Euro Heart Survey New Programme Sentinel Registry Transcatheter Valve Treatment (TCVT) Carlo Di Mario, London, UK President EAPCI

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1 Euro Heart Survey New Programme Sentinel Registry Transcatheter Valve Treatment (TCVT) Carlo Di Mario, London, UK President EAPCI

2 Alan Cribier, Rouen, France Andreas Gruentzig Award 2010 Cardiogenic shock, surgery denied 16th of April 2002

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4 EURObservational Research Program Sentinel Registry TCVT Executive Committee Carlo Di Mario, UK (Chairman), EAPCI Neal Moat, UK, EACTS Bernhard Iung, France, ESC WG on Valve Disease Gerhard Schuler, Germany, EAPCI Pepe Zamorano, Spain, EAE Ottavio Alfieri, Italy, ESC WG of Cardiovascular Surgery Olaf Franzen, Germany, EAPCI Susanna Price, UK, ESC WG Acute Cardiac Care Luigi Tavazzi, ESC, Oversight Committee Patrick Serruys. Chairman CEC, Netherlands Aldo Maggioni, EHH, Statistical Analysis 1 st Meeting Paris April 28 th 2 nd Meeting : Stockholm August 28 th

5 EURObservational Research Program Sentinel Registry TCVT Approved CE Marked Devices Consecutive enrolment Automatic data transfer from existing national DB VARC (Valve Academic Research Council) definitions TAVI TMVR Recruitment End

6 Sentinel Registry: TAVI Aims of the Registry (1) Monitor the frequency of use and indications of TAVI Assess peri-procedural device success (combined endpoint of VARC definitions) Assess one-month safety (combined endpoint of VARC definitions) Assess 12 month efficacy (combined endpoint of VARC definitions)

7 VARC Definitions: TAVI Combined Safety and Efficacy EndPoints 30 day safety is defined as survival without major stroke, lifethreatening (or disabling) bleeding, Grade 3 acute kidney injury, peri-procedural MI, repeat procedure One year efficacy endpoint is defined as survival with no hospitalizations for symptoms of valve-related dysfunction or cardiac decompensation or recurrence of aortic stenosis (valve area < 1.2 cm 2, mean aortic valve gradient 20 mmhg or peak velocity 3 m/sec) or moderate to severe prosthetic valve AR.

8 Sentinel Registry: TAVI Aims of the Registry (2) Assess the effectiveness in reducing symptoms and improving quality of life at 1 year Identify the predictors of success/complications Compare results with the expected surgical results and natural history of medically treated degenerative aortic valve stenosis.

9 Identification of Mortality Predictors The EuroSCORE as an Example Relative weight of individual predictors of 30-day mortality after cardiac surgery. Developed based on a registry of nearly 20,000 consecutive patients. 128 hospitals in 8 European countries. 97 risk factors assessed in all patients. Most clinical important, reliable and objective risk factors integrated into a scoring system. (Roques et al. Eur J Cardio-Thorac Surg 1999) 9

10 VARC Definitions Cardiovascular Death Mortality: The inclusion of patients inoperable or at high risk for surgery implies that a high mortality is expected because of comorbidities or advanced heart failure even if the device achieves complete success in restoring valve functionality. VARC proposes to use all-cause mortality as a primary clinical endpoint, but strongly recommends careful investigation of the cause of death, with individual adjudication by a clinical events committee and particular detailed attention to deaths caused by device malfunction or direct complications. Mortality will be described as non-cardiovascular (infection, malignancy, accident, suicide, etc), cardiovascular (device or procedure related complications, sudden death, acute ischaemic event, heart failure, stroke, etc) or of unknown etiology. For the purpose of analysis, death of unknown etiology will be bundled with cardiovascular death

11 32 centres 1038 patients ALL 179 Causes of Death Cardiac 45 (25.1%) Non Cardiac 88 (49.2%) Unknown 46 (25.7%) Heart Failure 28 (62.2%) Pulmonary** 21 (23.9%) Sudden Death 18 (39.1%) Myocardial Infarction 6 (13.3%) Renal Failure 11 (12.5%) Unknown 18 (39.1%) Endocarditis 3 (6.7%) Cancer 10 (11.4%) Other 10 (21.7%) 11 Other* 8 (17.8%) Stroke 9 (10.2%) Gastrointestinal 5 (5.6%) Other*** 32 (36.4%) Other * = Arrhythmia, cardiac arrest Pulmonary**= Respiratory Failure, Pulmonary Embolism and Pneumonia Other*** = Sepsis, vascular access related, major bleeding, infection, suicide, and multiple organ failure From O. Wendler, London, UK

12 Chairman s Conclusions 2913 Pts

13 81.6% 79.5%

14 Mortality and Logistic EuroScore AVR in Ultraoctogenarians in Leipzig Leontyev et al, Ann Thorac Surg 2009;87:1440-5

15 EURObservational Research Program Sentinel Registry TCVT Proposal from F. Mohr, Leipzig, Germany Extend the registry to include all consecutive AVR in the same centres (as currently done in Germany Officially contacted President EACTS, A.P. Kappetein, Rotterdam, Netherlands EACTS should be in charge of the surgical arm using same endpoints definitions Feasibility in other European countries should be explored

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17 PreTreatment TTE O. Franzen, C. Di Mario, N. Moat, Royal Brompton, London, UK

18 Final TOE O. Franzen, C. Di Mario, N. Moat, Royal Brompton, London, UK

19 EVEREST I & II Studies Randomised trial showed non inferiority MitralClip v Surgical Repair for 1 Year Death, repeat surgical treatment, > grade 2 MR Enrollment Population n EVEREST I Feasibility (1 st patient 7/2/2003) Registry patients 55 EVEREST II Randomized n=279 Roll-in Randomized Clip Randomized Surgery EVEREST II High Risk Registry 78 Total enrolled 472 Presented T. Feldman, ACC 2010

20 EVEREST II Exclusion Criteria Mitral Degeneration (78%) Greatest distance between the ventricular side of the flail leaflet segment to the atrial side of the opposing leaflet edge > 10 mm Width of flail leaflet segment as measured along the line of coaptation in the short axis view > 15 mm

21 EVEREST II Exclusion Criteria Functional Mitral Regurgitation: 22% Distance from the plane of the mitral valve annulus to the first point of leaflet coaptation > 11 mm Vertical length of leaflets that is in contact, or is available for contact < 2mm

22 EVEREST II: Some More Exclusion Criteria + All Patients had to be Operable, have Severe MR due to malcoaptation P2-A2 The need for any other cardiac surgery Femoral vein cannot accommodate a 24 F catheter or ipsilateral DVT Severe left ventricular dysfunction, defined as an ejection fraction <25%,and/or end-systolic dimension >55mm Mitral valve orifice area <4.0 cm2

23 European Implant Experience* (through 8/20/2010) 8% Etiology Centres: 55 Patients 1 : 1031 Implants 1 : 986 Implant % 1 : 96% Acute MR reduction 1,2 : implants 28% Avg. device time 1,3 : 1:52 hrs 98% of 1 Includes first-time procedures only not 2 nd Clip interventions. 2 Applies only to successful implants does not include non-implants. 3 Does not include time to perform the transseptal puncture. DMR M FMR 64% Courtesy Stephane Piat, Director MitralClip European Program, Abbott Vascular Confidential

24 Sentinel Registry: MitralClip Aims of the Registry Monitor the frequency of use and indications of TMVR Assess peri-procedural device success, one-month safety,12 month efficacy (combined endpoint of modified VARC definitions) Assess the effectiveness in reducing symptoms and improving quality of life at 1 year Identify the predictors of success/complications through in-depth analysis of TOE characteristics before and implantation technique Compare results with the expected surgical results and natural history of medically treated degenerative and functional mitral insufficiency. Reduction of LVESV (echo, CMR) at follow-up, quantification of pre-post and follow-up MR

25 EURObservational Research Program Sentinel Registry TCVT Agree on the outline protocol (ESC-EACTS: explore possibility to expand to AVR) Modify and improve the database Invite National Societies and define with them Steering Committee Develop automatic transfer of data from national registries to survey. Start EC approval process Next Steps Start Enrolment (Mitral) end 2010