Mar 4, 2013

Watch carefully, watchman device for AF, at ACC 2013: PREVAIL trail.

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.

 PROTECT-AF trial 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.