Major Bleeding Predictors in Patients with Left Atrial Appendage Closure: The Iberian Registry II

Abstract

Introduction and objective: Major bleeding events in patients undergoing left atrial appendage closure (LAAC) range from 2.2 to 10.3 per 100 patient-years in different series. This study aimed to clarify the bleeding predictive factors that could influence these differences. Methods: LAAC was performed in 598 patients from the Iberian Registry II (1093 patient-years; median, 75.4 years). We conducted a multivariate analysis to identify predictive risk factors for major bleeding events. The occurrence of thromboembolic and bleeding events was compared to rates expected from CHA2DS2-VASc (congestive heart failure, hypertension, age, diabetes, stroke history, vascular disease, sex) and HAS-BLED (hypertension, abnormal renal and liver function, stroke, bleeding, labile INR, elderly, drugs or alcohol) scores. Results: Cox regression analysis revealed that age ≥75 years (HR: 2.5; 95% CI: 1.3 to 4.8; p = 0.004) and a history of gastrointestinal bleeding (GIB) (HR: 2.1; 95% CI: 1.1 to 3.9; p = 0.020) were two factors independently associated with major bleeding during follow-up. Patients aged <75 or ≥75 years had median CHA2DS2-VASc scores of 4 (IQR: 2) and 5 (IQR: 2), respectively (p < 0.001) and HAS-BLED scores were 3 (IQR: 1) and 3 (IQR: 1) for each group (p = 0.007). Events presented as follow-up adjusted rates according to age groups were stroke (1.2% vs. 2.9%; HR: 2.4, p = 0.12) and major bleeding (3.7 vs. 9.0 per 100 patient-years; HR: 2.4, p = 0.002). Expected major bleedings according to HAS-BLED scores were 6.2% vs. 6.6%, respectively. In patients with GIB history, major bleeding events were 6.1% patient-years (HAS-BLED score was 3.8 ± 1.1) compared to 2.7% patients-year in patients with no previous GIB history (HAS-BLED score was 3.4 ± 1.2; p = 0.029). Conclusions: In this high-risk population, GIB history and age ≥75 years are the main predictors of major bleeding events after LAAC, especially during the first year. Age seems to have a greater influence on major bleeding events than on thromboembolic risk in these patients.

Incidence and Predictors of Clinically Significant Bleedings after Transcatheter Left Atrial Appendage Closure

“…The study identifies patients with a high risk of nonprocedural bleeding after LAAC. Firstly, it confirms the elevated nonprocedural bleeding rate with prior gastrointestinal bleeding history [ 5 , 11 ]. In the contemporary real-life LAAC registries, the majority of patients undergoing the procedure had prior bleeding episodes, with a notably high rate of a gastrointestinal bleeding history [ 2 , 11 ].…”

“…The reason for this might be persistent structural gastrointestinal disorder predisposing to bleeding. In the LAAC cohort, patients with gastrointestinal bleeding history have high comorbidities burden and advanced age [ 5 ]. Gastrointestinal bleeding on anticoagulation was associated with a 13-fold higher hazard of new cancer diagnosis, much higher than with other bleeding types [ 13 ].…”

“…In the current high-volume series, most LAAC recipients have a history of prior bleeding complications in up to 72% [ 2 ]. A prior study identified gastrointestinal bleeding history as a predictor of bleeding events after LAAC, suggesting differences in the bleeding rates depending on the susceptible site [ 5 ]. Other suggested predictors included age ≥ 75 years [ 5 ] and longer postprocedural dual antiplatelet therapy (DAPT) [ 6 ].…”

“…A prior study identified gastrointestinal bleeding history as a predictor of bleeding events after LAAC, suggesting differences in the bleeding rates depending on the susceptible site [ 5 ]. Other suggested predictors included age ≥ 75 years [ 5 ] and longer postprocedural dual antiplatelet therapy (DAPT) [ 6 ]. However, the available data remain limited.…”

New Perspective in Atrial Fibrillation

“…Despite a large number of publications on this subject, the pathophysiological mechanisms involved in atrial fibrillation (AF) onset and recurrence are uncertain. Moreover, though several thrombo-embolic and bleeding prediction [1] scores for AF patients have been developed, their performance is still limited [2]. Taken together, these facts suggest that we are still missing a global theory of atrial fibrillation pathophysiology (or at least some parts of it).…”