AMADEUS研究: 二尖瓣返流患者植入Carillon成为可能 

AMADEUS: Carillon Implant Feasible in Patients with Mitral Regurgitation

根据AMADEUS试验结果，对于绝大多数功能性二尖瓣返流的患者应用Carillon Mitral Contour系统是可行的。

AMADEUS: Carillon Implant Feasible in Patients with Mitral Regurgitation 

Key Points:

No compromise in patients with crossed coronary arteries.

By TCT Daily Staff

Implantation of the Carillon Mitral Contour System is feasible in most patients with functional mitral regurgitation, according to the AMADEUS trial.

Reduction of mitral regurgitation (MR) was achieved safely in 30 patients who underwent coronary sinus-based percutaneous mitral annuloplasty with the Carrillon device (Cardiac Dimensions), according to Tomasz Siminiak, MD, PhD, of the Poznan University of Medical Sciences Cardiac & Rehabilitation Hospital in Poland.

On Tuesday, Siminiak reviewed the acute procedural results of the AMADEUS study, a European multicenter study of the device.

Acute results

Acute reduction of MR from grade 3.0 to grade 2.0 (P<.0001) and permanent implantation of the device were achieved in the majority of eligible patients (30 of 43 attempted; 83%), Siminiak said. The coronary artery was crossed in 36 patients (84%), but arterial compromise contributed to inability to achieve implantation in only six patients (14%), he said.

Procedural success, defined as acute MR reduction and successful permanent implantation, improved as the study progressed, Siminiak said. The increase in success was attributed to operator learning curve, improvements in technique, and modifications of the device.

MR changes were assessed using transesophageal echocardiography in all patients. In the last 20 patients successfully implanted, additional measurements were taken, showing reductions in vena contracta, effective regurgitant orifice area, regurgitant volume, and jet area/left atrial area.

In patients in which implantation could not be achieved, all implants were successfully retrieved and removed.

Procedure time decreased during the course of the study, from a mean of 57 minutes for the first 10 patients to a mean of 47 minutes for the final 10 patients. Fluoroscopy time also decreased, from a mean of 26 minutes for the first 10 patients to a mean of 22 minutes for the final 10.

Managing coronary arteries

Siminiak said coronary arteries can be successfully managed with the Carillon system. In AMADEUS, 11 cases with crossed arteries required retrieval of the device; in five of those cases, a second device was implanted more proximally. The operator determined the precise implant location and the amount of tension deployed. In the case of any compromise, the retrieval feature allows immediate relief, Siminiak said.

The occasional lack of efficacy of the device is not explained by a more remote position of the coronary sinus relative to the valvular annulus, Siminiak said.

Long-term clinical observation in a larger number of patients is needed to assess the clinical value of the technique, Siminiak said. Secondary endpoints in the AMADEUS study will include safety and efficacy with regard to hemodynamics and patient function at one, three, and six months follow-up.

Disclosures:

Dr. Siminiak reports no relevant conflicts of interest.

(source：www.tctmd.com)