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)

The reference multimedia journal in interventional cardiology

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.

Forgot your password?

No account yet?
Sign up for free!

Create my pcr account

Join us for free and access thousands of articles from EuroIntervention, as well as presentations, videos, cases from PCRonline.com