Transcatheter Aortic Valve Implantation (TAVI) Overview for Wales. Dr Richard Anderson University Hospital of Wales, Cardiff, UK

Transcription

1 Transcatheter Aortic Valve Implantation (TAVI) Overview for Wales Dr Richard Anderson University Hospital of Wales, Cardiff, UK

2 Aortic stenosis is a disease of old age

3 Age demographics in Wales % Wales England Scotland N Ireland Under % Wales UK Over ( people) 5.0

4 Small hole in the leg under LA

5 Meta-analysis of SAVR vs TAVI Less post op AF Less Renal failure (dialysis) More PPM More PVL (AR)

6 Meta-analysis of SAVR vs TAVI

7 Intermediate Risk CoreValve US Pivotal Trial: Two-Year All-Cause Mortality p=0.04 for superiority Adams DH et al. N Engl J Med 2014;370:1790-8

8 Durability

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10 SAVR, Age and Survival

11 Outcome in the over 85 year olds patients: 48 patients TAVI 82% Transfemoral Mean age patients surgery 14.5% AVR 33.9% AVR + 1 graft 27.4% AVR + 2 grafts 21% AVR + 3 grafts 3.2 AVR + 4 grafts Obaid D et al BGS 2015

12 What is a high risk patient High risk for operative complications or death - coexisting conditions with a risk of death >15% by 30 days. The final determination of high operative risk was made by surgeons Guideline score of at least 10% on the risk model developed by the STS, which uses an algorithm that is based on the presence of coexisting illnesses in order to estimate the 30-day operative mortality.

13 Developed from data on CABG surgery in 1990 s Poor correlation with short and longer term outcome in TAVI Replaced by Euroscore II in 2011 for cardiac surgical risk prediction

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15 TAVI patient selection and pathway All patients seen by cardiologist and cardiac surgeon Dedicated TAVI clinic with surgeon, cardiologist and MDT on the day (MCC) Co-opted review by anaesthetist, care of elderly physician, etc as needed according to individual patient Decision re: medical therapy, conventional surgery or TAVI made after MDT review and not decided by risk scores as per BCS/ BCIS/ SCTS guidelines Following decision for TAVI, procedural planning with gated CT angiography

16 Heart MDT Process 6 Questions Is there an indication for AV Intervention? What are the risks and technical considerations for SAVR? What are the risks and technical considerations for TAVI? Is there need for re-vascularization? (CABG/PCI) Is there need for PPM in advance? Is the patient suitable for UK TAVI Trial (clinical equipoise)?

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18 MDT decides on the Treatment NICE guidance NICE IP Commissioning position of England Scotland N Ireland But not Wales

19 WHSCC document circa Nov 2012

20 What Drives Intermediate Risk Aortic Stenosis? CABG reoperation risk Hostile chest Previous chest radiotherapy Porcelain aorta Severe lung disease Orthopaedic disease Age >90 years old Severe pulmonary hypertension Neuromuscular disease Frailty

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24 S Wales TAVI numbers

25 TAVI cases UHW MCC

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27 S Wales data MOR Mean Logistic Euroscore for Morriston TAVI patients in 2016 = 23.9 UHW 81 yrs MCC 82 yrs

28 The Expansion of Indication for TAVI Aortic stenosis by STS Score SURTAVI trial (3% mortality risk) Intermediate Risk (Top 33% Surgical Risk) STS 4 High Risk (Top 10% Surgical Risk) STS 8 Low Risk Surgical AVR Extreme Risk Inoperable Cohort C Do not treat Direction of Travel 80% of patients in STS Database* 14% 6% * Thourani, AnnThorac Surg 2015

29 TAVI procedures - Clinical Outcomes - C&V (n=184) (%) MCC (n=165) (%) UK TAVI * (n=410) (%) Mortality 30 days 8 (4.3%) 4 (2.4%) 8.5% Stroke 5 (2.7%) 2 (1.4%) 3% ASC 5 (2.7%) 5 (3%) 6% Total in-hosp MACCE 15 (8.1%) 7 (6.8%) 11.7% * Moat et al. J Am Coll Cardiol 2011; 58:

30 UK TAVI Outcomes

31 Improved TAVI Outcomes Why? Increased operator experience Better Patient selection Optimizing clinical practice (LA etc) (80+% both centres ), closure devices Improved valve technologies Recapturable, repositionable valves Smaller sheath sizes (lower Vascular complications)

32 Data summary for UHW and MCC Despite a more aged population Lowest TAVI numbers in the UK Excellent clinical outcomes Despite treating higher risk patients than the UK average Clinician driven changes increased efficiency

33 Current waiting times/numbers

34 Current waiting times/numbers Has not been routinely recorded until recently What point does the clock start? Referral to CTS? Referral to IC? When all tests are done? When accepted by MDT for TAVI? When WHSSC return a positive funding approval?

35 WAG performance metric 36 WEEKS

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39 Waiting times and risk of death

40 Current priority Decrease this waiting time OPA - Cardiologist Echo Angiogram CT aorta CTS/IC assessment MDT discussion

41 TAVI 2017 TAVI is now a well established standard cardiac interventional procedure better outcomes that high risk SAVR Heart Valve MDT is best placed to decide who in S Wales should undergo TAVI - NICE IP Commissioning arrangements are outdated, not consistent with NICE guidance - suboptimal and limiting the service to Welsh patients Wales TAVI provision is lowest compared to anywhere in the UK Waiting lists are too long Major clinical risk

42 Costs

43 Costs are decreasing further too! LA techniques Straight to CCU Decrease CITU utilization Decreased hospital stays and outcomes in high risk and selected intermediate risk patients

44 S3i Economics Total 1-Year Costs D = - 15,511 (p<0.001) $100,000 $80,000 $60,000 $40,000 $20,000 $96,489* $80,977* $38,238 $26,861 $54,117 $58,250 Index hospitalization cost savings driven mainly by a 6.5 day reduction in LOS (3.5 ICU days) Follow-up F/u cost savings driven by significant in CV and non-cv hospitalizations, along with a >50% reduction in rehab/snf days $- * Trimmed means S3-TAVR SAVR

45 S3i Economics Index Hospitalization: Resource Use

46 Service improvement needs for Wales Better waiting list management UHB level Commissioning services properly to match the rest of UK To allow patients of Wales the timely service they deserve