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主动脉位置的Freestyle无支架生物假体的长期结果:500例患者的单中心前瞻性队列研究

Long-term results of Freestyle stentless bioprosthesis in the aortic position: a single-center prospective cohort of 500 patients.

作者信息

Amabile Nicolas, Bical Olivier M, Azmoun Alexandre, Ramadan Ramzi, Nottin Remi, Deleuze Philippe H

机构信息

Cardiology Department, Centre Chirurgical Marie Lannelongue, Le Plessis-Robinson, France.

Cardiac Surgery Department, Centre Chirurgical Marie Lannelongue, Le Plessis-Robinson, France.

出版信息

J Thorac Cardiovasc Surg. 2014 Nov;148(5):1903-11. doi: 10.1016/j.jtcvs.2014.02.063. Epub 2014 Feb 26.

DOI:10.1016/j.jtcvs.2014.02.063
PMID:24685376
Abstract

OBJECTIVE

Stentless xenograft bioprostheses may be the future valve of choice for aortic valve replacement. The study aim was to investigate the long-term clinical outcome after aortic valve replacement with the Medtronic Freestyle bioprosthesis (Medtronic Inc, Minneapolis, Minn).

METHODS

Between April 1997 and November 2004, a total of 500 patients (mean age, 74.5±9.6 years; 52% were male) underwent aortic valve replacement with a Freestyle bioprosthesis, without population selection. The surgical procedure used a modified subcoronary technique in 479 patients and a complete root replacement in 21 patients, conducted with mini-extracorporeal circulation. Concomitant procedures included coronary artery bypass grafting in 122 patients (24%) and mitral valve repair/replacement in 11 patients.

RESULTS

The mean cardiopulmonary bypass time was 98±26 minutes, and total aortic crossclamp time was 77±19 minutes. Operative mortality was 5.2%. The median follow-up time was 104.8±5.7 months. During this period, there were 224 deaths (n=122 cardiovascular and n=102 noncardiovascular deaths). The actuarial survivals from cardiovascular and valve-related mortality were 67%±3% and 70%±4%, respectively, at 10 years. Freedom from structural valve deterioration at 10 years was 94%±2%. The linearized structural valve deterioration incidence was 0.6% per patient/year. Multivariate Cox regression analysis revealed that older age, impaired renal function, and coronary artery disease were independent predictors of cardiovascular death. In the subgroup of patients aged less than 65 years at implantation (n=45), the actuarial cardiovascular survival was 83%±8% and freedom from structural valve deterioration was 89%±6% at 10 years.

CONCLUSIONS

The use of the Freestyle bioprosthesis for aortic valve replacement resulted in good long-term cardiovascular survival and freedom from structural valve deterioration in this cohort regardless of age at implantation.

摘要

目的

无支架异种生物瓣膜可能是未来主动脉瓣置换术的首选瓣膜。本研究旨在调查使用美敦力Freestyle生物瓣膜(美敦力公司,明尼阿波利斯,明尼苏达州)进行主动脉瓣置换术后的长期临床结果。

方法

1997年4月至2004年11月期间,共有500例患者(平均年龄74.5±9.6岁;52%为男性)接受了Freestyle生物瓣膜主动脉瓣置换术,未进行人群选择。479例患者采用改良的冠状动脉下技术进行手术,21例患者采用完整的根部置换术,均在体外循环下进行。同期手术包括122例患者(24%)进行冠状动脉旁路移植术和11例患者进行二尖瓣修复/置换术。

结果

平均体外循环时间为98±26分钟,主动脉总阻断时间为77±19分钟。手术死亡率为5.2%。中位随访时间为104.8±5.7个月。在此期间,共有224例死亡(n = 122例心血管死亡和n = 102例非心血管死亡)。10年时,心血管和瓣膜相关死亡率的精算生存率分别为67%±3%和70%±4%。10年时无瓣膜结构恶化的比例为94%±2%。每位患者每年的线性瓣膜结构恶化发生率为0.6%。多因素Cox回归分析显示,年龄较大、肾功能受损和冠状动脉疾病是心血管死亡的独立预测因素。在植入时年龄小于65岁的患者亚组(n = 45)中,10年时心血管精算生存率为83%±8%,无瓣膜结构恶化的比例为89%±6%。

结论

在该队列中,无论植入时的年龄如何,使用Freestyle生物瓣膜进行主动脉瓣置换术均可带来良好的长期心血管生存率且无瓣膜结构恶化。

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