Bleeding risk in all-comer TAVI patients

Background Severe aortic stenosis is the most common valvular heart disease in the elderly and is primarily treated with transcatheter aortic valve implantation (TAVI). Post-TAVI antithrombotic therapy prevents thromboembolic events but increases bleeding, which is associated with higher mortality and morbidity. Stratifying according to bleeding risk is crucial for optimizing post-procedural management and outcomes. Purpose To characterize high bleeding risk (HBR) patients and assess the temporal trends in the proportion of HBR patients among all-comer TAVI patients. Methods From 2015 to 2021, consecutive TAVI patients were identified from two hospital registries and classified as HBR or non-HBR (nHBR) using available Valve Academic Research Consortium HBR (VARC-HBR) criteria. HBR was defined as patients with ≥1 major and/or ≥2 minor criteria. Of the 15 defined major VARC-HBR criteria, 7 were available in our data: body mass index <20, prior stroke any time before TAVI, peripheral artery disease, liver disease, estimated glomerular filtration rate <30 mL/min, hemoglobin <11 g/dL, and need for long-term oral anticoagulation (OAC) combined with antiplatelet therapy. Similarly, 4 out of 6 minor criteria were available: age >90 years, non-transfemoral access, need for long-term OAC, and need for dual antiplatelet therapy. Baseline characteristics were presented as medians (interquartile ranges) and frequencies (percentages), and differences were assessed using the Wilcoxon rank-sum test for numerical variables and the chi-square test for categorical variables. Statistical significance was set at p<0.05. Temporal trends in proportion of patients at HBR and nHBR were illustrated. Results A total of 2099 TAVI patients were included, of whom 64.1% were classified as HBR and 35.9% as nHBR (Figure 1A). As expected, the HBR criteria differed between HBR and nHBR patients. Additionally, HBR patients had higher EURO score II, higher NYHA classes, more comorbidities (hypertension, atrial fibrillation, prior myocardial infarction, prior PCI, and prior CABG), lower max pressure gradient (69 mmHg vs. 73 mmHg), and they were less often treated with self-expandable valves (67.3% vs. 75.2%) compared with nHBR patients. Figure 1B shows temporal trends in bleeding risk classification from 2015 to 2021. Conclusion Almost two-thirds of all-comer TAVI patients were at HBR according to the VARC-HBR criteria. HBR patients were more symptomatic, had a higher comorbidity burden, and less often self-expandable valves implanted than nHBR patients. There was a rising proportion of nHBR patients relative to HBR over time, suggesting a shift in the overall risk profile of TAVI patients.Fig. 1A+B:Flowchart and temporal trends Table 1:Baseline characteristics