title: Percutaneous transvenous mitral annuloplasty: initial human experience with a novel coronary sinus implant device.
abstract: BACKGROUND
  We assessed the safety and feasibility of permanent implantation of a novel coronary sinus mitral repair device (PTMA, Viacor Inc).
  
  
  RESULTS
  Symptomatic (New York Heart Association class 2 or 3) patients with primarily functional mitral regurgitation (MR) were included. A diagnostic PTMA procedure was performed in the coronary sinus venous continuity. MR was assessed and the PTMA device adjusted to optimize efficacy. If MR reduction (> or =1 grade) was observed, placement of a PTMA implant was attempted. Implanted patients were evaluated with echocardiographic, quality of life, and exercise capacity metrics. Nineteen patients received a diagnostic PTMA study. Diagnostic PTMA was effective in 13 patients (MR grade 3.2+/-0.6 reduced to 2.0+/-1.0), and PTMA implants were placed in 9 patients. Four devices were removed uneventfully (7, 84, 197, and 216 days), 3 for annuloplasty surgery due to observed PTMA device migration and/or diminished efficacy. No procedure or device-related major adverse events with permanent sequela were observed in any of the diagnostic or implant patients. Sustained reductions of mitral annulus septal-lateral dimension from 3D echo reconstruction dimensions were observed (4.0+/-1.2 mm at 3 months).
  
  
  CONCLUSIONS
  Percutaneous implantation of the PTMA device is feasible and safe. Acute results demonstrate a possibly meaningful reduction of MR in responding patients. Sustained favorable geometric modification of the mitral annulus has been observed, though reduction of MR has been limited. The PTMA method warrants continued evaluation and development.
authors.affiliation: Department of Cardiology, West German Heart Center, Essen, Germany. stefan.sack@klinikum-muenchen.de
authors.forename: Stefan
authors.initials: S
authors.lastname: Sack
authors.forename: Philipp
authors.initials: P
authors.lastname: Kahlert
authors.forename: Luc
authors.initials: L
authors.lastname: Bilodeau
authors.forename: Luc A
authors.initials: LA
authors.lastname: Pièrard
authors.forename: Patrizio
authors.initials: P
authors.lastname: Lancellotti
authors.forename: Victor
authors.initials: V
authors.lastname: Legrand
authors.forename: Jozef
authors.initials: J
authors.lastname: Bartunek
authors.forename: Marc
authors.initials: M
authors.lastname: Vanderheyden
authors.forename: Rainer
authors.initials: R
authors.lastname: Hoffmann
authors.forename: Patrick
authors.initials: P
authors.lastname: Schauerte
authors.forename: Takahiro
authors.initials: T
authors.lastname: Shiota
authors.forename: David S
authors.initials: DS
authors.lastname: Marks
authors.forename: Raimund
authors.initials: R
authors.lastname: Erbel
authors.forename: Stephen G
authors.initials: SG
authors.lastname: Ellis
mesh_terms: D000368:Aged; D002170:Canada; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods; D054326:Coronary Sinus; D020878:Device Removal; D019560:Echocardiography, Three-Dimensional; D017548:Echocardiography, Transesophageal; D005060:Europe; D017079:Exercise Tolerance; D005240:Feasibility Studies; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods; D006801:Humans; D008297:Male; D008875:Middle Aged; D008943:Mitral Valve / Q000000981:diagnostic imaging / Q000503:physiopathology; D008944:Mitral Valve Insufficiency / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000628:therapy*; D010865:Pilot Projects; D011474:Prosthesis Design; D011475:Prosthesis Failure; D011788:Quality of Life; D020127:Recovery of Function; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome