Comparison on the efficacy of Chinese-made novel-designed mechanical-locked and elastic self-locked transcatheter edge-to-edge repair system in the treatment of patients with functional mitral regurgitation.
10.3760/cma.j.cn112148-20230504-00254
- Author:
Da ZHU
1
;
Shou Zheng WANG
2
;
Zhi Ling LUO
3
;
Jia Hua PAN
1
;
Ke YANG
4
;
Chun Mei XIE
4
;
Yong Yan TANG
1
;
Hong Bo YANG
1
;
Mi Er MA
1
;
Jian Bin GAO
1
;
Xiang Bin PAN
2
Author Information
1. Department of Structure Heart Center, Fuwai Yunnan Cardiovascular Hospital, Affiliated Cardiovascular Hospital of Kunming Medical University, Kunming 650102, China.
2. Department of Structure Heart Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100037, China.
3. Department of Ultrasound, Fuwai Yunnan Cardiovascular Hospital, Affiliated Cardiovascular Hospital of Kunming Medical University, Kunming 65010,China.
4. Department of Anesthesiology, Fuwai Yunnan Cardiovascular Hospital, Affiliated Cardiovascular Hospital of Kunming Medical University, Kunming 650102, China.
- Publication Type:Journal Article
- MeSH:
Humans;
Female;
Middle Aged;
Aged;
Male;
Mitral Valve Insufficiency/etiology*;
Retrospective Studies;
East Asian People;
Heart Valve Prosthesis Implantation;
Treatment Outcome;
China;
Heart Failure/etiology*;
Cardiac Catheterization
- From:
Chinese Journal of Cardiology
2023;51(8):832-837
- CountryChina
- Language:Chinese
-
Abstract:
Objective: To evaluate and compare the short-term efficacy of domestic mechanical-locked (Clip2Edge) and elastic self-locked (ValveClip) transcranial mitral valve edge-to-edge interventional repair (TEER) devices in the treatment of functional mitral regurgitant valves. Methods: In this retrospective non-randomized comparative study, patients underwent TEER procedure in Fuwai Yunnan Cardiovascular Disease Hospital from May 2022 to April 2023 for heart failure combined with moderate to severe or severe functional mitral valve were divided into Clip2Edge and ValveClip groups based on the TEER system used. Baseline, perioperative, and postoperative 30 d follow-up data were collected and compared between the two groups. The primary outcome was the success rate on the 30 d post operation, while secondary outcomes included immediate postoperative technical success rate and the incidence of all-cause mortality on the 30 d post operation, readmission rate of acute heart failure, cerebral infarction, severe bleeding, and other serious adverse events rates. Results: A total of 60 patients were enrolled, 34 patients were in the Clip2Edge group and 26 in the ValveClip group, mean age was (63.8±9.3) years, and 24 patients (40%) were female. There were no significant differences in baseline data of age, cardiac function, comorbidities, mitral regurgitation 4+(19(73%) vs. 29(85%)), the end-diastolic volume of left ventricle ((220.8±91.2) ml vs. (210.8±71.7) ml) between the two groups (all P>0.05). The technical success rate immediately after the procedure was 100%. There were no readmission of acute heart failure, death, cerebral infarction, severe bleeding, and other serious adverse events up to the 30 d follow-up. Device success rate was similar between the ValveClip group (24 cases (100%)) and the Clip2Edge group (27 cases (96%)) (P>0.05). Conclusion: Both types of novel domestic TEER devices are safe and feasible in treating patients with functional mitral regurgitation.
