Tuesday, October 16, 2007

If It Ain't Broke, Don't Fix It

Reiterating most electrophysiologists' recommendations regarding Medtronic's Sprint Fidelis recall from the market, Tom Burton from the Wall Street Journal reports this morning:
Perhaps most important, Medtronic isn't recommending that the leads be taken out unless they are actually fractured. And cardiologists overwhelmingly agree with that advice. Surgical removal of a lead is potentially deadly itself. The lead sits in the patient's vein. Scar tissue forms there and at the point in the heart where the lead attaches. So extracting it can trigger bleeding, which can be lethal.

If a lead is found to be fractured, patients may have a choice of intervention. Doctors differ as to whether lead extraction or adding a new lead threaded through the same vein is a better approach. But many patients will have to have it extracted because there isn't room for a new lead in the vein.
What most agree, again, is that if a patient does not have an actual fracture, that leaving the lead alone is probably the most prudent advice and to continue close monitoring. Every time a device pocket is opened to revise the system, there is also a small but real risk of infecting the defibrillator system.

Should a lead become fractured and the defibrillator system require revision, however, one other option exists that was not mentioned in the WSJ article: a new lead (or even a new system), could be implanted from the contralateral (opposite) arm. In some cases of lead fracture, this might be the safest route to take.



Anonymous said...

what are you planning on doing with pm dependent patients with the fidelis?

has your experience been positive with right sided icd implants successfully resuscitating patients? would you consider them only for primary prevention implants?

DrWes said...


Pacer-dependent patients will be followed for now as prescribed. For normally-functioning Fidelis leads, the combined risks of lead removal and infection (from re-operation) appear greater than the risk of lead failure at this time.

Regarding right-sided ICD implants, my experience has been that usually acceptable defibrillation thresholds can be achieved, but they may not be quite as low as a left-sided implant.

"would you consider them only for primary prevention implants?"

I have no idea what is being asked here.

Anonymous said...

i was asking if you would consider a right sided implant only for patients receiving the device for the indication of primary prevention of sca. do you implant icd's on the right side in survivors of sudden cardiac arrest if patient's are lefty or for whatever reason want it on the right side?

DrWes said...

Anony 5:24-
Initial implant site varies from patient to patient based on multiple clinical issues - but I do not consider whether the implant is for primary or secondary indications to determine my side to implant - rather it is based on what is best for proper device function for an individual patient. For instance, sometimes the right side is preferred because of a preexisting pacemaker is being upgraded to an ICD and one of the leads already implanted can be reused. Or perhaps the patient hunts with a shotgun and prefers to hold the gun on his left shoulder - then a rightsided implant would avoid damage to the defibrillator system. Certainly ejection fraction also plays into the decision with the weakest hearts usually having a left-sided implant because of the slight defibrillation threshold advantage. Bottom line: everyone's clinical issues are different and implant site are chosen based on a balance of these issues.