European experience with the Mosaic bioprosthesis.
OBJECTIVE
The purpose of this study was to prospectively evaluate the clinical and hemodynamic performance of the Mosaic bioprosthesis (Medtronic, Inc, Minneapolis, Minn).


METHODS
The stented porcine bioprosthesis combines the amino-oleic acid antimineralization treatment and the zero-pressure differential fixation technique for improved tissue durability. From February 1994 to May 1999, a total of 561 patients underwent valve replacement with the Mosaic bioprosthesis at 5 centers in Europe: 461 in the aortic and 100 in the mitral position. There were 261 women and 300 men; mean age at implantation was 70 years (range, 23-89 years). Mean follow-up was 2.9 years (range, 0-6.2 years), with a total follow-up of 1710.1 patient-years.


RESULTS
Postoperative mortality was 4.2% per patient-year, including a valve-related mortality of 0.4% per patient-year. The freedom from event rates in the aortic position at 5 years and in the mitral position at 4 years were, respectively, 96.6% +/- 1.1% and 94.9% +/- 3.3% for primary thromboembolism, 96.4% +/- 5.0% and 87.1% +/- 4.8% for antithromboembolic-related hemorrhage, 99.1% +/- 0.5% and 100% for thrombosed prosthesis, 98.8% +/- 1.2% and 100% for structural valve deterioration, 98.8% +/- 0.7% and 100% for nonstructural dysfunction, 98.4% +/- 0.6% and 94.4% +/- 3.8% for endocarditis, and 95.4% +/- 1.6% and 95.3% +/- 3.7% for explant and reoperation. Mean pressure gradient values at 5 years ranged from 7.5 to 15.9 mm Hg in the aortic position and at 4 years from 2.0 to 6.9 mm Hg in the mitral position across all valve sizes.


CONCLUSIONS
Clinical and hemodynamic performance of the Mosaic bioprosthesis were very satisfactory during the first 6 years after clinical introduction.
Eichinger
Walter Benno
WB
Department of Cardiovascular Surgery, Deutsches Herzzentrum Munich, Lazarettstrasse 36, D-80636 Munich, Germany. eichinger@dhm.mhn.de
Botzenhardt
Florian
F
Gunzinger
Ralf
R
Kemkes
Bernhard M
BM
Sosnowski
Andrzej
A
Maïza
Dominique
D
Coto
Eduardo Otero
EO
Bleese
Niels
N
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001705:Bioprosthesis; D005060:Europe; D005260:Female; D019918:Heart Valve Prosthesis Implantation / Q000401:mortality; D006439:Hemodynamics; D006801:Humans; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000453:epidemiology; D011446:Prospective Studies; D011475:Prosthesis Failure; D015607:Stents; D016019:Survival Analysis; D013923:Thromboembolism / Q000453:epidemiology; D016896:Treatment Outcome