Prophylactic Left Atrial Appendage Exclusion in Cardiac Surgery Patients With Elevated CHA₂DS₂-VASc Score: Results of the Randomized ATLAS Trial

Abstract

Objective: Patients with elevated CHA2DS2-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, CHA2DS2-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 CHA2DS2-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.

Enhanced Recovery After Surgery Cardiac Society turnkey order set for prevention and management of postoperative atrial fibrillation after cardiac surgery: Proceedings from the American Association for Thoracic Surgery ERAS Conclave 2023

“…15 Concomitant prophylactic surgical left atrial appendage closure at the time of cardiac surgery has not been shown to reduce the risk of stroke or incidence of POAF in patients without atrial fibrillation. 13 , 19 …”

Prophylactic Left Atrial Appendage Ligation During Coronary Artery Bypass Graft Surgery Allows Safe Avoidance of Anticoagulation Regardless of Postoperative Atrial Fibrillation

“…The multi-national randomized controlled LAAOS III trial showed that surgical ligation of the LAA with an epicardial clip, in addition to coronary artery bypass grafting (CABG), reduced the risk of ischemic stroke or systemic embolism compared to CABG alone in patients with a history of atrial fibrillation, even with similar rates of postoperative anticoagulation in both groups [17]. The ATLAS feasibility trial also demonstrated that LAAL reduced cerebral thromboembolism risk in patients at high risk for stroke and bleeding compared to no ligation [18]. Furthermore, Gerçek and colleagues showed the long-term durability of these results, with a 4.1% decrease in stroke incidence over five years following LAAL in addition to CABG compared to CABG alone, and a 6.3% stroke incidence reduction in patients with CHA 2 DS 2 -VASc scores > 3 [19].…”

The ATLAS Trial: A Look Before We LeAAPS

“…With the AtriClip Left Atrial Appendage Exclusion Concomitant to Structural Heart Procedures (ATLAS) study, Gerdisch et al have taken an important step toward expanding the LAAO evidence to patients without atrial fibrillation. 5 Key takeaways from ATLAS are as follows:…”

“…By demonstrating that LAAO using the AtriClip (AtriCure, Inc., Mason, OH, USA) can be performed safely and effectively, the ATLAS investigators set the stage for a trial demonstrating the efficacy of the procedure at reducing ischemic stroke risk in patients without a history of atrial fibrillation at the time of surgery. 5 The ATLAS study focused on patients who developed postoperative atrial fibrillation, but based on overlap of the risk factors for cardiac surgery and atrial fibrillation, it is likely that a significant proportion of the recruited patients will develop atrial fibrillation over time, becoming like LAAOS III patients. For this reason, long-term follow-up will be essential in a trial of LAAO in patients without atrial fibrillation.…”