On-X人工心脏瓣膜的早期临床经验。
Early clinical experience with the On-X prosthetic heart valve.
作者信息
Laczkovics A, Heidt M, Oelert H, Laufer G, Greve H, Pomar J L, Mohr F W, Haverich A, Birnbaum D, Regensburger D, Palatianos G, Wolner E
机构信息
Universitätsklinikum Bergmannsheil, Bochum, Germany.
出版信息
J Heart Valve Dis. 2001 Jan;10(1):94-9.
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.
研究背景与目的
本研究旨在通过多中心经验调查On-X人工心脏瓣膜的临床性能。
方法
1996年9月至1999年9月期间，301例患者（56%为男性）在11个欧洲中心按照标准化方案接受了单纯On-X瓣膜置换术（184例单纯主动脉瓣置换术（AVR），117例单纯二尖瓣置换术（MVR））。植入时的平均年龄为60.2岁。方案要求进行门诊或住院随访；所有患者的平均随访时间为11个月。
结果
本研究中，AVR的30天死亡率为2.2%，MVR为6.0%，AVR的瓣膜相关死亡率为0.5%。有8例晚期死亡（AVR为0.7%/患者年，MVR为2.3%/患者年）。其中2例死亡为猝死，因此可能与瓣膜相关（1例AVR，1例MVR）。AVR的早期总瓣膜相关发病率为3.5%，MVR为2.6%。共发生13例血栓栓塞事件；AVR的1例早期事件导致死亡（0.5%），MVR发生1例短暂性早期事件（0.9%）。有11例晚期事件（7例AVR（1.7%/患者年）和4例MVR（1.8%/患者年）），AVR术后两年无血栓栓塞的自由度为96.6%，MVR为97.1%。发生3例晚期出血事件，均发生在AVR术后（0.7%/患者年，两年时98.9%无出血）。早期有2例需要再次手术的严重瓣周漏（1例AVR（0.5%），1例MVR（0.8%）），晚期MVR有1例（0.5%/患者年）。3例AVR患者（0.7%/患者年）和1例MVR患者（0.5%/患者年）发生晚期轻微、未治疗的瓣周漏。人工瓣膜心内膜炎发生4次（2例AVR（0.5%/患者年），2例MVR（0.9%/患者年）），均在术后12个月内。AVR术后两年所有瓣膜相关事件的无事件生存率为88.7%，MVR为88.1%。术后两年，75.8%的AVR患者和70.6%的MVR患者纽约心脏协会（NYHA）心功能分级得到改善。
结论
这些早期结果表明，On-X瓣膜在术后即刻提供了令人满意的临床结果，且该瓣膜安全有效。
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