Prophylactic left atrial appendage exclusion during cardiac surgery achieved 99% technical success, with thromboembolic events in 3.4% of LAAE patients versus 5.6% of controls at 1 year.
RCT (n=562)
2:1
Yes
Does prophylactic left atrial appendage exclusion reduce thromboembolic events and demonstrate safety in cardiac surgery patients with elevated stroke and bleeding risk scores?
Prophylactic left atrial appendage exclusion during structural heart surgery is highly successful and safe, with a low rate of thromboembolic events at 1 year.
Absolute Event Rate: 3.4% vs 5.6%
Objective: Patients with elevated CHA 2 DS 2 -VASc scores are at high risk for atrial fibrillation (AF) and thromboembolic events (TE) after cardiac surgery. Left atrial appendage exclusion (LAAE) is a permanent, continuous approach to stroke prevention in AF, overcoming limitations of oral anticoagulation (OAC). We report ATLAS trial results focused on LAAE technical success and perioperative safety and TE rates with and without LAAE in cardiac surgery patients who developed postoperative AF (POAF). Methods: ATLAS (NCT02701062) was a prospective, multicenter, feasibility trial. Patients age ≥18 years, undergoing structural heart procedure, with no preoperative AF, CHA 2 DS 2 -VASc ≥2, and HAS-BLED ≥2 were randomized 2:1 to LAAE or no LAAE. Patients who developed POAF and/or received LAAE were followed for 1 year. LAAE was evaluated with intraoperative transesophageal echocardiography. Results: A total of 562 patients were randomized to LAAE ( n = 376) or no LAAE ( n = 186). Mean CHA 2 DS 2 -VASc (3.4 vs 3.4) and HAS-BLED (2.8 vs 2.9) scores were similar for LAAE and no LAAE groups. LAAE success (no flow nor residual stump >10 mm) was 99%. One LAAE-related serious adverse event (0.27%) occurred and was resolved without sequelae. There were 44.3% of patients who developed POAF. Through 1 year, 3.4% of LAAE patients and 5.6% of no LAAE patients had TE. OAC was used by 32.5% of POAF patients. Bleeding was higher with OAC than without (16.1% vs 5.4%, P = 0.008). Conclusions: ATLAS demonstrated a high rate of successful LAAE with low LAAE-related serious adverse events in cardiac surgery patients. Study results should be considered in future trial design to further evaluate prophylactic LAAE for stroke prevention in cardiac surgery patients with elevated stroke risk.
Gerdisch et al. (Tue,) conducted a rct in Cardiac surgery patients with elevated CHA2DS2-VASc score (n=562). Left atrial appendage exclusion (LAAE) vs. No LAAE was evaluated on Thromboembolic events (TE). Prophylactic left atrial appendage exclusion during cardiac surgery achieved 99% technical success, with thromboembolic events in 3.4% of LAAE patients versus 5.6% of controls at 1 year.