Durability and clinical experience using a bovine pericardial prosthetic aortic valve

Objectives: To report the implant experience and long-term outcomes from a large tertiary care referral center on surgical aortic valve replacement (SAVR) with a contemporary stented pericardial bioprosthesis with anticalcification treatment.

Methods: Patients underwent SAVR using the Trifecta valve at a single institution. Endpoints included procedural outcomes, adverse events, prosthesis-patient mismatch (PPM), long-term survival, and valve durability. Follow-up included 30-day, 6-month, and annual assessments. Treatment for structural valve deterioration (SVD) included surgical explant and valve-in-valve (V-in-V) transcatheter aortic valve implantation (TAVI).

Results: SAVR was performed in 1241 patients (median age, 73.5 ± 6.4 years; 54% male; median logistic EuroSCORE, 7.8) with concomitant procedures in 713 cases (57.5%). Intraprocedural mortality was 1.4%, and 30-day mortality was 6.0%. At hospital discharge, 68 patients (5.5%) had moderate PPM, and no patients had severe PPM. Adverse events included cardiac arrhythmias (44.7%, mostly atrial fibrillation), respiratory failure (22.9%), acute renal failure requiring temporary renal replacement therapy (12.9%), and low cardiac output syndrome (3.3%). Follow-up data were available over a total of 5469 patient-years (median duration of follow-up, 4.7 years). Freedom at 8 years from all-cause mortality, valve-related mortality, reoperation for SVD (redo SAVR or V-in-V TAVI), and endocarditis were 78.4%, 98.0%, 93.3%, and 96.5%, respectively. Of the 30 patients with SVD, 17 were treated by V-in-V TAVI and 13 underwent surgical explant.

Conclusions: Outcomes from this large single-center cohort at increased surgical risk demonstrate excellent long-term durability of the Trifecta valve for SAVR and feasibility of treating SVD by V-in-V TAVI.