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. METHODS AND 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). CONCLUSION: Among patients with paroxysmal AF and standard bradycardia indications, PPTs are safe and associated with less AF burden compared with conventional pacing.
RCT Entities:
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. METHODS AND 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). CONCLUSION: Among patients with paroxysmal AF and standard bradycardia indications, PPTs are safe and associated with less AF burden compared with conventional pacing.
Authors: Jana Grune; Andrew J M Lewis; Masahiro Yamazoe; Maarten Hulsmans; David Rohde; Ling Xiao; Shuang Zhang; Christiane Ott; David M Calcagno; Yirong Zhou; Kerstin Timm; Mayooran Shanmuganathan; Fadi E Pulous; Maximilian J Schloss; Brody H Foy; Diane Capen; Claudio Vinegoni; Gregory R Wojtkiewicz; Yoshiko Iwamoto; Tilman Grune; Dennis Brown; John Higgins; Vanessa M Ferreira; Neil Herring; Keith M Channon; Stefan Neubauer; David E Sosnovik; David J Milan; Filip K Swirski; Kevin R King; Aaron D Aguirre; Patrick T Ellinor; Matthias Nahrendorf Journal: Nat Cardiovasc Res Date: 2022-07-11
Authors: George H Crossley; Luigi Padeletti; Steven Zweibel; J Harrison Hudnall; Yan Zhang; Giuseppe Boriani Journal: Pacing Clin Electrophysiol Date: 2019-04-29 Impact factor: 1.976