Laczkovics, Axel and Heidt, Martin Clemens and Oelert, H. and Laufer, Guenther and Greve, Hans and Pomar, Jose Luis and Mohr, F. W. and Haverich, Axel and Birnbaum, Dietrich and Regensburger, D. and Palatianos, George M. and Wolner, Ernst (2001) Early clinical experience with the On-X (R) prosthetic heart valve. JOURNAL OF HEART VALVE DISEASE, 10 (1). pp. 94-99. ISSN 0966-8519
Full text not available from this repository.Abstract
Background and aim of the study: The study was designed to investigate the clinical performance of the On-X prosthetic heart valve in a multicenter experience. Methods: Between September 1996 and September 1999, 301 patients (56% males) underwent isolated On-X valve replacement (184 isolated aortic (AVR), 117 isolated mitral (R-IVR) at II European centers under a standardized protocol. Average age at implant was 60.2 years. Office or hospital follow up was required by the protocol; average follow up on all patients was II months. Results: Thirty-day mortality in the study was 2.2% for AVR and 6.0% for MVR, with valve-related mortality of 0.5% for AVR, There were eight late deaths (0.7%/pt-yr AVR and 2.3%/pt-yr MVR). Two of these deaths were sudden, and thus possibly valve-related (one AVR, one MVR). Early total valve-related morbidity was 3.5% for AVR and 2.6% for MVR. In total, 13 thromboembolic events occurred; one early event in AVR resulted in death (0.5%), and one transient early event occurred in MVR (0.9%). There were 11 late events (seven AVR (1.7%/pt-yr) and four MVR (1.8%/pt-yr)), for a two-year freedom from thromboembolism of 96.6% after AVR and 97.1% after MVR. Three late bleeding events occurred, all after AVR (0.7%/pt-yr and 98.9% free at two years). Major paravalvular leaks requiring reoperation occurred on two occasions early tone AVR (0.5%), one MVR (0.8%)) and once late in MVR (0.5%/pt-yr). late minor, untreated paravalvular leaks occurred in three AVR patients (0.7%/pt-yr) and in one MVR patient (0.5%/pt-yr). Prosthetic endocarditis occurred four times (two AVR (0.5%/pt-yr), two A?VR (0.9%/pt-yr)), all within the first 12 months of surgery. Actuarial freedom from all valve-related events at two years was 88.7% for AVR and 88.1% for MVR. NYHA class was improved in 75.8% of AVR patients and 70.6% of MVR patients at two years after surgery. Conclusion: These early results indicate that the Only valve provides satisfactory clinical outcome in the immediate postoperative period, and that the valve is both safe and effective.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | REPLACEMENT; POSITION; |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Herz-, Thorax- und herznahe Gefäßchirurgie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 01 Mar 2022 09:49 |
| Last Modified: | 01 Mar 2022 09:49 |
| URI: | https://pred.uni-regensburg.de/id/eprint/41893 |
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