Key result
SafeR mode significantly reduced the mean percentage of ventricular pacing at 1 year to 4.5%, compared to 37.9% with DDD/AMC and 16.7% with DDD/LD modes (P<0.0001 for both).
Why the study?
Does SafeR mode reduce the percentage of ventricular pacing compared to DDD modes in patients with dual-chamber pacemakers without persistent AV block and persistent AF?
RCT (n=422)
1:1:1
Does SafeR mode reduce the percentage of ventricular pacing compared to DDD modes in patients with dual-chamber pacemakers without persistent AV block and persistent AF?
Absolute Event Rate: 4.5% vs 37.9%
p-value: p=<0.0001
SafeR mode significantly reduces unnecessary ventricular pacing compared to standard DDD modes in patients with dual-chamber pacemakers without persistent AV block.
SafeR mode should be prioritized to minimize ventricular pacing in eligible patients; confirms RCT superiority over DDD modes for pacing avoidance.
AIMS: SafeR performance versus DDD/automatic mode conversion (DDD/AMC) and DDD with a 250-ms atrioventricular (AV) delay (DDD/LD) modes was assessed toward ventricular pacing (Vp) reduction. METHODS: After a 1-month run-in phase, recipients of dual-chamber pacemakers without persistent AV block and persistent atrial fibrillation (AF) were randomly assigned to SafeR, DDD/AMC, or DDD/LD in a 1:1:1 design. The main endpoint was the percentage of Vp (%Vp) at 2 months and 1 year after randomization, ascertained from device memories. Secondary endpoints include %Vp at 1 year according to pacing indication and 1-year AF incidence based on automatic mode switch device stored episodes. RESULTS: Among 422 randomized patients (73.2±10.6 years, 50% men, sinus node dysfunction 47.4%, paroxysmal AV block 30.3%, bradycardia-tachycardia syndrome 21.8%), 141 were assigned to SafeR versus 146 to DDD/AMC and 135 to DDD/LD modes. Mean %Vp at 2 months was 3.4±12.6% in SafeR versus 33.6±34.7% and 14.0±26.0% in DDD/AMC and DDD/LD modes, respectively (P<0.0001 for both). At 1 year, mean %Vp in SafeR was 4.5±15.3% versus 37.9±34.4% and 16.7±28.0% in DDD/AMC and DDD/LD modes, respectively (P<0.0001 for both). The proportion of patients in whom Vp was completely eliminated was significantly higher in SafeR (69%) versus DDD/AMC (15%) and DDD/LD (45%) modes (P<0.0001 for both), regardless of pacing indication. The absolute risk of developing permanent AF or of remaining in AF for >30% of the time was 5.4% lower in SafeR than in the DDD pacing group (ns). CONCLUSIONS: In this selected patient population, SafeR markedly suppressed unnecessary Vp compared with DDD modes.
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Davy et al. (2012) conducted an RCT in Dual-chamber pacemaker recipients without persistent AV block and persistent AF (n=422). SafeR mode vs. DDD/AMC and DDD/LD modes was evaluated on Percentage of ventricular pacing (%Vp) at 1 year (p=<0.0001). SafeR mode significantly reduced the mean percentage of ventricular pacing at 1 year to 4.5%, compared to 37.9% with DDD/AMC and 16.7% with DDD/LD modes (P<0.0001 for both).
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