TY - JOUR
T1 - One-year outcomes associated with a novel stented bovine pericardial aortic bioprosthesis
AU - PERIGON Investigators
AU - Sabik, Joseph F.
AU - Rao, Vivek
AU - Lange, R. diger
AU - Kappetein, A. Pieter
AU - Dagenais, Francois
AU - Labrousse, Louis
AU - Bapat, Vinayak
AU - Moront, Michael
AU - Weissman, Neil J.
AU - Patel, Himanshu J.
AU - Reardon, Michael J.
AU - Asch, Federico M.
AU - Zeng, Cathy
AU - Klautz, Robert J. M.
PY - 2018
Y1 - 2018
N2 - Objectives: The study objectives were to evaluate the safety, effectiveness, and hemodynamic performance of a new stented bovine pericardial aortic valve. Methods: This trial enrolled patients with symptomatic moderate or severe aortic stenosis or chronic, severe aortic regurgitation. We assessed death, valve-related adverse events, functional recovery, and hemodynamic performance at discharge, 3 to 6 months, and 1 year, as required by the US Food and Drug Administration for regulatory approval. The primary analysis compared late linearized rates of valve-related adverse events after implantation with Food and Drug Administration–specified objective performance criteria to determine whether the adverse event rates associated with the valve are within acceptable limits. Adverse events included thromboembolism, thrombosis, all and major hemorrhage, all and major paravalvular leak, and endocarditis. Results: The primary analysis included 864 patients who received an implant and 904.1 valve-years of follow-up. A total of 577 patients completed the 1-year evaluation. The primary end point was met for death, thromboembolism, thrombosis, all and major paravalvular leak, and endocarditis, but not for all and major hemorrhage. At 1 year, freedom from all death and from valve-related death was 96.4% and 99.7%, respectively. From baseline to 1 year, New York Heart Association class changed as follows: I, 10.8% to 73.7%; II, 48.9% to 22.6%; III, 38.0% to 3.5%; and IV, 2.3% to 0.2%. Effective orifice area increased from 0.9 ± 0.5 to 1.5 ± 0.4 (P <.0001), and mean aortic gradient decreased from 42.7 ± 16.5 to 12.5 ± 4.3 (P <.0001). Conclusions: This analysis of a new stented bovine pericardial aortic valve demonstrated low overall mortality and valve-related adverse events, and hemodynamic performance comparable to that of other surgical aortic valves.
AB - Objectives: The study objectives were to evaluate the safety, effectiveness, and hemodynamic performance of a new stented bovine pericardial aortic valve. Methods: This trial enrolled patients with symptomatic moderate or severe aortic stenosis or chronic, severe aortic regurgitation. We assessed death, valve-related adverse events, functional recovery, and hemodynamic performance at discharge, 3 to 6 months, and 1 year, as required by the US Food and Drug Administration for regulatory approval. The primary analysis compared late linearized rates of valve-related adverse events after implantation with Food and Drug Administration–specified objective performance criteria to determine whether the adverse event rates associated with the valve are within acceptable limits. Adverse events included thromboembolism, thrombosis, all and major hemorrhage, all and major paravalvular leak, and endocarditis. Results: The primary analysis included 864 patients who received an implant and 904.1 valve-years of follow-up. A total of 577 patients completed the 1-year evaluation. The primary end point was met for death, thromboembolism, thrombosis, all and major paravalvular leak, and endocarditis, but not for all and major hemorrhage. At 1 year, freedom from all death and from valve-related death was 96.4% and 99.7%, respectively. From baseline to 1 year, New York Heart Association class changed as follows: I, 10.8% to 73.7%; II, 48.9% to 22.6%; III, 38.0% to 3.5%; and IV, 2.3% to 0.2%. Effective orifice area increased from 0.9 ± 0.5 to 1.5 ± 0.4 (P <.0001), and mean aortic gradient decreased from 42.7 ± 16.5 to 12.5 ± 4.3 (P <.0001). Conclusions: This analysis of a new stented bovine pericardial aortic valve demonstrated low overall mortality and valve-related adverse events, and hemodynamic performance comparable to that of other surgical aortic valves.
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85046881719&origin=inward
UR - https://www.ncbi.nlm.nih.gov/pubmed/29778342
U2 - https://doi.org/10.1016/j.jtcvs.2018.03.171
DO - https://doi.org/10.1016/j.jtcvs.2018.03.171
M3 - Article
C2 - 29778342
SN - 0022-5223
VL - 156
SP - 1368-1377.e5
JO - Journal of Thoracic and Cardiovascular Surgery
JF - Journal of Thoracic and Cardiovascular Surgery
IS - 4
ER -