经导管主动脉瓣置换术的现状与发展趋势

目前,尽管严重主动脉狭窄的治疗指南仍以外科手术置换(surgical aortic valve replacement,SAVR)为治疗标 准,但随着大血管外科技术的不断发展,经导管主动脉瓣置换术(transcatheter aortic valve implantation,TAVI)逐渐成为 高危和禁忌SAVR患者的常规治疗措施。近年来各瓣膜厂商,包括国内医药公司,对瓣膜技术极力地推进,使得TAVI 技术取得了显著成效,加上其并发症也得到了有效控制,TAVI有望在治疗主动脉狭窄乃至关闭不全上取代传统术 式,应用前景可观。     

Transcatheter aortic valve implantation versus surgical aortic valve replacement for severe aortic stenosis: a meta analysis

Background Transcatheter aortic valve implantation (TAVI) has emerged as the treatment choice for non-operable patients with severe symptomatic aortic stenosis (AS) and may be a good alternative to sur...     

经导管主动脉瓣膜植入与常规主动脉瓣膜置换手术在多风险因素主动脉瓣狭窄患者中的应用

［摘要］ 目的评价经导管主动脉瓣膜植入（transcatheter aortic valve implantation,TAVI）与常规主动脉瓣膜置换在高风险因素患者中应用的安全性及效果。 方法选择主动脉瓣狭窄患者80例,按手术方式分为常规组47例、小切口组18例和TAVI组15例。常规组采用常规开胸主动脉瓣膜置换手术,小切口组采用胸骨上段小切口主动脉瓣膜置换手术,TAVI组采用全身麻醉非体外循环下TAVI。比较3组患者手术效果及并发症发生情况。 结果小切口组24 h引流量明显少于常规组（P＜0.01）。常规组和小切口组阻断时间差异无统计学意义（P＞0.05）。小切口组手术时间、呼吸机辅助通气时间、重症监护室（intensive care unit,ICU）停留时间短于常规组,术中出血量少于常规组（P＜0.01）;TAVI组手术时间、呼吸机辅助通气时间、ICU停留时间短于常规组和小切口组,术中出血量少于常规组和小切口组,平均动脉压（mean artery pressure,MAP)变化值大于常规组和小切口组,住院费用多于常规组和小切口组（P＜0.05或P＜0.01）。3组并发症发生率差异无统计学意义（P＞0.05）。 结论TAVI手术在治疗高风险因素的患者中较常规主动脉瓣膜置换手术安全性高,创伤小,并发症少,恢复快,值得临床推广应用。     

Procedural results and 30-day clinical events analysis following Edwards transcatheter aortic valve implantation in 48 consecutive patients: initial experience

Background  Transcatheter aortic valve implantation (TAVI) is a rapidly evolving strategy for therapy of aortic stenosis. We presented the procedural results and analyzed the death causes of 30-day mortality and clinical events in patients who underwent TAVI with Edwards prosthetic valves in University Hospital of Caen, France.

Methods  The patients with severe aortic stenosis but at high surgical risk or inoperable were considered as candidates for TAVI. Forty-eight patients undergoing TAVI from July 2010 to September 2011 were enrolled in this registry. The Edwards prosthetic valves were solely used in this clinical trial.

Results  Overall 48 patients underwent TAVI, 28 of which accepted TAVI by trans-femoral (TF) approaches, 20 by trans-apical approaches (TA). The aortic valve area (AVA) was (0.70±0.23) cm², left ventricular ejection fraction (LVEF) was (57.4±17.6)%, Log EuroSCORE was (19.2±15.8)%, mean gradient was (47.0±16.6) mmHg. There were no significant differences between TF and TA groups in all these baseline parameters. Device success rate was 95.8%, and procedural success rate was 93.7% in total. Procedural mortality was 6.7% (3/48): two deaths in TA group (10%), and one death in TF group (3.6%). Forty-six Edwards valves were implanted: 10 Edwards Sapien and 36 Edwards XT. Procedure-related complications included cardiac tamponade in 2 cases (4.2%), acute myocardial infarction (AMI) in 1 case (2.1%), permanent pacemaker implantation in 1 case (2.1%), life-threatening and major bleeding in 3 cases; access site related major complication in 1 case, AKI stage 3 in 3 cases (6.3%), minor stroke in 1 case (2.1%). Thirty-day survival rate was 89.6%. There were 5 deaths in total (10.4%): 4 in TA group (20%) and 1 in TF group (3.6%).

Conclusion  The procedural success rate and 30-day mortality were acceptable in these high risk patients with Edwards prosthetic valves in the first 48 TAVI.

     

经主动脉途径植入主动脉支架瓣膜一例报道

经导管主动脉瓣植入术（TAVI）是治疗主动脉瓣狭窄患者的新技术,适用于无法外科手术和外科高风险的主动脉瓣狭窄患者,其常规植入途径为股动脉和心尖。该文介绍1例92岁高龄患者,经股动脉途径植入主动脉瓣失败后,改由经主动脉途径植入的成功经验。     

Perspective on transcatheter aortic valve implantation: past， present， and future

It is well recognized that any disruptive innovation in medicine looks at first unfeasible and unacceptable.It has been the case for transcatheter aortic valve implantation (TAVI) as the project appeared totally unrealistic in the early 1990s.It is quite thrilling,therefore,to observe the current expansion of this technology worldwide,20 years after the birth of the concept and 10 years after the first-in-man TAVIprocedure performed in Rouen on April 16,2002.To date,more than 80 000 patients have benefitted from TAVIworldwide and the number is consistently increasing.     

One-year results of transcatheter aortic valve implantation as an alternative treatment for severe aortic stenosis in high-risk patients

BackgroundAortic valve replacement (AVR) remains the gold standard treatment for symptomatic severe aortic stenosis (AS). For the past 10 years, transcatheter aortic valve implantation (TAVI) has been applied in patients with high surgical mortality and morbidity risks. The preliminary results of our TAVI patients are presented in this study.MethodsTen high-risk patients with severe AS, for AVR, were referred and accepted for TAVI in the 6 month period from May 2010 to October 2010. The patient age, logistic EuroSCORE, femoral arterial diameter, aorta annulus size, aorta valve area (AVA), mean aortic pressure gradient (MPG), as well as coronary angiography results were all collected. Six patients were treated via the transapical approach in March 2010, whereas the other four were treated with the transfemoral approach, according to their femoral artery diameter and arterial quality. This study focuses on the immediate, 1 month, 3 month, and 1 year results of TAVI.ResultsThe average age of the 10 patients receiving TAVI was 81.5 years. The mean calculated EuroSCORE was 28.3 ± 7.9%. The mean AVA was 0.61 ± 0.19 cm². The MPG was 48 ± 16 mmHg. The surgical technical success achieved 100%. There was no reported moderate to severe postoperative paravalvular aortic regurgitation, permanent complete atrioventricular block, major access site complication, or embolic stroke. Chronic renal failure, which necessitated permanent hemodialysis, developed in 10% of the patients. One acute myocardial infarction and one case of pneumonia developed postoperatively. The AVA was increased by 251%, whereas the MPG was decreased by 80% at the 3 month follow-up. The 30-day mortality rate was 10%. The all-cause 1-year mortality rate was 20%.ConclusionThis new technique and device requires greater caution and needs more practice to accumulate sufficient experience. The studied patients were very fragile, due to old age and multiple comorbidities. Our results are similar to findings of multicenter trials. With careful patient screening and selection, TAVI can be a promising treatment for high-risk severe AS patients.     

经心尖导管植入自膨胀式主动脉瓣支架动物实验

 目的  探讨开胸穿刺经心尖导管植入国产自膨胀式带瓣膜支架置换动物主动脉瓣的可行性和有效性。方法  自主设计酒杯状镍钛合金自膨胀支架,将新鲜的猪心包经脱细胞、防钙化等处理后裁剪成人工瓣膜,缝合在支架上,制成自膨胀式带瓣膜主动脉支架。选择健康羊8只,左侧开胸小切口暴露心尖,穿刺左心室心尖,送入加硬钢丝经左心室-升主动脉-降主动脉建立轨道,透视引导下沿加硬钢丝通过18F输送鞘管将自膨胀式带瓣膜支架送至羊主动脉瓣位置,确认正确定位后退出输送鞘管释放支架,置换动物原主动脉瓣。手术后即刻行超声和血管造影检查瓣膜工作情况。结果  1只羊因支架植入位置过高导致冠状动脉堵塞当场死亡;1只羊因为术中支架置入位置过低导致主动脉瓣大量瓣周漏,术后死亡;余6只实验羊经导管瓣膜置换术均获得成功,术后即时DSA影像、超声检查结果表明人工主动脉瓣膜植入位置理想,无明显反流及瓣周漏,人工瓣膜代替原瓣膜工作正常。结论  使用国产自膨胀式带瓣膜支架及其输送系统通过经心尖途径经导管植入置换动物主动脉瓣方法可行、有效。     

经导管主动脉瓣膜植入术的可选瓣膜植入途径

经导管主动脉瓣膜植入术（TAVI）是介入方法治疗严重主动脉瓣狭窄的一种新技术,经过十余年的发展,TAVI的效果与中期存活率与外科手术治疗效果相当。随着输送装置、支架瓣膜的改进,TAVI的适应证扩大,安全性、有效性进一步提升。本文将TAVI术中瓣膜植入途径的现状作一介绍。     

经皮导管内主动脉瓣置入术的麻醉管理

经皮导管内主动脉瓣置入术的迅速发展给麻醉医师带来了巨大的挑战,伴随着人工合成瓣膜技术逐步优化、操作者经验日渐丰富,成为越来越多外科手术高风险的主动脉狭窄患者的新选择。麻醉管理也越来越复杂且精细,需要麻醉医师掌握更多相关新知识、新技术,现就其麻醉方法的选择及其特殊性加以综述。     

单中心100例经导管主动脉瓣置换(TAVR)结果分析

目的 报道单中心100例经导管主动脉瓣置换术(transcatheteraortic valve replacement,TAVR)结果,总结相关经验。方法 连续入选2010年10月至2018年3月在我中心行TAVR的主动脉瓣狭窄患者100例,观察分析手术成功率、死亡率、术后并发症等结果。结果 患者平均年龄(78.1±6.8)岁,其中男性68例,胸外科协会(Society of Thoracic Surgeons's,STS)平均分数9.9±6.0。12例患者经颈动脉途径,87例经股动脉,1例经升主动脉。均使用自膨胀瓣膜,手术成功率97%。术中预扩张球囊平均大小(19.6±2.0) mm,后扩张球囊平均大小(21.4±2.2) mm,瓣膜植入平均深度为瓣环下(4.3±3.4) mm。术前、术后平均跨主动脉瓣压分别为(51.3±19.7) mmHg和(11.7±6.1) mmHg (P<0.001),术前、术后瓣口面积分别为(0.6±0.2) cm2和(1.7±0.5) cm2 (P<0.001)。随访30天内,死亡率为2%,中风发生率为1%,永久心脏起搏器植入率9%,TAVR术后起搏器植入组与非起搏器植入组的瓣膜植入深度分别为(7.2±3.1) mm和(4.2±3.3) mm (P=0.011)。二叶式主动脉瓣组与三叶式主动脉瓣组在并发症及血流动力学方面未见明显异常。结论 TAVR对我国主动脉瓣狭窄患者具有较高的安全性及有效性,二叶式与三叶式主动脉瓣膜的手术结果相似。TAVR永久性起搏器植入发生率较低,这与植入深度密切相关,可能与较小球囊扩张有关。     

二维超声心动图评价经导管主动脉瓣置入术后早期左心形态及收缩功能

目的 利用二维超声心动图监测并分析经导管主动脉瓣置入术（TAVI）术后早期患者心脏形态及功能状态。方法 选择2017年12月至2019年12月在我院心血管外科就诊并行TAVI的33例患者,收集患者年龄、性别、NYHA心功能分级、既往心脏外科手术史、美国胸外科医师学会（STS）评分、手术入路、并发疾病等基本资料,以及术前和术后早期（0~2个月）超声心动图检查数据。结果 33例患者中重度主动脉瓣狭窄（SAS）组20例,重度主动脉瓣反流（SAR）组8例,SAS合并SAR组（合并组）5例。术后早期SAS组1例患者2次因心律失常加重心力衰竭再次住院治疗,4例患者出现微量瓣周漏,1例患者出现大量瓣周漏;SAR组1例患者出现中度瓣周漏;合并组1例患者出现轻度瓣周漏。与术前相比,术后早期33例患者总体左心室舒张末期容积（LVEDV）、左心房容积（LAV）、最大主动脉瓣跨瓣压差（AVPG_max）均下降（P均<0.01）,主动脉瓣有效瓣口面积（AVA）增加（P<0.01）,左心室射血分数（LVEF）、室间隔厚度（IVST）、后壁厚度（PWT）均未发生明显变化（P均>0.05）;SAS组LVEF升高（P<0.05）,LAV、AVPG_max均下降（P<0.05,P<0.01）,AVA增加（P<0.01）;SAR组LVEDV、LAV均下降（P均<0.01）,IVST增加（P<0.05）;合并组LVEDV、LAV、AVPG_max均下降（P均<0.05）,AVA增加（P<0.01）。结论 对于SAS、SAR和SAS合并SAR患者,TAVI术后早期心脏逆重构、收缩功能均有不同程度改善。单纯SAR及合并SAS的高危患者可从TAVI获益。     

新型带瓣膜主动脉瓣球囊扩张支架的研制及测试

目的通过体外测试评价新型带瓣膜主动脉瓣球囊扩张支架及输送装置的各项性能,为下一步动物体内实验提供依据。方法支架材料采用钴基合金,设计成圆柱形网状结构。人工瓣膜取材于经处理的新鲜牛心包,将人工瓣膜缝合在支架上制成带瓣膜主动脉支架。使用人工心脏瓣膜脉动流测试仪和人工心脏瓣膜加速疲劳测试仪,分别对带瓣膜支架瓣叶材料脉动流和人工瓣膜耐疲劳情况进行测试。将带瓣膜支架压缩至自行研制的输送装置的球囊上,取离体羊心脏标本,经升主动脉将支架直视下置入羊主动脉瓣位置,扩张球囊释放支架,注水观察瓣膜功能。结果人工瓣膜瓣叶脉动流测试结果表明人工瓣膜启闭良好,无明显反流,符合生理需求。人工瓣膜耐疲劳测试结果表明瓣膜耐疲劳性能良好。带瓣膜支架经压缩后可通过输送鞘管送入离体羊主动脉瓣,支架释放后可牢固地置于羊主动脉瓣位置,人工瓣膜启闭功能良好。结论带瓣膜支架设计合理,性能良好,可用于动物经导管主动脉瓣置入实验。     

经导管主动脉瓣置换术治疗选择与应用进展

重度主动脉瓣狭窄是常见的心脏瓣膜疾病,外科主动脉瓣置换术是其传统的治疗方法。随着技术的不断发展,经导管主动脉瓣置换术已成为无法行外科手术或手术风险较高的严重症状性主动脉瓣狭窄患者的有效治疗手段,其适应证也在不断扩大。该文阐述经导管主动脉瓣置换术在不同人群的适应证选择、手术入路、人工瓣膜类型选择、术后治疗和康复等进展,为主动脉瓣狭窄患者的治疗提供参考。     

经导管主动脉瓣置换术中瓣中瓣技术的应用进展

 随着社会老龄化的进展,主动脉瓣疾病的患病率显著上升。目前经导管主动脉瓣置换术（transcatheter aortic valve replacement,TAVR）已成为中高危主动脉狭窄患者的首选治疗方案,且其在主动脉瓣反流患者中的应用不断增加。受到个体解剖结构、血流动力学及不同瓣膜特点的影响,部分患者在TAVR术中接受首个瓣膜植入后的效果欠佳。经导管瓣中瓣置入术在TAVR初次效果不佳患者中的应用不断增加,且多项临床研究显示其即刻效果及短中期随访效果良好。本文就TAVR术中需要瓣中瓣置入的危险因素、瓣中瓣技术的预后及技术难点作一综述。     

经股动脉球囊扩张式主动脉瓣置换术的初步经验

目的探讨经股动脉球囊扩张式主动脉瓣置换术治疗严重主动脉瓣狭窄患者的可行性。方法选取3例严重主动脉瓣钙化狭窄的患者,术前评估无法耐受传统开放手术,行经股动脉球扩式主动脉瓣置换术。结果 3例均经股动脉完成,其中1例经心尖穿刺辅助完成。3例手术全部成功,术后患者主动脉瓣功能显著改善,无并发症,无死亡。结论经股动脉球扩式主动脉瓣置换术可用于国人严重主动脉瓣狭窄患者,但在术前准备与评估、术中操作等方面提出了更高的要求。     

国人主动脉瓣狭窄主动脉根部解剖的研究

目的:随着经导管主动脉瓣置换术的发展,了解主动脉根部的解剖对于主动脉瓣瓣膜支架的选择和减少并发症是非常必要的?方法:34例主动脉瓣狭窄患者及39例正常对照行双源CT(Dual Source CT,DSCT)及经胸心脏超声(transthoracic echocardiography,TTE)检查,DSCT在斜冠状面及矢状面分别测量收缩末期及舒张末期主动脉根部各径线,瓣环直径和左室流出道直径?超声测量主动脉根部及左室流出道直径,并且和DSCT测量值对比?结果:主动脉瓣狭窄组左冠状动脉(left coronary ostia,LCO)高度?右冠状动脉(right coronary ostia,RCO)高度?冠状窦(sinus of Valsalva,SV)直径?左右冠状窦高度与对照组相比,差异无统计学意义;主动脉瓣狭窄组瓣环(aortic annulus,AA)直径?主动脉窦和升主动脉连接处(Sino-Tubular Junction,STJ)直径?升主动脉 (ascending aorta,AO) 直径?左室流出道 (left ventricular outer tract,LVOT) 直径?主动脉瓣和二尖瓣之间纤维结构(continuity fibrous,CF)距离,室间隔 (interventricular septum,IVS) 厚度明显比对照组大(P < 0.05)?主动脉瓣狭窄组及对照组收缩末期AA?SV?STJ?AO直径?IVS厚度明显比舒张末期大(P < 0.05),收缩末期LVOT直径明显比舒张末期小(P < 0.05)?主动脉瓣狭窄组及对照组AA及LVOT直径冠状面测量值均大于矢状面测量值?主动脉根部直径(AA?SV?STJ?AO)TTE测量值与DSCT测量值相比,相关性好(相关系数分别为r = 0.84,r = 0.87,r = 0.82,r = 0.82),差异均有统计学意义(P < O.05)?结论:主动脉瓣狭窄患者主动脉根部扩张?左室流出道变长扩张?室间隔变厚及冠状动脉变异较大,由于TTE的诊断作用有限,因此经导管主动脉瓣置换患者术前进行DSCT检查对于瓣膜支架的选择及减少并发症有重要意义?     

经导管人工生物主动脉瓣膜置换动物实验

目的:探索经导管人工生物主动脉瓣膜置换动物实验的可行性和安全性。方法:将自膨胀镍钛支架三叶式猪心包瓣膜装配入18F导管输送系统,在X线和超声引导下,经颈总动脉逆行性放置到8只健康的实验用绵羊主动脉瓣膜位置。植入前、后即刻进行主动脉根部及左心室造影、超声心动图检查评估植入支架瓣膜的功能及对冠脉血流灌注及二尖瓣功能等的影响。结果:6只实验动物植入支架瓣膜成形良好,无移位,冠脉血流未受影响,可见微量瓣周漏。因瓣膜位置放置不良导致2只实验动物术中死亡,其中1例因为瓣膜植入位置过深,影响到二尖瓣开放与闭合,引起急性心功能不全;另1例因为瓣膜植入位置偏高,影响到冠状动脉血流,导致急性心肌梗死和恶性心律失常。结论:经颈总动脉逆行性植入支架式主动脉生物瓣膜动物实验取得初步成功,即刻效果满意。     

不同路径行经导管主动脉瓣置入术围手术期常见并发症的meta分析

目的 系统评价不同路径经导管主动脉瓣置入术(TAVI)围手术期常见并发症的发生情况.方法 通过对PubMed、Embase、Ovid Medline数据库和效果评价文摘数据库(DARE)进行文献检索,获得已公开发表的行经心尖(TAp)、经股动脉(TF)及经升主动脉(TAo)3种路径TAVI的随机对照研究,统计各路径患者术后早期(30 d内)病死率、人工瓣膜瓣周漏、严重出血事件、大血管并发症、卒中、急性肾损伤及起搏器依赖型传导阻滞等手术相关或常见的严重并发症的发生情况,用Review Manager 5.3软件行meta分析.结果 研究共纳入22篇文献,总病例数11 530例.TAp组、TAo组患者术后早期人工瓣膜瓣周漏发生率均低于TF组[4.6％(63/1 384) vs 9.2％(400/4 366),P＜0.000 01;6.4％(33/518) vs 9.3％(331/3 541),P=0.002],而术后早期病死率均高于TF组[10.0％(271/2 711) vs4.8％ (326/6 756),P＜0.000 01;8.9％(46/518) vs 4.5％(160/3 541),P=0.002].TAp组、TAo组患者的术后早期严重出血发生率均高于TF组[8.4％(186/2 204) vs 3.9％(268/6 818),P＜0.000 01;6.5％(35/542) vs 1.4％(50/3 569),P=0.01].TAp组患者术后早期大血管并发症发生率低于TF组[2.3％(58/2 524) vs 6.5％(417/6 367),P＜0.000 01],而TAo组与TAp组、TF组相比差异均无统计学意义.3组患者的术后早期卒中发生率差异均无统计学意义(P＞0.05).TF组患者术后早期急性肾损伤发生率低于TAp组[8.3％(610/7 334) vs 22.8％(615/2 699),P＜0.000 01]和TAo组[3.1％(110/3 569) vs 12.5％(68/542),P＜0.000 01].TF组患者术后早期起搏器依赖型传导阻滞发生率高于TAo组[13.2％(472/3 569) vs 9.2％(50/542),P=0.003].结论 经TAp路径及经TF路径行TAVI路径较短,可以有效减少瓣周漏及大血管损伤的发生,具备独特的优势与潜在价值.     

Characteristics and outcomes following transcatheter aortic valve replacement in China: a report from China aortic valve transcatheter replacement registry (CARRY)

Background:The past decade has witnessed an ever-increasing momentum of transcatheter aortic valve replacement (TAVR) and a subsequent paradigm shift in the contemporary management of severe aortic stenosis (AS). We conducted a multi-centric TAVR registry based on Chinese patients (the China Aortic valve tRanscatheter Replacement registrY [CARRY]) to delineate the clinical characteristics and outcomes of Chinese patients who underwent TAVR and compare the results between different valve types in different Chinese regions.Methods:CARRY is an all-comer registry of aortic valve disease patients undergoing TAVR across China and was designed as an observational study that retrospectively included all TAVR patients at each participating site. Seven hospitals in China participated in the CARRY, and 1204 patients from April 2012 to November 2020 were included. Categorical variables were compared using the chi-squared test, and continuous variables were analyzed using a t test or analysis of variance (ANOVA) test. The Kaplan–Meier curve was used to estimate the risk of adverse events during follow-up.Results:The mean age of the patients was 73.8 ± 6.5 years and 57.2% were male. The median Society of Thoracic Surgeon-Predicted Risk of Mortality score was 6.0 (3.7–8.9). Regarding the aortic valve, the proportion of bicuspid aortic valve (BAV) was 48.5%. During the hospital stay, the stroke rate was 0.7%, and the incidence of high-degree atrioventricular block indicating permanent pacemaker implantation was 11.0%. The in-hospital all-cause mortality rate was 2.2%. After 1 year, the overall mortality rate was 4.5%. Compared to patients with tricuspid aortic valve (TAV), those with BAV had similar in-hospital complication rates, but a lower incidence of in-hospital mortality (1.4% vs. 3.3%) and 1 year mortality (2.3% vs. 5.8%).Conclusions:TAVR candidates in China were younger, higher proportion of BAV, and had lower rates of post-procedural complications and mortality than other international all-comer registries. Given the use of early generation valves in the majority of the population, patients with BAV had similar rates of complications, but lower mortality than those with TAV. These findings further propel the extension of TAVR in low-risk patients.Trial Registration:https://www.chictr.org.cn/ (No. ChiCTR2000038526).