tavi - summitmd.com grube.pdf · 22 fr (od) 26.7-29.7fr (od) corevalve w/ 18fr cook sheath sapien...

Eberhard Grube MD, FACC, FSCAIUniversity Hospital, Dept of Medicine II, Bonn, Germany

Hospital Alemão Oswaldo Cruz, São Paulo, BrazilStanford University, Palo Alto, California, USA

TAVITechnology and Procedural

Changes

TCT AP 2013Seoul, South Korea April , 2013

Eberhard Grube, MD

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, ABValtech: E, SB, Claret: SB

KeyG – Grant and or Research Support E – Equity Interests S – Salary, AB – Advisory Board

C – Consulting fees, Honoraria R – Royalty Income I – Intellectual Property Rights SB – Speaker’s Bureau O – Ownership OF – Other Financial Benefits‘

Technology and Procedural Changes

• Current State: Positive Overall Therapy Outcomes

• Opportunities to Advance Outcomes– Stroke

– Aortic Regurgitation and Paravalvular leak

– Vascular complications

– Conduction disturbances

• Future Innovation

• New Indications

Positive Survival is Being Consistently Achieved1-Year Mortality

p=0.68

Major Procedural Complications are RareCoreValve ADVANCE | Procedural Results

Remaining TAVI Challenges

Sizing

Post-implant intervention

(dilation, snare)

Depth of Implant

Depth of Implant

Balloon strategies

AR and PVL

Conduction

Disturbances

Procedure/Technique Technology

Frame design

Advanced Sealing

Positioning, Recapture

Frame design

Stable deployment

with recapture

Balloon strategies

Anti-coagulation mgmtStroke Embolic Protection

Vascular

Complications Alternative Access

Lower profile

Access specific delivery

Coatings







• Future Innovation, New Indications

Neuro-Imaging with TAVI

JACC 2011N=60

JACC 2010N=30

JACC Int 2010N=25

Circulation 2010N=32

EJCTS 2011N=80

Daneault et al., JACC 2011;58: 2143-50

Embolic Material after TAVI

Anti-platelet therapy/anticoagulation in TAVI

Intraprocedural therapy:- Aspirin 500mg- Clopidogrel 300/75mg- Heparin

Postprocedural therapy:- Aspirin 100mg- Clopidogrel 75mg- Oral anticoagulation (Afib)

Duration ???3 or 6 monthsPrasugrel/TicagrelorDabigatran/Rivaroxaban?LAA closure in Afib patients?

Therapeutic Procedure Open Questions

Alternatives???Aspirin onlyPrasugrel/TicagrelorBivalirudine

No evidence-based recommendations!

0

5

10

15

20

25

Grube, Circ, 2006 Leon, NEJM,

2010 Abdel-Wahab, Heart, 2011 Tamburino,

Circ, 2011 Smith, NEJM, 2011 Moat, JACC,

2011 Sinning, JACC, 2012 Gilard, NEJM,

2012 Vasa-Nicotera, JACC INT, 2012

19.0

15.217.2

21.0

13.1 13.615.1

16.516.4

Moderate/severe paravalvular AR

Medtronic CoreValveEdwards-SAPIEN

Challenges Remain

Can we improve pAR?

(balloon dilation, V-in-V, snare)

Before

InterventionAfter

Intervention

pAR grade

Can we improve pAR?

(balloon dilation, V-in-V, snare)

Pre-

TAVI

Immediately

post TAVI

Final

TAVI

New Technologies to Further Reduce PVL

Annular Sealing• Optimized radial force

• Positioning arms

• Skirt design

Optimal Positioning• Stable Deployment

• Recapture capability

• Accessories (e.g. guidewire)

CoreValve Evolut R System with EnVeo R DCSFully resheathable, repositionable, recapturable

Ability to recapture across all valve sizes

InLine™ Sheath for 15F delivery profileFull annulus range 18-29+ mm

Evolut R Valve EnVeo R Delivery System

P (log rank) = 0.069

Major Vascular Complication (n=31)

No Major Vascular Complication (n=148)

Mort

alit

y (

%)

Months

27.7%

47.2%

Mortality and Major Vascular ComplicationsPARTNER B—TAVI patients

Complications & Adverse Events: Frequency, Timing, Causes and Impact on Short- and Long-Term Outcome; Webb;

TCT, 2010.

Larger Sheath Size Can Contribute to Major Vascular Complications

A Sheath to Femoral Artery Ratio (SFAR) ≥ 1.05 is a Predictor of both VARC Major Vascular Complications and 30-Day Mortality

Sapien or Sapien XT (n = 102)CoreValve (n = 28)

Decreased Delivery System Profile to

Reduce Major Vascular Complications InLine™ Sheath Eliminates Need for External Sheath

18FR

22 FR (OD) 26.7-29.7FR (OD)

CoreValve w/ 18Fr

Cook SheathSapien XT w/

Edwards Sheath

1 Hayashida K., Lefevre T., Chevalier B.; et al. Transfemoral Aortic Valve Implantation; New Criteria to Predict Vascular Complications, J Am Coll Cardiol Intv 4 2011 851-858

Current

Inner Diameter Becomes Effective Delivery Profile, resulting

in 15FR delivery profile when using InLine™ Sheath

18FR

18 FR (OD)

CoreValve Evolut R

w/ InLine Sheath

Future

16FR

Sheath-to-femoral artery ratio (SFAR) with the InLine™ Sheath is less than 1.00

for all valve sizes (23, 26, 29, and 31mm) in vessels down to 6mm in diameter

Gutierrez et al. Am Heart J 2009, (N=33)

Implant Depth Impacts Conduction Disturbances

• A lower (ventricular) position of the valve relative to the hinge point of the anterior mitral leaflet was associated with a higher incidence of new LBBB (35% vs. 0%, P = .029).

Implanted Below → 35% of patients developed LBBB

Hinge Point of the Anterior Mitral Valve

Implanted Above → 0% of patients developed LBBB

• Pilot study of 60 consecutive patients

• Procedural success: 96.7% (58 of 60 patients).

• A new pacemaker:

• 11.7% (7 of 60) of the patients without balloon pre-dilation

• 27.8% in a historical control group (n=126)

• Additionally the stroke rate was 5% in patients without balloon pre-dilation as compared to 11.9% in the historical control group.

• TAVI without balloon pre-dilation seems to be feasible and should be investigated further in a larger trial.

Grube et al., JACC CV Interv 2011;4:751-7

0

5

10

15

20

25

30

35

Comb. Endpoint 30-day Mortality Stroke Pacemaker

21.0

6.2

1.3

19.7

30.4

6.14.8

27.0Direct TAVI

Direct TAVI: Bonn-Heidelberg Cohort

Sinning et al, DGK 2013

N = 310 patients

Re

lati

ve F

req

ue

ncy

(%

)

P = 0.05

P = 0.97

P = 0.067

P = 0.16

CoreValve Evolut frame

• Shorter valve with reduced

angulation

• Less traumatic Inflow Crowns

Evolut R with EnVeo R DCS

• Stable, controlled release

• Recapturability

Reducing Post-TAVI Conduction DisturbanceCoreValve Next Generation Systems optimize frame design and provide ability to recapture

10% Shorter

CoreValve Evolut Innovation Pipeline

Time

CoreValve Evolut23 mm

18FR System

EnVeo18FR Delivery System

CoreValve Evolut

Recaptureable

with EnVeo R23 mm

15 FR System

CoreValve Evolut

Recaptureable

with EnVeo R26/29/31 mm

15FR System

AccuTrak

Delivery System

Compatible with

CoreValve

26/29/31 mm

These devices have NOT obtained CE Mark. They are not approved in the EU or the US for commercialization.

18 mm to 29 mm Annulus Size Range to

Avoid Patient Prosthesis Mismatch

•Nitinol technology – expands and contracts

•Allows navigation of heavily calcified arteries

• Eliminates need for manual shaping of wire

• Variable wire stiffness throughout for ease

of implantation and use

Pre-Curved Guidewire

Minimizing TAVI Complications:

Procedural Solutions

13F Profile Adaptive Sheath

Potential for Expanded Indications

Failed

Bioprothesis

Pure

Aortic

Insufficiency

Bicuspid

Valve

tavi - summitmd.com grube.pdf · 22 fr (od) 26.7-29.7fr (od) corevalve w/ 18fr cook sheath sapien...

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