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  • Title: Early clinical experience with the On-X prosthetic heart valve.
    Author: Laczkovics A, Heidt M, Oelert H, Laufer G, Greve H, Pomar JL, Mohr FW, Haverich A, Birnbaum D, Regensburger D, Palatianos G, Wolner E.
    Journal: J Heart Valve Dis; 2001 Jan; 10(1):94-9. PubMed ID: 11206775.
    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 (MVR)) at 11 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 11 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 (one 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 MVR (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 On-X valve provides satisfactory clinical outcome in the immediate postoperative period, and that the valve is both safe and effective.
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