Trans-catheter Aortic Trans-catheter Aortic Valve Replacement: a UK Valve Replacement: a UK

update.update.

Dr Martyn ThomasDr Martyn Thomas

Guys and St Thomas’ Guys and St Thomas’ HospitalHospital

So, is there a So, is there a clinical need for less clinical need for less invasive method of invasive method of replacing the aortic replacing the aortic

valve?? valve??

Severe Symptomatic AorticSevere Symptomatic AorticStenosis is a fatal condition.Stenosis is a fatal condition.

““Surgical Surgical intervention intervention should be should be performed performed promptly once promptly once even… minor even… minor symptoms symptoms occur”occur”11

Chart: Ross J Jr, Braunwald E. Aortic stenosis. Circulation 1968;38 (Suppl 1)

1 C.M. Otto. Valve Disease: Timing of Aortic Valve Surgery. Heart 2000

Chart:: Ross J Jr, Braunwald E. Aortic stenosis. Circulation. 1968;38 (Suppl 1):61-7.

Valvular Aortic Stenosis in Adults(Average Course)

31.8% did not undergo intervention, most frequently because of comorbidities

Treated vs. UntreatedCulmulative Survival : No AVR vs AVR

Congestive Heart Failure Pts

0%

20%

40%

60%

80%

100%

1 5 10Time in Years

Cu

mu

lati

ve S

urv

ival

%

No AVR

AVR

Prof. Alain CribierProf. Alain CribierFirst Clinical ExperiencesFirst Clinical Experiences

First described First described percutaneous aortic percutaneous aortic valve interventions in valve interventions in 19851985

Proved that a stent Proved that a stent could be deployed could be deployed without removing the without removing the diseased native valvediseased native valve

Implanted first Implanted first percutaneous aortic percutaneous aortic valve on a patient on valve on a patient on April 16, 2002April 16, 2002

Currently available Currently available systems in the UK.systems in the UK.

Corevalve: trans-femoralCorevalve: trans-femoral Registry complete. CE mark. Now in Registry complete. CE mark. Now in

commercial phase.commercial phase.

Edwards Sapien Valve: trans-femoral Edwards Sapien Valve: trans-femoral and transapical.and transapical.

European Registry complete at the end European Registry complete at the end of Jan. CE mark for both approaches. of Jan. CE mark for both approaches. Now in commercial phase. Now in commercial phase.

Diamond cell configuration

Nitinol (memory shaped)

Multi-level design incorporates three different areas of radial

and hoop strength• Low radial force area orients the system

• Constrained area to avoid coronaries and featuring supra-annular valve leaflets

• High radial force for secure anchoring – no recoil – constant force mitigates leak

Radiopaque

Self-Expanding Multi-level Support Frame

• Specifically designed for transcatheter delivery

• Single layer porcine pericardium

• Tri-leaflet configuration

• Tissue valve sutured to frame

• Standard tissue fixation techniques

• 200M cycle AWT testing completed

• Supra-annular valve function

• Intra-annular implantation and sealing skirt

Porcine Pericardial Tissue Valve

18F Delivery Catheter System

12F shaft body

18F distal end

Dual speed release handle

Over-the-wire 0.035 compatible

Generation 125F

TranscatheterGeneration 2

21FTranscatheter

Technology Progress & Total Technology Progress & Total ExperienceExperience

Generation 3

18FPercutaneous

14 patients14 patients14 patients14 patients

65 65 patients*patients*65 65 patients*patients*

184 184 patients** patients** 184 184 patients** patients**

* Including 2 ReDo

** Updated August 30, 2007 Including Expanded Evaluation Registry

2004-2005

2004-2005

2005-2006

2005-2006

Oct 2006

Oct 2006

CoreValve PAVR CoreValve PAVR ReValvingReValving™™ System System

Time Period Time Period Implant PhaseImplant Phase Device UsedDevice Used Number of Number of

PatientsPatients

July 2004-July 2005 July 2004-July 2005 First in ManFirst in Man 25 French25 French 1414

August2005-August2006 August2005-August2006 21F Intl Trial21F Intl Trial 21 French21 French 6565

May 2006-Ongoing May 2006-Ongoing 18F Intl Trial18F Intl Trial 18 French18 French 112112

June 2007-Ongoing June 2007-Ongoing Expanded EvaluationExpanded Evaluation 18 French18 French 7676

Total Worldwide PAVRTotal Worldwide PAVR ReValving™ReValving™ Patients TreatedPatients Treated 267267Updated August 31, 2007

Procedural Success 161 (92%)

Mean Total Procedure Time 170 ± 77 Minutes± 77 Minutes

Mean ReValving™ Time 11 ±± 14 Minutes

Discharged with CoreValve 159 (91%)

Discharged after surgical conversion 3 (2%)

Procedural Results – N=175Procedural Results – N=175

Access to the aortic valve

Edwards SAPIENEdwards SAPIEN™™ THV THV

Transfemoral Approach

Transapical Approach

Cribier-EdwardsCribier-Edwards™™ and Edwards SAPIEN and Edwards SAPIEN™™ THV* THV* Aortic Transfemoral/Transapical Trial Implants Aortic Transfemoral/Transapical Trial Implants (21 Dec 07 (21 Dec 07

Update)Update)

* The Edwards SAPIEN™ valve incorporates* The Edwards SAPIEN™ valve incorporates

bovine pericardial tissue and TFX™ treatmentbovine pericardial tissue and TFX™ treatment

622 Patients622 Patients2002-20072002-2007

TransfemoralTransfemoral(n=353)(n=353)

TransapicalTransapical(n=269)(n=269)

AntegradeAntegradeN=59N=59 TRAVERCETRAVERCE n=145 n=145RetrogradeRetrograde

N=294N=294

RECAST n = 24RECAST n = 24

iREVIVE n = 22iREVIVE n = 22REVIVE I n = 4REVIVE I n = 4

REVIVAL I n = 7REVIVAL I n = 7

REVIVE II n = 101REVIVE II n = 101

REVIVAL II n = 55REVIVAL II n = 55

CANADIAN SPECIAL CANADIAN SPECIAL ACCESS n =90ACCESS n =90

REVIVAL IIREVIVAL II n =33 n =33

CANADIAN SPECIAL CANADIAN SPECIAL ACCESS n =37ACCESS n =37

US Compassionate n=2US Compassionate n=2 US Compassionate n=2US Compassionate n=2

PARTNER EUPARTNER EU n= 52 n= 52PARTNER EUPARTNER EU n =48 n =48

PARTNER IDEPARTNER IDE n ~ 40

RetroFlex II Offers:RetroFlex II Offers:• Greatly improved native valve crossabilityGreatly improved native valve crossability• Smoother trackingSmoother tracking• Improved handle functionalityImproved handle functionality• Fewer system componentsFewer system components

RetroFlex RetroFlex II

Transfemoral Transfemoral Procedure: Procedure: EdwardsEdwards

Transfemoral Transfemoral Procedure: Procedure: EdwardsEdwards

Valve deployment with 3D Valve deployment with 3D echo.echo.

The UK positionThe UK position 15 centres would like to start a programme.15 centres would like to start a programme. Active centres, n=6.Active centres, n=6.

Number of cases:Number of cases: - Corevalve 71- Corevalve 71 - Edwards 16- Edwards 16

Early Mortality approx 7%. 3/87 cath lab deaths, 5/87 in Early Mortality approx 7%. 3/87 cath lab deaths, 5/87 in patient deaths (2 non cardiac) and 6/87 deaths at 3/12.patient deaths (2 non cardiac) and 6/87 deaths at 3/12.

Also pacemaker, surgical conversion, peripheral vascular Also pacemaker, surgical conversion, peripheral vascular complications, stroke, pericardial drain.complications, stroke, pericardial drain.

Complex procedure but considering the patient mix Complex procedure but considering the patient mix encouraging.encouraging.

TrainingTraining Centre selection currently controlled by Centre selection currently controlled by

industry.industry. Responsible attitude being taken.Responsible attitude being taken. MHRA (or whatever they are now called!) MHRA (or whatever they are now called!)

happy and do not feel central control is happy and do not feel central control is necessary.necessary.

Training consists (in general) of theory, Training consists (in general) of theory, simulators, observation and cases performed simulators, observation and cases performed with proctors.with proctors.

2008 an interesting, dangerous and 2008 an interesting, dangerous and challenging year!!challenging year!!

UK FundingUK Funding Currently undergoing a NICE Currently undergoing a NICE

assessment.assessment.

Most centres trying to use a Most centres trying to use a “surgical” tariff.“surgical” tariff.

““Top ups” being locally negotiated Top ups” being locally negotiated with PCTs. with PCTs.

Early “NICE” assessment (like PFO Early “NICE” assessment (like PFO closure) may facilitate the process.closure) may facilitate the process.

Trans-catheter Aortic Valve Trans-catheter Aortic Valve Replacement: a UK update.Replacement: a UK update.

ConclusionsConclusions 2008 will be an exciting but “dangerous” 2008 will be an exciting but “dangerous”

year for trans-catheter heart valve year for trans-catheter heart valve replacement.replacement.

Training and case selection is all.Training and case selection is all. Irresponsible use of the device could set Irresponsible use of the device could set

Europe and the UK back for many years.Europe and the UK back for many years.

This exciting development in This exciting development in interventional cardiology could well be interventional cardiology could well be the future for tertiary/surgical centre the future for tertiary/surgical centre intervention (at least in the medium intervention (at least in the medium term!) term!)