P1011Cryptogenic stoke and asymptomatic atrial fibrillation in a real world population: a single centre, implantable loop recorder study

EP Europace ◽  
2020 ◽  
Vol 22 (Supplement_1) ◽  
Author(s):  
M Faustino ◽  
V Di Stefano ◽  
R Franciotti ◽  
N Furia ◽  
E Di Girolamo ◽  
...  

Abstract Funding Acknowledgements None Background The incidence of atrial fibrillation (AF) in cryptogenic stroke (CS) patients has been studied in carefully controlled clinical trials, but real-world data are limited. Purpose Aim of this study was to investigated the incidence of AF in clinical practice among CS patients with an implantable cardiac monitor (ICM) recommended (IIA) for AF detection. Methods Patients with CS admitted to our Stroke Unit were included in the study. Patiens received an ICM and were monitored for up to 2 years for AF detection (in-hospital clinic and remote monitoring). All detected AF episodes (≥30 sec) were considered. Results From March 2016 to March 2019, 58 patients (mean age 68 ±12 years, 67% male) received an ICM to detect AF after a CS.  No patients were lost during follow-up. AF was detected in 23 patients (40% overall; AF group mean age 72 ± 11 years; 65% male) after a mean time of 6 months from ICM implantation (ranging from 2 days up to 2 years) and 8 months after CS (ranging from 1 month up to 2 years). In these AF patients anticoagulant treatment was prescribed, and no further stroke was reported. Conclusions AF episodes were detected via continuous monitoring with ICMs in 40% of implanted CS patients. AF after CS was asymptomatic and thus unlikely to be detected by strategies based on intermittent short-term recordings. Therefore, ICMs should be considered as part of daily practice in the evaluation of CS patients. Abstract Figure 1. Detection rate over time

2019 ◽  
Vol 27 (12) ◽  
pp. 605-612 ◽  
Author(s):  
A. J. W. M. de Veer ◽  
N. Bennaghmouch ◽  
M. C. E. F. Wijffels ◽  
J. M. ten Berg

Abstract Background Current guidelines recommend non-vitamin‑K oral anticoagulants (NOACs) as the first-choice therapy for stroke prevention in patients with atrial fibrillation (AF). The use of drugs in a clinical trial setting differs from that in real-world populations. Real-world data are important to accrue more heterogeneous patient populations with respect to co-morbidities and co-medication use. The aim of this study was to evaluate the use of NOACs in daily practice in a large tertiary hospital in the Netherlands. Methods A single-centre prospective study was conducted among all patients with AF using a NOAC in the St. Antonius Hospital between 2013 and June 2017. The outcomes were the rates of any bleeding, stroke/transient ischaemic attack, mortality, discontinuation rate and adverse drug reactions. Results In total, 799 patients were enrolled with a mean follow-up of 1.7 years. Mean age was 69.8 (SD ± 11) and 61.2% were male. Mean CHA2DS2-VASc score was 2.8 (SD ± 1.6) and mean HAS-BLED score was 1.4 (SD ± 0.9). Bleeding occurred in 6.0, major bleeding in 1.8, stroke in 1.2 patients per 100 patient-years, and 87 patients (10.9%) died during the follow-up period. Adverse drug reactions were reported by 59 patients (7.4%). Finally, 249 patients (31.2%) reported a temporary interruption and 132 (16.5%) permanent discontinuation of NOAC treatment, of whom 33 (25%) patients switched to a vitamin‑K antagonist. Conclusions We observed low rates of bleeding and adverse drug reactions. However, rates of mortality and discontinuation were relatively high. These results could possibly be explained by the real-world nature of the data including higher-risk patients.


2015 ◽  
Vol 40 (3-4) ◽  
pp. 175-181 ◽  
Author(s):  
Paul D. Ziegler ◽  
John D. Rogers ◽  
Scott W. Ferreira ◽  
Allan J. Nichols ◽  
Shantanu Sarkar ◽  
...  

Background: The characteristics of atrial fibrillation (AF) episodes in cryptogenic stroke patients have recently been explored in carefully selected patient populations. However, the incidence of AF among a large, real-world population of patients with an insertable cardiac monitor (ICM) placed for the detection of AF following a cryptogenic stroke has not been investigated. Methods: Patients in the de-identified Medtronic DiscoveryLink™ database who received an ICM (Reveal LINQ™) for the purpose of AF detection following a cryptogenic stroke were included. AF detection rates (episodes ≥2 min) were quantified using Kaplan-Meier survival estimates at 1 and 6 months and compared to the CRYSTAL AF study at 6 months. The time to AF detection and maximum duration of AF episodes were also analyzed. Results: A total of 1,247 patients (age 65.3 ± 13.0 years) were followed for 182 (IQR 182-182) days. A total of 1,521 AF episodes were detected in 147 patients, resulting in AF detection rates of 4.6 and 12.2% at 30 and 182 days, respectively, and representing a 37% relative increase over that reported in the CRYSTAL AF trial at 6 months. The median time to AF detection was 58 (IQR 11-101) days and the median duration of the longest detected AF episode was 3.4 (IQR 0.4-11.8) h. Conclusions: The real-world incidence of AF among patients being monitored with an ICM after a cryptogenic stroke validates the findings of the CRYSTAL AF trial and suggests that continuous cardiac rhythm monitoring for periods longer than the current guideline recommendation of 30 days may be warranted in the evaluation of patients with cryptogenic stroke.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
E Ebrille ◽  
C Amellone ◽  
M.T Lucciola ◽  
F Orlando ◽  
M Suppo ◽  
...  

Abstract Objective The main objective of our study was to analyze the incidence and predictors of atrial fibrillation (AF) in patients with cryptogenic stroke (CS) who received an implantable cardiac monitor (ICM) at our Institution. Methods From November 2013 to October 2017, a total of 133 patients who had suffered a CS were implanted with an ICM after a thorough screening process. The median time between the thromboembolic event and ICM implantation was 64 days [IQ range: 16–111]. All implanted patients were followed with remote monitoring until the first detected episode of AF or up to December 2018. Every remote monitoring transmission and related electrograms were analyzed by the dedicated Electrophysiology Nursing team and confirmed by experienced Electrophysiologists. AF was defined by any episode lasting greater than or equal to 2 minutes. Results During a median follow-up of 14.8 months [IQ range: 3.0–31.2], AF was detected in 65 out of 133 patients (48.9%). The median time from ICM implantation and AF detection was 3.5 months [IQ range: 0.9–6.7]. The prevalence of AF was 22.6%, 34.4%, 40.8% and 48.3% at 3, 6, 12 and 24 months respectively. At the multivariate analysis, high premature atrial contractions (PAC) burden and left atrium (LA) dilation were the only independent predictors of AF detection (HR 2.82, 95% CI 1.64–4.83, p<0.001 for PAC; HR 1.75, 95% CI 1.03–2.97, p=0.038 for LA dimension). Patients were dived into categories based on the probability of AF detection (low, intermediate and high risk) and a new risk stratification algorithm was implemented (Figure 1). Conclusion After a thorough screening process, AF detection in patients with CS and ILM was quite high. Having a high PAC burden and LA dilation predicted AF episodes at the multivariate analysis. A new risk stratification algorithm was developed. Figure 1 Funding Acknowledgement Type of funding source: None


2021 ◽  
Vol 3 (1) ◽  
pp. e000089
Author(s):  
Sanket S Dhruva ◽  
Guoqian Jiang ◽  
Amit A Doshi ◽  
Daniel J Friedman ◽  
Eric Brandt ◽  
...  

ObjectivesTo determine the feasibility of using real-world data to assess the safety and effectiveness of two cardiac ablation catheters for the treatment of persistent atrial fibrillation and ischaemic ventricular tachycardia.DesignRetrospective cohort.SettingThree health systems in the USA.ParticipantsPatients receiving ablation with the two ablation catheters of interest at any of the three health systems.Main outcome measuresFeasibility of identifying the medical devices and participant populations of interest as well as the duration of follow-up and positive predictive values (PPVs) for serious safety (ischaemic stroke, acute heart failure and cardiac tamponade) and effectiveness (arrhythmia-related hospitalisation) clinical outcomes of interest compared with manual chart validation by clinicians.ResultsOverall, the catheter of interest for treatment of persistent atrial fibrillation was used for 4280 ablations and the catheter of interest for ischaemic ventricular tachycardia was used 1516 times across the data available within the three health systems. The duration of patient follow-up in the three health systems ranged from 91% to 97% at ≥7 days, 89% to 96% at ≥30 days, 77% to 90% at ≥6 months and 66% to 84% at ≥1 year. PPVs were 63.4% for ischaemic stroke, 96.4% for acute heart failure, 100% at one health system for cardiac tamponade and 55.7% for arrhythmia-related hospitalisation.ConclusionsIt is feasible to use real-world health system data to evaluate the safety and effectiveness of cardiac ablation catheters, though evaluations must consider the implications of variation in follow-up and endpoint ascertainment among health systems.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
P.D Ziegler ◽  
J.D Rogers ◽  
M Richards ◽  
A.J Nichols ◽  
S.W Ferreira ◽  
...  

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


Stroke ◽  
2016 ◽  
Vol 47 (suppl_1) ◽  
Author(s):  
Mark Richards ◽  
John D Rogers ◽  
Scott W Ferreira ◽  
Allan J Nichols ◽  
Jodi L Koehler ◽  
...  

Introduction: Detection of atrial fibrillation (AF) in patients with a cryptogenic stroke (CS) is critical for reducing the risk of recurrent stroke by enabling oral anticoagulation therapy. However, the impact of age on AF detection and the optimum duration of AF monitoring in patients following a CS is not well characterized. We investigated the impact of age on AF detection among a large, real-world cohort of unselected patients with an implantable cardiac monitor (ICM) placed following CS. Methods: Patients in the de-identified Medtronic Discovery™ Link database who received an ICM (Reveal LINQ™) for AF detection following CS were included and monitored for up to 182 days. All AF episodes were adjudicated. We compared the mean age between patients with vs. without AF detected and compared the median time to detection of the first AF episode between younger (age ≤65) and older (age >65) patients. Results: Among 1247 patients (mean age 65.3±13.0, 53% male) followed for 182 [IQR 182-182] days, 1521 AF episodes were detected in 147 patients and resulted in an AF detection rate of 12.2%. Patients with AF detected were significantly older than patients without AF detected (71.3±10.9 vs. 64.5±13.1 years, respectively; p<0.001). The median time to detection of the first AF episode was shorter for older vs. younger patients (43 [10-91] vs. 89 [29-127] days, respectively; p=0.016; Figure). Conclusion: Continuous monitoring of CS patients with an ICM resulted in an AF detection rate of 12.2% within the initial 6 months. Patients with AF detected were older and patients >65 years of age had shorter times to initial AF detection. However even among older patients, the majority of AF occurred outside the range of external monitoring devices and thus highlights the importance of long-term monitoring with ICMs in the management of CS patients.


Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Naga Venkata K Pothineni ◽  
Uyanga Batnyam ◽  
Jeffrey Arkles ◽  
John Bullinga ◽  
Brett L CUCCHIARA ◽  
...  

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.


2022 ◽  
Vol 8 ◽  
Author(s):  
Vincenzo Russo ◽  
Antonello D'Andrea ◽  
Stefano De Vivo ◽  
Anna Rago ◽  
Gianluca Manzo ◽  
...  

Introduction:Little is known about the clinical performance of single-chamber leadless pacemaker (LLPM) in patients without atrial fibrillation (AF) as pacing indication. The aim of this study was to describe the clinical characteristics of patients who underwent single chamber LLPM implantation at three tertiary referral centers and to compare the safety and effectiveness of the single-chamber LLPM among patients with or without AF.Materials and Methods:All the consecutive patients who underwent LLPM implantation at three referral centers were analyzed. The indications to LLPM in a real-world setting were described. The study population was divided into two groups according to AF as pacing indication. We assessed the procedure-related complications; moreover, we compared syncope, cardiac hospitalization, pacemaker syndrome, and all-cause death recurrence during the follow-up between patients with and without AF as pacing indication.Results:A total of 140 consecutive patients (mean age, 76.7 ± 11.24 years, men 64.3%) were included in the study. The indication to implantation of LLPM was permanent AF with slow ventricular response (n: 67; 47.8%), sinus node dysfunction (n: 25; 17.8%), third atrioventricular block (AVB) (n: 20; 14.2%), second-degree AVB (n: 18; 12.8%), and first degree AVB (n: 10; 7.1%). A total of 7 patients (5%) experienced perioperative complications with no differences between the AF vs. non-AF groups. During a mean follow-up of 606.5 ± 265.9 days, 10 patients (7.7%) died and 7 patients (5.4%) were reported for cardiac hospitalization; 5 patients (3.8%) experienced syncope; no patients showed pacemaker syndrome. No significant differences in the clinical events between the groups were shown. The Kaplan–Meier analysis for the combined endpoints did not show significant differences between the AF and non-AF groups [hazard ratio (HR): 0.94, 95% CI: 0.41–2.16; p = 0.88].Conclusion:Our real-world data suggest that LLPM may be considered a safe and reasonable treatment in patients without AF in need of pacing. Further studies are needed to confirm these preliminary results.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
M Samuel ◽  
M Abrahamowicz ◽  
J Joza ◽  
V Essebag ◽  
L Pilote

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)


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