Near elimination of ventricular pacing in SafeR mode compared to DDD modes: a randomized study of 422 patients.
OBJECTIVE
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.
Clinique du Coeur et des Vaisseaux, CHU de Montpellier, Hôpital Arnaud de Villeneuve, Montpellier, France. jm-davy@chu-montpellier.fr
Jean-Marc
JM
Davy
Ellen
E
Hoffmann
Axel
A
Frey
Kurt
K
Jocham
Stefano
S
Rossi
Jean-Marc
JM
Dupuis
Lorenzo
L
Frabetti
Pascale
P
Ducloux
Emmanuel
E
Prades
Gaël
G
Jauvert
D000368:Aged; D000369:Aged, 80 and over; D001281:Atrial Fibrillation / Q000628:therapy*; D054537:Atrioventricular Block / Q000628:therapy; D001919:Bradycardia / Q000628:therapy; D002304:Cardiac Pacing, Artificial / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010138:Pacemaker, Artificial; D012804:Sick Sinus Syndrome / Q000628:therapy; D013577:Syndrome; D013610:Tachycardia / Q000628:therapy; D016896:Treatment Outcome