Abstract 3051: Percutaneous Repair of Functional Mitral Regurgitation Using CARILLON™ Mitral Contour System. Acute Transesophageal Echocardiography Results from AMADEUS™ Trial
Left ventricular dilatation with subsequent mitral insufficiency exacerbates heart failure. New techniques for percutaneous repair of Functional Mitral Regurgitation (FMR) are being developed to minimize the high procedural risk of conventional cardiac surgery therapies. To evaluate the feasibility and procedural safety of percutaneous mitral valve repair with CARILLON™ Mitral Contour System™ (Cardiac Dimensions® Inc.) in FMR patients AMADEUS™ trial has been designed. Patients with FMR of both ischemic and non-ischemic origin were enrolled to this multicenter phase I trial. The device is implanted into the coronary venous system and applies tension to the mitral ring in order to improve coaptation of the leaflets. Transesophageal echocardiography (TEE) was used to assess the MR changes. Acute procedural data, obtained in the cath lab immediately before and after the procedure, are reported. Percutaneous mitral annuloplasty in patients with FMR and dilated cardiomyopathy resulted in acute MR reduction (grade 3.0±0.6 to 2.0±0.8, p<0.0001) and permanent device implantation in 30 out of 43 attempts. Additional measurements in final 20 implanted patients showed reductions in vena contracta (0.69±0.29 cm to 0.46±0.26 cm, p<0.0001), effective regurgitant orifice area (0.33±0.17 cm2 to 0.19±0.08 cm2, p<0.0001), regurgitant volume (40±20 ml to 24±11 ml, p= 0.0005), and jet area/left atrial area (45±13% to 32±12%, p<0.0001). Coronary arteries were crossed in 36 patients (84%), but arterial compromise contributed to lack of implantation in 6 patients (14%). All unsuccessful implants were recaptured and removed in these patients without procedural complications. Permanent implantation of the device is safely achievable in the majority of eligible patients resulting in acute MR reduction. Arteries are crossed in most patients and without significant impact. Phase two trials including long term clinical observations on larger number of patients are needed to asses the clinical value of the technique.