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You are here: Contents > 2006 > Volume 15 Number 3 May 2006 > DEVICE EVALUATION > The Worldwide Mid-Term Experience with the Medtronic ADVANTAGEŽ Bileaflet Mechanical Heart Valve

The Worldwide Mid-Term Experience with the Medtronic ADVANTAGEŽ Bileaflet Mechanical Heart Valve

Reiner Kšrfer1, Jan L. Svennevig2, Friedrich W. Mohr3, Alain Leguerrier4, Lorenzo Menicanti5, Peter S. Olsen6, Asbjorn Karevold7, Ruediger S. Lange8, Dirk Seifert1, for the Investigators of the ADVANTAGE® Prosthetic Heart Valve

1Herzzentrum NRW Bad Oeynhausen, Bad Oeynhausen, Germany, 2Dept. of Thoracic and Cardiovascular Surgery, Rikshospital, Oslo, Norway, 3Herzzentrum Leipzig GmbH, Universitatsklinik, Leipzig, Germany,
4CHU Hôpital Pontchaillou, Rennes, France, 5Ospedale Clinicizzato San Donate, Milan, Italy, 6Rigshospitalet, Copenhagen, Denmark, 7St. Elisabeth Heart Center, University Hospital Trondheim, Trondheim, Norway, 8Deutsches Herzzentrum MŸnchen, Munich, Germany

Background and aim of the study: 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 (£30 days or prior to discharge) and late (≥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.
Conclusion: The evolutionary bileaflet design of the ADVANTAGE valve achieved the desired clinical functionality and performance.
The Journal of Heart Valve Disease 2006;15:404-413

The Worldwide Mid-Term Experience with the Medtronic ADVANTAGE® Bileaflet Mechanical Heart Valve

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