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Multicenter Study
. 2017 Nov;109(5):440-447.
doi: 10.5935/abc.20170150. Epub 2017 Oct 19.

First results of the Brazilian Registry of Percutaneous Left Atrial Appendage Closure

[Article in English, Portuguese]
Ênio Eduardo Guérios  1 , Francisco Chamié  2 , Márcio Montenegro  3 , Eduardo Benchimol Saad  4 , Fabio Sandoli de Brito Junior  5 , Paulo Avancini Caramori  6 , Luiz Carlos Simões  7 , Flávio Roberto Azevedo de Oliveira  8 , Luiz Carlos Giuliano  9 , Cláudio Munhoz da Fontoura Tavares  10   11
Affiliations
Multicenter Study

First results of the Brazilian Registry of Percutaneous Left Atrial Appendage Closure

[Article in English, Portuguese]
Ênio Eduardo Guérios et al. Arq Bras Cardiol. 2017 Nov.

Abstract

Background: Left atrial appendage closure (LAAC) is an effective alternative to oral anticoagulation (OA) for the prevention of stroke in patients with non-valvular atrial fibrillation (NVAF).

Objective: To present the immediate results and late outcomes of patients submitted to LAAC and included in the Brazilian Registry of Percutaneous Left Atrial Appendage Closure.

Methods: 91 patients with NVAF, high stroke risk (CHA2DS2VASc score = 4.5 ± 1.5) and restrictions to OAC (HAS-BLED score = 3.6 ± 1.0) underwent 92 LAAC procedures using either the Amplatzer cardiac plug or the Watchman device in 11 centers in Brazil, between late 2010 and mid 2016.

Results: Ninety-six devices were used (1.04 device/procedure, including an additional non-dedicated device), with a procedural success rate of 97.8%. Associated procedures were performed in 8.7% of the patients. Complete LAAC was obtained in 93.3% of the successful cases. In cases of incomplete closure, no residual leak was larger than 2.5 mm. One patient needed simultaneous implantation of 2 devices. There were 7 periprocedural major (5 pericardial effusions requiring pericardiocentesis, 1 non-dedicated device embolization and 1 coronary air embolism without sequelae) and 4 minor complications. After 128.6 patient-years of follow-up there were 3 deaths unrelated to the procedure, 2 major bleedings (one of them in a patient with an unsuccessful LAAC), thrombus formation over the device in 2 cases (both resolved after resuming OAC for 3 months) and 2 strokes (2.2%).

Conclusions: In this multicenter, real world registry, that included patients with NVAF and high thromboembolic and bleeding risks, LAAC effectively prevented stroke and bleeding when compared to the expected rates based on CHA2DS2VASc and HASBLED scores for this population. Complications rate of the procedure was acceptable considering the beginning of the learning curve of most of the involved operators.

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Conflict of interest statement

Potential Conflict of Interest

Guérios EE is proctor for St. Jude Medical / Abbott for percutaneous left atrial appendage closure.

Figures

Figure 1
Figure 1
Watchman device (left) and Amplatzer Cardiac Plug (right)
Figure 2
Figure 2
Contraindications to oral anticoagulation*. INR: international normalized ratio; OAC: oral anticoagulation. * the same patient may have multiple contraindications.
Figure 3
Figure 3
Implantation of the Amplatzer Cardiac Plug (ACP) and Watchman devices. 3a and 3c) left atrial appendage angiographies, pre-occlusion; 3b) Post-implantation, ACP device; 3d) Post-implantation, Watchman device (*).
Figure 4
Figure 4
Distribution of the sizes of the implanted devices (mm). Data are expressed in number of devices
Figure 5
Figure 5
Comparison between mean CHADS2 (5a) and CHA2DS2-VASc (5b) scores and proportion of patients with HAS-BLED score ≥ 3 (5c) in the populations studied in the Brazilian Registry of Percutaneous Left Atrial Appendage Closure vs other registries and trials
See this image and copyright information in PMC

Comment in

References

    1. Sanna T, Diener HC, Passman RS, Di Lazzaro V, Bernstein RA, Morillo CA, et al. CRYSTAL AF Investigators Cryptogenic stroke and underlying atrial fibrillation. N Engl J Med. 2014;370(26):2478–2486. doi: 10.1056/NEJMoa1313600. - DOI - PubMed
    1. Miyasaka Y, Barnes ME, Gersh BJ, Cha SS, Bailey KR, Abhayaratns WP, et al. Secular trends in incidence of atrial fibrillation in Olmsted County, Minnesotta, 1980 to 2000, and implications on the projections for future prevalence. Circulation. 2006;114(2):119–125. doi: 10.1161/CIRCULATIONAHA.105.595140. Erratum in: Circulation. 2006;114(11):e498. - DOI - PubMed
    1. Di Minno MN, Ambrosino P, Dello Russo A, Casella M, Tremoli E, Tondo C. Prevalence of left atrial thrombus in patients with non-valvular atrial fibrillation. A systematic review and meta-analysis of the literature. Thromb Haemost. 2016;115(3):663–677. doi: 10.1160/TH15-07-0532. - DOI - PubMed
    1. Stoddard MF, Dawkins PR, Prince CR, Ammash NM. Left atrial appendage thrombus is not uncommon in patients with acute atrial fibrillation and a recent embolic event: a transesophageal echocardiographic study. J Am Coll Cardiol. 1995;25(2):452–459. - PubMed
    1. Meier B, Blaauw Y, Khattab AA, Lewalter T, Sievert H, Tondo C, et al. EHRA / EAPCI expert consensus statement on cateter-based left atrial appendage occlusion. Eurointervention. 2015;10(9):1109–1125. doi: 10.4244/EIJY14M08_18. - DOI - PubMed

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