This memorandum has been developed as of October 21, 2007.  As of this date, we feel, based on the current information available, that these guidelines are appropriate for our patients who have the Medtronic Sprint Fidelis lead in place.  Please note, that these are simly guidelines and not specific recommendations pertaining to your particular case.  Every patient is different and a recommendation can only be made regarding your specific case after you have been evaluated by your cardiologist or seen in this office.  These guidelines may change as additional information regarding the long term follow-up of this lead and its risk profile become available.  This website may not contain current information and it again is important that all specific recommendations regarding your case come from a timely consultation with your health care professionals.  

For all patients with the Medtronic Sprint Fidelis ICD lead we are recommending that their defibrillator be interrogated to ensure that the lead is functioning correctly.  At the time of this device interrogation , we are also recommending that the ICD be reprogrammed to make it less likely to shock a patient should a lead fracture occur. We are also recommending that all patients with this lead be enrolled in home monitoring via the Medtronic Carelink network.  This will allow an early lead fracture to potentially be detected quicker and hopefully prior to any inappropriate shocks being delivered.  During the reprogramming we will also turn on a feature called "Patient Alert".  The patient alert feature will sound a warning tone which the defibrillator will emit once daily should it detect any signs of an impending fracture of the lead.  This tone will be programmed to go on every day at 10 AM and the defibrillator will ring for one minute at this time with a sound which sounds like a British police siren.  Due to daylight saving time changes, your ICD may ring at 11 AM or 9 AM depending on the time of the year your ICD was programmed.  Most people will be able to hear this sound but some patients who have the ICD deep in their chest or are hearing impaired may not hear this sound.  Neither the ICD reprogramming nor the Carelink monitoring nor the patient alert feature will completely prevent inappropriate shocks from occurring but all of these changes should help some patients who develop a lead fracture avoid a shock.  Approximately a 50% decrease in the rate of inappropriate shocks will occur with this set of programming changes.

These changes will do nothing to actually prevent the lead from fracturing and if a lead fracture is ever detected, it is essential that the patient be hospitalized immediately at which time the defibrillator will be shut off until a new ICD lead can be inserted. Numerous other issues can however cause the patient alert feature to ring.  Most of these other issues are minor technical issues which do not require immediate surgery but do require that you be seen. If you do hear your defibrillator beeping, contact our office and come in to see us that day.  If this occurs on the weekend and you have a Sprint Fidelis lead, we suggest you go to the emergency room to have the ICD checked by Medtronic.

For some patients we are recommending consideration for elective lead replacement.  At this juncture, we are recommending this for patients who are at the highest risk for either developing a lead fracture or who have the potential for severe harm should a fracture occur.  Patients we are currently recommending consider having the Sprint Fidelis lead replaced with a new lead include:

1. Patients under the age of 60 who, aside from heart disease, are otherwise healthy and who have an expected overall survival exceeding 5 years.
2. Patients at any age who are "pacer dependent" and whose hearts would stop should this lead fail.
3. Patients at any age with this lead who pace >50% of the time.
4. Patients whose ICD battery is expected to run out within the next year and who have had the Sprint Fidelis lead in place for less then 18 months.
5. Patients showing a greater then 100 Ohm acute change in chronic pace/sense lead impedances when this lead is checked or who develop such changes while being followed.
6. Patients who need their ICD battery changed anyway who also happen to have a functioning Sprint Fidelis lead should consider having the lead electively replaced at the time of the device exchange.
7. Patients who specifically request revision of this lead and do not wish to assume even a small chance of the lead fracturing and causing unneeded shocks.

The above guidelines are not rules for replacement of this lead but suggestions for when a patients should consider lead revisions surgery.  Lead replacement surgery is not risk free and we therefore only recommend that a patient consider such surgery if we feel after evaluating your particular case that the risks of leaving the lead in place exceed the risks of the revision surgery.  Please note, lead replacement surgery is different from lead removal surgery and the devision whether to remove the Sprint Fidelis lead (versus simply leaving it in place and replacing it with a new lead) will be made on a case by case basis at the time of the lead revision procedure.  It is currently unknown what will happen to these leads over the next several years.  It is possible that we may find that these leads have increased fracture rates the longer they are left in place and it is also possible we may find that the fracture rate of these leads plateaus at a certain time and then remains stable. As additional information becomes available regarding the potential for future degradation of this leads performance with time, these guidelines are likely to be subject to change.

Page posted for worldwide Internet dissemination October 15, 2007.  Revised 10/23/2007.  Copyright Florida Electrophysiology Associates. This page cannot be reproduced without express permission of the authors.  Content is informational in nature only.  Specific advice and health care decisions require individualized advice and can only be made via specific one on one professional interactions with health care professionals.