Abstract
In the last decades, the overlapping areas of intervention between
cardiac surgeons and interventional cardiologists are rocketing,
especially in the field of treatment of heart valve disease. But, while
for the aortic valve the competition, even for non-high risk patients,
has become tightened, in the context of mitral regurgitation, the
surgery seems to not have competitors .In fact looking the results of
studies published so far, a question arises: Is surgery the fair
competitor for the Mitraclip?
The meta-analysis by Abdul Khader et al summarized few evidences present
in this field, only 11 observational studies and 1 randomized trial,
providing an awesome response: “NO”.
Is therefore not a case if recently two trials, MITRA-FR and COAPT,
chose to use as competitor for MitraClip, more rightly, medical therapy
instead of surgery.
In conclusions, in case of mitral regurgitation, surgery is still
largely the gold standard treatment and so MitraClip cannot be mention
at all as competitor of surgery. It can be the right choice of case of
primary MR where patients showed high risk for surgery. In case of
secondary MR, especially with large and poor left ventricle we should
wait for a clear answer on its role, yet.
In the last decades, the overlapping areas of intervention between
cardiac surgeons and interventional cardiologists are rocketing,
especially in the field of treatment of heart valve disease [1,2].
But, while for the aortic valve the competition, even for non-high risk
patients, has become tightened [3], in the context of mitral
regurgitation, the surgery seems to not have competitors [4] In fact
looking the results of studies published so far, a question arises: Is
surgery the fair competitor for the Mitraclip?.
The meta-analysis by Abdul Khader et al [4] summarized few evidences
present in this field, only 11 observational studies and 1 randomized
trial, providing an awesome response: “NO”.
The authors, indeed, compared 1210 patients receiving MitraClip with
3009 patients undergoing surgery. Although, the length of hospital stay
was unsurprisingly shorter for Mitraclip group, the rate of failure
significantly lower when surgery was performed. So, even this
meta-analysis confirmed the overwhelming superiority of surgery over
Mitraclip.
The only trial published, the EVEREST II trial [5] showed several
limitations, firstly excluding high-risk patients, that later became
instead the class of reference for this treatment, then only 27% of
patients had secondary MR, where surgery is the gold standard, yet.
There are some pathophysiological reasons supporting the concept that
percutaneous edge-to-edge and surgery cannot be played off against each
other. MitraClip was developed starting from the Alfieri stitch
procedure which did not acted on the annulus but only fixing the two
leaflets each other so to solve the mitral regurgitation transforming
the valve in a double orifice structure [6]
Alfieri himself wrote “The absence of annuloplasty definitely
leads to accelerated failure of mitral valve repair. As a matter of
fact, the surgical experience reveals that freedom from reoperation is
remarkably lower when annuloplasty is, for some reasons,
omitted ” [6,7]
This is particularly true in the setting of secondary MR with dilated
cardiomyopathy where annular dilatation play a key-role in the
pathophysiology of the regurgitation [8-10]. Moreover, we recently
discovered as in this subset of patients, especially the ischemic ones,
the valve structure undergoes changes in terms of leaflets and chords
[11-13] which alongside with papillary muscle displacement make
MitraClip unsuitable as treatment, since even surgery deserves to adopt
a new paradigm [13]. In fact, the reasons why the results of
isolated mitral annuloplasty are still flaws, has to be search in the
need to surgically address not only the annulus but also the subvalvular
apparatus [14,15]. Hence, the question is how can an interventional
procedure, which per se act only on a part of the valve, solve a more
complex problem?.
If we give a glance wot European and North American guidelines
[16,17], the place for MitraClip is very limited and the level of
evidence (LOE) is low.
For ESC/EACTS guidelines [16], Mitraclip is indicated in patients
with either primary or secondary severe mitral regurgitation (MR), with
low ejection fraction, refractory to medical therapy or cardiac
resynchronization therapy (CRT), with high comorbidity, where a durable
surgical valve repair is not feasible or surgical revascularization is
not need (Class IIb; LOE C). Moreover, an heart team discussion should
precede the procedure and feasibility criteria have to be met.
The North American Guidelines [17] provides similar indications for
Mitraclip, that are in case of severely symptomatic patients with
chronic severe primary MR, with favorable anatomy for the repair
procedure and a reasonable life expectancy but who have a prohibitive
surgical risk because of severe comorbidities and remain severely
symptomatic despite optimal medical therapy or CRT for heart failure
(HF) (Class IIB, LOE B). In the latter guidelines, Mitraclip is not
cited in the range of treatments.
Is therefore not a case if recently two trials, MITRA-FR [18] and
COAPT [19], chose to use as competitor for MitraClip, more rightly,
medical therapy instead of surgery.
In the MITRA-FR and COAPT trials, patients with moderate to severe and
severe secondary MR with reduced left ventricular function received
either medical treatment or MitraClip implantation. However, the results
were conflicting, with the COAPT trial showing better clinical outcomes
in the device group, while MITRA-FR failed to evidence any superiority.
This different conclusions can be due to some difference between the two
trials. Firstly, COAPT trial double sized respect to MITRA-FR, then
typology of enrolled patients seems not to be similar, since the
definition of MR was different and so patients with worse MR were
enrolled in the COAPT trial. Conversely, patients enrolled in the
MITRA-FR showed wider ventricular damage.
From these divergences is possible to conclude that patients with too
severe LV dilatation or dysfunction may not benefit from the MitraClip
procedure [20]
In conclusions, in case of mitral regurgitation, surgery is still
largely the gold standard treatment and so MitraClip cannot be mention
at all as competitor of surgery. It can be the right choice of case of
primary MR where patients showed high risk for surgery. In case of
secondary MR, especially with large and poor left ventricle we should
wait for a clear answer on its role, yet.
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