EROICA: A First Pan-European Registry comparing Treatment of pure Aortic Regurgitation using a Dedicated THV vs. Surgical AVR

M. Geyer (Mainz)¹, E. Zancanaro (Mainz)¹, H. S. Wienemann (Köln)², M. Adam (Köln)², S. Gerfer (Köln)³, T. K. Rudolph (Bad Oeynhausen)⁴, S. Waezsada (Bad Oeynhausen)⁵, A. Unbehaun (Berlin)⁶, O. De Backer (København)⁷, M. Abdel-Wahab (Leipzig)⁸, A. Baumbach (London)⁹, K. Patel (London)⁹, D. Blackman (Leeds)¹⁰, N. Buzzatti (Milano)¹¹, F. Bedogni (Milano)¹², A. Sala (Milano)¹², N. M. Van Mieghem (Rotterdam)¹³, N. Dumonteil (Toulouse)¹⁴, D. Tchetche (Toulouse)¹⁴, T. Modine (Bordeaux)¹⁵, H. Treede (Mainz)^16
1Universitätsmedizin Mainz Zentrum für Kardiologie, Kardiologie I Mainz, Deutschland; ²Herzzentrum der Universität zu Köln Klinik III für Innere Medizin Köln, Deutschland; ³Uniklinik Köln Herzchirurgie Köln, Deutschland; ⁴Herz- und Diabeteszentrum NRW Allgemeine und Interventionelle Kardiologie/Angiologie Bad Oeynhausen, Deutschland; ⁵Herz- und Diabeteszentrum Bad Oeynhausen Bad Oeynhausen, Deutschland; ⁶Deutsches Herzzentrum der Charite (DHZC) Klinik für Kardiologie, Angiologie und Intensivmedizin | CBF Berlin, Deutschland; ⁷Ringhospitalet København, Dänemark; ⁸Herzzentrum Leipzig - Universität Leipzig Klinik für Innere Medizin/Kardiologie Leipzig, Deutschland; ⁹Barts Heart Centre London, Großbritannien; ¹⁰NHS Teaching Hospital Leeds, University of Leeds Leeds, Großbritannien; ¹¹Ospedale San Raffaele Milano Milano, Italien; ¹²IRCCS San Donato Milano, Italien; ¹³Erasmus MC Rotterdam, Niederlande; ¹⁴Clinique Pasteur Toulouse Toulouse, Frankreich; ¹⁵Hospital Center University Bordeaux Bordeaux, Frankreich; ¹⁶Universitätsmedizin der Johannes Gutenberg-Universität Mainz Klinik und Poliklinik für Herz- und Gefäßchirurgie Mainz, Deutschland

Aims
The 2025 European Guidelines endorse transcatheter therapy of pure aortic valve regurgitation (AR) in patients at high surgical risk, following the availability of dedicated transcatheter heart valves (THV) for the treatment of pure, non-calcified AR, such as JenaValve Trilogy / JVT. However and in contrast to Aortic stenosis, comparative evidence between dedicated THV and surgical aortic valve replacement (SAVR) in patients with pure AR remains scarce. EROICA (European Registry comparing Outcomes after Interventional treatment vs. Cardiosurgery for pure Aortic valve regurgitation) is a retrospective multicenter study designed to compare clinical outcomes following treatment with JVT and SAVR.

Methods and Results
A total of 1,194 patients were retrospectively included from 13 European high-volume centers accross 6 countries (764 SAVR, 430 JVT). To ensure comparability, only isolated SAVR-procedures were included in the surgical cohort, excluding e. g., concomitant aortic root or bypass surgery. Baseline characteristics differed substantially between both groups: Patients treated by JVT were relevantly older (80 (73-83) vs. 65 (56-72) years, p<0.001), more frequently female (45 vs. 30%, p<0.001) and had a higher calculated surgical risk (EuroScore II 3.6 (2.4-6.1) vs. 1.7 (0.9-4.7), p<0.001). They also exhibited a greater burden of relevant comorbidities (e.g., coronary artery disease 19 vs. 7.5%, p<0.001, COPD 12 vs. 5.6%, p<0.001, chronic kidney disease 52 vs. 7.7%, p<0.001 and pre-existing right-bundle branch block (RBBB) 15% vs. 3.3%, p<0.001). Furthermore, pre-procedural transvalvular gradients were higher (5 (2/9) vs. 1.3 (1.3/5.4) mmHg, p<0.001) in the JVT-cohort, despite lower left-ventricular ejection fraction (50 (42/55) vs. 55 (55/60)%, p<0.001).

No significant difference in 30-days survival was observed between both groups (98.2 vs. 98.6%, p=0.67). One-year survival was lower in the JVT-cohort (93.5 vs. 96.7%, p=0.042) – however, after propensity matching for age, gender and EuroScore (matched cohort n=474), mortality did not differ significantly at one year (91.7 vs. 94.2%, p=0.42).

Overall complication rates were low: rates of bleeding (VARC3 type 2 or 3: 3.3 vs. 2.7%, p=0.7), major vascular complications (1.4 vs. 0%, p<0.001), kidney injury stage 2 or 3 (2.8 vs. 6.3%, p<0.001 and stroke (1.2 vs. 1.8%, p<0.001) were low in both groups. Permanent pacemaker implantation was relevantly more common in the JVT-cohort (17% vs. 3.4%). While mild paravalvular regurgitation occurred more frequently following JVT (7.0 vs. 0.1%, p<0.001), no moderate or severe paravalvular leaks were observed. In contrast, JVT-patients showed significantly lower transvalvular gradients at discharged compared with SAVR (4.0 (3/6) vs. 11 (8/14) mmHg, p<0.001).

Conclusion
Despite marked differences in baseline age and risk profile, treatment of pure AR with a dedicated THV seems to be similarly effective compared to SAVR regarding outcomes, safety and hemodynamic performance. Prospective studies are warranted to further define dedicated patient selection pathways for each treatment strategy.