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.

Role of rate control and regularization through pacing in patients with chronic atrial fibrillation and preserved ventricular function: the VRR study.

AIM: High heart rates in chronic atrial fibrillation (CAF) is one of the factors responsible for hemodynamic alterations and may lead to tachycardiomyopathies. The ventricular rate regulation (VRR) study evaluates the effect of ventricular rate regularization in CAF patients with preserved ventricular function, marked ventricular rate variability, and indications for pacemaker (PM) implantation owing to symptomatic pauses. Rate regularization was achieved using VRR algorithm (INSIGNIA pacemakers, Guidant Corp., St. Paul, MN, USA). METHODS: One month after PM implantation, 58 patients followed two 3-month crossover periods (VRR-OFF; VRR-ON) in which the VRR algorithm was randomized and compared to fixed rate stimulation at 60 ppm. During follow-up visits a 6-minute walk test was performed under partially inhibited conditions (PM at 40 ppm) and ventricular response was recorded. The following parameters were measured: mean ventricular rate (MR), rate variability (RR30), rate recovery after exercise (SLOPE = (R-END - R-REC)/(R-END - 40)), R-END being the rate at end of walk and R-REC the rate 1 minute after exercise. RESULTS: The VRR algorithm decreased rate variability (RR30: -7.36 +/- 8.8; P < 0.01) without increasing ventricular rate (MR: -1.11 +/- 8.3 P = NS), while SLOPE improved significantly (SLOPE: +15.41 +/- 16.8 P < 0.01). CONCLUSIONS: VRR effectively stabilizes rate, without increasing pacing rate above spontaneous rhythm and helps achieve a more favorable autonomic balance, improving rate recovery after exercise.