A Transvalvular Bridge Implantation Effectively Eliminates Tricuspid Regurgitation In A Nonstructural Tricuspid Valve Disease
Stepan Cerny1, Valavanur A. Subramanian2, Miroslava Benesova1, Ivo Skalsky1
1Na Homolce Hospital, Prague, Czech Republic, 2HRT - Heart Repair Technologies Inc., Morgan Hill, CA, USA
BACKGROUND: Functional tricuspid regurgitation [TR] is primarily due to antero-posterior [AP] dilatation of tricuspid annulus. Standard ring annuloplasty achieves an indirect reduction of this diameter with circumferential annular cinching which results in frequent TR recurrence. A transvalvular bridge which achieves a direct reduction of the mitral annular septo-lateral diameter has recently received CE Mark approval for treatment of mitral regurgitation. In this study, we evaluate the feasibility, safety, and performance of this transvalvular bridge for the treatment of functional TR. METHODS: This was a prospective observational single-center study. Six consecutive patients with symptomatic 4+ TR underwent surgical implantation of the transvalvular bridge on tricuspid annulus with sub-annular pledgeted sutures at the midpoint of the anterior leaflet and a point straddling the commissure between the septal and posterior tricuspid leaflets. All patients had concomitant mitral annuloplasty, bi-atrial cryoablation and left atrial appendage excision. Serial clinical and echocardiographic follow-up [F/U] was done at baseline, pre-discharge, 1, 3 and 6 months postoperatively. RESULTS: There were 4 females and 2 males with a mean age of 73.5±2.36 years and mean left ventricular ejection fraction 62.6±4.78 %. The mean F/U was 5.5±1.0 months with all patients reaching the 3 months F/U and 3 (50%) the 6 months F/U. All patients had freedom from MACE (death, myocardial infarction, stroke, reoperation, and device-related adverse events) at 3 months F/U. Echocardiographic F/U showed a significant AP diameter reduction from 44.0±3.22 to 27.0±2.24 mm (p=0,031), and increase in coaptation height from 2.33±0.47 to 7.83±2.67 mm (p=0,031) which had led to significant reduction of the mean grade of TR from 4.0±0.0 to 0.92±0.61 (p=0,031), ERO from 0.75±0.34 to 0.11±0.06 cm2 (p=0,031) and RV from 66.0±28.73 to 10.5±8.18 ml (p=0,031) at 3 month F/U (Wilcoxon sign rank test). CONCLUSIONS: Direct reduction of AP diameter of the dilated tricuspid annulus with the transvalvular bridge is feasible, safe and effective in the significant reduction and elimination of TR in patients with symptomatic TR. Validation of this novel concept in a larger study is required. Simplicity of the concept and the device has the potential for trans catheter adaptation which is currently in preclinical development.
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