Patient follow-up and Study Endpoints:
Patient demographics and co-morbidities, including salient details of
the patient’s AF, baseline left ventricular ejection fraction (LVEF),
and medications were recorded. Standard follow-up protocol included a
1-week post-procedure electrocardiogram (EKG) and a 24–48-hour Holter
monitor at 1, 3, 6, 12, 24, and 48 months. At minimum, an EKG was
obtained on every follow up visit. The primary outcome was defined as
freedom of arrhythmia outside of the 90-day blanking period. Secondary
outcomes included AAD at discharge, 12, and 36 months as well as the
following procedure-related complications: incidence of complications;
bleeding requiring >2 units PRBCs; wound infection;
transient phrenic nerve palsy; and atrioesophageal fistula.