Five-year outcomes of rapid-deployment aortic valve replacement with the Edwards Intuity valve. 2021

E Pelce, and A Porto, and V Gariboldi, and A Ben Lagha, and C Amanatiou, and F Collart, and A Theron
Department of Cardiac Surgery, La Timone Hospital, Marseille, France.

BACKGROUND This report presents 5-year outcomes of the rapid-deployment Edwards Intuity valve in a prospective, single-center study. METHODS All patients who underwent an aortic valve replacement (AVR) with an Edwards Intuity bioprosthesis at La Timone Hospital, Marseille, France, from July 2012 to June 2015 were assessed over a 5-year follow-up period. The primary outcome was overall mortality at 5 years. Secondary outcomes were reoperation, overall mortality and stroke, cardiovascular mortality, composite endpoints defined by the updated Valve Academic Research Consortium-2 (VARC-2), periprosthetic regurgitation, prosthesis-patient mismatch, and the need for new pacemaker implantation. RESULTS In total, 170 consecutive patients were assessed, of which 67.1% were males. The mean age was 76 years, mean EuroSCORE II was 3.5% and 5-year overall mortality was 12.4%. At 5 years, reoperation was 2.9%, overall mortality and stroke was 4.1% per patient-year, and cardiovascular mortality was 4.7%. VARC clinical efficacy and VARC time-related valve safety were achieved in 46.0% and 59.9% of patients, respectively. At one month VARC device success was 71.2% and VARC early safety was 87.1%. At one year, mild and moderate periprosthetic regurgitation were 2.4% and 0.6%, respectively, and moderate and severe prosthesis-patient mismatch were 18.8% and 4.8%, respectively. Conduction disturbances needing new PPI occurred in 3.5% patients. CONCLUSIONS The 5-year outcomes of AVR with the Edwards Intuity valve system demonstrate satisfactory midterm safety and excellent haemodynamic performance.

UI MeSH Term Description Entries
D008297 Male Males
D011446 Prospective Studies Observation of a population for a sufficient number of persons over a sufficient number of years to generate incidence or mortality rates subsequent to the selection of the study group. Prospective Study,Studies, Prospective,Study, Prospective
D011474 Prosthesis Design The plan and delineation of prostheses in general or a specific prosthesis. Design, Prosthesis,Designs, Prosthesis,Prosthesis Designs
D005602 France A country in western Europe bordered by the Atlantic Ocean, the English Channel, the Mediterranean Sea, and the countries of Belgium, Germany, Italy, Spain, Switzerland, the principalities of Andorra and Monaco, and by the duchy of Luxembourg. Its capital is Paris. Corsica,Saint Pierre and Miquelon,Miquelon and Saint Pierre,Miquelon and St. Pierre,St. Pierre and Miquelon
D006350 Heart Valve Prosthesis A device that substitutes for a heart valve. It may be composed of biological material (BIOPROSTHESIS) and/or synthetic material. Prosthesis, Heart Valve,Cardiac Valve Prosthesis,Cardiac Valve Prostheses,Heart Valve Prostheses,Prostheses, Cardiac Valve,Prostheses, Heart Valve,Prosthesis, Cardiac Valve,Valve Prostheses, Cardiac,Valve Prostheses, Heart,Valve Prosthesis, Cardiac,Valve Prosthesis, Heart
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000368 Aged A person 65 years of age or older. For a person older than 79 years, AGED, 80 AND OVER is available. Elderly
D001021 Aortic Valve The valve between the left ventricle and the ascending aorta which prevents backflow into the left ventricle. Aortic Valves,Valve, Aortic,Valves, Aortic
D001024 Aortic Valve Stenosis A pathological constriction that can occur above (supravalvular stenosis), below (subvalvular stenosis), or at the AORTIC VALVE. It is characterized by restricted outflow from the LEFT VENTRICLE into the AORTA. Aortic Stenosis,Aortic Valve Stenoses,Stenoses, Aortic,Stenoses, Aortic Valve,Stenosis, Aortic,Stenosis, Aortic Valve,Valve Stenoses, Aortic,Valve Stenosis, Aortic
D001705 Bioprosthesis Prosthesis, usually heart valve, composed of biological material and whose durability depends upon the stability of the material after pretreatment, rather than regeneration by host cell ingrowth. Durability is achieved 1, mechanically by the interposition of a cloth, usually polytetrafluoroethylene, between the host and the graft, and 2, chemically by stabilization of the tissue by intermolecular linking, usually with glutaraldehyde, after removal of antigenic components, or the use of reconstituted and restructured biopolymers. Glutaraldehyde-Stabilized Grafts,Heterograft Bioprosthesis,Porcine Xenograft Bioprosthesis,Xenograft Bioprosthesis,Bioprostheses,Bioprostheses, Heterograft,Bioprostheses, Porcine Xenograft,Bioprostheses, Xenograft,Bioprosthesis, Heterograft,Bioprosthesis, Porcine Xenograft,Bioprosthesis, Xenograft,Glutaraldehyde Stabilized Grafts,Glutaraldehyde-Stabilized Graft,Graft, Glutaraldehyde-Stabilized,Grafts, Glutaraldehyde-Stabilized,Heterograft Bioprostheses,Porcine Xenograft Bioprostheses,Xenograft Bioprostheses,Xenograft Bioprostheses, Porcine,Xenograft Bioprosthesis, Porcine

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