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Masiero et al. Mini-invasive Surg 2020;4:71 I http://dx.doi.org/10.20517/2574-1225.2020.56 Page 5 of 12

Figure 2. The PASCAL implant consists of a 10 mm central nitinol woven spacer that acts as a filler in the regurgitant orifice of the MV,
and in its closed conformation is attached to the valve leaflets by two paddles and clasps. Differently from the MitraClip system, each
of the 2 clasps can be activated independently and the device can take an elongated form. LA: left atrium; LV: left ventricle; MV: mitral
valve

percutaneous approach, producing a “double-orifice” valve and reducing the severity of the regurgitation.
The steerable 24 Fr catheter with a clip delivery system on its proximal end clip is advanced in the LA
through a transseptal approach using a venous femoral access, and then further advanced in the LV to
effectively grasp together the MV leaflets. The whole procedure is carried out under general anesthesia and
with fluoroscopic and TEE imaging guidance. As opposed to the MitraClip system, the PASCAL implant
consists of a 10 mm central nitinol woven spacer that acts as a filler in the regurgitant orifice of the MV,
and in its closed conformation is attached to the valve leaflets by two paddles and clasps [Figure 2]. The
paddles, which rest on the ventricular side of the valve leaflets, secure the leaflets against the nitinol spacer
and ensure a low and homogeneous pressure distribution on the valve tissue. Furthermore, the paddles
flex on every heart beat so that the system dynamically flexes as the valve opens and closes, preserving the
native anatomical geometry. Using the PASCAL system, each of the 2 clasps can be activated independently,
so that tissue insertion between the paddles and the spacer can be optimized, improving results, allowing
distribution of the traction on valve leaflets while maintaining a larger mitral orifice. Furthermore, low
mitral gradients are ensured even in the case that two devices are needed. The PASCAL system consists of a
steerable guide sheath intended to provide height on the mitral annulus plane, a steerable catheter allowing
access to different locations across the coaptation line and an implant catheter that extends from the left
atrium into the LV, used to deliver the implant. The three independent catheter movements in all planes
allow for an easy height compensation in cases of sub-optimal trans-septal crossing, an intuitive control of
the delivery system and a very simple positioning and orientation of the implant. Therefore, it is intended
to assist the operator in the treatment of challenging anatomies, such as short posterior leaflets, large flail
gaps, severe tethering, and severe annular dilatation. However, further studies are needed to assess the
safety and effectiveness of this novel device in this complex anatomical setting.

Standard medical treatment to prevent clinically relevant stroke after percutaneous edge-to-edge MV repair
is still a debated issue, due to the lack of dedicated randomized clinical trials aimed at comparing different
treatment strategies. In the EVEREST II trial, patients were treated with heparin during the procedure,
and a combination of aspirin (at a dose of 325 mg daily) for 6 months and clopidogrel (at a dose of 75 mg
[16]
daily) for 30 days after the procedure . Therefore, in the absence of risk factors requiring antithrombotic
therapy such as atrial fibrillation, dual antiplatelet therapy using aspirin and clopidogrel for up to 6 months