Key result
Temporary percutaneous transvenous mitral annuloplasty reduces regurgitant volume ~71% in a small feasibility series.
Why the study?
Does a temporary percutaneous transvenous mitral annuloplasty device reduce ischemic mitral regurgitation in symptomatic patients?
Does a temporary percutaneous transvenous mitral annuloplasty device reduce ischemic mitral regurgitation in symptomatic patients?
First-in-man experience demonstrates that a temporary percutaneous transvenous mitral annuloplasty device is feasible and acutely reduces ischemic mitral regurgitation.
Hypothesis-generating for temporary percutaneous mitral annuloplasty; should not change practice until larger trials confirm durability and benefit.
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.
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Dubreuil et al. (2007) studied Ischemic mitral regurgitation (n=4). Percutaneous transvenous mitral annuloplasty (PTMA) device (Viacor) was evaluated on Regurgitant volume and mitral annulus anterior-posterior diameter. Temporary placement of a percutaneous transvenous mitral annuloplasty device reduced regurgitant volume from 45.5 to 13.3 ml and anterior-posterior diameter from 40.75 to 35.2 mm in 3 of 4 patients.