Sergio Berti Ospedale del Cuore Fondazione C.N.R. Reg ... · Sergio Berti Ospedale del Cuore...
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Sergio Berti Ospedale del Cuore Fondazione C.N.R. Reg Toscana Massa/Pisa
Transcript of Sergio Berti Ospedale del Cuore Fondazione C.N.R. Reg ... · Sergio Berti Ospedale del Cuore...
Sergio BertiOspedale del Cuore
Fondazione C.N.R. Reg Toscana Massa/Pisa
Prevalence of Valvular Disease
The Lancet, Vol. 368, Nkomo, V. T. et al., Burden of valvular heart diseases: a population-based study, Pages 1005–1011, Copyright (2006)
Mitral Valve Phisiology
The expanding portfolio of transcatheter mitral repair and replacement
MitraClip
Neochord
Harpoon
Chordart
….
Cardioband
Mitralign
Carillon
Millipede
….
Tendyne
Neovasc
CardiaQ
Twelve
….............
CE marked therapiesCompany Abbott NeoChord CardiacDim ValTech Mitralign
Name MitraClip DS1000 Carillon CardioBand TA and TF Bident and Tricuspid
Description Alfieri technique Neochordal implant from the TA approach
Coronary sinus cinching Surgical ring implanted percutaneously Plication device
Strengths • Minimal invsivenes • Strong surgical background simplicity• Strong surgical background• Atrial delivery
• simplicity
Weaknesses • Lack of annuloplasty • TA approach • Limited efficacy• Complexity• imaging
• Efficacy limited in mitral position
Status • >40000 • 200-300 pts • 600 pts• 80-100 • >80-100
CEO / Loc. Miles White / Redwood City, CA David Chung / Eden Prairie, MN Rick Stewart / Kirkland, WA Amir Gross / Or Yehuda, Israel Rick Geoffrion / Salem, NH
CE marked therapies
PMVR devices under development
Trascatheter devices for MR: Device Landscape 2017
Edge to Edge• Abbott Mitraclip• Edwards Pascal• Mitraflex
Coronary sinus annuloplasty• Cardiac Dimension Carillon• Cerclage Annuloplasty
Direct Annuloplasty• Edwards Cardioband• Mitralign TAMR• Valcare Amend• GDS Ancora Heart Accucinch• Millipere IRIS• MVRx ARTO• Mardil Ven Touch• Mitraspan TASRA• Micardia enCor• Cardiac Implants RDS• QuantumCor (RF)• Valfix
MV replacement
• Abbott Tendyne (83)
• Medtronic Intrepid (44)
• Neovasc TIARA (26)
• Edwards CardiaQ (13)
• Highlife (8) Livanova
• Caisson (6) Livanova
• Edwards Fortis
• Mvalve
• NCSI Navigate
• Cephea
• St.Jude
• Micro Interventional
• Valtech CardioValve
• ValveXchange
• MitrAssist
• BraileQuattuor
• Direct Flow
• Sinomed Accufit
• Corona MVR w/Amend ring• MitraHeal• HT Consultant Saturn• Lutter Valve• Transchatheter Technologies
– Tresillo– Venus– Verso
• Trasmural Systems• 4C
Other Approaches• Neochord DS 1000• Harpoon neochords Edwards• Babic chords• Middle Peak Medical• St.Jude leaflet plication• Cardiosolutions Mitra Spacer• Mitralix• Valtech Vchordal• Coromaze Mitramaze
l
CE MARKEDFIM (number of patients as of May 2017)
Mitraclip
First
Second
10
Freedom From Mortality
Freedom From MV Surgery in mitraclipgroup or Re-operationin surgery group
EVEREST II RCT5 YEAR RESULTS
Direct Annuloplasty by Cardioband
Trans-femoral venous access
(transeptal) – best for safety
• Supraannular fixation like in surgery
• Significant Reduction of Annular
dimensions – device enables reduction
of up to size 28 surgical ring
• Preserves the native anatomy – keeps
future options open
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Direct Annuloplasty by Cardioband
Trans-femoral venous access
(transeptal) – best for safety
• Supraannular fixation like in surgery
• Significant Reduction of Annular
dimensions – device enables reduction
of up to size 28 surgical ring
• Preserves the native anatomy – keeps
future options open
12
Direct Annuloplasty by Cardioband
Trans-femoral venous access
(transeptal) – best for safety
• Supraannular fixation like in surgery
• Significant Reduction of Annular
dimensions – device enables reduction
of up to size 28 surgical ring
• Preserves the native anatomy – keeps
future options open
13
3D TEE views for different regions
Surgical view - overview
P1 P1
P1 P2 - non surgical view P3
Direct Annuloplasty by Cardioband
Direct Annuloplasty by Cardioband
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3-4+
3-4+ 3-4+ 3-4+ 3-4+
2+
2+ 2+ 2+ 2+
0-1+ 0-1+0-1+ 0-1+
0%
20%
40%
60%
80%
100%
Baseline Discharge 30 days 6 Months 12 Months
95% MR ≤ 2+
at 12 Months
95% MR ≤ 2+
at 6 Months
92% MR ≤ 2+
at 30 Days
N=39
Edwards Cardioband Mitral CE Mark TrialMR reduction sustained at 1 year in paired analysis by core lab*
*Dr. Paul Grayburn – Baylor University
A. Vahanian, Multicentre trial results of the transcatheter mitral valve repair system for functional mitral regurgitation, presented at PCR London Valves 2017.
20
22
24
26
28
30
32
34
36
38
Baseline 12 Months
Sep
tola
tera
lD
iam
eter
[m
m]
36±4(29-46)
25±4(19-35)
18
*P<0.01
36±4(29-46)
Edwards Cardioband Mitral CE Mark Trial28% average reduction in septolateral diameterby core lab*
17
22
27
32
37
42
47
Baseline 12 Months
Sep
tola
tera
lDia
met
er [
mm
]
N=31*Dr. Paul Grayburn – Baylor University
A. Vahanian, Multicentre trial results of the transcatheter mitral valve repair system for functional mitral regurgitation, presented at PCR London Valves 2017.
AMEND™ - A Breakthrough in MR Treatment
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Ring located linearly inside the delivery system
Ring deployment into D shapeSnappingStabilizing tool engagementReady for anchoring
Valcare Amend Deployment
Millipede IRIS Implant
Baseline
Valcare Amend + Mitraclip
Ospedale del Cuore CNR Massa
NEOVASC-TIARA
• 35 mm and 40 mm valves
• 32 Fr and 36 Fr sheathless systems
• Includes a loading system and pickups for loading
• Self dilating tip
• Transapical approach
• 0.035” guidewire compatible
• 35 mm and 40 mm valves
• 32 Fr and 36 Fr sheathless systems
• Includes a loading system and pickups for loading
• Self dilating tip
• Transapical approach
• 0.035” guidewire compatible
Size(mm)
Mitral Annulus Circumference
(cm)
Atrial Height(cm)
Annulus Area(cm2)
Distance
A-P(mm)
C-C(mm)
35 9.3 – 11.0 ≥ 5.0 6.5 – 9.026.5 –30.0
31.0 –35.0
40 11.0 – 12.5 ≥ 5.0 9.0 – 12.030.0 –34.0
35.0 –40.0
NEOVASC-TIARA
NEOVASC-TIARA
NEOVASC-TIARA
NEOVASC-TIARA
NEOVASC-TIARA
Ospedale del Cuore FTGM-CNR Massa
Ospedale del Cuore FTGM-CNR Massa
NEOVASC-TIARA
Ospedale del Cuore FTGM-CNR Massa
NEOVASC-TIARA
Ospedale del Cuore FTGM-CNR Massa
NEOVASC-TIARA
Ospedale del Cuore FTGM-CNR Massa
NEOVASC-TIARA
Ospedale del Cuore FTGM-CNR Massa
NEOVASC-TIARA
Tendyne Transcatheter Mitral Valve
Tendyne Device
• D-Shaped Self-Expanding Nitinol Outer Frame
• Designed to Conform to Native MV Anatomy
• Circular Self-Expanding Nitinol Inner Frame
• Large Effective Orifice Area (>3.0cm2)
• Larger EOA than any Surgical Valve
• Porcine Pericardial Tri-Leaflet Valve
• Large Valve Size Matrix to Treat Varying Anatomies
• Outer Frame Sizes: 30-43mm AP x 34-50mm CC
• Valve Tether to Apex
• Provides Valve Stability - Designed to Reduce PVL
• Apical Pad Assists in Access Closure
30 Day 4D-CT Reconstruction
Image courtesy of D- Muller, St Vincent’s Hospital
Three-chamber view
Three-chamber view of the heart and implanted valve showsthe valve, left ventricular outflow tract, and tether placement
IVC
TK
AoSVC
Fossa
bicaval
SAX
4-Ch
RA aspect IAS
The power of imaging
The power of imaging: 2D-3D-4D CT scan
The power of imaging: 3D ICE
3DECHO
CARDIACCT
IMAGE FUSION
XA
3D ECHO MODEL
3D CT MODEL
2D PROJECTION
XA-CT-ECHO FUSION
FTGM CNR Massa
• The treatment of MR is now an emerging hot topic inthe field of valve heart diseases therapies:
Large unmet clinical need
• Percutaneous MV technologies may be useful for alarge amount of patients who are at high risk for open-heart surgery.
• Cardiac Surgery experience in repair/replacement isirreplaceable in new percutaneous devicesdevelopment
Take-Home Messages
Sergio BertiOspedale del Cuore
Fondazione C.N.R. Reg Toscana Massa/Pisa
