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Incidence, outcomes and predictors of bleeding after transfemoral TAVR

31 Jan 2024

Transcatheter aortic valve replacement (TAVR) has emerged as the preferred treatment for older patients suffering from severe aortic valve stenosis, surpassing the annual patient count of those opting for surgical aortic valve replacement. Notably, TAVR demonstrates lower rates of periprocedural major bleeding compared to traditional surgery. Despite this, bleeding remains one of the most common complications associated with TAVR. Individuals with severe aortic valve stenosis undergoing TAVR are inherently at a heightened risk for bleeding due to pre-existing comorbidities. Furthermore, procedural characteristics significantly influence the occurrence of bleeding post-TAVR. Notably, comprehensive studies investigating temporal trends, clinical outcomes, and risk factors related to bleeding in the contemporary TAVR population are scarce.

Hence, the primary objective of the CENTER2 study was to evaluate the incidence, temporal patterns, clinical consequences, and predictors of bleeding complications in patients undergoing TAVR. The CENTER2 study utilized a consolidated patient-level database from ten clinical studies, encompassing individuals who underwent TAVR between 2007 and 2022.

Among 23,562 patients undergoing transfemoral TAVR, the mean age was 81.5 ± 6.7 years, with 56% being women. Major bleeding within the initial 30 days occurred in 1,545 patients (6.6%), while minor bleeding was reported in 1,143 patients (4.7%). Major bleeding rates decreased from 11.5% in 2007-2010 to 5.5% in 2019-2022. Dual antiplatelet therapy correlated with higher major bleeding rates compared to single antiplatelet therapy (12.2% vs. 9.1%; OR: 1.40; 95% CI: 1.13-1.72; P = 0.002). Patients experiencing major bleeding faced an elevated risk of mortality during the initial 30 days (14.1% vs. 4.3%; OR: 3.66; 95% CI: 3.11-4.31; P < 0.001) and the 1-year follow-up (27.8% vs. 14.5%; HR: 1.50; 95% CI: 1.41-1.59; P < 0.001). Conversely, minor bleeding did not impact the 1-year mortality risk (16.7% vs. 14.5%; HR: 1.11; 95% CI: 0.93-1.32; P = 0.27).

The authors found that predictors of major bleeding included female sex and peripheral vascular disease. Furthermore, researchers emphasized that bleeding complications continue to be prevalent and clinically significant in patients undergoing transfemoral TAVR. The heightened mortality risk associated with major bleeding persists beyond the initial 30 days.

This study underscores the critical need for preventing major bleeding in patients undergoing transfemoral TAVR. Identifying at-risk patients before the procedure could empower TAVR operators to implement preventive strategies effectively. Researchers highlighted the ambiguity surrounding whether bleeding is primarily attributed to the procedure or the patient. Frailty is suggested as a significant predictor for major bleeding and mortality in older patients undergoing percutaneous coronary intervention (PCI). Notably, studies on frailty and its impact on major bleeding in TAVR patients are limited, indicating a gap in current research.

The authors suggested that future investigations should explore the link between frailty and major bleeding, along with potential interventions to mitigate preprocedural frailty. Additionally, the text emphasizes the importance of research on periprocedural antithrombotic management and streamlined TAVR procedures, such as single-access and radial approaches. Patient-tailored heparin and protamine doses need further investigation through randomized controlled trials. Beyond overt bleeding complications, future studies should address the significance of nonovert bleeding, often underreported and characterized by unexplained drops in hemoglobin post-TAVR. Undertreating nonovert bleeding may contribute to heightened mortality risk following TAVR.

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Original article: Van Nieuwkerk AC et al. J Am Coll Cardiol Intv 2023;16:2951–2962.


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