A cost-effectiveness analysis of a proactive management strategy for the Sprint Fidelis recall: A probabilistic decision analysis model

The Medtronic Sprint Fidelis® lead history revisited—Extended follow‐up of passive leads

“…As the survival rate of passive SFL declines considerably over time, the question of optimal management of patients with a functioning lead is legitimate. Bashir et al estimated that an elective lead replacement might trigger only half of the costs compared to a lead revision in an emergency setting. Still, patients with a functioning SFL have a survival similar to patients with the nonadvisory Medtronic Quattro lead .…”

Very Late Follow‐Up of a Passive Defibrillator Lead Under Recall: Do Failure Rates Increase during Long‐Term Observation

“…Prophylactic replacement of a normally functioning SFL at time of battery depletion remains a topic of discussion and extraction of the functioning lead is even more controversial given the possible risk involved. Bashir et al compared the cost‐effectiveness of a proactive strategy with elective lead replacement to emergent replacement of defective leads. Applying a probabilistic Markov model to patients <60 years, they calculated cost savings of 12,800 USD.…”

Managing patients with advisory defibrillator leads: what can we learn from published data?

“…Only patients who would die in the absence of a working defibrillator are at risk from lead failure: in populations similar to the SCD-HeFT and MADIT II cohorts, this would account for 2–3 % every year (6 % mortality reduction in SCD-HeFT during a 3-year follow up, and 6.4 % in MADIT II after 2 years) [ 14 – 16 ]. In case of Fidelis leads and assuming a lead failure rate of 3 % per year, the natural attrition of around 5 % per year, and malfunctioning leads being replaced after routine controls or inappropriate shocks, some approximating calculus will show that the mortality risk is less than 0.1 % per year [ 15 – 17 ].…”

“…It may be more favourable to replace advisory leads during elective generator replacement, as only the additional risk of inserting a new lead has to be accounted for. Bashir et al calculated the cost and effectiveness of a proactive lead replacement strategy at the time of an elective generator replacement for patients under 60 years, with normally functioning Sprint Fidelis leads, and an expected failure rate of 5.2 % per year as observed in their population [ 17 ]. Even when the cost of elective lead extraction in one-third of the procedures was included, they still prove that the proactive strategy was more cost-effective than waiting for lead failure to occur.…”

“…A conservative approach also avoids unnecessary extraction procedures in more than 95 % of patients, and hereby considerably reduces the cost of managing advisory leads: Mehrotra et al calculated an additional cost of $ 12,000 to $ 13,000 per extraction procedure compared with abandoning the leads [ 49 ]. Bashir et al calculated that extraction of two-thirds of the leads in the setting of proactive replacing advisory leads at the time of generator exchange would result in an incremental cost of $ 12,779 per ICD lead failure avoided [ 17 ].…”