Sergio Berti Ospedale del Cuore Fondazione C.N.R. Reg Toscana Massa/Pisa

Transcription

1 Sergio Berti Ospedale del Cuore Fondazione C.N.R. Reg Toscana Massa/Pisa

2 Prevalence of Valvular Disease The Lancet, Vol. 368, Nkomo, V. T. et al., Burden of valvular heart diseases: a population-based study, Pages , Copyright (2006)

3 Mitral Valve Phisiology

4 The expanding portfolio of transcatheter mitral repair and replacement MitraClip Neochord Harpoon Chordart. Cardioband Mitralign Carillon Millipede. Tendyne Neovasc CardiaQ Twelve...

5 CE marked therapies CE marked therapies Company 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 > pts 600 pts > 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

6 PMVR devices under development

7 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 MARKED FIM (number of patients as of May 2017)

8 Mitraclip First Second

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10 EVEREST II RCT 5 YEAR RESULTS Freedom From Mortality Freedom From MV Surgery in mitraclip group or Re-operation in surgery group 10

11 11 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 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 13 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

14 3D TEE views for different regions Surgical view - overview P1 P1 P1 P2 - non surgical view P3

15 Direct Annuloplasty by Cardioband

16 Direct Annuloplasty by Cardioband

17 Edwards Cardioband Mitral CE Mark Trial MR reduction sustained at 1 year in paired analysis by core lab* 100% 92% MR 2+ at 30 Days 95% MR 2+ at 6 Months 95% MR 2+ at 12 Months 80% 2+ 60% % % % Baseline Discharge 30 days 6 Months 12 Months N=39 *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

18 Septolateral Diameter [mm] Septolateral Diameter [mm] Edwards Cardioband Mitral CE Mark Trial 28% average reduction in septolateral diameter by core lab* *P< Baseline 12 Months ±4 (29-46) Baseline 3 6 ± 4 ( ) 25±4 (19-35) 12 Months 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

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20 AMEND - A Breakthrough in MR Treatment Ring located Ring Stabilizing Ready deployment for tool linearly Snapping inside into engagement anchoring D shape the delivery system 20

21 Valcare Amend Deployment

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24 Millipede IRIS Implant

25 Baseline

26 Valcare Amend + Mitraclip Ospedale del Cuore CNR Massa

27 NEOVASC-TIARA 35 mm and 40 mm valves 32 Fr and 36 Fr sheathless systems Includes a loading system and pickups for loading 35 mm and 40 mm valves Self dilating tip 32 Fr and 36 Fr sheathless systems Transapical approach Includes a loading system and pickups for loading guidewire compatible Self dilating tip Transapical approach guidewire compatible Size (mm) Mitral Annulus Circumference (cm) Atrial Height (cm) Annulus Area (cm 2 ) A-P (mm) Distance C-C (mm)

28 NEOVASC-TIARA

29 NEOVASC-TIARA

30 NEOVASC-TIARA

31 NEOVASC-TIARA

32 NEOVASC-TIARA Ospedale del Cuore FTGM-CNR Massa

33 NEOVASC-TIARA Ospedale del Cuore FTGM-CNR Massa

34 NEOVASC-TIARA Ospedale del Cuore FTGM-CNR Massa

35 NEOVASC-TIARA Ospedale del Cuore FTGM-CNR Massa

36 NEOVASC-TIARA Ospedale del Cuore FTGM-CNR Massa

37 NEOVASC-TIARA Ospedale del Cuore FTGM-CNR Massa

38 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

39 30 Day 4D-CT Reconstruction Three-chamber view Three-chamber view of the heart and implanted valve shows the valve, left ventricular outflow tract, and tether placement Image courtesy of D- Muller, St Vincent s Hospital

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45 The power of imaging bicaval RA aspect IAS 4-Ch SAX SVC Fossa TK IVC Ao

46 The power of imaging: 2D-3D-4D CT scan

47 The power of imaging: 3D ICE

48 IMAGE FUSION XA 3D ECHO CARDIAC CT 2D PROJECTION 3D ECHO MODEL 3D CT MODEL XA-CT-ECHO FUSION FTGM CNR Massa

49 Take-Home Messages The treatment of MR is now an emerging hot topic in the field of valve heart diseases therapies: Large unmet clinical need Percutaneous MV technologies may be useful for a large amount of patients who are at high risk for openheart surgery. Cardiac Surgery experience in repair/replacement is irreplaceable in new percutaneous devices development

50 Sergio Berti Ospedale del Cuore Fondazione C.N.R. Reg Toscana Massa/Pisa