Fatal Outcome in a Pacemaker‐Dependent Patient

Abstract

The recent advisory of Medtronic Sprint Fidelis leads has resulted in significant controversy over proper management of patients. The current manufacture's guidelines recommend programming specific device alerts with close follow-up and implantable cardioverter-defibrillator lead replacement in patients with evidence of breach in lead integrity. Recently, several studies have identified significant limitations in this method of surveillance. We report the case of a pacemaker-dependent patient with an ischemic cardiomyopathy, who presented with cardiac arrest and evidence of fracture of the pace/sense portion of a Sprint Fidelis lead during postmortem interrogation. Likely mechanisms leading to his ultimate demise are discussed.

Natural history of the Sprint Fidelis lead: survival analysis from a large single-center study

“…Failure to deliver pacing or defibrillator therapy in patients who are pacemaker dependent or have life-threatening arrhythmias may be lethal [18]. Patients with Fidelis leads are also exposed to the potential risk of inappropriate shocks which are arrhythmogenic, cause myocardial stunning, are associated with increased mortality, are painful, and may be psychologically damaging.…”

Multicenter Experience With Extraction of the Sprint Fidelis Implantable Cardioverter-Defibrillator Lead

“…The reported failure rate of the Sprint Fidelis defibrillator lead (Medtronic, Minneapolis, Minnesota) has increased to a range greater than initially appreciated with emerging evidence of an accelerating rate of fracture (1)(2)(3). With observed failure rates as high as 3.75% per year (3), the limitations of available programmable alerts and alarms (4 -6), and the potential for significant morbidity and mortality (6,7), clinicians remain uncertain as to the best management of patients with active and failed Sprint Fidelis defibrillator leads. Available management options include observation (for functioning leads), adding a new implantable cardioverter-defibrillator (ICD) or pace sense lead to the system while abandoning the Fidelis lead, and extracting the Fidelis lead and reimplanting a new ICD lead.…”

“…Given the exponential failure rate for the Sprint Fidelis ICD lead (1)(2)(3), these data raise the concern that a strategy of surveillance followed by removal only when the lead fails may not be the best strategy. Although leaving the lead intact with implementation of the Lead Integrity Alert software patch (Medtronic, Minneapolis, Minnesota) is "expected to provide three days advance notice prior to inappropriate therapy to 76% of the patients with lead fractures" (7), its utility remains to be tested (4)(5)(6). ICD lead fracture is associated with significant morbidity and even mortality.…”

“…The fracture can result in nondelivery of pacing or defibrillator therapy, which can be particularly dangerous in patients who are pacemaker dependent, have a history of appropriate therapy, or received their device for a secondary prevention indication (2,6). Inappropriate shocks have significant negative psychological effects (27), and, although rare, inappropriate therapy can induce a life-threatening arrhythmia, which may not be treated due to lead failure (6). In addition, recent studies suggest that inappropriate shocks themselves can have a negative impact on mortality (28 -30).…”

How Much Scrutiny and Stress Can the Fidelis Lead Withstand?

“…The most common complication of lead fracture is rapid oversensing of electrical noise and delivery of inappropriate shocks, but failure to deliver bradycardia pacing and antitachycardia pacing due to elevated impedance or inhibition of pacing by oversensing has also been reported. 2 The most concerning complication when fracture of the high-voltage electrode occurs, however, is failure to deliver the lifesaving therapy intended: defibrillatory shock(s).…”