Earlier- versus latest generation self-expanding and balloon-expandable valve platforms in transcatheter aortic valve implantation in large aortic annuli

N. Lankisch (Leipzig)¹, A. Abdelhafez (Leipzig)¹, O. Dumpies (Leipzig)¹, J. Rotta Detto Loria (Leipzig)¹, I. Richter (Leipzig)², S. Desch (Leipzig)¹, P. Kiefer (Leipzig)³, N. Majunke (Leipzig)¹, H.-J. Feistritzer (Leipzig)¹, H. Thiele (Leipzig)¹, M. Abdel-Wahab (Leipzig)^1
1Herzzentrum Leipzig - Universität Leipzig Klinik für Innere Medizin/Kardiologie Leipzig, Deutschland; ²Helios Park-Klinikum Leipzig Klinik für Innere Medizin I - Kardiologie, Angiologie Leipzig, Deutschland; ³Herzzentrum Leipzig - Universität Leipzig Universitätsklinik für Herzchirurgie Leipzig, Deutschland

Introduction
While knowledge on TAVI in small annuli has grown, evidence on TAVI in large annuli is scarce. Retrospective studies suggest that balloon-expandable valves (BEV) may outperform earlier-generation self-expanding valves (SEV) in large annuli. However, these studies are flawed by their retrospective design. Additionally, refinements of the latest-generation transcatheter heart valves (THV) have addressed challenges of TAVI in this patient subset. We therefore sought to compare BEV with earlier- versus latest-generation SEV in patients with large annuli.

Methods
We analyzed TAVI-procedures at a high-volume center between 2017 and 2025 with an aortic annular area of >540 mm². The principal endpoint of this analysis was device success, defined according to the Valve Academic Research Consortium (VARC)-3.

Results
Overall, 1156 patients were included in the analysis, with a mean age of 79.3±6.7 years, 1093 (95%) men, and a median annular area of 590 mm². Of these, 864 (75%) were treated with a BEV (29 mm Edwards Sapien 3 valve, Edwards Lifesciences), and 292 (25%) received an SEV. Of the latter, 183 (63%) received an earlier-generation 34 mm Evolut R/Pro+ valve (Medtronic), and 109 (37%) the latest-generation Evolut FX/+ SEV. Device success was achieved in 92% using BEV and 88% with earlier-generation SEV (p=0.07), as compared to device success rates of 94% for BEV and 92% for latest generation SEV (p=0.49). Moderate-to-severe paravalvular regurgitation (PVR) was lower with BEV vs. earlier-generation SEV (1.9% vs. 7%, p<0.001), but similar when comparing BEV and latest-generation SEV (1.1% vs. 1.8%, p=0.61). BEV exhibited higher mean gradients compared to SEV (BEV vs. earlier-generation SEV: 9.6 vs. 7.3 mmHg; BEV vs. latest-generation SEV: 9.5 vs. 7.4 mmHg; p<0.001 for both).

Conclusion
This study indicates enhanced performance of the latest-generation SEV in patients with large annuli compared to earlier-generation SEV. Moderate-to-severe PVR was low and similar to BEV, while mean gradients were significantly lower with SEV. To overcome possible selection bias of available retrospective studies, a randomized trial using the latest-generation THV in patients with large annuli is warranted.