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Published on: February 26, 2013
Prophylactic Left Atrial Appendage Exclusion in Cardiac Surgery Patients With Elevated CHA2DS2-VASc Score: Results of
Marc W Gerdisch1, H Edward Garrett2, Mubashir A Mumtaz3
1Franciscan Health Indianapolis, IN, USA.
Insights
Left atrial appendage exclusion (LAAE) is a safe and effective stroke prevention method for cardiac surgery patients at high risk for atrial fibrillation (AF) and thromboembolic events (TE). The ATLAS trial showed high LAAE success and low adverse events, suggesting its potential for future stroke prevention strategies.
Area of Science:
- Cardiology
- Cardiac Surgery
- Thrombosis Prevention
Background:
- Patients undergoing cardiac surgery with elevated CHA2DS2-VASc scores face high risks of atrial fibrillation (AF) and thromboembolic events (TE).
- Left atrial appendage exclusion (LAAE) offers a permanent stroke prevention strategy in AF, addressing limitations of oral anticoagulation (OAC).
Purpose of the Study:
- To evaluate the technical success, perioperative safety, and thromboembolic event (TE) rates of Left Atrial Appendage Exclusion (LAAE) in cardiac surgery patients.
- To compare TE rates in patients who developed postoperative AF (POAF) with and without LAAE.
Main Methods:
- The prospective, multicenter ATLAS feasibility trial randomized 562 patients (2:1) to LAAE or no LAAE.
- Patients with no preoperative AF, CHA2DS2-VASc ≥2, and HAS-BLED ≥2 were followed for 1 year, with LAAE assessed via intraoperative transesophageal echocardiography.
Main Results:
- LAAE achieved 99% technical success with a low serious adverse event rate (0.27%).
- TE occurred in 3.4% of LAAE patients versus 5.6% of no LAAE patients over 1 year.
- Bleeding was significantly higher in patients on OAC (16.1%) compared to those not on OAC (5.4%).
Conclusions:
- The ATLAS trial demonstrated high success and safety for LAAE in cardiac surgery patients.
- Prophylactic LAAE warrants further investigation for stroke prevention in high-risk cardiac surgery patients.
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.
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