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

Henri  Benkemoun; Sébastien  Prevot; José Antonio  Lapuerta; Xavier  Dessenne; Pierre  Khattar; Mara  Rolando; Philippe  Deutsch; Roger  Villuendas

doi:10.4236/wjcd.2015.511036

Henri Benkemoun¹^*, Sébastien Prevot², José Antonio Lapuerta³, Xavier Dessenne⁴, Pierre Khattar⁵, Mara Rolando⁶, Philippe Deutsch⁷, Roger Villuendas⁸

Abstract: 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.

Keywords: Bradycardia Lead, Acute Lead Performance, Lead Handling, Lead Safety, Active Fixation Lead, Passive Fixation Lead, X-Fine, Beflex

Cite this paper: Benkemoun, H. , Prevot, S. , Lapuerta, J. , Dessenne, X. , Khattar, P. , Rolando, M. , Deutsch, P. and Villuendas, R. (2015) Safety, Handling and Electrical Performances of Bradycardia Leads in Acute Conditions: Results from the FINE Registry. World Journal of Cardiovascular Diseases, 5, 313-319. doi: 10.4236/wjcd.2015.511036.

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