The Ventouch System : A New Device For The Treatment Of Functional Mitral Regurgitation In Patients With Reduced Ejection Fraction
Vincent Chauvette1, Anita Asgar1, FranÁois Dagenais2, IstvŠn HartyŠnszky3, Denis Bouchard1
1Montreal Heart Institute, Montreal, QC, Canada, 2Quebec Heart and Lung Institute, Quebec, QC, Canada, 3Rozsakert Medical Center, Budapest, Hungary
OBJECTIVE: Functional mitral regurgitation (FMR) often presents in the context of left ventricular dilatation. It is associated with a poor prognosis if left untreated. The VenTouch System is a new, minimally invasive device designed to treat FMR using 3 inflatable non-permeable chambers (annular, postero-medial and antero-medial) placed around the mitral apparatus (Figure 1) to allow better leaflet coaptation.
METHODS: The VenTouch System is currently being evaluated in a prospective international study. Patients with severe FMR, left ventricular ejection fraction (LVEF) 20-50% are eligible. The device is initially inserted in the pericardium and therapy adjustment (chamber inflation) is performed approximately 30 days after the procedure. This is an early report of the results from the first 2 patients enrolled. Both implantations were performed through a left anterior thoracotomy.
RESULTS: Both patients had FMR graded 4+, reduced LVEF (30% and28%), dilated ventricles (LVEDDi= 38 mm/m2 and 39 mm/m2, respectively) and were in NYHA class 2 and 3, respectively. The procedures were carried out off-pump with a mean procedural time of 165 minutes. Intra-operative assessment showed MR resolution upon inflation of the chambers. After confirming that the device was not obstructing coronary flow, the chambers were left uninflated (as per protocol) and the patients’ chests were closed. One patient required early therapy adjustment with inflation of the chambers on postoperative day 3 (due to heart failure decompensation). Another therapy adjustment was performed on POD 41 for recurrence of MR. The other patient had therapy adjustment on POD 31 (per protocol). In all cases, volume adjustment of the chambers effectively decreased MR from 4+ to trace. Both patients have now completed their 6 months follow-up and currently both show 1+ MR. Their LVEF has increased to 40% and 33%, their LVEDDi have decreased (33 mm/m2 and 35 mm/m2, respectively) and they are in NYHA 2.
CONCLUSIONS: The VenTouch System is a new technology that allows off-pump, minimally invasive treatment of FMR. Early results show that it significantly reduces the severity of MR, improves LVEF and patient symptoms. Analyses of a larger cohort with long-term follow-up are warranted to confirm these results.
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