User Manual

18. SUPPLEMENTAL INFORMATION
The graph shows that many patients programmed to SafeR (AAI <> DDD) had less than 1%
ventricular pacing:
─ 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 %).
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SORIN – INTENSIA SonR CRT-D 184 – U150A