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1、历史背景主动脉瓣狭窄常见于老年(75岁)的主动脉瓣钙化、风湿性心脏病和先天性二叶瓣。主动脉瓣狭窄会逐渐进展,左心室壁肥厚,最终导致左心衰竭。一旦出现症状,预后极差。从症状出现到死亡的平均时间:心衰2年,昏厥3年,心绞痛5年。药物治疗1、2年死亡率为25、50。严重主动脉瓣狭窄的定义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.严重主动脉瓣狭窄的治疗选择With severe, s
2、ymptomatic, 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延长生命的唯一有效治疗方法。严重主动脉瓣狭窄的治疗选择一、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。严重主动脉
3、瓣狭窄的治疗选择外科手术AVR的限制性Despite substantial contemporary experience with successful AVR in elderly patients, multiple series have documented that 30% to 40% of patients with severe AS do not undergo surgery owing to advanced age, LV dysfunction, multiple coexisting conditions, and patient preference or p
4、hysician recommendation。严重主动脉瓣狭窄的治疗选择二、Balloon aortic valvuloplasty.预后较差。Restenosis or recoil of the aortic valve usually occurs within 6 months. Patients treated with balloon aortic valvuloplasty alone have shown poor prognosis, with survival rates of 50% at 1 year, 35% at 2 years, and 20% at 3 yea
5、rs . In addition, serious complications due to balloon aortic valvuloplasty occur in 15% to 25% of patients。严重主动脉瓣狭窄的治疗选择三、经皮主动脉瓣置换术Transcatheter Aortic Valve Replacement。TAVR。经皮主动脉瓣置换术历史:1992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。经皮主动脉瓣置换术Device Description:(一)Sapien valve (Figure 1) Edwar
6、ds 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 devices required a 22- or 24-French sheath for delivery of the prosthesis. Recent iterations (NovaFlex) have
7、 decreased this to 18-French. Sapien valve经皮主动脉瓣置换术(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。经皮主动脉瓣置换术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-French, but now 18-Fr
8、ench delivery sheaths are used. This valve has only been used by a retrograde approacheither via transfemoral, subclavian, or direct aortic access.经皮主动脉瓣置换术An estimated 40,000 patients have received TAVR worldwide. Multiple single and multicenter registries, and a single randomized trial, have docum
9、ented favorable outcomes using a wide spectrum of endpoints, including survival, symptom status, quality of life, and need for repeat hospitalization.经皮主动脉瓣置换术There are only limited clinical data on the durability of TAVR valvesup to 2 yearsin the PARTNER trial and up to 5 years in other registry ex
10、periences.Table 1. Edwards Sapien Transcatheter Heart Valve RegistriesTable 2. Medtronic CoreValve Transcatheter Heart Valve RegistriesRandomized Controlled TrialPARTNER Trial DesignA prospective, unblinded, randomized, controlled, multicenter pivotal trial evaluating the safety and effectiveness of
11、 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表3 人口基线特征Table 4. Major Outcomes at 30 Days and 1 Year in Cohort B of the PARTNER TrialTable 6. Major Outcomes at 30 Days and 1 Year in Cohort A of the PARTNER TrialTable 7. Quality of Life and Symptom Assessment in TAVR TrialsTable 9. Patient Selection: Inclusion and Exclusion Criteria in Clinical TrialsTable 9. Patient Selection: Inclusion and Exclusion Criteria in Clinical TrialsTAVR所需图像设备心脏彩超CT心脏磁共振观察主动脉瓣、瓣环、瓣环距冠状动脉的距离、升
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