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OBJECTIVE: Mitral valve repair developed to the first-line therapy in patients suffering from mitral valve regurgitation (MR). A clinically relevant number of patients returns due to recurrent MR. We investigated a novel mitral ring which allows for a reduction of the anterior-posterior diameter through remote adjustment at any time point after surgery. Herein we present our clinical experience and considerations for device handling and patient selection.
METHODS: Twenty-four patients (71+/-9 years; 16m/8f) received the adjustable ring between 2011 and 2013. The mean logistic EuroScore was 14. All but two patients underwent concomitant procedures. The activation lead of the mitral ring was run through a small puncture in the left atrial wall and placed subcutaneously above the rectus sheath.
RESULTS: Ring implantation was safe and did not result in prolonged aortic cross clamp times. Twenty-two patients are alive with a mean follow-up of 13 months. One patient was successfully adjusted applying a minimally invasive approach 13 months post implantation. He had a recurrent MR II-III, deterioration of his cardiac function and an increase in ventricular dimensions. Following adjustment, MR was reduced to grade I. In one patient with ischemic MR, the ring, which was deliberately downsized, became partially dehiscent and the valve was replaced. One ring could not be adjusted due to technical problems.
CONCLUSIONS: Implantation of this adjustable mitral ring is safe and feasible. Late adjustment can be performed by a minimally invasive approach. The clinical benefit of this device remains to be revealed. We changed our implantation strategy to use this device in ischemic MR and annular dilatation, because these patients are at a higher risk for recurrent MR. Our experience with the new device led to the development of a white paper regarding optimal lead placement. Furthermore, an expert statement on the optimal time point of activation was developed (recurrent MR 2+).