Impact of Peridevice Leak on 5-Year Outcomes After Left Atrial Appendage Closure

Dukkipati, Srinivas R.; Holmes, David R.; Doshi, Shephal K.; Kar, Saibal; Singh, Sheldon M.; Gibson, Douglas; Price, Matthew J.; Mansour, Moussa; Sievert, Horst; Houle, Vicki M.; Allocco, Dominic J.; Reddy, Vivek Y.

doi:10.1016/j.jacc.2022.04.062

Cited by 58 publications

(47 citation statements)

References 24 publications

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“…Currently, the generally accepted treatment plan is cases with PDL < 3 mm are not associated with embolism events and do not require special treatment, while PDL > 5 mm requires OAC treatment. However, recent studies revealed that small leaks (0–5 mm) after the LAAC procedure were related to a modestly higher occurrence of thromboembolic and bleeding events, and on the opposite side, larger leaks (>5 mm) were not related to adverse events 30,31 . In this study, the incidence of PDL > 5 mm was significantly higher in Watchman group than in ACP/Amulet group (2.7% vs. 1%).…”

Section: Discussioncontrasting

confidence: 50%

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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Section: Discussioncontrasting

confidence: 50%

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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“…However, these studies had small sample sizes, and more data is needed to verify these conclusions. PDL is also identified as a potential risk factor for major adverse events (34,35); however, it is not associated with the anticoagulation strategy, according to our results. The current study reported PDL >5 mm was similar between the two groups (0.6 vs. 0.5%).…”

Section: Discussionmentioning

confidence: 44%

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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“…A cohort study of 1,054 patients using combined data from the Percutaneous Closure of the Left Atrial Appendage Versus Warfarin Therapy for Prevention of Stroke in Patients with Atrial Fibrillation (PROTECT-AF), Evaluation of the WATCH-MAN Left Atrial Appendage (LAA) Closure Device in Patients with Atrial Fibrillation Versus Long Term Warfarin Therapy (PREVAIL), and Carbohydrate and Prostate Study 2 (CAPS2) trials sought to answer this question. 24 In this study, the mean age was 74 ± 8.3 years and the CHA 2 DS 2 -VASc score was 4.1 ± 1.4 points. The presence of PDL ≤ 5 mm as assessed by transesophageal echocardiography (TEE) at 1 year (but not at 45 days) was associated with an increased 5-year risk of ischemic stroke or systemic embolism compared to the risk of those who had no leak (9.5% vs. 5.1%, P = .014).…”

Section: New Developments In Stroke Preventionmentioning

confidence: 59%

A Year in Review: Atrial Fibrillation 2022

SARDANA¹,

KARNIK²,

Doshi³

2023

J Innov Cardiac Rhythm Manage.

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Impact of Peridevice Leak on 5-Year Outcomes After Left Atrial Appendage Closure

Cited by 58 publications

References 24 publications

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

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

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

A Year in Review: Atrial Fibrillation 2022

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