Elsevier

American Heart Journal

Volume 262, August 2023, Pages 140-147
American Heart Journal

Clinical Investigations
Incidence, source, and prognostic impact of major bleeding across the spectrum of aortic stenosis

https://doi.org/10.1016/j.ahj.2023.04.011Get rights and content

Background

Severe aortic stenosis (AS) has been associated with bleeding. However, there is a lack of prospective assessment of bleeding events and their clinical significance in a large population of outpatients with variable degree of AS severity.

Objectives

To assess the incidence, source, determinants, and prognostic impact of major bleeding in patients with variable degree of AS severity.

Methods

Between May 2016 and December 2017, consecutive outpatients were included. Major bleeding was defined as type ≥3 bleed using the Bleeding Academic Research Consortium definition. Cumulative incidence was calculated with death as the competing event. Data was censored at time of aortic valve replacement.

Results

Among 2,830 patients, 46 major bleeding events occurred (0.7%/year) during a median follow-up of 2.1 years (interquartile range: 1.4-2.7). Most frequent sites of bleeding were gastrointestinal (50%) and intracranial (30.4%). Major bleeding was significantly associated with all-cause mortality (hazard ratio: 5.93 (95% confidence interval 3.64-9.65); P < .001). AS severity was associated with major bleedings (P = .041). By multivariable analysis, severe AS was an independent determinant of major bleeding (hazard ratio vs mild AS: 3.59 [95% confidence interval 1.56-8.29]; P = .003). The increased risk of bleeding associated with severe AS was significantly exacerbated in patients using oral anticoagulation.

Conclusion

In AS patients, major bleeding is rare but a strong independent predictor of death. AS severity is a determinant of bleeding events. Severe AS and oral anticoagulation should be identified as an association at very high risk of major bleeding.

Section snippets

Background

There has been considerable interest in the recent literature regarding bleeding events occurring in patients with cardiovascular diseases. Previous studies performed in patients with atrial fibrillation,1 acute coronary syndrome,2,3 coronary revascularization,4,5 stable coronary artery disease6 or heart failure (HF)7 have identified major bleedings as events associated with important prognostic consequences. Identifying patients at risk of bleeding is thus an integral part of patient

Study population

The VALVENOR registry was a prospective multicenter study that enrolled 2830 outpatients with native valvular AS.19 Patients were included between May 2016 and December 2017 by 117 cardiologists from the Nord-Pas-de-Calais region in France during outpatient visits. The cardiologists were selected based on geographic distribution to provide a representative sample of the area's current cardiology practices in university public hospitals, non-university public hospitals, and private centers. This

Baseline characteristics

Among the 2,830 included patients, 2,812 (99.4%) underwent clinical follow-up at a median of 2.1 years (interquartile range: 1.4-2.7). The baseline characteristics of the study population are summarized in Table I. This was an elderly population, with a mean age of 75.9 ± 11.1 years. There was a high prevalence of risk factors and underlying cardiovascular diseases (coronary artery disease, atrial fibrillation and stroke). At inclusion, 1,191 (42.4%) patients had mild AS, 1,165 (41.4%) moderate

Discussion

The results of the present study can be summarized as follow: (1) in the overall population of AS outpatients with variable degree of severity, the cumulative incidence of major bleeding is relatively low, ie, 0.7%/year; (2) AS severity is independently associated with bleeding events; (3) the increased risk of major bleeding in severe AS is restricted to the subgroup of patients receiving oral anticoagulation.

Bleeding from gastrointestinal angiodysplasia in severe AS patients (Heyde's

Conclusions

In outpatients with AS, major bleeding events occur at a rate of 0.7%/year and are a strong predictor of death. There is a progressive increase in bleeding risk with increased severity of AS. Patients with severe valvular disease (peak aortic jet velocity ≥ 4 m/s) receiving oral anticoagulation are at the highest risk of bleeding. This should be kept in mind while managing AS patients, especially when considering the frequent indications of anticoagulation in this elderly population with high

Funding

This study was supported by the Fédération Française de Cardiologie, Paris, France.

Disclosures

None reported.

Acknowledgments

Michel Deneve for the monitoring of the VALVENOR study.

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    Both authors contributed equally and are joint first authors.

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