Transcatheter Mitral Valve Implantation Using the HighLife System

Abstract Objectives This study is the first report of 2 cases of HighLife (HighLife, Paris, France) implantation in humans. Background Transcatheter mitral valve implantation represents a promising approach to treating mitral regurgitation in patients at increased risk of perioperative mortality. The HighLife transcatheter mitral valve is a 2-component system. The valve is implanted in the mitral position and is anchored by interacting and then reaching an equilibrium position with a previously positioned subannular implant. Methods The procedures were successfully performed in a 69-year-old man and a 65-year-old woman with severe functional mitral regurgitation. Both patients were in New York Heart Association functional class IV heart failure with depressed left ventricular ejection fraction and additional comorbidities. Results The valve was implanted uneventfully in both patients. General anesthesia was used. The subannular implant was deployed through the transfemoral access, whereas the transcatheter mitral valve was released using the transapical access. Patients maintained hemodynamically stable. There were no intraoperative complications. Acutely, post-procedural echocardiograms demonstrated excellent prosthetic valve function with a low transvalvular gradient and no paravalvular leak and left ventricular outflow tract obstruction. Both patients had mild intraprosthetic regurgitation. Patient #1 survived at 5-months follow-up in New York Heart Association functional class II with excellent prosthesis performance. Patient #2 expired 4 days after a technically successful procedure, because the left ventricle did not tolerate the reduction of mitral regurgitation and despite a high dose of inotropic agents the left ventricular function rapidly deteriorated. Conclusions Transcatheter mitral valve implantation using the 2-component HighLife system is technically feasible and can be performed safely. Early hemodynamic performance of the prosthesis was excellent.