HEARTLINE Genova 10-11 novembre 2017 Cardioband: una chance per l insufficienza mitralica funzionale Sergio Berti Ospedale del Cuore Fondazione C.N.R. Reg Toscana Massa/Pisa
Reduction of Septo Lateral (A-P) Diameter by Cinching Reduction in A-P Cinching performed on Cadaveric Heart (TVT 2012) 2
Cardioband procedure: Major Steps 3
Cardioband procedure: Major Steps 4
No complex etiology : No chord rupture No pseudo prolapsed No severe tethering > 11mm (tethering height ) - unless considered for CB +clip LVEDD<70 mm Consideration for Success Systolic Sphericity index < 0.7 No thin ventricle wall No Severe Right heart failure and or Severe TR
Leaflets Angles < 45 Intercommissural diameter (IC) Coaptation depht (CD) IC/CD Angles between annulus plane and leaflets
CT Scan quality Good/Fair/Bad CT scan quality 10
On Face View of Annulus Sizing 108 mm -> Implant Size D Measuremen ts mitral valve Annulus commissure to commissure by CT (mm) Implant size ATA Anchor to anchor diatance SAT MAX No Of anchors required 73-80 A 77 3.5 12 81-88 B 85 4 13 89-96 C 93 4.5 14 97-104 D 101 5 15 105-112 E 109 5.5 16 113-120 F 117 5.5 17
Fluoroscopy Projections Onface View LAO CAU short axis Perpendicular View RAO CRA long axis LAO: 35 CAU: 20 RAO: 20 CRA: 0 CLD114 comments: Fluoroscopic angles was manually calculated from the CT scan
Cardioband-procedural steps Imaging modalities used during different procedural steps Access Femoral vein Transseptal puncture Transseptal sheath (TSS) positioning Guide catheter (GC) positioning at the landing zone for the 1st anchor Navigation of the GC/device deployment Size adjustment and evaluation of final result (Annular dimensions/ MR grade) Echo/ Fluoro Echo/ Flouro Echo/ Fluoro Echo/ Fluoro Echo/ Flouro
Cardioband- procedural steps 1. Transseptal puncture & introduction of TSS
TSP - available area of puncture Not possible TSP area Possible TSP area Optimal Point
4 Ch Puncture height: Optimal transseptal puncture site Trans-septal Puncture ME Bicaval view reconstruction Pre-defined by CT Bicaval 16 mm from muscular part SAX 24 mm from Aorta
bicaval Transseptal puncture 2D TEE views RA aspect IAS SVC 4-Chambers Short AX Ao Fossa TK IVC
Transseptal puncture 3D TEE Anterior of the postero-medial commissure
Cardioband- procedural steps 2. System insertion
Insertion of the transseptal sheath 3D TEE Avoid wire in the LAA
Cardioband- procedural steps 3. Implant deployment
The first three anchors Cardioband Implant 1 st 2 nd & 3 rd anchor serve as root foundation for the procedure
Navigation scheme Anterior TSS CW rot TSS +\- GC +/- GC - \ + TSS CCW rot. TSS + GC +/- TSS + \ System pull back GC +/- GC + hooking TSS - CLD114 2 Posterior
Imaging for deployment of the 1st anchor As anterior as possible! Navigation LAO and 3D Zoom imaging Spool IC tip
Imaging for deployment of the 1st anchor SAX at the base Final check 2D/biplane imaging Spool Spool Hinge point Sometimes it s easier to find Distance from aorta? the first / last anchor location from Short Axis at the base. Distance from hinge point? Deployment angle? Proximity to vessels? Spool lateral?
Biplane imaging- check for each anchor: Distance to the hinge point Examples Position of the Implant Catheter (IC) tip on the annulus with regard to Distance from hinge point Proximity of vessels Angle of deployment in two orthogonal planes (angle towards annulus and early feed back angle, see figure)
Check for each anchor Distance to vessels Examples Position of the Implant Catheter (IC) tip on the annulus with regard to Distance from hinge point Proximity of vessels Angle of deployment in two orthogonal planes (angle towards annulus and early feed back angle, see figure) 90 150 Distance from hinge point
Imaging for Anchor deployment Anchor deployment RAO and 2D/biplane imaging pull test RAO and 2D/biplane imaging Tip of the implant and tissue move in unison Relative movement of GC tip towards IC tip Extrasystolic beats may occur
Landing zone and hinge point in 3D Workflow: from AL to PM commissure AL PM P1 P3 P2 Diastole Systole
3D TEE views for different regions Examples Surgical view - overview P1 P1 P1 P2 - non surgical view P3 Distance from hinge point
Cardioband- procedural steps 4. Implant size adjustment
Cardioband- Pre-size procedural adjustment steps Measure IC and AP diameters
Final result Edwards Comparison Cardioband pre and post System size adjustment Results PRE POST Dr. Eustachio Agricola Ospedale San Raffaele, Milano 33
Cardioband- Size adjustment procedural steps
Cardioband- Release procedural steps
Annular dimesnions pre and post size adjustment D1= 4.5cm D2= 3.45cm D1= 3.11cm D2= 2.47cm D3= 3.12cm D4= 4.44cm A1=10.33cm² D3= 2.64cm D4= 3.81cm A1=6.96cm² Pre cinching Post cinching Annular area reduction of 32%
Edwards Cardioband Mitral CE Mark Trial Study Demographics (Full Analysis Set N=61) Variable Age (years) Gender Euroscore II (%) Baseline NYHA Class of III or IV Ischemic Non Ischemic LVEDD (mm) Avg SD EF (%) Avg SD Previous CABG COPD Moderate to Severe Renal Failure Severe Pulmonary Hypertension Atrial Fibrillation No. (%) or Mean±SD 72 ± 7 Male 44 (72%) Female 17 (28%) 7.1 52 (85%) 36 (59%) 25 (41%) 60 ± 6 33 ± 11 19 (31%) 13 (21%) 46 (75%) 15 (25%) 46 (75%) A. Vahanian, Multicentre trial results of the transcatheter mitral valve repair system for functional mitral regurgitation, presented at PCR London Valves 2017.
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% 0-1+ 0-1+ 0-1+ 0-1+ 40% 3-4+ 20% 2+ 2+ 2+ 2+ 0% 3-4+ 3-4+ 3-4+ 3-4+ 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 2017.
Septolateral Diameter [mm] Septolateral Diameter [mm] Edwards Cardioband Mitral CE Mark Trial 28% average reduction in septolateral diameter by core lab* 47 38 *P<0.01 42 36 34 37 32 27 22 32 30 28 26 24 22 36±4 (29-46) 36 ±4 (29-46) 25±4 (19-35) 17 Baseline 12 Months 20 Baseline 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 2017.
Meters Walked MLHFQ Score % of population Edwards Cardioband Mitral CE Mark Trial Significant functional improvement at 12 months 400 6MWT P<0.01 Δ = 58 MLHFQ Score P<0.01 Δ = -21 NYHA Class P<0.01 375 40 42 350 325 300 275 309 367 30 20 21 79% NYHA I/II 250 225 10 200 Baseline 12 Months 0 Baseline 12 Months N = 29 N = 36 N = 39 6MWT Six Minute Walk Test; MLHFQ - Minnesota Living With Heart Failure Questionnaire; NYHA Class - New York Heart Association (NYHA) Functional Classification A. Vahanian, Multicentre trial results of the transcatheter mitral valve repair system for functional mitral regurgitation, presented at PCR London Valves 2017. 42
Conclusions Transcatheter mitral repair using the Edwards Cardioband Mitral Repair System is safe and feasible Provides significant and consistent reduction in septolateral diameter Delivers a significant and consistent reduction in mitral regurgitation in patients with secondary functional MR Further studies are warranted A. Vahanian, Multicentre trial results of the transcatheter mitral valve repair system for functional mitral regurgitation, presented at PCR London Valves 2017. 43
HEARTLINE Genova 10-11 novembre 2017 Cardioband: una chance per l insufficienza mitralica funzionale Sergio Berti Ospedale del Cuore Fondazione C.N.R. Reg Toscana Massa/Pisa