Accelerating risk of Fidelis lead fracture

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

“…However, the pattern of Fidelis conductor fractures is consistent with a nonrandom time-dependent mechanical failure mode, and it is likely that young active adults with these inherited cardiac diseases mechanically stress Fidelis leads more vigorously than older sedentary patients who have severe ischemic cardiomyopathy and heart failure. The observation that patients who have higher left ventricular ejection fractions also experience higher Fidelis fracture rates 3,5,18 further supports the notion that the Fidelis conductors are vulnerable to normal physiological stresses. The influence of gender is less clear, but women have had a higher early complication rate after de novo ICD implantation than men, 19 and their vascular anatomy may subject leads to the aggressive bend conditions that have been shown to affect Fidelis more than Quattro leads.…”

“…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 implantable cardioverter-defibrillators lead patient management and survival: Single center study

“…This study has not confirmed previous findings [21][22][23][24] that patients with confirmed SF lead fracture have statistically significantly higher LVEF, the results obtained herein present contrary results -in our population patients with dysfunctional lead had lower LVEF. Additionally, no statistically significant correlation has been found according to gender www.cardiologyjournal.org [7,9,12,25] or age at implantation [23].…”

“…No single death could be categorized as associated with lead defect, which concurs with other studies [7,8,23,24,29]. In the literature, there are slightly lower mortality rates in SF recipients [6].…”

“…Additionally, no statistically significant correlation has been found according to gender www.cardiologyjournal.org [7,9,12,25] or age at implantation [23]. Neither was any statistical correlation found between the type of prevention (primary vs. secondary), venous access [7,18,21,24,26,27] (cephalic vs. other), nor position of the lead tip in the right ventricle (apex vs. right ventricular outflow track). All parameters were analyzed and were found to be insignificant in multivariate analysis, as well in a univariate analysis.…”