Abstract:Background: Left atrial appendage (LAA) occlusion is an alternative therapy for atrial fibrillation patients who have high embolic risk and contraindications to anticoagulant therapy.Objective: To evaluate the feasibility, safety, and mid-term outcomes of percutaneous LAA occlusion, including device-related thrombosis.Methods: Sixty consecutive patients who had undergone percutaneous LAA occlusion with AMPLATZER™ Amulet™ device from September 2015 to March 2018 were enrolled. Patients were followed for 21 ± 15… Show more
“…Regarding DRT, the incidence after WATCHMAN implantation was higher in the studies by Aonuma et al [ 14 ] (4.8%) and Xue et al [ 15 ] (4.4%) than in those by Mazzone et al [ 16 ] (2.7%), Boersma et al [ 17 ] (2.8%), and Saw et al [ 18 ] (1%). Three studies on Amulet implantation found a lower incidence of DRT than that reported in studies on WATCHMAN, with Sahinar et al, Landmesser et al and Masoud et al reporting incidence of 0%, 1.6%, and 1.2%, respectively [ 19 – 21 ]. Fig.…”
Section: Resultsmentioning
confidence: 99%
“…In total, 2855 patients were included from all studies, and the range of the sample size among the selected studies was 42-1088. Among these, WATCHMAN was used for 1624 patients over five studies [14][15][16][17][18] and Amulet was used for 1231 patients over three studies [19][20][21]. In the DOAC group, a total of 21,200 patients from three studies (with sample sizes between 4838 and 9578 patients) that used rivaroxaban were included [22][23][24].…”
Section: Analyzed Studiesmentioning
confidence: 99%
“…In the DOAC group, a total of 21,200 patients from three studies (with sample sizes between 4838 and 9578 patients) that used rivaroxaban were included [22][23][24]. The overall male enrollment was 62% (LAAC device groups, 62%; DOAC group, 62%), except for the study by Sahiner et al [19], (female = 58.3%). The average follow-up periods for the LAAC device groups and DOAC groups were 13 and 17 months, respectively (Table 3).…”
Left atrial appendage closure (LAAC) are emerging treatment for patients with atrial fibrillation (AF). However, data on the safety, efficacy, and medications for LAAC devices in patients with AF are lacking. We aimed to investigate the incidence of all-cause mortality, stroke, and major bleeding in AF patients with LAAC devices and DOACs. Moreover, we aimed to investigate the incidence rate of device-related thrombus (DRT) and the medications used in the management of AF patients with LAAC devices to gain insights into achieving better outcome. Based on a literature search using PubMed, EMBASE, Cochrane Library, and Web of Science databases between January 2015 and December 2020, eight LAAC device studies that used WATCHMAN and Amulet, and three DOAC studies that used rivaroxaban, with a total of 24,055 AF patients (LAAC devices, n = 2855; DOAC, n = 21,200), were included. A random-effects model was used to incorporate heterogeneity among studies. The pooled incidence of events per person-years were as follows: all-cause mortality, 0.06 (95% confidence interval [CI] 0.02–0.10) for WATCHMAN, 0.04 (95% CI 0.00–0.14) for Amulet, and 0.03 (95% CI 0.01–0.04) for rivaroxaban; stroke; 0.02 (95% CI 0.00–0.04) for WATCHMAN, 0 for Amulet, and 0.01 (95% CI 0.01–0.02) for rivaroxaban; major bleeding, 0.04 (95% CI 0.02–0.06) for WATCHMAN, 0.02 (95% CI 0.00–0.06) for Amulet, and 0.02 (95% CI 0.01–0.03) for rivaroxaban. The incidence rate of DRT was 2.3%, and complications were reported in 9%. The incidence of all-cause mortality, stroke, and major bleeding were similar between LAAC devices and DOACs. The rate of complications was acceptable, and those of DRT were lower than the average incidence reported in previous studies. However, further follow-up is needed. Concomitant anticoagulant and antiplatelet therapies should be further evaluated to find the optimal regimen for AF patients with LAAC devices.
“…Regarding DRT, the incidence after WATCHMAN implantation was higher in the studies by Aonuma et al [ 14 ] (4.8%) and Xue et al [ 15 ] (4.4%) than in those by Mazzone et al [ 16 ] (2.7%), Boersma et al [ 17 ] (2.8%), and Saw et al [ 18 ] (1%). Three studies on Amulet implantation found a lower incidence of DRT than that reported in studies on WATCHMAN, with Sahinar et al, Landmesser et al and Masoud et al reporting incidence of 0%, 1.6%, and 1.2%, respectively [ 19 – 21 ]. Fig.…”
Section: Resultsmentioning
confidence: 99%
“…In total, 2855 patients were included from all studies, and the range of the sample size among the selected studies was 42-1088. Among these, WATCHMAN was used for 1624 patients over five studies [14][15][16][17][18] and Amulet was used for 1231 patients over three studies [19][20][21]. In the DOAC group, a total of 21,200 patients from three studies (with sample sizes between 4838 and 9578 patients) that used rivaroxaban were included [22][23][24].…”
Section: Analyzed Studiesmentioning
confidence: 99%
“…In the DOAC group, a total of 21,200 patients from three studies (with sample sizes between 4838 and 9578 patients) that used rivaroxaban were included [22][23][24]. The overall male enrollment was 62% (LAAC device groups, 62%; DOAC group, 62%), except for the study by Sahiner et al [19], (female = 58.3%). The average follow-up periods for the LAAC device groups and DOAC groups were 13 and 17 months, respectively (Table 3).…”
Left atrial appendage closure (LAAC) are emerging treatment for patients with atrial fibrillation (AF). However, data on the safety, efficacy, and medications for LAAC devices in patients with AF are lacking. We aimed to investigate the incidence of all-cause mortality, stroke, and major bleeding in AF patients with LAAC devices and DOACs. Moreover, we aimed to investigate the incidence rate of device-related thrombus (DRT) and the medications used in the management of AF patients with LAAC devices to gain insights into achieving better outcome. Based on a literature search using PubMed, EMBASE, Cochrane Library, and Web of Science databases between January 2015 and December 2020, eight LAAC device studies that used WATCHMAN and Amulet, and three DOAC studies that used rivaroxaban, with a total of 24,055 AF patients (LAAC devices, n = 2855; DOAC, n = 21,200), were included. A random-effects model was used to incorporate heterogeneity among studies. The pooled incidence of events per person-years were as follows: all-cause mortality, 0.06 (95% confidence interval [CI] 0.02–0.10) for WATCHMAN, 0.04 (95% CI 0.00–0.14) for Amulet, and 0.03 (95% CI 0.01–0.04) for rivaroxaban; stroke; 0.02 (95% CI 0.00–0.04) for WATCHMAN, 0 for Amulet, and 0.01 (95% CI 0.01–0.02) for rivaroxaban; major bleeding, 0.04 (95% CI 0.02–0.06) for WATCHMAN, 0.02 (95% CI 0.00–0.06) for Amulet, and 0.02 (95% CI 0.01–0.03) for rivaroxaban. The incidence rate of DRT was 2.3%, and complications were reported in 9%. The incidence of all-cause mortality, stroke, and major bleeding were similar between LAAC devices and DOACs. The rate of complications was acceptable, and those of DRT were lower than the average incidence reported in previous studies. However, further follow-up is needed. Concomitant anticoagulant and antiplatelet therapies should be further evaluated to find the optimal regimen for AF patients with LAAC devices.
“…2 ). The lowest incidence of ischemic stroke observed in the included articles was 0 events [ 22 , 28 , 32 , 38 , 43 ] and the highest incidence rates observed were 3.8 per 100 patient-years [ 21 ] (Fig. 2 ).…”
Purpose
The recommended stroke prevention for patients with atrial fibrillation (AF) and increased risk of ischemic stroke is oral anticoagulation (OAC). Parts of the patient population are not eligible due to contraindication, and percutaneous left atrial occlusion (LAAO) can then be a preventive treatment option. The aim of this systematic review and meta-analysis is to estimate the long-term clinical effectiveness of LAAO as stroke prevention in patients with AF, increased risk of ischemic stroke, and contraindication to OAC.
Methods
We performed a systematic review and meta-analysis, using Poisson random effect models, to estimate the incidence rate (events per 100 patient-years) of ischemic stroke, transient ischemic attack, major bleeding, and all-cause death after LAAO treatment. We also calculated the risk reduction of ischemic stroke with LAAO compared with no stroke prevention estimated through a predicted risk in an untreated population (5.5 per 100 patient-years).
Results
We included 29 observational studies in our meta-analysis, including 7 951 individuals and 12 211 patient-years. The mean CHA2DS2-VASc score among the patients in the included studies is 4.32. The pooled incidence rate of ischemic stroke is 1.38 per 100 patient-years (95% CI 1.08; 1.77). According to a meta-regression model, the estimated incidence rate of ischemic stroke at CHA2DS2-VASc 4 is 1.39 per 100 patient-years. This implies a risk reduction of 74.7% with LAAO compared to predicated risk with no stroke prevention.
Conclusions
Our results suggest that LAAO is effective as stroke prevention for patients with AF, increased risk of stroke, and contraindication to oral anticoagulation.
“…In this issue of the Brazilian Archives of Cardiology, Şahiner et al 14 disclose retrospective data from a center in Turkey, which included 60 patients submitted to implantation of the Amplatzer Amulet device. The main indication for the procedure was the occurrence of bleeding (usually gastrointestinal) in the presence of oral anticoagulation.…”
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