title: The Medtronic Intact bioprosthesis: clinical and hemodynamic performance over 13 years.
abstract: We evaluated our results over 13 years with the aortic-position Medtronic Intact bioprosthesis. Our study involved 91 consecutive patients with isolated aortic valve replacement with the Medtronic Intact bioprosthesis. The follow-up was complete for 95%. Mean follow-up was 6.61 years (range 16 days-13 years), 590 patient years. Early mortality rate was 3.3%. Late mortality was 23 patients. Survival at 13 years was 53.52% (SD = 7.63%). The linearized rate of major thromboembolism was 0.34% per patient year; rate of major bleeding events was 0.33% per patient year. The rate of nonstructural dysfunction was 0.16% per patient year. Rate of reoperation was 0.53% and rate of structural valve deterioration was 0.16% per patient year. New York Heart Association (NYHA) postoperative classes were I to II in 92.21%. Gradients were as follows: 21 to 23.87 mm Hg, 23 to 18 mm Hg, 25 to 15.5 mm Hg, and 27 to 16.50 mm Hg. Structural valve deterioration was low during the 13 years of follow-up. Valve gradients and areas remained the same over the follow-up period. The Medtronic Intact bioprosthesis shows excellent clinical and hemodynamic performance at 13 years of follow up.
authors.affiliation: Department of Cardiac Surgery, Hospital de Navarra, Pamplona, Spain. adelafuc@cfnavarra.es
authors.forename: Anselmo
authors.initials: A
authors.lastname: de la Fuente
authors.forename: José Ramón
authors.initials: JR
authors.lastname: Sánchez
authors.forename: Juan Luis
authors.initials: JL
authors.lastname: Fernández
authors.forename: Javier
authors.initials: J
authors.lastname: Romero
authors.forename: Jesús
authors.initials: J
authors.lastname: Berjon
authors.forename: Ignacio
authors.initials: I
authors.lastname: Moriones
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000503:physiopathology* / Q000601:surgery*; D001705:Bioprosthesis; D005260:Female; D005500:Follow-Up Studies; D006349:Heart Valve Diseases / Q000401:mortality / Q000503:physiopathology* / Q000601:surgery*; D006350:Heart Valve Prosthesis; D006439:Hemodynamics / Q000502:physiology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D015996:Survival Rate; D013997:Time Factors; D016896:Treatment Outcome