Contemporary transcatheter aortic valve replacement with third‐generation balloon‐expandable versus self‐expanding devices

Objectives

To evaluate balloon‐expandable and self‐expanding third‐generation transcatheter aortic valve replacement (TAVR) devices according to patient selection criteria and outcomes.

Background

Two competing third‐generation TAVR technologies are currently commercially available in the US. There are no published head‐to‐head comparisons of the relative performance of these two devices.

Methods

257 consecutive patients undergoing TAVR with a third‐generation balloon‐expandable (Edwards Sapien 3) or self‐expanding device (Medtronic CoreValve Evolut R) at a single US medical center were included. Choice of TAVR device was at the discretion of the multidisciplinary Heart Team. Baseline clinical characteristics, echocardiographic and CT imaging, procedural and 30‐day outcomes were prospectively collected.

Results

74 patients received a self‐expanding valve (SEV) and 183 received a balloon‐expandable valve (BEV). Patients selected for SEV were more frequently women, with lower body surface area and smaller calcified iliofemoral arteries. Three SEV patients required implantation of a second valve to successfully treat paravalvular leak. Only one BEV patient had moderate paravalvular regurgitation. There was no difference in the rate of stroke, major vascular complication or bleeding. Permanent pacemaker implantation rate was significantly higher with SEV (12.7% vs 4.7%, P = 0.49) and hospital length of stay was longer (8.3% vs 6.5%, P = 0.043), but 30‐day mortality was comparable (1.4% vs 1.6%, P = 1.00).

Conclusions

Short‐term outcomes were equivalent between the two technologies. Clinically significant paravalvular regurgitation was rare. SEV were more frequently selected in women and patients with challenging transfemoral access, but were associated with higher permanent pacemaker implantation rate and longer hospital length of stay.

     

Initial experience of a large,self‐expanding,and fully recapturable transcatheter aortic valve: The UK & Ireland Implanters’ registry

Objectives : The UK & Ireland Implanters’ registry is a multicenter registry which reports on real‐world experience with novel transcatheter heart valves. Background : The 34 mm Evolut R transcatheter aortic valve is a self‐expanding and fully recapturable transcatheter aortic valve, designed to treat patients with a large aortic annulus. Methods : Between January 2017 and April 2018, clinical, procedural and 30‐day outcome data were prospectively collected from all patients receiving the 34 mm Evolut R valve across 17 participating centers in the United Kingdom and Ireland. The primary efficacy outcome was the Valve Academic Research Consortium‐2(VARC‐2)‐defined endpoint of device success. The primary safety outcome was the VARC‐2‐defined composite endpoint of early safety at 30 days. Results : A total of 217 patients underwent attempted implant. Mean age was 79.5 ± 8.8 years and Society of Thoracic Surgeons Predicted Risk of Mortality Score 5.2% ± 3.4%. Iliofemoral access was used in 91.2% of patients. Device success was 79.7%. Mean gradient was 7.0 ± 4.6 mmHg and effective orifice area 2.0 ± 0.6 cm². Paravalvular regurgitation was more than mild in 7.2%. A new permanent pacemaker was implanted in 15.7%. Early safety was demonstrated in 91.2%. At 30 days, all‐cause mortality was 3.2%, stroke 3.7%, and major vascular complication 2.3%. Conclusions : Real‐world experience of the 34 mm Evolut R transcatheter aortic valve demonstrated acceptable procedural success, safety, valve function, and incidence of new permanent pacemaker implantation.     

A word of caution using self‐expanding transcatheter aortic valve‐frame infolding

Transcatheter aortic valve replacement has become a mainstay alternative to surgical aortic valve replacement in patients with severe aortic stenosis at high and intermediate surgical risk. Two commercially approved valves are available in the United States: balloon‐expandable and self‐expanding. We report here a rare complication of a self‐expanding Evolut PRO (Medtronic, Minneapolis, Minnesota) valve failing to expand due to nitinol frame infolding. This results in a malopposed valve with a severe paravalvular leak, even though treated successfully with balloon valvuloplasty. It is important to recognize the characteristic angiographic signature of this complication—the “straight line” sign—and how to avoid this potentially serious complication by balloon valvuloplasty or by recapture and deployment of a new valve.     

The novel echo‐guided ProGlide technique during percutaneous transfemoral transcatheter aortic valve implantation

Objectives

The aim of this study was to assess clinical benefit of the Echo‐guided ProGlide technique in patients undergoing percutaneous transfemoral transcatheter aortic valve implantation (TF‐TAVI).

Background

The efficacy of the Echo‐guided ProGlide technique during percutaneous TF‐TAVI was not previously clarified.

Methods

A total of 121 consecutive patients who underwent percutaneous TF‐TAVI at our institution between February 2014 and July 2017 were enrolled in this study. According to the introduction of this novel technique in March 2016, patients were divided into two groups (echo‐guided group who underwent TAVI from March 2016 to July 2017, n = 63; not echo‐guided group who underwent TAVI from February 2014 to February 2016, n = 58). The incidence of major vascular complications, defined per the Valve Academic Research Consortium‐2 criteria, and ProGlide complications including acute femoral artery stenosis or occlusion and bleeding requiring any intervention.

Results

The incidence of major vascular complication and ProGlide complication were significantly lower in the echo‐guided group than in not echo‐guided group (1.6% vs 17.2%, P < 0.002; 1.6% vs 15.5%, P = 0.003; respectively). Use of the Echo‐guided ProGlide technique was independently associated with prevention of ProGlide complications (odds ratio, 0.11; 95% confidential interval, 0.01‐0.76; P = 0.03).

Conclusions

This novel Echo‐guided ProGlide technique was associated with a lower rate of major vascular complications, particularly ProGlide complications during percutaneous TF‐TAVI.     

重度主动脉瓣狭窄患者经股动脉主动脉瓣膜置换术后预后的性别差异分析

【摘要】 目的 探讨重度主动脉瓣狭窄（AS）患者经股动脉主动脉瓣膜置换术（TAVR）后预后的性别差异。方法 本研究为单中心回顾性研究,连续纳入2016年01月至2020年07月在武汉亚洲心脏病医院行TAVR治疗的患者共111例,入选86例患者进行分析,按照性别分为两组,其中男性组54例,女性组32例,比较两组间基线资料、术前超声心动图特征、手术过程资料和临床预后,主要终点为术后30 d和1年随访期内全因死亡率,次要终点为院内和术后30d手术并发症发生率。结果 女性组有着更小的体表面积、股动脉动脉鞘和置入瓣膜直径,更高的主动脉瓣平均跨瓣压差;男性组则有着更高的近期吸烟（＜1年）、冠心病和球囊后扩张的比例。两组间院内和术后30 d的次要终点,包括血管并发症、出血事件、卒中、置入永久起搏器、中度及以上瓣周漏、急性肾损伤发生率差异均无统计学意义(P＞0.05),两组间均未发生心肌梗死。两组间术后30 d死亡患者共3例,其中男性组心力衰竭合并多脏器功能衰竭1例,心源性休克1例,女性组心脏原因死亡1例（具体不详）;术后1年新增死亡患者4例,其中多脏器功能衰竭1例,呼吸衰竭1例,死亡原因不详2例,均在男性组。术后30 d和1年的全因死亡率差异无统计学意义;Kaplan?Meier曲线显示,两组1年的全因死亡率差异无统计学意义 (P＞0.05)。结论 重度AS患者经股动脉TAVR治疗在不同性别之间预后相似。     

Transcatheter aortic valve implantation for high risk patients With severe aortic stenosis using the Edwards Sapien balloon‐expandable bioprosthesis: A single centre study with immediate and medium‐term outcomes

Background : Transcatheter aortic valve implantation (TCAVI) is an emerging alternative therapy to open‐heart surgery in high‐risk patients with symptomatic aortic stenosis. Methods : Between January 2007 and May 2009, 46 patients underwent TCAVI with the 23 mm or 26 mm Edwards Sapien bioprosthesis via either the transapical (TA‐AVI) or transfemoral (TF‐AVI) approach. All patients had an estimated operative mortality risk of >15%. Results : A total of 46 patients (30 TA‐AVI, 16 TF‐AVI) with a mean aortic valve area (AVA) of 0.63 ± 0.2 cm² and mean gradient of 54 ± 16 mm Hg were treated. Predicted operative mortality was 25.3% by logistic Euroscore and 8.7% by Society of Thoracic Surgeons risk score. Procedural success was 93% in the TA‐AVI group and 88% in the TF‐AVI group. There was one intraprocedural death in the TA‐AVI group. Overall 30‐day mortality was 6.5% (2‐TA‐AVI, 1‐TF‐AVI). Four patients (9.5%) died from noncardiac causes after 30 days. Successful TCAVI was associated with a significant increase in AVA from 0.6 ± 0.1 cm² to 1.6 ± 0.6 cm² in the TA‐AVI group and 0.6 ± 0.1 cm² to 1.4 ± 0.2 cm² in the TF‐AVI group at a mean follow up of 7.4 ± 4.4 and 8.3 ± 5.0 months, respectively. At discharge, there was significant improvement in AVA (P < 0.0001), transaortic mean gradient (P < 0.0001), and mitral regurgitation (P = 0.01). At medium term follow up, the valve area was maintained and there was significant improvement in NYHA class in both groups (P < 0.0001). Conclusion : At medium term follow‐up, both transcatheter approaches demonstrated good valve durability with no cardiac‐related mortality post hospital discharge. © 2009 Wiley‐Liss, Inc.     

Balloon valuloplasty prior to transcatheter valve‐in‐valve implantation in a degenerated mitroflow aortic bioprosthesis

Transcatheter valve‐in‐valve implantation is an emerging treatment option for high‐risk patients with failing aortic bioprostheses. The presence of the prosthesis stents is thought to prevent coronary artery obstruction, a known complication of transcatheter aortic valve implantation in the native aortic valve. The Sorin Mitroflow aortic bioprosthesis (Sorin Group, Saluggia, Italy) has a particular design in that the pericardial leaflets are mounted outside the valve stent. As a consequence, the pericardial leaflets of this prosthesis may be displaced well away from the stents during the deployment of transcatheter valves. This might explain why both the cases of coronary occlusion following valve‐in‐valve implantation reported to date occurred in patients with a malfunctioning Mitroflow bioprosthesis. We describe a patient with a malfunctioning 25 mm Mitroflow bioprosthesis successfully treated by percutaneous transcatheter valve‐in‐valve implantation, and discuss the role that balloon aortic valvuloplasty plays in the performance of this delicate procedure. © 2012 Wiley Periodicals, Inc.