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Rodinò et al. Mini-invasive Surg 2020;4:70 I http://dx.doi.org/10.20517/2574-1225.2020.55 Page 5 of 10

Table 2. Real-world registries on safety and efficacy results of the MitraClip procedure
No. of Primary Procedural 30-day 1-year 1-year 1-year
Registry Age
pts. MR success mortality mortality MR grade ≤ 2+ NYHA class ≤ II
REALISM [26] 351 76 ± 11 30% 86% 5% 23% 83.6% 82.9%
ACCESS-EU [27] 567 74 ± 10 23% 91% 3% 17% 78.9% 71.4%
SENTINEL [28] 628 74 ± 10 23% 95% - 15% 94% 74.2%
TRAMI [15,29] 828 76 (71-81) 29% 97% 5% 20% - 63.3%
GRASP-IT [30] 304 72 ± 10 21% 92% 3% 13% - -
STS/ACC TVT [31] 2952 82 (74-86) 86% 92% 5% 26% - -
MITRA-SWISS [32] 100 72 ± 12 38% 85% - 15% 78% 80%
pts: patients; MR: mitral regurgitation; NYHA: New York Heart Association

Figure 2. Upper panel shows the PASCAL Delivery System handle, comprising three different parts, one for each catheter. Independent
movement of the three catheters is actuated by the use of control knobs. Lower panel shows the PASCAL implant in the closed, opened
and elongated configurations (from left to right, respectively)

cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, mechanical
ventilation for more than 48 h, gastrointestinal complication requiring surgery, new-onset permanent atrial
fibrillation, septicemia, and transfusion of 2 units or more of blood; to note, the former was the major
driver of superiority for the MitraClip procedure. When considering any MAE excluding transfusion, no
significant differences were observed between surgical and percutaneous treatment. At 12 months follow-
up, the primary efficacy endpoint was greater in the surgical group compared to the percutaneous group
(respectively 73% vs. 55%, P = 0.007) but with similar improvements in clinical outcomes such as LV size,
[17]
New York Heart Association (NYHA) functional class and quality of life measures . At a longer follow-
up, patients requiring surgery for residual MR or MV dysfunction during the first year after treatment
were more commonly those initially treated with percutaneous repair, but comparably low rates of surgery
[18]
[19]
were observed in both groups between 1- and 5-year follow-up . More recently, Buzzatti et al. showed
lower acute postoperative complications and improved 1-year survival after MitraClip treatment compared
to surgery in elderly patients (age > 75) affected by primary MR and STS-PROM < 8%. However, the
percutaneous procedure was once again associated with greater MR recurrence and reduced survival