Transcatheter Mitral Valve Implantation Using the HighLife System.

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.

Midterm follow-up of the reimplantation technique in patients with relatively normal annulus: is David I still a clinically valid option?

OBJECTIVE: The aim of this study was to evaluate the midterm results of the reimplantation technique with a straight tubular graft in patients with aortic root aneurysms with or without aortic insufficiency. METHODS: From February 2002 to November 2012, 51 consecutive patients underwent the David I valve-sparing aortic procedure for aortic root aneurysm; the mean age was 59.9±12.3 years. Nine patients (17.6%) had a bicuspid aortic valve. Patients were followed prospectively for 4.78±3.60 years (median, 5 years). Operative results, survival, freedom from redo aortic surgery and from recurrent aortic insufficiency greater than 2+ were assessed. RESULTS: No in-hospital mortality was recorded. In 5 cases, adjunctive procedures on the aortic valve were needed to achieve good leaflet coaptation. Aortic regurgitation was significantly lower at discharge (2.3±1.0 vs 0.3±0.5; P<.001). There were 5 postoperative deaths, all noncardiac related. Survival was 91.0%±4.4% at 5 years; freedom from redo aortic surgery was 96.8%±3.2% and freedom from recurrent aortic insufficiency greater than 2+ was 96.8%±3.2%. The outcomes in patients with repaired bicuspid aortic valves showed no significant differences compared to the outcomes in patients with repaired tricuspid valves. CONCLUSIONS: The reimplantation procedure using a straight tube is a safe and reproducible valve-sparing technique that can achieve no in-hospital mortality and durable midterm results, either in bicuspid or tricuspid valves. Further studies are needed to assess the behavior of repaired valves under physical stress at long-term follow-up.