Eastbourne Syncope Assessment Study - EASYAS
Randomized trial comparing implantable loop recorder and usual care for the diagnosis and management of syncope.
Implantable loop recorder will lead to earlier diagnosis and improved management of unexplained syncope.
Patients Screened: 421
Patients Enrolled: 201
Mean Follow Up: 6 months. Mean 276 +/-134 days
Mean Patient Age: 54-91. Mean 74 years
1) Age >16 years 2) Acute syncope presentation 3) >2 syncopal episodes in the preceding 12 months 4) No diagnosis obtained within 24 hour clinical work-up
1) Indication for cardiac pacing after carotid sinus massage and head-up tilt testing 2) Known neurocardiogenic syncope
1) Time to first syncopal episode following study initiation 2) Time to second syncopal episode following study initiation 3) Time to introduction of device, drug, or other therapy 4) Quality of life
Implantable loop recorder vs. usual care
33% of patients with implantable loop recorders obtained an ECG diagnosis during the follow-up period. The time to ECG diagnosis was more rapid in patients receiving the implantable loop recorder (Hazard ratio 8.9; [95% CI 3.2-25]; p<0.00001). Of diagnosed patients, bradycardia (26%), ventricular tachycardia (8%), and supraventricular tachycardia (3%) were identified. 64% of patients were diagnosed as having sinus rhythm with vasovagal syncope (45%), hyperventilation (8%) and epilepsy (11%). Patients received therapy sooner if implanted with a loop recorder (Hazrad ratio 7.9, [95% CI 2.8-22.3];p<0.0001). Wile 33% of patients in the loop recorder arm received ECG guided therapy only 4% of conventionally treated patients received therapy. The times to first and second syncopal episodes were not significantly different. The device was not able to identify a cause in 47% of patients after the first episode of syncope and in 12% of patients after the second episode after device implantation due to delayed patient activation and other management difficulties. 21% of diagnoses were obtained with the auto-holter feature. Despite lower hospitalization and investigation costs with loop recorders, costs including device acquisition were higher with loop recorders with no difference in quality of life.
This small trial demonstrated that the use of implantable loop recorders are associated with an improvement in the ability to make an electrocardiographic diagnosis in cases of unexplained syncope. Use of the device was also associated with earlier initiation of therapy at a higher initial cost. As evidenced by similar times to recurrence of syncope with and without loop recorders, therapies for syncope remain poor and despite a diagnosis being made electrocardiographically, recurrence rates remain high. While the recorders functioned properly, ECG diagnoses were not obtained in almost half of the patients after their first syncopal episode. Patient education regarding the use of this device is important to improve diagnostic sensitivity.
Presented by N. Sulke at the Annual Meeting of the European Society of Cardiology, September 2, 2002.
Keywords: Hyperventilation, Tachycardia, Supraventricular, Tachycardia, Ventricular, Quality of Life, Syncope, Epilepsy, Bradycardia, Electrocardiography, Hospitalization
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