Study Endpoints
The endpoints selected to assess anticoagulation success with usual care, versus a protocol guided approach were: (A) The proportion of therapeutic ACT’s on first draw after heparin administration; (B) Time to therapeutic ACT after transseptal access; (C) Time to therapeutic ACT after heparin administered; (D) The proportion of therapeutic ACT during the case; (E) The proportion of supra-therapeutic ACT during the case, defined as greater than 400 seconds, and (F) The proportion of supra-therapeutic ACT’s on first draw after heparin administration.
Major complication endpoints were all cause death, major thrombotic events, and major bleeding events within 30 days of the procedure. Major thrombotic events included ischemic stroke, transient ischemic attack, peripheral embolic events, and deep vein thrombosis. Major hemorrhagic events were those requiring surgical intervention, pericardial effusion requiring drainage, bleeding resulting in transfusion> 2 units of blood, or fatal bleeding.