Alec Vahanian,FESC, FRCP (Edin.) Bichat Hospital University Paris VII, Paris, France

Transcription

1 Future Percutaneous Therapies for Mitral Valve Disease (Mitraclip,percutaneous annuloplasty and transcatheter valve implantation) Will they reach the TAVI s success? Alec Vahanian,FESC, FRCP (Edin.) Bichat Hospital University Paris VII, Paris, France

2 Disclosures Relationship with companies who manufacture products used in the treatment of the subjects under discussion Relationship Manufacturer(s) Speaker's Honoraria Consultant (Advisory Board) Edwards Lifesciences Abbott, Medtronic Saint Jude Medical,Valtech

3 «The TAVI s Success»

4 The Devices for TAVI Medtronic CoreValve Edwards SAPIEN CE mark 2007 CE mark 2007 > patients treated

5 TAVI: The Proof of Concept

6 Gradient (mmhg) Echocardiographic Findings Mean and Peak Gradients (AT) Peak Gradient - TAVR Mean Gradient - TAVR Peak Gradient - AVR Mean Gradient - AVR Numbers at Risk TAVR AVR

7 All-Cause Mortality (ITT)

8 Clinical Outcome at 30 Days ADVANCE Transfemoral N=1015 SOURCE Transfemoral N = 1694 SOURCE Transapical N = 906 All-cause Mortality (%) Any Stroke (%) Aortic regurgitation 2/4(%) Myocardial Infarction (%) New Pacemaker (%) Vascular Complication Major (%) Renal Failure with Temporary Dialysis) (%) Major Bleeding (%) (Bauernschmidt ; EuroPCR 2012)

9 TAVI and AVR in Germany 29% in 2011 (Quelle: DGTHG Statistik 2010)

10 Today, TAVI is only indicated in inoperable or high risk patients with severe AS and severe symptoms Further research is needed on risk stratification models for AVR and TAVI - improvement of safety and ease of the procedure- technology- evaluation in comparison with surgery Then, indications will be expanded to lower risk patients

11 The Mitral Valve

12 Mitral Valve Apparatus Annulus Commissures Leaflets Complex interaction Subvalvular apparatus Papillary muscles

13 Surgeons use many different techniques to individualize treatment 2008-Hugo Vanermen

14 «The Best of Surgery in MR» In expert centers, in patients with primary MR, the repair rate is >90% and >90% of patients are alive and free from reoperation after years. Surgery for secondary MR remains a challenge. Most studies failed to demonstrate improved long-term clinical outcome following surgical correction.

15 Functional Mitral Regurgitation (Courtesy of A Berrebi)

16 Percutaneous Edge to Edge Repair

17 Edge-to-Edge Technique

18 Surgical Edge-to-Edge technique (Alfieri. J Thorac Cardiovasc Surg 2001;122:674-81)

19 Percutaneous Edge to Edge repair MitraClip System Clip toward MV Clip across MV Leaflets grasped

20

21

22

23

24 Worldwide Clinical Experience with MitraClip Therapy (March 2012) Over 5,000 patients have been treated with the MitraClip device worldwide: 75% are considered high risk* for mitral valve surgery 67% have functional mitral regurgitation (MR) * Determination of high surgical risk based on: logistic EuroSCORE 20%, or STS calculated mortality 12%, or pre-specified high surgical risk co-morbidities specified in EVEREST II High Risk Study protocol.

25 ACCESS EU: Baseline Demographics and Co-Morbidities Demographics and Co-morbidities EVEREST II RCT Device Patients N=178 ACCESS EU MitraClip Patients N=566 Age (mean ± SD), years 67 ± ± 10 Logistic EuroSCORE 20%, (%) NA 45 Coronary Artery Disease, (%) Previous Cardiovascular Surgery, (%) Moderate to Severe Renal Failure, (%) 3 42 Atrial Fibrillation, (%) ACCESS EU ACC 2012 (Courtesy of F.Maisano) Investigational Device only in the U.S. Not available for sale in the U.S. 25

26 ACCESS EU: Baseline Demographics and Co-Morbidities Demographics and Co-morbidities EVEREST II RCT Device Patients N=178 ACCESS EU MitraClip Patients N=566 Mitral Regurgitation Grade 3+, (%) NYHA Functional Class III or IV, (%) Ejection Fraction < 40%, (%) 6 53 Functional MR, (%) ACCESS EU ACC 2012 Investigational Device only in the U.S. Not available for sale in the U.S. 26

27 ACCESS EU: Events At 30 Days 99.6% Implant Rate 30 Day Events* Patients Experiencing Event, # (%) All Patients N=566 Death 3.4% Stroke 0.7% Myocardial Infarction 0.7% Renal Failure 4.2% Respiratory Failure 0.7% Need for Resuscitation 1.8% Cardiac Tamponade 1.1% Bleeding Complications 3.7% * As reported by sites as of January 12, 2012 ACCESS EU ACC 2012 Investigational Device only in the U.S. Not available for sale in the U.S. 27

28 ACCESS EU: Mitral Regurgitation Grade p< Percent Patients * As assessed by the sites ACCESS EU ACC Baseline months N = 392 Matched Cases 80% MR 2+ at 6 Months Investigational Device only in the U.S. Not available for sale in the U.S. 28

29 ACCESS EU: NYHA Functional Class p< I II I Percent Patients III II III 71% NYHA Class I or II at 6 Months 0 IV IV Baseline 6 months N = 378 Matched Cases ACCESS EU ACC 2012 Investigational Device only in the U.S. Not available for sale in the U.S. 29

30 The Trial we Need in Secondary MR HF patients with Severe MR and Low EF «RESHAPE» and «COAPT» will start soon Symptoms despite Optimal Medical Management (including Revascularisation and/or CRT) Edge to Edge Medical therapy

31 The Current Situation : Mitraclip Experience in Hamburg (Treede,J Thorac Cardiovasc Surg 2012;143:78-84)

32 Coronary Sinus Annuloplasty

33 Limitations of Percutaneous Coronary Sinus Annuloplasty Circumflex artery Mitral valve Coronary sinus

34 The Devices The Edwards MONARC system* Proximal Anchor Bridge Distal Anchor Elongated bridge at implant Foreshortened state at ~6 weeks The CARILLON device The PTMA Implant System* * abandoned

35 TITAN Patient Enrollment < 1 grade MR Reduction n=9 Transient coronary compromise n=7 < 1 grade MR reduction + coronary compromise n=1 (Pieciky EuroPCR 2012) 35

36 cm cm ml ml 36 LV Remodeling N = ** ** * ** N = * ** Implanted Non-Implanted

37 meters Clinical Results 24 Months Implanted Patients NYHA Class P=0.005 P< N = 15 N = 19 Baseline 1 Month 6 Months 12 Months 24 Months 37

38 What is Next?

39 Direct Annuloplasty Mitralign GDS Cinching cable P1 P2 P3 In clinical trial In clinical trial

40 Direct Annuloplasty Millipede Valtech Cardioband In clinical trial

41 Chordal Implant NeoChord Valtech V-Chordal MitraFlex In clinical trial In clinical trial

42 Combination of Annuloplasty with other techniques Edge to Edge Chordal Replacement

43 Transcatheter Valve Replacement CardiAQ

44 Transcatheter Valve Replacement Endovalve Tiara Challenges Positionning Fixation Paravalvular leaks Valve gradient and LV outflow track obstruction Thrombosis Durability Lutter

45 Combination of Techniques to Improve LV Function in Secondary MR Annuloplasty Ring +CRT

46 percent percent MitraClip in CRT Non-Responders (PERMIT-CARE registry) 50 pts, 33 months after CRT; LVEF: 27%; STS Score=14% P<0.001 P<0.001 P<0.001 P<0.001 P<0.001 P< Pre-CRT Pre-MC Discharge 3M 6M 12M NYHA I NYHA II NYHA III NYHA IV Pre-CRT Pre-MC Discharge 3M 6M 12M MR 1 MR 2 MR 3 MR 4 (Aurrichio J Am Coll Cardiol. 2011;58: ). 46

47 Percutaneous Tricuspid Valve Intervention (Agarwal et al. Circ Cardiovasc Interv 2009;2: )

48 Transcatheter Treatment after Surgical Failure

49 Transcatheter «Valve in a Valve»for Mitral Bioprosthesis Failure Transapical Transseptal

50 Mitral Valve-in-Valve Implantation (n#25) 2 Series (n=6 to 11) Transapical (n=23), transvenous (n=2) Degenerated bioprostheses Type: CE Perimount and porcine,baxter Edwards, Medtronic Mosaic, Medtronic Intact, Edwards SAV Sizes: 23 to 29mm Outcomes Procedural failure: 1 (transvenous) Death: n=2 Valve function Mean gradient: 7± 3 mmhg Leakage: none (n=16), mild (n=7)

51 Transcatheter Valve in a Ring LA LV B (De Weger. Eur J Cardio-thorac Surg ) (Himbert, J Am Coll Cardiol,in Press)

52 Transcatheter Valve in a Ring 15 pts in 5 centers :71yrs ; NYHA Class III/IV; LES 35% Annuloplasty ring 26-31mm Transeptal : 8 ; transapical : 7 Sapien XT 26 : 14, 23mm : 1 Procedural success : 93% (1 emergency surgery) Mean gradient : 7± 3mmHg No - mild MR : 87% In 2 cases dynamic intra ventricular gradient (15-17mmHg max) 73 % improved to NYHA class II at 1month (Descoutures et al. ESC 2012)

53 Transcatheter Treatment after Surgical Failure (Courtesy of D Himbert)

54 (Wunderlich EuroPCR2012)

55 Conclusions The current results of the Edge to Edge technique suggest that it may be useful in selected high risk patients. Long- term FU and RCT in secondary MR are needed. The results of coronary sinus annuloplasty are disappointing Numerous new devices (>20) are currently being developed The evaluation of new devices aimed at reproducing surgical techniques and combination of techniques for percutaneous mitral valve repair are awaited. Transcatheter valve replacement is an attractive option, but will be challenging Preliminary data on transcatheter treatment after surgical failure show that it is feasible. The new mitral transcatheter techniques may represent a satisfactory palliation in patients who are at high surgical risk or inoperable, however it is unlikely that they could be applied to lower risk patients.

56 «We need to be sure that we do not sacrifice proven long-term effectiveness for short-term issues, such as convenience, invasiveness, or irreversible procedural complications» Catherine Otto NEJM 2011

57 Remember..

58 extra hours Talent & Innovation Engagement