Abstract 15024: Management of the Sprint Fidelis Lead at the Time of Pulse Generator Change: A Markov Analysis
Background: The Sprint Fidelis (Fidelis) (Medtronic, Inc, Minneapolis, MN) defibrillator lead introduced in 2004 and recalled in 2007 has a high failure rate. Our objective is to determine, independent of Medtronic, which parameters are relevant in deciding to electively remove from service a defibrillator lead at the time of pulse generator (PG) replacement.
Methods: A Markov decision model was constructed using published annual Fidelis failure rates to evaluate the risks and benefits at PG change associated with operative lead replacement versus continued monitoring. Variables included device indication (primary prevention, secondary prevention, and pacemaker-dependent states), procedural mortality due to lead removal from service with and without re-insertion (0-2.0%), annual lead failure rate (0-25.0%), and annual mortality rate due to lead failure (0-50.0%) based on known complications or device failure rates. Removal of the lead from service (capping or extraction) with new lead insertion during PG change was preferred only when it favored greater survival. Multi-way sensitivity analyses were performed on the variables.
Results: Device indication and annual failure rate of the lead are the most sensitive parameters to consider in this decision. Procedural mortality is an important secondary consideration. Using current Fidelis lead annual failure rates, continued monitoring is favored when the device indication is primary or secondary prevention; whereas lead removal is favored in pacemaker-dependent states. Either management strategy is equivalent at a 4.2% annual Fidelis failure rate (threshold value) in primary prevention patients. The threshold value falls to 3.3%, 1.6%, and 1.5% rates when the indication for device placement is secondary prevention; pacemaker-dependent/primary prevention; and pacemaker-dependent/secondary prevention, respectively.
Conclusions: Our analysis supports continued monitoring of the Fidelis lead at the time of PG change in primary or secondary prevention alone while pacemaker-dependent patients benefit from removal of the Fidelis lead from service. This model may help direct elective capping or extraction of any lead based on known annual failure rates and device indication.
- © 2011 by American Heart Association, Inc.