The worldwide mid-term experience with the Medtronic ADVANTAGE bileaflet mechanical heart valve.
OBJECTIVE
A total of 639 patients (479 men, 160 women; mean age 60 +/- 10 years) underwent isolated aortic valve replacement (AVR) between 25 November 1999 and 20 October 2003, using the Medtronic ADVANTAGE bileaflet mechanical heart valve. The study aim was to quantify the clinical performance of a valve with two design modifications: (i) an enlarged central orifice intended to improve blood flow characteristics; and (ii) an asymmetric butterfly pivot recess with expanded outflow component designed to enhance the washing of blood flow through the pivot region.


METHODS
Patients were enrolled at 21 centers located in Europe, Canada, Australia, and the USA. The study was conducted under the authority of regional ethics committees, as well as the respective national regulatory agencies. All centers adhered to a common protocol.


RESULTS
The total follow up was 1,215.9 patient-years. The average systolic mean pressure gradient across the prosthesis was < 10 mmHg. The mean left ventricular mass index decreased by 22.87 g/m2 (13% reduction) over 12 months. The numbers of valve-related intraoperative, early (< or = 30 days or prior to discharge) and late (> or = 31 days) deaths were 0, 10 and 19, respectively. After one year and four years of follow up, 99.3% (n = 560) and 100% of patients (n = 37), respectively, were in NYHA class I or II.


CONCLUSIONS
The evolutionary bileaflet design of the ADVANTAGE valve achieved the desired clinical functionality and performance.
Körfer
Reiner
R
Herzzentrum NRW Bad Oeynhausen, Bad Oeynhausen, Germany.
Svennevig
Jan L
JL
Mohr
Friedrich W
FW
Leguerrier
Alain
A
Menicanti
Lorenzo
L
Olsen
Peter S
PS
Karevold
Asbjorn
A
Lange
Ruediger S
RS
Seifert
Dirk
D
D000328:Adult; D017677:Age Distribution; D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000033:anatomy & histology; D004562:Electrocardiography; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation / Q000706:statistics & numerical data*; D006801:Humans; D008875:Middle Aged; D011183:Postoperative Complications / Q000145:classification / Q000453:epidemiology; D016019:Survival Analysis; D016896:Treatment Outcome; D016277:Ventricular Function, Left