Abstract
Objectives
To evaluate the feasibility, efficacy, and safety of the MitraClip system in patients with severe MR.
Background
Mitral valve repair for mitral regurgitation (MR) has been performed by the use of a surgically created double orifice. Percutaneous repair based on this surgical approach has been developed by the use of a MitraClip device.
Methods
Five patients with 3 to 4+ MR were selected in accordance with the American Heart Association/American College of Cardiology guidelines between March 2013 and May 2013 and underwent percutaneous mitral repair with the MitraClip system with 6 months follow up after the procedure. The primary acute safety endpoint was freedom from major adverse events (MAEs) at 30 days. The primary efficacy endpoint was acute procedural success defined as clip implant with the reduction of MR to equal or less than grade II, based on current guidelines.
Results
No transseptal complications were reported (0%). There was no procedural mortality. No patients experienced MAE at 30 days. No cases of clip detachment or embolization were observed. Acute procedural success was achieved in all treated patients (100%). There was an improvement in the severity of MR in all patients as assessed acutely. Acute MR reduction by 3 grades was achieved in 2 patients and by 2 grades in 3 patients (reduction ⩾2 grades in 100%).
Conclusions
Our initial results with the MitraClip device in a very small number of patients indicate that percutaneous edge-to-edge mitral valve repair is feasible and may be accomplished with favorable short-term safety and efficacy results. |
