Improving mitral valve coaptation with adjustable rings: outcomes from a European multicentre feasibility study with a new-generation adjustable annuloplasty ring system

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 dev...

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Published in:European journal of cardio-thoracic surgery 2013-11, Vol.44 (5), p.913-918
Main Authors: Maisano, Francesco, Falk, Volkmar, Borger, Michael A., Vanermen, Hugo, Alfieri, Ottavio, Seeburger, Joerg, Jacobs, Stefan, Mack, Michael, Mohr, Friederich W.
Format: Article
Language:English
Subjects:
Aged
Echocardiography, Transesophageal
Europe
Feasibility Studies
Female
Heart Valve Prosthesis - adverse effects
Heart Valve Prosthesis - statistics & numerical data
Humans
Male
Middle Aged
Mitral Valve - diagnostic imaging
Mitral Valve - surgery
Mitral Valve Annuloplasty - adverse effects
Mitral Valve Annuloplasty - instrumentation
Mitral Valve Annuloplasty - methods
Prospective Studies
Reconstructive Surgical Procedures
Surgery, Computer-Assisted
Treatment Outcome
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Summary: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.
ISSN:1010-7940
1873-734X
DOI:10.1093/ejcts/ezt128