MULTICENTER STUDY
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Effectiveness and safety of percutaneous coronary sinus-based mitral valve repair in patients with dilated cardiomyopathy (from the AMADEUS trial).

This report presents the procedural results from the AMADEUS trial that support coronary sinus (CS)-based percutaneous mitral annuloplasty. Despite therapeutic advances, functional mitral regurgitation (MR) continues to be a significant clinical problem for patients with dilated cardiomyopathy. CS approaches to mitral valve repair have been viewed with skepticism because of the distance of the CS/great cardiac vein from the mitral valve annulus and the potential to compress a coronary artery. This report presents the procedural results from the AMADEUS trial that support CS-based percutaneous mitral annuloplasty. Patients who met the inclusion criteria were eligible to receive a mitral annuloplasty device. Transesophageal echocardiography was used to assess changes in MR, angiography was used to assess the coronary arteries, and multislice computed tomography was used to evaluate the anatomic relations between the coronary venous system and the mitral valve. Acute MR reduction (grade 3.0 +/- 0.6 to 2.0 +/- 0.8, p <0.0001) and permanent implantation were achieved in 30 of 43 patients in whom an attempt was made. Additional measurements in 20 patients with implants showed reductions in the vena contracta (0.69 +/- 0.29 to 0.46 +/- 0.26 cm, p <0.0001), effective regurgitant orifice area (0.33 +/- 0.17 to 0.19 +/- 0.08 cm(2), p <0.0001), regurgitant volume (40 +/- 20 to 24 +/- 11 ml, p = 0.0005), and jet area/left atrial area (45 +/- 13% to 32 +/- 12%, p <0.0001). The coronary arteries were crossed in 36 patients (84%). Arterial compromise contributed to a lack of implantation in 6 patients (14%). No difference was found in the CS/great cardiac vein position relative to the annulus between the patients who did and did not have a reduction in MR. In conclusion, percutaneous mitral annuloplasty reduces MR and permanent implantation can be achieved in most eligible patients.

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