1Herzzentrum Dresden GmbH an der TU Dresden Klinik für Innere Medizin und Kardiologie Dresden, Deutschland; 2Herzzentrum Dresden GmbH an der TU Dresden Klinik für Innere Medizin, Kardiologie und Intensivmedizin Dresden, Deutschland; 3Herzzentrum Dresden GmbH an der TU Dresden Klinik für Herzchirurgie Dresden, Deutschland
Background: Bicuspid anatomy poses some therapeutic challenges related to anatomic differences compared with tricuspid valve anatomy for transcatheter aortic valve implantation (TAVI). Few data are available comparing the performance of 3rd generation balloon expandable transcatheter heart valves (THV) in bicuspid compared with tricuspid anatomy. We aimed to investigate the hemodynamic performance and clinical outcomes after TAVI with the Sapien 3 ultra/Sapien 3 29 mm THV in bicuspid anatomy.
Methods: Consecutive patients with calcific aortic stenosis having tricuspid and bicuspid anatomy undergoing TAVI with Sapien 3 ultra/Sapien 3 29 mm between 01/2019 and 12/2022 after HeartTeam discussion were included in this analysis. VARC-3 defined technical and device success as well as early safety were the primary outcomes. Single parameters of the composite outcomes, new permanent pacemaker implantation (PPI) rates and echocardiographic data are reported.
Results: Bicuspid (n=35) and tricuspid (n=180) patients were comparable regarding age and sex, but bicuspid had a lower risk profile as indicated by a lower STS-PROM (2.2% (IQR 1.6; 3.1) vs. 2.8% (IQR 1.9; 4.9), p<0.027) and lower burden of relevant comorbidities.
Comparing bicuspid with tricuspid valves, VARC-3 defined technical (100% vs. 98.9%, p=1.00) and device success (88.6% vs. 80.6%, p=0.26) was comparable between groups. Early safety (77.1% vs. 78.9%, p=0.82) was also not different. There were no differences with regard to the single components of the composite outcomes. PPI occurred in 13.6% and 13.3% of tricuspid and bicuspid cases, respectively (p=1.00). There was no severe AR in either group, and the rate of none/mild AR was about 97% post operation and after a median follow up of 182 (IQR 103; 248) days in both groups. Mean gradients decreased significantly and remained low at follow up without significant differences between groups.
The 30-day mortality (bicuspid 5.7% vs. tricuspid: 1.7%, p=0.19) and the Kaplan-Meier estimated 1-year survival (bicuspid: 94.0% (95%-CI 86.3; 100.0) vs. tricuspid: 96.6 (95%-CI 93.0; 100.0), p=0.21) was comparable between groups.
Conclusion: TAVI with the Sapien 3 ultra/Sapien 3 29 mm led to comparable and favourable outcomes in bicuspid and tricuspid anatomies with regard to VARC-3 defined technical and device success as well as early safety. The promising echocardiographic findings and the high survival rate at 1 year support the use of the Sapien THV in bicuspid anatomies.