Increasing hazard of Sprint Fidelis implantable cardioverter-defibrillator lead failure

Longevity of Sprint Fidelis Implantable Cardioverter-Defibrillator Leads and Risk Factors for Failure

“…In contrast, Quattro leads exhibited a failure rate well below the suggested benchmark of 0.6%/y, 4 and none of the clinical variables studied appeared to affect Quattro survival. Except for inappropriate shocks, we did not observe major adverse clinical events in our patients who experienced either Fidelis or Quattro lead failure.…”

“…7 However, there are no independent multicenter long-term performance data for this lead, and recent studies suggest that Medtronic's estimates of Fidelis survival do not reflect the experience with this lead in other populations. 4,5 Moreover, additional information is needed that may identify patients who are at greater risk for Fidelis failure. Such knowledge is important because it may affect Fidelis patient management and improve our understanding of lead failure mechanisms.…”

“…1 The manufacturer voluntarily removed Fidelis leads from the market in 2007 after 268 000 were implanted worldwide. 2 Subsequently, the Fidelis fracture rate was observed to accelerate during the first 2 years after implantation, [3][4][5] and leads in younger 6 more active patients with less impairment of left ventricular function appeared to be more prone to failure. 3 …”

Sprint Fidelis Lead Fractures in Patients With Cardiac Resynchronization Therapy Devices

“…14 The present study also confirmed observations reported previously, including an increased hazard of fracture over time and a decrease in inappropriate shocks with the lead integrity algorithm software. [2][3][4] No differences in mortality or heart failure hospitalizations were observed in the Fidelis and non-Fidelis groups. This has been observed in another largescale study examining mortality among patients with Fidelis and Quattro leads at 3 tertiary care centers in the United States, in which adjusted survival was found to be similar in the 2 groups.…”

“…1 The scope of the advisory was unforeseen, as the incidence of lead fracture has continued to accelerate over time. 2,3 The most significant adverse event related to the advisory has been the occurrence of inappropriate shocks, caused by oversensing from a lead fracture, which occurred in up to 50% of patients with fractures. Inappropriate shocks have been reduced by the introduction of the lead integrity algorithm.…”