Percutaneous mitral valve annuloplasty for ischemic mitral regurgitation: first in man experience with a temporary implant.

OBJECTIVE: This study evaluated human feasibility and acute efficacy of a novel percutaneous transvenous mitral annuloplasty (PTMA) device (Viacor) placed temporarily in the coronary sinus (CS): the implant allows in-situ incremental adjustment to optimally reduce the anterior-posterior mitral annulus (MA) dimension, and improve leaflet co-aptation and reducing mitral regurgitation (MR).

BACKGROUND: Surgical annuloplasty remains the standard treatment of severe ischemic MR but its application is limited by high morbidity and mortality. The effectiveness of PTMA device (Viacor) to reduce MR in the short-term has been demonstrated in animals studies but not in humans.

METHODS: Symptomatic patients with ischemic MR graded 2+ to 4+ requiring surgical mitral annuloplasty were screened. Patients with any mitral leaflet or mitral apparatus abnormality were excluded. Preoperatively, under general anesthesia and transesophageal echocardiography guidance, a temporary PTMA device was placed via the right internal jugular or subclavian vein.

RESULTS: Four patients were studied. After device placement and adjustment, regurgitant volume was substantially reduced (45.5 +/- 24.4 to 13.3 +/- 7.3 ml) via MA anterior-posterior diameter reduction (40.75 +/- 4.3 to 35.2 +/- 1.6 mm) in 3 patients. In one patient, the PTMA device could not be deployed due to extreme angulated anatomy.

CONCLUSIONS: PTMA in human is feasible and reduces ischemic MR (to grade 1+) by reducing MA anterior-posterior diameter. Temporary placement of the PTMA device may assist in the development of permanent implants and ensure optimal efficacy.