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Page 6 of 12 Masiero et al. Mini-invasive Surg 2020;4:71 I http://dx.doi.org/10.20517/2574-1225.2020.56
[17]
is currently the preferred therapeutic strategy . However, recent observational studies suggest that
temporary oral anticoagulation, with coumadin or apixaban, might be an effective strategy to reduce the
incidence of stroke within the first 30 days after the MitraClip procedure in patients with maintained sinus
rhythm, without an increase in minor and major bleeding events [18,19] . Adjunctive data relevant to medical
treatment after a PASCAL implantation procedure are inadequate. Further studies should be conducted to
address this important issue.

EVIDENCE ON PERCUTANEOUS “EDGE-TO-EDGE” LEAFLET TREATMENT IN SECONDARY
MR
Data on safety and effectiveness of the MitraClip device for the treatment of functional MR mainly result
from two real-word prospective European multicenter registries and the two latest major trials [14,15,20,21] .

The ACCESS-EU study enrolled a total of 567 elderly patients with significant MR between 2009 and 2011,
of which 79% presented with secondary MR, 85% with NYHA class III or IV, and 53% with LVEF ≤ 40%.
Acute procedural success occurred in 99.6% of patients. The survival rate at 1-year follow-up was 82% with
low rate of subjects (6%) requiring MV surgery. Moreover, there was significant clinical improvement, with
durable residual MR < 2+ and NYHA class I/II in the majority of patients (respectively 79% and 71%) with
[20]
a higher six-minute-walking-test and Minnesota-living-with-heart-failure score performance .

In the following two years, the SENTINEL registry enrolled 628 patients with a mean age of 74 ± 10 years,
lower than that of the ACCESS-EU study. Once again, functional MR was the prevalent pathogenesis (72%).
Acute procedural success was high (95%) with only one clip implanted in two thirds of the population.
The 1-year mortality was comparable to previous studies (15%), with a significantly higher rate of
rehospitalization compared to the degenerative group (26% vs. 12%, P = 0.009). Echocardiographic follow-
up data showed a persistent reduction in the degree of mitral regurgitation at 1 year, with 6.0% of patients
[21]
with residual severe MR .
More recently, two large randomized clinical trials compared the MitraClip procedure to conservative
treatment [14,15] . Despite their similarities, the studies showed conflicting results and conclusions, fostering
the debate about the potential association between this transcatheter mitral repair and a significant survival
benefit. Both MITRA-FR and COAPT were multicenter, randomized, open-label trials that enrolled 304
and 614 high surgical risk patients with HFrEF and symptomatic moderate-to-severe or severe functional
MR respectively, with comparable rates of ischemic and non-ischemic etiologies. However, different
from the first study, the latter involved higher volume centers and greater performance, performed a
more rigorous clinical and instrumental patient selection, and proved a more careful medical therapy up-
titration. At 12 months follow-up, the rate of the primary outcome (death from any cause or unplanned
hospitalization for HF) was comparable between the two treatment groups of the MITRA-FR (55% in the
interventional group vs. 51% in the control group, P = 0.53) with no significative difference among the
[14]
individual components of the composite endpoint . Conversely, the primary outcome in the COAPT
trial consisted of all hospitalizations for HF within 24 months of follow-up, showing a significantly lower
annualized rate in the device group as compared with the control group (respectively, 36% per patient-year
vs. 68% per patient-year, P < 0.001). Moreover, the secondary endpoint of death from any cause within
24 months occurred in 29% of the patients in the MitraClip group as compared with 46% in the
conservative group (P < 0.001). These clinical improvements and benefits were consistent across numerous
subgroups, including patients who had ischemic MR etiology and non-ischemic cardiomyopathy, and
[15]
were independent of the MR grade and LV volume and function at baseline . Therefore, several authors
highlighted that the studies indeed enrolled 2 distinctly different groups of patients; as a matter of fact, the
patients enrolled in the COAPT trial had an almost 30% higher mean EROA with an approximately 30%