TAVI: 10 Years After the First Case Low-Risk and High-Risk Patients What are the Limits? Dr Bernard Prendergast DM FRCP FESC John Radcliffe Hospital

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1 TAVI: 10 Years After the First Case Low-Risk and High-Risk Patients What are the Limits? Dr Bernard Prendergast DM FRCP FESC John Radcliffe Hospital Oxford

2 I have financial relationships to disclose Honoraria from: Edwards Lifesciences

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4 3 bovine pericardial leaflets Slotted steel stent (14x21-23mm) Pilot data in 60 sheep 1 human case report moribund patient trans-septal approach Coronary ostia patent Valve area: 0.6 to 1.9cm2 Clinical improvement TOE: AV diameter 21mm AVG 9mmHg Moderate AR Non-cardiac 17/52 Cribier et al. Circulation 2002;106:

5 Ten Things to Know About TAVI in TAVI is an established treatment option in inoperable patients, with 1 life saved per 5 patients treated PARTNER B 2. TAVI is an alternative to surgical AVR in selected high-risk operable patients - PARTNER A 3. >50,000 procedures worldwide 4. Mortality for transfemoral procedures is now <5% 5. Complication rates are falling fast 6. The procedure is cost effective in well selected patients (especially TF procedure)

6 Ten Things to Know About TAVI in Ongoing trials will evaluate TAVI in intermediate-risk patients 8. Future studies and technological developments are required Optimal treatment of associated CAD Paraprosthetic aortic regurgitation Stroke Vascular access site complications 9. Current tools for risk stratification are inadequate 10. The role of the Heart Team is vital in patient selection and procedural performance

7 Evidence-Based Medicine Who Should Get TAVI?

8 PARTNER B: 2 YEAR FOLLOW UP Published on line March 26 th 2012: nejm.org

9 PARTNER A: 2 YEAR FOLLOW UP Published on line March 26 th 2012: STS nejm.org Score > 10%

10 The Real World Who Is Getting TAVI?

11 835 pts (26%): Log Euroscore <20%, STS score <10% but CI to surgery Chest wall deformity or chest radiation 17% Severe aortic calcification 8% O2 dependent respiratory disease or other non risk score condition 51% Technical CI to extracorporeal circulation 7% Patient expressed choice for TAVI 16% 3195 patients, 34 centres, The FRANCE 2 Investigators. N Engl J Med 2012;366:

12 All UK procedures: 2011 data recently locked, cumulative n= Age 30% 25% Euroscore Transfemoral not transfemoral 82 20% 81 15% 80 10% 5% 79 14% 12% 10% Transfemoral not transfemoral Year Poor LV function 0% 45% 40% 35% 30% Year Prior CABG Transfemoral not transfemoral 8% 25% 6% 20% 4% 2% 15% 10% 5% 0% 0% Year Year The UK TAVI Investigators. J Am Coll Cardiol 2011;58: Recent preliminary analysis Cunningham D, Ludman P.

13 420 consecutive TAVI procedures in a single centre Analysis by quartiles according to treatment date Comparison: baseline characteristics, 1 and 6 month mortality Euroscore Q1 25+/-16 Q2 19+/-10 Q3 18+/-11 Q4 18+/-12 J Am Coll Cardiol 2012;59:

14 Nation Existing Registry Cases in 2010 Belgium Yes 290 (22) Czech Republic Yes 260 (10) Denmark Yes??? France Yes 1550 (36) Germany Yes (Surgical) Large number Israel Yes 450 (10) Italy? 1600 (?) Netherlands Yes 1000 (12) Poland Yes 208 (11) Spain Yes 818 (26) Sweden Yes 143 (7) Switzerland Yes 400 (12) UK Yes 745 (25) Data ESC Munich 2012 C Di Mario

15 How Do We Assess Risk?

16 Operative Risk Assessment The Logistic Euroscore

17 The Oxford MDT: JC 73 year old, sole carer for disabled daughter Severe AS, good LV Normal coronary arteries Hypertension Chronic renal failure creatinine 190 COPD FEV1 1.1L, FVC 1.64L FEV1/FVC 64% Tortuous aortic root Euroscore = 9%

18 Euroscore/STS score not validated in valve surgery TAVI specific measures overlooked Porcelain aorta Annular diameter Ileofemoral assessment Social and QOL issues neglected Clinical judgement remains vital Heart 2010;96:5-6.

19 Valve specialists for valve patients

20 Risk Assessment The High-Risk Patient Patient Preferences Individualized Risk Assessment Natural Disease History Risk of Intervention Long-term postprocedural outcome Risk Scores? Life Expectancy Timing and Choice of Procedure Team Approach ESC Working Group on Valvular Heart Disease Position Paper. Assessing the Risk of Interventions in Patients with Valvular Heart Disease Eur Heart J 2011 (in press)

21 442 consecutive patients with severe AS allocated to treatment after standardised pre-procedural assessment and MDT review Medical therapy n=78, surgical AVR n=107, TAVI n=257 J Am Coll Cardiol 2011;58:

22 100% UK TAVI: The MDT meeting 80% 60% 40% 20% No Yes 0% *UK survey 24/25 centres

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25 Surgical AVR is a very good operation

26 TAVI: Risky and Costly Acknowledge underprovision of treatment for AS Large commercial market Unduly rapid expansion in Europe beyond evidence base Use of TAVI in surgical candidates Device regulation insufficiently strict Criticisms of PARTNER Cost effectiveness data unpublished Benefits of TA approach unclear Cohort B poorly matched Cost premiums vs surgery unjustified Learning curve concerns Van Brabandt H, Neyt M, Hulstaert F. BMJ 2012;345:24-27.

27 UK TAVI Trial Severe symptomatic aortic stenosis Age 80 years or over or Age 70 years or over + intermediate or high operative risk Guideline STS score 4% - 12% but MDT has discretion Both AVR and TAVI deemed to be acceptable options UK HTA funded industry independent Any TAVI device eligible Eligibility will be determined by the Heart Team No major exclusion criteria Primary End-Point 12-month Mortality

28 J Am Coll Cardiol: doi /j.jacc

29 Personal Conclusions TAVI is no longer an experimental, new wave procedure TAVI should be actively considered in all high risk patients with AS Risk too high Euroscore >40 Severe LV impairment (especially if TF not feasible) Severe RV impairment Severe respiratory disease Severe immobility eg. stroke, arthritis, Parkinsons Disease Co-morbidity with life expectancy < 1 year Risk too low Euroscore <10-15 (?), certainly <10 Especially if selection of TAVI driven by patient choice alone Comprehensive assessment by the Heart Team is essential