https://doi.org/10.1007/s00392-025-02625-4
1Herzzentrum der Universität zu Köln Klinik III für Innere Medizin Köln, Deutschland; 2Medizinisches Versorgungszentrum des Universitätsklinikums Köln gGmbH, Klinikum der Universität zu Köln Radiologie Köln, Deutschland; 3Universitätsklinikum Köln Klinik III für Kardiologie, Angiologie, Pneumologie und Internistische Intensivmedizin Köln, Deutschland; 4Universitätsklinikum Köln Herzzentrum - Kardiologie Köln, Deutschland; 5Herzzentrum der Universität zu Köln Klinik für Kardiologie, Angiologie, Pneumologie und Internistische Intensivmedizin Köln, Deutschland
Background:
Pivotal transcatheter aortic valve implantation (TAVI) studies excluded patients with bicuspid aortic valve morphology. Furthermore, studies focusing on TAVI in bicuspid aortic valve stenosis have largely been limited to 1-year follow-up data and long-term outcomes beyond 2 years are scarce.
Objective:
The aim of this analysis was to investigate clinical and echocardiographic long-term outcomes of patients with severe bicuspid aortic valve stenosis in a German all-comers cohort.
Methods:
All patients with severe bicuspid aortic valve stenosis (all subtypes) who underwent TAVI at the University Hospital Cologne between 2018 and 2022 were included. Patients underwent TAVI with self-expanding (Evolut R, PRO, PRO+, ACURATE neo/neo 2) or balloon-expanding (Sapien 3, Sapien 3 Ultra) devices. Follow-up data were collected at 30 days and at a mean follow-up of 2.9 years (range: 2.0-6.5 years).
Results:
A total of 92 TAVI procedures in patients with severe aortic valve stenosis and bicuspid anatomy were performed. The mean age was 78.8 (Q1-Q3: 73.0-82.6) years, 41.3% (38/92) of patients were women, and the mean European System for Cardiac Operative Risk Evaluation II score was 2.3% (Q1-Q3: 1.7-3.5). The mean aortic annulus perimeter was 79.40 (Q1-Q3: 73.70-87.05). Technical success was achieved in 96.7% (89/92) of the procedures and no patient died during the in-hospital stay. At 30 days, one patient (1/89, 1.1%) experienced a disabling stroke, 2 patients (2/81, 2.5%) experienced valve migration and the rate of new permanent pacemakers was 16.8% (14/83). The rates of all-cause death and cardiovascular death were 3.2% (3/92) and 2.2% (2/92), respectively. The 30-day echocardiographic follow-up was complete for 69 patients. The mean aortic valve gradient was 9.0 mmHg (Q1-Q3: 6.0-12.0), the mean aortic valve area (AVA) was 1.70 cm2 (1.60-2.20) and the rate of paravalvular regurgitation (PVR) ³ moderate was 8.6% (6/69). At a median follow-up of 2.9 years (range: 2.0 – 6.5 years) the rate of disabling stroke was 3.1% (2/65) and 2 (2.2%) more patients received a permanent pacemaker. All-cause mortality and cardiovascular mortality were 27.0% (24/89) and 19.1% (17/89), respectively. The mean aortic valve gradient and the mean AVA were 9.0 mmHg (Q1-Q3: 7.0-10.8) and 1.80 cm2 (Q1-Q3: 1.60-2.35). The rate of PVR ³ moderate was 5.0% (3/60).
Conclusions:
TAVI is a safe and effective treatment option for patients with severe aortic valve stenosis and bicuspid anatomy in a German all-comers cohort. The hemodynamic outcomes observed over a 2.9-year period were favorable. In absence of a randomized studies comparing TAVI and surgical aortic valve replacement, these registry data may provide valuable insights into the long-term performance of TAVI prostheses in patients with bicuspid aortic valves.
Figure 1: Paravalvular Regurgitation after TAVI in bicuspid aortic valve stenosis