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Belluschi et al. Mini-invasive Surg 2020;4:58 I http://dx.doi.org/10.20517/2574-1225.2020.48 Page 9 of 12

Figure 4. The PASCAL device. The image shows the percutaneous edge-to-spacer system approximating mitral leaflets (Courtesy of
Edwards Lifesciences)

The most recent device developed to replicate the edge-to-edge technique is the PASCAL system (Edwards
Lifesciences, Irvine, CA, USA), first implanted in 2016. It has obtained CE mark in early 2019, but it
is still awaiting FDA approval. Its name, recalling the French scientist Blais Pascal, is linked to that of
Professor Alfieri as well (from “Paddles, Spacer, Clasps, Alfieri”). Despite gross similarity to the MitraClip,
it substantially differs from it since the mitral leaflets are approximated to the central spacer by using
paddles and the grasping is provided by clasps (with a horizontal rather than vertical alignment). In this
way, an “edge-to-spacer” repair can be performed with a lower level of tension on the leaflets [Figure 4].
In addition, the higher degree of steerability provides an enhanced navigation into the left heart, allowing
independent grasping. This unique feature could be particularly useful in cases of large gaps and significant
tethering.

The first-in-man study reported 23 compassionate cases, showing MR ≤ 2+ in 97% of patients at
[46]
[45]
discharge . In 2019, Lim et al. reported the early outcome of 62 patients treated with PASCAL (CLASP
study). Among them, 56% suffered of functional, 36% of degenerative and 8% of mixed MR etiologies. At
30 days, 98% of patients showed MR ≤ 2+, all-cause mortality rate was 1.6% and there was no occurrence
of strokes. A significant reduction of New York Heart Association class and improvement in quality of life
were reported as well.

CONCLUSION
The introduction of the edge-to-edge technique almost 30 years ago has dramatically changed the world of
mitral valve repair, not only from a surgical point of view, but also (and even more) from the percutaneous
perspective. This simple and versatile surgical gesture has been adopted in a variety of pathologies
on thousands of patients. It has also laid the foundations for the percutaneous correction of mitral
regurgitation. In other words, it has represented a true milestone in the history of cardiac surgery and,
probably, it will keep playing a pivotal role in the future of technological innovations.