Recent advances in transcatheter aortic valve replacement for high-risk patients

Aortic stenosis is the most common valvular heart disease of old age. Patients with severe aortic stenosis who develop symptoms have a very poor prognosis without valve intervention. Surgical aortic valve replacement has historically been the only treatment option for these patients. However a significant minority are considered inoperable or at high surgical risk and therefore are refused or decline surgery. In recent years, transcatheter aortic valve replacement has emerged as an alternative treatment option in these high-risk patients. The aim of this review is to summarize the current role of transcatheter aortic valve replacement in contemporary clinical practice including recent advances in technological and procedural aspects and then discuss future directions.     

超声心动图在经导管主动脉瓣置换术前评估与术后随访中的应用价值

目的探讨超声心动图在评估经导管主动脉瓣置换（TAVR）术前与术后心脏结构和功能改变中的应用价值。 方法回顾性选取2014年9月至2019年7月在复旦大学附属中山医院心内科行TAVR的重度主动脉瓣狭窄（SAS）患者47例。所有患者均于术前及术后6个月行经胸超声心动图检查并记录常规超声心动图参数和主动脉瓣相关参数,包括左心室收缩末期内径（LVESD）、左心室舒张末期内径（LVEDD）、室间隔厚度（IVST）、后壁厚度（PWT）、肺动脉收缩压（PASP）、主动脉瓣最大跨瓣压差（AVPGmax）、主动脉瓣平均跨瓣压差（AVPGmean）、主动脉瓣有效瓣口面积（AVA）、左心室射血分数（LVEF）、主动脉根部内径（AORD）、左心房内径（LAD）,分析TAVR术前与术后的超声心动图参数变化。 结果与术前相比,术后47例患者的LVESD、IVST、PWT、PASP、AVPGmax、AVPGmean均明显减小,差异均有统计学意义（P均＜0.05）;AVA和LVEF均明显变大,差异均有统计学意义（P均＜0.05）。术后合并二尖瓣反流中度及以上或三尖瓣反流中度及以上的患者较术前明显减少（8例vs 3例,7例vs 2例）。 结论TAVR可纠正主动脉瓣狭窄,改善患者心功能。超声心动图相关参数有助于TAVR术后人工瓣膜及患者心脏结构功能的随访评估。     

经导管主动脉瓣置入术中的护理

目的分析总结经导管主动脉瓣置入的术中护理要点,以指导临床术中护理。方法回顾性分析2012年4月-5月新开展经股动脉逆行法经导管主动脉瓣置入术3例患者的临床资料。术前备齐手术用物及急救药品、术中协助患者正确体位,准确使用临时起搏器、除颤仪、认真做好病情及并发症观察和护理,总结术中临床护理方法。结果经导管主动脉瓣置入手术顺利成功,术中护理效果满意,无因物品或药品准备不齐及护理不当而影响手术进程、造成患者意外损伤及并发症发生。结论经导管主动脉瓣置入术,术前备齐相应的导管导丝,术中操作规范细致、及时、准确传递用物、认真进行临床观察和护理,手术顺利、成功无不良事件发生及并发症发生。     

First-in-man implantation of the retrievable and repositionable VenusA-Plus valve

BACKGROUND: No retrievable and repositionable second generation transcatheter aortic valve is available in China. Here, we report the first-in-man implantation of the retrievable and repositionable VenusA-Plus valve.METHODS: A 76-year-old patient with symptomatic severe aortic stenosis and high surgical risk (STS 13.8%) was recommended for transcatheter aortic valve replacement (TAVR) by heart valve team. Type 0 bicuspid aortic valve with asymmetric calcification was identified by dual source computed tomography, and the unfavorable anatomies increased the possibility of malposition and paravalvular leakage during TAVR. Therefore, we used the retrievable and repositionable VenusA-Plus valve for the patient.RESULTS: Transfemoral TAVR was performed under local anesthesia with sedation, and a 26-mm VenusA-Plus valve was successfully implanted. No transvalvular pressure gradient and trace paravalvular leakage were found.CONCLUSION: The successful first-in-man implantation indicates the retrievable and repositionable VenusA-Plus valve is feasible in complicated TAVR cases such as bicuspid aortic valve.     

经导管主动脉瓣置换术后肺动脉压力的变化

目的应用超声心动图评估重度主动脉瓣狭窄患者经导管主动脉瓣置换(TAVI)术后肺动脉压力(PASP)的变化。方法入选94例重度主动脉瓣狭窄患者,均成功完成TAVI手术。根据术前PASP分为两组,无肺动脉高压组(PASP<40mmHg)和肺动脉高压组(PASP≥40mmHg)。结果TAVI术后,无肺动脉高压组和肺动脉高压组PASP均降低。肺动脉高压组具有更小的主动脉瓣面积[(0.58±0.16vs 0.67±0.16)cm^2,P=0.014],更高的主动脉瓣平均跨瓣压差[(60.8±17.3vs 53.9±17.2)mmHg,P=0.035],中度以上二尖瓣反流[(11.6vs 3.9)%,P<0.001]和中度以上三尖瓣反流[(13.9vs 1.9)%,P<0.001]发生率更高。结论TAVI术后1年,肺动脉压力明显降低。     

Ascending aortic dilatation rate after transcatheter aortic valve replacement in patients with bicuspid and tricuspid aortic stenosis: A multidetector computed tomography follow-up study

BACKGROUND: Current data is lacking about the progression of ascending aortic dilatation after transcatheter aortic valve replacement (TAVR) in aortic stenosis (AS) patients with bicuspid aortic valve (BAV) and tricuspid aortic valve (TAV). This study aims to assess the ascending aortic dilatation rate (mm/year) after TAVR in patients with BAV versus TAV using a multidetector computed tomography (MDCT) follow-up and to determine the predictors of ascending aortic dilatation rate.METHODS: Severe AS patients undergoing TAVR from March 2013 to March 2018 at our center with MDCT follow-ups were included. BAV and TAV were identified using baseline MDCT. Baseline and follow-up MDCT images were analyzed, and the diameters of ascending aorta were measured. Study end point is ascending aortic dilatation rate (mm/year). Furthermore, factors predicting ascending aortic dilatation rate were also investigated.RESULTS: Two hundred and eight patients were included, comprised of 86 BAV and 122 TAV patients. Five, 4, 3, 2, and 1-year MDCT follow-ups were achieved in 7, 9, 30, 46, and 116 patients. The ascending aortic diameter was significantly increased after TAVR in both BAV group (43.7±4.4 mm vs. 44.0±4.5 mm; P<0.001) and TAV group (39.1±4.8 mm vs. 39.7±5.1 mm; P<0.001). However, no difference of ascending aortic dilatation rate was found between BAV and TAV groups (0.2±0.8 mm/year vs. 0.3±0.8 mm/year, P=0.592). Multivariate linear regression revealed paravalvular leakage (PVL) grade was independently associated with ascending aortic dilatation rate in the whole population and BAV group, but not TAV group. No aortic events occurred during follow-ups.CONCLUSION: Ascending aortic size continues to grow after TAVR in BAV patients, but the dilatation rate is mild and comparable to that of TAV patients. PVL grade is associated with ascending aortic dilatation rate in BAV patients post-TAVR.     

超声心动图在二叶式主动脉瓣及其并发症诊治中的应用价值

目的探讨超声心动图在二叶式主动脉瓣(BAV)及其相关并发症诊治中的应用价值。 方法研究对象为2017年1月至10月于复旦大学附属中山医院心脏超声诊断科行超声心动图检查并诊断为BAV的患者,共120例,回顾性分析其超声及临床特点。选取孤立性主动脉瓣狭窄(AS)患者35例,依据美国心脏协会(AHA)/美国心脏病学会(ACC)标准,以平均跨瓣压差为标准分为轻度AS(<20 mmHg)(1 mmHg＝0.133 kPa)6例,中度AS(20～39 mmHg)17例,和重度AS(≥40 mmHg)12例,并比较BAV合并轻中度AS患者与合并重度AS患者的临床及超声特征。 结果120例BAV患者年龄为18～82岁,男性75例,平均年龄为(51.11±15.46)岁;女性45例,平均年龄为(55.84±13.81)岁,男女患者之间年龄差异无统计学意义(t＝－1.69,P>0.05)。19例(15.8%)患者为单纯BAV而无相关并发症,101例(84.2%)患者均存在不同程度的并发症。35例(29.2%)并发AS,平均年龄为(60.17±13.54)岁,16例(13.3%)并发主动脉瓣反流(AR),平均年龄为(46.44±15.28)岁,并发AR者年龄小于并发AS者(t＝－3.23,P<0.05)。30例患者(25.0%)并发升主动脉扩张,平均年龄(54.83±10.11)岁;另有20例患者(16.7%)同时合并1种及以上并发症。共有27例患者(22.5%)接受手术治疗;12例合并重度AS的患者中有9例接受手术治疗,其中1例为经导管主动脉瓣置换术(TAVI)。并发重度AS者室间隔厚度[(12.80±2.20)mm]及左室后壁厚度[(11.90±1.97)mm]较轻中度AS者增厚[(9.96±1.40)mm,(9.30±1.02)mm; t＝－4.49,Z＝－3.39,均P<0.05]。 结论BAV合并各种并发症的患者比例高,合并严重并发症而需接受外科或心脏介入手术治疗的患者比例亦高,超声心动图对这部分患者有极大的监测价值。     

Ten-year experience with transcatheter and surgical aortic valve replacement in Finland

Aim: We investigated the outcomes of transcatheter (TAVR) and surgical aortic valve replacement (SAVR) in Finland during the last decade.

Methods: The nationwide FinnValve registry included data from 6463 patients who underwent TAVR or SAVR with a bioprosthesis for aortic stenosis from 2008 to 2017.

Results: The annual number of treated patients increased three-fold during the study period. Thirty-day mortality declined from 4.8% to 1.2% for TAVR (p?=?.011) and from 4.1% to 1.8% for SAVR (p?=?.048). Two-year survival improved from 71.4% to 83.9% for TAVR (p?<?.001) and from 87.2% to 91.6% for SAVR (p?=?.006). During the study period, a significant reduction in moderate-to-severe paravalvular regurgitation was observed among TAVR patients and a reduction of the rate of acute kidney injury was observed among both SAVR and TAVR patients. Similarly, the rate of red blood cell transfusion and severe bleeding decreased significantly among SAVR and TAVR patients. Hospital stay declined from 10.4?±?8.4 to 3.7?±?3.4 days after TAVR (p?<?.001) and from 9.0?±?5.9 to 7.8?±?5.1 days after SAVR (p?<?.001).

Conclusions: In Finland, the introduction of TAVR has led to an increase in the invasive treatment of severe aortic stenosis, which was accompanied by improved early outcomes after both SAVR and TAVR.

Clinical Trial Registration: ClinicalTrials.gov Identifier: NCT03385915

• Key Messages

• This study demonstrated that the introduction of transcatheter aortic valve replacement has led to its widespread use as an invasive treatment for severe aortic stenosis.

• Early and 2-year survival after transcatheter and surgical aortic valve replacement has improved during past decade.

• Transcatheter aortic valve replacement has fulfilled its previously unmet clinical needs and has surpassed surgical aortic valve replacement as the most common invasive treatment for aortic stenosis.

     

Modular aortic valve prosthesis for transcatheter aortic valve implantation: a novel concept with a new implantation method

Transcatheter aortic valve implantation (TAVI) is a relatively new medical intervention. Research on dedicated TAVI devices is an exciting and dynamic field to be explored by professionals involved in technological innovation. The authors describe in this article the first engineering concept and part of the US Patent of a new valve prosthesis. Divided into two pieces to be separately implanted using a single catheter by means of an innovative technique, this device aims at reducing prosthesis and delivery catheter profile. Miniaturization of the valve and delivery system is probably the best solution to reduce the morbidity and mortality that derive from vascular complications associated with TAVI.     

Transcatheter aortic valve implantation in a 54-year-old patient with aggressive HIV

We report a case of a 54-year-old patient who was denied surgical replacement for severe aortic stenosis because of complicated acquired immunodeficiency syndrome and who successfully underwent transcatheter aortic valve implantation at our institution.     

经心尖途径经导管主动脉瓣置换术救治单纯性主动脉瓣重度反流1例

目的 探讨经心尖途径经导管主动脉瓣置换术治疗单纯性主动脉瓣关闭不全的可行性.方法 回顾性分析2016年9月8日浙江大学医学院附属第二医院心脏中心开展的浙江省首例经心尖途径经导管主动脉瓣置换术的术前评估、术中操作以及患者术后情况.结果 患者严格进行术前评估,术中行全身麻醉、气管插管,透视下定位后第五肋间小切口进胸,打开心包,选择心尖裸区预置荷包,穿刺后导入超滑泥鳅导丝跨过主动脉瓣到达降主动脉,导入J-Valve输送系统逐步释放,经食道超声心动图评估主动脉瓣反流从术前的大量到瓣膜释放后无反流,撤出瓣膜输送系统,手术成功结束.术后患者症状明显缓解,出现Ⅰ度房室传导阻滞,未发生死亡、心肌梗死、心包填塞、动脉夹层等并发症.结论 经心尖途径经导管主动脉瓣置换术是安全可行的,患者的远期预后还有待进一步观察.     

Repeat Pregnancy after Prior Aortic Valve-in-Valve Replacement: A Cautionary Tale

Transcatheter aortic valve replacement (TAVR) within a severely stenotic native aortic valve or previously placed surgical biologic aortic valve replacement (SAVR) is a rare occurrence in pregnant patients. The short- and long-term procedural outcomes for future pregnancies in these women or any woman of child bearing age who have received prior TAVR or TAVR in SAVR, are unknown. We describe the first result of a repeat pregnancy outcome in a woman with a history of prior TAVR in SAVR. Both maternal and fetal outcomes were favorable, but maternal cardiac complications observed in the third trimester emphasize our concerns regarding risk for cardiac complications in subsequent pregnancies in patients with a prior TAVR in SAVR. Despite the maternal complications that occurred during repeat pregnancy in this patient, a successful pregnancy outcome reaffirms our recommendation to utilize a multidisciplinary team for pregnancy management in patients with prior TAVR or TAVR in SAVR and to help in the management of any cardiac complications that may occur during or shortly after pregnancy.     

A case of unicuspid aortic valve associated with a single coronary artery and ventricular septal defect

The patient was a 26-year-old man who had undergone patch closure of a ventricular septal defect at 2 years of age. After this surgery, his condition was satisfactory until he visited our hospital for treatment of paroxysmal supraventricular tachycardia in November 2000. Echocardiography revealed moderate to severe aortic valve regurgitation and dilatation of the left ventricle and ascending aorta. These echocardiographic abnormalities were attributed to a bicuspid aortic valve. Coronary angiography suggested the presence of a single coronary artery originating from the left Valsalva sinus. We performed Bentall’s operation in January 2003. The intraoperative findings revealed that the aortic valve consisted of an extensively calcified single cusp, and there was a single coronary artery originating from the left Valsalva sinus. Because adult patients with a unicuspid aortic valve are rare, and no cases of unicuspid aortic valve associated with a single coronary artery have been reported, we herein report this case with a review of the literature.This paper was presented at the 19th meeting of the Chubu Chapter of the Japan Society of Ultrasonics in Medicine.     

二维、三维经食管超声心动图在经导管主动脉瓣植入术中的应用价值

目的探讨二维、三维经食管超声心动图在经导管主动脉瓣植入术（TAVI）中的应用价值。 方法对2010年5月至2015年10月在复旦大学附属中山医院行TAVI的11例重度主动脉瓣狭窄[主动脉瓣狭窄口面积<1.0 cm²,主动脉瓣口最大流速>4 m/s,平均跨瓣压差>40 mmHg（1 mmHg=0.133 kPa）]和1例人工生物主动脉瓣中重度反流患者术前均行常规经胸超声心动图检查及二维、三维经食管超声心动图检查（2DTEE、3DTEE）,术中二维、三维经食管超声心动图监测,术后常规经胸超声心动图随访。采用Pearson相关分析分析3DTEE与计算机断层扫描（MDCT）评价主动脉瓣环最大值、最小值、瓣环面积以及狭窄口面积的相关性及3DTEE、MDCT与连续性方程评价狭窄口面积的相关性。 结果所有患者均成功植入人工生物主动脉瓣,其中1例患者术中发现心脏压塞合并升主动脉夹层分离,经心包穿刺以及升主动脉夹层分离保守治疗3 d后突发心脏压塞死亡。所有患者MDCT与3DTEE评价主动脉瓣环最大径、最小径、瓣环面积及狭窄口面积的相关性均较好（r=0.98、0.97、0.97、0.99,P均<0.01）;术前连续性方程测量的主动脉狭窄口面积与MDCT及3DTEE评价结果的相关性均很好（r值均为0.99,P均<0.01）。 结论2DTEE、3DTEE能快速、准确地定量主动脉瓣环的大小及评价主动脉的解剖结构,能实时引导和监测经导管主动脉瓣植入及其并发症。     

多层螺旋CT在经导管主动脉瓣植入术中的应用

近年来,经导管主动脉瓣植入术（TAVI）为临床治疗外科手术禁忌的重度高危主动脉瓣狭窄提供了新的选择。治疗前全方位评估患者心脏和大血管的解剖有助于选择合适的TAVI手术方式、降低手术风险。MSCT具有高时间分辨率、高空间分辨率及单次即可完成大范围覆盖扫描等优点,可为TAVI提供更全面的信息。本文对MSCT在TAVI术前评估及术后随访中的应用予以综述。     

超声心动图评价二瓣化主动脉瓣瓣膜功能

目的 探讨超声心动图在二瓣化主动脉瓣病理生理进展评价中的应用,分析二瓣化主动脉瓣各年龄瓣膜病变的程度.方法 回顾性分析135例二瓣化主动脉瓣患者超声资料及病例资料,结合临床资料分析患者病程进展中瓣膜功能的变化.结果 二瓣化主动脉瓣关闭不全最常见,本组资料中为68例(50%),单纯狭窄仅19例(14%).狭窄并关闭不全者29例(22%),瓣膜功能正常者19例(14%).各年龄组内主动脉瓣病变均以关闭不全多见.病程晚期的手术患者各年龄组内主动脉病变亦均以关闭不全为主.结论 超声心动图能对主动脉瓣的病变作出早期诊断.二瓣化主动脉瓣最常见的瓣膜病变是主动脉瓣关闭不全.     

Towards real-time cardiovascular magnetic resonance guided transarterial CoreValve implantation: in vivo evaluation in swine

Background

Real-time cardiovascular magnetic resonance (rtCMR) is considered attractive for guiding TAVI. Owing to an unlimited scan plane orientation and an unsurpassed soft-tissue contrast with simultaneous device visualization, rtCMR is presumed to allow safe device navigation and to offer optimal orientation for precise axial positioning. We sought to evaluate the preclinical feasibility of rtCMR-guided transarterial aortic valve implatation (TAVI) using the nitinol-based Medtronic CoreValve bioprosthesis.

Methods

rtCMR-guided transfemoral (n = 2) and transsubclavian (n = 6) TAVI was performed in 8 swine using the original CoreValve prosthesis and a modified, CMR-compatible delivery catheter without ferromagnetic components.

Results

rtCMR using TrueFISP sequences provided reliable imaging guidance during TAVI, which was successful in 6 swine. One transfemoral attempt failed due to unsuccessful aortic arch passage and one pericardial tamponade with subsequent death occurred as a result of ventricular perforation by the device tip due to an operating error, this complication being detected without delay by rtCMR. rtCMR allowed for a detailed, simultaneous visualization of the delivery system with the mounted stent-valve and the surrounding anatomy, resulting in improved visualization during navigation through the vasculature, passage of the aortic valve, and during placement and deployment of the stent-valve. Post-interventional success could be confirmed using ECG-triggered time-resolved cine-TrueFISP and flow-sensitive phase-contrast sequences. Intended valve position was confirmed by ex-vivo histology.

Conclusions

Our study shows that rtCMR-guided TAVI using the commercial CoreValve prosthesis in conjunction with a modified delivery system is feasible in swine, allowing improved procedural guidance including immediate detection of complications and direct functional assessment with reduction of radiation and omission of contrast media.     

TAVR术后传导阻滞及起搏器植入的预测因子研究进展

主动脉瓣狭窄(AS)是由先天或后天因素所引起的瓣膜结构改变,其发病率随着年龄的增长而增加,在80岁以上人群中患病率可达到10%左右,其中严重主动脉瓣狭窄导致的猝死每年发生率约为 1%[1]。经导管主动瓣膜置换术 (TAVR)是一种安全可行的重度AS微创治疗方法,自2011年FDA首次获批应用于无法进行外科手术治疗的重度AS患者,其适应症不断拓展至中低手术风险人群的治疗。人工瓣膜的置入压迫位于主动脉根部的房室传导系统,导致术后心脏传导异常的发生,永久起搏器的植入(PPMI)是其治疗手段。TAVR术后PPMI与患者预后密切相关。因此,本文对TAVR术后传导功能障碍发生及PPMI进行综述。     

Left ventricular reverse remodeling after transcatheter aortic valve implantation: a cardiovascular magnetic resonance study

Background

In patients with severe aortic stenosis, left ventricular hypertrophy is associated with increased myocardial stiffness and dysfunction linked to cardiac morbidity and mortality. We aimed at systematically investigating the degree of left ventricular mass regression and changes in left ventricular function six months after transcatheter aortic valve implantation (TAVI) by cardiovascular magnetic resonance (CMR).

Methods

Left ventricular mass indexed to body surface area (LVMi), end diastolic volume indexed to body surface area (LVEDVi), left ventricular ejection fraction (LVEF) and stroke volume (SV) were investigated by CMR before and six months after TAVI in patients with severe aortic stenosis and contraindications for surgical aortic valve replacement.

Results

Twenty-sevent patients had paired CMR at baseline and at 6-month follow-up (N=27), with a mean age of 80.7±5.2 years. LVMi decreased from 84.5±25.2 g/m² at baseline to 69.4±18.4 g/m² at six months follow-up (P<0.001). LVEDVi (87.2±30.1 ml /m²vs 86.4±22.3 ml/m²; P=0.84), LVEF (61.5±14.5% vs 65.1±7.2%, P=0.08) and SV (89.2±22 ml vs 94.7±26.5 ml; P=0.25) did not change significantly.

Conclusions

Based on CMR, significant left ventricular reverse remodeling occurs six months after TAVI.     

孤立性主动脉瓣感染性心内膜炎的治疗

目的：根据孤立性主动脉瓣感染性心内膜炎的特点,确定及早换瓣手术在其治疗中的重要地位。方法：将３３例未及时行主动脉瓣换瓣术的孤立性主动脉瓣感染性心内膜炎患者作为对照组,１１例急诊手术者为治疗组,比较其疗效及预后。结果：急诊行主动脉瓣换瓣术者成功率（８１．８％）,随访６个月～５年,均尚存活,且无一例再发感染,存活率明显高于未及时换瓣者（病情好转６例出院后随访２年内均死亡）。结论：孤立性主动脉瓣感染性心内膜炎急诊手术是挽救患者生命的唯一途径。准确地掌握手术适应证,合理应用抗生素,及时纠正心力衰竭是保证手术成功、获得良好预后的关键。