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ISSUE II: Implantable electrocardiography monitor allows effective syncope therapy
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Among patients with suspected neurally mediated syncope, diagnosis and risk stratification with an implantable electrocardiographic monitor was safe. The device delays therapy until documentation of syncope.
Traditionally, in the absence of an ECG documentation of syncope, clinicians are guided by tilt testing results. However, controlled trials of tilt testing have often failed to show a benefit.
Michele Brignole, MD, of Ospedali del Tigullio in Italy, presented results of the ISSUE II (International Study on Syncope of Uncertain Etiology 2) trial at the European Society of Cardiology Congress 2005. ISSUE II tested the utility of the Implantable Loop Recorder (Medtronic).
The Implantable Loop Recorder is placed subcutaneously and captures high fidelity electrocardiography recordings through patient activation of the device or automatic activation using predefined arrhythmia triggers.
ISSUE II enrolled 442 patients from 63 centers in nine countries. All patients had to have at least three severe syncopal events over the previous two years with normal ECGs.
During the first phase of the trial, patients were followed until their first syncopal episode. Episodes were identified in 103 patients of whom 47 received pacemaker therapy and six received antitachyarrhythmia therapy based on the findings of the Implantable Loop Recorder. The remaining 50 patients, the control group, did not receive specific therapy.
After a one year follow-up period, phase 2 of the trial, researchers noted a 10% rate of syncope recurrence in the group that had been given therapy guided by the Implantable Loop Recorder and a 41% rate of recurrence in controls (P=.002).
No differences in safety outcomes were noted between the two groups.
For more information:
- Brignole M. ISSUE II: The Implantable Loop Recorder allows a mechanism-based effective therapy in patients with recurrent suspected or certain neurally mediated syncope. Presented at the European Society of Cardiology Congress 2005. Sept. 3-7, 2005. Stockholm.