Periprocedural Outcomes Associated With Use of a Left Atrial Appendage Occlusion Device in China

Su, Fangju; Gao, Chao; Liu, Jianzheng; Ning, Zhongping; He, Beng; Liu, Yi; Yang, Bing; Li, Yuechun; Zhang, Junfeng; Zhao, Xianxian; Zhang, Yushun; Hu, Hao; Du, Xianfeng; Xie, Ruiqin; Zhou, Lei; Zeng, Jie; Ruan, Zhongbao; Liu, Haitao; Guo, Jun; Wang, Rutao; Garg, Scot; Soliman, Osama Ibrahim Ibrahim; Holmes, David R.; Serruys, Patrick W.; Tao, Ling

doi:10.1001/jamanetworkopen.2022.14594

Cited by 18 publications

(16 citation statements)

References 41 publications

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“…Several studies have reported that percutaneous closure of the left atrial appendix (LAAC) was not inferior to warfarin or NOAC for the prevention of thromboembolic events with additional reductions in major bleeding (3)(4)(5)(6). In a larger-scale real-world study (7)(8)(9), the results have also confirmed the safety and efficacy of LAAC in stroke prevention.…”

Section: Introductionmentioning

confidence: 85%

“…However, both pre-LAAC planning and post-LAAC management have evolved over time, as there is a greater understanding of the peculiar and variable anatomy of the left atrial appendage (LAA) and how to balance the risk of bleeding and ischemic events. While warfarin has been widely used to prevent device-related complications ( 4 – 7 ), NOAC has been prescribed more frequently in contemporary studies ( 9 , 11 ). Almost 66% of patients received new oral anticoagulants (NOAC) in the RECORD study ( 9 ), and all patients included in PINNACLE FLX were required to receive NOAC treatment at least 45 days of follow-up ( 11 ).…”

Section: Introductionmentioning

confidence: 99%

“…While warfarin has been widely used to prevent device-related complications ( 4 – 7 ), NOAC has been prescribed more frequently in contemporary studies ( 9 , 11 ). Almost 66% of patients received new oral anticoagulants (NOAC) in the RECORD study ( 9 ), and all patients included in PINNACLE FLX were required to receive NOAC treatment at least 45 days of follow-up ( 11 ).…”

Section: Introductionmentioning

confidence: 99%

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Comparison of outcomes between novel oral anticoagulants and warfarin monotherapy in patients with left atrial appendage closure: A systematic review and meta-analysis

Sun

Chen²,

Gao³

et al. 2022

Front. Cardiovasc. Med.

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BackgroundPivotal trials of percutaneous left atrial appendage closure (LAAC) used dedicated post-procedure antithrombotic protocols. However, there is no consensus on the selection of new oral anticoagulants (NOAC) and warfarin monotherapy after LAAC. This study aims to compare NOAC with warfarin monotherapy for efficacy and safety in patients undergoing LAAC.MethodsA database search was conducted using PubMed, EMBASE, Cochrane Library, and Clinicaltrials.gov for trials that compared NOAC with warfarin monotherapy after LAAC. The effective outcomes included any major adverse events (all-cause death, stroke, major bleeding) and their individual components. Safety outcomes included all-cause death, major bleeding, total bleeding, DRT, and PDL >5 mm.ResultsWe included 10 non-randomized clinical trials with 10,337 patients, of whom 4,960 patients received NOAC, while 5,377 patients received warfarin. There were no statistically significant differences in any major adverse events (LogOR: −0.11, 95% CI: −0.27, 0.04, P = 0.16), stroke (LogOR: 0.00, 95% CI: −0.42, 0.42, P = 1.00), all-cause death (LogOR: −0.23, 95% CI: −0.48, 0.02, P = 0.07), major bleeding (LogOR: −0.22, 95% CI: −0.45, 0.01, P = 0.06). NOAC was associated with a significant reduction in total bleeding (LogOR: −1.01, 95% CI: −1.47, −0.55, P < 0.0001) compared to warfarin. No statistically significant differences were found in DRT (LogOR: −0.19, 95% CI: −0.15, 0.52, P = 0.27) and PDL >5 mm (LogOR: 0.19, 95% CI: −0.33, 0.72, P = 0.47). Meta-regression and subgroup analysis showed that total bleeding (LogOR: −1.56, 95% CI: −2.15, −0.97, P < 0.001) was significantly lower in the NOAC group in the subgroup of <75 y.ConclusionAfter LAAC, NOAC monotherapy was associated with a lower risk of bleeding compared to warfarin monotherapy for 45 days. There was no significant difference between NOAC and warfarin in terms of other results.Systematic review registrationwww.york.ac.uk/inst/crd, identifier: CRD42022361244.

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Section: Introductionmentioning

confidence: 85%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Comparison of outcomes between novel oral anticoagulants and warfarin monotherapy in patients with left atrial appendage closure: A systematic review and meta-analysis

Sun

Chen²,

Gao³

et al. 2022

Front. Cardiovasc. Med.

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“…First, more specific antithrombotic strategies are required. Warfarin had been widely used in the first 45 days for the postimplant anticoagulation after LAAC for preventing device‐related complications in previous pivotal trials, 3,4 while novel oral anticoagulants (NOAC) was used more frequently in resent studies 33 . Nowadays, neither the American College of Cardiology/American Heart Association (ACC/AHA) nor the European Society of Cardiology (ESC) guidelines had specific recommendations on NOAC or warfarin at discharge after LAAC and the choice is left at the clinician's discretion 1,2 .…”

Section: Discussionmentioning

confidence: 99%

Clinical efficacy and safety comparison of Watchman device versus ACP/Amulet device for percutaneous left atrial appendage closure in patients with nonvalvular atrial fibrillation: A study‐level meta‐analysis of clinical trials

Sun

Chen

2022

Clinical Cardiology

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Left atrial appendage occlusion is not inferior to oral anticoagulants in the prevention of stroke in several randomized controlled trials. However, the clinical efficacy and safety comparison of the Watchman and amplatzer cardiac plug (ACP)/Amulet devices for percutaneous left atrial appendage closure (LAAC) in patients with non‐valvular atrial fibrillation was controversial. A database search was conducted using PubMed, EMBASE, Cochrane Library, and http://Clinicaltrials.gov for trials that compared Watchman device vs ACP/Amulet device. The effective outcomes were stroke and systemic embolism. Safety outcomes were all‐cause death, cardiovascular death, and major bleeding. Device‐related complications included device‐related thrombus (DRT), peri‐device leaks (PDL > 5 mm). A total of 19 articles involving 6224 patients were included in the present study. The Watchman and ACP/Amulet groups comprised 3267 and 2957 patients, respectively. No statistically significant differences were detected in the stroke (odd ratio [OR]:1.24, 95% confidence interval [CI]: 0.92−1.67, p = .17, I2 = 0), systemic embolism (OR:1.10, 95% CI: 0.51−2.35, p = .81, I2 = 0%), all‐cause death (OR:0.97, 95% CI: 0.80−1.18, p = .77, I2 = 1%), cardiogenic death (OR:0.99, 95% CI: 0.77−1.29, p = .96, I2 = 0%), major bleeding (OR:1.18, 95% CI: 0.98−1.43, p = .08, I2 = 25%). DRT (OR:1.48, 95% CI: 1.06−2.06, p = .02, I2 = 0%) and PDL > 5 mm (OR:2.57, 95% CI: 1.63−4.04, p < .0001, I2 = 0%) were significantly lower in ACP/Amulet group compared to Watchman group. The effective and safety outcomes were comparable between two groups. ACP/Amulet group had significantly lower rates of DRT and PDL > 5 mm than Watchman group.

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“…Globally, insurance coverage policies vary, affecting the LAAO procedures rate. For instance, the Watchman device was approved for use in China in 2013, and by 2017, there was a relatively low rate of ~2,000 implantations annually ( 66 ). Moreover, a recently published US study from the NIS database showed that minority patients undergoing Watchman implantation had a higher burden of key comorbidities and also experienced increased Watchman-related procedural complications ( 67 ).…”

Section: Introductionmentioning

confidence: 99%

Left atrial appendage exclusion in atrial fibrillation

Rozen

Margolis²,

Marai³

et al. 2022

Front. Cardiovasc. Med.

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Although oral anticoagulants (OACs) are first-line therapy for stroke prevention in patients with atrial fibrillation (AF), some patients cannot be treated with OACs due to absolute or relative contraindications. Left atrial appendage (LAA) exclusion techniques have been developed over the years as a therapeutic alternative for stroke prevention. In this paper, we review the evolution of surgical techniques, employed as an adjunct to cardiac surgery or as a stand-alone procedure, as well as the recently introduced and widely utilized percutaneous LAA occlusion techniques. Until recently, data on surgical LAAO were limited and based on non-randomized studies. We focus on recently published randomized data which strongly support an add-on surgical LAAO in eligible patients during cardiac surgery and could potentially change current practice guidelines. In recent years, the trans-catheter techniques for LAA occlusion have emerged as another, less invasive alternative for patients who cannot tolerate oral anticoagulation. We review the growing body of evidence from prospective studies and registries, focusing on the two systems which are in widespread clinical use nowadays: the Watchman and Amulet type devices. These data show favorable results for both Watchman and Amulet devices, setting them as an important tool in our arsenal for stroke reduction in AF patients, especially in those who have contraindications for OACs. A better understanding of the different therapeutic alternatives, their specific benefits, and downfalls in different patient populations can guide us in tailoring the optimal therapeutic approach for stroke reduction in our AF patients.

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Periprocedural Outcomes Associated With Use of a Left Atrial Appendage Occlusion Device in China

Cited by 18 publications

References 41 publications

Comparison of outcomes between novel oral anticoagulants and warfarin monotherapy in patients with left atrial appendage closure: A systematic review and meta-analysis

Comparison of outcomes between novel oral anticoagulants and warfarin monotherapy in patients with left atrial appendage closure: A systematic review and meta-analysis

Clinical efficacy and safety comparison of Watchman device versus ACP/Amulet device for percutaneous left atrial appendage closure in patients with nonvalvular atrial fibrillation: A study‐level meta‐analysis of clinical trials

Left atrial appendage exclusion in atrial fibrillation

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