Efectividad y seguridad de una estrategia de antiagregación plaquetaria simple tras cierre percutáneo de orejuela izquierda en pacientes con FA / Single antiplatelet therapy after left atrial appendage closure in patients with AF: safety and effectiveness

Introduction and objectives The optimal antithrombotic strategy following left atrial appendage closure (LAAC) is poorly defined in patients with nonvalvular atrial fibrillation. We assessed the safety and effectiveness of a single antiplatelet treatment (SAPT) strategy after LAAC in a population at high risk of ischemic and bleeding events. Methods This single-center, observational, prospective study included a consecutive cohort of patients who underwent LAAC using the LAmbre device (Lifetech Scientific, China) and who were discharged with SAPT. The primary outcome was a composite of stroke, systemic embolism, and device-related thrombosis during follow-up. Secondary endpoints were cardiovascular mortality and major bleeding events (BARC ≥3a). Clinical follow-up was performed at 1, 6, and 12 months and subsequently on an annual basis. Transesophageal echocardiography was performed at 1 and 12 months of follow-up. Results The study comprised 74 patients. The median age was 77 [72-83] years and 43% were women. The cohort exhibited a high prevalence of comorbidities and cardiovascular risk factors. The median CHA2DS2-VASc and HAS-BLED scores were 4 [3-6] and 4 [4-5], respectively. The median length of follow-up was 2.5 years (188 patients-year). During follow-up, device-related thrombosis occurred in 3 patients (4%). Ischemic stroke occurred in 1 patient (1.3%, rate 0.5%/y), representing a 90.9% relative risk reduction compared with the risk predicted by CHA2DS2-VASc. Major bleeding events occurred in 12 patients (16%, 6.4%/y), with a relative risk reduction of 26.4% of that predicted by HAS-BLED. Cardiovascular-related mortality was observed in 2 patients (2.7%). Conclusions SAPT appears to be a safe and effective treatment following LAAC in patients at high ischemic and hemorrhagic risk. Further studies are needed to confirm our findings (AU)

Introducción y objetivos Se desconoce cuál es la terapia antitrombótica óptima tras el cierre percutáneo de la orejuela izquierda (CPOI) en pacientes con fibrilación auricular no valvular. El objetivo de este estudio es analizar la efectividad y la seguridad de un régimen de tratamiento antiagregante plaquetario simple (TAPS) tras el CPOI en una población con alto riesgo isquémico y hemorrágico. Métodos Estudio observacional prospectivo que incluyó una cohorte consecutiva de pacientes a los que se realizó CPOI con dispositivo LAmbre (Lifetech Scientific, China) y que recibieron TAPS al alta. El evento primario fue un combinado de ictus, embolia sistémica y trombosis del dispositivo. Los eventos secundarios fueron mortalidad cardiovascular y hemorragia mayor (BARC ≥ 3a). Se realizó seguimiento clínico al mes y a los 6 y 12 meses y cada año después. Se realizó ecocardiograma transesofágico al mes y a los 12 meses. Resultados Se incluyó a 74 pacientes (el 43% mujeres) con una mediana de edad de 77 [intervalo intercuartílico, 72-83] años, que presentaban gran comorbilidad y factores de riesgo cardiovascular. Los valores de CHA2DS2-VASc y HAS-BLED fueron una mediana de 4 [3-6] y 4 [4-5] respectivamente. Durante el seguimiento (mediana, 2,5 años), 3 pacientes (4%) presentaron trombosis del dispositivo. Uno sufrió ictus isquémico (1,3%, 0,5%/año), lo que supone, según la incidencia esperada por CHA2DS2-VASc, una reducción del riesgo relativo del 90,9%. Sufrieron eventos hemorrágicos 12 pacientes (16%; 6,4%/año), una tasa el 26,4% menor que el riesgo HAS-BLED predicho. Se produjo la muerte cardiovascular de 2 pacientes (2,7%). Conclusiones Una estrategia de TAPS tras el CPOI parece ser una opción efectiva y segura para los pacientes con altos riesgos isquémico y hemorrágico. Se necesitan más estudios que corroboren nuestros resultados (AU)

Single antiplatelet therapy after left atrial appendage closure in patients with AF: safety and effectiveness.

INTRODUCTION AND OBJECTIVES: The optimal antithrombotic strategy following left atrial appendage closure (LAAC) is poorly defined in patients with nonvalvular atrial fibrillation. We assessed the safety and effectiveness of a single antiplatelet treatment (SAPT) strategy after LAAC in a population at high risk of ischemic and bleeding events. METHODS: This single-center, observational, prospective study included a consecutive cohort of patients who underwent LAAC using the LAmbre device (Lifetech Scientific, China) and who were discharged with SAPT. The primary outcome was a composite of stroke, systemic embolism, and device-related thrombosis during follow-up. Secondary endpoints were cardiovascular mortality and major bleeding events (BARC ≥3a). Clinical follow-up was performed at 1, 6, and 12 months and subsequently on an annual basis. Transesophageal echocardiography was performed at 1 and 12 months of follow-up. RESULTS: The study comprised 74 patients. The median age was 77 [72-83] years and 43% were women. The cohort exhibited a high prevalence of comorbidities and cardiovascular risk factors. The median CHA2DS2-VASc and HAS-BLED scores were 4 [3-6] and 4 [4-5], respectively. The median length of follow-up was 2.5 years (188 patients-year). During follow-up, device-related thrombosis occurred in 3 patients (4%). Ischemic stroke occurred in 1 patient (1.3%, rate 0.5%/y), representing a 90.9% relative risk reduction compared with the risk predicted by CHA2DS2-VASc. Major bleeding events occurred in 12 patients (16%, 6.4%/y), with a relative risk reduction of 26.4% of that predicted by HAS-BLED. Cardiovascular-related mortality was observed in 2 patients (2.7%). CONCLUSIONS: SAPT appears to be a safe and effective treatment following LAAC in patients at high ischemic and hemorrhagic risk. Further studies are needed to confirm our findings.

Left Atrial Appendage Closure with a New Occluder Device: Efficacy, Safety and Mid-Term Performance.

The LAmbreTM device is a novel system designed for left atrial appendage closure (LAAC). First registries showed a high rate of device implantation success. However, few mid-term results are available. We present our 1- and 12-month follow-up results for this device. This prospective, single-center registry included consecutive patients with nonvalvular atrial fibrillation who underwent LAAC with the LAmbreTM device. Transesophageal echocardiography (TEE) was performed at 1-month follow-up. In total, 55 patients were included. The population was elderly (75 ± 9.4 years), with a high proportion of comorbidities. The mean CHA2DS2-VASc and HAS-BLED scores were 4.6 ± 1.6 and 3.9 ± 1.0, respectively. Previous history of a major bleeding event was present in 37 patients (67.3%). Procedural success was achieved in 54 patients (98.2%). Device success was achieved in 100% of patients in whom device implantation was attempted (54 patients). Major in-hospital device-related complications included mortality of one patient (1.8%) and pericardial tamponade in two patients (3.6%); the incidence of stroke was 0%. No thrombus or significant leaks (≥5 mm) were observed on 1-month TEE. At 12 months, adverse events were overall death (1.8%), transient ischemic attack/ischemic stroke (1.8%), and major bleeding events (Bleeding Academic Research Consortium (BARC) 3a and 3c; 11%). In this high-risk population, the LAmbreTM device seems to be a safe and effective option for LAAC with a remarkable mid-term performance.