Impact of CHA2DS2-VASc Score in the Outcomes of Patients Undergoing a Simplified Pathway for Percutaneous Left Atrial Appendage Closure
Claudio Sanfilippo and Marco Frazzetto are contributed equally to this study.
ABSTRACT
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 CHA2DS2-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 CHA2DS2-VASc scores ≥ 5 and 133 had CHA2DS2-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%, plog-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 CHA2DS2-VASc score ≥ 5 and those with CHA2DS2-VASc score < 5.
Conflicts of Interest
Prof. Barbanti is consultant for Medtronic, Edwards Lifescience and Boston Scientific. Prof. Capodanno reports speaker or consulting fees from Bristol-Meyers Squibb, Novo Nordisk, Sanofi, and Terumo. Guilherme Attizzani is a consultant, serves on the advisory board and has research grants for Medtronic, Boston Scientific, Dasi Simulations, and Elixir. Dr. Di Salvo is proctor for Gore, Lifetech, Occlutech and Innova Medical. Dr. Grasso is proctor for Abbott, Boston Scientific and Eclipse Medical. Prof. Tamburino is consultant for Medtronic. The other authors declare no conflicts of interest.
Open Research
Data Availability Statement
The data that support the findings of this study are available from the corresponding author upon reasonable request.
