Key result
Intraoperative adjustment of the Cardinal annuloplasty ring during mitral valve repair significantly improved mean leaflet coaptation length from 7 ± 3 mm to 10 ± 3 mm (P < 0.0001).
Why the study?
Does the Cardinal adjustable annuloplasty ring improve leaflet coaptation and reduce residual mitral regurgitation in patients undergoing mitral valve repair?
Does the Cardinal adjustable annuloplasty ring improve leaflet coaptation and reduce residual mitral regurgitation in patients undergoing mitral valve repair?
Absolute Event Rate: 10% vs 7%
p-value: p=< 0.0001
The Cardinal adjustable annuloplasty ring allows for beating-heart optimization of leaflet coaptation, significantly improving coaptation length and reducing residual mitral regurgitation.
May support adjustable rings for mitral repair optimization; leaves open need for RCTs on regurgitation and durability.
OBJECTIVES: To evaluate the performance and safety of an adjustable semi-rigid annuloplasty ring for mitral regurgitation (MR) in a multicentre study. METHODS: Between March 2010 and December 2011, 30 subjects underwent mitral valve (MV) repair using the Cardinal adjustable annuloplasty ring. This device is a semi-rigid ring allowing postimplantation size adjustment, under beating-heart conditions, to optimize leaflet coaptation under echocardiographic guidance. Coaptation length was determined before and after adjustment by transoesophageal echocardiography. RESULTS: The study enrolled 21 (70%) male and 9 (30%) female subjects with a mean age of 64 years. The approach was conventional midline sternotomy or mini-invasive right thoracotomy. Leaflet resection was done in 17 subjects, and chordal repair was used in 13. Concomitant procedures included coronary artery bypass grafting in 2 (7%) subjects, atrial ablation in 4 (13%) and tricuspid repair in 4 (13%). There was 1 (3%) early death unrelated to the study device. Intraoperative ring adjustment was performed in 24 of the 30 subjects. Residual MR was detected prior to adjustment in 6 subjects (4 mild and 2 moderate MR). Following adjustment, 5 subjects had no MR and 1 had trace MR. After adjustment, mean coaptation length improved from 7 ± 3 to 10 ± 3 mm (P < 0.0001). All patients who completed 1-year follow-up had less-than-mild MR, with the exception of 1 patient with ring dehiscence (and resultant 2+ MR) and 1 functional MR patient who developed recurrent 2+ MR due to persistent leaflet tethering. CONCLUSIONS: MV repair with the Cardinal adjustable annuloplasty ring is a reliable technique that enables the adjustment of the ring diameter on a beating heart under echocardiographic control. Such technology allows the optimization of leaflet coaptation, providing minimal residual MR and durable repair.
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Maisano et al. (2013) studied mitral regurgitation (MR) (n=30). Cardinal adjustable annuloplasty ring vs. Pre-adjustment baseline was evaluated on mean coaptation length (p=< 0.0001). Intraoperative adjustment of the Cardinal annuloplasty ring during mitral valve repair significantly improved mean leaflet coaptation length from 7 ± 3 mm to 10 ± 3 mm (P < 0.0001).
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