Percutaneous left atrial appendage occlusion (LAAO) is presented as an alternative to chronic oral anticoagulation in patients with non-valvular atrial fibrillation. By isolating the left atrial appendage, it is possible to prevent the migration of thrombi associated with atrial fibrillation, which tend to appear in this region. However, since it involves an external device, there is a possibility of in-situ thrombus formation (device-related thrombus, DRT), which warrants intensive antithrombotic treatment during the endothelialization phase.
This initial phase is critical, especially in patients with a very high or prohibitive risk of bleeding. The objective of this study, presented by Mesnier et al., was to assess the incidence, predictors, and clinical consequences of early bleeding unrelated to the procedure.
The study included patients who underwent LAAO in nine centers across Europe and Canada between 2009 and 2021. Bleeding events were classified as life-threatening, major, or minor. Major bleeding included fatal bleeding, bleeding in critical organs, bleeding causing hypovolemic shock or a drop in hemoglobin of at least 3 g/dL, and bleeding requiring more than 2 units of red blood cells. “Early” was defined as occurring within the first 3 months after the procedure.
The primary endpoint (PE) was the occurrence of early bleeding unrelated to the procedure. The secondary endpoint (SE) included early major bleeding, all-cause mortality, DRT, ischemic stroke, and peripheral cardioembolic disease. DRT was defined as the presence of a thrombus attached to the left side of the device, as detected by tomography or transesophageal echocardiography.
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The number of patients who underwent LAAO and were included amounted to 1649. Early bleeding occurred in 7.3% of cases, of which 4.2% were major bleeding events, which accounted for 57% of all bleeding events.
Patients who experienced early bleeding tended to be older (77.5 ± 7.3 years vs. 75.8 ± 8.3 years; P=0.03), had a higher degree of renal failure (50.4% [61/121] vs. 36.8% [562/1528]; P=0.003), a history of coronary artery disease (46.3% [56/121] vs. 32.2% [492/1528]; P=0.002), and had experienced previous episodes of heart failure or some type of bleeding (94.2% [114/121] vs. 81.3% [1242/1528]; P<0.001). Among the latter, gastrointestinal bleeding was the most significant type (61.2% [74/121] vs. 34.4% [526/1528]; P<0.001).
In the multivariate model, factors associated with an increased risk of early post-procedural bleeding included the use of dual antiplatelet therapy (DAPT) (adjusted hazard ratio [aHR]: 1.61; 95% confidence interval [CI]: 1.12-2.33; P=0.01), prior gastrointestinal bleeding (aHR: 2.15; 95% CI: 1.38-3.35; P<0.001), and bleeding in other places (aHR: 2.33; 95% CI: 1.34-4.05; P<0.001).
After an average follow-up of 2.3 years, 33.3% of the patients died, and 50.3% of those deaths attributed to vascular causes. Early bleeding unrelated to the procedure was independently associated with an increase in all-cause mortality (aHR: 1.53; 95% CI: 1.15-2.06; P<0.001).
Conclusions
According to the results observed in these centers, early bleeding occurred in 7.3% of cases, with the use of DAPT being the only modifiable factor. Furthermore, the occurrence of bleeding significantly reduced the survival of these patients.
Original Title: Early Nonprocedural Bleeding After Left Atrial Appendage Occlusion.
Reference: Mesnier, J, Cruz-González, I, Guedeney, P. et al. Early Nonprocedural Bleeding After Left Atrial Appendage Occlusion. J Am Coll Cardiol Intv. 2024 Aug, 17 (15) 1765–1776. https://doi.org/10.1016/j.jcin.2024.05.032.
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