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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 [email protected] and [email protected]

 

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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PFO Closure in PFO-related Stroke

Last week, Gore REDUCE study, a randomized open-label trial with a median duration of follow-up of 5.0 years [4.8 to 5.2] demonstrated that 1.8% of patients with PFO closure had recurrent ischemic strokes (hazard ratio, 0.31; 95% confidence interval, 0.13 to 0.76), compared with 5.4% patients who treated with an antiplatelet-only group (Figure).1 A patent foramen ovale (PFO) is far and away from the most common congenital heart defect with an estimated prevalence of 1 in 4 adults.  The FDA has previously approved the Amplatzer PFO Occluder device in 2016, however initial trials such as the RESPECT, PC, and CLOSER I trials did not show any benefit for PFO closure in the reduction of recurrent embolic stroke, compared to medical therapy. Interestingly, more recent trials conducted within the last 5 years, such as the DEFENSE‐PFO, REDUCE, CLOSE and RESPECT trials, demonstrated that PFO closure had reduced incidence of stroke compared to medical therapy. Given this influx of new evidence from recent trials, it has been suggested that PFO closure be considered in patients 60 years or younger with a PFO-related stroke. However, other potential etiologies such as atrial fibrillation (AF, requires at least 30 days of cardiac monitoring based on recent trials), autoimmune disorders, uncontrolled diabetes or hypertension must first be ruled out.

Last year, the 2020 practice advisory update summary by the American Academy of Neurology suggested that PFO closure probably reduces the risk of stroke recurrence with an HR of 0.41 with acceptable heterogeneity (I2 = 12%) and an absolute risk reduction of 3.4% at 5 years for patients with cryptogenic stroke and presence of a PFO based on meta-analyses using fixed-effect.2 This was unsurprising to me given the trends seen in the RESPECT and CLOSE trials. Interestingly, the report suggested an increased risk of developing AF with RR 3.12 in participants who received closure compared with those receiving medical treatment. This raised an interesting causality dilemma similar to the story of the chicken and the egg. Did these trials capture paroxysmal AF using 30 days of ambulatory monitoring and exclude those with paroxysmal AF prior to PFO closure? If that is the case, what was the primary mechanism for the development of AF after PFO closure? Atrial stunning? If a patient were to develop AF following PFO closure would that increase their risk of recurrent stroke?  And if so, is the risk of recurrent stroke higher or lower with PFO closure compared to those without PFO closure? Indeed, it would be interesting see which echo parameters are independent predictors of developing AF in PFO closure (after adjustment for potential confounders). Moreover, the American Academy of Neurology recommends (level C) that aspirin or anticoagulation may be considered in patients who opt to receive medical therapy alone without PFO closure.2 In fact, the comparison between PFO closure and systemic anticoagulation (e.g., DOAC) to prevent recurrent ischemic stroke remains unknown.

Switching gears, let us look at post-PFO closure management. Again, very limited data currently exists on the optimal duration of DAPT (dual antiplatelet therapy) after PFO closure. RESPECT and CLOSE used DAPT for 1 and 3 months, respectively, while some experts recommend ranges DAPT anywhere from 1 to 6 months. A European position paper on the management of PFO, suggested that following PFO closure patients should be on DAPT for 1-6 months followed by antiplatelet monotherapy for ≥5 years.3

In a nutshell, PFO closure should be considered for patients 60 years or younger with PFO-related stroke patients without the comorbidities of the previously mentioned risk factors.  A multidisciplinary discussion between neurology, geriatrics, and interventional cardiology are key in decision-making regarding PFO management.  Further research should include a randomized controlled trial regarding DAPT duration and the use of DOACs (direct oral anticoagulants) following PFO closure in patients with PFO-related left circulation embolism.

Credit: Figure from the New England Journal of Medicine 2021; 384:970-971

Reference

  1. Kasner SE, Rhodes JF, Andersen G, Iversen HK, Nielsen-Kudsk JE, Settergren M, Sjöstrand C, Roine RO, Hildick-Smith D, Spence JD, Søndergaard L; Gore REDUCE Clinical Study Investigators. Five-Year Outcomes of PFO Closure or Antiplatelet Therapy for Cryptogenic Stroke. N Engl J Med. 2021 Mar 11;384(10):970-971. doi: 10.1056/NEJMc2033779.
  2. Messé SR, Gronseth GS, Kent DM, Kizer JR, Homma S, Rosterman L, Carroll JD, Ishida K, Sangha N, Kasner SE. Practice advisory update summary: Patent foramen ovale and secondary stroke prevention: Report of the Guideline Subcommittee of the American Academy of Neurology. Neurology. 2020 May 19;94(20):876-885. doi: 10.1212/WNL.0000000000009443. Epub 2020 Apr 29.
  3. Pristipino C, Sievert H, D’Ascenzo F, Louis Mas J, Meier B, Scacciatella P, Hildick-Smith D, Gaita F, Toni D, Kyrle P, Thomson J, Derumeaux G, Onorato E, Sibbing D, Germonpré P, Berti S, Chessa M, Bedogni F, Dudek D, Hornung M, Zamorano J; Evidence Synthesis Team; Eapci Scientific Documents and Initiatives Committee; International Experts. European position paper on the management of patients with patent foramen ovale. General approach and left circulation thromboembolism. Eur Heart J. 2019 Oct 7;40(38):3182-3195. doi: 10.1093/eurheartj/ehy649.
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Post-Stroke Cognitive Impairment And Dementia And Risk Factors and Prevention

Dr. Rebecca Gottesman presented on Thursday during the Stroke Conference of 2021. She addressed the past, present, and future related to vascular dementia, mixed dementia, early stroke recovery, and precision medicine.

https://pubmed.ncbi.nlm.nih.gov/30784556/

In the past, the definition of post-stroke dementia was not necessarily uniform. She explains this is related to the term vascular dementia being sort of “tricky”. When classifying dementia you should consider, when you look, where you look, and whom you are looking at?

Many people can have dementia prior to having the stroke, this important when reviewing the prevalence rates after the stroke. Nearly 10% has dementia prior to stroke onset (1).

Dr. Gottesman highlights the need to review mixed pathologies for vascular dementia. The trajectories of onset and recovery vary between people. There can be a decline in cognition, followed by a recovery, then a further decline or an improvement. The Individual-level risk is important in post-stroke dementia.

https://www.ahajournals.org/doi/epub/10.1161/STROKEAHA.117.017319

Dr. Gottesman shared that the same stroke does not affect the person the same way (not every stroke leads to the same outcome). The individual risk profile will help individualize treatments and allow for more precision in medicine. She acknowledges that it is difficult to identify everyone who may have a stroke before they have an actual stroke. The meta-analysis from Oberlin highlights leisure activity as a potential way to reduce post-stroke dementia (2). Near the end of the presentation, Dr. Gottesman suggests we consider the following questions:

1) How do you consider aphasia and other cognitive deficits from the stroke?

2) How much time should pass after the stroke before you call it “dementia”?

3) How do you characterize dementia?

4) How do you characterize the dementia subtype?

5) How might future studies improve post-stroke cognitive outcomes?

We should consider the different prevention approaches due to the number of the different pathologies related to post-stroke dementia.

References

  1. Pendlebury ST, Rothwell PM. Incidence and prevalence of dementia associated with transient ischaemic attack and stroke: analysis of the population-based Oxford Vascular Study. The Lancet Neurology. 2019 Mar 1;18(3):248–58.
  2. Oberlin LE, Waiwood AM, Cumming TB, Marsland AL, Bernhardt J, Erickson KI. Effects of Physical Activity on Poststroke Cognitive Function: A Meta-Analysis of Randomized Controlled Trials. Stroke. 2017 Nov;48(11):3093–100.

“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 “PFO Headache”: PFO closer in severe and refractory migraine

Migraine headaches are a heterogeneous and recurrent condition with multiple potential phenotypes, making long-term management and preventive treatment extremely challenging on clinicians. In the general population, the prevalence of migraine headaches is approximately 15% with a female-to-male ratio of 3:1.  Once diagnosed, simple analgesics should be used in mild to moderate cases, while triptans, -ditans, or -gepants should be used in the treatment of severe migraines. Emerging evidence has suggested that patent foramen ovale (PFO) may be associated with the development of migraines.  Surprisingly, at least half of people who suffer from migraines, particularly those with aura, have a PFO.[1, 2] It is important to consider that the prevalence in the general population is quite high, with an estimated prevalence of 20-25%. Indeed, most individuals with a PFO do not develop related health issues and remain generally asymptomatic. My theory is that the pathogenesis of refractory migraines, particularly those with an associated aura, is multifactorial including activation of neurons in the central or peripheral nervous system, hormonal dysregulation, structural changes (e.g., PFO), and genetic heterogeneity. Echo screening for PFO in severe and refractory migraines may be useful.

There is emerging evidence regarding PFO closure in patients with severe, refractory migraines based on several recent clinical trials (MIST, MIST II, ESCAPE, EASTFORM, PRIMA, and PREMIUM trials). These RCTs assessed the effect of PFO closure on preventing migraines.  Although they did not demonstrate a significant benefit of PFO closure (e.g., a significant reduction in migraine attacks at 6, 9 months or 1 year), these RCTS shed some light on the potential benefits of PFO closure (e.g., migraine improvement) in this population, compared to medical therapy alone. Interestingly, in a recent study published in JACC: Cardiovascular Interventions with a median follow up 3.2 [2.1 to 4.9] years, investigators found that PFO closure was associated with a significant improvement in migraine burden (headaches both with and without aura) and, notably, the absence of residual right-to-left shunt was a predictor of a significant reduction in migraine burden.[3] Emerging evidence suggests that both presence of PFO and migraine headaches have a genetic predisposition. I believe that migraines and PFOs are primarily heterogeneous polygenic disorders (except familial hemiplegic migraine – monogenic) and that the triage and algorithmic approach should be similar to that taken for patients with hypertrophic cardiomyopathy (HCM).  HCM is a monogenic disorder with an autosomal dominant pattern of inheritance, and a recent study showed that PFO and Migraine may be inherited in an autosomal dominant pattern as well. Overall, there are still many lessons to be learned from the HCM in order to adapt this methodology to the treatment of patients with PFO and migraines. A good place to start might be to determine whether PFO closure in migraines using the -omic approach (e.g., GWAS and PheWAS) to identify markers (e.g., SNP, metabolites associated with atrial stunning) is needed. Ideally, testing common genetic mutations in individuals (e.g., endocardial and neuronal alteration-related genes) with both PFO and migraine may a good start before a genome-driven clinical trial of prophylactic PFO closure. I proposed the algorithm to use genetic-guided PFO-migraine management. (Figure)

In the future, PFO screening in Migraine patients with high-risk features (e.g., genetic mutations and deep-sea divers) may be needed and PFO closure in these populations may be beneficial. Currently, there is a significant lack of genetic data in this area, and future clinical trials are needed to determine the potential benefit from PFO closure in patients who suffer from migraine headaches.

REFERENCES

  1. Niessen, K. and A. Karsan, Notch signaling in the developing cardiovascular system. Am J Physiol Cell Physiol, 2007. 293(1): p. C1-11.
  2. Sadrameli, S.S., et al., Patent Foramen Ovale in Cryptogenic Stroke and Migraine with Aura: Does Size Matter? Cureus, 2018. 10(8): p. e3213.
  3. Ben-Assa, E., et al., Effect of Residual Interatrial Shunt on Migraine Burden After Transcatheter Closure of Patent Foramen Ovale. JACC: Cardiovascular Interventions, 2020. 13(3): p. 293-302.

“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.”