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Vol. 73. Issue 1.
Pages 28-34 (January 2020)
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Vol. 73. Issue 1.
Pages 28-34 (January 2020)
Original article
DOI: 10.1016/j.rec.2019.02.013
Left atrial appendage occlusion for stroke despite oral anticoagulation (resistant stroke). Results from the Amplatzer Cardiac Plug registry
Cierre de la orejuela izquierda por ictus pese a la anticoagulación oral (ictus resistente): resultados del registro Amplatzer Cardiac Plug
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Ignacio Cruz-Gonzáleza,
Corresponding author
cruzgonzalez.ignacio@gmail.com

Corresponding author: Servicio de Cardiología, Hospital Clínico Universitario de Salamanca. Paseo de San Vicente 139, 37007 Salamanca, Spain.
, Rocío González-Ferreiroa, Xavier Freixab, Sameer Gafoorc, Samera Shakird, Heyder Omrane, Sergio Bertif, Gennaro Santorog, Joelle Keferh, Ulf Landmesseri, Jens Erik Nielsen-Kudskj, Prapa Kanagaratnamk, Fabian Nietlispachd,i, Steffen Gloeklerd, Adel Aminianl, Paolo Dannam, Marco Rezzaghif, Friederike Stocke, Miroslava Stolcovag, Luis Paivan, Marco Costan, Xavier Milláno, Reda Ibrahimp, Tobias Tichelbäckerq, Wolfgang Schillingerq, Jai-Wun Parkr, Horst Sievertc, Bernhard Meierd, Apostolos Tzikass
a Servicio de Cardiología, Hospital Universitario de Salamanca, Instituto de Investigación Biomédica de Salamanca (IBSAL), CIBERCV, Salamanca, Spain
b Servicio de Cardiologia, Hospital Clínico, Universidad de Barcelona, Barcelona, Spain
c Department of Cardiology, CardioVascular Center Frankfurt, Frankfurt, Germany
d Department of Cardiology, University Hospital of Bern, Bern, Switzerland
e Department of Cardiology, University Hospital of Bonn, Bonn, Germany
f Department of Cardiology, Fondazione Toscana Gabriele Monasterio, Massa, Italy
g Department of Cardiology, Ospedale Careggi di Firenze, Florence, Italy
h Department of Cardiology, St-Luc University Hospital, Brussels, Belgium
i Department of Cardiology, University Hospital of Zurich, Zurich, Switzerland
j Department of Cardiology, Aarhus University Hospital, Skejby, Denmark
k Department of Cardiology, Imperial College Healthcare NHS Trust, London, United Kingdom
l Department of Cardiology, Centre Hospitalier Universitaire de Charleroi, Charleroi, Belgium
m Department of Cardiology Ospedale Luigi Sacco, Milan, Italy
n Department of Cardiology, Coimbra University Hospital Centre, Coimbra, Portugal
o Servicio de Cardiología, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain
p Department of Cardiology, Montreal Heart Institute, Montreal, Canada
q Department of Cardiology, University of Cologne, Faculty of Medicine and University Hospital Cologne, Heart Center Cologne, Cologne, Germany
r Department of Cardiology, Coburg Hospital, Coburg, Germany
s Department of Cardiology, AHEPA University Hospital, Thessaloniki, Greece
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Tables (5)
Table 1. Baseline patient characteristics
Table 2. Procedural characteristics
Table 3. Risk scores and predicted annual risk of thromboembolism and major bleeding
Table 4. Procedural success and major adverse events
Table 5. Antithrombotic medication at baseline and follow-up
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Abstract
Introduction and objectives

Despite the efficacy of oral anticoagulant (OAC) therapy, some patients continue to have a high residual risk and develop a stroke on OAC therapy (resistant stroke [RS]), and there is a lack of evidence on the management of these patients. The aim of this study was to analyze the safety and efficacy of left atrial appendage occlusion (LAAO) as secondary prevention in patients with nonvalvular atrial fibrillation who have experienced a stroke/transient ischemic attack despite OAC treatment.

Methods

We analyzed data from the Amplatzer Cardiac Plug multicenter registry on 1047 consecutive patients with nonvalvular atrial fibrillation undergoing LAAO. Patientes with previous stroke on OAC therapy as indication for LAAO were identified and compared with patients with other indications.

Results

A total of 115 patients (11%) with RS were identified. The CHA2DS2-VASc and the HAS-BLED score were significantly higher in the RS group (respectively 5.5±1.5 vs 4.3±1.6; P <.001; 3.9±1.3 vs 3.1±1.2; P <.001). No significant differences were observed in periprocedural major safety events (7.8 vs 4.5%; P=.1). With a mean clinical follow-up of 16.2±12.2 months, the observed annual stroke/transient ischemic attack rate for the RS group was 2.6% (65% risk reduction) and the observed annual major bleeding rate was 0% (100% risk reduction).

Conclusions

Patients with RS undergoing LAAO showed similar safety outcomes to patients without RS, with a significant reduction in stroke/transient ischemic attack and major bleeding events during follow-up. Adequately powered controlled trials are needed to further investigate the use of LAAO in RS patients.

Keywords:
Left atrial appendage occlusion
Ischemic stroke
Anticoagulant therapy
Atrial fibrillation
Abbreviations:
LAAO
NOAC
OAC
RS
TIA
VKA
Resumen
Introducción y objetivos

A pesar de la eficacia de los anticoagulantes orales (ACO), algunos pacientes mantienen una alto riesgo residual y presentan ictus aun estando en tratamiento con ACO, y falta evidencia sobre el tratamiento de estos pacientes. El objetivo del estudio es analizar la seguridad y la eficacia del cierre percutáneo de la orejuela izquierda (OI) como prevención secundaria para pacientes con fibrilación auricular no valvular que han experimentado un ictus/accidente isquémico transitorio a pesar de los ACO (ictus resistente [IR]).

Métodos

Se estudió a 1.047 pacientes consecutivos con fibrilación auricular no valvular sometidos a cierre percutáneo de la OI incluidos en el registro multicéntrico Amplatzer Cardiac Plug. Se seleccionó a los pacientes con IR como indicación para el cierre de la OI, y se los comparó con pacientes con otras indicaciones.

Resultados

En un total de 115 pacientes (11%) se produjo un IR. Las escalas CHA2DS2-VASc y HAS-BLED eran significativamente más altas en el grupo de IR (5,5±1,5 frente a 4,3±1,6; p <0,001 y 3,9±1,3 frente a 3,1±1,2; p <0,001). No hubo diferencias significativas en los eventos mayores de seguridad periprocedimiento (el 7,8 frente al 4,5%; p=0,1). Tras 16,2±12,2 meses de seguimiento medio, la tasa anual de ictus/accidente isquémico transitorio observada fue del 2,6% (el 65% de reducción del riesgo) y la tasa anual de hemorragia mayor observada fue del 0% (el 100% de reducción del riesgo) en los pacientes con IR.

Conclusiones

Los pacientes con IR sometidos a cierre percutáneo de la OI presentaron resultados de seguridad similares que los pacientes sin IR, con una reducción significativa de los eventos de ictus/accidente isquémico transitorio y hemorragia mayor durante el seguimiento.

Palabras clave:
Cierre percutáneo de la orejuela izquierda
Ictus isquémico
Anticoagulación oral crónica
Fibrilación auricular

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