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Multicenter Study
. 2024 Jul 2;26(7):euae188.
doi: 10.1093/europace/euae188.

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

Errol W Aarnink  1 , Hueseyin Ince  2   3 , Stephan Kische  4 , Evgeny Pokushalov  5 , Thomas Schmitz  6 , Boris Schmidt  7 , Tommaso Gori  8 , Felix Meincke  9 , Alexey Vladimir Protopopov  10 , Timothy Betts  11 , Patrizio Mazzone  12 , Marek Grygier  13 , Horst Sievert  14 , Tom De Potter  15 , Elisa Vireca  16 , Kenneth Stein  17 , Martin W Bergmann  18 , Lucas V A Boersma  1
Affiliations
Multicenter Study

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

Errol W Aarnink et al. Europace. .

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.

Keywords: Atrial fibrillation; Left atrial appendage occlusion; Mortality; Risk stratification.

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Conflict of interest statement

H.I. is a proctor for Boston Scientific and received personal fees from Boston Scientific, outside the submitted work. B.S. reports personal fees from Boston Scientific and St Jude Medical, outside the submitted work. T.B. reports personal fees from Boston Scientific, outside the submitted work. P.M. is a proctor for Boston Scientific and a consultant for St Jude Medical. M.G. is a Boston Scientific advisory board member, receives honoraria for lectures from Boston Scientific and Abbott, and is a proctor for Boston Scientific and Abbott. E.V. and K.S. are employees and shareholders at Boston Scientific. T.D.P. reports fees to the cardiology department research fund from Boston Scientific, outside the submitted work. M.W.B. reports personal fees from Boston Scientific, St Jude Medical, Biosense Webster, and Johnson & Johnson, outside the submitted work. H.S. reports personal fees from Abbott, Aptus, Atrium, Biosense Webster, Boston Scientific, Carag, Cardiac Dimensions, CardioKinetix, CardioMEMS, Cardiox, Celonova, CGuard, Coherex, Comed B.V., Contego, Covidien, CSI, CVRx, ev3, FlowCardia, Gardia, Gore, GTIMD Medical, Guided Delivery Systems, Hemoteq, InSeal Medical, InspireMD, Kona Medical, Lumen Biomedical, LifeTech, Lutonix, Maya Medical, Medtronic, Occlutech, pfm Medical, Recor, Trireme, Trivascular, Valtech, Vascular Dynamics, Venus Medical, Veryan, and Vessix, outside the submitted work, and he reports stock options in Cardiokinetix, Access Closure, Coherex, and SMT, outside the submitted work. L.V.A.B. reports fees to the Cardiology Department from Boston Scientific, and Medtronic, outside the submitted work. The other authors report no conflicts.

Figures

Graphical Abstract
Graphical Abstract
The mortality risk within EWOLUTION increased gradually with a growing number of risk factors. Risk factors included age, heart failure, vascular disease, valvular disease, abnormal liver function, and abnormal kidney function. CI, confidence interval; IR, incidence rate; RF, risk factor.
Figure 1
Figure 1
Kaplan–Meier estimates for all-cause death and subcategories. (A) Kaplan–Meier estimates for cumulative incidence within subcategories of mortality. (B) Proportional distribution of mortality classification within the first 2 years after LAAO. The x-axis is identical to the x-axis in A. CI, confidence interval.
Figure 2
Figure 2
Temporal relation of clinical events and death. Horizontal lines represent timelines for individual patients that both had a clinical event and died within 2 years after LAAO. Multiple events of the same type within individual patients were not registered and are therefore not plotted. LAAO, left atrial appendage occlusion; TIA, transient ischaemic attack.
Figure 3
Figure 3
Multivariate hazard ratios for 2-year mortality. CI, confidence interval; HR, hazard ratio; LAA, left atrial appendage; mm: millimetre.
Figure 4
Figure 4
Two-year mortality rates for subgroups. Univariate predictors include LAA ostium diameter, diabetes mellitus and prior major bleed or predisposition. Multivariate predictors include age, valvular disease, congestive heart failure, vascular disease, abnormal liver function and abnormal renal function. Incidence rates are calculated per subgroup. The vertical reference line represents the mortality rate within the whole cohort. CI, confidence interval; HR, hazard ratio; LAA, left atrial appendage; mm: millimetre.
Figure 5
Figure 5
Two-year mortality rates according to number of risk factors. The table on the right side represents 2-year mortality rates with 95% CI per risk subgroup. CI, confidence interval; IR, incidence rate; RF, risk factors.
See this image and copyright information in PMC

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