Short-term clinical and echocardiographic outcomes of the novel domestic transcatheter edge-to-edge repair Neonova? system in patients with mitral regurgitation
10.3760/cma.j.cn131148-20220509-00332
- VernacularTitle:国产经导管缘对缘修复系统Neonova?治疗二尖瓣反流短期临床结局及超声评估
- Author:
Yun YANG
1
;
He LI
;
Wenqian WU
;
Xiaoke SHANG
;
Shu CHEN
;
Yucheng ZHONG
;
Manwei LIU
;
Lin HE
;
Zhenxing SUN
;
Ziming ZHANG
;
Yi ZHOU
;
Xin ZHANG
;
Nianguo DONG
;
Lingyun FANG
;
Mingxing XIE
Author Information
1. 华中科技大学同济医学院附属协和医院超声医学科 湖北省影像医学临床医学研究中心 分子影像湖北省重点实验室，武汉 430022
- Keywords:
Echocardiography;
Mitral valve regurgitation;
Transcatheter edge-to-edge repair
- From:
Chinese Journal of Ultrasonography
2023;32(1):51-59
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To investigate short-term safety, efficacy and the learning curve of this self-developed novel transcatheter valve repair system (Neonova?) in patients with mitral regurgitation, and explore the role of perioperative echocardiography.Methods:Ten patients who visited the Union Hospital of Tongji Medical College, Huazhong University of Science and Technology from June 2021 to March 2022 and met the inclusive criteria were prospectively enrolled. All the patients were at high risk of surgery with moderate to severe or severe mitral regurgitation (MR). Clamps of Neonova? were implanted under guidance of transesophageal echocardiography and digital subtraction angiography. Clinical outcomes, echocardiography indexes and learning curves of this technique were evaluated immediately after intervention, 7 d, 1 month and 3 months post-intervention.Results:The technical success rate was 100% with MR relieved in all patients immediately after intervention. The device and procedural success rates were both 90.0% with 1 patient received surgical replacement at 37 days post-intervention while the others′ reduced to mild (8/9) and moderate (1/9) MR. New York Heart Association class and the Kansas City Cardiomyopathy Questionnaire improved significantly (all P<0.001). Mean mitral valve pressure gradient didn′t increase significantly after intervention when compared with that before intervention( P=0.324), and no mitral stenosis was observed. Left ventricular end-diastolic diameter decreased significantly ( P=0.008) during follow up.Procedure duration ranged from 60 to 300 (175.8±75.2)minutes. The simple linear regression model between procedure volume and duration showed that procedure duration decreased significantly with the increase of procedure volume ( F=15.857, P=0.004). Conclusions:Neonova? implantation can improve MR severity and clinical symptoms safely and effectively. Transthoracic echocardiography and transesophageal echocardiography are essential for perioperative management of transcatheter mitral valve repair.
