Percutaneous mitral annuloplasty for functional mitral regurgitation: results of the CARILLON Mitral Annuloplasty Device European Union Study

Joachim Schofer, Tomasz Siminiak, Michael Haude, Jean P Herrman, Jindra Vainer, Justina C Wu, Wayne C Levy, Laura Mauri, Ted Feldman, Raymond Y Kwong, David M Kaye, Stephen J Duffy, Thilo Tübler, Hubertus Degen, Mathias C Brandt, Rich Van Bibber, Steve Goldberg, David G Reuter, Uta C Hoppe, Joachim Schofer, Tomasz Siminiak, Michael Haude, Jean P Herrman, Jindra Vainer, Justina C Wu, Wayne C Levy, Laura Mauri, Ted Feldman, Raymond Y Kwong, David M Kaye, Stephen J Duffy, Thilo Tübler, Hubertus Degen, Mathias C Brandt, Rich Van Bibber, Steve Goldberg, David G Reuter, Uta C Hoppe

Abstract

Background: Functional mitral regurgitation (FMR), a well-recognized component of left ventricular remodeling, is associated with increased morbidity and mortality in heart failure patients. Percutaneous mitral annuloplasty has the potential to serve as a therapeutic adjunct to standard medical care.

Methods and results: Patients with dilated cardiomyopathy, moderate to severe FMR, an ejection fraction <40%, and a 6-minute walk distance between 150 and 450 m were enrolled in the CARILLON Mitral Annuloplasty Device European Union Study (AMADEUS). Percutaneous mitral annuloplasty was achieved through the coronary sinus with the CARILLON Mitral Contour System. Echocardiographic FMR grade, exercise tolerance, New York Heart Association class, and quality of life were assessed at baseline and 1 and 6 months. Of the 48 patients enrolled in the trial, 30 received the CARILLON device. Eighteen patients did not receive a device because of access issues, insufficient acute FMR reduction, or coronary artery compromise. The major adverse event rate was 13% at 30 days. At 6 months, the degree of FMR reduction among 5 different quantitative echocardiographic measures ranged from 22% to 32%. Six-minute walk distance improved from 307+/-87 m at baseline to 403+/-137 m at 6 months (P<0.001). Quality of life, measured by the Kansas City Cardiomyopathy Questionnaire, improved from 47+/-16 points at baseline to 69+/-15 points at 6 months (P<0.001).

Conclusions: Percutaneous reduction in FMR with a novel coronary sinus-based mitral annuloplasty device is feasible in patients with heart failure, is associated with a low rate of major adverse events, and is associated with improvement in quality of life and exercise tolerance.

Figures

Figure 1
Figure 1
The CARILLON Mitral Contour System is a fixed-length, double-anchor, nitinol device designed to be positioned within the CS/GCV to reduce FMR. The arc of the nitinol ribbon, which connects the 2 anchors, serves to orient the device automatically during deployment.
Figure 2
Figure 2
A, Venogram demonstrating vein length and dimensions. B, Distal anchor deployed near the terminal aspect of the GCV. C, Traction applied to the delivery system pulls the proximal anchor toward the CS ostium, plicating the periannular tissue and reducing annular dimensions. D, Device deployed.
Figure 3
Figure 3
Enrollment tree for the intention-to-treat patient population.
Figure 4
Figure 4
Comparison of mitral regurgitant jet area and left atrial area (A), regurgitant volumes (B), effective regurgitant orifice area (C), and vena contracta (D).
Figure 5
Figure 5
Results of 6-minute walk test.
Figure 6
Figure 6
Changes in Kansas City Cardiomyopathy Questionnaire (KCCQ) before and after CARILLON implantation.
Figure 7
Figure 7
Plot of 6-minute walk distance (6 MWD) at 6 months follow-up compared to baseline, with line of identity depicting no change. As shown, most patients had a significant improvement in 6 MWD at 6 months.

Source: PubMed

Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

3
Subskrybuj