Mitral Valve Ring Abstract - sha

2/16/2014
Mitral Valve Ring Abstract
Mitral Valve Ring Experience at Prince Sultan
Cardiac Center
Haytham El Shurafa, Ahmed Al Fagih, Yahya Alhebashi, Abdulah
Alkhushail, Abdulrahman Almoghairi, Hussain Alamri, Abeer Aldhaferi,
Yousef Alanazi, Meshael Almyman, and Ali Masood
Outline
• Guidelines
• Mitral regurgitation treatment
• Carillon
• Idea
• Device features
• Device limitations
• European clinical experience
• PSCC mitral valve ring experience
• Conclusion
1
2/16/2014
Guidelines
• The 2005 ACC/AHA heart failure guidelines note that the effectiveness of
mitral valve repair or replacement for severe secondary mitral
regurgitation in refractory end-stage HF is not established
• The 2010 Heart Failure Society of America (HFSA) practice guidelines
lack of
proven
long-term
of mitral
repair
or
note thatThe
isolated
mitral
valve
repair orbenefit
replacement
forvalve
severe
mitral
regurgitation
secondary
to
ventricular
dilatation
in
the
presence
of
severe
replacement for functional MR is reflected in published
LV systolic dysfunction is not generally recommended
guidelines from major societies
• The 2006 International Society for Heart and Lung Transplantation (ISHLT)
guidelines for cardiac transplant candidates note that isolated mitral valve
repair (not associated with revascularization or ventricular restoration)
should not be routinely performed in patients with advanced LV
dysfunction and HF
Mitral Regurgitation Treatment
2
2/16/2014
Mitral Regurgitation Treatment
Idea Behind Carillon
• Why Carillon?
• Easy Access to the Coronary Sinus
• Rap and squeeze to reduce the Annulus Diameter
• Therapy looks promising
• Fast procedure
3
2/16/2014
Device Features
• Adjustable
• Addresses variable anatomies
• Optimize MR reduction
• Anchor Architecture in CS
• Preserves treatment options
• Designed to maintain position within CS
• Straight forward Access in CS
• Rapid deployment
• No trans-septal puncture
• Recapture Feature
• Avoid coronary compression
• Enables repositioning
Limitations of Carillon
4
2/16/2014
European Clinical Experience Overview
• Over than 200 devices implanted worldwide
• CE Mark approved
• Clinical outcomes consistently demonstrate:
• Significant reduction in MR
• Improvement in Functional capacity.
• Improvement in MR reduction is continuous over time
• Most recent clinical study (TITAN II) confirming positive outcomes seen in initial two
studies.
Study Results
AMADEUS
TITAN
TITAN II
30 patients implanted with 6month f/u
36 patients implanted with 3year f/u
30 patients implanted
Feasibility study of CARILLON
system
Safety and efficacy trial w/ nonblinded, non-randomized
comparison group
Safety and efficacy trial of
CARILLON mXE2
Feasibility established with
improvement in MR, functional
status and quality of life
Long-term improvements in MR,
functional status, quality of life
and reverse remodeling observed
Assessment of long-term
improvements in MR, functional
status, quality of life & reverse
remodeling
5
2/16/2014
PSCC Mitral Valve Ring Experience
Aim:
To assess clinical and echocardiographic improvement
following mitral annuloplasty using carillon mitral ring
device
PSCC Mitral Valve Ring Experience
Inclusion criteria:
• All patients with DCM and severe functional MR with
Class III – IV SOB in spite of maximum anti-failure
therapy.
6
2/16/2014
PSCC Mitral Valve Ring Experience
Exclusion criteria :
• Any heart failure secondary to valve pathology
• Any heart failure secondary to Ischemic heart disease
• Any heart failure secondary to DCM but mitral valve anteroposterior annulus
less than 3.5 cm
• Any heart failure secondary to DCM and with wide QRS complex on 12 leads
ECG ( more than 130 m.sec )
• Any heart failure secondary to DCM with Mitral Valve Regurgitation volume
less than or equal to moderate MR
PSCC Mitral Valve Ring Experience
Exclusion criteria :
• Any heart failure secondary to DCM not on maximum anti-failure therapy or
not more than 6 months
• Any heart failure secondary to DCM who are not symptomatic or midly
symptomatic (NYHA Class II or less )
• Any heart failure secondary to DCM with unsuitable coronary artery
• Any heart failure secondary to DCM with Creatinine clearance less than 30
ml/min
7
2/16/2014
PSCC Mitral Valve Ring Experience
Detecting parameters by echocardiography:
• MR severity by color Doppler assessment
• Vena contracta (VC)
• Effective Regurgitant Orifice area (EROA)
Clinical parameters:
• Heart failure out patient clinic visit for assessment for NYHA class and level of
medical therapy
• Clinical efficacy by performing 6 min walk
PSCC Mitral Valve Ring Experience
Primary Endpoint:
• Significant MR reduction (≥2
grades)
Secondary end point:
• Any MR reduction
• Clinical improvement
• 6 min walk improvement
8
2/16/2014
Study Design
Baseline
3 month
Follow-up
12 month
Follow-up
N= 12
N= 7
N= 0
1 month
Follow-up
6 month
Follow-up
N= 8
N= 0
Results
Screened Patients
Enrolled Patients
N=63
N=12
Successful
Implantation
Unsuccessful
Implantation
N=10
N=2
Non Device
related
mortality
Lost Follow-up
Non responders to
Echocardiography
Measurements
Significant
Improvement by
Echocardiography
N= 1
N= 1
N= 2
N= 4
Mild
Improvement
N= 2
Due to LCX
Compromise
9
2/16/2014
Complications
N=2
Heart failure post
procedure
Mild pericardial effusion
post procedure
N= 1
N= 1
Color Doppler Assessment
Baseline
Post- procedure
10
2/16/2014
Pre-Procedure
Post-Procedure
M-mode Assessment
Pre-procedure M-mode
Post-procedure M-mode
11
2/16/2014
Pre-procedure M-mode
Post-procedure M-mode
Echocardiographic Improvements following
Mitral Annuloplasty
Effective Regurgitant Orifice Area
Vena Contracta
1
0.8
0.9
0.7
0.6
0.7
EROA(CM²)
∆VC(CM)
0.8
0.6
0.5
0.4
0.3
0.5
0.4
0.3
0.2
0.2
0.1
0.1
P=0.004
0
P=0.003
0
Baseline
1month
∆VC (cm)
3month
Baseline
1month
3month
EROA(cm²)
12
2/16/2014
Mitral Regurgitation Reduction over time
MR Grade Reduction
4.5
4
3.5
MR GRADE
3
2.5
2
1.5
1
0.5
P≤0.001
0
Baseline
1month
3month
Clinical Efficacy
NYHA Class
6 Minute Walk Test
4
600
507
3.72
3.5
500
3
300
NYHA CLASS
METERS
400
266
200
2.77
2.66
2.5
2
1.5
1
100
P≤0.001
0.5
0
0
Baseline
1month
Baseline
1month
3month
13
2/16/2014
Conclusion
• The results showed significant clinical and echocardiographic
improvements when implanted in severe functional MR patients
• The initial results at our center appeared to be promising
• Short term significant reduction in MR was noted in some patients
• Further data and follow up investigations are required for a better
overall evaluation
Thank You
14

Download Report