Long-Term Clinical Outcomes of the Transcatheter Aortic Valve System for Aortic Valve Stenosis.

Abstract

Objective: To evaluate the clinical safety and efficacy of the self-expanding transcatheter aortic valve system in Chinese patients with severe aortic stenosis (AS) during follow-up.

Study design: Observational study. Place and Duration of the Study: Department of Cardiology, Yulin First People's Hospital, The Sixth Affiliated Hospital of Guangxi Medical University, Yulin, Guangxi, China, from April 2020 to September 2022.

Methodology: A retrospective analysis was conducted on 101 patients with severe symptomatic AS who underwent transcatheter aortic valve replacement (TAVR) using a self-expanding transcatheter aortic valve system. Inclusion criteria were patients with severe symptomatic AS at high surgical risk or with contraindications for traditional surgery. Exclusion criteria included active infections and untreated severe coronary artery stenosis. The primary endpoint of this study was the mortality rate or complications within one year after TAVR.

Results: The average age of the cohort was 69.5 ± 7.9 years, with 39.6% (n = 40) being female. The average risk score according to the Society of Thoracic Surgeons was 3.5 ± 2.7%. At one-year follow-up, the all-cause or cardiovascular disease mortality rate was 7.9% (n = 8). Importantly, no reports of major stroke or coronary artery obstruction occurred during the one-year follow-up, and the prognosis of patients with bicuspid aortic valve and tricuspid valve stenosis was comparable.

Conclusion: The studied transcatheter valve replacement system is a safe and effective treatment option for Chinese patients with severe aortic valve stenosis. Future multicentre and larger-scale randomised controlled trials are needed to verify that the self-expanding system can provide long-term benefits.

Key words: Aortic valve stenosis, Transcatheter aortic valve replacement, Self-expanding transcatheter aortic valve system.