1. Trans-catheter Aortic Valve Implantation Should we all be doing this? Dr Philip MacCarthy BSc PhD FRCP Consultant Cardiologist King’s College Hospital, London, UK. BCIS Autumn Meeting, Crewe Hall, Crewe, September 26th 2008

5. Otto et al N Engl J Med 1999;341:142–7

6. Is there an unmet need?

7. (SCTS 5 th Blue Book 2003) AVR has become more common in the elderly

8. Is there an unmet need?

10. What do we currently have to offer?

11. Trans-catheter aortic valve implantation CoreValve ‘Revalving’ system – trans-femoral CoreValve ‘Revalving’ system – trans-femoral Edwards Sapien™ prosthesis Edwards Sapien™ prosthesis Trans-femoral (using the ‘RetroFlex’ catheter) Trans-femoral (using the ‘RetroFlex’ catheter) Trans-apical (using the ‘Ascendra’ catheter) Trans-apical (using the ‘Ascendra’ catheter)

12. CoreValve ‘ ReValving’ System

15. Edwards Sapien™ Trancatheter Heart Valve prosthesis

21. What are the challenges of setting up a TAVI programme in the real world?

22. King’s College Hospital Experience 35 patients treated with the Edwards device 35 patients treated with the Edwards device 17 Trans-femoral 17 Trans-femoral 18 Trans-apical 18 Trans-apical First 17 of these as part of the PARTNER- EU study, First 17 of these as part of the PARTNER- EU study, Next 18 in the SOURCE registry Next 18 in the SOURCE registry

23. King’s College Hospital Experience 20 women (57%) 20 women (57%) Mean age - 83.9yrs Mean age - 83.9yrs Mean Log Euroscore - 20.3 (porcelain aorta) Mean Log Euroscore - 20.3 (porcelain aorta) Mean peak AV gradient - 85.8mmHg Mean peak AV gradient - 85.8mmHg Mean AVA - 0.61cm 2 Mean AVA - 0.61cm 2 Median LOS - 8 days Median LOS - 8 days In-hospital mortality - 2 (5.7%) In-hospital mortality - 2 (5.7%)

24. Patient work-up Lung/renal function tests Lung/renal function tests Carotid Dopplers Carotid Dopplers CT aorta – without contrast CT aorta – without contrast Trans-thoracic echo Trans-thoracic echo Morphology of AV – peak/mean grad + AVA Morphology of AV – peak/mean grad + AVA Dimensions of AV annulus Dimensions of AV annulus Morphology of septum Morphology of septum Presence/mechanism of MR Presence/mechanism of MR LV systolic function LV systolic function PAP if possible PAP if possible TOE – if annulus 24mm or greater TOE – if annulus 24mm or greater

25. Patient work-up Cardiac Catheterisation Cardiac Catheterisation Coronary angiogram Coronary angiogram RH cath with PAP RH cath with PAP Aortogram (PA or LAO) – 30ml @ 15ml/sec Aortogram (PA or LAO) – 30ml @ 15ml/sec Iliofemoral angiogram – 30ml @ 6ml/sec Iliofemoral angiogram – 30ml @ 6ml/sec No angioseal! No angioseal!

26. The Team Dedicated Anaesthetist(s) Dedicated Anaesthetist(s) Echocardiologist Echocardiologist Perfusionist Perfusionist Surgical scrub nurse Surgical scrub nurse Cath lab scrub nurse Cath lab scrub nurse Surgeon(s) Surgeon(s) Interventional Cardiologist(s) Interventional Cardiologist(s) The Company (for valve crimping) The Company (for valve crimping)

27. Fluoro Cardio CT Surg Cath lab kit Valve crimping Surgical kit Echo Machine Echo CP bypass Anaes. Machine Anaes Nurse Screens Nurse Rad Tech ODA Rep

28. The Learning Curve

31. Trans-femoral pAVR

32. TF Valve deployment

33. Trans-apical pAVR A higher risk patient group

34. TA valve deployment

35. The importance of peri- procedural imaging

36. Stenosed native aortic valve

37. Guidewire across native AV

38. Valve deployment

39. Edwards Sapien valve in-situ

40. Potential peri-procedural complications Vascular access Vascular access Passage of introducer sheath Passage of introducer sheath Surgical repair Surgical repair Iliac dissection/rupture Iliac dissection/rupture Balloon valvuloplasty Balloon valvuloplasty Aortic regurgitation Aortic regurgitation CHB on background of RBBB CHB on background of RBBB Valve deployment Valve deployment Occlusion of coronary ostia Occlusion of coronary ostia Displacement of prosthesis Displacement of prosthesis Rapid pacing Rapid pacing Other – Other – Interference with the mitral valve Interference with the mitral valve CVA CVA

41. Failed femoral access

42. Iliac balloon occlusion

43. Occlusive iliac dissection

44. Iliac artery rupture…

45. …repaired with a covered stent

46. The importance of case selection Patients with advanced pulmonary disease may do better with a TF approach Patients with advanced pulmonary disease may do better with a TF approach Poor LV systolic function - less room for error Poor LV systolic function - less room for error The aetiology of depressed LV function and MR The aetiology of depressed LV function and MR Beware RBBB Beware RBBB

48. So should we all be doing it?

49. Some words of caution The precise need is unknown The precise need is unknown There is currently no long-term data There is currently no long-term data Funding issues remain a problem Funding issues remain a problem

51. So should we all be doing it? At the moment NO - because: Experience should be concentrated in major centres Experience should be concentrated in major centres New centres should be closely proctored New centres should be closely proctored Centre must have:- Centre must have:- Experienced cardiac anaesthetists Experienced cardiac anaesthetists Cardiopulmonary bypass facility Cardiopulmonary bypass facility Excellent imaging ability Excellent imaging ability Dedicated cardiac ITU/recovery area Dedicated cardiac ITU/recovery area Long-term data/a solution to funding is needed Long-term data/a solution to funding is needed

52. Acknowledgements King’s TAVI Team:- King’s TAVI Team:- CT Surgeons- Olaf Wendler & Ahmed El-Gamel CT Surgeons- Olaf Wendler & Ahmed El-Gamel Cardiologists – Phil MacCarthy & Martyn Thomas Cardiologists – Phil MacCarthy & Martyn Thomas Echocardiologist – Mark Monaghan Echocardiologist – Mark Monaghan Anaesthetists – Emma Alcock & Kailasam Rajagopal Anaesthetists – Emma Alcock & Kailasam Rajagopal Research Sister/Co-ordinator – Karen Wilson/Beth Brickham Research Sister/Co-ordinator – Karen Wilson/Beth Brickham Other cath lab/theatre staff involved Other cath lab/theatre staff involved