Clinical and echocardiographic assessment of the Medtronic Advantage aortic valve prosthesis: the Scandinavian multicentre, prospective study.

Abstract

The aim of this report is the prospective, multicentre evaluation of clinical results and haemodynamic performance of the Medtronic Advantage aortic valve prosthesis. From April 2001 to June 2003, 166 patients (male:female 125:41; mean (SD) age 61.8 (11.8) years) received an aortic advantage valve prosthesis. Complete cumulative follow-up was 242.7 patient-years (maximum 3.2; mean 1.6 years). Postoperatively, patients underwent early (within 30 days) and 1 year transthoracic echocardiography. 30 day mortality was 2.4% (n = 4). Kaplan-Meier estimates of freedom from complications and linearised rates were as follows: 96.9 (1.6)% survival; 94.7 (1.3)% (2.06 patients/year) thrombo-embolism; 99.4 (0.6)% (0.4 patients/year) bleeding; 98.8 (0.9)% (0.8 patients/year) non-structural valve dysfunction; 98.8 (0.9)% (0.8 patients/year) reoperation. Valvular mean pressure gradients ranged from 16 (3) mm Hg for size 19 to 7 (2) mm Hg for size 27 and the corresponding effective orifice areas ranged from 1.2 (0.25) to 3.2 (0.66) cm(2). In all, left ventricular mass significantly decreased (p<0.001) and fractional shortening increased (p<0.001) from postoperative to 1 year echocardiography. Haemodynamic performance and early clinical results of Medtronic advantage in the aortic position were satisfactory and comparable with those of other bileaflet valves in current clinical use.