49
© RADCLIFFE CARDIOLOGY 2014
Heart Failure
Diseases of the mitral valve (MV) are the second most frequent
clinically significant form of valvular disease in adults. In particular, MV
regurgitation occurs with increasing frequency as part of degenerative
changes in the ageing process.
1
The annual incidence of degenerative MV disease is estimated at
approximately 2–3 %. In addition to degenerative valve disease, MV
regurgitation can be caused by cardiac ischaemia (functional mitral
regurgitation), infective endocarditis and rheumatic diseases (prevalent
in less developed countries).
1
Severe mitral regurgitation (MR) develops
gradually over the years and carries a high annual mortality rate of at
least 5%.
2
Medical therapy relieves symptoms but does not reverse the
underlying mitral pathology.
Conventional surgical repair or replacement has been the standard of
care for symptomatic severe MR.
3,4
Those with degenerative MR (DMR)
have excellent outcomes with repair surgery.
5
However, the long-term
benefits of surgical treatment of functional MR (FMR) are harder to
demonstrate and remain controversial.
6,7
Before the emergence of transcatheter valve therapies, optimal
medical therapy and cardiac resynchronisation therapy in selected
candidates have been the only treatment for patients deemed
too high-risk for conventional surgery.
8–11
Although a variety of MV
transcatheter therapies grew in parallel with aortic valve therapies,
the MV therapies have had a slower development path.
2
Percutaneous
edge-to-edge MV repair with the Mitraclip® system was demonstrated
to be a safe and feasible alternative to surgical treatment for
severe MR.
12–15
Adverse valve morphology and severe left ventricular
dysfunction have been the two major challenges for the treatment with
the Mitraclip system.
16–18
Multidisciplinary assessment is essential for high-risk patients. A
heart team including surgeons, interventional cardiologists, clinical
cardiologists and imaging experts should discuss individual cases,
considering the surgeon’s/institution experience with MV repair
versus replacement.
Degenerative Mitral Regurgitation
Degenerative MV disease frequently have leaflet prolapse due to
elongation or rupture of the chordal apparatus, resulting in varying
degrees of MV regurgitation due to leaflet malcoaptation during
ventricular systole. Physiopathology of systolic flow reversal into the
left atrium leads to atrial dilatation/fibrillation, ventricular function
impairment and dilatation, secondary pulmonary hypertension and
risk of sudden death.
Surgical Treatment
There are several types of degenerative MV regurgitation
19,20
(see
Figure 1). Current guidelines recommend MV repair when patients
develop New York Heart Association (NYHA) class II symptoms, any
deterioration in left ventricular function or an end-systolic diameter
of 4.5 cm.
21
Recent evidence suggests that the best outcomes after
repair of severe DMR are achieved in asymptomatic or minimally
symptomatic patients, who are selected for surgery soon after
diagnosis on the basis of echocardiography.
22
Valve repair in patients with degenerative MV disease is associated
with an improved quality of life with less morbidity as well as better
long-term survival as opposed to replacement. Recent guidelines on
valvular heart disease
21
contain a reported mortality for isolated MV
repair of 1.6–2.1% and 4.3–7.8% mortality for MV replacement. More
than 80 % of the patients are free from re-operation at five years.
Abstract
Mitral regurgitation is an increasing valvular disease that represents a difficult management challenge. Surgical treatment for
degenerative mitral regurgitation is the standard of care treatment. Percutaneous therapies have emerged rapidly over the past years
as an option for treatment of mitral regurgitation for selected, predominantly high-risk patients. Catheter-based devices mimic these
surgical approaches with less procedural risk. Mitraclip® implantation mimics the surgical edge-to-edge leaflet repair technique,
reducing the regurgitant area. We review the increasing evidence with the Mitraclip device reported to date.
Keywords
Mitral valve, mitral regurgitation, mitral valve surgery, mitraclip, functional mitral regurgitation, degenerative mitral regurgitation
Disclosure: Olaf W Franzen is a consultant for Abbott Vascular. Eduardo Alegria-Barrero has no conflicts of interest to declare.
Received: 24 June 2014 Accepted: 5 July 2014 Citation: European Cardiology Review, 2014;9(1):49–53
Correspondence: Eduardo Alegria-Barrero, Interventional Cardiology, Torrejon University Hospital, Mateo Inurria s/n. 28850, Madrid, Spain.
E: ealegriabarrero@secardiologia.es
Mitral Regurgitation – A Multidisciplinary Challenge
Eduardo Alegria-Barrero
1
and Olaf W Franzen
2
1. Interventional Cardiology, Torrejon University Hospital, Madrid, Spain; Cardiovascular Biomedical Research Unit, Royal Brompton Hospital, London, UK;
2. Interventional Cardiology, Klinik im Park, Hirslanden Zurich, Zurich, Switzerland
Heart Failure
EUROPEAN CARDIOLOGY REVIEW
50
However, even in developed countries, MV replacement remains
frequent in this setting. In the Euro Heart Survey, repair rates were
documented around 50%, meaning that MV replacement continues
to be performed far too frequently in the modern era of reconstructive
valve surgery.
23
MV repair for degenerative disease follows two fundamental principles:
•restore a good surface of leaflet coaptation (5–8 mm); and
• correct for annular dilatation – Carpentier´s techniques being the
most commonly performed worldwide.
19,24
Long-term survival following MV repair is similar to age matched
controls if the operation is performed before the onset of symptoms,
ventricular dysfunction or atrial fibrillation.
25
Percutaneous Edge-to-Edge Repair
To date, up to 14,000 patients have been treated with the Mitraclip
device worldwide, with nearly 2,000 enrolled in prospective clinical
trials. The majority of patients included were considered at high
peri-operative risk for MV surgery. After CE mark in 2008, numerous
patients have been recruited in several studies. In 2013, the Food
and Drug Administration (FDA) approved the Mitraclip device for
symptomatic degenerative mitral valve regurgitation for patients at
prohibitive risk for MV surgery by a heart team.
The Mitraclip system consists of a steerable guide catheter and
a clip delivery system (CDS), which includes the clip attached at
the end of the CDS (see Figure 2).
26,27
The guide catheter is 24 Fr
proximally, and tapers to 22 Fr at the point where it crosses the
interatrial septum (see Figure 2). These steering controls allow
the operator to manoeuvre the clip over the MV. The clip is
Dacron-covered with two clip arms that are opened and closed by
control mechanisms on the CDS. Leaflet tissue is secured between
the clip arms and opposing grippers (see Figure 2). The clip arms
are then closed to zero degrees, then locked to effect and maintain
coaptation of the two leaflets.
28
Technical success is achieved in a high
number of procedures.
29,30
In this technically demanding procedure,
the co-operation and communication between the operators
and the guidance by transoesophageal echocardiography (see Figure
3) are of great importance. Therefore, the effect of learning curve
and co-operation between heart team members could impact on the
clinical outcome in terms of MR reduction and complication rates.
The safety and efficacy of the percutaneous edge-to-edge with Mitraclip
was initially tested in the Endovascular Valve Edge-to-Edge REpair
Study (EVEREST I),
15
and then compared with surgery in the randomised
standard-risk patients EVEREST II trial.
31
Procedural success was defined
as successful and stable Mitraclip placement with residual MR ≤2+ on
discharge. However, most of the patients enrolled in the EVEREST trials
had DMR and all patients were surgical candidates. The real-world
setting is very different from the original EVEREST trials – most of the
patients treated with MitraClip are at high surgical risk and MR is more
often functional rather than degenerative (see Table 1).
Of note, during the implantation of MitraClip, there is often a
compromise between complete reductions of MR and resultant mitral
stenosis by placing further clips. Several studies have reported that
in these patients, significant improvement in symptoms can still be
achieved despite a complete resolution of MR.
30,32,33
EVEREST II trial
31
included 74 % patients with FMR randomised to
surgery or Mitraclip treatment. Latest five-year data have recently
been presented at the EuroPCR2014, Paris, France. Mean age
in the DMR Mitraclip group was 67 years, 45 % of the patients
were in NYHA class III/IV and mean ejection fraction was 64 %.
Adverse event rates at 30-days (cardiac, vascular, renal, neurological)
were low (25 %) compared with surgical DMR patients (33 %). At
one-year, nine patients experienced single leaflet device attachment
but no embolisation was observed. From one to five years follow-up,
no further single device attachment or embolisation was observed.
Survival rates at five years were similar in the Mitraclip and surgical
groups (89.4 % versus 85.9 %, respectively). There was a concern
on the need of re-operation for the Mitraclip patients. At one-year
after the procedure, 75 % of the Mitraclip patients were free from
re-operation/MV surgery compared with 100 % of the surgical
group. However, from one to five years follow-up, 69 % Mitraclip
patients were free from re-operation/MV surgery compared with
96 % of the surgical group, meaning that beyond one-year they
observed comparable success rates for surgery and Mitraclip when
index Mitraclip procedure was successful (92.2% versus 95.8 % at
five years).
MR grade at five years follow-up, was ≤2+ in 81 % of the Mitraclip
patients and in all surgical patients (100%), and both groups exerted
reduction of left ventricular (LV) end-diastolic diameters. NYHA
I/II functional class at five years was present in DMR in 95% of the
Mitraclip patients compared with 97 % of surgical survivors at five
years. Mitraclip patients had comparable stability of mitral annular
dimensions at five years compared to baseline (4.0 cm versus 3.9 cm,
p=0.18). Improved clinical performance in the six-minute walking test
have also been reported.
34
In the EVEREST II high surgical risk cohort,
a 55% reduction of the annual rate of hospitalisations was observed
(0.71–0.32, p=0.006) after Mitraclip implantation.
Figure 1: Carpentier´s Classification of Mitral Regurgitation
(A) Normal mitral valve anatomy. (B) Types of mitral regurgitation: Type I, normal leaflet
motion; Type II, increased leaflet motion (leaflet prolapse); Type IIIa, restricted motion
during systole and diastole (restricted leaflet opening); Type IIIb, restricted leaflet motion
predominantly during systole (restricted leaflet closure)*.
* Modified from Carpentier, et al., 2010.
45
Chordae
tendineae
Posteromedial
papillary muscle
Anterolateral
papillary muscle
Type I Type II
Type IIIa
Type IIIb
(ischaemic)
A
B
Mitral Regurgitation – A Multidisciplinary Challenge
EUROPEAN CARDIOLOGY REVIEW
51
Table 1: Guidelines Recommendations for Percutaneous Edge-to-Edge Mitral Valve Repair
ESC/EACTS Guidelines on the management of valvular heart disease (version 2012)
21
•Percutaneousedge-to-edgeproceduremaybeconsideredinpatientswithsymptomaticsevereprimaryMRwhofulfiltheechocriteriaofeligibility,are
judged inoperable or at high surgical risk by a ‘heart team’ and have a life expectancy >1 year (recommendation class IIb, level of evidence C)
•ThepercutaneousmitralclipproceduremaybeconsideredinpatientswithsymptomaticseveresecondaryMRdespiteoptimalmedicaltherapy(including
CRT if indicated), who fulfil the echo criteria of eligibility, are judged inoperable or at high surgical risk by a team of cardiologists and cardiac surgeons, and
who have a life expectancy >1 year (recommendation class IIb, level of evidence C)
ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2012
42
In (secondary MR) patients with an indication for valve repair but judged inoperable or at unacceptably high surgical risk, percutaneous edge-to-edge repair
may be considered in order to improve symptoms
2013 ACCF/AHA Guideline for the management of heart failure
43
Transcatheter mitral valve repair or mitral valve surgery for functional mitral insufficiency is of uncertain benefit and should only be considered after careful
candidate selection and with a background of GDMT (recommendation class IIb, level of evidence B)
2014 AHA/ACC Guideline for the management of patients with valvular heart disease
44
Transcatheter MV repair may be considered for severely symptomatic patients (NYHA class III/IV) with chronic severe primary MR (stage D) who have a
reasonable life expectancy but a prohibitive surgical risk* because of severe co-morbidities (recommendation class IIb, level of evidence B)
* Prohibitive surgical risk is defined as having one of the following:
• Predictive risk with surgery of death or major morbidity (all-cause) >50 % at one-year.
• ≥3 major organ system compromise not to be improved post-operatively (cardiac – severe left ventricular [LV] systolic or diastolic dysfunction or right ventricular [RV] dysfunction, fixed
pulmonary hypertension; chronic kidney disease stage 3 or worse; pulmonary dysfunction with FEV1 <50 % or DLCO2 <50 % of predicted; neurological dysfunction [dementia, Alzheimer’s
disease, Parkinson’s disease, vascular disease with persistent physical limitation]; gastrointestinal dysfunction – Crohn’s disease, ulcerative colitis, nutritional impairment or serum albumin
<3.0; cancer – active malignancy; and liver – any history of cirrhosis, variceal bleeding or elevated INR in the absence of therapy).
• Severe procedure-specific impediment (for example: tracheostomy present, heavily calcified ascending aorta, chest malformation, arterial coronary graft adherent to posterior chest wall or
radiation damage).
ACC = American College of Cardiology; ACCF = American College of Cardiology Foundation; AHA = American Heart Association; CRT = cardiac resynchronisation therapy; DLCO2 = diffusing
lung capacity for carbon dioxide; EACTS = European Association for Cardio-Thoracic Surgery; ESC = European Society of Cardiology; FEV1 = forced expiratory volume in one second; GDMT =
guideline-directed medical therapy; INR = international normalised ratio; MR = mitral regurgitation; NYHA = New York Heart Association.
Figure 2: MitraClip
®
Delivery System and Guiding Catheter and Characteristics of the Clip
Figure 3: Three-dimensional Transoesophageal Echocardiogram Guidance During MitraClip
®
Implantation
A B C
(A) After transseptal puncture, the position and distance to the mitral valve is measured. A high and posterior puncture is aimed. (B) Orientation of the clip in the mitral valve (MV),
perpendicular to the MV opening, assessed by three-dimensional transoesophageal echocardiogram (3D-TOE), from the left atrium (LA). (C) Final result after MitraClip implantation from the LA
with two MV orifices, mimicking the Alfieri´s surgical edge-to-edge leaflet technique.
Heart Failure
EUROPEAN CARDIOLOGY REVIEW
52
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Functional Mitral Valve Regurgitation
Ischaemic MR is characterised by restrictive mitral leaflet mobility
due to dyskinesia or akinesia of the ventricular wall involving one
or both papillary muscles, thus, extending the distance between the
ventricular wall and the leaflets. The posterior papillary muscle is
the most frequently affected.
FMR is associated with a poor prognosis in heart failure patients
with post-ischaemic or idiopathic dilated cardiomyopathy.
3
Surgical
MV repair may be considered in severely symptomatic patients
with severe FMR despite optimal medical therapy and cardiac
resynchronisation therapy.
35,36
Although several studies have reported
reverse LV remodelling and improvements in symptoms and quality of
life after surgical mitral repair,
36
operative mortality is not negligible,
ranging from 8.8% to 21.0%.
37
Moreover, there is a high number of
patients with severe FMR who are not referred for surgery because
of advanced age, high surgical risk and co-morbidities.
8
Surgical Treatment
Historically, the surgical approach to patients with FMR was to perform
MV replacement, but it had a high impact on LV systolic function and
exerted high mortality rates. Techniques of MV replacement, such
as prosthesis implantation with preservation of the subvalvular
apparatus, and prosthesis implantation with preservation of one
or both leaflets (usually posterior) have evolved to improve the
long-term haemodynamic function and clinical status of these
patients
38
Replacement should be reserved for cases of acute
papillary muscle rupture in relation to acute myocardial infarction.
39
In
appropriately selected patients, restrictive annuloplasty is associated
with low operative mortality and is effective in eliminating MR.
Acker et al.
40
have recently published the randomised comparison of
MV repair versus replacement for severe ischaemic MR. At 12 months,
the rate of death was 14.3% in the repair group and 17.6% in the
replacement group (hazard ratio with repair, 0.79; 95 % confidence
interval, 0.42–1.47; p=0.45), with an increased rate of moderate or
severe recurrence of MR at 12 months in the repair group compared
with the replacement group (32.6% versus 2.3%, p<0.001). Patient
selection for repair is crucial. When the pre-operative clinical and
echocardiographic data suggest that annuloplasty alone is unlikely to
be successful and durable, additional surgical procedures should be
used to enhance the effectiveness of MV repair.
39
Since FMR exerts high mortality and high incidence of recurrence of
MR after repair, several alternative treatments have been proposed.
Percutaneous Edge-To-Edge Repair
EVEREST II trial included 26 % patients with FMR randomised to
surgery or Mitraclip treatment. Recently reported five-year data
(EuroPCR2014) have shown that freedom from mortality in Mitraclip
patients (n=48) and surgical patients (n=18) is comparable within
aetiologies: FMR Mitraclip 59.7% and FMR Surgery 55.0%, compared
with a 86.0–89.0 % survival for the DMR group. Moreover, 90 %
of FMR patients treated with Mitraclip were free from MV surgery of
re-operation at five years, compared with 81 % treated surgically.
Durability of the Mitraclip repair was confirmed at five years follow-up,
with 86% of the patients in both groups with MV regurgitation grades
1+ or 2+. NYHA I/II functional class at five years was present in FMR
in 76 % of the Mitraclip patients compared with 100 % of surgical
survivors at five years. Mitraclip patients had comparable stability of
mitral annular dimensions at five years compared to baseline (3.8 cm
versus 3.7 cm, p=0.20).
Taramasso et al.
41
have recently published the results of Mitraclip
implantation in 109 consecutive patients with FMR and prohibitive
surgical risk (logistic EuroSCORE [LogEuroscore] 22 ± 16 %). Mean
ejection fraction (EF) was 28 ± 11 %; left ventricular end-diastolic
diameter (LVEDD) was 68 ± 8 mm. Procedural success was 99.0%
and 30-day mortality was 1.8 %. At discharge, 87 % patients had
MR ≤2+. At 12 months, EF was 34.7 ± 10.4 % (p=0.002 compared
with pre-operative value). Actuarial survival at three years was 74.5
± 7.0%. Actuarial freedom from MR ≥3+ at 2.5 years was 70 ± 6%.
At one-year follow-up, 86 % of patients were in NYHA Class I-II.
Pre-operative pro-B-type natriuretic peptide (pro-BNP) level ≥1,600
pg/ml was identified as an independent risk factor of mortality
at follow-up.
Recently, the new European guidelines included the MitraClip as a
treatment option in high-risk and inoperable patients with FMR and
severe symptoms despite optimal medical therapy (class IIb indication
with evidence C) (see Table 1).
21, 42–44
In the EVEREST II high surgical risk
cohort, a 44% reduction of the annual rate of hospitalisations was
observed (0.82–0.46, p=0.0004) after Mitraclip implantation.
After EVEREST II trial results (EuroPCR2014), including standard-risk
patients, future guidelines may consider Mitraclip treatment as an
option for FMR since it exerts sustained reduction of MR severity,
sustained improvement in LV volumes and dimensions, and sustained
improvement in NYHA functional class at five years, with low rates of
conversion to MV surgery overall.
Conclusions
MitraClip therapy is a safe procedure in selected high-risk patients
and can be accomplished with low morbidity and mortality.
MV repair is the preferred treatment for degenerative MV regurgitation.
However, Mitraclip implantation should be considered for high-risk
surgical patients.
For FMR, Mitraclip is a valuable clinical option in patients with adequate
anatomy who are considered inoperable or with a high surgical risk,
and should be considered as an important therapeutic modality in the
multidisciplinary treatment of heart failure. We need to treat patients at
an earlier stage to achieve better prognostic outcomes. n
Mitral Regurgitation – A Multidisciplinary Challenge
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