Early Experience With a Novel Transfemoral Mitral Valve Implantation System in Complex Degenerative Mitral Regurgitation.

OBJECTIVES: The aim of this study was to evaluate the feasibility, procedural results, and 6-month outcomes of a novel transfemoral transcatheter mitral valve implantation (TMVI) system (Cephea) in patients with complex primary mitral regurgitation (MR). BACKGROUND: TMVI is emerging as an alternative to surgery in patients with severe MR. To date, the great majority of TMVI systems use the transapical surgical approach. METHODS: This study included consecutive patients undergoing transfemoral TMVI with the Cephea valve system. All patients were suboptimal candidates for catheter-based repair for anatomic reasons. Patients underwent clinical, echocardiographic, and computed tomographic angiographic follow-up at 6 months. Main outcomes were procedural success, peri-procedural complications, and valve hemodynamic status early and at 6-month follow-up. RESULTS: Three patients with severe primary MR (2 women, mean age 79 ± 3 years) at prohibitive surgical risk (mean European System for Cardiac Operative Risk Evaluation II score 13.8 ± 2.4%) were included. The valves were successfully implanted in all patients, with no procedural complications. Post-procedural echocardiography showed normal valve function in all patients (mean transvalvular gradient 3 mm Hg; range: 2 to 4 mm Hg), no moderate to severe valvular or paravalvular leak, and no clinically significant left ventricular outflow tract obstruction. At 6 months, all patients had improved quality of life (mean improvement vs. baseline 16.4 ± 12 points). All valve hemodynamic parameters were maintained. Computed tomographic angiography confirmed annular stability, proper valve geometry and no structural failure. CONCLUSIONS: The transfemoral delivery of a purposely designed mitral prosthesis (Cephea valve) was safe and feasible in prohibitive risk patients. Valve performance was sustained, and clinical outcomes improved at 6 months. Larger clinical studies are required.

Transcarotid Transcatheter Aortic Valve Replacement: General or Local Anesthesia.

OBJECTIVES: The study sought to assess the safety and efficacy of a minimally invasive strategy (MIS) (local anesthesia and conscious sedation) compared to general anesthesia (GA) among the largest published cohort of patients undergoing transcarotid transcatheter aortic valve replacement (TAVR). BACKGROUND: Transcarotid TAVR has been shown to be feasible and safe. There is, however, no information pertaining to the mode anesthesia in these procedures. METHODS: Between 2009 and 2014, 174 patients underwent transcarotid TAVR at 2 French centers. All patients were unsuitable for transfemoral TAVR due to severe peripheral vascular disease. An MIS was undertaken in 29.8% (n = 52) and GA in 70.1% (n = 122). One-year clinical outcomes were available in all patients and were described according to the Valve Academic Research Consortium-2 consensus. RESULTS: Transcarotid vascular access and transcatheter valve deployment was successful in all cases. Thirty-day mortality was 7.4% (n = 13) and 1-year all-cause and cardiovascular mortality were 12.6% (n = 22) and 8.0% (n = 14), respectively. According to the type of anesthesia, there was no between group difference in 30-day mortality (GA 7.3% vs. MIS 7.6%; p = 0.94), 1-year mortality (GA 13.9% vs. MIS 9.6%; p = 0.43), 1-month clinical efficacy (GA 85.2% vs. MIS 94.2%; p = 0.09), and early safety (GA 77.8% vs. MIS 86.5%; p = 0.18). There were 10 (5.7%) periprocedural cerebrovascular events: 4 strokes (2.2%) and 6 transient ischemic attacks (3.4%) among those treated with GA. There was neither stroke nor transient ischemic attack in the MIS group (p < 0.001). CONCLUSIONS: The transcarotid approach for TAVR is feasible using general or local anesthesia. A higher rate of perioperative strokes was observed with GA.