Safety, Handling and Electrical Performances of Bradycardia Leads in Acute Conditions: Results from the FINE Registry

Background: Beflex is an active fixation atrial and ventricular lead with a retractable screw;X-Fine is a passive fixation ventricular lead. These two bradycardia lead models were evaluated in the FINE study, an observational prospective trial conducted in France and Spain. Methods: Patients enlisted for pacemaker or defibrillator implants were enrolled. The primary objective was to assess acute dislodgement rates at the 3-month follow-up visit. Safety and electrical performances of the leads were assessed in acute conditions at implant and at the follow-up visit up to three months later. A handling questionnaire was submitted to implanting investigators immediately after implant. Results: A total of 2254 patients were enrolled in 95 centers;investigators implanted 1153 active atrial leads, mainly in the right atrium;1021 active right ventricular leads, mainly in the septum and 712 passive right ventricular leads, mainly in the apex. After a mean follow-up of 54.9 ± 37.6 days, dislodgement rates were 1.0% and 1.6% for atrial and ventricular active, and 3.2% for ventricular passive leads. No unexpected adverse reactions were observed during the course of the study and the electrical performances at implant and follow-up visits remained within normal ranges. Overall, most investigators (84%) rated leads’ handling as superior (better or best) to what observed with other bradycardia leads. Conclusion: Different bradycardia leads showed a dislodgement rate of 1.0% and 1.6% for atrial and ventricular active leads, and 3.2% for ventricular passive leads, at 3-month follow-up. Acute safety and electrical performances were within expected ranges and very good handling performances were observed.

Validation of a Marker of Atrial Contraction in the SonR Signal

Introduction: The main component of the endocardial acceleration signal (SonR) is today used for cardiac resynchronization therapy (CRT) optimization. This prospective, single center pilot study focuses on another signal component, SonR4 that may provide further information on the atrial activity. Methods and Results: SonR signal and ECG tracings were recorded simultaneously during a CRT-D optimization procedure in 15 patients (12 men, 68 ± 9.5 years, ischemic heart disease 53%) indicated for CRT. Correlation between SonR4 signal, recorded using SonR and atrial contraction, identified by Echo Doppler was evaluated by Pearson and Student’s t tests under different Atrio-Ventricular (AV) delay programming. From 15 consecutive screened patients, 9 had concomitant analyzable SonR4 and ECG recordings and were included in the study population. The presence of the SonR4 component was systematically correlated to the presence of the A wave. A significant correlation was observed between SonR4 and A wave timings (r = 0.75, p = 0.02) according to different AV delays, with a high reproducibility in SonR4 assessment. Conclusion: A strong correlation between SonR4 and atrial contraction timings was observed, further suggesting that SonR4 is a marker of the atrial contraction. Additional assessments in larger populations are required to confirm these results and build further applications.