What Have We Learned From The UK TAVI Registry? Simon Ray UHSM Manchester Academic Health Sciences Centre

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UK TAVI Registry The 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 Dataset

100% of consecutive UK TAVI implants – 1 st Jan 2007 to 31 st 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 Registry The United Kingdom Transcatheter Aortic Valve Implantation Registry Data as Additional 43 cases from Belfast not included

UK TAVI Registry Demographics AllTransfemoralOther routes Male52% 54%p=ns Age median (IQR) yr83 (78-87) 83 (79-87)p=ns Age range (yr) Diabetes23% p=ns Prior CABG26%23%33%p=0.002 PVD32%23%51%p< CAD48%44%57%P< LMS disease5.6%4.6%8.0%p=ns Data as

UK TAVI Registry Casemix AllTransfemoralOther routes Peak AV gradient (mmHg)808277p=ns Valve Area (cm 2 ) p=ns LVEF>50%64%65%63%p=ns LVEF < 30%8%7%9%p=ns Logistic EURO Score21.6%20.3%24.5%P<0.01 Data as

UK TAVI Registry The United Kingdom Transcatheter Aortic Valve Implantation Registry *41 subclavian, 2 other undeployed device in 10 cases Data as

UK TAVI Registry Casemix AllTransfemoralOther routes Angina43%44%39% Data as

UK TAVI Registry In Hospital Outcomes Other MACCEAllTransfemoralOther routes TIA0.6%0.3%1.1% Emergency Surgical AVR0.7%0%2.2% Breakdown 54 (6.2%) of patients died 88 (10.1%) died or had MI or CVA 10 died subsequent to CVA or MI 34 had CVA or MI and survived Data as

UK TAVI Centres Mortality tracking to Dec 31 st 2009 TAVI (intention to Rx) n=872 Mortality tracked n=842 Not tracked: life status reported at 1 year or discharge n=30 Not tracked Unknown outcome n=0 Survival curves based on n=872 Tracking

Data as /76/121 yr18/122 yr Survival: Transfemoral94.8%86.5%82.4%80.4%78.3% Number at risk Survival: Other routes89.1%79.6%75.5%71.1%66.5% Number at risk Other Transfemoral p=0.017 UK TAVI Registry 2 cases route unknown

Proctored case Unproctored case p=n.s. First 20 cases Subsequent cases p=n.s. Data as UK TAVI Registry Minimising the learning curve?

UK TAVI Registry The United Kingdom Transcatheter Aortic Valve Implantation Registry Data as 22/12/10N=1472 French Registry N=244, German Registry N=697

Data Submission Timeline

UK TAVI Registry The United Kingdom Transcatheter Aortic Valve Implantation Registry

UK TAVI Registry What 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 Registry What 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 Registry Acknowledgements – Steering group Data Oversight Group: Mark de Belder, Ben Bridgewater, David Cunningham, Peter Ludman, Neil Moat Chair: Huon Gray Cardiologists Andreas Baumbach Mark de Belder Tony Gershlick David Hildick-Smith Jan Kovac Peter Ludman Phil MacCarthy Michael Mullen Simon Ray Martyn Thomas William Toff National Institute for Clinical Excellence Hannah Patrick Cardiothoracic surgeons Neil Moat Uday Trevidi Olaf Wendler Chris Young Central Cardiac Audit Database (CCAD) David Cunningham Specialist commissioners Tim Daniel Su Sethi Department of Health Roger Boyle Sue Dodd