Implantable ECG device effective in improving atrial fibrillation detection in ischemic stroke patients, study shows
In patients with ischemic stroke without prior evidence of atrial fibrillation, 12 months of implantable ECG monitoring was more likely to detect AF than 30 days of external monitoring, according to the results of the PER DIEM trial.
The researchers randomly assigned 300 ischemic stroke patients (median age, 64 years; 40% female; median CHA2DS2-VASc score 4) with undiagnosed atrial fibrillation to receive a long-term implantable loop recorder (Reveal LINQ, Medtronic), plus remote monitoring (MyCareLink, Medtronic) or external event-triggered loop recorders (Spiderflash-t, Sorin).
At 12 months, 15.3 percent of the implanted group and 4.7 % of the external group had definite or very likely AF (defined as a confirmed AF episode lasting at least 2 minutes), with a between-group difference of 10.7 percentage points for the primary outcome; 95% CI, 4-17.3; RR = 3.29; 95% confidence interval, 1.45-7.42; P = 0.003.
The secondary outcome of time to first AF episode lasting at least 2 minutes was lower in the implant group compared to the external group (adjusted HR = 3.36; 95% CI, 1.44-7.84; P = 0.005; log-rank P = 0.002), according to the researchers, secondary outcomes of death or AF detection at 12 months occurred more frequently in the implant group (17.3% vs 6.7%; between-group difference 10.7 percentage points; 95% CI, 3.4-17.9 ; P=0.007; aHR=2.64; 95% CI, 1.27-5.29; P=0.009).
There were no differences between the two groups with regard to secondary outcomes of transient ischemic attack, recurrent ischemic stroke, intracerebral hemorrhage, or death. One serious adverse event related to the device occurred in the implant group but none in the external group. All atrial fibrillation diagnoses resulted in prescriptions for oral anticoagulants, the researchers wrote.
"Long-term cardiac monitoring of all stroke patients with no documented occurrence of atrial fibrillation would have cost implications," Buck and colleagues wrote. The implantable loop recorder used in this study was a single-use Devices.While the daily PER DIEM trial found that the amount of monitoring required for AF was relatively small, it remains unproven whether wider adoption of implantable cycle recorders translates into lower stroke rates and health economic benefits ...research is needed to identify subgroups of stroke patients in whom empiric anticoagulation is more cost-effective than an extended cardiac monitoring strategy."
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