22/06/2017. Oxford City. Transcatheter aortic valve replacement 2017 guidelines. 1. First time I have heard about it. 2.

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1 Oxford City Transcatheter aortic valve replacement 2017 guidelines Monday 19 th June Jim Newton Oxford Oxford University Hospitals NHS FT How familiar are you with TAVR? 1. First time I have heard about it 2. I know a little 3. I have been involved in assessing patients 4. I am regularly involved in TAVI 5. I hold patents for several new Transcatheter valves What s in a name? TAVR Centre Territorial Auxiliary and Volunteer Reserve Association 1

2 TAVI guidelines Industry involvement Transcatheter Aortic Valve Implantation What is TAVI? Why does it exist? Who should be considered for TAVI? How are patients selected as suitable? What is it and how is it done? What are the outcomes? What are the risks? What is to come in the next 3 5 years? Curing aortic stenosis Curing aortic stenosis 10:17 11:05 2

3 Recovery post TAVI Transcatheter aortic valve implantation(tavi) 24 hours post procedure Discharge on day 3 Why do we need TAVI? Why we need TAVI? A solution for a rapidly growing problem A solution for a rapidly growing problem Poor outcomes with medical therapy Undiagnosed Undiagnosed 4 Diagnosed 4 Diagnosed Year Year 65 year olds with moderate or severe VHD 65 year olds with moderate or severe VHD 71% rate of mortality or repeat admission at 1 year for medical therapy Surgical aortic valve replacement Surgical aortic valve replacement 30 day mortality after AVR in the UK day mortality after AVR in the UK Proportion of patients receiving AVR Predicted Actual Predicted Actual

4 First TAVI procedure performed UK TAVI procedure numbers Surgeons remain busy TAVI decision making Decision making in aortic stenosis Decision making in aortic stenosis 72 year old male Severe aortic stenosis Breathless walking uphill Single vessel CAD Good LV function Normal renal function Rx for prostate cancer Osteoarthritis of left hip SURGICAL AORTIC VALVE REPLACEMENT 72 year old male Severe aortic stenosis Breathless walking uphill Single vessel CAD Good LV function Normal renal function Rx for prostate cancer Osteoarthritis of left hip SURGICAL AORTIC VALVE REPLACEMENT 84 year old male Severe aortic stenosis Breathless walking >50 yds. CABG 12 yrs. before patent Moderate LV impairment CKD stage III creat 160 Inhaler therapy Prior TIA in AF Transcatheter Aortic Valve Implantation 4

5 Who should not have TAVI? Non-severe aortic stenosis Poor mobility wheelchair dependent / nursing home Cognitive issues early dementia Life expectancy < 2 years Severe pulmonary disease on O2 Severe pulmonary hypertension Risk assessment Risk groups Assessment of risk Risk group STS score Frailty Comorbidity Low risk <4% - - Intermediate risk 4 8% mild 1 major High risk > 8% Moderate - severe 2 major Prohibitive risk >50% risk Severe 3 major TAVI imaging assessment Steps in proceeding to TAVI Accurate diagnosis and staging of aortic stenosis Severe symptomatic aortic stenosis Valve anatomy Valve haemodynamics Haemodynamic consequences Patient symptoms 5

6 Aortic stenosis High gradient aortic stenosis Valve haemodynamics Peak aortic velocity > 4.0m/s Aortic valve area < 1.0cm 2 Indexed aortic valve area <0.6cm 2 /m 2 Valve haemodynamics Low gradient aortic stenosis Left ventricular ejection fraction < 50% Calcified restricted valve with aortic valve area < 1.0cm 2 Aortic velocity is <4m/s at rest but increases to >4m/s with Dobutamine Valve haemodynamics Low gradient low flow aortic stenosis Left ventricular ejection fraction is normal Calcified restricted valve with aortic valve area < 1.0cm 2 Aortic velocity is < 4m/s Mean gradient is < 40mmHg Stroke volume index < 35ml/m 2 Continuity equation Assumes accurate measurement of diameter Assumes LVOT is circular Doppler assessment can be unreliable 3D measurement of LVOT area 6

7 3D Aortic valve TTE or TEE? Aortic valve planimetry Aortic root anatomy Aortic root anatomy Measure annulus diameter Measure annulus diameter 7

8 Measure annulus diameter Edwards Sapien valve 23mm 26mm 29mm Measure annulus diameter Medtronic Corevalve 26mm 29mm 31mm Measure annulus diameter Measure annulus diameter Edwards Sapien valve 23mm 26mm 29mm Medtronic Corevalve 26mm 29mm 31mm Annulus and coronary height 3D Workflow 8

9 3D Workflow Vascular access 14 22Fr sheath Vascular access 14 22Fr sheath Vascular access 14 22Fr sheath Aortic stenosis Aortic stenosis 9

10 Management of aortic stenosis Management of aortic stenosis VALVE Confirm severe aortic stenosis VALVE Confirm severe aortic stenosis Identify symptoms PATIENT Consider alternative causes Assess if suitable for gold standard therapy SURGEON Undertake surgical aortic valve replacement if acceptable risk Identify symptoms PATIENT Consider alternative causes Assess if suitable for gold standard therapy SURGEON Undertake surgical aortic valve replacement if acceptable risk TAVI Assess anatomical suitability TAVI if turned down for surgical aortic valve replacement TAVI Assess anatomical suitability TAVI if turned down for surgical aortic valve replacement Aortic root anatomy Patient selection Valve anatomy and annulus size? Coronary ostia location? Vascular access 14 22Fr sheath Vascular access Caliber of ilio-femoral vessels? Tortuosity and calcification? Procedure Suitable for sedation? Pre-procedural pacing? Procedure Delivery of Lotus valve 10

11 Delivery of Lotus valve Check angiogram Closure of arteriotomy Outcomes of TAVI Oxford outcomes Route Oxford Source 30 day femoral 96% 94% 1 year femoral 89% 81% 30 day apical 84% 89% 1 year apical 70% 72% 5% in hospital mortality 5% risk of stroke What are the risks? 25% risk of needing a pacemaker 10% risk of needing a vascular stent 5% risk of tamponade 11

12 TAVI the future The future Smaller delivery systems Wider range of treatable anatomy Pre-prepared valves Vascular access solutions Expansion into mitral and tricuspid pathology Growth in valve in valve procedures Potentially extension into lower risk groups TAVI key messages Surgical aortic valve replacement remains the gold standard TAVI excellent therapy for high risk patients Trials underway in intermediate risk patients TAVI not for low risk patients (yet..) 12