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Published on: February 26, 2013
Cryptogenic stroke and underlying atrial fibrillation
Tommaso Sanna1, Hans-Christoph Diener, Rod S Passman
1From the Catholic University of the Sacred Heart, Institute of Cardiology (T.S.), and Institute of Neurology, Campus Bio-Medico University (V.D.L.) - both in Rome; the Department of Neurology and Stroke Center, University Hospital Essen, Essen (H.-C.D.), and Hospital Klinikum Coburg, Teaching Hospital of the University of Würzburg, Coburg (J.B.) - both in Germany; Bluhm Cardiovascular Institute (R.S.P.) and Davee Department of Neurology (R.A.B.), Northwestern University Feinberg School of Medicine, Chicago; Population Health Research Institute, McMaster University, Hamilton, ON, Canada (C.A.M.); University of Kansas Medical Center, Kansas City (M.M.R.); the KU Leuven Department of Neurosciences, the VIB-Vesalius Research Center, and the Department of Neurology, University Hospitals Leuven - all in Leuven, Belgium (V.T.); Medtronic, Mounds View, MN (T.R., K.L.); and Medtronic, Maastricht, the Netherlands (F.B.).
Insights
Long-term monitoring with an insertable cardiac monitor (ICM) significantly improved the detection of atrial fibrillation in cryptogenic stroke patients compared to standard follow-up. This finding has important implications for stroke management and prevention strategies.
Area of Science:
- Cardiology
- Neurology
- Medical Devices
Background:
- Current guidelines suggest 24-hour ECG monitoring post-ischemic stroke to detect atrial fibrillation (AF).
- The optimal duration and method for AF detection remain unclear, especially in cryptogenic stroke cases where the cause is often undetermined.
- Identifying AF in cryptogenic stroke patients is crucial for guiding therapeutic decisions and preventing recurrent events.
Purpose of the Study:
- To evaluate the efficacy of long-term monitoring using an insertable cardiac monitor (ICM) versus conventional follow-up for detecting atrial fibrillation in patients with cryptogenic stroke.
- To compare the time to the first detection of atrial fibrillation within 6 and 12 months between the ICM and control groups.
Main Methods:
- A randomized, controlled trial involving 441 patients aged 40 years or older with cryptogenic stroke and no initial evidence of AF.
- Patients were randomized to either ICM monitoring or conventional follow-up within 90 days of the index event.
- The primary endpoint was the detection of atrial fibrillation (lasting >30 seconds) within 6 months, with a secondary endpoint at 12 months. Data analysis followed the intention-to-treat principle.
Main Results:
- At 6 months, atrial fibrillation was detected in 8.9% of the ICM group versus 1.4% of the control group (HR 6.4; P<0.001).
- By 12 months, atrial fibrillation detection rates were 12.4% in the ICM group compared to 2.0% in the control group (HR 7.3; P<0.001).
- The ICM group demonstrated a significantly higher rate of AF detection throughout the study period.
Conclusions:
- Insertable cardiac monitor (ICM) use is superior to conventional follow-up for detecting atrial fibrillation in patients with cryptogenic stroke.
- Long-term ICM monitoring offers a more effective strategy for identifying AF, enabling timely therapeutic interventions.
- The CRYSTAL AF study (NCT00924638) provides robust evidence supporting ICMs in cryptogenic stroke management.
Background:
Current guidelines recommend at least 24 hours of electrocardiographic (ECG) monitoring after an ischemic stroke to rule out atrial fibrillation. However, the most effective duration and type of monitoring have not been established, and the cause of ischemic stroke remains uncertain despite a complete diagnostic evaluation in 20 to 40% of cases (cryptogenic stroke). Detection of atrial fibrillation after cryptogenic stroke has therapeutic implications.
Methods:
We conducted a randomized, controlled study of 441 patients to assess whether long-term monitoring with an insertable cardiac monitor (ICM) is more effective than conventional follow-up (control) for detecting atrial fibrillation in patients with cryptogenic stroke. Patients 40 years of age or older with no evidence of atrial fibrillation during at least 24 hours of ECG monitoring underwent randomization within 90 days after the index event. The primary end point was the time to first detection of atrial fibrillation (lasting >30 seconds) within 6 months. Among the secondary end points was the time to first detection of atrial fibrillation within 12 months. Data were analyzed according to the intention-to-treat principle.
Results:
By 6 months, atrial fibrillation had been detected in 8.9% of patients in the ICM group (19 patients) versus 1.4% of patients in the control group (3 patients) (hazard ratio, 6.4; 95% confidence interval [CI], 1.9 to 21.7; P<0.001). By 12 months, atrial fibrillation had been detected in 12.4% of patients in the ICM group (29 patients) versus 2.0% of patients in the control group (4 patients) (hazard ratio, 7.3; 95% CI, 2.6 to 20.8; P<0.001).
Conclusions:
ECG monitoring with an ICM was superior to conventional follow-up for detecting atrial fibrillation after cryptogenic stroke. (Funded by Medtronic; CRYSTAL AF ClinicalTrials.gov number, NCT00924638.).
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