经导管主动脉瓣膜置换术在重症主动脉瓣膜病中的临床应用

目的 评估经导管主动脉瓣置换术治疗重症主动脉瓣膜疾病患者的临床应用效果.方法 回顾性分析2018年7月至2020年6月期间广州市第一人民医院心脏大血管外科进行经导管主动脉瓣置换术(TAVR)的14例患者,其中男性7例、女性7例,平均手术年龄(69.5±7.5)岁,美国胸外科医师协会STS平均评分(14.1±6.2)％,...     

A Case of Late Presenting Unicuspid Aortic Valve in a 62‐Year‐Old Female

We describe the case of a 62‐year‐old female presenting with new onset progressive dyspnea on exertion and a new diagnosis of aortic stenosis. Transesophageal echocardiography showed fusion of the aortic valve leaflets suspicious for bicuspid aortic valve with dilated ascending aorta. Surgical replacement of the valve revealed a unicuspid aortic valve with one true commissure at the level of the left and noncoronary cusps. The case is supported by clinical, echocardiographic and angiographic imaging and discussion of current imaging modalities used in diagnosis of aortic valve pathology.     

Transcatheter Aortic Valve Replacement in Bicuspid Aortic Stenosis Using Lotus Valve System

Bicuspid aortic stenosis (BAS) has been excluded in clinical trials on transcatheter aortic valve replacement (TAVR) due to the presumed uneven expansion of the aortic prosthesis, leading to significant paravalvular regurgitation (PVR). There is no transcatheter heart valve (THV) commercially approved for treating BAS. The Lotus Valve System mitigates PVR by possessing an adaptive seal and being fully re‐positionable. The latter is also important in preventing embolization, as the location of prosthesis fixation in BAS could be variable due to the presence of less expandable raphe. We report our early experience with the Lotus Valve System in three consecutive TAVR for BAS. They all provide good clinical and hemodynamic results without significant PVR. We conclude that the use of Lotus Valve System for treating BAS is feasible and safe, and may have advantages over the previous generation TAVR systems. © 2016 Wiley Periodicals, Inc.     

Transcatheter Aortic Valve Replacement for Severe Symptomatic Aortic Stenosis Using a Repositionable Valve System : 30-Day Primary Endpoint Results From the REPRISE II Study

Background

Transcatheter aortic valve replacement provides results comparable to those of surgery in patients at high surgical risk, but complications can impact long-term outcomes. The Lotus valve, designed to improve upon earlier devices, is fully repositionable and retrievable, with a unique seal to minimize paravalvular regurgitation (PVR).

Objectives

The prospective, single-arm, multicenter REPRISE II study (REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System: Evaluation of Safety and Performance) evaluated the transcatheter valve system for treatment of severe symptomatic calcific aortic valve stenosis.

Methods

Patients (n = 120; aortic annulus 19 to 27 mm) considered by a multidisciplinary heart team to be at high surgical risk received the valve transfemorally. The primary device performance endpoint, 30-day mean pressure gradient, was assessed by an independent echocardiographic core laboratory and compared with a pre-specified performance goal. The primary safety endpoint was 30-day mortality. Secondary endpoints included safety/effectiveness metrics per Valve Academic Research Consortium criteria.

Results

Mean age was 84.4 years, 57% of the patients were female, and 76% were New York Heart Association functional class III/IV. Mean aortic valve area was 0.7 ± 0.2 cm². The valve was successfully implanted in all patients, with no cases of valve embolization, ectopic valve deployment, or additional valve implantation. All repositioning (n = 26) and retrieval (n = 6) attempts were successful; 34 patients (28.6%) received a permanent pacemaker. The primary device performance endpoint was met, because the mean gradient improved from 46.4 ± 15.0 mm Hg to 11.5 ± 5.2 mm Hg. At 30 days, the mortality rate was 4.2%, and the rate of disabling stroke was 1.7%; 1 (1.0%) patient had moderate PVR, whereas none had severe PVR.

Conclusions

REPRISE II demonstrates the safety and effectiveness of the Lotus valve in patients with severe aortic stenosis who are at high surgical risk. The valve could be positioned successfully with minimal PVR. (REPRISE II: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System - Evaluation of Safety and Performance; NCT01627691)