1Herzzentrum der Universität zu Köln Klinik III für Innere Medizin Köln, Deutschland; 2Universitätsmedizin der Johannes Gutenberg-Universität Mainz Zentrum für Kardiologie Mainz, Deutschland; 3Universitätsklinikum Köln Klinik für Herzchirurgie, herzchirurgische Intensivmedizin und Thoraxchirurgie Köln, Deutschland; 4Herzzentrum der Universität zu Köln Klinik für Kardiologie, Angiologie, Pneumologie und Internistische Intensivmedizin Köln, Deutschland
Background:
Vascular complications and bleeding remain relevant drawbacks after transcatheter aortic valve implantation (TAVI). In 2021 the Valve Academic Research Consortium (VARC) has updated criteria for vascular and bleeding complications. Technical success has been introduced as a new composite endpoint.
Objective:
The aim of this analysis was to investigate the incidence of vascular complications, bleeding and technical success. Furthermore, we analyzed the impact of complications on mortality.
Methods:
All patients undergoing TAVI between February 2018 and 2023 at the University Hospital Cologne were included. Vascular complications and bleeding were classified according to VARC-2 and VARC-3 criteria and compared. Technical success was classified according to the VARC-3 definition.
Results:
A total of 2405 TAVI procedures were performed with technical success in 2280 cases (94.8%). Technical failure was composed of mortality (3 cases, 0.1 %), surgery or intervention due to major vascular or cardiac structural complications (98 cases, 4.1 %), implantation of a second transcatheter heart valve (19 cases, 0.8 %) and anatomically incorrect positioning of the device (5 cases, 0.2 %). According to VARC-3 criteria, bleeding and vascular complications occurred in 307 (12.8 %) and 292 (12.1 %) patients respectively. Access-related non-vascular complications occurred in 8 cases (0.3 %). Considering VARC-2 criteria, bleeding and vascular complications occurred in 319 (13.3%) and 292 (12.1%) patients respectively. The distribution of bleeding among the subgroups can be seen in Figure 1.
VARC-3 type 1 bleeding had no impact on in-hospital-mortality (OR: 1.00 [95% CI: 1.00 – 1.00], P: 0.99). Type 2 and type 3 bleedings were strongly associated with an increased mortality risk (OR: 4.17 [95% CI: 1.99 – 8.75], P < 0.001). Per definition all type 4 bleeding events led to death. When the VARC-2 criteria were applied, the correlation between bleeding severity and mortality persisted as minor bleeding had no impact on mortality (OR: 1.00 [95% CI: 1.00 – 1.00], P: 0.99) whilst major bleeding and life-threatening bleeding were associated with mortality (OR: 2.85 [95% CI: 1.08 – 7.51], P: 0.035 and OR: 42.34 [95% CI: 22.81 – 78.68], P < 0.001, respectively). Major vascular complications were similarly associated with mortality (OR: 13.67 [95% CI: 7.44 – 25.12], P < 0.001), whereas minor vascular complications had no impact on mortality (OR: 0.51 [0.07 – 3.79], P: 0.51).
Conclusions:
TAVI performed at a high-volume center is associated with encouraging early outcomes, reaching technical success in more than 9 of 10 patients. Bleeding and vascular complications still have a significant impact on mortality after TAVI. The new VARC-3 criteria provide a precise risk stratification with an incremental mortality risk in proportion to the severity of both bleeding and vascular complications.
Figure 1: Incidence of bleeding events according to VARC-2 and VARC-3 criteria