Frater Robert W M, Sussman Martin, Middlemost Shirley, Walther Thomas, Mohr Frederick, Al Halees Zohair, Shahid Maie
Montefiore Medical Center, Bronx, NY, USA.
J Heart Valve Dis. 2006 Mar;15(2):230-7; discussion 237.
The Quattro valve is a stentless pericardial mitral bioprosthesis that is treated with a post-tanning aldehyde capping designed to reduce calcification. A prospective trial was started in December 1996; herein are reported the results of the three centers that performed the surgery and followed up patients in the majority of cases. Young patients were deliberately included in the trial.
Follow up data from 175 patients (mean age 46 years; range: 12-87 years) were collected and analyzed. Among patients, 44% were aged < 40 years. Follow up was 91% complete; mean follow up was 3.4 years (range: 0-7.5 years); total follow up was 465 patient-years (pt-yr). Clinical outcome was assessed according to the AATS/STS guidelines, and results analyzed according to Kaplan-Meier product limit calculation and by FDA Optimal Performance Criteria (OPC).
Early mortality was 1.7% (all non-valve related). At 60 months after surgery, mean overall survival was 84.8 +/- 3.6%, mean overall freedom from valve-related death was 99.2 +/- 0.9%, and mean overall freedom from calcification, pannus and tears was 96.1 +/- 2.2%. FDA OPC values (data for mechanical valve, tissue valve, Quattro valve in patients aged < 40 years and of all ages, respectively; expressed as %/pt-yr) were as follows: thromboembolism/stroke 3.0, 2.5, 0, 0.4; thrombosis 0.8, 0.2, 0, 0; major hemorrhage 1.5, 0.9, 0, 0.4; major perivalvular leak 0.6, 0.6, 0.4, 0.6; late endocarditis 1.2, 1.2, 1.8, 1.3; calcification/pannus 0, 0, 0.8, 0.6. Statistical analysis of these data showed there to be no difference between patients aged less or more than 40 years.
Overall mid-term results with the Quattro valve were acceptable. The lack of early calcification in young patients shows promise. More young patient-years of follow up will be needed to establish a secure indication for use in young, rheumatic patients where anticoagulation control is deficient.
Quattro瓣膜是一种无支架心包二尖瓣生物假体，采用鞣后醛封端处理以减少钙化。1996年12月启动了一项前瞻性试验；本文报告了三个进行该手术并在大多数病例中对患者进行随访的中心的结果。该试验特意纳入了年轻患者。
收集并分析了175例患者（平均年龄46岁；范围：12 - 87岁）的随访数据。患者中44%年龄小于40岁。随访完成率为91%；平均随访时间为3.4年（范围：0 - 7.5年）；总随访时间为465患者年（pt - yr）。根据美国胸外科医师协会/美国胸科医师学会（AATS/STS）指南评估临床结局，并根据Kaplan - Meier乘积限计算法和美国食品药品监督管理局（FDA）最佳性能标准（OPC）分析结果。
早期死亡率为1.7%（均与瓣膜无关）。术后60个月时，平均总生存率为84.8±3.6%，平均无瓣膜相关死亡生存率为99.2±0.9%，平均无钙化、血管翳和撕裂生存率为96.1±2.2%。FDA OPC值（分别为机械瓣膜、组织瓣膜、年龄小于40岁患者和所有年龄段患者使用Quattro瓣膜的数据；以%/pt - yr表示）如下：血栓栓塞/中风3.0、2.5、0、0.4；血栓形成0.8、0.2、0、0；大出血1.5、0.9、0、0.4；主要瓣周漏0.6、0.6、0.4、0.6；晚期心内膜炎1.2、1.2'、1.8、1.3；钙化/血管翳0、0、0.8、0.6。对这些数据的统计分析表明，年龄小于或大于40岁的患者之间无差异。
Quattro瓣膜的总体中期结果是可接受的。年轻患者缺乏早期钙化显示出前景。需要更多年轻患者年的随访，以确定在抗凝控制不佳的年轻风湿性患者中使用的可靠指征。
