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Page 6 of 10 Rodinò et al. Mini-invasive Surg 2020;4:70 I http://dx.doi.org/10.20517/2574-1225.2020.55

beyond 1 year of follow-up. As a matter of fact, current clinical guidelines still recommend surgical valve
repair as the gold standard for the treatment of primary MR, restricting the percutaneous “edge-to-edge”
[2]
option to patients judged inoperable or at high surgical risk . In this population, improvements in quality
of life, NYHA functional class, LV reverse remodeling and reduction in heart failure hospitalizations are
[20]
consistently observed after treatment with MitraClip . Data on the new MitraClip XT are still limited to
R
initial experiences in selected patients with DMR and complex MV anatomies, such as Barlow’s disease [21,22] .
A large observational prospective study, the MitraClip EXPAND Study (NCT03502811) is designed to
enroll up to 1000 patients to confirm the safety and performance of the NT and XT System, identifying
R
R
trends in patient selection for MitraClip therapy in a real-world use.

Current data about the PASCAL Repair System are limited to the first-in-man study, which enrolled 23
[16]
patients , and the CLASP study, a multicenter prospective single-arm study in 62 patients with primary
[23]
and secondary moderate-to-severe or severe MR (36% of degenerative etiology) . In the latter, successful
implantation was achieved in 95% of patients. At 30 days, encouraging results were shown, with a MAE rate
of 6.5%, with an all-cause mortality rate of 1.6% and no occurrence of stroke; procedural residual MR grade
2+ or less was achieved in 98% patients, and 85% were in NYHA functional class I or II. The mean 6-min
walk distance increased by 36 m from baseline and both the Kansas City Cardiomyopathy Questionnaire
and EQ-5D Health Questionnaire scores improved significantly. Further results collecting 6-month and
1-year follow-up have been recently presented showing sustained results compared to the previous one [24,25] .
The forthcoming Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial (CLASP IID/IIF; NCT03706833)
is the first randomized controlled trial that is going to specifically investigate the safety and effectiveness
of the Pascal system compared to the MitraClip system in patients with degenerative MR at high or
prohibitive risk for MV surgery by the Heart Team.

CASE EXAMPLE: PRIMARY MR TREATED WITH THE MITRACLIP SYSTEM
We report here the case of a 75-year-old man affected by symptomatic severe degenerative MR and a
history of hypertension, paroxysmal atrial fibrillation and ischemic cardiopathy initially treated with triple
coronary artery bypass graft and later with percutaneous coronary stenting on left main and circumflex
artery because of venous graft occlusion. He also underwent mechanical aortic valve prothesis implantation
because of severe aortic insufficiency and several comorbidities, including beta-thalassemia minor with
moderate-to-severe anemia often requiring blood transfusions, chronic obstructive pulmonary disease,
kyphoscoliosis, left kidney atrophy with chronic renal insufficiency and previous thoracic radiotherapy
and splenectomy for the treatment of a Hodgkin’s lymphoma. A 2D and 3D transthoracic echocardiogram
showed a normal-sized left ventricle with preserved EF and unchanged regional wall motion abnormalities,
a well-functioning mechanical aortic prothesis and a severe MR due to P2 leaflet prolapse extended to P3
and a P1-P2 cleft. Of note, calcification of the anterior leaflet was present outside the grasping area reducing
mobility and producing a mean gradient of 3 mmHg. Left atrium was severely dilated, and a moderate
tricuspid regurgitation was also detected, with a mean arterial pressure of 37 mmHg. These findings were
confirmed with 2D and 3D TEE, which allowed us to positively assess anatomic suitability of MitraClip
implant [Figure 3]. After multidisciplinary Heart Team clinical evaluation, the patient became a suitable
candidate for percutaneous “edge-to-edge” repair, with an intended treatment strategy of implantation
of two convergent clips. The procedure was carried out through a right femoral venous access and under
fluoroscopic and both 2D and 3D TEE guidance. The transseptal puncture was done in a posterosuperior
position of the fossa ovalis with a measured height of 4.3 cm over the atrioventricular plane. A guidewire
was then positioned in the left superior pulmonary vein and the MitraClip delivery system was advanced
into the left atrium [Figure 4]. Subsequently, the first clip was aligned on the main regurgitation jet in
A2-P2 position with a slight counterclockwise orientation, arms were opened with a 180° angle, grippers
were raised, and the clip was advanced into the left ventricle. The system was then retracted to reach a
stable grasping of both leaflets and clip arms were closed [Figure 5]. Therefore, after a careful TEE final
assessment, the first clip was deployed. The same procedural steps were repeated for the placement of a