Background: While functional mitral regurgitation (MR) commonly accompanies heart failure and contributes to heart failure progression, mitral repair in the setting of HF is not routinely practiced because of the attendant significant morbidity and mortality. This limitation has fostered the development of percutaneous devices to reduce MR, and our group has recently reported the short- and long-term effectiveness of a percutaneous mitral annuloplasty device placed in the coronary sinus (Percutaneous Mitral Annuloplasty Device (PMAD), Cardiac Dimensions(R), Inc., Kirkland, WA) in reducing MR in experimental animal models of heart failure with associated MR. In this article, we report results of a "first-in-human" study of temporary placement of the PMAD device. The aim of this study was to demonstrate the feasibility and safety of temporary deployment of this device in patients with functional MR in association with heart failure.
Methods: Five patients undergoing scheduled coronary angiography with heart failure and functional MR (mean age 52 +/- 9 [SD] years) were recruited, and four had anatomy suitable for deployment of the device. Transthoracic echocardiography and coronary angiography were performed before and after temporary placement and tensioning of the PMAD via the right internal jugular vein.
Results: Temporary deployment of the device resulted in a significant reduction in the septal-lateral mitral annular dimension from 35.5 +/- 4.7 to 32.2 +/- 4.6 mm (P = 0.02), with evidence of a reduction in the MR color Doppler area from 98.3 +/- 43.6 to 83.3 +/- 35.1 mm(2) (P = 0.09). There were no complications.
Conclusions: This first-in-human study of a novel device for percutaneous treatment of functional MR has shown that temporary placement of this device in the coronary sinus/great cardiac vein of patients with heart failure and MR is feasible and safe. Evidence of temporary reduction in MR and a reduction in mitral annular area indicate promise for device effectiveness in chronic implantation.