Implant and long-term evaluation of atrial signal amplification in a single-lead ICD.
BACKGROUND
In patients without clinical indications for pacing the use of a single-lead implantable cardioverter defibrillator (ICD) implementing atrial sensing capability with proper signal amplification management may represent a useful therapeutic option, combining the positive features of both single and dual-chamber devices. The aim of the study was to evaluate the atrial signal amplification and its long-term stability in a single-lead ICD system adding atrial sensing to a standard single-chamber ICD.


METHODS
P-wave amplitudes were collected and compared at implant both with a conventional external device ("unfiltered" P wave) and telemetrically with the implanted ICD ("filtered" P wave). Filtered/unfiltered P-wave ratio (amplification factor, AmF) was evaluated at implant and during follow-up.


RESULTS
In 43 enrolled patients (38 men, age 64 ± 16 years), the mean filtered P wave at implant was significantly higher than the unfiltered P wave (3.85 ± 0.81 mV vs 2.0 ± 1.49 mV; P < 10(-11) ), with a mean AmF value of 2.77 ± 1.62. In seven patients with atrial fibrillation at implant, the AmF was higher (4.62 ± 1.94) than in patients in sinus rhythm (2.41 ± 1.30; P < 0.001). A significant linear correlation was found between the inverse of P wave and the AmF (R = 0.82, P < 0.00001). In 25 patients followed for 384 ± 244 days, atrial undersensing was never documented and AmF did not change from implant (3.19 ± 1.82; P = 0.24), also in different body position and breathing conditions.


CONCLUSIONS
The single-lead ICD system evaluated reliably amplified P-wave amplitudes by a factor of about three, maintaining this performance during the observed follow-up.