Clinical and hemodynamic outcomes of the Perceval sutureless aortic valve from a real-world registry

Abstract

OBJECTIVES: Perceval sutureless valve has been in clinical use for >15 years. The aim of this study is to report the real-word clinical and haemodynamic performance from the SURE-aortic valve replacement international prospective registry in patients who underwent aortic valve replacement with Perceval valve. METHODS: From 2011 to 2021, patients from 55 institutions received a Perceval valve. Postoperative, follow-up, and echocardiographic outcomes were analysed. RESULTS: A total of 1652 patients were included; mean age was 75.3 ± 7.0 years (53.9% female); mean EuroSCORE II was 4.1 ± 6.3. Minimally invasive approach was performed in 45.3% of patients; concomitant procedures were done in 35.9% of cases. Within 30 days, 0.3 and 0.7% valve-related reinterventions were reported. Transient ischaemic attack, disabling and non-disabling strokes were limited (0.4%, 0.4% and 0.7%, respectively). Pacemaker implant was required in 5.7% of patients. Intra-prosthetic regurgitation ≥2 was present in 0.2% of cases, while paravalvular leak ≥2 in only 0.1%. At a maximum follow-up of 8 years, 1.9% of cardiovascular deaths and 0.8% of valve-related reintervention occurred. Among the 10 cases of structural valve deterioration (mean 5.6 ± 1.4 years after implant; range: 2.6-7.3 years), 9 were treated with a transcatheter vale-in-valve implantation and 1 with explant. Mean pressure gradient decreased from 45.8 ± 16.5 mmHg preoperatively to 13.3 ± 5.2 mmHg at discharge and remained stable during follow-up. CONCLUSIONS: This experience represents the largest prospective real-world cohort of patients treated with Perceval showing that Perceval is a safe and effective alternative to conventional surgical aortic valve replacement, providing favourable clinical and haemodynamic results also at mid-term follow-up.