User's Manual

― 84 % of patients without AV block at implant.
― 63 % of patients with AV block at implant.
In a representative reference group
(1)
of patients programmed to DDD, none had less than 1
% ventricular pacing and only 10 % had less than 90 % ventricular pacing regardless of AV
block indication at implant.
The actual reduction of ventricular pacing that SafeR (AAI <> DDD) provides in an individual
will depend on the amount of time that the patient spends in AV block. SafeR (AAI <> DDD)
cannot and should not provide any decrease in ventricular pacing while the patient is in AV
block.
(1)
Pioger G, Jauvert G, Nitzsché R, Pozzan J, Laure H, Zigelman M, Leny G, Vandrell M,
Ritter P, and Cazeau S. Incidence and predictive factors of atrial fibrillation in paced patients.
PACE, 28, Supp 1: S137-141; January 2005. This was a prospective observational study of
377 patients with a functionally similar device programmed to DDD. The primary indications
for implant were: AV block (49 %), sinus node disease (16 %), brady-tachy syndrome (5 %),
AV block + sinus node disease (19 %), AV block + brady-tachy syndrome (6 %), and brady-
tachy syndrome + sinus node disease (5 %).
18. SUPPLEMENTAL INFORMATION
SORIN – PLATINIUM 4LV CRT-D 1744 – U904A 51