Real-world Data On The Avalus Pericardial Aortic Valve: Initial Results Form A Prospective, Multi-center Registry
Tom Verbelen1, Rafael Llorens2, Jean-Christian Roussel3, Paolo Centofanti4, Koen Cathenis5, Davide Pacini6, Laurent De Kerchove7, Nicolas Doll8, Bart Meuris1.
1University Hospitals Leuven, Leuven, Belgium, 2Hospital Universitario Hospiten Rambla, Santa Cruz de Tenerife, Spain, 3Centre Hospitalier Universitaire de Nantes, Nantes, France, 4Azienda Ospedaliera Oridine Mauriziano Torino, Torino, Italy, 5Academisch ziekenhuis Maria Middelares, Gent, Belgium, 6Ospedaliero-Universitaria Sant'Orsola-Malpighi, Bologna, Italy, 7Cliniques universitaires Saint-Luc, Brussels, Belgium, 8Schüchtermann-Klinik, Bad Rothenfelde, Germany.
OBJECTIVE: The Avalus™ pericardial aortic valve was introduced into worldwide clinical practice in 2017. This is an intermediate report from a prospective, real-world registry, aiming at 1000 inclusions throughout Europe and the Middle-East on behalf of all ACE (Avalus Clinical Evidence) investigators. METHODS:
The ACE registry is a prospective, observational, single-arm, multi-center registry. Aortic valve replacement (AVR) in patients younger than 18 years and salvage procedures are the only exclusion criteria. Outcome is evaluated in accordance with VARC-2 criteria. RESULTS:
Up to October 2022, 350 patients from 18 centers are enrolled. Mean age is 72±6 years (42-87), mean EuroSCORE II is 3.4 (0.5-61). Combined surgery (55%) consists out of CABG (30%), double valve (7%), triple valve (3%), ascending aorta (9%), ablation (4%) or other combinations (2%). Minimal access is used 58% of single AVR cases. Early mortality and stroke rates are low: 2.5% and 1.6% respectively. In single AVR, these death and stroke rates are 1.4% and 0%, respectively. Postoperative hemodynamics show peak and mean gradients of 21±8 mmHg and 12±4 mmHg, respectively; effective orifice area (EOA) of 2±0.5 cm2 and an EOA-index of 1±0.3 cm2. This results in 67% having no patient-prosthesis mismatch (PPM); 29% having moderate PPM and 4% severe PPM (Fig. 1). Paravalvular leakage >1/4 is present in 0.3% of cases. Postoperative pacemaker implantation is needed in 2.5%. CONCLUSIONS:
The first results from a real-world, prospective, multi-center registry on the Avalus™ pericardial aortic valve show very low rates of early major events and excellent hemodynamics with low gradients and low rates of PPM. As expected in surgical AVR, pacemaker need and paravalvular leakage rates are very low. This registry aims to enroll 1000 patients from more than 30 centers and will continue to monitor the outcome. 
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