TY - JOUR
T1 - Chronic performance of an active fixation coronary sinus lead
AU - Crossley, George H.
AU - Exner, Derek
AU - Mead, R. Hardwin
AU - Sorrentino, Robert A.
AU - Hokanson, Robert
AU - Li, Shelby
AU - Adler, Stuart
N1 - Funding Information:
Drs. Crossley and Mead are on advisory boards for Medtronic, Inc., and receive income from research, consulting, and lecturing for Medtronic. Dr. Adler receives income from Medtronic for research and consulting. Dr Exner is supported by the Canadian Institute of Health and the Alberta Foundation for Medical Research. Dr. Sorrentino is a consultant for Medtronic. Mr. Hokanson and Ms. Li are employees of Medtronic.
Funding Information:
This study was supported by Medtronic, Inc., Minneapolis, Minnesota.
PY - 2010/4
Y1 - 2010/4
N2 - Background: Cardiac resynchronization therapy (CRT) reduces morbidity and mortality in appropriately selected patients with heart failure. Optimal left ventricular (LV) lead placement is useful in enhancing response from CRT. Three significant obstacles to LV lead placement are patient-specific variations in coronary venous anatomy, phrenic nerve stimulation, and a significant rate of LV lead dislodgement or microdislodgement. Objective: The primary objective of this study was to determine the safety and effectiveness of the Medtronic StarFix active fixation LV lead. Secondary objectives evaluated implant success, lead placement and procedure time, lead handling and lobe deployment, additional electrical performance, and all adverse events reported in the study. Methods: There were 441 patients enrolled in this multicenter study. Standard cardiac resynchronization therapy (CRT) inclusion criteria were used. Patients were followed up for a mean of 23 months. Implant data, success with CRT, LV lead performance, clinical outcomes, and experience with LV lead revisions were prospectively evaluated. Results: The mean LV stimulation threshold at implant was 1.3 ± 1 volts and was stable over time. Sensing was also excellent. In 96.3% of the implantations in this study, the physician was able to place the lead in a nonanterior position. Extracardiac (phrenic nerve) stimulation required invasive intervention in 11 subjects (2.5%). Only 3 dislodgements (0.7%) were observed. Two occurred in the first 5 implants and were attributed to inadequate engagement of the venous subbranch. Conclusion: The Medtronic 4195 is safe and highly efficacious. It affords the physician more choices in lead placement location and has a remarkably low dislodgement rate.
AB - Background: Cardiac resynchronization therapy (CRT) reduces morbidity and mortality in appropriately selected patients with heart failure. Optimal left ventricular (LV) lead placement is useful in enhancing response from CRT. Three significant obstacles to LV lead placement are patient-specific variations in coronary venous anatomy, phrenic nerve stimulation, and a significant rate of LV lead dislodgement or microdislodgement. Objective: The primary objective of this study was to determine the safety and effectiveness of the Medtronic StarFix active fixation LV lead. Secondary objectives evaluated implant success, lead placement and procedure time, lead handling and lobe deployment, additional electrical performance, and all adverse events reported in the study. Methods: There were 441 patients enrolled in this multicenter study. Standard cardiac resynchronization therapy (CRT) inclusion criteria were used. Patients were followed up for a mean of 23 months. Implant data, success with CRT, LV lead performance, clinical outcomes, and experience with LV lead revisions were prospectively evaluated. Results: The mean LV stimulation threshold at implant was 1.3 ± 1 volts and was stable over time. Sensing was also excellent. In 96.3% of the implantations in this study, the physician was able to place the lead in a nonanterior position. Extracardiac (phrenic nerve) stimulation required invasive intervention in 11 subjects (2.5%). Only 3 dislodgements (0.7%) were observed. Two occurred in the first 5 implants and were attributed to inadequate engagement of the venous subbranch. Conclusion: The Medtronic 4195 is safe and highly efficacious. It affords the physician more choices in lead placement location and has a remarkably low dislodgement rate.
KW - Active fixation
KW - Cardiac resynchronization therapy
KW - Coronary sinus lead
KW - Implantable cardioverter defibrillator
KW - Lead dislodgement
KW - Lead extraction
KW - Lead revision
KW - Left ventricular lead
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U2 - 10.1016/j.hrthm.2010.01.007
DO - 10.1016/j.hrthm.2010.01.007
M3 - Article
C2 - 20156616
AN - SCOPUS:77949484911
SN - 1547-5271
VL - 7
SP - 472
EP - 478
JO - Heart Rhythm
JF - Heart Rhythm
IS - 4
ER -