Istituto Clinico S. Ambrogio, Milano

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TrattamentoTrans-catetere
dell’insufficienza mitralica
Francesco Bedogni
Severe MR Leads to Increased Hospital Admissions
and Lower Survival Rates
Significantly higher hospital admissions
experienced by patients with moderate to
severe MR1
Significantly lower survival rates
experienced by patients with
moderate to severe MR2
P= 0.021
100%
18
16
14
12
10
79%
18.8
80%
Higher HF
Readmission Rate
Survival Probability
HF Re-Hospitalization
Hospitalization Rate
(# events / # patients)
20
10.5
8
6
4
60%
40%
P= 0.0001
20%
2
No MR
Mild MR (1+ or 2+)
Mod/sev MR (3+ or 4+)
0
No/Mild MR
Moderate/Severe MR
Through follow-up ~ 7 yrs (N=218 cases matched 1:1)
0%
0
1
2
3
4
5
Years
In pts hospitalized for HF ~ 74% had a moderate or severe MR
1
2
The risk of mortality is proportional to the grade of
regurgitation
Markwick et al. Prognostic Implications of Moderate and Severe Mitral Regurgitation in Contemporary Clinical Care. TCT 2012
Trichon BH et al. Am J Card. 2003,91:538-43
Survival of Heart Failure Patients with MR by Degree of MR Adjusted for
demographics and clinical variables at baseline
Survival Post-Surgery for Isolated FMR
N = 482
Mean age = 65 yrs
Prior MI = 100%
77%
at 1yr
~72%
at 2yrs
Gillinov et al. J Thorac Cardiovasc Surg; 2001
Glower et al J Thoracic Cardiovasc Surg 2005
Percutaneous MV Repair
Device Landscape 20102010-2015
Edge--to
Edge
to--Edge
MitraClip*
Edwards Mobius
ReCor (US)*
Quantum Cor (RF)
Valtech Cardioband
Micardia enCor
Coronary sinus annuloplasty Mitral valve replacement
Cardiac Dimensions Carillon*
Edwards Monarc*
Viacor PTMA*
Cerclage annuloplasty
Indirect annuloplasty
Ample PS3
St. Jude AAR
Mycor i-Coapsys
Direct annuloplasty
Mitralign*
QuantumCor
MiCardia ebCor
Accucinch*
• EndoValve
• CardiAQ
• Valtech Cardiovalve
• ValveXchange
• Tiara
Chordal shortening and
other
Cardiosolutions
Mitra-Spacer*
NeoChord
Valtech VChordal
*in patients
MitraClip System
Growing adoption
Worldwide Experience
Study
Population
N*
EVEREST I (Feasibility)
Feasibility patients
55
EVEREST II (Pivotal)
Pre-randomized patients
60
Non-randomized patients
(High Risk Study)
78
Randomized patients
(2:1 Clip to Surgery)
REALISM (Continued Access)
899
Compassionate/Emergency Use
66
ACCESS Europe Phase I
567
ACCESS Europe Phase II
286
Commercial Use
Commercial patients
Total
*Data as of 02/28/2015. Source: Abbott Vascular
279
184 Clip
95 Surgery
18,338
20,533
+95 surgery
MitraClip Therapy
Current Global Adoption
Treating Centers
Patients
(clinical and commercial)
Patients1 (commercial)
Implant
Rate1
Mixed
1.
2.
20,533
19,191
96%
Functional MR
Degenerative
483
MR2
65%
22%
13%
First-time procedures only. Includes commercial patients, ACCESS I and ACCESS II patients
Etiology not inclusive of U.S. cases as of 04/14/2014
Expanding European Adoption
145 sites
20 countries
United Kingdom
Turkey
Switzerland
Sweden
Austria Czech Republic
Belgium
Denmark Finland
France
Spain
Saudi Poland
Arabia
Norway
Netherlands
Kuwait
Italy
Germany
Israel
Greece
Mitraclip implant in Italy
291
GISE Dati Attività
Lombardia
126
126
74
2010
122
68
2011
122
291
102
2012
Italia
419
161
2013
620
204
2014
MR Etiology
Degenerative MR
Functional MR
Degenerative MR
85y MVP cordal roupture NYHA class III-IV
BASAL
2 CLIP
Functional MR
82 y/o Ischemic CMP 25% EF
ICD-CRT NYHA III-IV
3 hospitalisations in 2 months
1 year follow up:
no more hospitalisations
Changing demographics
Mitraclip 2011-2013 347 pz
Totale
<80
≥ 80
Pazienti
FMR
DMR
347
246 (70.8%)
101 (29.2%)
249 (71.7%)
208 (83.5%)
41(16.5 %)
98 (29.3%)
38 (38.7%)
60 (61.3%)
Evolving experience
75% considered high risk for MV surgery*
* Log Euroscore >20 STSscore > 12
67% Functional MR
Treating Centers:
Patients1:
476
19,191
Mixed
10%
DMR
23%
FMR
67%
What we have learned?
TRAMI Registry (Elderly)
Acute Results
Mitral Regurgitation Grade*
Volker Rudolph
Maisano ACC 2012
N = 392 Matched Cases
EuroPCR 2012
N = 4,025 Matched Cases
* As assessed by the sites
80% MR ≤ 2+
at 6 Months
p<0.0001
90% MR ≤ 2+
Post-Procedure
0+
2+
0
80
3+
1+
Percent Patients
100
60
40
100%
80%
60%
2+
4+
20
3+
4+
0
Baseline
6 months
3+
4+
40%
0+
1+
2+
20%
3+ 4+
0%
PreProcedure
PostProcedure
Left Ventricular Volumes
Left Ventricular End
Diastolic Volume
Left Ventricular End
Systolic Volume
Mean = -8.1 ml
97.5% UCB = -4.8 ml
p<0.0001
Mean = -17.9 ml
97.5% UCB = -13.5 ml
p<0.0001
Baseline
1 Year
Paired data (N=203)
Baseline
1 Year
Paired data (N=202)
Anti Remodelling Effect of
Various Therapies vs Placebo
2
%
10
20
Ace-i
Beta blockers
*vs baseline
CRT
Mitraclip
*
Courtesy of Michele Senni, Duino
Relation Between End Systolic Volume
and Natural History Outcomes
Migrino RO et al. Circulation. 1997;96:116-121
30
Mortality
CHF
25
Percent
20
15
10
5
0
<20
20-30
30-40
40-50
50-60
End-Systolic Volume (mL/m2)
>60
Functional improvement
Hospitalizations for Heart Failure
48%
reduction
p<0.0001
All treated
Che risultato possiamo accettare
Per ottenere una adeguato
successo clinico al follow-up ?
Left Ventricular End Diastolic Volume
Everest II High surgical risk cohort
Hospitalizations for CHF
Survival by MR Grade
LIM DS et al JACC in Press
Mitraclip
♦Long term efficacy
♦Impact on long term
mortaliy
♦Timing of treatment
EVEREST II RCT 4-year Results
•Long term event free survival comparable to surgery *initial
efficacy difference
Source: Mauri et al JACC 2013
KM observed vs predicted survival
following mitraclip therapy in FMR pts
San Raffaele hospital FMR population
Unpubblished data
Courtesy of Francesco Maisano
J Am Coll Cardiol 2012;59:130–9
Survival Curves
M.J Swans JACC Cardiovascular Intervention Vol 7 N.8 2014
Randomized trials vs OMT
COAPT TRIAL
Randomization 1:1 Device or Control
DEVICE GROUP CONTROL GROUP
MitraClip Device +
Optimal Standard of
Care Therapy
(Device)
Optimal Standard of
Care Therapy
(Control)
RESHAPE-HF Trial
Randomization 1:1 Device or Control
DEVICE GROUP
MitraClip Device +
Optimal Standard of
Care Therapy
(Device)
CONTROL GROUP
Optimal Standard of
Care Therapy
(Control)
Mitraclip
♦Long term efficacy
♦Impact on long term
mortaliy
♦Timing of treatment
Vicious Circle
Time is crucial
Robbins, Am J Cardiol 2003
Eisuke Amiya, Circ J 2006
Bursi, European J Heart failure 2010
Agricola, Eur J Heart Fail. 2009
MR:need for early diagnosis and referral
What we know from surgery
Risk Factors
with excess risk postpost-op
Symptoms
LV EF
LV ESD
Pulm.. HTN
Pulm
ERO
LA enlargement
BNP
AFib..
AFib
Predictor of combined events post Mitraclip
Eur J Heart Failure, Michael Neuss, 2013
Symptoms?
(Franzen et al)
End stage heart failure
Eur J Heart Failure, Michael Neuss, 2013
Natural history of MR
Trans-catheter Mitral Anuloplasty
CARILLON
CARDIOBAND
Trans-catheter Mitral Valve
CRT Mechanistic Outcomes
Outcome
Systolic BP (mm Hg)
Inter-ventricular
mechanical delay (ms)
Ejection fraction (%)
Left ventricular endsystolic volume (ml)
Mitral regurgitation (%
of LA Area)
NT Pro-BNP [pg mL-1]
Mean difference
at 3 mo*
+5.8
(P < 0.0001)
-21
(P < 0.0001)
+3.7
(P < 0.0001)
-18.2
(P < 0.0001)
-5.1
(P < 0.0001)
-225
(P = 0.36)
at 18 mo*
+6.3
(P < 0.0001)
-21
(P < 0.0001)
+6.9
(P < 0.0001)
-26.0
(P < 0.0001)
-4.2
(P = 0.003)
-1,122
(P = 0.0016)
* Positive values indicate higher value with CRT compared to control
52

Istituto Clinico S. Ambrogio, Milano

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