How many patients fulfil the surface electrocardiogram criteria for subcutaneous implantable cardioverter-defibrillator implantation?

Abstract

To determine the number of patients with a primary or secondary prevention implantable cardioverter-defibrillator (ICD) indication who are eligible for subcutaneous ICD (S-ICD) implantation according to the S-ICD manufacturer's surface electrocardiogram (ECG) screening template. One hundred and ninety-six ICD patients with a non-paced ventricle were assessed using erect and supine ECG limb lead recordings to simulate the three S-ICD sensing vectors. Each ECG lead was scrutinized by two independent observers. Subcutaneous ICD eligibility required two or more leads to satisfy the S-ICD screening template in both erect and supine positions. Overall, 85.2% of patients [95% confidence interval (CI): 80.2-90.2%] fulfilled surface ECG screening criteria. The proportion of patients with 3, 2, 1, and 0 qualifying leads were 37.2% (95% CI: 30.4-44.0%), 48.0% (95% CI: 41.0-55.0%), 11.2% (95% CI: 6.8-15.6%), and 3.6% (95% CI: 1.0-6.2%). The S-ICD screening template was satisfied more often by Lead III (primary vector, 83.7%, 95% CI: 78.5-88.9%) and Lead II (secondary vector, 82.7%, 95% CI: 77.4-88.0%) compared with Lead I (alternate vector, 52.6%, 95% CI: 45.6-59.6%). A prolonged QRS duration was the only baseline characteristic independently associated with ineligibility for S-ICD implantation. There was 92.9% agreement between the two independent observers in assessment of eligibility using the S-ICD screening template. About 85.2% of patients with an indication for a primary or secondary prevention ICD have a surface ECG that is suitable for S-ICD implantation when assessed with an S-ICD screening template. There is minor inter-observer variation in assessment of eligibility using the S-ICD screening template.