经皮主动脉瓣置换专家共识

1、 对于左心室收缩功能正常的患者： 主瓣峰值血流速度4.0 m/s (对应跨主瓣峰 值压差64 mm Hg), 平均压差40 mm Hg, 或主瓣瓣口面积1.0 cm2. 考虑到患者体表面积不同，主瓣面积常用 体表面积指数表示，0.6 cm2/m2 作为严重 主瓣狭窄的标准. With severe, symptomatic, calcific AS, AVR is the only effective treatment that improves symptoms and prolongs survival (30,31). 对于严重的、有症状的、钙化性主动脉瓣 狭窄，换瓣术是能够改善症状和

2、延长生命 的唯一有效治疗方法。 一、外科AVR。 机械瓣。相对年轻患者。 生物瓣。常会发生生物瓣叶的钙化。在年 轻患者平均发生时间为1012年，老年患 者平均发生时间为1518年。 实际上，应用现代生物瓣，术后5年有95 的患者瓣膜仍然良好，不必再次手术；10 年时90；15年时降为70。 外科手术AVR的限制性 Despite substantial contemporary experience with successful AVR in elderly patients, multiple series have documented that 30% to 40% of patien

3、ts with severe AS do not undergo surgery owing to advanced age, LV dysfunction, multiple coexisting conditions, and patient preference or physician recommendation。 二、Balloon aortic valvuloplasty. 预后较差。Restenosis or recoil of the aortic valve usually occurs within 6 months. Patients treated with ball

4、oon aortic valvuloplasty alone have shown poor prognosis, with survival rates of 50% at 1 year, 35% at 2 years, and 20% at 3 years . In addition, serious complications due to balloon aortic valvuloplasty occur in 15% to 25% of patients。 三、经皮主动脉瓣置换术Transcatheter Aortic Valve Replacement。TAVR。 历史：1992

5、开始动物实验；2002年实现经 皮置入人体第一个可扩张的马心包支架瓣 膜。 之后多种TAVR瓣膜问世。 Device Description： （一）Sapien valve (Figure 1) Edwards Life Sciences, Inc., Irvine, CA)：三瓣牛心包瓣固定在可球囊扩张的钴铬合金 支架上。 The Sapien valve is available in 23-mm and 26-mm sizes in the United States and 23-mm, 26-mm, and 29- mm sizes in Europe. The initial d

6、evices required a 22- or 24-French sheath for delivery of the prosthesis. Recent iterations (NovaFlex) have decreased this to 18- French. Sapien valve （二）CoreValve (Figure 2) (Medtronic, Inc., Minneapolis, MN). 三片猪心包固定于 可自膨胀的镍钛合金支架上。 CoreValve： It is available in 3 sizes26 mm, 29 mm, and 31 mm. This

7、 valve has also continued to iterate, with the initial devices being 25- French, but now 18-French delivery sheaths are used. This valve has only been used by a retrograde approach either via transfemoral, subclavian, or direct aortic access. An estimated 40,000 patients have received TAVR worldwide

8、. Multiple single and multicenter registries, and a single randomized trial, have documented favorable outcomes using a wide spectrum of endpoints, including survival, symptom status, quality of life, and need for repeat hospitalization. There are only limited clinical data on the durability of TAVR

9、 valvesup to 2 years in the PARTNER trial and up to 5 years in other registry experiences. Table 1. Edwards Sapien Transcatheter Heart Valve Registries Randomized Controlled Trial PARTNER Trial Design A prospective, unblinded, randomized, controlled, multicenter pivotal trial evaluating the safety a

10、nd effectiveness of the Edwards Sapien THV transcatheter aortic valve; 2 distinct populations were enrolled Cohort A - high-risk operable,699人; Cohort B inoperable,358人; PARTNER Trial Design Table 4. Major Outcomes at 30 Days and 1 Year in Cohort B of the PARTNER Trial Table 6. Major Outcomes at 30

11、Days and 1 Year in Cohort A of the PARTNER Trial Table 7. Quality of Life and Symptom Assessment in TAVR Trials Table 9. Patient Selection: Inclusion and Exclusion Criteria in Clinical Trials Table 9. Patient Selection: Inclusion and Exclusion Criteria in Clinical Trials 心脏彩超 CT 心脏磁共振 观察主动脉瓣、瓣环、瓣环距冠

12、状动脉的 距离、升主动脉、髂股动脉情况。 心内科、心外科 杂交手术室 设备齐全的、宽敞的、有双球管的C型臂。 全麻 肺动脉导管，经食管超声，临时起搏器， 除颤仪。 房间要足够温暖，甚至应用体下供热系统。 避免过长时间低血压。 穿刺或切开均可，依据具体情况，各有利 弊。 少数几个大医院。 国产TAVR瓣膜即将应用于临床。 CoreValve： It is available in 3 sizes26 mm, 29 mm, and 31 mm. This valve has also continued to iterate, with the initial devices being 25-

13、French, but now 18-French delivery sheaths are used. This valve has only been used by a retrograde approach either via transfemoral, subclavian, or direct aortic access. An estimated 40,000 patients have received TAVR worldwide. Multiple single and multicenter registries, and a single randomized trial, have documented favorable outcomes using a wide spectrum of endpoints, including