Why the study?
Pre-procedural TOE or CCTA before LAAC increases hospital resource use and time, prompting evaluation of outcomes without pre-procedural imaging across thromboembolic risk strata.
Does a simplified LAAC pathway without pre-procedural imaging yield comparable outcomes in patients with CHA2DS2-VASc score ≥ 5 compared to those with score < 5?
Cohort (n=227)
No
Does a simplified LAAC pathway without pre-procedural imaging yield comparable outcomes in patients with CHA2DS2-VASc score ≥ 5 compared to those with score < 5?
Effect estimate: aHR 0.85 (95% CI 0.48-1.50)
Absolute Event Rate: 24.81% vs 20.21%
p-value: p=0.58
A simplified LAAC pathway without pre-procedural imaging is feasible and safe, with comparable 2-year outcomes between patients with very high (CHA2DS2-VASc ≥ 5) and high (< 5) thromboembolic risk.
May support simplified LAAC without imaging in CHA2DS2-VASc ≥5 patients; leaves open need for randomized confirmation.
Background Percutaneous left atrial appendage closure (LAAC) is usually performed after a pre‐procedural evaluation by transesophageal echocardiography (TOE) or cardiac computed tomography angiography (CCTA). Nevertheless, these ad‐hoc examinations imply an additional use of hospital resources and time spending. Aims To investigate long‐term clinical outcomes, effectiveness and safety of performing LAAC procedures without pre‐procedural imaging assessment in patients with high and very high thromboembolic risk based on CHA 2 DS 2 ‐VASc score. Methods From January 2016 to January 2023, 227 consecutive patients undergoing LAAC following an optimized pathway that removed the use of pre‐procedural TOE or CCTA imaging assessment, were enrolled in this single‐center, retrospective study. Patients were divided into two groups based on thromboembolic risk: 94 had CHA 2 DS 2 ‐VASc scores ≥ 5 and 133 had CHA 2 DS 2 ‐VASc scores < 5). The primary endpoint was a composite of all‐cause death, stroke, systemic embolization, or bleeding events at 2 years. Co‐primary endpoints were device success, device‐related thrombosis (DRT) and peri‐device leaks (PDL) ≥ 3 mm at TOE follow‐up. Results At 2 years, no significant differences were observed between groups in the primary composite endpoint (KM est. 24.81% vs. 20.21%, p log‐rank = 0.7; aHR 0.85, CI: 0.48−1.50, p = 0.58). Device success was 98.7% overall, with no significant differences between groups (aOR 0.32% CI: 0.03−3.80; p = 0.37). DRT and PDL ≥ 3 mm rates were low (4.3% vs. 1.5%, p = 0.26% and 3.2% vs. 2.3%, p = 0.75, respectively). In‐hospital complications were low and comparable in both groups. Conclusions In a consecutive series of patients undergoing LAAC, a simplified approach without pre‐operative imaging assessment showed comparable results at 2‐year for the primary composite endpoint of all‐cause death, stroke, systemic embolization, or bleeding events in patients with CHA 2 DS 2 ‐VASc score ≥ 5 and those with CHA 2 DS 2 ‐VASc score < 5.
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Sanfilippo et al. (2025) conducted a cohort in High thromboembolic risk requiring LAAC (n=227). LAAC without pre-procedural imaging (CHA2DS2-VASc ≥ 5) vs. LAAC without pre-procedural imaging (CHA2DS2-VASc < 5) was evaluated on Composite of all-cause death, stroke, systemic embolization, or bleeding events at 2 years (aHR 0.85, 95% CI 0.48-1.50, p=0.58).
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