Thursday, December 13, 2007

More on Medtronic's Sprint Fidelis Lead

... recall appears in the New York Times today.

The issue regarding replacing these leads in pacemaker-dependent patients is raised in the article. This is a tough decision. It is clear that some are recommending extraction of leads in this case and at first blush, this might be appropriate. But the risk of introducing an infection anytime a pocket is opened remains. This risk is about 1%, even in experienced centers. Is the risk of replacement worth this? We have little data to know at this time. Unfortunately, we do not know if the incidence of lead fracture stays constant, increases, or decreases with time. This is important information and will only come as additional follow-up of these leads is forthcoming. If the risk of fracture is greatest in the first few months after implant, and then tapers off, perhaps NOT replacing a more chronic lead will become the more advisable approach. If it increases with time, then extraction might be worth the risk.

What is certain right now, is that none of us has the right answer - so patients should have a thorough discussion with their doctors about all of the pros and cons about lead extraction. Believe me, lead extraction is not always as easy as the Spectranetics company (with their video that accompanies the NYT article) would suggest.


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