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

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DOI: 10.4236/wjcd.2015.511036    3,842 Downloads   4,060 Views  

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.

Conflicts of Interest

The authors declare no conflicts of interest.

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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