In patients at high risk for functional mitral regurgitation, percutaneous direct annuloplasty is a feasible and safe treatment method, according to data published in the Journal of the American College of Cardiology. The annuloplasty initiated left ventricular (LV) reverse remodeling, and showed clinical improvement 6 months after treatment.
Researchers of the study reported the feasibility, safety, and efficacy data of the direct percutaneous annuloplasty Mitralign system from 71 patients with moderate to severe functional mitral regurgitation. The mean age of the cohort was 67.7 ± 11.3 years, and the mean LV ejection fraction was 34.0 ± 8.3%. All patients were taking stable medical heart failure medication at the time of enrollment.
The device was implanted successfully in 70.4% of patients. No deaths occurred during the procedure, and 8.9% experienced cardiac tamponade.
The 30-day (n=45) all-cause mortality rate was 4.4% and the 6-month (n=41) mortality rate was 12.2%. Rates of stroke at 30 days and 6 months were 4.4% and 4.9%, respectively, and no patients experienced myocardial infarction at either time point.
The transthoracic echocardiography indicated reverse LV remodeling with reduction of LV end-diastolic diameter (–0.20 ± 0.4 mm) and volume (–22 ± 39 mL). Researchers found that the observed reduction of LV dimensions could improve the long-term outcomes of heart failure patients.
“When putting this into perspective with identical clinical outcome data achieved with the MitraClip system, future studies are needed to compare the true importance of (a) direct mitral annuloplasty inducing reverse remodeling as compared to (b) acute reduction of MR by a direct approach on the MV leaflets without measurable effects on LV performance,” they explained.
In addition, at 6 months of follow-up, echocardiographic core analysis revealed that mitral regurgitation was reduced by an average of 1.3 grades in 50% of patients. Researchers observed a significant reduction in anterior-posterior dimensions (–0.31 ± 0.4 cm) and septal-lateral dimensions (–0.21 ± 0.3 cm). The mitral valve-tenting area also decreased by –0.57 ± 1.1 cm2 and coaptation length increased by 0.13 ± 0.2 cm.
Improvements were also observed in the 6-minute walking distance (56.5 ± 92.0 meters;P=.01), and in percentage of patients categorized as New York Heart Association functional class III/IV (53.3% to 23.3%; P=.02).
At 6 months, a nonurgent mitral surgery was performed in 1 patient, and nonurgent percutaneous repair was performed in 7 patients.
“The percutaneous annuloplasty system does not prevent other clinical options, as demonstrated by the ability to perform a percutaneous intervention, surgical repair, or even valve replacement if the initial treatment was ineffective,” they wrote.
“Due to its very small footprint, it could be surmised the percutaneous annuloplasty system can be used as the front line treatment for MR, if necessary in conjunction with other percutaneous MV [mitral valve] repair technologies or replace devices in the future.”
Nickenig G, Schueler R, Dager A, et al. Treatment of chronic functional mitral valve regurgitation with a percutaneous annuloplasty system. J Am Coll Cardiol. 2016;67(25):2927-2936. doi: 10.1016/j.jacc.2016.03.591.