Tuesday, February 24, 2009

More Concerning News About Medtronic's Sprint Fidelis Lead

... was published online before print in the journal Heart Rhythm yesterday:
"... the hazard of Sprint Fidelis failure accelerated after the first year and continued to increase during the study. In contrast to other defibrillator leads, the Sprint Fidelis failure rate was significantly higher (3.75%/year vs 0.58%/year) and the 3-year estimated survival significantly lower (87.9%, 95% CI 84.8,90.9 vs 98.5%, 95% CI 97.8, 99.3) (p<0.0001). The chance that a Sprint Fidelis lead would survive another year decreased progressively during the study. Most Sprint Fidelis failures were caused by pace-sense conductor fracture (n=63; 87.5%), which caused inappropriate shocks in 36 of 72 patients."
As far as I am aware, no new recommendations from Medtronic regarding the management of these leads has been forthcoming (e.g., the cautious "wait and watch approach" seems best for now), but we certainly have seen our share of patients with this problem.


Addendum: The story in the New York Times.

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