Novel Transcatheter Edge-to-Edge Repair System for Degenerative Mitral Regurgitation

Figures

• 

  Figure 1. Design of GeminiOne System The system has 4 different clip sizes (4/6 mm in clip arm width, 10/13 mm in clip arm length) with an independent leaflet grasping design. A 22-French steerable guide catheter was used with a 16-French transcatheter edge-to-edge repair delivery system. The innovative groove-cam mechanism allows for automatic locking and release of the clip at any angle. A “U-shape” arm with a threaded central shaft structure allows for wider leaflet insertion. The clip length in the closed position is also shortened compared with the MitraClip and, therefore, requires less supravalvular height for delivery and positioning.

• 

  Figure 2. MR Degree, NYHA Functional Class, KCCQ Score, and Freedom From All-Cause Mortality at 1-Year Follow-Up (A) MR reduction assessed by the core laboratory before and after the procedure. (B) NYHA functional class improvement at 1 year. P values for intergroup comparisons of degree of MR and NYHA functional class were calculated using the McNemar test. (C) Improvement in KCCQ scores at 1 year, with data presented as medians. (D) Kaplan-Meier estimates for freedom from all-cause mortality (Kaplan-Meier estimate±SE). Error bars represent 95% CIs. KCCQ = Kansas City Cardiomyopathy Questionnaire; MR = mitral regurgitation.

• 

  Figure 3. Freedom From Clinical Events Committee–Adjudicated Safety Endpoints The Kaplan-Meier estimates for freedom from (A) reintervention for mitral valve dysfunction, (B) MR >2+, (C) heart failure hospitalization (HFH), (D) clinical success at 1 year, and (E) composite of above events and (F) freedom from major adverse events (MAEs). The graph shows Kaplan-Meier estimate ± SE and error bars represent 95% CI. Plus symbols (+) indicate censored observations (lost to follow-up). Intergroup comparisons between 1 month and 1 year after intervention were performed using the log-rank test. Abbreviation as in Figure 2.

• 

  Central Illustration. 1-Year Outcome of GeminiOne System for Degenerative Mitral Regurgitation (A) Novel features of the GeminiOne transcatheter edge-to-edge repair system. (B) Mitral regurgitation (MR) reduction assessed by the core laboratroy before and after the procedure. (C) Improvement in Kansas City Cardiomyopathy Questionnaire (KCCQ) scores at 1 year, with data presented as medians. (D) The Kaplan-Meier estimates for freedom from composite rate of all-cause mortality, reintervention for mitral valve dysfunction, and MR >2+ at 1 year.