User's Manual

26 – US-ENGLISH
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 provides in an
individual will depend on the amount of time that the patient spends
in AV block. SafeR cannot and should not provide any decrease in
ventricular pacing while the patient is in AV block.
 Adverse events
Clinical study of the SafeR included 45 Symphony 2550 devices
implanted in 45 patients. No serious adverse events were device- or
feature-related. There were no deaths in the study. Table 1
summarizes the safety data for this study.
1.
(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 %).