Treatment of Chronic Functional Mitral Valve Regurgitation With a Percutaneous Annuloplasty System.
J Am Coll Cardiol
; 67(25): 2927-36, 2016 06 28.
Article
in En
| MEDLINE
| ID: mdl-27339489
ABSTRACT
BACKGROUND:
Current surgical and medical treatment options for functional mitral regurgitation (FMR) are limited and additional interventional approaches are required.OBJECTIVES:
This study sought to report the safety and performance data from the feasibility study with a novel direct annuloplasty system.METHODS:
Seventy-one patients with moderate to severe FMR (mean 67.7 ± 11.3 years of age, left ventricular [LV] ejection fraction 34.0 ± 8.3%), on stable medical heart failure medication were prospectively enrolled.RESULTS:
Device success rate was 70.4% (n = 50 of 71). No intraprocedural death occurred. In patients receiving implants, 4 patients (8.9%) experienced cardiac tamponade. Thirty-day (n = 45) and 6-month (n = 41) rates for all-cause mortality, stroke, and myocardial infarction were 4.4%, 4.4%, and 0.0% and 12.2%, 4.9%, and 0%, respectively. At 6 months, nonurgent mitral surgery was performed in 1 patient (2.4%) and nonurgent percutaneous repair in 7 patients (17.1%). Echocardiographic core analysis after 6 months showed mitral regurgitation reduction in 50% of treated patients by a mean of 1.3 grades. Concerning mitral valve (MV) annular geometry, we found significant reduction of anterior-posterior (-0.31 ± 0.4 cm) and septal-lateral dimensions (-0.21 ± 0.3 cm), a decreased MV-tenting area (-0.57 ± 1.1 cm(2)) and increase in MV coaptation length (0.13 ± 0.2 cm). Transthoracic echocardiography indicated reverse LV remodeling with reduction of LV end-diastolic diameter (-0.20 ± 0.4 mm) and volume (-22 ± 39 ml). Treatment was associated with significant improvement in 6-min walking distances (56.5 ± 92.0 m) and improvements in New York Heart Association functional class III/IV at 6 months from 53.3% to 23.3%.CONCLUSIONS:
Percutaneous direct annuloplasty is feasible and safe in high-risk FMR patients. This treatment initiates LV reverse remodeling, and provides clinical improvement during 6 months after treatment. (Mitralign Percutaneous Annuloplasty First in Man Study; NCT01852149).Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Mitral Valve Annuloplasty
/
Mitral Valve Insufficiency
Type of study:
Observational_studies
/
Risk_factors_studies
Limits:
Aged
/
Female
/
Humans
/
Male
Language:
En
Journal:
J Am Coll Cardiol
Year:
2016
Document type:
Article