Percutaneous valve therapies: present and future Transcatheter Mitral Valve Replacement Nicolas Dumonteil, MD Toulouse
Disclosure Statement of Financial Interest I currently have, or have had over the last two years, an affiliation or financial interests or interests of any order with a company or I receive compensation or fees or research grants with a commercial company : Speaker's name: Nicolas, Dumonteil, Toulouse ☑ Mes liens d’intérêt en rapport avec cette présentation sont : - proctoring fees : Abbott
Is there a need for a transcatheter mitral prosthesis ?
Is there a need for transcatheter mitral prosthesis ?
Transcatheter mitral prosthesis: technological challenges • Mitral valvar complex is large and assymetric large prosthesis , large sheaths (> 30 Fr) • Dynamic complex flexibility/resistance; fixation/anchoring system • Potential for left ventricular outflow tract obstruction by the device complex design
TMVR landscape … Braile Braile CardiAQ CardiAQ Cephea 1 st G Biomedica Biomedica Edwards Direct Flow Twelve M-Valve Edwards HighLife Medical Medtronic Fortis Navigate Neovasc PermaValve Sinomed Tendyne Tiara MID Abbott Others: Caisson, MitraHeal, Mitrassist, Mitraltech, Mehr Medical, Mitracath, Mitralix MAESTRO, Nakostech, St. George ATLAS, Transcatheter Technologies SATURN Valtech Daidalos Tresillo TMVR CardioValve sutureless clamp
Tendyne Transcatheter Mitral Valve • Tri-leaflet porcine pericardial valve • Self-expanding nitinol double frame • Large valve size matrix • Transapical access, valve tethered to apex • Valve fully retrievable and repositionable Muller DW et al , J Am Coll Cardiol. 2017 Duncan A et al, EuroIntervention. 2017
Tendyne Transcatheter Mitral Valve
Tendyne Transcatheter Mitral Valve Image Courtesy of D.Muller St Vincent’s hospital
Tendyne Transcatheter Mitral Valve • Compassionate case, Cl. Pasteur, Apr 2017 • Inoperable patient • Severe symptomatic FMR (ischemic) • LV EF 50 %
Tendyne Transcatheter Mitral Valve Baseline Demographics (n=75) 30 Day Outcomes (n=75) Age 74.7 ± 8.6 Mortality 6.7% (5/75) Female 33% Implant not Successful 4.0% (3/75) NYHA ≥ III 65% Re-Intervention 2.6% (2/75) FMR 73% PVL 1.3% (1/75) LVEF 48% Device Malpositioning 1.3% (1/75) STS Score 7.1 ± 4.8 Device Thrombosis 1.3% (1/75)
Tendyne Transcatheter Mitral Valve Baseline Demographics (n=75) 30 Day Outcomes (n=75) Age 74.7 ± 8.6 Mortality 6.7% (5/75) Female 33% Implant not Successful 4.0% (3/75) NYHA ≥ III 65% Re-Intervention 2.6% (2/75) FMR 73% PVL 1.3% (1/75) LVEF 48% Device Malpositioning 1.3% (1/75) STS Score 7.1 ± 4.8 Device Thrombosis 1.3% (1/75)
Tendyne : 1 year outcomes Outcome N=30 Death (all cause) 5 (16.7%) Cardiac 4 (13.3%) Non-cardiac 1 (3.3%) CVA/TIA 0 (0%) Re-hospitalisation Heart failure 3 (10.0%) MV surgery 0 (0%) Valve performance (n=28) Malposition/PVL/hemolysis 1 (3.6%) Leaflet thrombosis 1 (3.6%)
1 year MR assessment post Tendyne TMVR 100% 5.3 5.3 90% 80% 70% Grade 4 94.7 94.7 89.5 60% Grade 3 50% Grade 2 40% Grade 1 30% Grade 0 20% 10% 10.5 0% Baseline 1mth 12mths N: 19 19 19
NYHA Functional class at 1 year 100% 5.0 7.1 90% 17.9 80% 53.3 70% 55.0 60% Class 4 50.0 Class 3 50% Class 2 40% Class 1 30% 46.7 40.0 20% 25.0 10% N: 0% Baseline 1month 12months >1 class improvement in 60%
Medtronic Intrepid Product Overview • TA Delivery, self-expanding nitinol; conformable outer, circular inner, with a bovine pericardial trileaflet valve • Fixation achieved by radial expansion, barbs, • Next gen system includes partial retrievability and TF delivery. Bapat V et al , J Am Coll Cardiol. 2017
TWELVE Deploiement par voie transapicale 1 2 3 4 Advance across Deploy brim Retract to Expand Release mitral valve desired position fixation ring
FIH Results • Secure Fixation • No LVOT obstruction • Implant is in contact with the annulus around the entire perimeter L L A A Ao L L V V FIH-002 (19 Nov 2014) 18 --- Confidential ---
FIH Results • Implant Conforms to Anatomy • Outer structure conforms to the native annulus shape • Inner valve support remains round FIH-004 (6 May 2015) 19 --- Confidential ---
MDT Intrepid Baseline Demographics (n=50) 30-day Outcomes (n=75) Age 73 ± 9 Procedure Mortality 9% (4/44) Female 42 % 30-day Mortality 18% (8/44) NYHA ≥ III 86 % Overall Mortality 25% (11/44) FMR 84 % Implant not Successful 5% (2/43) LVEF ~43% STS Score 6.4 ± 5.5 Bapat V et al , J Am Coll Cardiol. 2017
MDT Intrepid Baseline Demographics 30-day Outcomes (n=50) Age 73 ± 10 Procedure Mortality 9% (4/50) Female 34% 30-day Mortality 14 % (7/50) NYHA ≥ III 86% Median deployment time 14 minutes FMR 80% Implant not Successful 4 % (2/50) LVEF ~43% Stroke (disabling) 0 STS Score 6.6 ± 6 Repeat interventions 0 Bapat V et al , J Am Coll Cardiol. 2017
TMVR worldwide Implants (Oct 2017): 246 Caisson CardiaQ Tiara Highlife Access TA / Trans Femoral (TF) TA TF TAp/TAtrial NiTi frame with unique- 2-part implant :D-shaped Nitinol wire frame with a NiTi frame anchored by ‘arms’ shaped leaflets which nitinol anchor, and a nitinol suture loop placed Description that engage the free-edge of anchors via 3 posts under valve frame with a porcine behind the leaflets to the leaflets the leaflets pericardial tissue valve anchor and seal Status CU/EFS CU/CE Mark CU/EFS CU/EFS Implants 24 34 12 8 CE Mark and US EFS 10 TF 14 TA Special access:20 FIM TA experience Comp:5-TF 9-TA Tiara I : 13 study: 11 EFS 5-TF 5-TA Tiara II: 1 Compassionate:1 30-d mortality 38 % (5/13) 12 % (4/33) 17 % (2/12) 25 % (2/8) 2 2
TMVI pre-op screening: CT scan
TMVI pre-op screening: CT scan
Conclusion • Early stage of development, only compassionate cases or early feasibility/CE mark trials • Inoperable or High surgical risk patients, partially explaining observed mortality • Both degenerative (primary) and functional (secondary) MR can be treated • Good short-term outcomes : functional improvement, effective MR reduction • Technically standardized, reproducible • Very restrictive anatomical selection with a high rate of screening failure, mainly related to non suitable size or prohibitive risk of LVOT obstruction
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