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TRANSCRIPT
Siegburg
New TAVI Devices: More of the Same or Meaningful
Differences?
Eberhard Grube MDIntl. Heart Center Rhein – Ruhr, Essen, Germany
Hospital Oswaldo Cruz - Dante Pazzanese, São Paulo, Brazil Stanford University, Palo Alto, California, USA
ANGIOPLASTY SUMMIT-TCTAP 2010
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Within the past 12 months, the presenter or their spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below.
Physician Name Company/Relationship
Eberhard Grube, MD Medtronic, CoreValve: C, SB, AB, OFSadra Medical: E, C, SB, ABDirect Flow: C, SB, ABMitralign: AB, SB, EBoston Scientific: C, SB, ABBiosensors: E, SB, C, ABCordis: ABAbbott Vascular: ABCapella: SB, C, ABDevax: SB, AB,
KeyG – Grant and or Research Support E – Equity Interests S – Salary, AB – Advisory BoardC – Consulting fees, Honoraria R – Royalty Income I – Intellectual Property Rights SB – Speaker’s Bureau O – Ownership OF – Other Financial Benefits‘
Disclosure Statement of Financial Interest
Edwards~5,500 patients
CoreValve~5,500 patients
Current Generation DevicesCurrent Generation Devices
Transcatheter AVRTranscatheter AVR
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Success, but Opportunity for Improvement
• Percutaneous Aortic Valve Replacement (PAVR) has established itself as a viable therapy• Solid clinical results• Expanding number of MD’s performing PAVR
• Challenges remain with current devices• Steep, unforgiving learning curves• Difficult to place with precision• Cannot be easily repositioned for optimization• Cannot be atraumatically removed if needed• Perivalvular Leaks• Permanent Pacemaker Implant• Stroke
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Positioning is Critical
LM
Anterior Mitral Leaflet
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MDT Corevalve Positioning Challenges
• Challenging deployment in horizontal aorta
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Edwards – Positioning Challenges
Migration of valve during deployment due to escape beats
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AV-Block III° Following COREVALVE Implantation
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Mild = I Moderate = II
Severe = IIISevere + extension = IV
Annulus and LVOT Calcification Grades Correlate With AR - ‚Siegburg Score‘
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Para-Valvular Regurgitation
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POOLED* Monitored Edwards TAVIEcho AR Results
* REVIVE, REVIVAL, TRAVERCE* REVIVE, REVIVAL, TRAVERCEand PARTNER EUand PARTNER EU
32.432.417.817.8 14.514.5
21.521.5 18.518.5 25.125.1 21.621.6
37.537.5 39.539.5
41.141.1 49.849.850.850.8 52.952.9
50.050.0
33.6
14.719.622.0
27.331.1
35.0
5.95.9 0.00.01.61.64.44.46.46.49.59.510.410.4
2.90.00.50.00.00.7 1.4
Baseline 30 days 3 months 6 months 1 year 18 months 2 years
Follow Up
AR G
rade
4+
3+
2+
1+
None
AR
N=405 N=220 N=219 N=205 N=191 N=51 N=34
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Aortic regurgitation pre and post Change of regurgitation
CoreValve Siegburg ExperienceAortic Regurgitation
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Pre Post
4+3+2+1+0
34.6
34.6
30.9
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Pre-Post
WorsenedUnchangedImproved
24.3 28.9
54.4 51.2
19.1 18.2
0.701.5
1.7
Pre Post
4+3+2+1+0
34.6
34.6
30.9
Pre-Post
24.3 28.9
54.4 51.2
19.1 18.2
Grube E, et al. Circ Cardiovasc Intervent 2008;1:167Grube E, et al. Circ Cardiovasc Intervent 2008;1:167--75.75.
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Future Aortic Valve Concepts
– Direct Flow– Sadra– AorTx – Jena Valve– HLT– ABPS PercValve– EndoTech– Ventor Embracer
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Transcatheter Valve Therapy Next Generation Devices
Sadra DirectFlow
Low profile, repositionable, Low profile, repositionable, (?) less peri(?) less peri--valvular ARvalvular AR
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Sadra Medical Lotus Valve System
Designed for optimized aortic valve replacement with a user-friendly delivery system
• Highly accurate, controlled prosthesis positioning• Self-centering
• Easy repositioning, distally or proximally• Retrievability• Minimal Perivalvular Leakage
AdaptiveTM Seal
BovinePericardium
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Lotus Valve – Accurate Positioning
• Control in the MD’s hands• Rate of deployment• Ability to pause, unsheath, re-sheath, lock, unlock • Fully repositionable, distally and proximally
• Accurate positioning facilitated by• Self-centering • Predictable locking around central marker
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Procedure – Controlled Positioning
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Clinical Experience to Date
• Clinical experience• 10 patients enrolled – July 2007 – October 2008• 6 patients implanted, 5 surviving
• Intra-procedural results• Procedure time <20 minutes• No perivalvular leaks• No migration issues
• Follow-up at 1 year to be presented• European Trial with new Device started in April 2010
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Clinical Data Summary –Enrollment/Demographics
Number of Patients EnrolledGenderAge
1080% Female84.2±5.9 years
EuroScore (n=8)STS Score (n=8)
17.3%±7.8% (9.7 - 28.9%)9.6%±6.0% (2.3 - 22.1%)
Common Pre-existing Conditions COPD, Hypertension, hyperlipidemia, CHF, PVD, mitral valve disease
Pre-op Annulus Diameter (per CT) (n=10)
21.4±1.2 mm (20.1 – 23.7)
Pre-op Mean Gradient (n=10) 55.7±15.6 mmHg (32 – 80)
Pre-op AVA 0.58±0.08 cm2 (0.4 – 0.85)
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Long Term Follow-up – Gradient
0
10
20
30
40
50
60
70
Preop Discharge 30 Days 3 months 6 months 1 year
Mea
n G
radi
ent (
mm
Hg)
Patient 1 Patient 4 Patient 5 Patient 6 Patient 8 Patient 9
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Long Term Follow-up – Valve Area
0
0.5
1
1.5
2
2.5
Preop Discharge 30 Days 3 months 6 months 1 year
Effe
ctiv
e O
rific
e Ar
ea (c
m2 )
Patient 1 Patient 4 Patient 5 Patient 6 Patient 8 Patient 9
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Lessons from First Clinical Experience
• Lotus Valve Implant function is excellent, but
opportunities identified to improve delivery system:
• Valve attachment to and release from delivery system needed to be simplified.
• Handle needed to be redesigned with ease of use a foremost consideration
• Delivery System size limited use – needed to be reduced.
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Simplified Attachment: 15 à 3 fingers
Previous 15 finger design New 3 finger design
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Redesigned Handle: 7 à 2 controls
• Fewer controls – easier to use
• Ensures correct deployment sequence
• Reduced force required to lock
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Profile Reduction: 21 à 18 Fr
• Sadra-developed thin-wall introducer enables
fully percutaneous procedure:
• Same outer diameter as Cook 18Fr
• Reinforced for excellent kink resistance
Cook 18Fr Introducer Sheath Sadra Custom Introducer Sheath
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Latest Patient Implant – April 13, 2010
26
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Timeline• Multicenter European Trial started 13.April 2010
(PI. E.Grube)• Intl. Heart Center Rhein Ruhr (E.Grube)• University Hospital Essen (R.Erbel)• Heart Center Siegburg (R.Mueller)
• First 3 Patients enrolled with excellent acute hemodynamic and angiographic results• Zero Gradient• No Aortic Insufficiency• No Pacemaker Implant• Av. Implant Time 14 Minutes
Investigational device currently in European clinical trial Not available for sale
Multilumen
Slightly Tapered, ConformablePolyester Fabric Cuff
Tri-leaflet Valve constructed of Bovine Pericardium
Position Fill Lumens (PFLs)-Used to position/reposition valve-Complete Inflation Media Exchange
Ventricular and Aortic Rings-Inflate independently so device can be repositioned-deflatable so that device can be fully retrieved
The Direct Flow Medical (DFM) Aortic Valve Prosthesis
18F System Features18F System Features
22F Design 18F Design
3 sizes matching valvuloplasty balloons
Design: Prospective, non-randomized clinical evaluation of the DFM PAV at two centers in Germany
Hamburg University Cardiovascular Center (n=25)Siegburg, Helios Heart Center (n=6)
Purpose: Determine clinical feasibility and safety of treating patients at high-risk for cardiac surgery:
• EuroSCORE ≥ 20%• Age ≥ 70• Severe aortic valve stenosis
European Feasibility Trial
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All Values Reported - TTE All Values Reported - TTE
The DFM AV ProsthesisEuropean Clinical Trial
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• Next generation TAVR devices are rapidly evolving, providing substantial benefits over the first generation devices
• Issues addressed are repositionability, risk of paravalvular leakage, profile size etc.
• Valve + platform durability still must beconclusively demonstrated!
• Once durability is established, we can expandclinical trials and indications for TAVR to most(not all) patients with severe AS!
Summary Thoughts…Summary Thoughts…Summary Thoughts…Summary Thoughts…
Transcatheter AVR
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Aortic Atheroma: High Risk
• 268 of 3404 CABG patients (8%) had• atheroma (>/= 5 mm, or mobile)• Defined by epi-aortic ultrasound1
• 15.3% of group had intra-operative stroke1
•1Protruding aortic arch atheromas: risk of stroke during heart surgery with and without aortic arch endarterectomy. Stern et al. American Heart Journal Oct. 1999.
• High Risk for:Intra-operative strokeMultiple morbidityProlonged hospital stay,Death resulting from heart surgery.1
• Risk Factors for Aortic Atheroma:• > 70 years old• Diabetes Mellitus• Hyperlipidemia• Arterial hypertension• Aortic calcifications on chest X-ray• Elevated serum levels of C-reactive protein• Other inflammatory markers• Activated coagulation3
33
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Cerebral Filter ProtectionClaret
Filter in Truncus
Filter in left Carotid
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EmboliEmboli
Emboli
Emboli
Embolic Material
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Emboli
Embolic Material
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7 mm filter placed in left carotid
Claret Dual Filter
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Embrella Embolic Deflector™
• Porous membrane designed to deflect embolic debris
• Nitinol® Frame & Shaft
•Polyurethane Porous Membrane
• Heparin Coating
• 3 Radiopaque Markers
• Suture; Monofilament Nylon
38
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Embrella Case
Example
Brachiocephalic Artery
Left Common Carotid Artery
Embrella span width
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Thank you for your attention !
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Thank you
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There Is a Higher Incidence of Pacemaker Implant Associated with CoreValve
20
33 32
1923 25
0
10
20
30
40
(n=30) (n=102) (n=34) (n=91) (n=1521) (n=126)
Calvi (PACE2009)
Grube (CircInterv 2008)
Jilaihawi (AmHeart J 2009)
Rotterdam 18F EER 18F S & E
% p
atie
nts
New Permanent Pacemaker within 30 Days
Weighted average = 23%(n=1990 patients)
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5
2025
3336
5056
0
10
20
30
40
50
60
A B C D E F G
It is important to remember that pacemaker implantation may not mean pacing need
* 2 centers with < 5 implants excluded from the presentation; both centers had 0% 30-day
permanent pacemakers
% p
atie
nts
Participating CentersPhysicians’ decision to prophylactically implant play a big
role in the variability among centers
New Permanent Pacemaker within 30 Days18F Safety and Efficacy Study (n=126)
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Claret Dual Filter
44
The Device:
• Must be easy to use!• The filter device should not be present in the aorta• Catheter 6F (5F in development)• 140 micron pore size• Right radial/brachial delivery• System will accommodate variable aortic anatomy
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Claret
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Claret Dual Filter Device
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Claret Dual Filter Device
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Embrella
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Concept of EmbrellaProduct Requirements
• Separate access site from main procedure; radial or brachial artery
• Fits through a 6F sheath• Minimal orientation• Ease of use, no new techniques• Low profile• One size fits all• Deflect debris
49
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Brachiocephalic ArteryBrachiocephalic Artery
Left Common Carotid ArteryLeft Common Carotid Artery
RightCommon Carotid
Artery
RightCommon Carotid
Artery
Left Subclavian ArteryLeft Subclavian Artery
DescendingAorta
DescendingAorta
Ascending AortaAscending Aorta
Brachiocephalic Artery
Left Common Carotid Artery
RightCommon Carotid
Artery
Left Subclavian Artery
DescendingAorta
Ascending Aorta
Concept of EmbrellaHuman Aorta
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Embrella Case
Example
Aortic Arch
Brachiocephalic Artery
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Embrella Case
Example
Embrella Device placed in outer curve of aortic arch
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Embrella Case
Example
Passage of balloon along the Embrella Device