Long-term follow-up of left atrial appendage exclusion: Results of the V-CLIP multi-center post-market study

Authors

Elias Zias, Department of Cardiothoracic Surgery, New York University Langone Medical Center, 530 1st Ave, Ste 9V, New York, NY 10016, USA.
Katherine G. Phillips, Department of Cardiothoracic Surgery, New York University Langone Medical Center, 530 1st Ave, Ste 9V, New York, NY 10016, USA.
Marc Gerdisch, Department of Cardiothoracic Surgery, Franciscan Alliance dba Franciscan Health Indianapolis, 8111 South Emerson Ave, Indianapolis, IN 46237, USA.
Scott Johnson, Advocate Health - MidwestFollow
Ahmed El-Eshmawi, Department of Cardiothoracic Surgery, Icahn School of Medicine at Mount Sinai, 1 Gustave L. Levy Pl, New York, NY 10029, USA.
Kenneth Saum, Department of Cardiothoracic Surgery, Centra Lynchburg General Hospital, 1901 Tate Springs Rd, Lynchburg, VA 24501, USA.
Michael Moront, Department of Cardiothoracic Surgery, Toledo Hospital, 1 ProMedica Parkway, Toledo, OH 43606, USA.
Michael Kasten, Department of Cardiothoracic Surgery, Mercy Health Physicians, 1000 N Village Ave, Rockville Centre, NY 11570, USA.
Chanderdeep Singh, Department of Cardiothoracic Surgery, Albany Medical Center, 43 New Scotland Ave, Albany, NY 12208, USA.
Gautam Bhatia, Department of Cardiothoracic Surgery, Prisma Health-Greenville Memorial Hospital, 701 Grove Rd, Greenville, SC 29605, USA.
Hiroo Takayama, Department of Cardiothoracic Surgery, Columbia University Medical Center, 630 W 168th St, New York, NY 10032, USA.
Ralph Damiano, Department of Cardiothoracic Surgery, Washington University School of Medicine, 660 S Euclid Ave, St. Louis, MO 63110, USA.

Recommended Citation

Zias E, Phillips KG, Gerdisch M, et al. Long-Term Follow-Up of Left Atrial Appendage Exclusion: Results of the V-CLIP Multi-Center Post-Market Study. J Clin Med. 2025;14(15):5473. Published 2025 Aug 4. doi:10.3390/jcm14155473

Affiliations

Aurora Research Institute, Milwaukee

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.

Document Type

Article

PubMed ID

40807093