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PLoS One. 2018 Dec 19;13(12):e0208710. doi: 10.1371/journal.pone.0208710. eCollection 2018.

Long term outcomes after left atrial appendage closure with the LARIAT device-Stroke risk reduction over five years follow-up.

Author information

1
Department of Cardiovascular Surgery and Transplantology, Jagiellonian University, John Paul II Hospital, Krakow, Poland.
2
Departament of Pharmacology, Jagiellonian University, Krakow, Poland.
3
Department of Cardiac Surgery, Regional Specialist Hospital, Grudziadz, Poland.
4
Department of Cardiac and Vacsular Surgery, Medical University of Gdansk, Gdansk, Poland.
5
Department of Cardiac Surgery, Central Clinical Hospital of Ministry of Interior, Warsaw, Poland.
6
Warren Alpert School of Medicine, Brown University, Harvard Medical School, Boston MA, United States of America.
7
Division of Cardiovascular Diseases, Cardiovascular Research Institute, University of Kansas, Kansas City, KS, United States of America.
8
Department of Medicine, Division of Cardiac Electrophysiology, University of California San Francisco, San Francisco, CA, United States of America.
9
Cardiovascular Research Institute, Institute for Regeneration Medicine, University of California San Francisco, San Francisco, CA, United States of America.
10
Departament of Rehabilitation, Jagiellonian University, Krakow, Poland.

Abstract

INTRODUCTION:

Left atrial appendage closure (LAAC) with LARIAT offers an alternative to oral anticoagulation (OAC) for patients with atrial fibrillation. The aim of this study was to present long-term clinical outcomes of LAAC in these patients (AF).

MATERIAL AND METHODS:

A prospective, single-center study was performed in 139 patients undergoing LAAC with Lariat. Thromboembolic events, severe bleeding and mortality rate were recorded. The reduction in risk of thromboembolism and bleeding after LAAC was calculated.

RESULTS:

The mean CHADS2-score was 1.8 ± 1.0, mean CHA2DS2-VASc score was 2.9 ± 1.6 and HAS-BLED score was 3.1 ± 1.1. After 428.4 patient-years of follow-up (mean 4.2±1.0 years), the thromboembolism rate was 0.6% with a calculated thromboembolism risk reduction of 81%. The severe bleeding rate was 0.8%; calculated bleeding risk reduction was 78%. The overall mortality rate was 1.6%.

CONCLUSIONS:

Long-term outcomes show that LAAC with Lariat is a safe and effective treatment for stroke prevention and bleeding risk reduction in AF patients with a high level of underlying risk.

Conflict of interest statement

RL has equity ownership in Sentreheart. DL is co-chair of the AMAZE trial steering committee and has received an institutional research grant. KB is consultant to Sentreheart and recipient of research grant funded by the National Science Centre. This does not alter the authors' adherence to PLOS ONE policies on sharing data and materials.

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