Valvular & structural heart disease
Percutaneous Transcatheter Mitral Valve Replacement for Symptomatic Mitral Regurgitation: 2-Year Outcomes From the ENCIRCLE Trial
Authors' conclusion
The 2-year results of the ENCIRCLE trial demonstrated durable near MR elimination with sustained improvements in functional and health status outcomes in surviving patients. These findings support transseptal TMVR as a therapeutic option for carefully selected patients with symptomatic MR. (The ENCIRCLE Trial [ENCIRCLE]; NCT04153292).
Study context
- Population
- Eligible symptomatic patients with ≥3+ mitral regurgitation (MR) who were not suitable for surgery or transcatheter edge-to-edge repairpatients treated, 2-year follow-up data available for 202 of 210 eligible patients (96.2%)
- Participants
- 299 patients
- Outcome
- MR reduction
- Follow-up
- 2 years
Methodological detailsIndependent study oversight included an echocardiographic core laboratory and a clinical events committee, 2-year outcomes
- Independent study oversight included an echocardiographic core laboratory and a clinical events committee
- 2-year outcomes
Main finding
As reported in the abstract
MR ≤1+
97.0%
P < 0.001
Observational data: associations, not effects.
Further findings
Nonhierarchical composite of all-cause mortality or heart failure hospitalization (HFH) · 2 years
- Composite rate of all-cause mortality or HFH
- 35.6%
- All-cause mortality
- 25.1%
- HFH
- 23.0%
All-cause mortality and first HFH, 365-day landmark analysis · 1- to 2-year
- All-cause mortality
- 13.0%
- First HFH
- 10.6%
- 365-day landmark analysis
NYHA functional class · 2 years
- NYHA functional class I/II
- 87.0% (P < 0.001)
Kansas City Cardiomyopathy Questionnaire overall summary score · 2 years
- Mean score increase
- 17.2 points (P < 0.001)
6-minute walk distance · 2 years
- Increase compared to baseline
- +9.0 ± 97.3 m (P = 0.246)
Baseline characteristics
- Mean age
- 75.5 ± 9.3 years
- Men
- 50.8%
- Mean Society of Thoracic Surgeons Predicted Risk of Mortality score for mitral valve replacement
- 6.6% ± 4.1%
Follow-up completeness · 2 years
- 2-year follow-up data available for 202 of 210 eligible patients (96.2%)
Safety
Disabling stroke · 2 years
- Disabling stroke
- 6.6%
Clinically significant valve thrombosis · 2 years
- Clinically significant valve thrombosis
- 7.1%
Hemolysis requiring intervention · 2 years
- Hemolysis requiring intervention
- 7.6%
Clinically significant left ventricular outflow obstruction
- There were no instances of clinically significant left ventricular outflow obstruction
Original publication
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