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

摘要

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.