these registries, and advanced statistical methods are available to transform non-random samples into representative population estimates.

References:

  1. Centers for Disease Control and Prevention. Underlying Cause of Death, 1999–2018. CDC WONDER Online Database. Atlanta, GA: Centers for Disease Control and Prevention; 2018. Accessed March 5, 2020.
  2. George MG, Fischer L, Koroshetz W, et al. CDC Grand Rounds: Public Health Strategies to Prevent and Treat Strokes. MMWR Morb Mortal Wkly Rep 2017;66:479–481. DOI: http://dx.doi.org/10.15585/mmwr.mm6618a5external icon.
  3. Caprio FZ, Sorond FA. Cerebrovascular Disease: Primary and Secondary Stroke Prevention. Med Clin North Am. 2019;103(2):295-308. doi:10.1016/j.mcna.2018.10.001
  4. Skolarus LE, Sharrief A, Gardener H, Jenkins C, Boden-Albala B. Considerations in Addressing Social Determinants of Health to Reduce Racial/Ethnic Disparities in Stroke Outcomes in the United States. Stroke. 2020;51(11):3433-3439. doi:10.1161/STROKEAHA.120.030426
  5. Marshall IJ, Wang Y, Crichton S, McKevitt C, Rudd AG, Wolfe CD. The effects of socioeconomic status on stroke risk and outcomes. Lancet Neurol. 2015;14(12):1206-1218. doi:10.1016/S1474-4422(15)00200-8.
  6. Ormseth CH, Sheth KN, Saver JL, Fonarow GC, Schwamm LH. The American Heart Association’s Get With the Guidelines (GWTG)-Stroke development and impact on stroke care. Stroke Vasc Neurol. 2017;2(2):94-105. Published 2017 May 29. doi:10.1136/svn-2017-000092
  7. Committee on a National Surveillance System for Cardiovascular and Select Chronic Diseases; Institute of Medicine, IOM (Institute of Medicine). A Nationwide Framework for Surveillance of Cardiovascular and Chronic Lung Diseases. Washington: National Academies Press; 2011. 201 p. Available from: http://www.nap.edu/catalog/13145
  8. Sidney S, Rosamond WD, Howard VJ, Luepker RV. The “Heart Disease and Stroke Statistics–2013 Update” and the Need for a National Cardiovascular Surveillance System. Circulation. 2013;127(1):21–3 Available from: http://www.ncbi.nlm.nih.gov/pubmed/23239838.
  9. Centers for Disease Control and Prevention. Division for Heart Disease and Stroke Prevention. About the State, Local, and Tribal Programs. Atlanta, GA: Centers for Disease Control and Prevention; 2020. Accessed March 5, 2020. Available from: https://www.cdc.gov/dhdsp/programs/spha/overview.htm
  10. Ziaeian B, Xu H, Matsouaka RA, et al. National surveillance of stroke quality of care and outcomes by applying post-stratification survey weights on the Get With The Guidelines-Stroke patient registry. BMC Med Res Methodol. 2021;21(1):23. Published 2021 Feb 4. doi:10.1186/s12874-021-01214-z
  11. Shahraki AD, Ghabaee M, Shahmoradi L, Malak JS, Jazani MR, Safdari R. Smart Acute Stroke Quality Registry Design-Data Elements Identification. J Registry Manag. 2018;45(1):43-47.

“The views, opinions and positions expressed within this blog are those of the author(s) alone and do not represent those of the American Heart Association. The accuracy, completeness and validity of any statements made within this article are not guaranteed. We accept no liability for any errors, omissions or representations. The copyright of this content belongs to the author and any liability with regards to infringement of intellectual property rights remains with them. The Early Career Voice blog is not intended to provide medical advice or treatment. Only your healthcare provider can provide that. The American Heart Association recommends that you consult your healthcare provider regarding your personal health matters. If you think you are having a heart attack, stroke or another emergency, please call 911 immediately.”

 

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Interview with Dr. Shlee S. Song, Director, Comprehensive Stroke Center at Cedars-Sinai

Almost one year since COVID19 was deemed a pandemic, we are nowhere close to get it under control. Although it has affected the healthcare system in innumerable ways, stroke management has been particularly impacted. Not only by the disease itself, but also by the multidisciplinary and strictly protocols for its diagnosis and treatment that have been difficult to maintain for the past year. To understand the impact of COVID19 on stroke management, Dr. Shlee S. Song, the Director of the Comprehensive Stroke Center at Cedars-Sinai shared with me her experiences, and learnings through these unprecedented times.

Dr. Shlee S. Song, Director of is a board-certified vascular neurologist who completed her clinical and research fellowship at the National Institutes of Health. She has worked on steering committees and served as PI on multiple national and international multicenter stroke clinical trials.  She serves as Medical Director of Stroke Programs at Cedars Sinai, Torrance Memorial, and Marina del Rey hospital, affiliate sites of Cedars-Sinai, and has developed a telemedicine network that delivers acute stroke care, oversees stroke quality improvement, and clinical trials enrollment across network hospitals. As the previous program director for the vascular neurology fellowship program at Cedars-Sinai, she has trained many stroke neurologists that practice across the country.

MDQC: Dr. Song, what is the association between COVID19 and Stroke?

Dr. Song: So far, we know that COVID has been associated with an inflammatory state and hypercoagulable state. Patients with more severe COVID symptoms also develop cloths in both lungs and other end organs. When we had our initial surge in the spring months in 2020, we had avoided what our NY colleagues have seen, like large vessel occlusion (LVO) in young patients. However, we did see a surge since the end of November. We have had a case series of patients where they were young, without many comorbidities, but had large cloths in large vessels like the ICA and carotid.

MDQC: So, is there an association between COVID severity and stroke?

SS: Right, what I have seen so far is that patients may have one risk factor or a couple, whether it is on birth control, having hypertension, or diabetes, even if they are managing their risk factors well, a COVID infection tips the scale toward clotting. Maybe a 2 or 3 hit hypothesis, where if you have the individual risk factors you are not in an inflammatory state, you can manage them, but when the infection occurs, the other diseases set off this cascade of injury that we see.

MDQC: Has the standard of care for management for patients with stroke has changed during the pandemic?

SS: We have seen that during the pandemic, that we have to be flexible. With the demand so high for stabilization, the surge in patients to the ICU, and hospital systems being stressed, our usual stroke pathways are not available. The patients are spread out all over the hospital because the beds are hard to come by. We have to be able to train a lot of our other service line team members to be able to deliver emergency care and monitoring.

For example, sometimes, the patients cannot go to the Neuro ICU, our usual pathway. Sometimes they are going to the PACU, where the personnel might not have received that training to get the NIH stroke scale done. However, we are focusing on the things we can monitor in more severe COVID. ICU patients that require high ventilation settings have to be paralyzed, so it doesn’t make sense to do no an usual neuromonitoring ( antigravitational strength, speech, etc.), but we can do other things like checking the pupils. We have had to shift our thinking and pivot to tailor to our situation.

Right now, we are in the “stabilization mode.” We are no trying to plan a 3-6 12 follow-up because, before the pandemic, we were able to stabilize our patients quickly. However, right now, it takes longer to stabilize these patients because of the injury to their lungs. We are just trying to get patients through to the first one or two weeks and then talk about lipid-lowering and secondary prevention that can be addressed later on. Right now, we want them to survive this cascade and storm that is going on.

MDQC: Would you consider changing the mindset of strict diagnostic and treatment protocols for stroke has been the most significant challenge during the pandemic?

SS: I think there is an acknowledgment from our specialist, that are in the frontline, that we have to be flexible because we are all operating in the dark, but we are realizing collectively that we are dealing with such limited data, this is so new in terms of what we are experiencing.

Acknowledging that there is limited data allows us to focus right now on acute stabilization and realize that somethings can be done down the road. We are working on that standardized protocol to promote this mindset to streamline the process, so during night calls, there would be some guidance focused on stabilizing the patients when there is a limited team.

MDQC: Since stroke is an acute event, what has the hospital done to procure the healthcare personnel’s safety when a patient comes to the ER with an acute stroke regarding their COVID19 status?

SS: We are minimizing the amount of exposure to our team members. Since we are a small team, we want to preserve everyone’s safety. We have incorporated our telestroke robot in our emergency department (ED). Our stroke team nurses’ expertise is well-versed in maneuvering and is quick at getting their images done and answering the inclusion/exclusion criteria for thrombolytic criteria. We can see the ER with the robot’s camera. Although we agree that is this is not equivalent to see the patient at the bedside, we are aware that we oversee a system where our stroke neurologist covers multiple hospitals, not only Cedars-Sinai.

Everyone has the personal protective equipment (PPE) ready in their backpacks, our gown, N95 masks. In the setting of a stroke code, anything can happen, sometimes the patients’ airway gets compromised or has a seizure; while this happens, we can quickly gear up since we have it with us. Our pharmacies will now have 24-hour coverage as an additional help to stabilize these patients.

The rapid COVID19 test is available. We try to do it as early during the code if we suspect an LVO, so that information can be available to the IR colleagues who can be prepared. They are also assuming that many of our patients are COVID positive. However, suppose we don’t have the test results. In that case, we don’t delay the emergency recanalization procedure, if the patient is eligible, so we assume they are positive or suspected for Covid, and we gear up properly.

MDQC: What is the impact telestroke has had in managing stroke during the pandemic? And how do you think It will evolve in the years to come?

SS: Telemedicine and telestroke are here to stay. It has been around for decades. We started our program of telestroke in 2016 for covering Torrance Memorial Hospital, and the demand keeps growing. Every minute counts in the setting of a stroke code. It doesn’t make sense for someone to start driving to a hospital when we have a camera that can quickly help guide our ER or ICU colleagues.

Dr. Song, pictured on the monitor, practices treating a stroke patient remotely with other members of the care team.

The technology has been around for a while. It continues to improve, like being able to see the imaging, PAC access, able to quickly document assessments, and write the recommendations that can be seen by the team members that are accepting patients in the ICU. The technology is being improved regularly, the software, and hardware, such as upgrading the camera or reducing background noise.

One thing that I have seen during the pandemic in telestroke where I would like to see some improvement in our non-speaking English patients. Especially with the pandemic and the no-visitor policy of many hospitals, out of a concern for community spread. It’s been challenging to get accurate clinical history from our patients. We rely on witnesses from the family and relatives to determine their medication, clinical history, and bleeding risk. All of that information is difficult to get, especially if we don’t get translators in the room. If Telemedicine could get paired with translator services, so they could be available during the stroke codes, I think that would help move things along from us.

MDQC: This is especially problematic given that the Latinx population has been affected disproportionally.

SS: Yes, we saw that in our data as well. We have a paper submitted right now (REFERENCE), looking at the nine-stroke comprehensive centers in Los Angeles. We saw a disproportional amount of Latinx community affected with LVO going to our colleague hospitals, and they have noticed a sharp increase in their thrombectomy volume during the pandemic.

MDQC: Why is the Latinx community disproportionally affected?

SS: We are trying to figure out what the patient profile looks like for that cohort. We don’t know exactly; however, some theories, such as having type 2 diabetes, maybe factor in the clotting cascade in patients with COVID. Additionally, the situation with multigenerational housing and the high prevalence of essential workers within this community don’t allow them to shelter at home because they still need to go to work. These factors have been considered to contribute to stroke, but there is no known causal relationship to date.

MDQC: Nonetheless, the social determinants play a massive role in the LatinX community.

SS: Yes, and we have been seen this in feedback from our patients. For many patients getting their health maintenance evaluation is hard since they have not had their medication for HTA, DM, etc. Chronic diseases are not being controlled. Some of them haven’t seen their doctors since most clinical visits have moved to Telemedicine, which is contingent on having a computer and Wi-Fi.

In a community with many living in multigenerational households, the computers and internet might be limited resources. Sometimes they only have one computer that must be shared, for example, with kids, for distance learning, and they don’t have other devices to schedule their appointments. COVID has highlighted the gaps between the patients with more resources and those lacking them.

MDQC: We assume that everyone has a computer and good internet access, and unfortunately, that is not the reality. A pillar of medicine is the hands-on training for medical students, residents, fellows. What changes have occurred to guarantee appropriate learning during the pandemic?

SS: We have taken this opportunity to push our trainees’ telemedicine skills in the neurology residency program. Before the pandemic, we had separated telestroke training only for the fellow because we wanted the residence to have that bedside experience first before going to the telemedicine platform. We quickly realize that this skill set needed to be incorporated into the curriculum.

We wrote a paper about that and published it in Neurology, with Dr. Alicia Zha from the University of Texas and colleagues from the University of Utah.1 We have incorporated Telemedicine for the residency program. Using the telemedicine robot, our residents are directing the camera and maneuvering the robot. We also have the capability called multi presence where the attending and fellow can see what the resident is doing, so we can all see what the host resident is doing, and we can easily take over if we need to. Having this tool has been helpful and flexible. It allows the trainee to develop these skillsets for this technology that is here to stay. Other things that have improved since the pandemic are reimbursement since now Medicare allows the Telemedicine encounters to be equivalent to the side delivery of care. It has been helpful to continue to implement Telemedicine in our practice.

MDQC: So, is this being implemented just for acute stroke?

SS: The residents are using Telemedicine for the clinical encounters since we realize the virtual space is safer for both our patients and the provider. We moved much clinical evaluation to the iPad or evaluated with the desktop computer. It is also good to identify the gaps with Telemedicine, such as the subtle things with weakness and coordination we might not be able to pick up, which is very hard over the camera. Our residents are finding with their experience that things like visual fields cannot be done well with the equipment that we have right now. It’s important to know where our current gaps are so that this generation helps to problem-solve these issues to create apps or more tools to develop better telecare.

MDQC: Another colossal problem regarding stroke is the increase of the delay from symptom onset to arrival to the hospital. What has been your experience at Cedars-Sinai regarding this phenomenon?

SS: On the study with the nine-stroke comprehensive centers, we have seen that. Collectively we all had a decrease in our thrombolytic treatment patients, and IV tPA numbers have gone down, mostly the mild symptomatic patients. I think many patients and their family members are fearful. They have heard the system is currently overloaded and might think that their symptoms are very mild and not worth going to the hospital or are afraid of getting exposed to the virus. We have worked together with the AHA, Stroke association, and Los Angeles County to diffuse the message to tell people that if you have an emergency, a condition like a stroke, call 911.

Understanding patients and famile’ fear, we are trying to get patients home as soon as possible. In that streamlined workup, we intend to get patients out of this hospital as soon as possible. Suppose some things can be done outside of the hospital in the outpatient setting, then that is what we would like to do to reserve the hospital setting for the severe cases.

Some of our patients with mild symptoms when they get evaluated may have resolved their symptoms. We do urgent things for these high-risk TIA patients, such as the vessel evaluation of the carotids. However, maybe the Eco can be done in an outpatient setting, so we send the patient home with the Zio pad, telemonitoring, and have a home visit in 48-72 hours. We are more flexible in the way we deliver health. Not everything has to be delivered at the hospital, understanding patients’ fear and wanting to get home as soon as possible.

MDQC: Burning out syndrome has been a pressing issue in healthcare personnel even before the pandemic, how are you doing Dr. Song? and how are you and your peers coping with the stress this pandemic has caused?

SS: In terms of how we are manning with this crisis scenario is leaning on each other more. We have weekly check-ins, we called it our “stroke team huddles”, we have always had it because we have a very stressful job. We deal with patients and family members in a moment of crisis, are life and death situation during many of those codes, and now we are seen a lot more death.

Now there are lot more patients sicker, and we are seen more distress because they can’t have at the bedside their loved ones. How we have been dealing with ourselves? is giving each other the space to share that level of stress, so it is not something they are holding on to, but a shared collective, living process.

We have noticed that everyone has their highs and lows at different times, so we take advantage of that. The person who is doing well that day, really reaching out to say, “hey, unload a little bit, let me hear what is going on,” and for the person who is having a tougher day. Another really helpful thing has been laughter and sharing when we see something very funny; it has been really helpful to get us through. Sometimes we have to say what we are going through is so ridiculous, and just calling it out has relieved the tension when you share it, and I see it in the body language. It seems to lift from a burden and seems more relaxed.

We have counselors on checking areas, we have resources from Cedars, and if I see that something is helpful, I share it. I have been very open on how I’m getting through this crisis, either with therapy, with zoom check in with girlfriends, who are also experiencing high stress levels at home and work. All those coping mechanisms help and just check in with the clinic patients.

I have been writing letters and have encouraged residents and nurses to write letters to the patients and check in on them, especially those at higher risk because they live alone. You reach out to them, and they also give back to you and often ask how we are doing to the doctors, nurses. We are taking care of each other through this; the key is that we have each other, and we have a team approach.

MDQC: As the last question Dr. Song, what lesson have you learned from ongoing this pandemic?

SS: Lots of lessons. It has helped to solidify for me that we are doing meaningful work. In our team members, we are focusing more on what’s important and letting go of what is not. Our energy stores are getting depleted faster. We are learning to let go easier, focused on important things, and getting rid of the noise that doesn’t allow us to do so. Now we are getting more efficient in our work.

Also, we have all collectively seen that we need to do better, especially for our community areas where resources are lacking. There is a lot of goodwill and recognition in the stroke community. When it comes to leadership, we have to improve healthcare disparities. We are so grateful to the essential workers working delivering packages, in groceries, and getting us through the pandemic. They are the mail carriers, cashiers, all the people that have helped society keep moving during this pandemic. We need to give back to them.

 

Dr. Shlee Song shared that the pandemic has highlighted the consequences of an unequal healthcare system. We must strive to address this pressing issue as vehemently as finding new interventions or drugs. That flexibility and adaptation have been paramount to get through the pandemic. However, most important of all is teamwork, to rely on each other to provide the best care to patients and take care of each other.

 

Reference

  1. Zha AM, Chung LS, Song SS, Majersik JJ, Jagolino-Cole AL. Training in Neurology: Adoption of resident teleneurology training in the wake of COVID-19: Telemedicine crash course. Neurology. 2020;95(9):404-407.

“The views, opinions and positions expressed within this blog are those of the author(s) alone and do not represent those of the American Heart Association. The accuracy, completeness and validity of any statements made within this article are not guaranteed. We accept no liability for any errors, omissions or representations. The copyright of this content belongs to the author and any liability with regards to infringement of intellectual property rights remains with them. The Early Career Voice blog is not intended to provide medical advice or treatment. Only your healthcare provider can provide that. The American Heart Association recommends that you consult your healthcare provider regarding your personal health matters. If you think you are having a heart attack, stroke or another emergency, please call 911 immediately.”

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The Clock is Ticking: Door-to-Needle Time in Acute Ischemic Stroke

Lay of the Land

In 2008, after years of being the third-leading cause of death in the United States, stroke dropped to fourth. In part, this reflected the results of a commitment made by the American Heart Association/American Stroke Association (AHA/ASA) more than a decade prior to reduce stroke, coronary heart disease, and cardiovascular risk by 25% by the year 2010 (a goal met a year early in 2009). The reason for the success, although multifactorial, can largely be attributed to improved prevention and improved care within the first hours of acute strokes.1 As early as 2000, the benefits of time-dependent administration of intravenous tissue plasminogen activator (tPA) in patients with acute ischemic stroke were well supported (Figure 1).2

Figure 1. Graph of model estimating OR for favorable outcome at 3 months in recombinant tissue-type plasminogen activator (rt-PA) treated patients compared to placebo treated patients by time from stroke onset to treatment (onset-to-treatment time [OTT]) with 95% confidence intervals, adjusting for the baseline NIH Stroke Scale. OR > 1 indicates greater odds that rt-PA treated patients will have a favorable outcome at 3 months compared to the placebo treated patients. Range of OTT was 58 to 180 minutes with mean (μ) of 119.7 minutes.2

Guidelines began recommending a door-to-needle time for tPA administration of 60 minutes or less, however, studies found that less than 30% of US patients were treated within this time window. The Target: Stroke initiative was launched in 2010 to assist hospitals in providing timely tPA. As a result, the proportion of tPA administered within 60 minutes increased from 26.5% during the preintervention period to 41.3% after implementation. Despite national initiatives, shorter door-to-needle times have not been as quickly adopted as door-to-balloon times for percutaneous coronary intervention in acute coronary syndromes (Figure 2).4 Part of the problem is a lack of robust mortality outcomes data to support trends observed in the (only) two randomized trials conducted to assess long term outcomes with tPA in acute ischemic stroke; neither of which was powered to probe for mortality effects.

Figure 2. Trend in percentage of patients with door-to-balloon (D2B) time <90 minutes over 6 years.4

This brings us to the study published earlier this week in JAMA Man S et al. (corresponding author Fonarow GC) titled “Association Between Thrombolytic Door-to-Needle Time and 1-Year Mortality and Readmission in Patients With Acute Ischemic Stroke.” This nationwide study of US patients treated with intravenous tPA for acute ischemic stroke demonstrated that shorter door-to-needle times were significantly associated with better long-term outcomes, including lower 1-year all-cause mortality, 1-year all-cause readmission, and the composite of all-cause mortality or readmission at 1 year.5

Study Design

This US cohort included Medicare beneficiaries aged 65 years or older who were treated with intravenous tPA for acute ischemic stroke at Get With The Guidelines (GWTG)–Stroke participating hospitals between January 1, 2006, and December 31, 2016, with 1-year follow-up through December 31, 2017. Patient clinical data were obtained from the GWTG-Stroke database. Study entry criteria required patients to (1) have been aged 65 years or older; (2) have a discharge diagnosis of acute ischemic stroke; (3) have been treated with intravenous tPA within 4.5 hours of the time they were last known to be well; (4) have had a documented door-to-needle time; (5) not have been treated with a concomitant therapy with intra-arterial reperfusion techniques; (6) have had the admission be the first for stroke during the study period; and (7) not have been transferred to another acute care hospital, left against medical advice, or without a documented site of discharge disposition.5 Overall, 61426 participants met the inclusion criteria for the study.

The prespecified primary outcomes included 1-year all-cause mortality, 1-year all-cause readmission, and the composite of all-cause mortality or readmission at 1 year. One-year cardiovascular readmission was a prespecified secondary outcome and was defined as a readmission with a primary discharge diagnosis of hypertension, coronary artery disease, myocardial infarction, heart failure, abdominal or aortic aneurysm, valvular disease, and cardiac arrhythmia. Recurrent stroke readmission, a post hoc secondary outcome, was defined as a readmission for transient ischemic attack, ischemic and hemorrhagic stroke, carotid endarterectomy or stenting, but not for direct complications of index stroke.5

Door-to-needle time was first analyzed using the prespecified times of within 45 minutes and within 60 minutes versus longer than those targets, in line with prior studies on this topic. The authors also ingeniously also evaluated time as a continuous variable, as a categorical variable in 15-minute increments using within 30 minutes as the reference group, and in 45-minute and 60-minute increments. Cox proportional hazards models were used to examine the associations of door-to-needle timeliness and each 1-year outcome with robust variance estimation to ac- count for the clustering of patients within hospitals.5 On hours were defined as 7:00 AM to 6:00 PM on any weekday. Off hours were defined as any other time, including evenings, nights, weekends, and national holidays. The authors did this because prior studies using this prespecified time cutoff have shown that presenting during off hours was associated with inferior quality of care, inferior intravenous thrombolytic treatment, and in-hospital mortality.5

Results

Among the 61426 Medicare beneficiaries treated with intravenous tPA within 4.5 hours of the time they were last known to be well at the 1651 GWTG-Stroke participating hospitals, the median age was 80 years, 43.5% were male, 82.0% were non-Hispanic white, 8.7% were non-Hispanic black, 4.0% were Hispanic, and 5.3% were of other race/ethnicity. More patients that arrived during off hours were treated within longer door-to-needle times (40.7% for ≤30 minutes, 45.6% for 31-45 minutes, 50.6% for 46-60 minutes, 53.5% for 61-75 minutes, and 56.3% for >75 minutes; P < .001). Despite having longer onset-to-arrival times, some patients had shorter onset-to-needle and door-to-needle times.5

Most patients were treated at teaching hospitals (77.7%) and primary stroke centers (73.2%); 3% were treated at rural hospitals. More patients who were treated at teaching hospitals, but not at primary stroke centers, were treated within shorter door-to-needle times. The median door-to-needle time was 65 minutes, with 5.6% of patients treated with tPA within 30 minutes of hospital arrival, 20.8% within 45 minutes, and 44.1% within 60 minutes.5

Patients who received tPA after 45 minutes of hospital arrival had worse long-term outcomes than those treated within 45 minutes of hospital arrival, including significantly higher all-cause mortality (35.0% vs 30.8%, respectively; adjusted hazard ratio [HR], 1.13 [95% CI, 1.09- 1.18]), higher all-cause readmission (40.8% vs 38.4%; ad- justed HR, 1.08 [95% CI, 1.05-1.12]), higher all-cause mortality or readmission (56.0% vs 52.1%; adjusted HR, 1.09 [95% CI, 1.06-1.12]), and higher cardiovascular readmission (secondary outcome) (19.8% vs 18.4%; adjusted HR, 1.05 [95% CI, 1.00- 1.10]), but not significantly higher recurrent stroke readmission (a post hoc secondary outcome) (9.3% vs 8.8%; adjusted HR, 1.05 [95% CI, 0.98-1.12]).

Patients who received tPA after 60 minutes of hospital arrival vs within 60 minutes of hospital arrival had significantly higher adjusted all-cause mortality (35.8% vs 32.1%, respectively; adjusted HR, 1.11 [95% CI, 1.07-1.14]), higher all-cause readmission (41.3% vs 39.1%; adjusted HR, 1.07 [95% CI, 1.04-1.10]), higher all-cause mortality or readmission (56.8% vs 53.1%; adjusted HR, 1.08 [95% CI, 1.05-1.10]), and higher cardiovascular readmission (secondary outcome) (20.2% vs 18.6%; adjusted HR, 1.06 [95% CI, 1.01-1.10]), but not significantly higher recurrent stroke readmission (a post hoc secondary outcome) (9.3% vs 8.9%; adjusted HR, 1.03 [95% CI, 0.97-1.09]).

The absolute differences in outcomes increased with longer door-to-needle times. The cumulative incidence curves showed that approximately 42% of the deaths or readmissions occurred within 30 days.

Every 15-minute increase in door-to-needle times was significantly associated with higher all-cause mortality (adjusted HR, 1.04 [95% CI, 1.02-1.05] for door-to-needle time within 90 minutes of arrival. However, this association did not persist beyond 90 minutes of hospital arrival. Every 15-minute increase in door-to-needle times was significantly associated with higher all-cause readmission (adjusted HR, 1.02 [95% CI, 1.01- 1.03]) and higher all-cause mortality or readmission (adjusted HR, 1.02 [95% CI, 1.01-1.03]). Every 15-minute increase in door-to-needle times after 60 minutes of hospital arrival was significantly associated with higher cardiovascular readmission (secondary outcome) (adjusted HR, 1.02 [95% CI, 1.01- 1.04]) and higher stroke readmission (a post hoc secondary out- come) (adjusted HR, 1.02 [95% CI, 1.00-1.04]); however, these associations were not statistically significant for the door-to-needle times within 60 minutes of hospital arrival.

My Take

I would first like to commend the authors on this undertaking. The fact that early door-to-balloon time is still questionable seems contrary to our understanding of ischemic events and time to cell necrosis. This high-quality study further supports the notion that “time is muscle,” as seen in other ischemic events such as acute myocardial infarction and acute limb ischemia. However, the limitations of the study affects its generalizability and application to real world scenarios. The patients in this study are all over the age of 65, largely non-Hispanic whites, all with recorded times of last seen normal and mostly treated in academic centers with stroke units. Nonetheless, the authors have certainly progressed the field of stroke treatment, if even incrementally, in the right direction.

References:

  1. Jauch EC, Saver  JL, Adams  HP  Jr,  et al; American Heart Association Stroke Council; Council on Cardiovascular Nursing; Council on Peripheral Vascular Disease; Council on Clinical Cardiology.  Guidelines for the early management of patients with acute ischemic stroke: a guideline for healthcare professionals from the American Heart Association/American Stroke Association.  Stroke. 2013;44(3):870-947.
  2. Marler JR, Tilley  BC, Lu  M,  et al.  Early stroke treatment associated with better outcome: the NINDS rt-PA stroke study.  Neurology. 2000;55(11):1649-1655.
  3. Fonarow GC, Zhao X, Smith EE, et al. Door-to-needle times for tissue plasminogen activator administration and clinical outcomes in acute ischemic stroke before and after a quality improvement initiative. JAMA. 2014;311(16):1632- 1640. doi:10.1001/jama.2014.3203
  4. Krumholz HM, et al. Improvements in door-to-balloon time in the United States, 2005-2010. Circulation 2011;124:1038-45.
  5. Man S, Xian Y, Holmes DN, et al. Association Between Thrombolytic Door-to-Needle Time and 1-Year Mortality and Readmission in Patients With Acute Ischemic Stroke. JAMA. 2020;323(21):1-15. doi:10.1001/jama.2020.5697

“The views, opinions and positions expressed within this blog are those of the author(s) alone and do not represent those of the American Heart Association. The accuracy, completeness and validity of any statements made within this article are not guaranteed. We accept no liability for any errors, omissions or representations. The copyright of this content belongs to the author and any liability with regards to infringement of intellectual property rights remains with them. The Early Career Voice blog is not intended to provide medical advice or treatment. Only your healthcare provider can provide that. The American Heart Association recommends that you consult your healthcare provider regarding your personal health matters. If you think you are having a heart attack, stroke or another emergency, please call 911 immediately.”

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Hypertension and Stroke: Current State of Evidence

Stroke is the fifth leading cause of death in the country and the top reason for adult disability (1). Each year about 795,000 people experience a stroke in the United States with nearly 25% of these strokes being recurrent events in people with a prior history of a stroke (2).  Hypertension is the considered to be the most important modifiable risk factor for stroke. Therefore, treatment of hypertension is one of the most effective strategies for primary and secondary prevention of stroke (3). In a large meta-analysis from 2002, which included 1 million patients, a direct association was seen between blood pressure measurements and risk of vascular mortality including stroke and ischemic heart disease (4). There is a continuous relationship with risk throughout the normal range of blood pressure, down at least as far as 115/75 mm Hg according to this meta-analysis of 61 prospective clinical studies. However, there has been a lack of consensus among experts about the most appropriate blood pressure targets for cardiovascular disease and stroke prevention.

In the Secondary Prevention of Small Subcortical Strokes (SPS-3) trial, investigators compared systolic blood pressure targets of 130-149 mm Hg and less than 130 mm Hg (5). About 3000 patients with a recent history of an MRI confirmed lacunar stroke were randomized to one of the two treatment groups and followed for a mean of 3.7 years. Primary outcome of recurrent stroke was seen at a lower rate in the lower target group with an annualized stroke rate of 2.25% as compared to 2.77% in the higher target group. Despite a signal toward benefit of a lower BP target, these results did not reach statistical significance. The rates of intracerebral hemorrhage were noted to be significantly lower with a lower BP target.

In a clinical trial enrolling patients with diabetes and a high cardiovascular risk, blood pressure target of less than 120 mm Hg was not superior to a target of less than 140 mm Hg for reducing risk of cardiovascular events with the exception of stroke (6). In this study, the intensive blood pressure target lead to a significant risk reduction for stroke but not for myocardial infarction or all-cause mortality.

To further ascertain an ideal blood pressure target, investigators in the SPRINT trial enrolled over 9000 persons with SBP of more than 129 mm Hg without a history of diabetes (7). The participants were randomized to intensive treatment (target <120 mm Hg) or standard treatment groups (target <140 mm Hg). Primary outcome was a composite of myocardial infarction, heart failure, stroke or vascular death. After a median follow up of 3.3 years, the trial was stopped early due to a significantly lower rate of primary composite outcome in the intensive blood pressure group as compared to the standard treatment. Interestingly, even though there was a signal of benefit for stroke risk reduction, this was not statistically significant. The investigators of the study make note of this finding and hypothesize that this could be due to the fact that this trial excluded patients with a prior history of stroke and TIA. This has also raised questions about the limited applicability of these results to patients with a history of stroke.

The investigators also looked at cognitive outcomes for the two groups of patients in this trial (8). The composite outcome of mild cognitive impairment and dementia was seen in a significantly lower number of patients in the intensive BP treatment group as compared to the standard treatment group. Due to the early termination of SPRINT, the study was underpowered to show a significant difference in the risk of dementia.

The current guidelines (9) from the American Heart Association/ American College of Cardiology recommend initiating treatment at SBP>130 mm Hg for patients with a high cardiovascular risk. Using the current definition of hypertension, it is estimated that 46% of adults in the US have hypertension and about 36% should be prescribed antihypertensive medications (10). Applying these new guidelines, only about half of all US adults on medications for hypertension are currently below the target BP numbers.

With hypertension playing such an important role in the development of the two most common neurological illnesses (Stroke and cognitive disorders), authors of a recent paper in JAMA Neurology (11) urge neurologists to play a greater role in treatment of hypertension as a preventive strategy for their patients. Traditionally stroke neurologists and neurointensivists have been involved in treatment of the cardiovascular risk factors including hypertension but most of that is done after the patient has had a major event such as an ischemic stroke or intracerebral hemorrhage. The authors argue that neurologists should participate in treatment of hypertension for their patients as a primary preventive strategy as it would lead to an overall improved brain health of our ageing population.

To learn more about the latest advancements in the field of hypertension research, I encourage the readers to attend Hypertension 2019 Scientific Sessions being held in New Orleans September 5-8, 2019.

 

References:

  1. Vital Signs: Recent trends in stroke death rates – United States, 2000-2015. MMWR 2017;66.
  2. Benjamin EJ, Blaha MJ, Chiuve SE, et al. on behalf of the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics—2017 update: a report from the American Heart Association. Circulation. 2017;135:e229-e445.
  3. Katsanos AH, Filippatou A, Manios E, et al. Blood pressure reduction and secondary stroke prevention: a systematic review and metaregression analysis of randomized clinical trials. Hypertension. 2017;69(1):171-179.
  4. Lewington S, Clarke R, Qizilbash N, Peto R, Collins R; Prospective Studies Collaboration. Age-specific relevance of usual blood pressure to vascular mortality: a meta-analysis of individual data for one million adults in 61 prospective studies Lancet. 2002;360(9349):1903-1913.
  5. Benavente OR, Coffey CS, Conwit R, et al; SPS3 Study Group. Blood-pressure targets in patients with recent lacunar stroke: the SPS3 randomised trial. Lancet. 2013;382(9891):507-515.
  6. Cushman WC, Evans GW, Byington RP, et al. Effects of intensive blood-pressure control in type 2 diabetes mellitus. N Engl J Med 2010;362:1575-1585
  7. Wright JT  Jr, Williamson  JD, Whelton  PK,  et al; SPRINT Research Group.  A randomized trial of intensive versus standard blood-pressure control  [published correction appears in N Engl J Med. 2017;377(25):2506].  N Engl J Med. 2015;373(22):2103-2116.
  8. Williamson JD, Pajewski NM, Auchus AP, et al; SPRINT MIND Investigators for the SPRINT Research Group. Effect of intensive vs standard blood pressure control on probable dementia: a randomized clinical trial.JAMA. 2019;321(6):553- 561
  9. Whelton PK, Carey RM, Aronow WS, et al.
  10. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol 2018;71:e127-e248.
  11. Muntner P, Carey RM, Gidding S, et al. Potential US population impact of the 2017 ACC/AHA high blood pressure guideline. Circulation. 2018;137(2): 109-118.
  12. Betjemann J, Hemphill JC, Sarkar U. Time for Neurologists to Drop the Reflex Hammer on Hypertension. JAMA Neurol.Published online August 19, 2019. doi:10.1001/jamaneurol.2019.2588
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Race and In-Hospital Stroke Care

Intracerebral haemorrhage [ICH] accounts for ~15% of all strokes with an estimated 40% mortality at one month, with higher rates of occurrence among Black patients1. Differences have been observed in the burden of ICH by race, with a higher incidence among Black, Asian and Hispanic compared to White patients2,3.

The number of hospital admissions for ICH in the United States escalated from 150,000 in early 1990s to 175,000 in early 2000s2. Studies have reported racial differences in the quality and process of care among patients hospitalized with ICH4. A recent paper by Cruz-Flores found racial differences in In-hospital utilization of care including lifesaving and life-sustaining therapies, palliative care, do not resuscitate status and in-hospital mortality5.

Two recent studies showed that compared to whites, minority patients were more often younger with higher rates of medical comorbidities, longer length of stay and lower rates of do not resuscitate orders and in-hospital mortality2,5. Rates of hospital admissions have been also shown to be higher among minority men compared to women, however this might be a mere reflection of females not having equal access to care5.

A report on stroke performance measures by Xian in 2014 revealed smoking cessation counselling was less frequently completed among minority patients2. Counseling on modifiable risk factors is a key measure to reduce risk of stroke, recurrent stroke and coronary heart disease. In addition, Xian et al reported that Black patients were less likely than White patients to have a door to CT time of ≤ 25 minutes2. Rapid neuroimaging is one of the key class I recommendations of the American Heart Association/American Stroke Association for ICH patients2,6. Subsequent management is essentially dependent on identification of stroke subtype by neuroimaging. Further research is needed to identify mechanisms and causes of disparities in outcomes after stroke, ICH in particular, among minority patients.

 

REFERENCES

  1. Kleindorfer D, Khoury J, Moomaw CJ, Alwell K, Woo D, Flaherty ML, Khatri P, Adeoye O, Ferioli S, Broderick JP, Kissela BM. Stroke incidence is decreasing in whites, but not in blacks: a population-based estimate of temporal trends in stroke incidence from the Greater Cincinnati/Northern Kentucky stroke study. Stroke; a journal of cerebral circulation. 2010 Jul;41(7):1326.
  2. Xian Y, Holloway RG, Smith EE, et al. Racial/ethnic differences in process of care and outcomes among patients hospitalized with intracerebral hemorrhage. Stroke 2014; 45: 3243–3250.
  3. Woo D, Rosand J, Kidwell C, et al. The ethnic/racial variations of intracerebral hemorrhage (ERICH) study protocol. Stroke 2013; 44: e120–e125.
  4. Cruz-Flores S, Rabinstein A, Biller J, et al. Racial-ethnic disparities in stroke care: the American experience: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke 2011; 42: 2091–2116.
  5. Cruz-Flores, Salvador, Gustavo J. Rodriguez, Mohammad Rauf A. Chaudhry, Ihtesham A. Qureshi, Mohtashim A. Qureshi, Paisith Piriyawat, Anantha R. Vellipuram, Rakesh Khatri, Darine Kassar, and Alberto Maud. “Racial/ethnic disparities in hospital utilization in intracerebral hemorrhage.” International Journal of Stroke (2019): 1747493019835335.
  6. Morgenstern LB, Hemphill JC 3rd, Anderson C, Becker K, Broderick JP, Connolly ES Jr, et al; American Heart Association Stroke Council and Council on Cardiovascular Nursing. Guidelines for the management of spontaneous intracerebral hemorrhage: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2010; 41:2108–2129.

 

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Aspirin: The Good, the Bad and the Ugly

Last week, I was talking to one of my patients about her ischemic stroke, which led her to be admitted to the hospital. I discussed that I would be prescribing a daily aspirin along with other medications to reduce her risk of recurrent stroke. She replied, “But doc! I just read on the news that aspirin is no longer recommended to prevent heart attack and stroke.” It took me a moment to realize that she was referring to the recently released guidelines for “primary prevention of cardiovascular disease.” I explained to her the rationale, benefits, risks and evidence supporting the use of aspirin for secondary stroke prophylaxis. She felt better after our detailed conversation and agreed to initiate the medication as recommended. Later that day, I read several potentially misleading headlines on major news media websites about this new guideline. The headline on CNN1 read, “Daily aspirin to prevent heart attacks no longer recommended for older adults,” while USA Today2 reported, “Don’t take an aspirin a day to prevent heart attacks and strokes.”

The guidelines issued by the ACC now recommend against routine use of aspirin for primary cardiovascular prophylaxis in adults older than 70 years. This new recommendation is based on the ASPREE trial, published in 20183. During this trial, healthy adults older than 70 years with no prior history of cardiovascular disease were randomized to receive 100 mg aspirin or placebo. The low dose aspirin lead to a significantly higher risk of major hemorrhage without a significant benefit in terms of cardiovascular event prevention. The guidelines recommend using low dose aspirin for primary prophylaxis of cardiovascular events only in adults aged 40-70 years who are at a higher risk of atherosclerotic cardiovascular disease. The guidelines no longer recommend using the 10 year estimated ASCVD risk threshold of 10%, but in fact propose a more tailored approach to primary cardiovascular prophylaxis.  Patients at a high risk of cardiovascular disease and whose risk factors are not optimized despite maximal medical therapy may be candidates for prophylactic aspirin at low doses. Physicians should have a careful discussion of the individual risks and benefit of aspirin before prescribing a daily aspirin regimen to their patients. Aspirin should not be prescribed for primary prophylaxis to patients with an increased risk of hemorrhage, such as a history of gastrointestinal bleeding or thrombocytopenia.

These guidelines are obviously for patients without a prior history of a cardiovascular events such as an MI or ischemic stroke. There is unambiguous data that supports the use of aspirin for secondary cardiovascular prophylaxis. My patient from last week belonged to this category and I started our aspirin discussion with her by explaining this clear distinction. She understood the rationale for aspirin in her case and how the new guidelines did not apply to her. The news headlines are sometimes sensationalized which can render them misleading for the reader. The two news articles did in fact report that the guidelines refer to use of aspirin in healthy older adults with no history of heart disease or stroke. In today’s world of fast paced digital information, there is a tendency to just read the headlines and move on to the next thing. This can be very problematic if patients on aspirin for secondary prophylaxis stop taking their medication after reading these news headlines.

As healthcare professionals, it is our responsibility to tackle this kind of misinformation which can lead to potentially bad outcomes for our patients. One of the ways to do that is to enhance our presence on social media platforms which are increasingly becoming the major source of news and information for the public. The AHA Early Career Blogging Program is one such avenue which can help young healthcare professionals strengthen their digital and social media footprint. This also helps facilitate collaborative projects and ideas among healthcare professionals and can lead to improved patient outcomes, which is the ultimate goal in all our endeavors.

 

References:

  1. https://www.cnn.com/2019/03/17/health/aspirin-heart-disease-guidelines/index.html
  2. https://www.usatoday.com/story/news/health/2019/03/18/aspirin-prevent-heart-attacks-strokes-doctors/3199831002/
  3. N Engl J Med 2018; 379:1509-1518 DOI: 10.1056/NEJMoa1805819

 

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Success Does Not Always Leave A ‘Footprint’

Stroke is one of the leading causes of mortality and morbidity in the United States (US). Approximately one‐third of all ischemic strokes are considered cryptogenic, i.e not attributed to large‐vessel atherosclerosis, small‐artery disease, or embolism despite extensive vascular, serological, and cardiac evaluation. Until recently, the relationship between patent foramen ovale (PFO) and cryptogenic stroke was highly debated. Prior to 2006, use of transcatheter based PFO closure procedures were only permitted under Food and Drug Administration (FDA) Humanitarian Device Exemption for recurrent cryptogenic stroke from a PFO after failed conventional medical therapy1. However, the number of eligible patients exceeded the regulatory mandated annual limit of 4,000 patients in 2006. Thus, the Humanitarian Device Exemption process was voluntarily withdrawn1.

In the past two decades, several randomized clinical trials using the Amplatzer PFO Occluder, the Starflex Septal Occluder (NMT Medical Inc, Boston, MA), and the Gore Cardioform Septal Occluder were conducted. Based on long term follow up results of the RESPECT [Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment] and REDUCE [GORE® Septal Occluder Device for PFO Closure in Stroke Patients] trials, US FDA approved the Amplatzer PFO Occluder in 2016 and the Gore Cardioform Septal Occluder in 20181,2.  FDA approval for these devices for PFO closure in the United States is to reduce the risk of recurrent ischemic stroke in patients, predominantly between the ages of 18 and 60 years, who have had a cryptogenic stroke due to a presumed paradoxical embolism, as determined by a neurologist and cardiologist following an evaluation to exclude known causes of ischemic stroke2.”

Despite proven efficacy, the use of device based PFO closure techniques have potential risks of several early and late complications, including infection, thrombosis, device dislodgement, atrial wall erosion, perforation, fracture, migration-embolization, allergic reaction to nickel used in PFO occluder device, and induction of arrhythmias3,4. Further, there is need of post procedure antiplatelet therapy after implantation of these devices. These concerns lead to need for a ‘deviceless’ transcatheter system to close PFO. Ruiz et al have performed first-in-man transcatheter suture closure of a PFO in an 18-year-old female with chronic migraine with aura in 2008 without leaving ‘footprint’5.  Results of this novel approach were exciting; however, safety and efficacy of ‘deviceless’ transcatheter techniques on large scale was not established until early results of the NobleStitch EL Italian Registry were reported few months ago6. In this prospective registry, investigators successfully used suture based PFO closure system in 186 (out of 192) patients across 12 sites in Italy with no device related complication on 206±130 days follow-up6. FDA approves the NobleStitch™ EL for Vascular and Cardiovascular suturing in the US (interestingly the technique is not specifically labeled for treating PFOs).

Due to projected increase in numbers of left sided transcatheter interventions (e.g. left atrial appendage closure, arrhythmia ablation and mitral valve interventions), the deviceless technique could be a very attractive option in selected patient population as presence of interatrial septal prosthesis make trans-septal puncture more challenging. Though this technology has huge potential, we should still wait for long term data on safety and efficacy of this no foot print PFO closure system before advocating and supporting its widespread use.

 

References:

  1. Writing Group Members , American Heart Association Statistics Committee; Stroke Statistics Subcommittee . Heart disease and stroke statistics—2016 update: a report from the American Heart Association. Circulation. 2016; 133:e38–e360
  2. .https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm527096.htm
  3. Luermans JG, Post MC, Yilmaz A. Late device thrombosis after atrial septal defect closure. Eur Heart J. 2010;31:142
  4. Merkler AE, Gialdini G, Yaghi S, Okin PM, Iadecola C, Navi BB, Kamel H. Safety Outcomes After Percutaneous Transcatheter Closure of Patent Foramen Ovale. Stroke. 2017;48:3073-7
  5. Ruiz CE, Kipshidze N, Chiam PT, et al. Feasibility of patent foramen ovale closure with no-device left behind: first-in-man percutaneous suture closure. Catheter Cardiovasc Interv. 2008 Jun 1;71(7):921-6.
  6. Gaspardone A, De Marco F, Sgueglia GA, et al. Novel percutaneous suture-mediated patent foramen ovale closure technique: early results of the NobleStitch EL Italian Registry. EuroIntervention. 2018 Jun 8;14(3):e272-e279.