Jian&#039;an Wang; Xianbao Liu; Zhaoxia Pu; Mao Chen; Zhenfei Fang; Jun Jin; Jianzhen Dong; Yansong Guo; Biao Cheng; Jiancheng Xiu; Jianfang Luo; Yida Tang; Yan Wang; Xiaomen Chen; Gejun Zhang; Yibing Shao; Guangyuan Song; Lang Hong; Hong Jiang; Yangqin Wu; Yiqiang Yuan; Lianglong Chen; Ben He; Jingfeng Wang; Kai Xu; Yining Yang; Daxin Zhou; Qi Zhang; Yi Li; Kangmu Ma; Yat-yin Lam; Yaling Han; Junbo Ge; D. Scott Lim; for the DRAGONFLYDMR Pivotal Trial Investigators

doi:10.4244/EIJ-D-23-00361

The Official Journal of EuroPCR and the European Association of Percutaneous Cardiovascular Interventions (EAPCI)

Clinical research

DOI: 10.4244/EIJ-D-23-00361

Safety and efficacy of the DragonFly system for transcatheter valve repair of degenerative mitral regurgitation: one-year results of the DRAGONFLY-DMR trial

Jian'an Wang¹, MD, PhD; Xianbao Liu¹, MD, PhD; Zhaoxia Pu¹, MD; Mao Chen², MD, PhD; Zhenfei Fang³, MD, PhD; Jun Jin⁴, MD; Jianzhen Dong⁵, MD, PhD; Yansong Guo⁶, MD, PhD; Biao Cheng⁷, MD; Jiancheng Xiu⁸, MD, PhD; Jianfang Luo⁹, MD; Yida Tang¹⁰, MD, PhD; Yan Wang¹¹, MD, PhD; Xiaomen Chen¹², MD, PhD; Gejun Zhang¹³, MD, PhD; Yibing Shao¹⁴, MD, PhD; Guangyuan Song¹⁵, MD, PhD; Lang Hong¹⁶, MD; Hong Jiang¹⁷, MD, PhD; Yangqin Wu¹⁸, MD, PhD; Yiqiang Yuan¹⁹, MD; Lianglong Chen²⁰, MD, PhD; Ben He²¹, MD, PhD; Jingfeng Wang²², MD, PhD; Kai Xu²³, MD; Yining Yang²⁴, MD, PhD; Daxin Zhou²⁵, MD, PhD; Qi Zhang²⁶, MD, PhD; Yi Li²⁷, MD; Kangmu Ma²⁸, MD, PhD; Yat-Yin Lam²⁹, MD; Yaling Han²³, MD, PhD; Junbo Ge²⁵, MD, PhD; D. Scott Lim³⁰, MD; for the DRAGONFLYDMR Pivotal Trial Investigators

1. Department of Cardiology, Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China; 2. Department of Cardiology, West China Hospital, Sichuan University, Chengdu, China; 3. Department of Cardiovascular Medicine, The Second Xiangya Hospital, Central South University, Changsha, China; 4. Department of Cardiology, The Second Affiliated Hospital, Army Medical University, Chongqing, China; 5. Department of Cardiology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China; 6. Department of Cardiology, Fujian Provincial Hospital, Fuzhou, China; 7. Department of Cardiology, Sichuan Academy of Medical Sciences and Sichuan Provincial People’s Hospital, Chengdu, China; 8. Department of Cardiology, Nanfang Hospital, Southern Medical University, Guangzhou, China; 9. Department of Cardiology, Guangdong Provincial People’s Hospital, Guangzhou, China and Guangdong Academy of Medical Sciences, Guangzhou, China; 10. Department of Cardiology and Institute of Vascular Medicine, Peking University Third Hospital, Beijing, China; 11. Department of Medicine, Xiamen University Cardiovascular Hospital, Xiamen, China; 12. Cardiology Center, Ningbo First Hospital, Ningbo, China; 13. Department of Cardiology, Fuwai Cardiovascular Hospital of Yunnan Province, Kunming, China; 14. Department of Cardiology, Qingdao Municipal Hospital, Qingdao, China; 15. Interventional Center of Valvular Heart Disease, Beijing Anzhen Hospital, Capital Medical University, Beijing, China; 16. Department of Cardiology, Jiangxi Provincial People’s Hospital, Nanchang, China and The First Affiliated Hospital of Nanchang Medical College, Nanchang, China; 17. Department of Cardiology, Renmin Hospital of Wuhan University, Wuhan, China; 18. Department of Cardiovascular Medicine, The Second Affiliated Hospital of Nanchang University, Nanchang, China; 19. Department of Cardiology, Henan Chest Hospital, Zhengzhou, China; 20. Department of Cardiology, Union Hospital, Fujian Medical University, Fuzhou, China; 21. Department of Cardiology, Shanghai Chest Hospital, Shanghai, China and Shanghai Jiao Tong University, Shanghai, China; 22. Department of Cardiology, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Guangzhou, China; 23. Department of Cardiology, General Hospital of the Northern Theater of the Chinese People’s Liberation Army, Shenyang, China; 24. Department of Cardiology, The First Affiliated Hospital, Xinjiang Medical University, Urumqi, China; 25. Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai, China; 26. Department of Cardiology, Shanghai East Hospital, Shanghai, China and Tongji University, Shanghai, China; 27. The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China; 28. Valgen Medtech, Hangzhou, China; 29. Hong Kong Asia Heart Centre, Canossa Hospital, Hong Kong, China; 30. Department of Medicine, University of Virginia Health System Hospital, Charlottesville, VA, USA

Abstract

BACKGROUND: Severe degenerative mitral regurgitation (DMR) can cause a poor prognosis if left untreated. For patients considered at prohibitive surgical risk, transcatheter edge-to-edge repair (TEER) has become an accepted alternative therapy. The DragonFly transcatheter valve repair system is an innovative evolution of the mitral TEER device family to treat DMR.

AIMS: Herein we report on the DRAGONFLY-DMR trial (ClinicalTrials.gov: NCT04734756), which was a prospective, single-arm, multicentre study on the safety and effectiveness of the DragonFly system.

METHODS: A total of 120 eligible patients with prohibitive surgical risk and DMR ≥3+ were screened by a central eligibility committee for enrolment. The study utilised an independent echocardiography core laboratory and clinical event committee. The primary endpoint was the clinical success rate, which measured freedom from all-cause mortality, mitral valve reintervention, and mitral regurgitation (MR) >2+ at 1-year follow-up.

RESULTS: At 1 year, the trial successfully achieved its prespecified primary efficacy endpoint, with a clinical success rate of 87.5% (95% confidence interval: 80.1-92.3%). The rates of major adverse events, all-cause mortality, mitral valve reintervention, and heart failure hospitalisation were 9.0%, 5.0%, 0.8%, and 3.4%, respectively. MR ≤2+ was 90.4% at 1 month and 92.0% at 1 year. Over time, left ventricular reverse remodelling was observed (p<0.05), along with significant improvements in the patients’ functional and quality-of-life outcomes, shown by an increase in the New York Heart Association Class I/II from 32.4% at baseline to 93.6% at 12 months (p<0.001) and increased Kansas City Cardiomyopathy Questionnaire (KCCQ) score of 31.1±18.2 from baseline to 12 months (p<0.001).

CONCLUSIONS: The DRAGONFLY-DMR trial contributes to increasing evidence supporting the safety and efficacy of TEER therapy, specifically the DragonFly system, for treating patients with chronic symptomatic DMR 3+ to 4+ at prohibitive surgical risk.

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