Watchman (AtriTech/Boston Scientific) is a device deployed
percutaneously to seal Left Atrial Appendage, as in 90% embolisms of AF, clots originate
from Left Atrial Appendage. PROTECT-AF trial was presented at ACC 2009, showed
non-inferiority of device over warfarin. FDA approved the device with strings
attached (safety of device). In response
PREVAIL study was launched in 2010.
randomized, adult patients with non-valvular atrial fibrillation into warfarin
and watchman device closure. This was multicentre, non-inferiority trial. Patients
included in this trail should have at least one of the following previous
stroke or TIA, CCF, diabetes, hypertension, or age more than 75 years. Totally 707
patents were randomized 2:1 for device: warfarin receptively for 1065
patient-years of follow-up. Although device was non-inferior to warfarin, Periprocedural
complications were higher in device group.
PREVAIL trial has targeted enrolling of 475 patients
with paroxysmal, persistent and permanent AF from year Nov 2010. Inclusion criteria
CHADS2 score of at least 2, or a score of 1 in the presence of additional
stroke risk factors including advanced age plus CAD, heart failure (up to NYHA
class 3), or diabetes. Primary results of PREVAIL trail are to be presented in
ACC 2013 march 9-11. PREVAIL results are one of main attraction of ACC 2013.
Labels: Advanced level, Arrhythmia, For Doctors, Medical equipment