The procedure is performed in the cardiac catheterization laboratory with echocardiographic and fluoroscopic guidance while the patient is under general anesthesia. To access the left heart, standard transseptal catheterization is performed, and the guide catheter is then percutaneously inserted into the femoral vein. The delivery catheter is inserted into the guide, and the clip is positioned above the mitral valve. Manipulation of the steering mechanism on the handles of the guide and delivery catheter positions the clip on the mitral valve. The clip is actuated (i.e. opened and closed, locked, deployed) through manipulation of levers on the Inhibitors,research,lifescience,medical handle of the delivery catheter. More
than one clip can be delivered, and each one remains repositionable until detachment. Figure 1 MitraClip® System. The first MitraClip procedure was performed about 10 years ago.16 Inhibitors,research,lifescience,medical Subsequently, one randomized trial has proved MitraClip safety17 and short- to mid-term efficacy in selected patients.18 In the so-called “real world” the MitraClip therapy is usually reserved
to high-risk and extreme patients (mainly due to age, co-morbidities, and Inhibitors,research,lifescience,medical left ventricle dysfunction). Despite this, it has confirmed an excellent safety profile (30-day mortality 2%–5%) and acceptable mid-term outcomes (1-year survival 75%–85%, 1-year freedom from MR >2+ 80%) especially in terms of improvements in symptoms and quality of life.19–22 Major advantages of the MitraClip are its excellent safety even in end-stage patients and the possibility to operate on the beating heart, monitoring the efficacy of Inhibitors,research,lifescience,medical the implant chemical structure during the procedure. On the other hand, MR recurrence (higher than in the surgical experience) is the most debated issue. Longer follow-up is needed to verify MitraClip outcomes in terms of MR recurrence and clinical benefit (survival and quality of life). European guidelines assigned an indication class IIb, level of evidence C, signifying that MitraClip may be considered Inhibitors,research,lifescience,medical in patients with symptomatic severe MR despite optimal medical therapy, who are judged inoperable or at because high
surgical risk by a heart-team, and with life expectancy greater than 1 year.23 The randomized RESHAPE and COAPT trials, respectively in Europe and the US, are currently evaluating the benefit of MitraClip compared to optimal medical therapy to support a higher recommendation class in the forthcoming guidelines. A different approach to obtain transcatheter leaflet repair is off-pump adjustable chordal implantation, for which several devices are currently under development. The Babic device (from the name of the inventor, Uros Babic, MD)24 creates two continuous guiding tracks from the left ventricular puncture site through the target leaflet. The device is then exteriorized via the transseptal catheter and femoral vein.