Oclusão percutânea do apêndice atrial esquerdo com o Amplatzer Cardiac PlugTM na fibrilação atrial

Montenegro, Márcio José; Quintella, Edgard Freitas; Damonte, Aníbal; Sabino, Hugo de Castro; Zajdenverg, Ricardo; Laufer, Gustavo Pinaud; Amorim, Bernardo; Estrada, André Pereira Duque; Armas, Cristian Paul Yugcha; Sterque, Aline

doi:10.1590/s0066-782x2012005000012

Cited by 8 publications

(1 citation statement)

References 29 publications

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“…The ACP device ( Figure 1 ) has been previously described in the Arquivos Brasileiros de Cardiologia on the occasion of our initial experience. 8 …”

Section: Methodsmentioning

confidence: 99%

Left Atrial Appendage Closure with Amplatzer Cardiac Plug in Nonvalvular Atrial Fibrillation: Safety and Long-Term Outcome

Costa¹,

Ferreira²,

Quintella³

et al. 2017

Arquivos Brasileiros De Cardiologia

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BackgroundAtrial fibrillation (AF) is a cardiac arrhythmia with high risk for thromboembolic events, specially stroke.ObjectiveTo assess the safety of left atrial appendage closure (LAAC) with the Amplatzer Cardiac Plug for the prevention of thromboembolic events in patients with nonvalvular AF.MethodsThis study included 15 patients with nonvalvular AF referred for LAAC, 6 older than 75 years (mean age, 69.4 ± 9.3 years; 60% of the male sex).ResultsThe mean CHADS2 score was 3.4 ± 0.1, and mean CHA2DS2VASc , 4.8 ± 1.8, evidencing a high risk for thromboembolic events. All patients had a HAS-BLED score > 3 (mean, 4.5 ± 1.2) with a high risk for major bleeding within 1 year. The device was successfully implanted in all patients, with correct positioning in the first attempt in most of them (n = 11; 73.3%).ConclusionThere was no periprocedural complication, such as device migration, pericardial tamponade, vascular complications and major bleeding. All patients had an uneventful in-hospital course, being discharged in 2 days. The echocardiographic assessments at 6 and 12 months showed neither device migration, nor thrombus formation, nor peridevice leak. On clinical assessment at 12 months, no patient had thromboembolic events or bleeding related to the device or risk factors. In this small series, LAAC with Amplatzer Cardiac Plug proved to be safe, with high procedural success rate and favorable outcome at the 12-month follow-up.

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“…The ACP device ( Figure 1 ) has been previously described in the Arquivos Brasileiros de Cardiologia on the occasion of our initial experience. 8 …”

Section: Methodsmentioning

confidence: 99%

Left Atrial Appendage Closure with Amplatzer Cardiac Plug in Nonvalvular Atrial Fibrillation: Safety and Long-Term Outcome

Costa¹,

Ferreira²,

Quintella³

et al. 2017

Arquivos Brasileiros De Cardiologia

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Safety and Procedural Success of Left Atrial Appendage Exclusion With the Lariat Device

et al. 2015

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IMPORTANCE The Lariat device has received US Food and Drug Administration (FDA) 510(k) clearance for soft-tissue approximation and is being widely used off-label for left atrial appendage (LAA) exclusion. A comprehensive analysis of safety and effectiveness has not been reported. OBJECTIVES To perform a systematic review of published literature to assess safety and procedural success, defined as successful closure of the LAA during the index procedure, of the Lariat device. We performed a formal analytic review of the FDA MAUDE (Manufacturer and User Facility Device Experience) database to compile adverse event reports from real-world practice with the Lariat. DATA SOURCES For the systematic review, PubMed, EMBASE, CINAHL, and the Cochrane Library were searched from January 2007 through August 2014 to identify all studies reporting use of the Lariat device in 3 or more patients. The FDA MAUDE database was queried for adverse events reports related to Lariat use. DATA EXTRACTIONS AND SYNTHESIS Data were abstracted in duplicate by 2 physician reviewers. Events from published literature were pooled using a generic inverse variance weighting with a random effects model. Cumulative and individual adverse events were also reported using the FDA MAUDE data set. MAIN OUTCOMES AND MEASURES Procedural adverse events and procedural success. RESULTS In the systematic review, 5 reports of Lariat device use in 309 participants were identified. Specific complications weighted for inverse of variance of individual studies were urgent need for cardiac surgery (2.3%; 7 of 309 procedures) and death (0.3%; 1 of 309 procedures). Procedural success was 90.3% (279 of 309 procedures). In the FDA MAUDE database, there were 35 unique reports of adverse events with use of the Lariat device. Among these, we identified 5 adverse event reports that noted pericardial effusion and death and an additional 23 reported urgent cardiac surgery without mention of death. CONCLUSIONS AND RELEVANCE This review of published reports and case reports identified risks of adverse events with off-label use of the Lariat device for LAA exclusion. Formal, controlled investigations into the safety and efficacy of the device for this indication are warranted.

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Transcatheter Left Atrial Appendage Occlusion

Reisman,

Fuller

2014

Interventional Procedures for Structural Heart Disease

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Oclusão percutânea do apêndice atrial esquerdo com o Amplatzer Cardiac PlugTM na fibrilação atrial

Cited by 8 publications

References 29 publications

Left Atrial Appendage Closure with Amplatzer Cardiac Plug in Nonvalvular Atrial Fibrillation: Safety and Long-Term Outcome

Left Atrial Appendage Closure with Amplatzer Cardiac Plug in Nonvalvular Atrial Fibrillation: Safety and Long-Term Outcome

Safety and Procedural Success of Left Atrial Appendage Exclusion With the Lariat Device

Transcatheter Left Atrial Appendage Occlusion

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