Trans-catheter Aortic Valve Replacement: a UK update.

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Trans-catheter Aortic Valve Replacement a UK
update.

• Dr Martyn Thomas
• Guys and St Thomas Hospital

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

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Severe Symptomatic AorticStenosis is a fatal
condition.

• Surgical intervention should be performed
  promptly once even minor symptoms occur1

Valvular Aortic Stenosis in Adults(Average
Course)
Chart Ross J Jr, Braunwald E. Aortic stenosis.
Circulation 196838 (Suppl 1) 1 C.M. Otto. Valve
Disease Timing of Aortic Valve Surgery. Heart
2000 Chart Ross J Jr, Braunwald E. Aortic
stenosis. Circulation. 196838 (Suppl 1)61-7.
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31.8 did not undergo intervention, most
frequently because of comorbidities
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Treated vs. Untreated
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Prof. Alain CribierFirst Clinical Experiences

• First described percutaneous aortic valve
  interventions in 1985
• Proved that a stent could be deployed without
  removing the diseased native valve
• Implanted first percutaneous aortic valve on a
  patient on April 16, 2002

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Currently available systems in the UK.

• Corevalve trans-femoral
• Registry complete. CE mark. Now in commercial
  phase.
• Edwards Sapien Valve trans-femoral and
  transapical.
• European Registry complete at the end of Jan. CE
  mark for both approaches. Now in commercial
  phase.

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Self-Expanding Multi-level Support Frame

• 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

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Porcine Pericardial Tissue Valve

• 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

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18F Delivery Catheter System
Over-the-wire 0.035 compatible
12F shaft body
18F distal end
Dual speed release handle
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Technology Progress Total Experience
Generation 1 25F Transcatheter
Generation 2 21F Transcatheter
14 patients
2004-2005
Generation 3 18F Percutaneous
65 patients
2005-2006
184 patients
Including 2 ReDo Updated August 30, 2007
Including Expanded Evaluation Registry
Oct 2006
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CoreValve PAVR ReValving System
Updated August 31, 2007
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Procedural Results N175
Procedural Success 161 (92) Mean Total
Procedure Time 170 77 Minutes Mean
ReValving Time 11 14 Minutes Discharged
with CoreValve 159 (91) Discharged after
surgical conversion 3 (2)
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Edwards SAPIEN THV
Access to the aortic valve
Transapical Approach
Transfemoral Approach
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Cribier-Edwards and Edwards SAPIEN THV Aortic
Transfemoral/Transapical Trial Implants (21 Dec
07 Update)
The Edwards SAPIEN valve incorporates bovine
pericardial tissue and TFX treatment
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RetroFlex
RetroFlex II

• RetroFlex II Offers
• Greatly improved native valve crossability
• Smoother tracking
• Improved handle functionality
• Fewer system components

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• Transfemoral Procedure Edwards

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• Transfemoral Procedure Edwards

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Valve deployment with 3D echo.
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The UK position

• 15 centres would like to start a programme.
• Active centres, n6.
• Number of cases
• - Corevalve 71
• - Edwards 16
• Early Mortality approx 7. 3/87 cath lab deaths,
  5/87 in patient deaths (2 non cardiac) and 6/87
  deaths at 3/12.
• Also pacemaker, surgical conversion, peripheral
  vascular complications, stroke, pericardial
  drain.
• Complex procedure but considering the patient mix
  encouraging.

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Training

• Centre selection currently controlled by
  industry.
• Responsible attitude being taken.
• MHRA (or whatever they are now called!) happy and
  do not feel central control is necessary.
• Training consists (in general) of theory,
  simulators, observation and cases performed with
  proctors.
• 2008 an interesting, dangerous and challenging
  year!!

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UK Funding

• Currently undergoing a NICE assessment.
• Most centres trying to use a surgical tariff.
• Top ups being locally negotiated with PCTs.
• Early NICE assessment (like PFO closure) may
  facilitate the process.

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Trans-catheter Aortic Valve Replacement a UK
update.Conclusions

• 2008 will be an exciting but dangerous year for
  trans-catheter heart valve replacement.
• Training and case selection is all.
• Irresponsible use of the device could set Europe
  and the UK back for many years.
• This exciting development in interventional
  cardiology could well be the future for
  tertiary/surgical centre intervention (at least
  in the medium term!)