Palatianos, George M. and Laczkovics, Axel M. and Simon, Paul and Pomar, Jose Luis and Birnbaum, Dietrich E. and Greve, Hans H. and Haverich, Axel (2007) Multicentered European study on safety and effectiveness of the On-X prosthetic heart valve: Intermediate follow-up. ANNALS OF THORACIC SURGERY, 83 (1). pp. 40-46. ISSN 0003-4975,
Full text not available from this repository. (Request a copy)Abstract
Background. This study was performed to determine the safety and effectiveness of the On-X valve, a novel mechanical valve substitute. Methods. Eleven centers participated in a European, multicentered, longitudinal, nonrandomized study of the On-X valve performance. Isolated aortic or mitral valve replacement with an On-X valve was studied in 301 patients. Aortic valve replacement was performed in 184 patients (average follow-up, 5.0 years), whereas mitral valve replacement was performed in 117 patients (average follow- up, 4.4 years). Results. In patients with aortic valve replacement, mean transvalvular pressure gradients ranged from 8.3 to 4.7 mm Hg and effective orifice areas from 1.5 to 2.7 cm(2), for 19-mm through 25-mm valves, respectively. After mitral valve replacement, mean gradient was 4.2 mm Hg and effective orifice area by pressure half-time was 2.6 cm(2) regardless of valve size. Hemolysis was low, with postoperative serum lactate dehydrogenase at 225 +/- 41 IU (mean +/- standard deviation) or 253 +/- 65 IU, after aortic valve replacement or mitral valve replacement, respectively (upper normal value, 250 IU). At 1 year or greater postoperatively, 91.6% of patients after aortic valve replacement and 84.6% after mitral valve replacement were in New York Heart Association functional class I or II. Adverse event rates in percent per patient-year after aortic valve replacement or mitral valve replacement were thromboembolism, 0.88 or 1.76; thrombosis, 0.11 or 0.20; bleeding, 0.77 or 1.96, respectively. Late mortality was 1.97% or 2.55%, respectively. Conclusions. At the intermediate follow-up, the On-X valve exhibited improved hemodynamics, low hemolysis with in-range lactate dehydrogenase, and low adverse event rates, particularly in the aortic position.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | PYROLYTIC CARBON; INTRAVASCULAR HEMOLYSIS; REPLACEMENT; EXPERIENCE; CARBOMEDICS; MORTALITY; |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Herz-, Thorax- und herznahe Gefäßchirurgie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 11 Jan 2021 07:54 |
| Last Modified: | 11 Jan 2021 07:54 |
| URI: | https://pred.uni-regensburg.de/id/eprint/33332 |
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