Despite important advancements over the past decade, bleeding remains frequent and potentially fatal in patients undergoing transfemoral transcatheter aortic valve replacement (TAVR), according to a new analysis of pooled patient-level trial data. The study, published online Monday and in the Dec. 25 issue of JACC: Cardiovascular Interventions, cited bleeding as one of the most frequent complications in patients undergoing TAVR, adding that major bleeding is associated with poor clinical outcomes after TAVR. However, the team, led by the University of Amsterdam’s Astrid C. van Nieuwkerk, MD, and Hugo M. Aarts, MD, who is also with the University Medical Center Utrecht, Netherlands,, noted that large studies on bleeding complications in contemporary TAVR populations are limited. “TAVR has been associated with lower rates of periprocedural major bleeding compared with conventional surgery. However, bleeding is still among the most frequent complications of TAVR,” said van Nieuwkerk, Aarts and colleagues – adding that in general, patients with severe aortic valve stenosis undergoing TAVR have a higher risk for bleeding due to pre-existing comorbidities “Remarkably, large studies on temporal trends, clinical outcomes, and risk factors of bleeding in the contemporary TAVR population are limited,” they said. Study details As a result, van Nieuwkerk, Aarts and colleagues set out to assess the incidence, temporal trends, clinical outcomes and predictors of bleeding complications in patients undergoing TAVR using a pooled patient-level database from 10 clinical studies including patients who underwent TAVR between 2007 and 2022. The team noted that the 10 studies included in the CENTER2 (Cerebrovascular Events in Patients Undergoing Transcatheter Aortic Valve Implantation With Balloon-Expandable Valves Versus Self-Expandable Valves) study included 25,771 patients undergoing TAVR, of whom 24,321 (94.4%) underwent transfemoral TAVR; however, because historically, nontransfemoral TAVR is associated with increased risk for bleeding due to procedural aspects and is usually performed in patients with increased risk profiles, the current analysis focused only on patients treated with transfemoral TAVR. The average age of participants was 81.5 years, and 56% were women. Van Nieuwkerk, Aarts and colleagues reported that major bleeding within the first 30 days was observed in 1,545 patients (6.6%). Minor bleeding was reported in 1,143 patients (4.7%). Furthermore, the rates of major bleeding decreased from 11.5% in 2007-2010 to 5.5% in 2019-2022 (P trend < 0.001), they said. Their analysis showed that dual antiplatelet therapy (DAPT) was associated with higher major bleeding rates compared with single antiplatelet therapy (12.2% vs 9.1%; odds ratio [OR]: 1.40; 95% confidence interval [CI]: 1.13-1.72; P = 0.002). Additionally, they reported that major bleeding was associated with increased mortality risk at both short-term (14.1% vs 4.3%; OR: 3.66; 95% CI: 3.11-4.31; P < 0.001) and long-term (27.8% vs 14.5%; HR: 1.50; 95% CI: 1.41-1.59; P < 0.001) follow-up, whereas minor bleeding did not affect survival after TAVR (16.7% vs 14.5%; HR: 1.11; 95% CI: 0.93-1.32; P = 0.27). The team concluded that despite decreasing incidence since 2007, bleeding is a “frequent and important” periprocedural complication in patients undergoing transfemoral TAVR. “Patients with major bleeding after TAVR harbor increased mortality risk at both short- and long-term follow-up, whereas minor bleeding does not affect survival,” said the team, adding that female sex and peripheral vascular disease were identified as predictors of major bleeding in transfemoral TAVR. “Bleeding complications remain frequent and important in patients undergoing transfemoral TAVR,” they added, noting that increased mortality risk in major bleeding persists after the initial 30 days and that future studies should focus on preventive strategies to decrease the incidence of major bleeding in patients undergoing transfemoral TAVR, including both preprocedural and periprocedural interventions. Source: van Nieuwkerk AC, Aarts HM, Hemelrijk KI, et al. Bleeding in Patients Undergoing Transfemoral Transcatheter Aortic Valve Replacement: Incidence, Trends, Clinical Outcomes, and Predictors. JACC Cardiovasc Interv 2023;16:2951-2962. Image Credit: Artur – stock.adobe.com