Mille in Italia e oltre: ABC per il clinico sulle indicazioni e sull implementazione in rete del Sistema MitraClip

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1 Mille in Italia e oltre: ABC per il clinico sulle indicazioni e sull implementazione in rete del Sistema MitraClip Anna Sonia Petronio MD, FESC Head of Cardiac Catheterization Laboratory Cardiothoracic and Vascular Department University of Pisa, Italy

2 Percutaneous Mitral Valve Therapies

3 Transcatheter Mitral Valve Repair MitraClip System

4 Worldwide Experience Study Population N* EVEREST I (Feasibility) Feasibility patients 55 EVEREST II (Pivotal) Pre-randomized patients 60 EVEREST II (Pivotal) Non-randomized patients (High Risk Study) 78 EVEREST II (Pivotal) Randomized patients (2:1 Clip to Surgery) Clip 95 Surgery REALISM (Continued Access) Non-randomized patients 894 Compassionate/Emergency Use Non-randomized patients 66 ACCESS Europe Phase I Non-randomized patients 567 ACCESS Europe Phase II Non-randomized patients 286 Commercial Use Commercial patients 8,943 Total 11, surgery *Data as of 10/31/2013. Source: Abbott Vascular *Data as of 10/31/2013. Source: Abbott Vascular

5 MitraClip Therapy Current Global Adoption Treating Centers 296 Patients (clinical and 11,133 Patients1 (commercial) 9,796 commercial) Rate2 96% Acute MR reduction2 99% of implants Implant Functional MR2 67% Degenerative MR2 22% Mixed2 11% Commercial Investigational Special Access 1. First-time procedures only. Includes commercial patients, ACCESS I and ACCESS II patients. 2. Successful implants only.

6 Commercial MitraClip Implant Experience

7

8

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10

11

12

13 EVEREST II

14

15

16 Degenerative mitral regurgitation: The MitraClip procedure a resonable is a therapeutic option for select patients with DMR who cannot undergo surgery with suitable valve

17 Functional mitral regurgitation: The MitraClip therapy provides an additional therapeutic option for high risk surgical patients with functional mitral regurgitation who are symptomatic regardless optimal medical therapy Furthermore the MitraClip provides significant benefits when residual MR is = 2+ at 1 year.

18

19 Left Ventricular End Diastolic Volume

20 NYHA Functional Class

21 Hospitalizations for CHF

22 Functional mitral regurgitation: The MitraClip therapy provides an additional therapeutic option for high risk surgical patients with functional mitral regurgitation who are symptomatic regardless optimal medical therapy Furthermore the MitraClip provides significant benefits when residual MR is 2+ at 1 year. The question remains whether this procedure will affect long-term prognosis in patients with severely reduced LV-RV EF

23 Indication and timing of intervention is a crucial step in the diagnostic-therapeutic pathway of patients with mitral regurgitation. The Importance of Timing End stage HF

24 Eur J Heart Failure, Michael Neuss, 2013

25 Decision Key Eligibility making Criteria on EVEREST II High Surgical Risk Cohort CLINICAL criteria ANATOMICAL criteria Mean STS Mortality Risk for EVEREST II High Surgical Risk Cohort was 12.2 ±7.9 % Mauri L et al, Am Heart J 2010

26

27 Suitable anatomy criteria FMR A LA >2mm RA Coaptation length >2 mm B LA Ao Coaptation depth <11 mm <11mm LV

28 A Suitable anatomy criteria DMR C LA <10mm Flail gap <10 mm LV Ao D Flail width <15 mm <15mm

29

30 Grayburn J Cardiol 2011

31 Grayburn J Cardiol 2011

32 IM ¾+, NYHA III-IV Optimal DMR

33 Optimal DMR 2 clips

34 Optimal FMR: IM ¾+, NYHA III-IV

35 MitraClip Implantation:

36 Follow-up IM 1/2+, NYHA II-III IM 1/2+, NYHA II-III

37 Limited suitable

38 Limited suitable

39 Limited suitable IM 1/2+

40

41 Multiple jets Case I Multiple jet Case II 1 central 2 commissural

42 Severe annular dilation with excessive tethering 42 mm 40 mm 17 mm

43 Mitral calcified and stenotic

44 Barlow

45 Short and fibrotic PML Short PML 7 mm 7 mm

46 Anatomical criteria: not only a valve problem

47

48

49 FMR flow-chart

50 Mitral Regurgitation 2009 U.S. Prevalence A Largely Untreated Patient Population Total MR Patients 1,2 4,100,000 Eligible for Treatment 3,4 (MR Grade 3+) Annual Incidence 3 (MR Grade 3+) 1,700,000 1,670, ,000 84% Untreated Large and Growing Clinical Unmet Need 14% Newly Diagnosed Each Year Annual MV Surgery 5 30,000 Only 2% Treated Surgically 1. US Census Bureau. Statistical Abstract of the US: 2006, Table Nkomo et al. Burden of Valvular Heart Diseases: A Population-based Study, Lancet, 2006; 368: Patel et al. Mitral Regurgitation in Patients with Advanced Systolic Heart Failure, J of Cardiac Failure, ACC/AHA 2008 Guidelines for the Management of Patients with Valvular Heart Disease, Circulation: Gammie, J et al, Trends in Mitral Valve Surgery in the United States: Results from the STS Adult Cardiac Database, Annals of Thoracic Surgery 2009.

51 1. Ospedale San Raffaele (Milano) 2. Centro Cuore Columbus (Milano) 3. Istituto Clinico Sant Ambrogio (Milano) 4. Centro Cardiologico Monzino (Milano) 5. Ospedale Civile di Legnano (Legnano) 6. Ospedale Niguarda (Milano) 7. A.O. Luigi Sacco (Milano) 8. Istituto Clinico Humanitas (Rozzano) 9. Policlinico San Donato (San Donato M.se) 10. Policlinico San Matteo (Pavia) 11. A.O. Spedali Civili di Brescia (Brescia) 12. A.O. Papa Giovanni XXIII (Bergamo) 13. A.O. San Giovanni Battista (Torino) 14. A.O.U. Pisana (Pisa) 21. ULSS 12 VENEZIANA Ospedale dell Angelo (Mestre) 22. A.O.U. di Trieste (Trieste) 23. A.O.U. Policlinico S. Orsola-Malpighi 24. A.O. S.Maria della Misericordia (Perugia) 25. C.d.C. Pineta Grande (Castel Volturno) 26. A.O. Monaldi (Napoli) 27. Clinica Mediterranea (Napoli) 28. A.O. S. Giovanni di Dio e Ruggi d A. (Salerno) 29. A.O. SS. Anna e Sebastiano (Caserta) 15. Policlinico Tor Vergata (Roma) 16. Policlinico Gemelli (Roma) 17. Policlinico Umberto I (Roma) 18. A.O. San Camillo (Roma) 30. C.di C. Santa Maria (Bari) 31. A.O. San Carlo (Potenza) 19. Ospedale Ferrarotto (Catania) 20. ARNAS Civico (Palermo) 32. A.O.U. Mater Domini (Catanzaro) Novembre 2013 : 32 centri MitraClip attivi / pazienti trattati

52 Importance of the Learning Curve The MitraClip learning curve is characterized by 1 : Procedure time reduction: 180min to 55min Acute procedural success* from 80% to 92% Significant device time reduction is observed across the MitraClip centers of excellence *Acute procedural success: implanted MitraClip device and MR Schillinger W et al. Impact of the learning curve on outcomes after percutaneous mitral valve repair with MitraClip and lessons learned after the first 75 consecutive patients? -European Journal of Heart Failure Advance Access October 24, Data sources: Apollo System; Case Observation Forms. July This includes all submitted and reviewed procedures, including successful and unsuccessful procedures as reported in Apollo.

53 Bozza aggiornata al 24/05/12 Experience From TAVI Treatement trend German Heart Center Munich 30 days mortality German Heart Center Munich

54 COSTO PROCEDURA MITRACLIP :<9.2% DRG N

55 Creating the MitraClip Network BASED UPON Relationship of trust between implanting centre and referrer Key role of the referrer in patient treatment (diagnosis and follow-up) Sharing with referrer the patient s experience within the implanting centre Present the latest innovations/data

56 DIAGNOSIS REFERRER INOPERABLE or HIGH RISK SURGERY Patient Identification: FUNCTIONAL-DMR CARDIAC SURGEON MV Repair or Replacement

57 INOPERABLE or HIGH RISK SURGERY REFERRER FOLLOW UP Verification of MitraClip Criteria TEE IMPLANTING CENTER

58 Trends for future developments Procedural Cost Materials: NewProsthesis, Delivery Catheter, etc Device Costs Reimbursement Inter-Hospital Network Uniformity of the TAVI path Highly specialized Center Heart Team

59 THANK YOU

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