Trans-catheter Aortic Valve Replacement: a UK update.
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Transcript of Trans-catheter Aortic Valve Replacement: a UK update.
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!)