next generation tavr technologies...369 353 342 330 319 296 portico valve commercial valve 0 30 90...
TRANSCRIPT
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Alexandre Abizaid, MD, PhD, FACC
Instituto Dante Pazzanese de Cardiologia
Sao Paulo, Brazil
Next Generation TAVR Technologies
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Conflict of Interest
Proctor for Boston Scientific and Edwards Life Science
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New TAVI systems: Why do we need new valves?
Before… …Today.
Edwards
Centera
Braile Biom.
Inovare
MyVal
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New Generation TAVR Devices:
▪ Sapien 3 Ultra (Edwards)
▪ Evolut R (Medtronic)
▪ Portico (Abbott)
▪ Lotus (Boston Scientific)
▪ Acurate Neo 2 (Boston Scientific)
▪ Jena Valve (JVT)
▪ Allegra (NVT)
▪ MyValve (Meril Life Science)
▪ Leaflex (Pi Cardia)
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New Generation TAVR Devices:
▪ Sapien 3 Ultra (Edwards)
▪ Evolute R (Medtronic)
▪ Portico (Abbott)
▪ Lotus (Boston Scientific)
▪ Symetis Accurate (Boston Scientific)
▪ Jena Valve (JVT)
▪ Allegra (NVT)
▪ MyValve (Meril Life Science)
▪ Leaflex (Pi Cardia)
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Valve Outer Skirt Comparison
SAPIEN 3 Valve SAPIEN 3 Ultra Valve
Same biocompatible PET material
Flat woven fabric Textured fabric
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Sheath Size
14F 20 mm 14F
The Edwards SAPIEN 3 Ultra System: Axela Sheath
7
Transient expansion and active contraction
Next-generation seamless expandable
sheath design
14F 23 mm 14F
14F 26 mm 14F
14F 29 mm 14F
Valve Size
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New Generation TAVR Devices:
▪ Sapien 3 Ultra (Edwards)
▪ Evolut R (Medtronic)
▪ Portico (Abbott)
▪ Lotus (Boston Scientific)
▪ Symetis Accurate (Boston Scientific)
▪ Jena Valve (JVT)
▪ Nautilus (NVT)
▪ MyValve (Meril Life Science)
▪ Leaflex (Pi Cardia)
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CoreValve Evolut Design Goals
True Anatomical Fit:
• Tailored height and shape
• Conformability and sealing with
optimized radial force and
interference across annular ranges
• Coaptation in non-circular anatomy
with supra-annular valve position
AOA®
Anti-Mineralization Treatment:
• Reduce both early and late valvular
calcificationR
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New Generation TAVR Devices:
▪ Sapien 3 Ultra (Edwards)
▪ Evolute R (Medtronic)
▪ Portico (Abbott)
▪ Lotus (Boston Scientific)
▪ Symetis Accurate (Boston Scientific)
▪ Jena Valve (JVT)
▪ Nautilus (NVT)
▪ MyValve (Meril Life Science)
▪ Leaflex (Pi Cardia)
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369 Assigned Commercial valve381 Assigned Portico valve
375 Treatment Initiated
361 Implanted 371 Implanted
30 Day FU: 97.2%
1 Year FU: 98.1%
30 Day FU: 97.5%
1 Year FU: 97.4%
Pivotal RCT: Patient Flow
750 Randomized (ITT)
ITT= Intention-to-Treat population
3 Withdrew informed consent
2 Died before procedure
1 Did not meet eligibility criteria
1 Randomized after subject expired
3 Did not meet eligibility criteria
2 Withdrew informed consent
1 Investigator decision
2 Died during implant procedure
1 Converted to SAVR
1 Unable to gain vascular access
1 Converted to SAVR
362 Treatment Initiated
750 randomized subjects enrolled from 52 sites in US and AUS between May 2014 to Oct 2017
1% 7% 57% 4% 25% 6%
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2.9%
Pivotal RCT: Primary Effectiveness Components
381 360 338 333 320 301369 356 347 335 324 300
Portico valve
Commercial valve
0 30 90 180 270 365
Days from Randomization
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
All-
Cau
se M
ort
alit
y at
1 Y
ear
14.3%
12.0%
Mean difference 2.3%
Log-rank p = 0.30
All-Cause Mortality
381 355 335 330 319 300369 353 342 330 319 296
Portico valve
Commercial valve
0 30 90 180 270 365
Days from Randomization
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Dis
ablin
g S
tro
ke a
t 1
Yea
r
Disabling Stroke
Mean difference -1.3%
Log-rank p = 0.30
# At Risk# At Risk
1.6%
2.9%
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Pivotal RCT: Primary Safety Components
Clinical Endpoint at 30 DaysPortico valve
N=381
Commercial valve
N=369
All-Cause Mortality 3.5% (13) 1.9% (7)
Disabling Stroke 1.6% (6) 1.1% (4)
Life Threatening Bleeding Requiring Transfusion 4.5% (17) 3.6% (13)
Acute Kidney Injury Requiring Dialysis 1.1% (4) 0.8% (3)
Major Vascular Complications 9.6% (36) 6.3% (23)
Difference in safety profiles driven by higher N of major vascular complications in Portico valve group (+3.3%).
Data presented as Kaplan-Meier Estimate Event Rates % (n of subjects with event)
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• Moderate or greater PVL is higher in Portico valve group
• 63% of all commercial valves implanted had a PVL reducing feature
Pivotal RCT: Paravalvular Leak
Portico valve (n=381) Commercial valve (n=369)
0%
20%
40%
60%
80%
100%99.6
93.7 92.5
97.9 98.5
37.7
45.5
58.1 59.2
Per
cent
of R
ando
miz
ed S
ubje
cts
Mild
Moderate
Severe
None/Trace
30 Days
n=33412 Months
n=266
30 Days
n=329
12 Months
n=262
99.7
None/Trace
Mild
Moderate
Severe
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New Generation TAVR Devices:
▪ Sapien 3 Ultra (Edwards)
▪ Evolute R (Medtronic)
▪ Portico (Abbott)
▪ Lotus (Boston Scientific)
▪ Symetis Accurate (Boston Scientific)
▪ Jena Valve (JVT)
▪ Nautilus (NVT)
▪ MyValve (Meril Life Science)
▪ Leaflex (Pi Cardia)
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See GlossarySH-31314-AD Nov 2012 Slide 17 of 39
Lotus ValveDesigned for Controlled Deployment
Pre-loaded valve, attached to a18F
delivery system
23mm & 27mm Diameter
Accurate Placement &
Repositionable
True Retrievability
Adaptive seal designed to minimize
paravalvular leak
Deploy Retrieve
Release
iSleeve Expandable Introducer
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New Generation TAVR Devices:
▪ Sapien 3 Ultra (Edwards)
▪ Centera (Edwards)
▪ Evolute R (Medtronic)
▪ Portico (Abbott)
▪ Lotus (Boston Scientific)
▪ Accurate Neo 2 (Boston Scientific)
▪ Jena Valve (JVT)
▪ Nautilus (NVT)
▪ MyValve (Meril Life Science)
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ACURATE TF Aortic Bioprosthesis
LOWER CROWN
Minimal LV protrusion
Low risk of conduction
defects
UPPER CROWN
Supra-annular anchoring Stable positioning
Tactile feedback
STABILIZATION ARCHES
Flexible
Self-aligning
SELF-EXPANDING NITINOL
Conforms to native anatomy
3 sizes: 21mm to 27mmPERICARDIAL LEAFLETS
Porcine pericardium
Lower profile
PERICARDIAL SKIRT
Inner & outer skirt acts as
seal to prevent PVL
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ACURATE TF 3-Step Implantation
Initial Alignment
1. Open upper crown & gentle pressure forward
2. Open stabilization arches
3. Open lower crown for full deployment
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ACURATE TF FIM Case
Upper Crown
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ACURATE TF FIM Case
Stabilization
arches
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ACURATE TF FIM Case
Lower Crown
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ACURATE TF FIM case
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Primary Endpoint - Per Protocol Analyses
Non-inferiorityNon-inferiority margin = 7.7%
-2.0% 0% 2.0% 7.0% 12.0% Risk difference (M-H)
Upper-limit one-sided 95%-CI:12.1%
P value for non-inferiority: 0.39
Superiority
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ACURATE Aortic Valve Evolution
Information not intended for use in France. CE mark received 2014. Information for the ACURATE Valve System is for use in
countries with applicable product registrations. Indications, contraindications, warnings and instructions for use can be found in the
product labeling supplied with each device. The ACURATE neo2 is an investigational device only. Not approved for sale or use.
2nd Generation
ACURATE neo
TF (CE 2014) & TA (CE 2017)
3rd Generation
ACURATE neo2
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New Generation TAVR Devices:
▪ Sapien 3 Ultra (Edwards)
▪ Centera (Edwards)
▪ Evolute R (Medtronic)
▪ Portico (Abbott)
▪ Lotus (Boston Scientific)
▪ Symetis Accurate (Boston Scientific)
▪ Jena Valve (JVT)
▪ Allegra (NVT)
▪ MyValve (Meril Life Science)
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page 28© JenaValve™ Technology 2017 | confidential
JenaValve Everdur THV
THV CUSP
• PORCINE PERICARDIUM
• (3) LEAFLETS SEWN ONTO
FRAME
NITINOL FRAME
• SELF-EXPANDING
• LOW OVERALL HEIGHT
• OPEN CELL DESIGN
SEALING RING
• (24) RHOMBOID ELEMENTS
LOCATORS
• TISSUE-COVERED
• RADIOPAQUE MARKER
INTERMEDIATE STRUTS
• PROXIMAL END ATTACHED ONTO DELIVERY CATHETER
THV
• PORCINE PERICARDIAL TISSUE
• JASMINE™ (ANTI CALCIFICATION)
TREATMENT
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page 29© JenaValve™ Technology 2017 | confidential
Procedure Steps
1. Setting
Locators align with native cusps to mimic anatomy
✓ Inhibits coronary obstruction
✓ Better durability
✓ Enhanced hemodynamics
2. Seating
Locators ensure minimal protrusion into LVOT
✓ Less arrhythmia
✓ Low rate of permanent
pacemaker implantation
3. Sealing
Locators clip onto native leaflets forming a natural seal
✓ Less PVL
✓ Needs no calcium to anchor
✓ Can treat pure AR
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New Generation TAVR Devices:
▪ Sapien 3 Ultra (Edwards)
▪ Centera (Edwards)
▪ Evolute R (Medtronic)
▪ Portico (Abbott)
▪ Lotus (Boston Scientific)
▪ Symetis Accurate (Boston Scientific)
▪ Jena Valve (JVT)
▪ Allegra (NVT)
▪ MyValve (Meril Life Science)
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▪ Usable length 1150 mm, 18 Fr Cartridge / 15 Fr Catheter, Gradual
decrease in stiffness
▪ Squeeze-to-Release mechanism allows for stepwise and controlled
implantation avoiding rotation; 2 mm stepwise deployment
▪ PermaFlow deployment – Constant flow during implantation
▪ Integrated sheath for a stable implantation
▪ Radiopaque marker rings provide clear orientation during implantation
▪ Optimized catheter tip design enables an atraumatic implantation
▪ Safety locker mechanism
guarantees a safe release
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▪ Radiopaque marker rings enable precise positioning during implantation
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New Generation TAVR Devices:
▪ Sapien 3 Ultra (Edwards)
▪ Evolute R (Medtronic)
▪ Portico (Abbott)
▪ Lotus (Boston Scientific)
▪ Acurate Neo 2 (Boston Scientific)
▪ Jena Valve (JVT)
▪ Allegra (NVT)
▪ MyValve (Meril Life Science)
▪ Leaflex (Pi Cardia)
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Hyb
rid
Ho
ney
com
b C
ell
Des
ign
Co
nce
pt
Open cells on upper half to ensure un-jailing of coronary ostia
Closed cells on lower half for high radial strength
External PET buffing to minimize para-valvular leaks
Bovine pericardium Tri-leaflet valve
Internal PET sealing cuff for lower profile & puncture resistance
Nickel Cobalt alloy frame for high radial strength & RO
≈ 5
3%
Ø – 20 mm, 23 mm, 26 mm, 29 mm#
21.5 mm 24.5 mm 27.5 mm 32 mm new*
≈ 4
7%
Fram
e h
eigh
t 1
7-2
0 m
m
MyVal – Balloon Expandable THVDesign Philosophy
MyVal THV has been indigenously developed by Meril Life Sciences, Vapi, India
# - Sizes available now* - Sizes coming soon
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Atraumatic, 14 Fr Distal Entry ProfileAllows for percutaneous access
Python –Expandable Introducer Sheath
Sheath expands momentarily (like a python swallowing prey)
to allow passage of THV crimped balloon catheter
24 Fr Proximal Entry PortAllows for smooth valve loading
One-way hemostatic valve
14 Fr & 16 Fr versions
Python – Expandable Introducer Sheath has been indigenously developed by Meril Life Sciences Pvt. Ltd.
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MyVal 29 mm Deployment
Precise placement & deployment Final – Orthotopic Deployment
Clinical case, images and videos courtesy Dr. Samin Sharma & Dr. Ravinder Singh Rao, EHCC, Jaipur, India
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New Generation TAVR Devices:
▪ Sapien 3 Ultra (Edwards)
▪ Evolute R (Medtronic)
▪ Portico (Abbott)
▪ Lotus (Boston Scientific)
▪ Acurate Neo 2 (Boston Scientific)
▪ Jena Valve (JVT)
▪ Allegra (NVT)
▪ MyValve (Meril Life Science)
▪ Leaflex (Pi Cardia)
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The Leaflex Performer
Non-implant based treatment for AS
Principle Segmentation of calcium bridges (Scoring)
Effect Increased leaflet mobility, resulting in substantial improvement in valve area
Goal To provide a short and simplestandalone procedurealongside TAVI
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The Leaflex Procedure