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SAFARI: Prevention pacing therapies associated with less AF burden
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Prevention pacing therapies were safe and associated with a lower burden of atrial fibrillation compared with conventional pacing, study results suggested.
The study included 555 patients with standard pacemaker indications and documented symptomatic AF. Two hundred forty were randomly assigned to either a prevention pacing therapy ON group (n=118) or OFF group (n=122).
The researchers reported that the development of permanent AF was similar between the ON and OFF groups. The observed difference was –2.5% (P<.001 for equivalence within 10%). However, patients in the prevention pacing ON group had a lower burden of AF compared with patients in the prevention pacing OFF group. Prevention pacing therapies led to a median reduction of 0.08 hours per day of AF burden in the ON group compared with the OFF group (P=.03).
Patients in the high-burden ON group (n=51) had a median reduction of 1.38 hours per day of AF burden compared with an increase of 0.31 hours per day for those in the high-burden OFF group (n=50; P=.0007). There was a 3.1-fold higher odds (95% CI, 1.35-7.11) of having improved or nonworsening AF in the prevention pacing ON group compared with the OFF group. There was no difference in cumulative patient survival at six months following random assignment between the ON and OFF groups.
“The SAFARI study demonstrates that prevention pacing therapies are safe and effective among patients with paroxysmal AF and bradycardia,” the researchers wrote. “These results suggest that prevention pacing therapies may be useful adjunctive therapy for AF when atrial-based pacing and antiarrhythmic drug therapy are insufficient to achieve a low burden of arrhythmia.”
Gold M. Heart Rhythm. 2009;6:295-301.
Despite myriad attempts to use pacemakers to prevent AF, a panacea has yet to be found. Results from the SAFARI trial are in keeping with this history. Notably, to address different substrates and triggers, the SAFARI trial is different from others in that the researchers tested a “suite” of six prevention pacing therapies rather than just one.
Although there was no difference in the risk for developing permanent AF in the treatment and control groups, there was a significant reduction in AF burden of 0.08 hours per day in 10-month follow-up. It is certainly arguable that a change of 4.8 minutes of AF per day in patients to two to three hours of AF per day is clinically significant. Furthermore, for a patient with risk factors for stroke, the need for anticoagulation remains unchanged and indicated. Opportunities for further work in this area clearly remain.
– Andrew Epstein, MD
Cardiology Today Editorial Board member
