The Lead Integrity Alert (LIA) provides three days advance notice prior to inappropriate therapy to 76% of patients with lead fractures1. As a result, we strongly recommend that all Sprint Fidelis patients who have the ability to upgrade to Lead Integrity Alert do so promptly. Also ensure that high voltage lead impedance alerts (maximum of 100 ohms) are programmed. When a lead fracture is suspected or confirmed, immediate patient attention is strongly recommended. Physicians should inform their patients to seek medical attention without delay if they experience unexpected shocks.
If a Fidelis lead fracture of any type has occurred, we recommend implanting a new high voltage lead with or without extraction of the Fidelis lead.
In patients with normal device function and no manifestation of lead fracture, no action is recommended. The risk of prophylactic intervention appears to be greater than serious injury resulting from lead fracture even for pacemaker dependent patients, except in select individual patient circumstances as determined by the physician.
In the event of a device change-out or upgrade procedure, with no manifestation of lead fracture, consider the patient age and lead model data (for the latest data on patient age, patient gender, lead model and device type see the Sprint FIDELIS Lead Performance page), as well as patient life expectancy, co-morbidities, ease of extraction related to implant time, patient preference, etc., for the following options:
Swerdlow C, Gunderson, B, et al. “Downloadable Algorithm to Reduce Inappropriate Shocks Caused by Fractures of Implantable Cardioverter-Defibrillator Leads”, Circulation, November 2008, 118: 2122-2129.
“Transvenous Lead Extraction: Heart Rhythm Society Expert Consensus on Facilities, Training, Indications, and Patient Management”, Heart Rhythm, Vol 6, No 7, July 2009.