Impact of atrial prevention pacing on atrial fibrillation burden: primary results of the Study of Atrial Fibrillation Reduction (SAFARI) trial.
BACKGROUND
The role of atrial-based pacing algorithms in preventing atrial fibrillation (AF) remains controversial. The inconsistent results noted in previous trials may be due in part to differences in endpoints, pacing algorithms, and study design. SAFARI, a worldwide, prospective, randomized clinical trial, was designed to address these issues and to evaluate the safety and efficacy of a suite of prevention pacing therapies (PPTs) among patients with paroxysmal AF.


RESULTS
Patients who met standard pacemaker indications and documented symptomatic AF were implanted with a pacemaker (Vitatron Selection 9000). At 4 months, only patients with documented AF despite dual-chamber pacing were randomized to PPTs ON or PPTs OFF and followed for 6 months. Incidence of permanent AF and change in AF burden were compared between the two groups. Among the 555 patients enrolled, 240 had AF burden at 4 months and were randomized. The risk of developing permanent AF was similar in both groups (0 in the PPTs ON group vs. 3 in the OFF group). However, there was a significant reduction in AF burden between baseline and 10-month follow-up in the ON group compared with the OFF group (median decrease of 0.08 hours/day vs no change, P = .03).


CONCLUSIONS
Among patients with paroxysmal AF and standard bradycardia indications, PPTs are safe and associated with less AF burden compared with conventional pacing.
Gold
Michael R
MR
Medical University of South Carolina, Charleston, South Carolina 29425, USA. Goldmr@musc.edu
Adler
Stuart
S
Fauchier
Laurent
L
Haffajee
Charles
C
Ip
John
J
Kainz
Walter
W
Kawasaki
Raymond
R
Prakash
Atul
A
Táborský
Milos
M
Waller
Theodore
T
Wilson
Vance
V
Li
Shelby
S
Hoffmann
Ellen
E
D000368:Aged; D001281:Atrial Fibrillation / Q000517:prevention & control* / Q000628:therapy; D002304:Cardiac Pacing, Artificial / Q000009:adverse effects / Q000379:methods; D005260:Female; D006801:Humans; D008297:Male; D010138:Pacemaker, Artificial