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.