Revista Española de Cardiología (English Edition)
Date: August 2025
Pages: 668-678

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Original article
Impact of intensive versus nonintensive antithrombotic treatment on device-related thrombus after left atrial appendage closureImpacto del tratamiento antitrombótico intensivo frente al no intensivo en la trombosis del dispositivo tras cierre de la orejuela izquierda

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Abstract

Introduction and objectives

The optimal antithrombotic therapy (AT) after left atrial appendage closure (LAAC) is debated. We assessed the impact of intensive vs nonintensive AT on the incidence of device-related thrombus (DRT) based on whether the device implantation was classified as optimal or suboptimal.

Methods

This study included patients who underwent successful LAAC in 9 centers. Patients were classified according to the quality of device implantation: optimal (proximal implant without ≥ 3 mm peridevice leak) or suboptimal (distal implant and/or ≥ 3 mm peridevice leak). Postimplant AT was classified as either intensive (dual antiplatelet therapy, anticoagulants, or a combination of both) or nonintensive (no AT or a single antiplatelet therapy). The primary endpoint was the incidence of DRT between the 6th and 12th weeks postprocedure.

Results

A total of 1225 patients underwent LAAC, with 757 (61.8%) achieving optimal device implantation and 468 (38.2%) classified as suboptimal. After a median follow-up of 20 months, the incidence of DRT in the optimal implant group was 2.6% with intensive AT and 3.7% with nonintensive AT (P = .38). In the suboptimal implant group, the incidence of DRT increased to 11.2% with intensive AT and 15.5% with nonintensive AT (P = .19). On multivariate analysis, suboptimal implantation (HR, 4.51; 95%CI, 2.70-7.54, P < .001) but not intensive AT (HR, 0,66; 95%CI, 0.40-1.07, P = .09) emerged as an independent predictor of DRT.

Conclusions

The incidence of DRT after LAAC was higher in patients with suboptimal device implantation. In patients with optimal implantation, the incidence of DRT was low and similar between nonintensive and intensive AT strategies. Large, randomized trials are warranted to confirm these results.

Resumen

Introducción y objetivos

El tratamiento antitrombótico (TA) óptimo tras el cierre de la orejuela izquierda (COI) es objeto de debate. Se evaluó el impacto de los TA intensivo y no intensivo en la incidencia de trombosis relacionada con el dispositivo (TD) según el implante fuera óptimo o subóptimo.

Métodos

El estudio incluyó a pacientes que se sometieron a un COI exitoso en 9 centros. Se clasificó a los pacientes según el implante del dispositivo fuera óptimo (implante proximal sin fuga peridispositivo ≥ 3 mm) o subóptimo (implante distal y/o fuga ≥ 3 mm) y el TA, intensivo (doble antiagregación plaquetaria, anticoagulación o una combinación de ambas) o no intensivo (sin TA o antiagregación plaquetaria simple) tras el implante. El objetivo primario fue la incidencia de TD entre las semanas 6 y 12 tras el procedimiento.

Resultados

Un total de 1.225 pacientes se sometieron a COI. Se lograron implantes óptimo y subóptimo del dispositivo en 757 (61,8%) y 468 (38,2%) de ellos. Tras un seguimiento de 20 meses, los pacientes con implante óptimo y TA intensivo o no intensivo presentaron una incidencia de TD del 2,6 y el 3,7% (p = 0,38). En aquellos con un implante subóptimo, la incidencia de TD aumentó al 11,2% con TA intensivo y el 15,5% con TA no intensivo (p = 0,19). En el análisis multivariable, el implante subóptimo (HR = 4,51; IC95%, 2,70-7,54; p < 0,001), pero no el TA intensivo (HR = 0,66; IC95%, 0,40-1,07; p = 0,09), se identificó como un predictor independiente de TD.

Conclusiones

La incidencia de TD tras el COI fue mayor en pacientes con implante subóptimo del dispositivo. En el grupo de implante óptimo, la incidencia de TD fue baja y similar entre TA no intensivo y TA intensivo. Se requieren ensayos clínicos grandes y aleatorizados para confirmar estos resultados.

Keywords

Left atrial appendage closure
;
Atrial fibrillation
;
Antiplatelet agents
;
Anticoagulants
;
Device-related thrombosis
;
Stroke

Palabras clave

Cierre de la orejuela izquierda
;
Fibrilación auricular
;
Antiagregación plaquetaria
;
Anticoagulación
;
Trombosis relacionada con el dispositivo
;
Ictus

Abbreviations

AT,
antithrombotic treatment
;
DRT,
device-related thrombus
;
LAAC,
left atrial appendage closure
;
OAC,
oral anticoagulants
;
PDL,
peridevice leak
;
PR,
pulmonary ridge

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Section snippets

INTRODUCTION

Growing evidence supports left atrial appendage closure (LAAC) in selected patients with nonvalvular atrial fibrillation.1, 2 The adoption of the procedure has expanded at a remarkable rate, reflecting the major unmet need for an effective stroke prevention strategy in patients for whom long-term oral anticoagulation (OAC) is unacceptable.3 Recent refinements in procedural planning and technique have optimized the LAAC procedure and minimized complications.4, 5 Device-related thrombus (DRT) is

Study cohort

The study cohort has been previously described in detail.15 In brief, baseline characteristics, procedural features, postimplant AT and outcomes of patients who underwent successful LAAC in 9 centers from Europe and North America were collected in a dedicated database. Device selection, pre- and postprocedural type of imaging, as well as postprocedural AT was left at the operator's discretion. LAAC procedures were performed in accordance with current expert recommendations.17 Follow-up

RESULTS

A total of 1225 patients (35.0% female) undergoing successful transcatheter LAAC were included in the study (table 1 and figure 1). Among them, the achieved procedural result was optimal in 757 patients (61.8%) and suboptimal in 468 (38.2%) (figure 2). The AT in the study population is described in table 1 of the supplementary data. The baseline characteristics of the 2 groups are summarized in table 2 of the supplementary data. The proportion of patients with permanent nonvalvular atrial

DISCUSSION

The main findings of the present study assessing the impact of intensive vs nonintensive AT in patients with optimal and suboptimal implants after transcatheter LAAC were as follows: a) suboptimal implants were associated with a higher incidence of DRT after LAAC, which was not mitigated by intensive AT; b) in patients with optimal implants, the use of intensive AT might not be necessary, as the incidence of DRT was low and similar between the intensive and nonintensive AT groups; and c)

CONCLUSIONS

The incidence of DRT after LAAC was higher in patients with suboptimal implants, which was not mitigated by intensive AT. Compared with nonintensive AT, intensive AT was not associated with a lower incidence of DRT after either an optimal or suboptimal implant. Suboptimal implants, but not intensive AT, emerged as an independent predictor of DRT. Further studies are warranted to confirm these results.

FUNDING

This study received no funding.

ETHICAL CONSIDERATIONS

The study was conducted in accordance with the institutional ethics committee of each participating center, and all patients provided signed informed consent for the procedures. The study conformed to the guiding principles of the Declaration of Helsinki. In accordance with the SAGER guidelines, the information was disaggregated in table 1 with no difference between groups.

STATEMENT ON THE USE OF ARTIFICIAL INTELLIGENCE

The authors declare that they have not used any type of generative artificial intelligence for the preparation of this manuscript.

AUTHORS’ CONTRIBUTIONS

Each author contributed significantly to the submitted work. Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work: P. Garot, P. Cepas-Guillén, X. Freixa. Drafting the work or revising it critically for important intellectual content: E. Flores-Umanzor, N. Leduc, V. Bajoras, N. Perrin, A. McInerney, A. Lafond, J. Farjat-Pasos, X. Millán, G. ÓHara, S. Zandjebil, R. Ibrahim, P. Salinas, O. de Backer, J.E

CONFLICTS OF INTEREST

P. Garot reports receiving speaker/advisory/proctor fees from Abbott, Biosensors, Boston Scientific, Edwards Lifesciences, General Electric HealthCare, and Terumo. He is medical director and shareholder of the Cardiovascular European Research Center in Massy, France. O. de Backer received institutional research grants and consulting fees from Abbott and Boston Scientific. R. Ibrahim reports receiving speaker/advisory/proctor fees from Abbott, Boston Scientific, Edwards Lifesciences, and

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    Both authors contributed equally.
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