Percutaneous transvenous mitral annuloplasty: Initial human experience with a novel coronary sinus implant device
Sack S et al. – Percutaneous implantation of a novel coronary sinus mitral repair device (PTMA) is feasible and safe. Acute results show a possibly meaningful reduction of mitral regurgitation (MR) in responding pts. Sustained favorable geometric modification of the mitral annulus is reported, despite limited reduction of MR. Methods- Study of the safety and feasibility of permanent implantation of PTMA device
- Subjects: symptomatic (NYHA class 2 or 3) pts with primarily functional MR
- Diagnostic PTMA procedure in coronary sinus venous continuity
- Assessment of MR, then PTMA device adjustment to optimize efficacy
- PTMA implant placement attempted if MR reduction (≤1 grade)
- Echocardiographic, quality of life, and exercise capacity metrics evaluation of implanted pts
Results- Diagnostic PTMA study for 19 pts
- Diagnostic PTMA effective in 13 pts: MR grade 3.2±0.6 reduced to 2.0±1.0
- PTMA implants placed in 9 pts
- Uneventful removal of 4 devices (7, 84, 197, 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 in any diagnostic or implant pts
- Sustained reductions of mitral annulus septal-lateral dimension from 3D echo reconstruction dimensions (4.0±1.2 mm at 3 mo)
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