Treatment of Chronic Functional Mitral Valve Regurgitation With a Percutaneous Annuloplasty System.Citation: Journal of the American College of Cardiology. 67(25):2927-36, 2016 Jun 28PMID: 27339489Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: *Mitral Valve Annuloplasty/is [Instrumentation] | *Mitral Valve Insufficiency/su [Surgery] | Aged | Chronic Disease | Feasibility Studies | Female | Humans | Male | Prospective Studies | Treatment OutcomeYear: 2016Local holdings: Available online from MWHC library: 1995 - present, Available in print through MWHC library:1999-2007ISSN:
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Available online from MWHC library: 1995 - present, Available in print through MWHC library:1999-2007
BACKGROUND: Current surgical and medical treatment options for functional mitral regurgitation (FMR) are limited and additional interventional approaches are required.
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).
Copyright � 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
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.
OBJECTIVES: This study sought to report the safety and performance data from the feasibility study with a novel direct annuloplasty system.
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%.