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A meta-analysis for efficacy and safety evaluation of transcatheter left atrial appendage occlusion in patients with nonvalvular atrial fibrillation.

ABSTRACT: This meta-analysis was conducted to evaluate the efficacy and safety of transcatheter left atrial appendage (LAA) occlusion in patients with nonvalvular atrial fibrillation.The randomized controlled trials (RCT) or observational studies with any transcatheter LAA occlusion devices were searched in PubMed, Embase, and Cochrane library from inception to November 2015. The incidence rates from individual studies were combined to evaluate the procedural efficacy and safety, including all-cause death, cardiac/neurological death, stroke, transient ischemic attack (TIA), thrombosis, hemorrhagic complications, and pericardial effusion/tamponade.Thirty-eight studies involving 3585 patients and 6 different occlusion devices were eligible for our inclusion criteria. The procedural failure rate for LAA closure was 0.02 (95% CI: 0.02-0.03). The all-cause mortality was 0.03 (95% CI: 0.02-0.03) and cardiac/neurological mortality was 0 (95% CI: 0.00-0.01). The stroke/TIA rate was estimated only 0.01 (95% CI: 0.01-0.01). The incidence of thrombus on devices was 0.01 (95% CI: 0.01-0.02). The major hemorrhagic complication rate was estimated 0.01 (95% CI: 0.00-0.01). Pericardial effusion/tamponade was estimated 0.02 (95% CI: 0.02-0.03). No heterogeneity was observed for above pooled estimates (I?=?0). In devices subgroups analysis, the all-cause mortality and cardiac/neurological mortality of PLAATO group were the highest (P?=?0.01 and P?

SUBMITTER: Wei Z

PROVIDER: S-EPMC4979802 | biostudies-other | 2016 Aug

REPOSITORIES: biostudies-other

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A meta-analysis for efficacy and safety evaluation of transcatheter left atrial appendage occlusion in patients with nonvalvular atrial fibrillation.

Wei Zhonghai Z Zhang Xinlin X Wu Han H Xie Jun J Dai Qing Q Wang Lian L Xu Biao B

Medicine 20160801 31

<h4>Objectives</h4>This meta-analysis was conducted to evaluate the efficacy and safety of transcatheter left atrial appendage (LAA) occlusion in patients with nonvalvular atrial fibrillation.<h4>Methods</h4>The randomized controlled trials (RCT) or observational studies with any transcatheter LAA occlusion devices were searched in PubMed, Embase, and Cochrane library from inception to November 2015. The incidence rates from individual studies were combined to evaluate the procedural efficacy an ...[more]

PMID: 27495048

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Project description:Objective: Due to the clinical complexity of warfarin, novel oral anticoagulation (NOAC) has been a feasible and safe alternative anticoagulant approach during left atrial appendage closure (LAAC). This study was designed to compare the efficacy and safety of rivaroxaban and dabigatran for nonvalvular atrial fibrillation patients undergoing percutaneous LAAC. Methods: One single and prospective cohort study was performed among patients who received anticoagulation with dabigatran or rivaroxaban. All patients were medicated with a 3-month course of NOAC to facilitate device endothelialization, followed by dual antiplatelet therapy until 6 months, then lifelong aspirin after discharge. Repeated transesophageal echocardiography was scheduled to evaluate thrombosis formation on occluders and thrombus dissolution ability. Results: A total of 262 consecutive patients were initially enrolled. A final number of 250 patients were analyzed; two patients were excluded due to procedure failure and 10 patients had a loss of follow-up; 97 were from the dabigatran group and 153 from the rivaroxaban group. Three patients (1.9%) in the rivaroxaban group and eight (8.2%) in the dabigatran group were experiencing device-related thrombosis (DRT) events during follow-ups. Cumulative Kaplan-Meier estimates showed that the incidence of DRT was lower under rivaroxaban medication during the 6-month follow-ups (p = 0.038*, OR = 3.843, 95%CI: 0.991-14.836). The transesophageal echocardiography (TEE) results showed that the average length and width of DRT in the rivaroxaban group was significantly lower compared with that in the dabigatran group (2.16 vs. 1.60 mm, p = 0.017*, and 1.71 vs. 1.30 mm, p = 0.003*, respectively). The thrombosis dissolved after the switch from dabigatran or rivaroxaban to warfarin within the target range, represented by the average length and width of thrombus with the cooperation of secondary TEE for the dabigatran and rivaroxaban groups (0.64 vs. 0.40 mm, p = 0.206, and 0.43 vs. 0.27 mm, p = 0.082, respectively). No significant difference was found between the two groups with respect to the levels of coagulation parameters, cardiac function, and bleeding events. Conclusion: Compared to dabigatran, post-procedural rivaroxaban anticoagulation might be advantageous in preventing DRT complications expected after LAAC, without increasing the risk of hemorrhage.

Project description:BackgroundBoth catheter left atrial appendage occlusion combined with ablation (COA) and thoracoscopic surgical left atrial appendage clipping combined with ablation (TCA) have shown favorable outcomes in management of patients with atrial fibrillation (AFib). However, studies comparing the endpoints of both techniques are still lacking. Herein, a meta-analysis of safety and efficacy outcomes of COA versus TCA was performed in patients with AFib.MethodsPubmed, Embase, Cochrane, and Web of Science databases were searched for retrieving potential publications. The primary outcome was the incidence of stroke during follow-up period of at least 12 months. Secondary outcomes were acute success rate of complete left atrial appendage (LAA) closure by COA or TCA, postprocedural mortality and complications, and all-cause mortality during follow-up period of at least 12 months.Results19 studies of COA containing 1,504 patients and 6 studies of TCA with 454 patients were eligible for analysis. No significant difference in stroke and all-cause mortality was found in patients undergoing COA versus TCA after at least a 12-month follow-up (stroke: p = 0.504; all-cause mortality: p = 0.611). COA group had a higher acute success rate compared with TCA group (p = 0.001). COA placed the patients at a higher risk of hemorrhage during the postprocedural period compared with TCA (p = 0.023). A similar risk of other postprocedural complications (stroke/transient ischemic attack and pericardial effusion) and mortality was found in the COA group in comparison with TCA group (p>0.05).ConclusionThis meta-analysis showed that COA and TCA did not differ in stroke prevention and all-cause mortality in patients with AFib after a follow-up of at least 12 months. Postprocedural complications and mortality were almost comparable between the two groups. In the near future, high-quality randomized controlled trials exploring the optimal surgical strategies for AFib and endpoints of different procedures are warranted.Systematic review registration[https://www.crd.york.ac.uk/PROSPERO/], identifier [CRD42022325497].

Project description:BackgroundSurgical left atrial appendage occlusion (SLAAO) may be associated with a lower risk of thromboembolism in patients with atrial fibrillation undergoing cardiac surgery. However, evidence regarding the effectiveness of SLAAO in patients undergoing mechanical heart valve replacement (MHVR) is lacking. Therefore, we aimed to evaluate the association between SLAAO and the cardiovascular outcomes in patients with atrial fibrillation undergoing MHVR.MethodsWe retrospectively analyzed data for 497 patients with atrial fibrillation; 27.6% of the patients underwent SLAAO, and the remainder of the patients did not (No-SLAAO group). The primary outcome was a composite of ischemic stroke, systemic embolism, and all-cause mortality. Cumulative event-free survival rates were estimated using Kaplan-Meier curves, and we performed multivariate Cox analyses to evaluate the association between SLAAO and outcomes. We used one-to-one propensity score matching to balance patients' baseline characteristics, and analyzed 120 matching pairs.ResultsFive patients died within 30 days postoperatively, and there were no significant differences between the two groups regarding in-hospital complications (all P > 0.05). After a median follow-up of 14 months, 14 primary events occurred. Kaplan-Meier curves showed no difference in the cumulative incidence of freedom from the primary outcome (log-rank P = 0.830), hemorrhagic events (log-rank P = 0.870), and the secondary outcome (log-rank P = 0.730), between the two groups. Multivariable Cox proportional hazards regression analysis showed no association between SLAAO and any outcome (all P > 0.05). After propensity score matching, cardiopulmonary bypass time and aortic cross-clamp time, and the postoperative length of stay were significantly longer in the SLAAO group (all P < 0.05); results were similar to the unadjusted analyses.ConclusionsConcomitant SLAAO and MHVR was associated with longer length of stay, and cardiopulmonary bypass time and aortic cross-clamp time, but was not associated with additional protective effects against thromboembolic events and mortality during the 14-month follow-up.

Dataset Information

A meta-analysis for efficacy and safety evaluation of transcatheter left atrial appendage occlusion in patients with nonvalvular atrial fibrillation.

Publications

A meta-analysis for efficacy and safety evaluation of transcatheter left atrial appendage occlusion in patients with nonvalvular atrial fibrillation.

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