Changing stroke rehab and research worldwide now.Time is Brain! trillions and trillions of neurons that DIE each day because there are NO effective hyperacute therapies besides tPA(only 12% effective). I have 523 posts on hyperacute therapy, enough for researchers to spend decades proving them out. These are my personal ideas and blog on stroke rehabilitation and stroke research. Do not attempt any of these without checking with your medical provider. Unless you join me in agitating, when you need these therapies they won't be there.

What this blog is for:

My blog is not to help survivors recover, it is to have the 10 million yearly stroke survivors light fires underneath their doctors, stroke hospitals and stroke researchers to get stroke solved. 100% recovery. The stroke medical world is completely failing at that goal, they don't even have it as a goal. Shortly after getting out of the hospital and getting NO information on the process or protocols of stroke rehabilitation and recovery I started searching on the internet and found that no other survivor received useful information. This is an attempt to cover all stroke rehabilitation information that should be readily available to survivors so they can talk with informed knowledge to their medical staff. It lays out what needs to be done to get stroke survivors closer to 100% recovery. It's quite disgusting that this information is not available from every stroke association and doctors group.

Showing posts with label atrial fibrillation. Show all posts
Showing posts with label atrial fibrillation. Show all posts

Thursday, May 15, 2025

Direct oral anticoagulants increase bleeding risk after intracerebral hemorrhage in patients with atrial fibrillation

 Hope your stroke medical 'professionals' read AND IMPLEMENT RESEARCH!

Direct oral anticoagulants increase bleeding risk after intracerebral hemorrhage in patients with atrial fibrillation

1. Ischemic stroke occurred less often in patients with atrial fibrillation on DOACs compared to those on placebo.

2. Patients in the DOAC group reported an increased risk of intracerebral hemorrhage.

Evidence Rating Level: 1 (Excellent)

Study Rundown: Patients with atrial fibrillation are often prescribed direct oral anticoagulants (DOACs) to reduce the risks of thromboembolism and stroke. However, the safety and efficacy of restarting anticoagulation after spontaneous intracerebral hemorrhage (ICH) remains uncertain. This randomized controlled trial aimed to determine whether DOACs could reduce the risk of ischemic stroke without significantly increasing the risk of recurrent ICH in this high-risk population. The primary outcome was first occurrence of ischemic stroke, while key secondary outcome was recurrence of ICH. According to study results, DOACs significantly lowered the risk of ischemic stroke compared to no anticoagulation; however, they were also associated with a higher risk of recurrent ICH. Although this study was well done, it was limited by a small sample size, which may affect the generalizability of its findings.

Click to read the study in The Lancet

Relevant Reading: Early versus Later Anticoagulation for Stroke with Atrial Fibrillation

In-depth [randomized controlled trial]: Between May 31, 2019, and Nov 30, 2023, 327 patients were assessed for eligibility across 75 hospitals in 6 European countries. Included were patients ≥ 18 years with spontaneous ICH, a clinical diagnosis of atrial fibrillation, and a modified Rankin Scale score ≤ 4. Altogether, 319 patients (158 in DOAC group and 161 in no anticoagulant group) were included in the final analysis. The primary outcome of ischemic stroke occurred significantly less often in the DOAC group (hazard ratio [HR] 0.05, 95% confidence interval [CI] 0.01-0.36, log-rank p<0.0001). The secondary outcome of recurrent ICH occurred more frequently in the DOAC group (event rate 5.00 per 100 patient-years in DOAC vs. 0.82 per 100 patient-years in placebo). Findings from this study suggest that while DOACs reduce the risk of ischemic stroke in patients with atrial fibrillation, they increase bleeding.

Image: PD

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Friday, May 9, 2025

Endothelial Activation and Stress Index as a predictor of mortality in patients with atrial fibrillation

 For discussion about your competent? doctor's EXACT PREVENTION INTERVENTIONS! NO interventions; you DON'T have a functioning stroke doctor! I think you'd prefer not to have any mortality risk. So, ask for a competent doctor.

Endothelial Activation and Stress Index as a predictor of mortality in patients with atrial fibrillation

1. The Endothelial Activation and Stress Index (EASIX) is associated with in-hospital, short-term (28-day), and long-term (365-day) all-cause mortality in critically ill patients with atrial fibrillation (AF).

2. EASIX is a reliable indicator of poor prognosis in critically ill patients with AF.

Evidence Rating Level: 2 (Good)

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia and is strongly linked to increased risks of all-cause mortality, heart failure, hospitalization, and thromboembolic events. Many studies have shown an association between endothelial dysfunction (ED) and the development and progression of AF. The Endothelial Activation and Stress Index (EASIX) is a novel biomarker for assessing endothelial health and has been validated as a prognostic marker for mortality in various health conditions. However, research on the role of EASIX as a prognostic marker in patients with AF is limited. This study thus assessed the association between EASIX and prognosis in critically ill patients with AF. This retrospective study analyzed data from the Medical Information Mart for Intensive Care IV(MIMIC-IV) database and included patients aged 18-99 years with AF who had an intensive care unit stay of more than 24 hours. EASIX was calculated using the formula: lactate dehydrogenase (U/L) × creatinine (mg/dL)/platelets (109 cells/L) and log2-transformed for statistical analysis. Patients were grouped by EASIX quartiles: Q1: < 4.56, Q2: 4.56–5.64, Q3: 5.64–6.84, and Q4: > 6.84. In total, 4,896 patients were included (median age [interquartile range] = 75 [66, 83] years, male [%] = 2,871[58.64%]). All-cause mortality rates for in-hospital, 28-day, and 365-day were 26.04%, 29.25%, and 49.75%, respectively. Higher EASIX was associated with increased in-hospital (OR 1.28, 95% confidence interval [CI] 1.19–1.37), 28-day (HR 1.21, 95% CI 1.16–1.26, P < 0.001), and 365-day HR 1.16, 95% CI 1.12–1.21) all-cause mortality after multivariable adjustment. For each time point, patients in quartiles Q2, Q3, and Q4 had significantly higher mortality than those in Q1. The performance of EASIX in predicting both 28-day and 365-day all-cause mortality was comparable to the Sequential Organ Failure Assessment (SOFA) and higher than the CHADS–VASc score. Overall, this study found that EASIX is associated with in-hospital, short-term, and long-term all-cause mortality in critically ill patients with AF and that EASIX is a reliable indicator of poor prognosis in this patient population. Future prospective studies are necessary to confirm study findings.

Click to read the study in EJMR

Wednesday, May 7, 2025

AI helps cardiologists terminate AFib for good with ablation

 So you can effectively discuss your Afib with your doctor. 

AI helps cardiologists terminate AFib for good with ablation

Artificial intelligence (AI) can improve atrial fibrillation (AFib) outcomes by providing real-time feedback during cardiac ablation procedures, according to new data presented at Heart Rhythm 2025, the Heart Rhythm Society’s annual meeting in San Diego.

The study’s focus was the effectiveness of DeePRISM, an advanced AI algorithm that helps cardiologists and electrophysiologists perform cardiac ablation in a way that maximizes the odds of achieving AFib termination. 

DeePRISM was trained using data from 110 patients who presented for ablation due to persistent AFib. When testing the AI model, researchers found that it helped clinicians achieve acute AFib termination in 40% of ablation patients. The group added that the AI was associated with improved two-year outcomes, including freedom from recurrent AFib in up to 70% of patients.

“With the introduction of the DeePRISM model, we are taking a significant step forward in the treatment of persistent atrial fibrillation,” Chih-Min Liu, MD, PhD, a researcher with Taipei Veterans General Hospital in Taiwan, said in a statement. “Our study shows that AI-driven, real-time analysis not only enhances the success of the procedure but also ensures patient safety, marking a promising advance in electrophysiology.”

Heart Rhythm 2025 continues a long tradition

Heart Rhythm 2025 is the 46th annual meeting of the Heart Rhythm Society, which has said it received more than 3,400 scientific abstracts ahead of the show. Nearly 10,000 attendees are expected, including cardiologists, electrophysiologists, researchers, device manufacturers and many others.

“With the significant increase in both data submissions and attendee registration, this year’s meeting will highlight scientific advancements, discoveries, and real-world insights that electrophysiologists can apply to their daily clinical practice,” HRS President Ken Ellenbogen, MD, director of clinical cardiac electrophysiology at VCU Health, said in a statement ahead of the conference.

The Heart Rhythm Society stayed busy leading up to the conference, publishing detailed recommendations on how to develop AFib Centers of Excellence and when to consider same-day discharge after cardiac ablation


Sunday, April 6, 2025

Incidence, Prevalence, and Trends in Mortality and Stroke among Medicare Beneficiaries With Atrial Fibrillation: 2013 to 2019

 Of what use was this research? What next steps will follow that will help persons with atrial fibrillation? I blame the mentors and senior researchers for failing to instruct these researchers in what useful stuff should come out of research.

Incidence, Prevalence, and Trends in Mortality and Stroke among Medicare Beneficiaries With Atrial Fibrillation: 2013 to 2019

Circulation: Cardiovascular Quality and Outcomes
  • Abstract

    BACKGROUND:

    Atrial fibrillation (AF) is known to be associated with increased risks of stroke and death, but contemporary studies of this association are lacking. We evaluated trends in stroke and death among Medicare beneficiaries with AF between 2013 and 2019.

    METHODS:

    Medicare fee-for-service beneficiaries >65 years old (2011–2019) were included. AF incidence and prevalence were calculated overall and by age group, sex, race, and rurality. Within incident cohorts, the 1-year stroke rate was assessed. Age- and sex-adjusted mortality at 30 days, 1 year, and 3 years was calculated in each incident cohort.

    RESULTS:

    The mean number of Medicare beneficiaries with incident AF per year was 572 630 from 2013 to 2019 (30.44 per 1000 patient-years). The study cohort on average was 79±7.7 years old, 52% female, 88% white, and 83% urban dwelling. Incidence and prevalence of AF increased with age and was highest among White beneficiaries; the incidence was greater in male compared with female beneficiaries. Differences by rurality were not seen. Overall AF prevalence per 1000 beneficiaries increased minimally but steadily from 2013 to 2019 reflecting an increase among male (104–109 per 1000) but not female beneficiaries (82.5 per 1000). The 1-year rate of stroke after incident AF peaked in the 2015 cohort (50.5 per 1000); the rate was at its lowest among the 2018 cohort (41.89 per 1000). Incident AF was associated with mortality that was 3.2× greater than expected at 1 year, but overall mortality and the magnitude of the AF-related mortality risk decreased steadily over time from 22% to 20%.

    CONCLUSIONS:

    From 2013 to 2019, AF incidence and prevalence among Medicare beneficiaries were relatively stable but have varied by important demographic subgroups with age and sex remaining powerful risk factors. In contrast, mortality and stroke after incident AF have decreased significantly throughout this era.

    Get full access to this article

    Sunday, March 23, 2025

    Biomarker-Based Model for Prediction of Ischemic Stroke in Patients With Atrial Fibrillation.

    So you showed the biomarker works but uselessly gave NO protocols ON HOW TO PREVENT THAT POSSIBLE STROKE! Do you want to tell patients you likely will have a stroke, but we KNOW NOTHING ON HOW TO PREVENT IT? That sounds ripe for a lawsuit. 

     Biomarker-Based Model for Prediction of Ischemic Stroke in Patients With Atrial Fibrillation.

    Lars Wallentin, Johan Lindbäck, Ziad Hijazi, Jonas Oldgren, Anthony Carnicelli, John AlexanderSee All

    BACKGROUND: In patients with atrial fibrillation (AF) the risk of ischemic stroke is central to recommendations for stroke-prevention treatment.

    OBJECTIVES: The authors evaluated the biomarker-based Age, Biomarkers, Clinical history (ABC)-AF-stroke risk score and developed a modified ABC-AF-istroke risk score for prediction of respectively total and ischemic stroke in patients with AF.

    METHODS: In 26,452 patients with AF assigned to direct oral anticoagulants (DOACs) or warfarin, information on age, clinical history of stroke, and levels of N-terminal pro B-type natriuretic peptide and troponin were used for calculation of the ABC-AF-stroke score and the modified ABC-AF-istroke score.

    RESULTS: During follow-up, there were 756 cases with stroke or systemic embolism (SEE) including 534 with ischemic stroke/SEE. The discrimination of total stroke/SEE was superior for the ABC-AF-stroke score, C-index (0.667 [95% CI: 0.648-0.687]), compared with 0.632 (95% CI: 0.612-0.652) for the ATRIA (Anticoagulation and Risk Factors in Atrial Fibrillation) and 0.614 (95% CI: 0.594-0.633) for the CHA2DS2-VASc score (P < 0.001 for both). The results were similar for ischemic stroke/SEE with C-index for ABC-AF-istroke 0.677 (95% CI: 0.654-0.700) compared with 0.642 (95% CI: 0.618-0.666) for the ATRIA and 0.624 (95% CI: 0.601-0.647) for the CHA2DS2-VASc score (P < 0.001 for both). The ABC-AF-stroke scores showed good calibration for total and ischemic stroke. Results were consistent in relevant subgroups. Decision curve analyses showed a net benefit concerning stroke-prevention decision thresholds.

    CONCLUSIONS: The biomarker-based ABC-AF risk scores for the risk of total and ischemic stroke were well calibrated, showed better discrimination than clinical risk scores in predicting total and ischemic stroke, and provided meaningful decision support for stroke-prevention treatments(WHAT THE HELL ARE THEY?) in patients with AF.

    Ischemic StrokeAtrial FibrillationStroke
    Cardiology

    Sunday, March 9, 2025

    Abelacimab reduces bleeding risk compared to rivaroxaban in atrial fibrillation

     Your competent? doctor is current on all research and implements it immediately, right? NO? So, you DON'T have a functioning stroke doctor, do you? 

    Abelacimab reduces bleeding risk compared to rivaroxaban in atrial fibrillation

    1. In this randomized controlled trial, abelacimab led to significantly lower rates of major or clinically relevant nonmajor bleeding compared to rivaroxaban in patients with atrial fibrillation at moderate-to-high stroke risk.

    2. Abelacimab led to significantly reduced free factor XI levels compared to rivaroxaban. 

    Evidence Rating Level: 1 (Excellent)

    Study Rundown: Atrial fibrillation has a high prevalence and considerably increases the risk of stroke five-fold. Accordingly, those with atrial fibrillation commonly take anticoagulation agents to prevent thromboembolic events. These include direct oral anticoagulants such as rivaroxaban. However, there are significant bleeding risks associated with these medications even though they are safer than previous therapies like warfarin. Accordingly, factor XI-targeted therapy is being explored as a method for reducing stroke risk in atrial fibrillation patients. This phase 2b, multinational RCT (AZALEA-TIMI 71) assessed the safety of abelacimab, a factor XI inhibitor, in anticoagulation therapy for atrial fibrillation. The study was halted early due to a substantial reduction in bleeding events in the abelacimab groups. While abelacimab demonstrated a significant decrease in bleeding compared to rivaroxaban, ischemic stroke incidence was slightly higher in the abelacimab groups, though not statistically significant. The study suggests abelacimab may be a safer alternative for patients at risk of anticoagulant-associated bleeding. Limitations include its open-label design for treatment assignment and the need for larger trials to confirm efficacy in stroke prevention.

    Click to read the study in NEJM

    In-Depth [randomized controlled trial]: This multicenter, phase 2b, partially blinded RCT enrolled 1,287 patients with atrial fibrillation and a CHA2DS2-VASc score of ≥3. Patients were randomized in a 1:1:1 ratio to receive either subcutaneous abelacimab at 90 mg or 150 mg once monthly or oral rivaroxaban 20mg once daily (15 mg for patients with creatinine clearance ≤50 ml/min). The study aimed to assess safety outcomes, specifically major or clinically relevant nonmajor bleeding. At three months, the median reduction in free factor XI levels was 99% (interquartile range [IQR] 98–99) with 150 mg and 97% ([IQR] 51–99) with 90 mg of abelacimab. The trial was terminated early due to a significant reduction in major or clinically relevant nonmajor bleeding events in the abelacimab groups compared to rivaroxaban. The bleeding incidence rate was 3.2 events per 100 person-years for the 150 mg group and 2.6 events per 100 person-years for the 90 mg group, compared to 8.4 events per 100 person-years in the rivaroxaban group (Hazards Ratio [HR] 0.38; 95% Confidence Interval [CI], 0.24–0.60) for 150 mg vs. rivaroxaban, ([HR] 0.31; [CI], 0.19–0.51) for 90 mg vs. rivaroxaban, P<0.001 for both). Notably, gastrointestinal bleeding was markedly lower in the abelacimab groups (0.5% vs. 4.2% with rivaroxaban). However, the stroke incidence was slightly higher in the abelacimab groups (1.2% and 1.4% per year for 150 mg and 90 mg, respectively) than in the rivaroxaban group (0.8% per year), though the difference was not statistically significant. Overall, abelacimab demonstrated a strong safety profile with significantly lower bleeding risk than rivaroxaban, highlighting its potential as an alternative anticoagulant.

    Friday, January 10, 2025

    Atrial Fibrillation and Retinal Stroke

     Is your competent? doctor guaranteeing no retinal stroke from their treatment of your atrial fibrillation?

    Atrial Fibrillation and Retinal Stroke

    Key Points

    Question  Is atrial fibrillation associated with retinal stroke?

    Findings  In this cohort study of 1 090 144 Medicare beneficiaries aged 66 years or older, the rate of retinal stroke was 0.55 per 1000 person-years among beneficiaries with atrial fibrillation vs 0.50 per 1000 person-years among matched beneficiaries without atrial fibrillation, a result that was statistically significant after adjustment for key covariates.

    Meaning  These findings suggest that among older adults enrolled in Medicare, atrial fibrillation is associated with an increased hazard rate of retinal stroke.

    Abstract

    Importance  Atrial fibrillation (AF) is the most common, chronic, cardiac arrythmia in older US adults. It is not known whether AF is independently associated with increased risk of retinal stroke (central retinal artery occlusion), a subtype of ischemic stroke that causes severely disabling visual loss in most cases and is a harbinger of further vascular events.

    Objective  To determine whether there is an association between AF and retinal stroke.

    Design, Setting, and Participants  This retrospective cohort study was performed between July 2023 and May 2024 using computerized inpatient, outpatient, emergency department, and skilled nursing facility claims files for a 5% sample of US fee-for-service Medicare beneficiaries aged 66 years and older between 2000 and 2020. Follow-up ended at death, conclusion of fee-for-service Medicare coverage, end of the study period, or loss to follow-up of 85% of the study cohort.

    Exposure  AF, based on validated International Classification of Diseases, Ninth Revision, Clinical Modification and International Statistical Classification of Diseases, Tenth Revision, Clinical Modification diagnosis codes.

    Main Outcomes and Measures  The primary end point was incident retinal stroke in the primary diagnostic position of a single claim in any venue of care. Secondary end points included retinal stroke in any position of a single claim, 1 positive control end point (cerebral ischemic stroke), and 4 negative control end points (central retinal vein occlusion, urinary tract infection, humeral fracture, and cataract). Unadjusted and adjusted hazard ratios (HRs) and rate differences were computed across matched and overlap-weighted cohorts with and without AF (defined as 1 inpatient claim or 2 outpatient claims within a 365-day period).

    Results  In total, 1 090 144 patients (591 400 female [54.3%]; mean [SD] age, 76.92 [7.09] years) were included in the study; 545 072 patients had AF and 545 072 were matched controls. The median (IQR) follow-up was 45 (18 to 90) months. In total, 1333 patients with AF (rate, 0.55 per 1000 person-years) and 1082 AF-free matched controls (rate, 0.50 per 1000 person-years) experienced retinal stroke. The cause-specific, adjusted HR of retinal stroke after overlap weighting was 1.14 (95% CI, 1.02 to 1.28; adjusted rate difference, 0.05 [95% CI, −0.01 to 0.11]). AF was associated with cerebral ischemic stroke (adjusted HR, 1.73 [95% CI, 1.69 to 1.76]; adjusted rate difference, 10.11 [95% CI, 9.72 to 10.49]). Of 4 prespecified negative control end points, AF was not associated with central retinal vein occlusion but was associated with urinary tract infection, cataract, and humeral fracture.

    Conclusions and Relevance  In this cohort study of Medicare beneficiaries aged 66 years and older, AF was independently associated with retinal stroke. The magnitude of the association was small, and a contribution from residual, unmeasured confounding could not be excluded.


    Wednesday, January 8, 2025

    J&J pauses Varipulse pulsed field ablation system's US debut following 4 reports of strokes

     FYI. You'll have to ask your competent? doctor if this was because debris from the intervention traveled to the brain.

    J&J pauses Varipulse pulsed field ablation system's US debut following 4 reports of strokes

    Johnson & Johnson MedTech announced that it has halted U.S. procedures and sales of its recently approved Varipulse pulsed field ablation system following reports of four patient strokes.

    “On January 5, out of an abundance of caution, Johnson & Johnson MedTech temporarily paused the U.S. External Evaluation and all U.S. Varipulse cases while we investigate the root cause of four reported neurovascular events in the U.S. External Evaluation,” the company said in its notice.

    J&J added that, because the system’s use in the U.S. employed a unique configuration, there is no impact to Varipulse outside of the country.

    According to the company, the U.S. external evaluation has included more than 130 procedures among 14 sites and 40 operators as of the top of this year. Varipulse was approved by the FDA last November for treating atrial fibrillation.

    The ablation system—which comes integrated with J&J’s Carto 3 heart-mapping catheter—previously received a CE mark approval in Europe in February 2024. The company said Varipulse has been tapped for more than 3,000 commercial cases globally so far.

    “We are working diligently to complete the investigation according to our medical safety processes and resume the U.S. External Evaluation,” the company said in its statement. “We expect to have more information to communicate within the coming days.”

    Saturday, January 4, 2025

    ACC offers practical approaches for arrhythmia monitoring after stroke

     Did this get installed as a protocol in your hospital? NO? So, you DON'T have a functioning stroke hospital, do you?

    ACC offers practical approaches for arrhythmia monitoring after stroke   

    he American College of Cardiology (ACC) recently published a new expert consensus document on practical approaches for arrhythmia monitoring after stroke. The guidance offers clinicians tailored strategies to improve post-stroke care by identifying and managing atrial fibrillation (AF) and other arrhythmias linked to recurrent stroke risk.

    The ACC Solution Set Oversight Committee's "2024 ACC Expert Consensus Decision Pathway on Practical Approaches for Arrhythmia Monitoring After Stroke" includes comprehensive guidance for arrhythmia detection based on stroke subtype, leveraging extended monitoring and implantable cardiac monitors where appropriate.[1] The document offers a detailed evaluation of medical-grade and consumer-grade monitoring devices to support clinicians in selecting the right tools for individual patients. The document also emphases collaboration between clinicians and patients to personalize monitoring
    strategies and treatment plans.

    “There is growing consensus on the role of cardiac rhythm monitoring in patients after a stroke that is informed by outcomes of several recent landmark trials,” said Michael T. Spooner, MD, MBA, FACC, writing committee chair and director of electrophysiology and program director of the Mercy One North Iowa Cardiovascular Fellowship, in a statement from ACC. “Although improved monitoring leads to improved detection of arrhythmia after a stroke, there remains less clarity on the effect this detection has on secondary stroke prevention.”

    Stroke is a leading cause of disability and death worldwide and identifying its underlying cause is critical to preventing recurrent events. AF is a common but often silent arrhythmia, and it significantly increases stroke risk.

    Traditional methods of AF diagnosis, including brief electrocardiogram (ECG) recordings, often fall short of capturing transient AF, so longer duration of monitoring can increase the rate of AF detection, was one of the key takeaways from list created by Geoffrey D. Barnes, MD, MSc, FACC, associate professor, Frankel Cardiovascular Center, University of Michigan. He noted the document also states the longer the time interval between the ischemic stroke and the detected AF episode decreases the likelihood of AF as a proximal cause of the prior event.

    Barnes said in his takeaways that various technologies have been developed to identify AF, including continuous or intermittent ambulatory ECG monitors, which have gained wide adoption in the past few years. There are also medical-grade monitors (typically electrical activity monitoring) and consumer-grade monitors (either electrical activity monitoring or photoplethysmography) can also help in monitoring these patients.

    Arrhythmia monitoring after a stroke requires three important steps. First, a multidisciplinary evaluation should be undertaken to identify potential mechanism for stroke. Second, risk assessment is performed to determine the likelihood that a cardiac arrhythmia played a role in the stroke (or future stroke). Third, an optimal monitoring strategy should be selected to be accurate, practical, and establish follow-up.

    For patients in whom arrhythmia monitoring detects >5 minutes of AF, anticoagulation is likely recommended. This is particularly true if their CHA2DS2-VASc score is ≥3. For those with no AF, continuing antiplatelet therapy is recommended, Barnes wrote.

    Read more key takeaways.
     

    Read the full 25-page document.

                                                       

    Monday, December 2, 2024

    4 Reasons to Question Percutaneous Left Atrial Appendage Closure After AF Ablation

     Consult with your doctor if this applies to you.

    4 Reasons to Question Percutaneous Left Atrial Appendage Closure After AF Ablation

    The OPTION Trial

    John M. Mandrola, MD

    DISCLOSURES

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    If electrophysiologists were as skilled in critical appraisal of evidence as they are with procedures, the results of the OPTION trial comparing two strategies of stroke prevention after atrial fibrillation (AF) ablation would not lead to more percutaneous left atrial appendage closure (LAAC) procedures. 

    Sadly, though, the positive results probably will lead to many more of these unproven devices being implanted. As I wrote earlier this week, OPTION was designed to deliver positive results. And so it did. 

    Brief Recap of OPTION 

    The trial enrolled 1600 patients after AF ablation and randomly assigned them to continue with oral anticoagulation (OAC) or have a Watchman LAAC device inserted and discontinue anticoagulation after 90 days. 

    The idea was to show that LAAC could decrease the rate of bleeding while maintaining a low risk for stroke after ablation. 

    Patients were 70 years old on average, 35% were female, and the mean CHA2DS2–VASc score was 3.5. Just over 40% of patients had LAAC at the same time as their ablation and the rest had the device implanted weeks later. 

    OPTION Results 

    The primary safety endpoint of nonprocedural major bleeding or clinically relevant nonmajor bleeding occurred in 8.5% of patients in the device arm vs 18.1% in the anticoagulation group. The hazard ratio (HR) was 0.44 (95% CI, 0.33-0.59; <.001 for superiority). Two thirds of the bleeding events were nonmajor, including bruising, epistaxis, lacerations, and oral bleeding. 

    The primary efficacy endpoint of stroke, systemic embolism, and death occurred in 5.3% of patients in the device arm and 5.8% of patients in the anticoagulation arm and met noninferiority. 

    The secondary safety endpoint of major bleeding, which includes procedure-related bleeding, occurred in 3.9% of patients in the device arm and 5.0% of patients in the anticoagulation arm (HR, 0.77; 95% CI, 0.48-1.24). This met noninferiority but not superiority.

    Death rates were similar in both arms (3.8% vs 4.5% for anticoagulation). Ischemic stroke rates were very low and also similar in both arms (1.2% vs 1.3%). 

    In a noninferiority trial, you aim to establish noninferiority of an efficacy endpoint and superiority in safety. The topline results of OPTION confirm this for LAAC vs anticoagulation, but a closer look at endpoints and trial procedures refute this contention. 

    1. Wrong Primary Safety Endpoint

    Safety cannot be established as superior with a nonprocedural bleeding endpoint. The main safety concern with LAAC is procedure-related bleeding. 


    To assess safety properly, we should use the secondary safety endpoint of major bleeding including procedural bleeding. These rates were 3.9% for LAAC and 5.0% for anticoagulation, which did not establish superiority for the device. 

    Excluding procedural bleeding from the primary safety endpoint isn’t my only issue with its choice. The inclusion of nonmajor clinically relevant bleeding creates a possible bias in an unblinded trial. Patients on anticoagulation may be more likely to report nonmajor bleeding events. Indeed, bruising and oral bleeding were higher in the OAC arm. 

    Evidence for this bias is that the Kaplan-Meier curves for the primary safety endpoint diverge almost immediately in favor of the device arm — despite the fact that the LAAC patients were initially taking an anticoagulant and aspirin. This more intense antithrombotic regimen should cause more, not less, bleeding than anticoagulation alone. 

    2. Wrong Efficacy Endpoint

    The indication for LAAC or anticoagulation is to prevent thrombotic events, not death. Including death with stroke and systemic embolism in the composite endpoint simply inflated the numbers of primary efficacy endpoints. As expected, death rates were similar in both arms. 

    Yet even with these inflated rates, the actual event rates of 5.3% and 5.8% (LAAC vs OAC) were far lower than the expected 10% vs 15%. This is important because the fixed noninferiority margin of 5% is based on the expected event rates and translates to a relative risk of 1.5%. In other words, LAAC could have been 50% worse in terms of efficacy and still have met the threshold for noninferiority. 

    The actual event rates came in much lower than expected at 5.3% vs 5.8%. The risk difference of -0.5% has an upper bound of 1.8%, which is well below the noninferiority margin of 5%.

    Proponents might argue that even with the lower event rates, noninferiority is still met using the relative risk ratio. This is true. The HR of 0.91 had a 95% CI of 0.59-1.39, and the upper bound of 1.39 is indeed less than the margin of 1.5. 

    But this is deeply misleading because the actual stroke/systemic embolism rates were 1.2% and 1.3%, respectively. It would have taken nearly five times more patients to properly establish noninferiority in efficacy. OPTION, therefore, cannot tell us whether LAAC is noninferior to OAC for the reduction of stroke and systemic embolism. 

    The fact that stroke rates are this low 3 years after ablation leads me to believe that an arm of no device and no OAC would have performed as well. In fact, one of the discoveries in OPTION was that stroke rates were at least three times lower than predicted based on the mean CHA2DS2–VASc score of the patients. This observation counters the view of many LAAC proponents who argue that the device could be an alternative option for patients who do not want to take OAC. A better alternative in low-stroke risk patients could be no device and no OAC. This comparison has never been tested in a trial; OPTION argues for such a trial. 

    3. Missing Data


    The design of the trial is not the only reason I worry. The authors report missing data for 144 patients (8.8% overall), with most of those patients in the anticoagulation arm (10.5% vs 7.4% missing in the LAAC arm). 

    One way to assess whether the lost data might affect the outcome is to compare it with the event rates. Here, the rate of missing data is higher than both, what I would deem the correct safety endpoint (as outlined above) and the inflated efficacy endpoint. 

    While there is no perfect solution for missing data, the authors made no statistical adjustments for the issue. In a trial with low event rates, this much missing data adds even more uncertainty. 

    4. Incomplete LAAC and Possibility of Harm 

    The authors report that a complete seal of the opening to the left atrial appendage with the device was observed in 80% of patients at 12 months. The translation is that 1 in 5 patients had a leak. Device-related thrombus occurred in 1.9% of patients. 


    I see two potential issues relating to harm. The OPTION trial was done at expert centers. In the United States, large numbers of AF ablation and LAAC will be done by low-volume operators. The incomplete-seal numbers in OPTION probably represent a best-case scenario. If the results of this trial lead to a large increase in the implantation of these devices, there is a risk for serious harm on a population level. 

    The second problem with incomplete seals is the short duration of the trial. An implanted device that doesn’t completely seal the opening to the left atrial appendage may be forever. OAC can be stopped. A device in the heart cannot be easily removed. 

    Conclusion 

    Despite enrolling 1600 patients in a randomized trial, we don’t know whether percutaneous LAAC post-ablation is as safe or effective as OAC (or even if it’s better than doing nothing). 

    Despite the declaration of positive results, the OPTION trial was uninformative. It worries me greatly that this was easily predicted before knowing the results. 

    I hope my field of electrophysiology sees through the positive topline results and rejects the coming spin. Putting foreign bodies into the heart should pass a much higher bar than the one set by OPTION. There is potential for a serious amount of harm if this leads to more LAAC procedures. 

     

    John Mandrola practices cardiac electrophysiology in Louisville, Kentucky, and is a writer and podcaster for Medscape. He espouses a conservative approach to medical practice. He participates in clinical research and writes often about the state of medical evidence. 

    Sunday, October 13, 2024

    Common heart conditions raise the risk of dementia, experts say

     WOW, more generalities! If we had ANY 'professionals' out there at all, we would get EXACT PROTOCOLS TO PREVENT THESE PROBLEMS! But we don't; you're screwed!

    Common heart conditions raise the risk of dementia, experts say

    CNN  — 

    Keeping your brain sharp as you age has a lot to do with your heart — and the younger you start taking better care of it, the better — according to a new scientific statement published Thursday by the American Heart Association.

    “Dementia is commonly seen as an incurable and relentless disease that cannot be prevented,” said Dr. Fernando Testai, a professor of neurology and rehabilitation at the University of Illinois College of Medicine in Chicago, in a statement.

    “Evidence shows, however, that adopting a healthy lifestyle and identifying and treating vascular risk factors early may help preserve normal brain function and reduce the burden of Alzheimer’s disease and other related dementias,” said Testai, who chaired the statement writing group.

    Nearly 130 million adults in the United States have some form of heart disease, according to the AHA. Adopting a heart-heathy lifestyle should start early in life, even before a baby is born, said Dr. Andrew Freeman, director of cardiovascular prevention and wellness at National Jewish Health in Denver.

    “This call to action is especially critical right now because so many Americans have some form of heart disease and people are getting sicker and sicker earlier in life,” said Freeman, who was not involved in writing the AHA statement.

    “The typical American curse is that we all work hard our whole lives,” Freeman said. “We save our money, we get ready to retire, and then we look forward to heart attacks, strokes, dementia — diseases that are potentially avoidable if we can act early enough and change our lifestyles.”

    Staying on top of your heart's health will go a long way toward keeping your brain sharp as you age, experts say.

    Dementia and plaque in the arteries

    Coronary heart disease, which is the buildup of plaque in the body’s arteries, is the lead killer in the world, according to the World Health Organization. Deaths from coronary artery disease have risen from 6.4 million in 2000 to 9.1 million in 2021, the WHO said.

    The disease also takes a toll on the brain. The narrowing of arteries that occurs with coronary heart disease and high blood pressure can reduce blood flow and cause damage to the small blood vessels in the brain, resulting in cognitive impairment, the AHA said. High blood pressure and type 2 diabetes can also reduce blood flow to the brain and increase inflammation, leading to cognitive decline and dementia.

    Having coronary heart disease raises the risk of future dementia by 27% compared with people without heart disease, the AHA statement said. The disease can start in a person’s 40s and 50s, often with no visible symptoms to alert a person of the danger.

    Well, what will remove the plaque in the arteries?
    I'm sure your competent? doctor put together EXACT PROTOCOLS  based on these research points! NO? So you don't have a functioning stroke doctor, do you? RUN AWAY!
    plaque removal (5 posts to July 2017) Only 7 years for your doctor to prove incompetence!

    Heart attacks and heart failure

    About every 40 seconds, someone in the United States will have a heart attack, the AHA estimates. After that happens, up to 50% of those who survive experience loss of brain function, with some taking a sharper decline into cognitive impairment, the AHA statement said.

    Heart failure is a more severe form of heart disease, in which the heart is too weak to pump enough blood and oxygen to the body’s organs. According to the new scientific statement, up to 81% of people with heart failure can have some form of cognitive decline that impacts their memory, language, or ability to think and plan.

    “Emerging evidence suggests that the bidirectional relationship between the heart and the brain is deeper than we thought,” Testai said in an email. “Vascular risk factors associated with cardiac diseases, such as diabetes, can increase the levels of beta-amyloid in the brain. which is recognized as a key marker of Alzheimer’s disease.

    “In return, beta-amyloid has been found in the heart and is associated with cardiac dysfunction,” he said. “These findings suggest a fundamental biochemical connection between the heart and the brain.”

    A-fib and dementia

    Known as A-fib, atrial fibrillation is an irregular heartbeat often described by many people who have it as a “quiver,” “flutter” or “flip-flop” of the heart in the chest.

    Atrial fibrillation is the leading cause of stroke in the US. In addition, strokes connected to A-fib tend to be “more severe than strokes with other underlying causes,” according to the US Centers for Disease Control and Prevention.

    Small brain bleeds, called microhemorrhages, that can lead to cognitive decline are more common in people with atrial fibrillation, according to the new scientific statement. In fact, people with A-fib have a 39% increased risk of memory or thinking problems.

    The rate of atrial fibrillation in the US is growing — estimates suggest up to 16 million people will have A-fib by 2050.

    Focus on lifestyle changes

    Modern medicine has amazing drugs — such as statins and cholesterol-lowering medications — that can prevent or slow heart disease, especially if caught early, Freeman said. Regular checkups and taking prescribed medications on a daily basis are critical to making that happen, he added.

    However, there is a limit on what drugs can accomplish. For example, aggressively treating high blood pressure has shown promise in reducing mild cognitive impairment but not dementia, the AHA statement said.

    “Humans were designed to live very differently than we live today, and it’s an imperative that people understand how unbelievably important lifestyle is,” Freeman said.

    What are the key lifestyle factors that boost brain health? Nothing you haven’t heard before.

    Prioritize sleep

    Being well-rested boosts mood, improves energy and sharpens the brain. People who have more interrupted sleep in their 30s and 40s are more than twice as likely to have memory and thinking problems a decade later, a January study found.

    The “sweet spot” for restorative slumber is when you can sleep continuously through the four stages of sleep four to six times each night. Since each cycle is roughly 90 minutes long, most people need seven to eight hours of relatively uninterrupted z’s to achieve this goal.

    Concentrate on nutrients

    Be sure to eat a healthier plant-based diet, such as the award-winning Mediterranean diet.

    An August study found eating an anti-inflammatory diet of whole grains, fruits and vegetables instead of an inflammatory diet focused on red and processed meats and ultraprocessed foods, such as sugary cereals, sodas, fries and ice cream, lowered the risk of dementia by 31%.

    That benefit held true even for people with existing diagnoses of cardiometabolic conditions such as type 2 diabetes, heart disease and stroke.

    None of these have any specifics at all, so you don't know if you're doing it right. More pablum from your doctor that really doesn't help at all! What is needed is an EXACT DIET PROTOCOL!

    RELATED VIDEO: This diet could lengthen life, study says
    02:37 - Source: CNN

    Reduce stress

    High levels of cortisol — the so-called stress hormone — were associated with damage to the parts of the brain that move and manage information, an October 2018 study found. Another study published in March 2023 found people with elevated stress levels were 37% more likely to have poor cognition.

    What do you think?

    Stress isn’t inherently bad, and adopting ways to view stressors as healthy challenges can help, experts say. Other ways include getting plenty of sleep, eating healthy foods, and limiting your time following the news or engaging in social media, according to the World Health Organization. It also helps to stay connected with others and to employ calming practices such as meditation and deep breathing. One of the most successful tools, though, is physical activity.

    That’s right — exercise is critical

    If there is only lifestyle change you can make, focus on exercise, Freeman said. Adults should do 150 minutes of moderate-intensity activity or 75 minutes of vigorous activity each week, along with strength training, according to the CDC. You know you’re doing moderate exercise when you are breathing hard and unable to sing a song, but can still talk. Vigorous activities such as jogging, swimming laps or playing basketball will make it hard to speak at all.

    The increase in activity benefits the whole body, including the brain, studies have shown. A September 2022 study found people who walked at a very brisk pace of 112 steps per minute for 30 minutes a day lowered their risk of dementia by 62%.

    Don’t have a step counter? You can count the number of steps you take in 10 seconds and then multiply it by six — or the number of steps you take in six seconds and multiply it by 10. Either way works.

    “Physical activity is just absolutely magnificent,” Freeman told CNN. “And when if you blend that with eating a more plant-based diet, de-stressing, sleeping enough and connecting with others — that’s your magic recipe. It’s the fountain of youth, if you will.”