Mitral regurgitation (MR) is a frequent valvulopathy and when the optimal medical treatment at maximum tolerated doses is not enough, surgery is the first course of action. And even though edge-to-edge repair with clips has seen substantial improvement, it is currently reserved for those at high risk of surgery.
However, there is an increasing number of patients that will not benefit from neither of these strategies. This is why different devices have been developed to approach this condition.
A feasibility study was carried out with the system HighLife TSMVR, including 30 patients with moderate to severe or severe MR, symptomatic, and with high or prohibitive risk of surgical valve replacement.
Patients were mean age was 75, and 22 were men. All patients belong to functional class III or IV, and half had been hospitalized for cardiac failure within the last year. Also, 13 patients presented diabetes, 18 hypertension, 15 prior MI, 6 COPD, 21 atrial fibrillation, 8 were in resynchronization therapy and 5 had a pacemaker. Ejection fraction was 43%, and most presented secondary MR.
Successful implantation was achieved in 27 patients, with final gradient 3.9 mmHg. No patient presented MR or moderate or severe leaks, neither right ventricular outflow tract obstruction. Three patients experienced pericardial effusion, one required conversion to surgery and there was one device embolization. Mean hospital stay was 8 days.
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After one year, there were 5 deaths, only 2 were for cardiovascular causes. Two presented acute MI, one had a stroke and 7 needed hospitalization for cardiac failure. No patient required a reintervention and they all saw improved functional class and quality of life. ECG analysis revealed a 5.1 mmHg gradient and neither presented moderate or severe MR or left ventricular outflow tract obstruction.
Conclusion
To conclude, one year outcomes with HighLife TSMVR have shown technical success, excellent valve function and the absence of left ventricular outflow tract obstruction. We should highlight the lack of reintervention, even though we recognize the importance of a longer followup to confirm these findings.
Dr. Carlos Fava.
Member of the Editorial Board of SOLACI.org.
Original Title: 1-Year Outcomes Following Transfemoral Transseptal Transcatheter Mitral Valve Replacement. The HighLife TSMVR Feasibility Study.
Reference: Leonhard-Moritz Schneider, et al. Article in Press J Am Coll Cardiol Intv 2023.
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