Page 24 - Journal of Structural Heart Disease Volume 1, Issue 3

Original Scientific Article
130
Table 1: Summary of MitraClip studies
Study
No. of Patients
Etiology of MR
Age
STS Score
EuroScore
MR≤2+ %
30-d Mortality %
1-yr Mortality %
MR≥3+ at 1 yr
Need for Surgery
Franzen 51 et al.
Tamburino 31 et al.
PERMIT- 51 CARE
Rudolph 104 et al.
TRAMI 470 EVEREST I 107
EVEREST 78 High risk registry
ACCESS- 567 EUROPE
EVEREST II 186
EVEREST II 351 /REALISM
High risk registry
COAPT 430 (enrolling)
DMR 31% 73±10 FMR 69%
DMR 42% 71
FMR 58% (62–79)
FMR 70±9
DMR 34% 74±9 FMR 66%
DMR 33% 75±5 FMR 67%
DMR 79% 71
FMR 21% (26–88)
DMR 41% 77±10 FMR 59%
DMR 23% 74±10 FMR 77%
DMR 73% 67±13 FMR 27%
DMR 30% 76±11 FMR 70%
15±11 10±9 14±14 n/a
11 (4–19) n/a
14±8
n/a
5±4 11.3±7.7
29±22 94 2 14±12 97 3.2 30±19 82 4.2 36 (21–54) 94 3.8 23 (12–38) 94 2.5 n/a 74 0.9 n/a 80 7.7
23±18 79 3.4 n/a 78 1 n/a 86 4.8
n/a n/a n/a n/a 18 n/a 25 18 n/a n/a 4.1 n/a 24.4 20
17.3 21 6 22 22.8 14
n/a n/a n/a 6.7 n/a 29.9 0
6.3 20 0.3
FMR - - - - - - - -
tively high risk for, or do not benefit from, a surgical procedure, particularly those with functional MR. The MitraClip procedure is a novel, minimally invasive, transcatheter procedure that can be offered to such patients. To date, there have been a number of trials and registry studies examining the safety and efficacy of the MitraClip device when compared to standard medical therapy and to surgery.
The results of the relevant clinical studies are summarized in Table 1 [8-15]. In all of these studies, procedural success was achieved in the majority of patients with reduction of MR from 4+ to less than 2+. Furthermore, these results were generally achieved with an excellent safety profile without any signifi- cant rate of adverse procedural outcomes.
The EVEREST cohort is a prospective multicenter registry that analyzed the feasibility, safety and effi- cacy of MitraClip in patients with moderate-to-severe
(3+) or severe (4+) MR with class I surgical indication. A total of 107 patients were enrolled (55 from EVER- EST I and 52 in the prerandomization phase of EVER- EST II), with a mean follow-up of almost 2 years. The EVEREST cohort established that the MitraClip proce- dure is safe, with a low periprocedural complication rate. In carefully selected patients, it has acceptable efficacy achieving significant MR reduction in more than two-thirds of patients [13].
The landmark study was Everest II, a multicenter ran- domized clinical trial designed to compare the efficacy and safety of percutaneous treatment with MitraClip vs. conventional repair surgery or MV replacement. Compared to surgery, at 1 year, MitraClip was less ef- fective than surgical repair due to the increased prev- alence of residual MR compared to surgery. However, the clip reduced severity of MR, improved symptoms, and led to reverse LV remodeling [16]. The improve-
Journal of Structural Heart Disease, August 2015
Volume 1, Issue 3: 127-136