Valvular & structural heart disease
Safety and efficacy of the DragonFly system for transcatheter valve repair of degenerative mitral regurgitation: one-year results of the DRAGONFLY-DMR trial
Authors' conclusion
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.
Study context
- Population
- Patients with degenerative mitral regurgitation (DMR) ≥3+ at prohibitive surgical risk
- Participants
- 120 patients
- Outcome
- Clinical success: freedom from all-cause mortality, mitral valve reintervention and MR >2+
- Follow-up
- 1 year
Methodological detailsmulticentre, independent echocardiography core laboratory, clinical event committee
- Multicentre
- Independent echocardiography core laboratory
- Clinical event committee
Main finding
As reported in the abstract
Clinical success rate (95% CI 80.1-92.3%); prespecified primary efficacy endpoint achieved
87.5%
Observational data: associations, not effects.
Further findings
Mitral regurgitation (MR) ≤2+
- MR ≤2+ at 1 month
- 90.4%
- MR ≤2+ at 1 year
- 92.0%
LV reverse remodelling
- LV reverse remodelling observed over time
- P < 0.05
NYHA class I/II · 12 months
- NYHA class I/II at baseline
- 32.4%
- NYHA class I/II at 12 months (p<0.001)
- 93.6%
Kansas City Cardiomyopathy Questionnaire (KCCQ) score increase from baseline · 12 months
- KCCQ score increase (±18.2; p<0.001)
- 31.1
Safety
Major adverse events, all-cause mortality, MV reintervention, HF hospitalisation · 1 year
- Major adverse events
- 9.0%
- All-cause mortality
- 5.0%
- MV reintervention
- 0.8%
- HF hospitalisation
- 3.4%
Original publication
Summarised from the published abstract; every number is checked against it