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Page 6 of 12 Cepas-Guillen et al. Vessel Plus 2021;5:26 https://dx.doi.org/10.20517/2574-1209.2020.79

[13]
procedure .

The PASCAL® system
The Edwards PASCAL® Transcatheter Valve Repair System is a novel device based on the same principle as
the MitraClip [Figure 2]. It has been designed to address some of the limitations of previous systems. It is
intended to reduce the tension on the valve leaflets by introducing a 10-mm central spacer within the MV
regurgitant orifice. The device is also designed to ease navigation in the LA while offering a higher degree of
steerability . The CLASP study is a multicenter prospective trial of the PASCAL® system in 62 patients with
[21]
[30]
significant MR despite medical therapy . Based on these promising results, the PASCAL® system gained
“Conformite Europeenne” (CE) mark in early 2019. The pivotal CLASP IID/F randomized trial
(NCT03706833) has begun enrollment and will compare the efficacy and safety of PASCAL® vs. MitraClip®
in patients with significant DMR or FMR using a non-inferiority study design.

Annuloplasty systems
Cardioband system
Among various annuloplasty devices, percutaneous direct annuloplasty using the Cardioband system
(Edwards Lifesciences Corp., Irvine, CA, USA) is a relatively new mitral valve technique very similar to
conventional surgical annuloplasty rings [Figure 3] . The transseptal approach is used to deliver the device.
[31]
Ring implantation is performed directly on the posterior mitral annulus under fluoroscopic and TEE
guidance. Implantable metal anchors and anchor delivery shafts are mandatory for the procedure. The first
anchor is deployed in the lateral commissure. Between 12 and 17 anchors are implanted using a delivery
shaft. The first anchor is deployed in the lateral commissure. The anchors are fully repositionable and
retrievable until deployed. Finally, the band is cinched achieving a controlled decrement in the mitral
annulus dimensions with a subsequent MR reduction. The Cardioband® system received CE approbation in
2019 but is not yet available for use in USA. Currently, the Edwards Cardioband System ACTIVE Pivotal
Clinical trial (NCT03016975) is ongoing to evaluate safety and effectiveness of this device in a group of
patients with FMR.

A higher than expected rate of injuries during deployment of the Cardioband system has been notified.
Approximately 5.7% of patients treated with Cardioband experienced coronary artery damage, most as a
result of direct interaction between the anchors of the device and coronary arteries running contiguous to
the valve annulus, identified either during anchor deployment or following band contraction. Preventive
measures before using this system such as consistently use a guidewire in the coronary artery in order to
clearly visualize vessel throughout the procedure, performing a coronary angiogram prior to first anchor
deployment, verifying the proximity of the coronary artery to target anchor position throughout the
procedure, and performing a final coronary angiogram before disconnecting delivery system from implant
are recommended.

Carillon mitral contour system
The Carillon system is designed to treat FMR in patients with MR grades 2+ to 4+ [Figure 3] . It is a
[33]
percutaneous device for mitral annuloplasty designed to reshape the anatomy and improve the function of
the mitral apparatus from the coronary sinus. The device consists of two anchors connected by a shaping
band. The mitral apparatus is clinched through the coronary sinus obtaining significant reduction of the
regurgitant volume without affecting the valve or future treatment options. Recapture and retrieval of the
device prior to release are feasible. The REDUCE FMR (CARILLON Mitral Contour System® for Reducing
Functional Mitral Regurgitation) trial demonstrated a significant reduction of the mitral regurgitant volume
and LV volumes in symptomatic patients with functional MR receiving optimal medical therapy. Its use was