# Long-Term Follow-Up of Left Atrial Appendage Exclusion: Results of the V-CLIP Multi-Center Post-Market Study

## TL;DR

This study shows that a device called V-shape AtriClip safely and effectively excludes the left atrial appendage in cardiac surgery patients, reducing stroke risk.

## Contribution

The study provides long-term safety and performance data for the V-shape AtriClip device in excluding the left atrial appendage.

## Key findings

- Complete left atrial appendage exclusion was achieved in all 151 evaluable patients.
- The device met primary safety and performance endpoints with no serious adverse events in 97-100% of patients.
- One device-related adverse event occurred but resolved during the procedure.

## Abstract

Background: Cardiac surgery patients with pre- or post-operative atrial fibrillation are at an increased risk for thromboembolic stroke, often due left atrial appendage (LAA) thrombus. Surgical LAA exclusion (LAAE) can be performed and must be complete to avoid increased thrombus formation. Methods: This prospective, multi-center, post-market study (NCT05101993) evaluated the long-term safety and performance of the epicardial V-shape AtriClip device. Patients ≥18 years who had received V-shape AtriClip devices during non-emergent cardiac surgery consented to a prospective 12-month follow-up visit and LAA imaging. The primary performance was LAAE without residual left atrium-LAA communication, assessed by imaging at the last follow-up visit. The primary safety was device- or implant procedure-related serious adverse events (SAEs) (death, major bleeding, surgical site infection, pericardial effusion requiring intervention, myocardial infarction) within 30 days. Results: Of 155 patients from 11 U.S. centers, 151 patients had evaluable imaging. Complete LAAE was obtained in all patients. Primary performance in the intent-to-treat population was met, with 97% (95% CI 93.52%, 99.29%; p = 0.0001) complete LAAE. Primary safety was met, with 100% (95% CI 97.75%, 100%; p < 0.0001) of patients free from pre-defined SAEs within 30 days. One device-related SAE was reported, which resolved intraprocedurally. Conclusions: AtriClip V-Clip showed safe and successful LAAE through 12 months of follow-up.