Early clinical outcomes of the domestic Kokaclip<sup>TM</sup> transcatheter edge-to-edge mitral valve repair system for severe degenerative mitral regurgitation: A single-arm, prospective, single-group target value clinical trial_Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Authors：

TAN Tong ^1,2 , FU Bingqi ^1,3 , WEI Peijian ^1,3 , XIE Nianjin ^1,4 , LIU Haozhong ^1,4 , LI Xiaoyi ^1,4 , WANG Shengwen ^1,4 , GUO Haijiang ^1,4 ,  LIU Jian ^1,4 , CHEN Jimei ^1,4 , ZHUANG Jian ^1,4 ,  GUO Huiming ^1,4

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;
3. Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100037, P. R. China;
4. Department of Heart Surgery, Guangdong Provincial Key Laboratory of South China Structural Heart Disease, Guangzhou, 510080, P. R. China;

Corresponding author：

LIU Jian, Email: Jameslau1984@sina.com; GUO Huiming, Email: guohuiming@gdph.org.cn

Keywords：

Transcatheter edge-to-edge repair; degenerative mitral regurgitation; ultrasonic guidance; clinical outcomes; prospective study

DOI：

10.7507/1007-4848.202304083

Video：

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Objective To summarize and analyze the preliminary clinical outcomes of the Kokaclip^TM 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 Kokaclip^TM 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 Kokaclip^TM 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.

Citation： TAN Tong, FU Bingqi, WEI Peijian, XIE Nianjin, LIU Haozhong, LI Xiaoyi, WANG Shengwen, GUO Haijiang, LIU Jian, CHEN Jimei, ZHUANG Jian, GUO Huiming. Early clinical outcomes of the domestic Kokaclip^TM transcatheter edge-to-edge mitral valve repair system for severe degenerative mitral regurgitation: A single-arm, prospective, single-group target value clinical trial. Chinese Journal of Clinical Thoracic and Cardiovascular Surgery, 2024, 31(2): 269-275. doi: 10.7507/1007-4848.202304083 Copy

1.	Coutinho GF, Antunes MJ. Current status of the treatment of degenerative mitral valve regurgitation. Rev Port Cardiol (Engl Ed), 2021, 40(4): 293-304.
2.	Head SJ, Van Leeuwen WJ, Van Mieghem NM, et al. Surgical or transcatheter mitral valve intervention: Complex disease requires complex decisions. EuroIntervention, 2014, 9(10): 1133-1135.
3.	潘文志, 周达新, 葛均波. 中国二尖瓣反流患者人群数量的估测. 中国胸心血管外科临床杂志, 2021, 28(5): 495-498.
4.	Vahanian A, Beyersdorf F, Praz F, et al. 2021 ESC/EACTS guidelines for the management of valvular heart disease. Eur Heart J, 2022, 43(7): 561-632.
5.	Stone GW, Lindenfeld J, Abraham WT, et al. Transcatheter mitral-valve repair in patients with heart failure. N Engl J Med, 2018, 379(24): 2307-2318.
6.	叶蕴青, 许海燕, 周政, 等. 中国多中心老年二尖瓣关闭不全患者临床特点、治疗现状及预后分析—中国老年瓣膜性心脏病国家注册登记研究报告. 中国分子心脏病学杂志, 2021, 21(3): 3928-3932.
7.	Dziadzko V, Dziadzko M, Medina-Inojosa JR, et al. Causes and mechanisms of isolated mitral regurgitation in the community: Clinical context and outcome. Eur Heart J, 2019, 40(27): 2194-2202.
8.	仲肇基, 刘盛. 如何提高退行性二尖瓣病变二尖瓣成形术的疗效. 中国医药, 2022, 17(9): 1291-1296.
9.	诸葛瑞琪, 侯晓沛, 齐喜玲, 等. 老年二尖瓣反流住院患者的临床特征与诊疗现状分析. 中国循环杂志, 2018, 33(3): 231-235.
10.	Coutinho GF, Antunes MJ. Mitral valve repair for degenerative mitral valve disease: Surgical approach, patient selection and long-term outcomes. Heart, 2017, 103(21): 1663-1669.
11.	Condado JA, Acquatella H, Rodriguez L, et al. Percutaneous edge-to-edge mitral valve repair: 2-year follow-up in the first human case. Catheter Cardiovasc Interv, 2006, 67(2): 323-325.
12.	Taramasso M, Maisano F, Denti P, et al. Percutaneous edge-to-edge repair in high-risk and elderly patients with degenerative mitral regurgitation: Midterm outcomes in a single-center experience. J Thorac Cardiovasc Surg, 2014, 148(6): 2743-2750.
13.	Glower DD, Kar S, Trento A, et al. Percutaneous mitral valve repair for mitral regurgitation in high-risk patients: Results of the EVERESTⅡ study. J Am Coll Cardiol, 2014, 64(2): 172-181.
14.	Feldman T, KAR S, Elmariah S, et al. Randomized comparison of percutaneous repair and surgery for mitral regurgitation: 5-year results of EVERESTⅡ. J Am Coll Cardiol, 2015, 66(25): 2844-2854.
15.	高建斌, 马米尔, 史青, 等. 新一代国产自锁式经导管二尖瓣缘对缘修复系统Kokaclip^TM首次临床应用的研究结果. 中国介入心脏病学杂志, 2022, 30(11): 808-813.
16.	中华医学会心血管病学分会. 经导管二尖瓣缘对缘修复术的中国专家共识. 中华心血管病杂志, 2022, 50(9): 853-863.
17.	Estevez-Loureiro R, Franzen O, Winter R, et al. Echocardiographic and clinical outcomes of central versus noncentral percutaneous edge-to-edge repair of degenerative mitral regurgitation. J Am Coll Cardiol, 2013, 62(25): 2370-2377.
18.	Silva I, Turgeon PY, Paradis JM, et al. Percutaneous transcatheter edge-to-edge mitral valve repair with mitraclip system in the era of G4. Structural Heart, 2023, 7(2): 100114.

1. Coutinho GF, Antunes MJ. Current status of the treatment of degenerative mitral valve regurgitation. Rev Port Cardiol (Engl Ed), 2021, 40(4): 293-304.
2. Head SJ, Van Leeuwen WJ, Van Mieghem NM, et al. Surgical or transcatheter mitral valve intervention: Complex disease requires complex decisions. EuroIntervention, 2014, 9(10): 1133-1135.
3. 潘文志, 周达新, 葛均波. 中国二尖瓣反流患者人群数量的估测. 中国胸心血管外科临床杂志, 2021, 28(5): 495-498.
4. Vahanian A, Beyersdorf F, Praz F, et al. 2021 ESC/EACTS guidelines for the management of valvular heart disease. Eur Heart J, 2022, 43(7): 561-632.
5. Stone GW, Lindenfeld J, Abraham WT, et al. Transcatheter mitral-valve repair in patients with heart failure. N Engl J Med, 2018, 379(24): 2307-2318.
6. 叶蕴青, 许海燕, 周政, 等. 中国多中心老年二尖瓣关闭不全患者临床特点、治疗现状及预后分析—中国老年瓣膜性心脏病国家注册登记研究报告. 中国分子心脏病学杂志, 2021, 21(3): 3928-3932.
7. Dziadzko V, Dziadzko M, Medina-Inojosa JR, et al. Causes and mechanisms of isolated mitral regurgitation in the community: Clinical context and outcome. Eur Heart J, 2019, 40(27): 2194-2202.
8. 仲肇基, 刘盛. 如何提高退行性二尖瓣病变二尖瓣成形术的疗效. 中国医药, 2022, 17(9): 1291-1296.
9. 诸葛瑞琪, 侯晓沛, 齐喜玲, 等. 老年二尖瓣反流住院患者的临床特征与诊疗现状分析. 中国循环杂志, 2018, 33(3): 231-235.
10. Coutinho GF, Antunes MJ. Mitral valve repair for degenerative mitral valve disease: Surgical approach, patient selection and long-term outcomes. Heart, 2017, 103(21): 1663-1669.
11. Condado JA, Acquatella H, Rodriguez L, et al. Percutaneous edge-to-edge mitral valve repair: 2-year follow-up in the first human case. Catheter Cardiovasc Interv, 2006, 67(2): 323-325.
12. Taramasso M, Maisano F, Denti P, et al. Percutaneous edge-to-edge repair in high-risk and elderly patients with degenerative mitral regurgitation: Midterm outcomes in a single-center experience. J Thorac Cardiovasc Surg, 2014, 148(6): 2743-2750.
13. Glower DD, Kar S, Trento A, et al. Percutaneous mitral valve repair for mitral regurgitation in high-risk patients: Results of the EVERESTⅡ study. J Am Coll Cardiol, 2014, 64(2): 172-181.
14. Feldman T, KAR S, Elmariah S, et al. Randomized comparison of percutaneous repair and surgery for mitral regurgitation: 5-year results of EVERESTⅡ. J Am Coll Cardiol, 2015, 66(25): 2844-2854.
15. 高建斌, 马米尔, 史青, 等. 新一代国产自锁式经导管二尖瓣缘对缘修复系统Kokaclip^TM首次临床应用的研究结果. 中国介入心脏病学杂志, 2022, 30(11): 808-813.
16. 中华医学会心血管病学分会. 经导管二尖瓣缘对缘修复术的中国专家共识. 中华心血管病杂志, 2022, 50(9): 853-863.
17. Estevez-Loureiro R, Franzen O, Winter R, et al. Echocardiographic and clinical outcomes of central versus noncentral percutaneous edge-to-edge repair of degenerative mitral regurgitation. J Am Coll Cardiol, 2013, 62(25): 2370-2377.
18. Silva I, Turgeon PY, Paradis JM, et al. Percutaneous transcatheter edge-to-edge mitral valve repair with mitraclip system in the era of G4. Structural Heart, 2023, 7(2): 100114.

Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Early clinical outcomes of the domestic Kokaclip^TM transcatheter edge-to-edge mitral valve repair system for severe degenerative mitral regurgitation: A single-arm, prospective, single-group target value clinical trial

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Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

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

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Early clinical outcomes of the domestic Kokaclip^TM transcatheter edge-to-edge mitral valve repair system for severe degenerative mitral regurgitation: A single-arm, prospective, single-group target value clinical trial