Abstract 17109: Real World Assessment of Atrial Fibrillation and Other Arrhythmias After Cryptogenic Stroke

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Naga Venkata K Pothineni ◽  
Uyanga Batnyam ◽  
Jeffrey Arkles ◽  
John Bullinga ◽  
Brett L CUCCHIARA ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Trials ◽  
Real World ◽  
Cryptogenic Stroke ◽  
Premature Ventricular Contractions ◽  
Entire Cohort ◽  
Detection Algorithms ◽  
Term Monitoring

Introduction: Long-term monitoring for atrial fibrillation (AF) is recommended in patients, who have experienced a cryptogenic stroke (CS). Clinical trials have identified AF in ~30% of patients after 3 years of continuous monitoring with insertable cardiac monitors (ICMs). Hypothesis: In a real-world analysis from a large academic healthcare system, we sought to evaluate a CS population with ICMs and a) determine the yield of AF and subsequent initiation of anticoagulation; and b) identify the presence of other arrhythmias. Methods: We evaluated all CS patients who had received an ICM between October 2014 and April 2020. We manually reviewed all stored electrocardiograms that were automatically labeled as AF by the ICM and adjudicated them as either a) AF or b) other cardiac arrhythmia including premature atrial contractions (PAC), premature ventricular contractions (PVC), supraventricular tachycardia (SVT), or nonsustained ventricular tachycardia (NSVT). Results: A total of 84 CS patients with ICMs were included: 51% men, mean age 63 years, and mean CHA 2 DS 2 -VASc 4.1. Over a median follow-up duration of 15.7 months, there were 34 patients (40% of the cohort) who did not have any AF alerts. In the remaining 50 patients, there were 960 stored electrograms that were adjudicated. Only 154 recordings from 16 patients (19% of the entire cohort) were adjudicated as AF. Oral anticoagulation was initiated in all these patients with adjudicated AF. The remaining tracings, which had been automatically categorized by the ICM as AF alerts, represented 34 patients (40% of the cohort). These patients had other arrhythmias including frequent PACs or PVCs, SVT, or NSVT. Conclusions: Compared to clinical trials, our real-world assessment suggests that the yield of AF following CS is lower - approximately 20%. Our findings highlight the importance for reviewing device tracings given the high rates of false positive for AF. Further research to refine AF detection algorithms in ICMs is needed.

scholarly journals Supraventricular Runs in 7-Day Holter Monitoring Are Related to Increased Incidence of Atrial Fibrillation in a 3-Year Follow-Up of Cryptogenic Stroke Patients Free from Arrhythmia in a 24 h-Holter

2021 ◽  
Vol 8 (7) ◽  
pp. 81
Author(s):  
Andrzej Kułach ◽  
Milena Dewerenda ◽  
Michał Majewski ◽  
Anetta Lasek-Bal ◽  
Zbigniew Gąsior
Keyword(s):  
Atrial Fibrillation ◽  
Cryptogenic Stroke ◽  
Holter Monitoring ◽  
Ecg Monitoring ◽  
Stroke Patients ◽  
Long Term Monitoring ◽  
In Cis ◽  
Term Monitoring

Introduction: Silent atrial fibrillation (AF) is a common cause of cryptogenic ischemic stroke (CIS). The 24-h-Holter is insufficient to reveal an occult arrhythmic cause of stroke and the strategy to select the patients for long-term monitoring is missing. Objectives: The aim of the study was to evaluate 7-day-Holter monitoring to identify cases with the arrhythmic cause of stroke in CIS patients in whom 24-h-Holter was free from arrhythmia, and to assess the relation between supraventricular (SV) runs in baseline Holter and the incidence of AF in a 3-year follow-up period. Methods: 78 patients (aged 60 ± 9 years, 45 males) with CIS and no arrhythmic findings in 24-h-Holter were enrolled. All patients had 7-day-Holter monitoring after stroke and were followed up for 36 months, and then 7-day Holter was repeated. We assessed SV runs (≥5 QRS) in the initial 7-day Holter and analyzed the relation of the findings with clinical characteristics of novel AF episodes revealed early after stroke and during a 3-year follow-up. Results: Baseline 7-day-Holter revealed SV runs in 36% of patients and AF in 9% of cases. During a 3-year follow-up, 8 additional cases were confirmed, both in standard care and in repeated Holter (a total of 19% of AF cases). There was no difference with regard to CHADS2VASc score (3.6 ± 1.1 vs. 3.4 ± 1.5; p = NS) and left atrium parameters between patients with SV runs and the non-arrhythmic group. Patients with SV runs had a higher incidence of AF both after stroke and in a 3-year follow-up (46% vs. 4%, RR 11.6, p < 0.001). In 8 cases, patent foramen ovale was detected during follow-up. Conclusions: A strategy of baseline 7-day-Holter monitoring after stroke allows for disclosing SV runs in every third case and AF in 9% of stroke survivors. Patients with SV runs have a higher incidence of AF (RR 11.6, p < 0.001) and should be considered for extended continuous ECG monitoring.

scholarly journals Three year incidence and duration of atrial fibrillation episodes among a large, real-world population of cryptogenic stroke patients with insertable cardiac monitors

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
P.D Ziegler ◽  
J.D Rogers ◽  
M Richards ◽  
A.J Nichols ◽  
S.W Ferreira ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Real World ◽  
Stroke Prevention ◽  
Detection Rate ◽  
Large Population ◽  
Cryptogenic Stroke ◽  
World Population ◽  
Median Frequency ◽  
Secondary Stroke Prevention

Abstract Background/Introduction The primary goal of monitoring for atrial fibrillation (AF) after cryptogenic stroke (CS) is secondary stroke prevention. Therefore, long-term monitoring of CS patients with insertable cardiac monitors (ICMs) is likely important to ensure appropriate secondary stroke prevention therapy, regardless of when AF is detected after the index event. However, long-term data on the incidence and duration of AF from real-world populations are sparse. Purpose To investigate the long-term incidence and duration of AF episodes in real-world clinical practice among a large population of patients with ICMs placed for AF detection following CS. Methods We included patients from a large device manufacturer's database who received an ICM for the purpose of AF detection following CS and were monitored for up to 3 years. All detected AF episodes (≥2 minutes) were adjudicated. We quantified the AF detection rate for various episode duration thresholds using Kaplan-Meier survival estimates, analyzed the maximum duration of AF episodes, and measured the time to initial AF detection. Results A total of 1247 patients (65.3±13.0 years, 53% male) were included and followed for 763±362 days. AF episodes (n=5456) were detected in 257 patients, resulting in a median frequency of 5 episodes [IQR 2–19] per patient. At 3 years, the AF detection rate for episodes ≥2 minutes was 24.2%. The AF detection rates at 3 years for episodes ≥6 minutes, ≥30 minutes, and ≥1 hour were 22.4%, 20.6%, and 19.1%, respectively. The median duration of the longest detected AF episode was 4.4 [IQR 1.2–13.9] hours and the median time to AF detection was 129 [IQR 45–354] days. Conclusion AF episodes were detected via ICMs in approximately one-quarter of CS patients within 3 years of follow-up. More than 75% of patients with AF detected had episodes lasting ≥1 hour and half had episodes lasting ≥4 hours. Detection of the first AF episode typically occurred beyond the range of conventional ambulatory monitors. Long-term surveillance of CS patients is likely important given the appreciable incidence, frequency, and duration of these AF episodes. Funding Acknowledgement Type of funding source: None

scholarly journals Best Practices for Long-Term Monitoring and Follow-Up of Alemtuzumab-Treated MS Patients in Real-World Clinical Settings

2019 ◽  
Vol 10 ◽  
Author(s):  
Krista Barclay ◽  
Robert Carruthers ◽  
Anthony Traboulsee ◽  
Ann D. Bass ◽  
Christopher LaGanke ◽  
...  
Keyword(s):  
Best Practices ◽  
Real World ◽  
Clinical Settings ◽  
Long Term Monitoring ◽  
Term Monitoring

scholarly journals Long-term detection of atrial fibrillation with insertable cardiac monitors in a real-world cryptogenic stroke population

2017 ◽  
Vol 244 ◽  
pp. 175-179 ◽  
Author(s):  
Paul D. Ziegler ◽  
John D. Rogers ◽  
Scott W. Ferreira ◽  
Allan J. Nichols ◽  
Mark Richards ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Real World ◽  
Cryptogenic Stroke ◽  
Stroke Population

scholarly journals Diagnosis, prognosis, and management of cryptogenic stroke

F1000Research ◽  
2016 ◽  
Vol 5 ◽  
pp. 168 ◽  
Author(s):  
Cen Zhang ◽  
Scott Kasner
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Trials ◽  
Ischemic Stroke ◽  
Diagnostic Criteria ◽  
Paroxysmal Atrial Fibrillation ◽  
Cryptogenic Stroke ◽  
Outcome Studies ◽  
Long Term Outcomes ◽  
Therapeutic Challenge

Despite many advances in our understanding of ischemic stroke, cryptogenic strokes (those that do not have a determined etiology) remain a diagnostic and therapeutic challenge. Previous classification approaches to cryptogenic stroke have led to inconsistent definitions, and evidence to determine optimal treatment is scarce. These limitations have prompted international efforts to redefine cryptogenic strokes, leading to more rigorous diagnostic criteria, outcome studies, and new clinical trials. Improvement in our ability to detect paroxysmal atrial fibrillation in patients with cryptogenic stroke has strengthened the idea that these strokes are embolic in nature. Further, better understanding of acute biomarkers has helped to identify otherwise occult mechanisms. Together, these strategies will inform long-term outcomes and shape management.

scholarly journals Real-world safety and effectiveness of rivaroxaban using Japan-specific dosage during long-term follow-up in patients with atrial fibrillation: XAPASS

PLoS ONE ◽  
2021 ◽  
Vol 16 (6) ◽  
pp. e0251325
Author(s):  
Takanori Ikeda ◽  
Satoshi Ogawa ◽  
Takanari Kitazono ◽  
Jyoji Nakagawara ◽  
Kazuo Minematsu ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Myocardial Infarction ◽  
Atrial Fibrillation ◽  
Central Nervous System ◽  
Real World ◽  
Japanese Patients ◽  
Systemic Embolism ◽  
Long Term Follow Up

Background The Xarelto Post-Authorization Safety and Effectiveness Study in Japanese Patients with Atrial Fibrillation (XAPASS) was designed to investigate safety and effectiveness during long-term follow-up of rivaroxaban treatment, using reduced doses compared with other global regions, in Japanese patients with non-valvular atrial fibrillation in real-world clinical practice. Methods In this prospective, open-label, single-arm, observational study, 11,308 patients with non-valvular atrial fibrillation newly prescribed rivaroxaban (15/10 mg once daily) at 1416 sites across Japan were enrolled and followed for a mean of 2.5 years. Results In total, 10,664 and 10,628 patients were included in the safety and effectiveness analyses, respectively. In the safety population, mean (standard deviation) age was 73.1 (9.8) years and Congestive heart failure, Hypertension, Age ≥75 years, Diabetes mellitus, previous Stroke/TIA (2 points) (CHADS2) score was 2.2 (1.3). Incidences (95% confidence intervals) of any and major bleeding were 3.77 (3.53–4.01) and 1.16 (1.03–1.29) events per 100 patient-years, respectively. Age ≥75 years, creatinine clearance <50 mL/min, diabetes mellitus, and vascular disease were independently associated with incidence of major bleeding. The primary composite effectiveness outcome of stroke, non-central nervous system systemic embolism, and myocardial infarction occurred at an incidence (95% confidence interval) of 1.32 (1.18–1.46) events per 100 patient-years. Age ≥75 years, hypertension, prior ischemic stroke/transient ischemic attack, and concomitant use of antiplatelets were independently associated with incidence of the composite outcome of stroke, non-central nervous system systemic embolism, and myocardial infarction. Conclusion In the XAPASS, a large-scale study involving a broad range of patients with non-valvular atrial fibrillation newly prescribed rivaroxaban using Japan-specific dosage in real-world clinical practice, no unexpected safety or effectiveness concerns were detected during up to 5 years of follow-up.

scholarly journals Digoxin treatment and long-term mortality depending on left ventricular ejection fraction and atrial fibrillation: a propensity score matched analysis

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
M.R Grubler ◽  
N.D Verheyen ◽  
A Meinitzer ◽  
L Fiedler ◽  
M Tscharre ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Trials ◽  
Coronary Angiography ◽  
Propensity Score ◽  
Ejection Fraction ◽  
Propensity Score Matching ◽  
Increased Risk ◽  
All Cause Mortality

Abstract Background/Introduction Atrial fibrillation (AF) is a common heart rhythm disturbance, associated with an increased risk of stroke, hospital admissions and mortality, especially in patients with reduced ejection fraction. Among the oldest medications used for heart-rate control is digitalis, but largely due to observational studies showing an increased risk of death it has fallen out of favour. Recently newer clinical trials reported that the treatment with digitalis in permanent AF might be superior to beta blocker therapy in regard to functional status and symptom burden. Given this diverging results we attempt to analysis a large cohort of patients facilitating a propensity score matching algorithm. Purpose To assess the associations of digitalis treatment with mortality in patients with increased cardiovascular risk. Methods Patients were derived from a large cohort study including participants from a tertiary care centre who were referred to coronary angiography. The propensity score matching is based on a predefined list of variables, with digitalis as treatment. Matching strategy is nearest neighbour matching and to prove consistency, radius matching (radius = 0.1). For survival analysis we used a Cox proportional hazard regression comparing patients with and without digitalis for all-cause mortality. The analysis is conducted using STATA 13 MP. All patients provided written informed consent and the study was approved by the ethics committee. Results A total of 2457 patients (median age: 63.5 [IQR = 56.3–70.6] years, 30.1% women) referred to coronary angiography, with a median follow up of 9.9 (IQR = 8.5–10.7) years were included. The matching process and the resulting propensity score fulfilled all statistical assumptions and resulted in a balanced cohort. The risk for all-cause mortality was higher among propensity score matched participants not treated with digitalis compared to patients on treatment (n=514) HR 3.03 (95% CI 2.5 to 3.7). Total mortality in patients with AF on digitalis after a median follow-up of 9.9 years was 27.6%. At baseline, only 42.4% of patients with AF were on oral anticoagulation. Conclusions In the present cohort treatment with digitalis was associated with a lower risk of all-cause mortality after long-term follow-up. The patient population has a clinically significant 10-year mortality risk. The results may not apply to other cohorts but may help inform future clinical trials. FUNDunding Acknowledgement Type of funding sources: None.

P1024Catheter ablation is associated with reduced all-cause mortality in a real-world cohort of patients with atrial fibrillation and heart failure

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
M Samuel ◽  
M Abrahamowicz ◽  
J Joza ◽  
V Essebag ◽  
L Pilote
Keyword(s):  
Heart Failure ◽  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Real World ◽  
Population Based ◽  
World Population ◽  
Risk Of Death ◽  
All Cause Mortality

Abstract Background Atrial fibrillation (AF) and heart failure (HF) are common co-existing conditions. Randomized trial data suggests a reduction in all-cause mortality with catheter ablation (CA) in selected patients, however, whether these results are replicable in a real-world population and persist in the long-term remains to be shown. Purpose To evaluate the long-term effectiveness of CA in AF-HF patients in reducing the incidence of: a) all-cause mortality b) HF hospitalizations, and c) major morbidities (stroke/transient ischemic attack (TIA) and major bleeding). Methods A population-based administrative cohort was created of AF-HF patients with government prescription coverage in Quebec, Canada (1999–2015). Patients who underwent CA (cases) were matched 1:2 to controls using risk-set sampling. Cases were matched on time in the cohort and frequency of hospitalizations. Measured time-invariant confounders were controlled for using inverse probability of treatment weighting (IPTW) and included age, sex, clinical characteristics, presence of cardiac implantable electronic devices, and medication use. Multivariable Cox models adjusted the association of CA with the outcomes for the time varying confounders of the presence of an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT), anticoagulation use (warfarin or direct oral anticoagulation), and any antiarrhythmic (AAD) use during follow-up. For non-fatal outcomes, the competing risk of death was accounted for using the Lunn-McNeil approach. Results Of the 87,676 AF-HF patients, 298 underwent CA and were matched to 591 controls. After IPTW, the distribution of covariates was balanced between cases and controls [age 65.6±11.0 vs 61.6±11.6; women 24% vs 20%; CHA2DS2-Vasc score 3.2±2.3 vs 2.9±2.1; CA vs non-CA, respectively; standardized mean differences <0.1 for all]. Over a median follow-up of 3.3 (IQR 1.1–6.4) years, 19 (7.3%) of CA patients died compared to 144 (24.6%) non-CA patients. After weighting and adjustment, CA was associated with a statistically significant reduction in the incidence of all-cause mortality [adjusted HR 0.5 (95% CI 0.3–0.9)]. In addition, there was no statistically significant difference in the incidence of HF hospitalizations over the follow-up [CA: 22.5% vs non-CA: 27.1%; adjusted HR 0.9 (95% CI 0.6–1.2)]. The incidences of stroke/TIA (1.7% vs 6.8%) and major bleeding (1.7% vs 4.9%) for CA vs non-CA were not statistically different. Conclusion In a matched population-based AF-HF cohort, CA was associated with a reduced risk of all-cause mortality compared to patients who did not undergo CA. Although no difference in the risk of HF hospitalizations, stroke/TIA, and major bleeding was detected between CA and non-CA patients, larger studies are warranted. Acknowledgement/Funding Canadian Institute of Health Research; Fonds de recherché du Quebec-Santé, Clinical Research Scholar Award (V. Essebag) and Doctoral Award (M. Samuel)

Long-term bleeding risk prediction in ‘real world’ patients with atrial fibrillation: Comparison of the HAS-BLED and ABC-Bleeding risk scores

2017 ◽  
Vol 117 (10) ◽  
pp. 1848-1858 ◽  
Author(s):  
Vanessa Roldán ◽  
Vicente Vicente ◽  
Mariano Valdés ◽  
Gregory Y. H. Lip ◽  
María Asunción Esteve-Pastor ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Major Bleeding ◽  
Real World ◽  
Bleeding Risk ◽  
Risk Scores ◽  
Bleeding Events ◽  
Bleeding Score ◽  
Better Than

SummaryRisk scores in patients with atrial fibrillation (AF) based on clinical factors alone generally have only modest predictive value for predicting high risk patients that sustain events. Biomarkers might be an attractive prognostic tool to improve bleeding risk prediction. The new ABCBleeding score performed better than HAS-BLED score in a clinical trial cohort but has not been externally validated. The aim of this study was to analyze the predictive performance of the ABC-Bleeding score compared to HAS-BLED score in an independent “real-world” anticoagulated AF patients with long-term follow-up. We enrolled 1,120 patients stable on vitamin K antagonist treatment. The HAS-BLED and ABC-Bleeding scores were quantified. Predictive values were compared by c-indexes, IDI, NRI, as well as decision curve analysis (DCA). Median HAS-BLED score was 2 (IQR 2–3) and median ABC-Bleeding was 16.5 (IQR 14.3–18.6). After 6.5 years of follow-up, 207 (2.84%/year) patients had major bleeding events, of which 65 (0.89%/year) had intracranial haemorrhage (ICH) and 85 (1.17%/year) had gastrointestinal bleeding events (GIB). The c-index of HAS-BLED was significantly higher than ABC-Bleeding for major bleeding (0.583 vs 0.518; p=0.025), GIB (0.596 vs 0.519; p=0.017) and for the composite of ICH-GIB (0.593 vs 0.527; p=0.030). NRI showed a significant negative reclassification for major bleeding and for the composite of ICH-GIB with the ABC-Bleeding score compared to HAS-BLED. Using DCAs, the use of HAS-BLED score gave an approximate net benefit of 4% over the ABC-Bleeding score. In conclusion, in the first “real-world” validation of the ABC-Bleeding score, HAS-BLED performed significantly better than the ABC-Bleeding score in predicting major bleeding, GIB and the composite of GIB and ICH.Note: The review process for this manuscript was fully handled by Christian Weber, Editor in Chief.Supplementary Material to this article is available online at www.thrombosis-online.com.

scholarly journals Long-term real-world experience with ipilimumab and non-ipilimumab therapies in advanced melanoma: the IMAGE study

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Stéphane Dalle ◽  
Laurent Mortier ◽  
Pippa Corrie ◽  
Michal Lotem ◽  
Ruth Board ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Real World ◽  
Patient Reported Outcomes ◽  
Advanced Melanoma ◽  
Image Study ◽  
Patient Reported ◽  
Treatment Naïve ◽  
Systemic Therapies

Abstract Background Ipilimumab has shown long-term overall survival (OS) in patients with advanced melanoma in clinical trials, but robust real-world evidence is lacking. We present long-term outcomes from the IMAGE study (NCT01511913) in patients receiving ipilimumab and/or non-ipilimumab (any approved treatment other than ipilimumab) systemic therapies. Methods IMAGE was a multinational, prospective, observational study assessing adult patients with advanced melanoma treated with ipilimumab or non-ipilimumab systemic therapies between June 2012 and March 2015 with ≥3 years of follow-up. Adjusted OS curves based on multivariate Cox regression models included covariate effects. Safety and patient-reported outcomes were assessed. Results Among 1356 patients, 1094 (81%) received ipilimumab and 262 (19%) received non-ipilimumab index therapy (systemic therapy [chemotherapy, anti–programmed death 1 antibodies, or BRAF ± MEK inhibitors], radiotherapy, and radiosurgery). In the overall population, median age was 64 years, 60% were male, 78% were from Europe, and 78% had received previous treatment for advanced melanoma. In the ipilimumab-treated cohort, 780 (71%) patients did not receive subsequent therapy (IPI-noOther) and 314 (29%) received subsequent non-ipilimumab therapy (IPI-Other) on study. In the non-ipilimumab–treated cohort, 205 (78%) patients remained on or received other subsequent non-ipilimumab therapy (Other-Other) and 57 (22%) received subsequent ipilimumab therapy (Other-IPI) on study. Among 1151 patients who received ipilimumab at any time during the study (IPI-noOther, IPI-Other, and Other-IPI), 296 (26%) reported CTCAE grade ≥ 3 treatment-related adverse events, most occurring in year 1. Ipilimumab-treated and non-ipilimumab–treated patients who switched therapy (IPI-Other and Other-IPI) had longer OS than those who did not switch (IPI-noOther and Other-Other). Patients with prior therapy who did not switch therapy (IPI-noOther and Other-Other) showed similar OS. In treatment-naive patients, those in the IPI-noOther group tended to have longer OS than those in the Other-Other group. Patient-reported outcomes were similar between treatment cohorts. Conclusions With long-term follow-up (≥ 3 years), safety and OS in this real-world population of patients treated with ipilimumab 3 mg/kg were consistent with those reported in clinical trials. Patient-reported quality of life was maintained over the study period. OS analysis across both pretreated and treatment-naive patients suggested a beneficial role of ipilimumab early in treatment. Trial registration ClinicalTrials.gov, NCT01511913. Registered January 19, 2012 – Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT01511913

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