Seven-Year Outcomes Following Aortic Valve Replacement With a Novel Tissue Bioprosthesis

This study reports on the seven-year outcomes of an international trial, which evaluated a novel bioprosthetic aortic valve prosthesis aimed at improving tissue durability. The trial was conducted between January 2013 and March 2016, and included 689 patients with a mean age of 66.9 years and a relatively low Society of Thoracic Surgeons risk score of 2.0 percent. The follow-up included annual assessments with a subset reconsented for an extended 10-year follow-up.  The five-year follow-up was completed by 512 patients, and 225 patients continued for the extended period. By seven years, 194 patients completed follow-up, showing impressive results: freedom from all-cause mortality was 85.4 percent and freedom from structural valve deterioration was 99.3 percent. The effective orifice area was 1.82 cm² with a mean gradient of 9.4 mm Hg. Paravalvular and transvalvular regurgitation rates were low, with most patients experiencing none or trivial leakage.  This study highlights the durability and excellent performance of this novel tissue bioprosthesis, setting a new standard for future aortic valve replacements in both surgical and transcatheter procedures.