Seven-year outcomes following aortic valve replacement with a novel tissue bioprosthesis.
Publication/Presentation Date
9-29-2023
Abstract
OBJECTIVE: As bioprosthetic aortic valve replacement (AVR) extends to younger cohorts, tissue durability is of paramount importance. We report 7-year outcomes from an AVR bioprosthesis utilizing novel tissue.
METHODS: This was an international investigational device exemption trial for novel AVR with annual follow-up and a subset re-consented at 5 years for extended 10-year follow-up. Safety end points and echocardiographic measurements were adjudicated by an independent clinical events committee and by a dedicated core laboratory, respectively.
RESULTS: Between January 2013 and March 2016, 689 patients underwent AVR with the study valve. Mean age was 66.9 ± 11.6 years, Society of Thoracic Surgeons risk score was 2.0% ± 1.8%, and 74.3% of patients were New York Heart Association functional class II and III. Five-year follow-up was completed by 512 patients, and 225 re-consented for extended follow-up. Follow-up duration was 5.3 ± 2.2 years (3665.6 patient-years), and 194 and 195 patients completed 6- and 7-year follow-ups, respectively. One-, 5-, and 7-year freedom from all-cause mortality was 97.7%, 89.4%, and 85.4%, respectively. Freedom from structural valve deterioration at 7 years was 99.3%. At 7 years, effective orifice area and mean gradients were 1.82 ± 0.57 cm
CONCLUSIONS: We report the longest surgical AVR follow-up with novel tissue in an investigational device exemption trial utilizing an independent clinical events committee and an echocardiography core laboratory. This tissue demonstrates excellent outcomes through 7 years and is the benchmark for future surgical and transcatheter prostheses.
ISSN
1097-685X
Published In/Presented At
Beaver, T., Bavaria, J. E., Griffith, B., Svensson, L. G., Pibarot, P., Borger, M. A., Sharaf, O. M., Heimansohn, D. A., Thourani, V. H., Blackstone, E. H., Puskas, J. D., & COMMENCE Trial Investigators (2023). Seven-year outcomes following aortic valve replacement with a novel tissue bioprosthesis. The Journal of thoracic and cardiovascular surgery, S0022-5223(23)00873-5. Advance online publication. https://doi.org/10.1016/j.jtcvs.2023.09.047
Disciplines
Medicine and Health Sciences
PubMedID
37778503
Department(s)
Department of Surgery
Document Type
Article