In-Hospital Results in 4,571 TAVI Patients

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1 Transcatheter Valve Treatment: t Pilot Sentinel Registry In-Hospital Results in 4,571 TAVI Patients Rome, 7 June 2013 Istituto Superiore di Sanita Carlo Di Mario Chairman TCVT Registry on Behalf of Executive & Steering Committees and All Investigators Cardiovascular Biomedical Research Unit Cardiovascular Biomedical Research Unit Royal Brompton Hospital & Imperial College London, UK :Certified implanter of Corevalve and SapienXT via courses and proctorships organised by Medtronic and Edwards; participated to the Abbott Brussels Mitraclip Users course

2 Pilot Sentinel Registry TCVT Executive Committee Carlo Di Mario, UK (Chairman), EAPCI Neil Moat, UK, ESC WG of Cardiovascular Surgery Bernhard Iung, France, ESC WG on Valve Disease Gerhard Schuler, Germany, EAPCI Pepe Zamorano, Spain, EAE Ottavio Alfieri, Italy, EACTS Olaf Franzen, Denmark, EAPCI Susanna Price, UK, ESC WG Acute Cardiac Care Luigi Tavazzi, ESC, Oversight Committee Aldo Maggioni, EHH, Statistical Analysis

3 Management of Valvular Heart Disease (2012) TAVI is indicated for patients with severe symptomatic AS who are not suitable for AVR as assessed by a heart team and who are likely to gain improvement in their quality of life and have life expectancy of more than 1 year TAVI should be considered in high risk patients with severe symptomatic aortic stenosis who may still be suitable for surgery but in whom TAVI is favoured by a heart team based on the individual risk profile and anatomic suitability IIa B B MitraClip may be considered in eligible pts with symptomatic severe primary MR are judged inoperable or at high surgical risk and have a life expectancy greater than 1 year MitraClip may be considered in eligible pts with symptomatic severe secondary MR despite OMT including CRT IIb IIb C C

4 Sentinel Registry: TAVI/Mitraclip Aims of the Registry Monitor indications and procedural strategy (exclude inappropriate utilisation and document changes in technique pre-operative imaging, access site, type of anaesthesia-) Assess peri-procedural device success (confirm results of randomised trials are achievable in real-life patients and assess effects of improved device performance/operator experience compared with historical trials)

5 Transcatheter Valve Pilot Sentinel Registry TAVI: Type and Size of Valve Implanted 4,571 Pts from 10 Countries Enrolled Valve Type 1943 (42.6%) 2604 (57.4%) Small (23 E/26 C) 40.8% 44.2% Medium (26 E/ 29 C) 53.1% 48.7% Large (29 E/ 31 C) 6.1% 7.1% TCVT Pilot Registry

6 Transcatheter Valve Pilot Sentinel Registry TAVI 4571 Pts: Patient Distribution BE CZ FR DE IL IT PL SP CH GB CENTRES PATIENTS % Consecutive enrolment in participating centres for the entire 2011 (national registries) or between EC approval and June 2012 (web-based entries) Monitoring program of registries of participating countries (adjudicated results) or via queries generated at the Heart House

7 Transcatheter Valve Pilot Sentinel Registry TAVI Participating countries Spain Goicolea France Eltchaninoff Poland Zembala Check Rep: Kala Italy: Romeo, Ussia Switzerland: Wenaveser Israel: Danenberg Belgium Schroeder UK Prendergast Germany: Nickenig TCVT Pilot Registry

8 To view the e-crf, click on Demo tab To access the different pages Scroll back to access to Follow up 1 Month and Follow and Follow up 1 year

9 Transcatheter Valve Pilot Sentinel Registry TAVI 4571 Pts: Sex, Age and Body Mass Index Age % Mean 81.4 (SD 7,14) y/o M 50 Gender 40 total 30 male F BMI (SD 4.9) 20 female 10 <70 y >90 TCVT Pilot Registry

10 TAVI: Patient Characteristics (I) by Age Variable Total, n (%) <80, n (%) >80, n (%) (# observations) (37.5) 2850 (62.4) P value Male/Female (4571 pts) 2291(50.1)/2280(49.9) 1)/2280(49 9) (58.6)/(41.4) 4) (45.0)/(55.0) < Diabetes mellitus (4547 pts) 1259 (27.7) 618 (36.1) 641 (22.6) < 0.01 Hypertension (3664 pts) 2709 (73.9) 956 (73.3) 1753 (74.3) 0.52 Current Smoking (4357 pts) 185 (4.2) 122 (7.4) 63 (2.3) < 0.01 Atrial fibrillation (2773 pts) 557 (20.1) 177 (19.7) 380 (20.3) 0.65 COPD (3844 pts) 981 (25.5) 438 (31.5) 543 (22.1) < 0.01 Dialysis (3821 Pts) 265 (6.9) 142 (10.2) 123 (5.1) < 0.01 Previous stroke (4282 pts) 206 (12.1) 218 (12.7) 333 (11.7) 0.32 Previous MI (4549 pts) 769 (16.9) 348 (20.3) 421 (14.8) < 0.01 Prev cardiac surgery (4505 pts) 824 (18.0) 469 (27.8) 355 (12.6) < 0.01 Previous PCI (2289 pts) 463 (20.2) 227 (22.1) 236 (18.7) 0.04

11 TAVI: Patient Characteristics (II) by Age Variable ibl Total, n (%) <80, n (%) >80, n (%) (# observations) (37.5) 2850 (62.4) P value Previous PM (3676 pts) 430 (11.7) 114 (8.7) 316 (13.3) < 0.01 Extracard arteriopathy (2707pts) 671 (24.8) 238 (27.1) 433 (23.7) <0.05 Porcelain Aorta (465 pts) 104 (22.4) 58 (28.4) 46 (17.6) < 0.01 Chest df deformity (409 pts) 12 (2.9) 8 (4.6) 4 (1.7) Previous AVR (2141 pts) 74 (3.4) 40 (4.1) 34 (2.9) 0.05 LVEF <30% 40 (5.7) 28 (9.5) 12 (2.9) (701 pts) 30 50% 191 (27.2) 74 (25.2) 117 (28.7) >50% 470 (67.0) 192 (65.3) 278 (68.3) < 0.01 Significant CAD (3343 pts) 669 (20.0) 289 (21.5) 380 (19.0) 0.07 Significant LM (3343 pts) 215 (6.7) 92 (7.01) 123 (6.5) 0.54 Logistic Euroscore (4394 pts) 20.2 (13.3) 17.4 (13.2) 22.0 (13.1) <0.01

12 Transcatheter Valve Pilot Sentinel Registry TAVI Logistic EuroSCORE by Country : insufficient country sample Speaker TCVT Pilot Registry

13 Transcatheter Valve Pilot Sentinel Registry TAVI: Access Site % Access Site Femoral Apical Other (74.2%) (16.4%) (9.4%) TCVT Pilot Registry July 10, 2012

14 Patient and Procedural Characteristics by Access Site Transfemoral Transapical Other 3390 (74.2%) 749(16.4%) 432(9.4%) P value Male/Female (46.5)/(53.5) (62.4)/(37.5) (57.4)/(42.6) < 0.01 Diabetes mellitus 905 (26.8) 221 (29.9) 133 (30.9) 0.07 COPD 719 (25.3) 131 (22.3) 131 (31.7) < 0.01 Dialysis 176 (6.1) 45 (7.5) 44 (12.6) < 0.01 Previous MI 519 (15.4) 164 (22.1) 86 (19.9) < 0.01 Previous cardiac surgery 543 (16.2) 220 (30.2) 61 (14.2) < 0.01 Previous PCI 331 (19.0) 90 (24.5) 42 (23.3) 0.03 Previous PM 342 (12.3) 53 (9.0) 35 (11.1) 0.07 Previous AVR (valve in valve) 58 (1.7) 9 (1.2) 7 (1.6) 0.21 LVEF <30% 30 (5.0) 3 (5.6) 7 (15.2) 30 50% 165 (27.1) 16 (29.6) 12 (26.1) >50% 408 (67.9) 35 (64.8) 27 (58.7) Significant CAD (>= 1 vessel) 477 (18.8) 116 (23.3) 76 (24.8) < 0.01 Logistic Euroscore 19.6± ± ±13.9 <

15 Transcatheter Valve Pilot Sentinel Registry TAVI: Transfemoral Access by Country : insufficient country sample Speaker

16 Transcatheter Valve Pilot Sentinel Registry TAVI: Local Anaesthesia for Femoral Approach : insufficient country sample Speaker

17 Transcatheter Valve Pilot Sentinel Registry TAVI: Successful Deployment VALVE SUCCESSFULLY DEPLOYED: 96.5% Access % Transfemoral 96.8 Transapical 95.1 Other 97 AGE % <= 80y/o 96.5 > 80 y/o 96.5 p= 0.96 Valve % Corevalve 96.4 p= 0.08 TCVT Pilot Registry July 10, 2012 Sapien XT 96.8 p= 0.55

18 cm 2 TCVT Pilot Registry Haemodynamic Changes after TAVI AVA mmhg

19 TCVT Registry In-Hospital Complications by Access Site Death (Total 7.4%) <0.01 Stroke (Total 1.8%) MI (Total 0.9%) PM implantation <0.01 Haemodialysis < Transfusion(s) <0.01 New onset AF <0.01 Hosp. stay >10 days <0.01

20 TCVT Pilot Registry TAVI In-Hospital Complications by Valve Type Death (Total 7.4%) Surgical conversion <0.01 Second valve implanted <0.01 Haemodialysis/filtration < PM implantation <0.01 AR grade <0.01 AR grade <0.01 Speaker

21 Transcatheter Valve Pilot Sentinel Registry Predictors of TAVI In-Hospital Mortality at Multivariate Analysis VARIABLE ODDS RATIO 95% CI P VALUE Age (8 years interval) Euroscore (>Q3 vs <=Q1) Pre MR (Grade 2 vs no/grade1) Valve successfully deployed (No vs Yes) < TCVT Pilot Registry July 10, 2012

22 The Sentinel Registry provides essential information about contemporary patient selection and procedural outcome of TAVI. We anticipate i that the pilot Sentinel TAVI Registry will be the first of many reports from this collaborative group that will become more refined with age and experience. The expansion of TAVI has been performed in a safe and responsible fashion at least in part attributable to the efforts of these investigators. J Popma. EuroIntervention 2013;8:

23 Sentinel Registry: TAVI/Mitraclip Problems: Monitoring; Long-term Follow-up there are some potential limitations to the sole use of post-market registries for monitoring outcome after TAVI: stroke rates were lower (1.8%) than reported in randomised trials that included prospective surveillance and rigourous neurological testing. Future iterations may include long-term outcomes and the addition of newer TAVI devices J Popma. EuroIntervention 2013;8:

24 Presented May 2013 by Stephan Windecker

25 Presented May 2013 by Stephan Windecker

26 Sentinel Registry: TAVI/Mitraclip Conclusions Collection of meaningful transnational data on new procedures is possible outside traditional industry sponsored registries, allowing comparison of practice and acquisition of large databases in short time period 1 Year F-Up to be presented A dam ESC 2013 The ESC EORP Steering Committee has endorsed prolongation and enlargement of the Pilot Transcatheter Registry into a Permanent Registry

27 TCVT Long Term - New CRF Number of variables in the CRF has been reduced by 63% (661->242) This reduction has been performed following 2 criteria: 1. variables used in Statistical Analysis performed during the Pilot phase; 2. variables with acceptable data completeness during the Pilot phase Follow Up One Month has been removed 93.5% of the remaining variables are the same that we had in the Pilot New variables 2.5% (6) are new variables linked to Periprocedural complication 4% (10) are updates on new valves type/dimensions

28 Transcatheter Valve Permanent Registry TAVI Participating countries Poland Zembala Spain Goicolea France Eltchaninoff Check Rep: Kala Italy: Romeo, Ussia Switzerland: Wenaveser Israel: Danenberg Belgium Schroeder UK Prendergast Germany: Nickenig Portugal: Ireland Netherlands Denmark Sweden Norway Finland Austria Hungary Croatia Serbia Greece Turkey

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