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1[6 Years Clinical Experience with the TEKNA Bivalve Heart Valve Prosthesis].

M R Hoda,G Laufer,R Moidl,P Simon,E Eigenbauer,A Moritz,E Wolner

OBJECTIVE:The revised Edwards-Duromedics valve was introduced onto the market in June 1990. In September 1993, the producer changed the name of the valve to TEKNA, which is a low profile, bileaflet, mechanical prosthesis with a self-irrigating hinge mechanism. The results of a prospective follow-up study after valve replacement with this prosthesis are presented.METHODS:From November 1990 to December 1996, 173 TEKNA prostheses were implanted in 161 patients (73 men, 88 women), either in the aortic (AVR; 48.4%), mitral (MVR; 44.1%), or aortic and mitral positions (DVR; 7.5%). Patient ages ranged from 17 to 83 years (mean age 59.2 +/- 8.7 years). Follow-up was 97.5% complete, comprising 433.15 patient-years for a mean follow-up of 34.8 +/- 23 months.RESULTS:Overall operative (30-day) mortality was 4.97%. Fifteen patients died in the late period, corresponding to a linearized late mortality rate of 3.5%/pt-yr. Actuarial survival at six years was 75.3% +/- 6.2% overall. The actuarial freedom from complications was calculated as follows (linearized rates in parentheses): valve-related mortality 91.3% +/- 5.1% (0.92%/pt-yr); thromboembolism 94.2% +/- 2.5% (1.62%/pt-yr); valve thrombosis 98.6 +/- 1.0% (0.46%/pt-yr); bleeding events 85.9% +/- 4.7% (2.77%/pt-yr); prosthetic valve endocarditis 98.6 +/- 0.9% (0.46%/pt-yr); nonstructural dysfunction 93.2 +/- 3.2% (1.38%/pt-yr); reoperation 87.1 +/- 5.3% (2.08%/pt-yr). Functional class according to NYHA was improved from preoperatively 72.05% in III or IV to 6-year postoperative 94.2% in I or II.CONCLUSION:The clinical performance of the TEKNA valve is quite satisfactory, with low incidence of valve-related complications. No structural deterioration has been observed. Further, the patients physical ability and quality of life were significantly improved.

2000Zeitschrift fur Kardiologie（2000）引用：23

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2Sechs Jahre klinische Erfahrung mit TEKNA®- Doppelflügel-Herzklappenprothese@@@Six years of clinical experience with the TEKNA® bileaflet heart valve

M R Hoda,G Laufer,Reinhard Moidl,Paul Simon,Ernst Eigenbauer,Anton Moritz,Ernst Wolner

2000Zeitschrift Fur Kardiologie（2000）引用：23

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3Sechs Jahre Klinische Erfahrung Mit TEKNA®- Doppelflügel-Herzklappenprothese

M. R. Hoda,G. Laufer,R. Moidl,P. Simon,E. Eigenbauer,A. Moritz,E. Wolner

Problemstellung: Die modifizierte Edwards-Duromedics Doppelflügelprothese wurde nach Konstruktionsänderungen im Juni 1990 wieder am europäischen Markt eingeführt. Im September 1993 änderte der Hersteller den Produktnamen in TEKNA®. Die Klappe ist eine Zweiflügelprothese mit zentralem Strömungsprofil. Die Ergebnisse einer prospektiven Nachbeobachtungsstudie mit dieser Klappe werden präsentiert.

2000Zeitschrift für Kardiologie（2000）引用：4

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