Early clinical outcomes of the domestic KokaclipTM transcatheter edge-to-edge mitral valve repair system for severe degenerative mitral regurgitation: A single-arm, prospective, single-group target value clinical trial
- VernacularTitle:国产KokaclipTM经导管缘对缘二尖瓣修复系统治疗重度退行性二尖瓣关闭不全早期临床疗效的单臂、前瞻性、单组目标值临床试验
- Author:
Tong TAN
1
;
Bingqi FU
2
;
Peijian WEI
2
;
Nianjin XIE
3
;
Haozhong LIU
3
;
Xiaoyi LI
3
;
Shengwen WANG
3
;
Haijiang GUO
3
;
Jian LIU
3
;
Jimei CHEN
3
;
Jian ZHUANG
3
;
Huiming GUO
3
Author Information
1. 1. Department of Heart Surgery, Guangdong Cardiovascular Institute, Guangdong Provincial People s Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, 510080, P. R. China 2. Department of Cardiovascular Surgery, Beijing Anzhen Hospital, Capital Medical University, Beijing, 100029, P. R. China
2. 1. Department of Heart Surgery, Guangdong Cardiovascular Institute, Guangdong Provincial People s Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, 510080, P. R. China 3. Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100037, P. R. China
3. 1. Department of Heart Surgery, Guangdong Cardiovascular Institute, Guangdong Provincial People s Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, 510080, P. R. China 4. Department of Heart Surgery, Guangdong Provincial Key Laboratory of South China Structural Heart Disease, Guangzhou, 510080, P. R. China
- Publication Type:Journal Article
- Keywords:
Transcatheter edge-to-edge repair;
degenerative mitral regurgitation;
ultrasonic guidance;
clinical outcomes;
prospective study
- From:
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery
2024;31(02):269-275
- CountryChina
- Language:Chinese
-
Abstract:
Objective To summarize and analyze the preliminary clinical outcomes of the KokaclipTM transcatheter edge-to-edge mitral valve repair system for severe degenerative mitral regurgitation (DMR). Methods This study was a single-arm, prospective, single-group target value clinical trial that enrolled patients who underwent the KokaclipTM transcatheter edge-to-edge repair (TEER) system for DMR in the Department of Heart Surgery of Guangdong Provincial People's Hospital, Guangdong Cardiovascular Institute from June 2022 to January 2023. Differences in the grade of mitral regurgitation (MR) during the perioperative and follow-up periods were compared, and the incidences of adverse events such as all-cause death, thoracotomy conversion, reoperation, and severe recurrence of MR during the study period were investigated. Results The enrolled patient population consisted of 14 (50.0%) females with a mean age of 70.9±5.4 years. Twenty-eight (100.0%) patients were preoperatively diagnosed with typeⅡ DMR, with a prolapse width of 12.5 (11.0, 16.1) mm, a degree of regurgitation 4+ leading to pulmonary venous reflux, and a New York Heart Association cardiac function class≥Ⅲ. All patients completed the TEER procedure successfully, with immediate postoperative improvement of MR to 0, 1+, and 2+ grade in 2 (7.1%), 21 (75.0%), and 5 (17.9%) patients, respectively. Mitral valve gradient was 2.5 (2.0, 3.0) mm Hg. Deaths, thoracotomy conversion, or device complications such as unileaflet clamping, clip dislodgement, or leaflet injury were negative. Twenty-eight (100.0%) patients completed at least 3-month postoperative follow-up with a median follow-up time of 5.9 (3.6, 6.8) months, during which patients had a mean MR grade of 1.0+ (1.0+, 2.0+) grade and a significant improvement from preoperative values (P<0.001). There was no recurrence of ≥3+ regurgitation, pulmonary venous reflux, reoperation, new-onset mitral stenosis, or major adverse cardiovascular events. Twenty-two (78.6%) patients’ cardiac function improved to classⅠorⅡ. Conclusion The domestic KokaclipTM TEER system has shown excellent preliminary clinical results in selected DMR patients with a high safety profile and significant improvement in MR. Additional large sample volume, prospective, multicenter studies, and long-term follow-up are expected to validate the effectiveness of this system in the future.
