A cost-effectiveness analysis of a proactive management strategy for the Sprint Fidelis recall: a probabilistic decision analysis model.
BACKGROUND
The management of the recall is complicated by the competing risks of lead failure and complications that can occur with lead revision. Many of these patients are currently undergoing an elective generator change--an ideal time to consider lead revision.


OBJECTIVE
To determine the cost-effectiveness of a proactive management strategy for the Sprint Fidelis recall.


METHODS
We obtained detailed clinical outcomes and costing data from a retrospective analysis of 341 patients who received the Sprint Fidelis lead in British Columbia, where patients younger than 60 years were offered lead extraction when undergoing generator replacement. These population-based data were used to construct and populate a probabilistic Markov model in which a proactive management strategy was compared to a conservative strategy to determine the incremental cost per lead failure avoided.


RESULTS
In our population, elective lead revisions were half the cost of emergent revisions and had a lower complication rate. In the model, the incremental cost-effectiveness ratio of proactive lead revision versus a recommended monitoring strategy was $12,779 per lead failure avoided. The proactive strategy resulted in 21 fewer failures per 100 patients treated and reduced the chance of an additional complication from an unexpected surgery.


CONCLUSIONS
Cost-effectiveness analysis suggests that prospective lead revision should be considered when patients with a Sprint Fidelis lead present for pulse generator change. Elective revision of the lead is justified even when 25% of the population is operated on per year, and in some scenarios, it is both less costly and provides a better outcome.
Divisions of Cardiovascular Surgery. Electronic address: jmlbashir@gmail.com.
Jamil
J
Bashir
Simone
S
Cowan
Adam
A
Raymakers
Michael
M
Yamashita
Matthew
M
Danter
Andrew
A
Krahn
Larry D
LD
Lynd
D000293:Adolescent; D000328:Adult; D000368:Aged; D001145:Arrhythmias, Cardiac / Q000191:economics / Q000401:mortality / Q000628:therapy*; D001955:British Columbia / Q000453:epidemiology; D002423:Cause of Death / Q000639:trends; D002648:Child; D003362:Cost-Benefit Analysis / Q000379:methods; D003661:Decision Support Techniques; D017147:Defibrillators, Implantable / Q000191:economics*; D019468:Disease Management; D004868:Equipment Failure / Q000191:economics; D019544:Equipment Failure Analysis / Q000191:economics*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D057052:Medical Device Recalls; D008875:Middle Aged; D015233:Models, Statistical; D017410:Practice Guidelines as Topic; D012189:Retrospective Studies; D015996:Survival Rate / Q000639:trends; D013997:Time Factors; D055815:Young Adult
Arrhythmia; CI; Cost-effectiveness analysis; Defibrillation; Electrophysiology; ICD; ICER; Laser; SF; SPH; Sprint Fidelis; St. Paul’s Hospital; confidence interval; implantable cardioverter-defibrillator; incremental cost-effectiveness ratio