title: Treatment of Chronic Functional Mitral Valve Regurgitation With a Percutaneous Annuloplasty System.
abstract: Current surgical and medical treatment options for functional mitral regurgitation (FMR) are limited and additional interventional approaches are required.
  
  
  
  This study sought to report the safety and performance data from the feasibility study with a novel direct annuloplasty system.
  
  
  
  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.
  
  
  
  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%.
  
  
  
  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).
authors.affiliation: Department of Cardiology, Heart Center Bonn, University Hospital Bonn, Bonn, Germany. Electronic address: georg.nickenig@ukb.uni-bonn.de.
authors.forename: Georg
authors.initials: G
authors.lastname: Nickenig
authors.affiliation: Department of Cardiology, Heart Center Bonn, University Hospital Bonn, Bonn, Germany.
authors.forename: Robert
authors.initials: R
authors.lastname: Schueler
authors.affiliation: Angiographia de Occidente, Cali, Colombia.
authors.forename: Antonio
authors.initials: A
authors.lastname: Dager
authors.affiliation: Angiographia de Occidente, Cali, Colombia.
authors.forename: Pedro
authors.initials: P
authors.lastname: Martinez Clark
authors.affiliation: Institute Dante Pazzanese de Cardiologia, São Paulo, Brazil.
authors.forename: Alexandre
authors.initials: A
authors.lastname: Abizaid
authors.affiliation: Centrum Medical Center HCP, Poznan, Poland.
authors.forename: Tomasz
authors.initials: T
authors.lastname: Siminiak
authors.affiliation: American Heart of Poland, Bielsko-Biala, Poland.
authors.forename: Pawel
authors.initials: P
authors.lastname: Buszman
authors.affiliation: National Institute of Cardiology, Warsaw, Poland.
authors.forename: Marcin
authors.initials: M
authors.lastname: Demkow
authors.affiliation: Sanatorio Italiano, Asuncion, Paraguay.
authors.forename: Adrian
authors.initials: A
authors.lastname: Ebner
authors.affiliation: Medstar Heart Institute at the Washington Hospital Center, Washington, DC.
authors.forename: Federico M
authors.initials: FM
authors.lastname: Asch
authors.affiliation: Department of Cardiology, Heart Center Bonn, University Hospital Bonn, Bonn, Germany.
authors.forename: Christoph
authors.initials: C
authors.lastname: Hammerstingl
mesh_terms: D000368:Aged; D002908:Chronic Disease; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D058386:Mitral Valve Annuloplasty / Q000295:instrumentation*; D008944:Mitral Valve Insufficiency / Q000601:surgery*; D011446:Prospective Studies; D016896:Treatment Outcome
keywords: heart failure; mitral regurgitation; percutaneous annuloplasty