Long-term performance of the attain model 4193 left ventricular lead.
BACKGROUND
Cardiac resynchronization therapy (CRT) has proven to be a valuable therapy addition for patients with drug-refractory heart failure and a ventricular conduction delay. Delivery of CRT is dependent upon the successful implantation and chronic performance of a left ventricular (LV) pacing lead. This study assessed the long-term electrical performance and safety of a steroid-eluting, transvenous, over-the-wire, cardiac vein pacing lead.


METHODS
The Attain Model 4193 LV lead (Medtronic, Inc, Minneapolis MN, USA) was successfully implanted in 1,070 patients with 286 patients completing 3 years of follow-up. Clinical data were collected at pre-implant, implant, and at 6-month intervals for 3 years.


RESULTS
Over 3 years, the mean chronic pacing threshold ranged from 1.9 V to 2.1 V, the mean R-wave sensing amplitudes ranged between 13.6 mV and 15.0 mV, and the mean pacing impedance ranged between 562 ohms and 590 ohms. Additionally, the observed freedom from first post-implant LV-lead-related complications was 90.4%. Of 1,070 total patients, 82 experienced 89 LV-lead-related adverse events requiring invasive interventions or resulting in the termination of the CRT therapy. The LV lead was repositioned in 31 patients, replaced in 21 patients, and explanted/capped in four patients. There were no deaths related to the LV lead during implantation or during the follow-up period.


CONCLUSIONS
The data suggest that the 4193 LV lead is safe and effective over time. The LV lead electrical measurements remained stable through follow-up, demonstrating reliable long-term performance within the recommended value range at 36 months and had an acceptable complication rate.
Johnson
W Ben
WB
Iowa Heart Center, Des Moines, Iowa 50314, USA. wbjohnson@iowaheart.com
Abraham
William T
WT
Young
James B
JB
Wheelan
Kevin
K
Smith
Andrew L
AL
Chang
Yanping
Y
Brinkman
Paula
P
D000368:Aged; D002304:Cardiac Pacing, Artificial / Q000401:mortality* / Q000706:statistics & numerical data; D004567:Electrodes, Implanted / Q000706:statistics & numerical data*; D004867:Equipment Design; D019544:Equipment Failure Analysis; D005260:Female; D006801:Humans; D015994:Incidence; D008137:Longitudinal Studies; D008297:Male; D012042:Registries; D018570:Risk Assessment; D012307:Risk Factors; D016019:Survival Analysis; D015996:Survival Rate; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology; D018487:Ventricular Dysfunction, Left / Q000401:mortality* / Q000517:prevention & control*