The Growing Value of Multicentre, Prospective, Real-world Data: Early- Outcomes of 1000 Patients with the Avalus Aortic Valve

Author(s): Lennart Vanglabeke, Tom Verbelen, Jean-Christian Roussel, Christian Lildal Carranza, Lenard Conradi, Koen Cathenis, Giovanni Troise, Julien Guihaire, Juan Bustamante-Munguira, Davide Pacini, Paolo Centofanti, Nicolas Doll, Rafael Llorens, Yanai Ben-Gal, Francesco Musumeci, Tine Philipsen, Laurent de Kerchove, Roberto Lorusso, Alberto Giovanni Tripodi, Alberto Canziani, Antti Valtola, Bart Meuris

Background: As cardiac surgery becomes increasingly complex, real-world data is essential to evaluate bioprosthetic valve performance beyond controlled trials. The Avalus Clinical confidencE (ACE) registry provides real-world insights into the safety and effectiveness of the Avalus valve across diverse patient populations.

Methods: The ACE registry is a prospective, multicentre, single-arm, observational study including 1000 patients undergoing surgical aortic valve replacement with the Avalus bioprosthesis in 26 European centres between 2021-2023. Exclusion criteria were age <18y and salvage surgery, which lead to a real-world study population undergoing aortic valve replacement, either isolated or combined with various other procedures. Primary endpoints included all-cause mortality and disabling stroke. Secondary endpoints assessed prosthetic valve function and major complications. Clinical status and echocardiographic performance were evaluated at discharge and at one-year follow-up.

Results: In an all-comers population (mean age: 71.5±6.6years, mean EuroSCORE II: 3.4±5.8), early all-cause mortality was 1.7%. Median implanted valve size was 24mm, with 19.3% of valves being a 19 or 21mm prosthesis. Echocardiographic assessment at discharge showed a mean gradient of 11.6±5.3mmHg, with an effective orifice area of 1.98±0.61cm². Severe patient-prosthesis-mismatch (PPM) was observed in only 5.0% of patients, while 73.9% had no PPM. At one-year followup (n=703), overall mortality remained low at 3.3%, with continued stability in valve performance (mean gradient: 12.2±4.9mmHg). Functional improvement was significant, with 74% of patients improving to NYHA class I or II.

Conclusions: The ACE registry shows low stroke and mortality rates in a complex real-world population, with excellent hemodynamics and minimal PPM at one-year follow-up.