Incidence and predictors of 2-year mortality following percutaneous left atrial appendage occlusion in the EWOLUTION trial

Author:

Aarnink Errol W1ORCID,Ince Hueseyin23,Kische Stephan4,Pokushalov Evgeny5ORCID,Schmitz Thomas6,Schmidt Boris7ORCID,Gori Tommaso8,Meincke Felix9ORCID,Protopopov Alexey Vladimir10ORCID,Betts Timothy11ORCID,Mazzone Patrizio12ORCID,Grygier Marek13ORCID,Sievert Horst14,De Potter Tom15ORCID,Vireca Elisa16ORCID,Stein Kenneth17,Bergmann Martin W18ORCID,Boersma Lucas V A1ORCID

Affiliation:

1. Department of Cardiology, St Antonius Ziekenhuis Nieuwegein/AUMC Amsterdam , Koekoekslaan 1, 3435 CM Nieuwegein , The Netherlands

2. Department of Cardiology, Vivantes Klinikum Am Urban and Neukölln , Berlin , Germany

3. Department of Cardiology, Universitätsmedizin Rostock , Rostock , Germany

4. Department of Cardiology, Vivantes Klinikum im Friedrichshain , Berlin , Germany

5. State Research Institute of Circulation Pathology , Novosibirsk , Russia

6. Department of Cardiology, Elisabeth Krankenhaus Essen , Essen , Germany

7. Cardioangiologisches Centrum Bethanien , Frankfurt/Main , Germany

8. Department of Cardiology, Universitätsmedizin Mainz und DZHK Standort Rhein-Main , Mainz , Germany

9. Department of Cardiology, Asklepios Klinik Altona , Hamburg , Germany

10. Cardiovascular Center of Regional State Hospital , Krasnoyarsk , Russia

11. Department of Cardiology, Oxford University Hospitals NHS Trust , UK

12. Arrhythmology and Cardiac Pacing Unit, San Raffaele University-Hospital , Milan , Italy

13. Chair and 1st Department of Cardiology, Poznan University of Medical Sciences , Poznan , Poland

14. CardioVascular Center Frankfurt , Frankfurt , Germany

15. Department of Cardiology, Onze Lieve Vrouw Ziekenhuis , Aalst , Belgium

16. Boston Scientific , Diegem , Belgium

17. Boston Scientific , St Paul , USA

18. Department of Cardiology and Intensive Care Medicine, Asklepios Klinik Altona , Hamburg , Germany

Abstract

Abstract Aims Sufficient survival time following left atrial appendage occlusion (LAAO) is essential for ensuring the efficacy and cost-effectiveness of this strategy for stroke prevention. Understanding prognostic factors for early mortality after LAAO could optimize patient selection. In the current study, we perform an in-depth analysis of 2-year mortality after LAAO, focusing particularly on potential predictors. Methods and results The EWOLUTION registry is a real-world cohort comprising 1020 patients that underwent LAAO. Endpoint definitions were pre-specified, and death was categorized as cardiovascular, non-cardiovascular, or unknown origin. Mortality rates were calculated from Kaplan–Meier estimates. Baseline characteristics significantly associated with death in univariate Cox regression analysis were incorporated into the multivariate analysis. All multivariate predictors were included in a risk model. Two-year mortality rate was 16.4% [confidence interval (CI): 14.0–18.7%], with 50% of patients dying from a non-cardiovascular cause. Multivariate baseline predictors of 2-year mortality included age [hazard ratio (HR) 1.05, CI: 1.03–1.08, per year increase], heart failure (HR 1.73, CI: 1.24–2.41), vascular disease (HR 1.47, CI: 1.05–2.05), valvular disease (HR 1.63, CI: 1.15–2.33), abnormal liver function (HR 1.80, CI: 1.02–3.17), and abnormal renal function (HR 1.58, CI: 1.10–2.27). Mortality rate exhibited a gradual rise as the number of risk factors increased, reaching 46.1% in patients presenting with five or six risk factors. Conclusion One in six patients died within 2 years after LAAO. We identified six independent predictors of mortality. When combined, this model showed a gradual increase in mortality rate with a growing number of risk factors, which may guide appropriate patient selection for LAAO. Clinical trial registration The original EWOLUTION registry was registered at clinicaltrials.gov under identifier NCT01972282.

Funder

Boston Scientific Corporation

Publisher

Oxford University Press (OUP)

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