What Have We Learned From The UK TAVI Registry?

Simon RayUHSM

Manchester Academic Health Sciences Centre

NO CONFLICT OF INTEREST TO DECLARE

UK TAVI RegistryThe United Kingdom Transcatheter Aortic Valve Implantation Registry

• Development– Collaborative program

• Professional Societies (BCIS and SCTS)• Department of Health and Specialist Commissioners• Health Technology Assessment and Regulators (NICE)

– High quality data collection and analysis– Dataset developed and distributed in 2008– Data collection via Central Cardiac Audit Database

• encrypted data sent centrally from all units to CCAD servers

– Data entered prospectively

UK TAVI Datasetwww.bcis.org.uk

• 100% of consecutive UK TAVI implants– 1st Jan 2007 to 31st Dec 2009

• Mortality tracking– linkage of central TAVI database with the Office of

National Statistics (ONS)• 872 TAVI procedures

– 862 successful valve implants, 10 unsuccessful

UK TAVI RegistryThe United Kingdom Transcatheter Aortic Valve Implantation Registry

Data as 21-5-2010

Additional 43 cases from Belfast not included

UK TAVI Registry Demographics

All Transfemoral Other routes

Male 52% 52% 54% p=ns

Age median (IQR) yr 83 (78-87) 83 (78-87) 83 (79-87) p=ns

Age range (yr) 25-96 25-96 54-94

Diabetes 23% 23% 23% p=ns

Prior CABG 26% 23% 33% p=0.002

PVD 32% 23% 51% p<0.0001

CAD 48% 44% 57% P<0.0001

LMS disease 5.6% 4.6% 8.0% p=ns

Data as 21-5-2010

UK TAVI Registry Casemix

All Transfemoral Other routes

Peak AV gradient (mmHg) 80 82 77 p=ns

Valve Area (cm2) 0.68 0.71 0.63 p=ns

LVEF>50% 64% 65% 63% p=ns

LVEF < 30% 8% 7% 9% p=ns

Logistic EURO Score 21.6% 20.3% 24.5% P<0.01

Data as 21-5-2010

UK TAVI RegistryThe United Kingdom Transcatheter Aortic Valve Implantation Registry

417

179

43

220

3

050

100150200250300350400450500

MedtronicCoreValve

(n=460)

EdwardsSapien(n=402)

Number of Valves

Implanted

Unknown

Other*

Transapical

Transfemoral

*41 subclavian,

2 other

undeployed device in 10 cases

Data as 21-5-2010

UK TAVI Registry Casemix

All Transfemoral Other routes

Angina 43% 44% 39%

Data as 21-5-2010

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

All Transfemoral Other routes

NYHA I

NYHA II

NYHA III

NYHA VI

UK TAVI Registry In Hospital Outcomes

Other MACCE All Transfemoral Other routes

TIA 0.6% 0.3% 1.1%

Emergency Surgical AVR 0.7% 0% 2.2%

Non Hierarchical MACCE

6.2

1.2

4

9

3.9

1.3

5

1.5

3.8

0123456789

10

Death MI CVA

%

AllTransfemoralOther Routes

Breakdown54 (6.2%) of patients died88 (10.1%) died or had MI or CVA 10 died subsequent to CVA or MI34 had CVA or MI and survived

Data as 21-5-2010

UK TAVI CentresMortality tracking to Dec 31st 2009

TAVI(intention to Rx)

n=872

Mortality trackedn=842

Not tracked:life status

reported at 1 year or discharge

n=30

Not trackedUnknown outcome

n=0

Survival curves based on n=872

Tracking 21-5-2010

Data as 21-5-2010

0 30/7 6/12 1 yr 18/12 2 yrSurvival: Transfemoral 94.8% 86.5% 82.4% 80.4% 78.3%

Number at risk 602 555 461 281 168 94

Survival: Other routes 89.1% 79.6% 75.5% 71.1% 66.5%

Number at risk 268 237 191 108 44 18

Other

Transfemoral

p=0.017

UK TAVI Registry

2 casesroute unknown

Proctored case

Unproctored case

p=n.s.

First 20 cases

Subsequent cases

p=n.s.

Data as 21-5-2010

UK TAVI RegistryMinimising the learning curve?

0

100

200

300

400

500

600

700

67

272

533

600

Number of TAVI by year

UK TAVI RegistryThe United Kingdom Transcatheter Aortic Valve Implantation Registry

2008 2009 20102007

Data as 22/12/10N=1472

French Registry N=244, German Registry N=697

TAVI Submissions by month and centre

1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10 11 12BAL. Barts and the LondonBHL. Liverpool Heart and Chest HospitalBRI. Bristol Royal InfirmaryCHN. Nottingham City HospitalFRE. Freeman HospitalGEO. St George's HospitalGRL. Glenfield HospitalHAM. Hammersmith HospitalKCH. King's College HospitalLBH. London Bridge HospitalLGI. Leeds General InfirmaryMOR. Morriston HospitalMRI. Manchester Royal InfirmaryNCR. New Cross HospitalNHB. Royal Brompton HospitalPAP. Papworth HospitalPLY. Derriford HospitalQEB. Queen Elizabeth Hospital, EdgbastonRAD. John Radcliffe HospitalRSC. Royal Sussex County HospitalSCM. James Cook University HospitalSGH. Southampton General HospitalSTH. St Thomas HospitalSTO. University Hospital of North StaffordshireUCL. University College HospitalVIC. Victoria HospitalWYT. Wythenshawe Hospital

2007 2008 2009 2010

Data Submission Timeline

UK TAVI RegistryThe United Kingdom Transcatheter Aortic Valve Implantation Registry

MDT Decision1. Transcatheter Aortic Valve Implantation

2007 2008 2009 2010 Grand TotalBAL. Barts and the London 1 21 39 61BHL. Liverpool Heart and Chest Hospital 5 29 16 50BRI. Bristol Royal Infirmary 21 22 16 59CHN. Nottingham City Hospital 30 30FRE. Freeman Hospital 12 5 17GEO. St George's Hospital 2 19 24 23 68GRL. Glenfield Hospital 27 26 32 23 108HAM. Hammersmith Hospital 5 22 18 45KCH. King's College Hospital 14 34 23 32 103LBH. London Bridge Hospital 6 3 9LGI. Leeds General Infirmary 21 70 63 154MOR. Morriston Hospital 5 5MRI. Manchester Royal Infirmary 7 7NCR. New Cross Hospital 4 19 23 46NHB. Royal Brompton Hospital 21 39 54 32 146PAP. Papworth Hospital 6 17 23 46PLY. Derriford Hospital 3 6 7 16QEB. Queen Elizabeth Hospital, Edgbaston 2 8 17 27RAD. John Radcliffe Hospital 9 20 19 48RSC. Royal Sussex County Hospital 2 24 37 37 100SCM. James Cook University Hospital 8 27 35SGH. Southampton General Hospital 11 8 19STH. St Thomas Hospital 36 66 75 177STO. University Hospital of North Staffordshire 9 13 22UCL. University College Hospital 28 28VIC. Victoria Hospital 4 21 16 41WYT. Wythenshawe Hospital 23 25 7 55Grand Total 66 282 574 600 1522

UK TAVI RegistryWhat Have We Learned?

• Successful implementation of a National dataset– UK wide data collection– All procedures prospectively captured– Incorporates complete experience of all centres including the

proctored learning curves– Collaboration between all involved– Mortality tracking

• Encouraging early results

• In hospital mortality: 6.2%• 30/7 mortality: 6.9%• 1 yr mortality: 19.7%

UK TAVI RegistryWhat Have We Learned?

• Highlights substantial inequality of commissioned activity

• Continuing postcode lottery• Substantial numbers of patients have no

access to a proven treatment

UK TAVI RegistryAcknowledgements – Steering group

Data Oversight Group:Mark de Belder, Ben Bridgewater, David Cunningham, Peter Ludman, Neil Moat

Chair: Huon Gray

CardiologistsAndreas BaumbachMark de BelderTony GershlickDavid Hildick-SmithJan Kovac Peter LudmanPhil MacCarthyMichael MullenSimon Ray Martyn ThomasWilliam Toff

National Institute for Clinical Excellence Hannah Patrick

Cardiothoracic surgeonsNeil MoatUday TrevidiOlaf WendlerChris Young

Central Cardiac Audit Database (CCAD)David Cunningham

Specialist commissionersTim DanielSu Sethi

Department of HealthRoger BoyleSue Dodd