Safety, Handling and Electrical Performances of Bradycardia Leads in Acute Conditions: Results from the FINE Registry
Author(s)
Henri Benkemoun1*,
Sébastien Prevot2,
José Antonio Lapuerta3,
Xavier Dessenne4,
Pierre Khattar5,
Mara Rolando6,
Philippe Deutsch7,
Roger Villuendas8
Affiliation(s)
1 Saint Pierre Clinic, Perpignan, France. 2 Clairval Clinic, Marseille, France. 3 Cabuenes Hospital, Gijon, Spain. 4 Mousseau Clinic, Evry, France. 5 Public Hospital, Lorient, France. 6 SORIN CRM SAS, Lausanne, Switzerland. 7 Department of Cardiology, Public Hospital, Saint-Malo, France. 8 Germans Trias i Pujol Hospital, Carretera de Canyet, Badalona (Barcelona), Spain.
1 Saint Pierre Clinic, Perpignan, France. 2 Clairval Clinic, Marseille, France. 3 Cabuenes Hospital, Gijon, Spain. 4 Mousseau Clinic, Evry, France. 5 Public Hospital, Lorient, France. 6 SORIN CRM SAS, Lausanne, Switzerland. 7 Department of Cardiology, Public Hospital, Saint-Malo, France. 8 Germans Trias i Pujol Hospital, Carretera de Canyet, Badalona (Barcelona), Spain.
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.
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
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.
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.
References
[1] Mond, H.G., Hua, W. and Wang, C.C. (1995) Atrial Pacing Leads: The Clinical Contribution of Steroid Elution. Pacing and Clinical Electrophysiology, 18, 1601-1608.
http://dx.doi.org/10.1111/j.1540-8159.1995.tb06981.x [2] Lipchenca, I.A., Bar-Lev, D.S., Luria, D.M., Gurevitz, O.T., Granit, C., Rotstein, Z., et al. (2006) Clinical Surveillance of a Tined, Bipolar, Silicone-Insulated Ventricular Pacing Lead. Journal of the Working Groups on Cardiac Pacing, Arrhythmias, and Cardiac Cellular Electrophysiology of the European Society of Cardiology, 8, 118-121.
http://dx.doi.org/10.1093/europace/euj029 [3] Ellenbogen, K.A., Hellkamp, A.S., Wilkoff, B.L., Camunas, J.L., Love, J.C., Hadjis, T.A., et al. (2003) Complications Arising after Implantation of DDD Pacemakers: The MOST Experience. The American Journal of Cardiology, 92, 740-741.
http://dx.doi.org/10.1016/S0002-9149(03)00844-0 [4] Daubert, C., Gold, M.R., Abraham, W.T., Ghio, S., Hassager, C., Goode, G., et al. (2009) Prevention of Disease Progression by Cardiac Resynchronization Therapy in Patients with Asymptomatic or Mildly Symptomatic Left Ventricular Dysfunction: Insights from the European Cohort of the REVERSE (Resynchronization Reverses Remodeling in Systolic Left Ventricular Dysfunction) Trial. Journal of the American College of Cardiology, 54, 1837-1846.
http://dx.doi.org/10.1016/j.jacc.2009.08.011 [5] Stefano, B., Pietro, R.R., Maurizio, G., Maurizio, L., Renato, M., Maurizio, L., et al. (2011) Defibrillation Testing during Implantable Cardioverter-Defibrillator Implantation in Italian Current Practice: The Assessment of Long-Term Induction Clinical Value (ALIVE) Project. American Heart Journal, 162, 390-397.
http://dx.doi.org/10.1016/j.ahj.2011.04.008 [6] Rickard, J., Taborsky, M., Bello, D., Johnson, W.B., Ramza, B., Chang, Y., et al. (2014) Short- and Long-Term Electrical Performance of the 5086MRI Pacing Lead. Heart Rhythm, 11, 222-229.
http://dx.doi.org/10.1016/j.hrthm.2013.10.056 [7] Ghani, A., Delnoy, P.P., Ramdat Misier, A.R., Smit, J.J., Adiyaman, A., Ottervanger, J.P., et al. (2014) Incidence of Lead Dislodgement, Malfunction and Perforation during the First Year Following Device Implantation. Netherlands Heart Journal, 22, 286-291.
http://dx.doi.org/10.1007/s12471-014-0556-6 [8] Zoppo, F., Zerbo, F., Brandolino, G., Bacchiega, E., Lupo, A. and Bertaglia, E. (2011) Straight Screw-In Atrial Leads “J-Post Shaped” in Right Appendage versus J-Shaped Systems for Permanent Atrial Pacing: A Safety Comparison. Pacing and Clinical Electrophysiology, 34, 325-330.
http://dx.doi.org/10.1111/j.1540-8159.2010.02986.x [9] Kistler, P.M., Liew, G. and Mond, H.G. (2006) Long-Term Performance of Active-Fixation Pacing Leads: A Prospective Study. Pacing and Clinical Electrophysiology, 29, 226-230.
http://dx.doi.org/10.1111/j.1540-8159.2006.00327.x [10] Cornacchia, D., Fabbri, M., Puglisi, A., Moracchini, P., Bernasconi, M., Nastasi, M., et al. (2000) Latest Generation of Unipolar and Bipolar Steroid Eluting Leads: Long-Term Comparison of Electrical Performance in Atrium and Ventricles. Journal of the Working Groups on Cardiac Pacing, Arrhythmias, and Cardiac Cellular Electrophysiology of the European Society of Cardiology, 2, 240-244.
http://dx.doi.org/10.1053/eupc.2000.0103 [11] Lotze, U., Fischer, S., Hofs, T., Liebetrau, J., Fettin, W., Scheiner, J., et al. (2009) Electrical Performance and Automatic Capture Characteristics of a 3.5-mm(2) Passive Fixation Lead during 1-Year Follow-Up. Pacing and Clinical Electrophysiology, 32, 1050-1055.
http://dx.doi.org/10.1111/j.1540-8159.2009.02437.x [12] Nagatomo, T., Abe, H., Numata, T., Tamura, K., Kikuchi, K., Oginosawa, Y., et al. (2000) Clinical Surveillance of a Thin Bipolar Pacing Lead. Japanese Circulation Journal, 64, 933-936.
http://dx.doi.org/10.1253/jcj.64.933 [13] Schuchert, A., Muto, C., Maounis, T., Frank, R., Boulogne, E., Polauck, A., et al. (2013) Lead Complications, Device Infections, and Clinical Outcomes in the First Year after Implantation of Cardiac Resynchronization Therapy-Defibrillator and Cardiac Resynchronization Therapy-Pacemaker. Journal of the Working Groups on Cardiac Pacing, Arrhythmias, and Cardiac Cellular Electrophysiology of the European Society of Cardiology, 15, 71-76.
[1] Mond, H.G., Hua, W. and Wang, C.C. (1995) Atrial Pacing Leads: The Clinical Contribution of Steroid Elution. Pacing and Clinical Electrophysiology, 18, 1601-1608.
http://dx.doi.org/10.1111/j.1540-8159.1995.tb06981.x [2] Lipchenca, I.A., Bar-Lev, D.S., Luria, D.M., Gurevitz, O.T., Granit, C., Rotstein, Z., et al. (2006) Clinical Surveillance of a Tined, Bipolar, Silicone-Insulated Ventricular Pacing Lead. Journal of the Working Groups on Cardiac Pacing, Arrhythmias, and Cardiac Cellular Electrophysiology of the European Society of Cardiology, 8, 118-121.
http://dx.doi.org/10.1093/europace/euj029 [3] Ellenbogen, K.A., Hellkamp, A.S., Wilkoff, B.L., Camunas, J.L., Love, J.C., Hadjis, T.A., et al. (2003) Complications Arising after Implantation of DDD Pacemakers: The MOST Experience. The American Journal of Cardiology, 92, 740-741.
http://dx.doi.org/10.1016/S0002-9149(03)00844-0 [4] Daubert, C., Gold, M.R., Abraham, W.T., Ghio, S., Hassager, C., Goode, G., et al. (2009) Prevention of Disease Progression by Cardiac Resynchronization Therapy in Patients with Asymptomatic or Mildly Symptomatic Left Ventricular Dysfunction: Insights from the European Cohort of the REVERSE (Resynchronization Reverses Remodeling in Systolic Left Ventricular Dysfunction) Trial. Journal of the American College of Cardiology, 54, 1837-1846.
http://dx.doi.org/10.1016/j.jacc.2009.08.011 [5] Stefano, B., Pietro, R.R., Maurizio, G., Maurizio, L., Renato, M., Maurizio, L., et al. (2011) Defibrillation Testing during Implantable Cardioverter-Defibrillator Implantation in Italian Current Practice: The Assessment of Long-Term Induction Clinical Value (ALIVE) Project. American Heart Journal, 162, 390-397.
http://dx.doi.org/10.1016/j.ahj.2011.04.008 [6] Rickard, J., Taborsky, M., Bello, D., Johnson, W.B., Ramza, B., Chang, Y., et al. (2014) Short- and Long-Term Electrical Performance of the 5086MRI Pacing Lead. Heart Rhythm, 11, 222-229.
http://dx.doi.org/10.1016/j.hrthm.2013.10.056 [7] Ghani, A., Delnoy, P.P., Ramdat Misier, A.R., Smit, J.J., Adiyaman, A., Ottervanger, J.P., et al. (2014) Incidence of Lead Dislodgement, Malfunction and Perforation during the First Year Following Device Implantation. Netherlands Heart Journal, 22, 286-291.
http://dx.doi.org/10.1007/s12471-014-0556-6 [8] Zoppo, F., Zerbo, F., Brandolino, G., Bacchiega, E., Lupo, A. and Bertaglia, E. (2011) Straight Screw-In Atrial Leads “J-Post Shaped” in Right Appendage versus J-Shaped Systems for Permanent Atrial Pacing: A Safety Comparison. Pacing and Clinical Electrophysiology, 34, 325-330.
http://dx.doi.org/10.1111/j.1540-8159.2010.02986.x [9] Kistler, P.M., Liew, G. and Mond, H.G. (2006) Long-Term Performance of Active-Fixation Pacing Leads: A Prospective Study. Pacing and Clinical Electrophysiology, 29, 226-230.
http://dx.doi.org/10.1111/j.1540-8159.2006.00327.x [10] Cornacchia, D., Fabbri, M., Puglisi, A., Moracchini, P., Bernasconi, M., Nastasi, M., et al. (2000) Latest Generation of Unipolar and Bipolar Steroid Eluting Leads: Long-Term Comparison of Electrical Performance in Atrium and Ventricles. Journal of the Working Groups on Cardiac Pacing, Arrhythmias, and Cardiac Cellular Electrophysiology of the European Society of Cardiology, 2, 240-244.
http://dx.doi.org/10.1053/eupc.2000.0103 [11] Lotze, U., Fischer, S., Hofs, T., Liebetrau, J., Fettin, W., Scheiner, J., et al. (2009) Electrical Performance and Automatic Capture Characteristics of a 3.5-mm(2) Passive Fixation Lead during 1-Year Follow-Up. Pacing and Clinical Electrophysiology, 32, 1050-1055.
http://dx.doi.org/10.1111/j.1540-8159.2009.02437.x [12] Nagatomo, T., Abe, H., Numata, T., Tamura, K., Kikuchi, K., Oginosawa, Y., et al. (2000) Clinical Surveillance of a Thin Bipolar Pacing Lead. Japanese Circulation Journal, 64, 933-936.
http://dx.doi.org/10.1253/jcj.64.933 [13] Schuchert, A., Muto, C., Maounis, T., Frank, R., Boulogne, E., Polauck, A., et al. (2013) Lead Complications, Device Infections, and Clinical Outcomes in the First Year after Implantation of Cardiac Resynchronization Therapy-Defibrillator and Cardiac Resynchronization Therapy-Pacemaker. Journal of the Working Groups on Cardiac Pacing, Arrhythmias, and Cardiac Cellular Electrophysiology of the European Society of Cardiology, 15, 71-76.