Percutaneous Mitral Interventions. Alec Vahanian, FESC, FRCP (Edin.) Bichat Hospital, Paris University Paris VII

Transcription

1 Percutaneous Mitral Interventions Alec Vahanian, FESC, FRCP (Edin.) Bichat Hospital, Paris University Paris VII

2 Rationale for Percutaneous Mitral Valve Interventions Mitral valve disease is frequent and carries a poor prognosis Patients are often elderly with several comorbidities Surgery may be high-risk or even contraindicated In practice, many patients are denied surgery

3 The «Mitral Complex» The annulus, the leaflets, the chordae, the papillary muscles, the inflow and outflow of the ventricle, the aortic valve

4 Percutaneous mitral commissurotomy Percutaneous mitral valve repair Transcatheter mitral valve implantation

5 Percutaneous Mitral Commissurotomy The Proof of Concept for Percutaneous Valve Intervention

6 Percutaneous Mitral Commissurotomy Percutaneous mitral commissurotomy has been used for 30 years in thousands of patients The procedure is effective and also safe in experts hands Results are maintained > 20 years The prediction of the results is multifactorial Re-intervention,either interventional or surgical, is feasible and effective in selected patients

7 The Role of PMC 5001 Patients admitted in 92 centres from April to July 2001 N = % 80% 60% 40% 20% Percut. Int. Valve Repair Bioprosthesis Mech Prosthesis Homograft Autograft 0% AS AR MS MR (Iung. Eur Heart J 2003;24:1231)

8 Mitral Valve Implantation in Native Mitral Annular Calcification (Himbert. J Am Coll Cardiol 2014)

9 Mitral Valve Implantation in Severe Mitral Annular Calcification > 100 patients in a registry and cases reports TMVI using the SAPIEN XT / 3 valve can be performed in selected, inoperable, patients with severely calcified native mitral valve disease, whatever the mode of failure The hemodynamic results are satisfactory, however the complication rate is high with a high risk of LVOT obstruction Experience as well as procedural and device refinements will be key in patient selection and procedural performance and further studies are needed

10 Percutaneous mitral commissurotomy Percutaneous mitral valve repair Transcatheter mitral valve implantation

11 Percutaneous Repair Techniques with Approval in Europe Mitralign

12 Line of coaptation

13 Current status of MitraClip > patients treated worldwide using MitraClip A RCT comparing this technique to surgery in < 300 pts, including a mix of primary and secondary MR, showed better safety & equivalent functional results but more residual MR. Results are stable up to 5 years A number of registries, mostly in high-risk patients with secondary MR, but also more recently in primary MR, confirm the safety of the procedure & improvement in symptoms, but the majority of patients still have mild to moderate residual MR

14 Registries on MitraClip

15 (Feldman ACC 2014)

16 (Feldman ACC 2014)

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18 Survival and Need for Rehospitalisation Survival Need for Rehospitalisation MitraClip treated patients Medically treated patients (Source: CERGAS Dr Tarricone)

19 Predictors of 1-Yr Mortality in TRAMI (Puls M et al, Eur Heart J 2016;37:703-12)

20 MitraClip in Patients with Low EF (Schafer ACCESS EU Registry EuroPCR 2015)

21 Timing of Intervention is Key (Rudolph V et al. Eur J Heart Fail 2013;15: )

22 ESC/ EACTS Guidelines for the Management of Valvular Heart Disease «The percutaneous MitraClip procedure may be considered in symptomatic patients with severe primary or secondary MR despite optimal medical therapy, who fulfil the echo criteria of eligibility, are judged inoperable or at high risk for surgery by a heart team, and who have a life expectancy greater than one year» (Recommendation class IIb, level of Evidence C) European Heart Journal doi: /eurheartj/ehs109 & European Journal of Cardio-Thoracic Surgery doi: /ejcts/ezs455).

23 ACC/AHA Recommendations for chronic primary MR Recommendations COR LOE Transcatheter mitral valve repair may be considered for severely symptomatic patients with chronic severe primary MR who have a reasonable life expectancy but a prohibitive surgical risk because of severe comorbidities IIb B (Nishimura et al. J Am Coll Cardiol 2014 In Press. DOI: /j.jacc )

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25 Degenerative MR (Feldman T et al JACC 2009;54: ) Flail gap Flail width

26 Ideal morphologies for a MitraClip implantation (Wunderlich NC, Eur Heart J Cardiovasc Imag 2013;14: )

27 Secondary MR (Feldman T et al JACC 2009; 54 :686-94) Coaptation length Coaptation depth

28 Unsuitable valve morphology Perforated mitral valve leaflet or cleft Severe calcification in the grip-zone Haemodynamically significant mitral stenosis (valve opening area <3cm2, MPG 5mmHg) Mobile length of the posterior leaflet <7mm Rheumatic leaflet thickening and restriction in systole and diastole (Carpentier IIIA) Barlow s syndrome with multisegment flail leaflets (Boekstegers et al. Clin Res Cardiol 2014;103:85 96)

29 Anatomic Indications to be Investigated Conditionally suitable valve morphology Pathology in segment 1 of 3 Mild calcification outside of the grip-zone of the clip system; ring calcification, post annuloplasty Mitral valve opening area >3cm2 with good residual mobility Mobile length of the posterior leaflet 7-<10mm Coaption depth 11mm Leaflet restriction in systole (Carpentier IIIB) Flail-width >15mm only with a large ring width and the option for multiple clips (Boekstegers et al. Clin Res Cardiol 2014; 103:85 96)

30 Edge-to-edge surgical mitral valve repair what if the annuloplasty ring is missed? Without annuloplasty With annuloplasty (De Bonis Curr Op Cardiol : J Thorac Cardiovasc Surg 2012;144: )

31 (Courtesy S Von Bardeleben)

32 Percutaneous Repair Techniques with Approval in Europe Mitralign

33 Percutaneous Coronary Sinus Annuloplasty Mitral valve Tricuspid valve Coronary sinus

34 Percutaneous Repair Techniques with Approval in Europe Mitralign

35 Mitral Ring Annuloplasty Surgery Cardioband

36 Fluoro and echo guidance Cardioband implantation Implantation completed Annular reduction

37 Reported Major Safety Events at 30 Days 30 Day Events* Patients Experiencing Event, # (%) All Patients N=59 -Death 2 (3.4%) Hemorrhagic Stroke** 1 (1.7%) Need for elective Mitral Operation** 1 (1.7%) Myocardial Infarction 1 (1.7%) Major Bleeding Complications 2 (3.4%) Renal Failure 4 (6.8%) Respiratory Failure 0 (0%) Cardiac Tamponade 1 (1.7%) * VARC Guidelines (European Heart Journal, 2012, 33: ) ** Part of the Death case One additional death case within 40 days per ITT - compassionate 38

38 % Patients 92% patients with MR 2+ At 24 Months By Core Lab* 89% MR 2+ at Discharge 86% MR 2+ at 30 Days 93% MR 2+ at 6 Months 93% MR 2+ at 12 Months 92% MR 2+ at 24 Months 100% 80% 2+ 60% % % % Baseline N= Discharge N=56 *Dr. Paul Grayburn Baylor University 30 days N= Months N=38 12 Months N=28 24 Months N=12 39

39 Septo Lateral Dimension [mm] A-P Dismension [mm] Annular Reconstruction by Significant Reduction in Septo Lateral (A-P) Dimension (N=45) Baseline 30% average reduction in A-P Discharge ±4 (29-46) Baseline 26±4 (18-35) Discharge *P<

40 Meters Walked MLHFQ Score % of population Functional Improvement at 24 Months MWT P<0.5 Δ = MLHFQ score P<0.02 Δ = NYHA Class P<0.01 II III I II 77% N1YHA I/II III 200 Baseline 24 Months 0 Baseline 24 Months 0 baseline 24 months N = 9 N = 11 N = 13 41

41 Percutaneous Repair Techniques with Approval in Europe Mitralign

42 Mitralign Experience 71 patients with secondary MR 56% NYHA Class II/IV; LVEF:35% At 30 days Device success rate :70% No death, tamponade : 9% At 6 months No death; stroke:12%; MI :4.8% 23% in NYHA Class II/IV ;Increase in 6MWT: + 56m MR reduction in 50% by 1.3 grade Reduction in septal-lateral annular diameter :12% (Lateeb, TCT 2015)

43 Percutaneous Repair Techniques with Approval in Europe Mitralign

44 The TACT Study (Seeburger. J Am Coll Cardiol 2014;63:914 9)

45 Patient Stratification in Padova Ideal (Type A) Adequate (Type B) Challenging (Type C) Central P2 Eccentric Jet Good Coapt. towards P1/P3Pericommissural +Central jet component Marginal Coapt. No LV Dilatation No Tethering LV Dilatation Leaflet Tethering

46 Freedom From Return of MR By Patient Type 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 96% 81% 58% Type A Type B Type C At Risk: Type A Type B Type C (Courtesy Dr Gerosa)

47 Combining Annuloplasty + Mitraclip (Courtesy of F Maisano)

48 MitraClip after Annuloplasty Failure (Courtesy of KH Kuck)

49 Percutaneous mitral commissurotomy Percutaneous mitral valve repair Transcatheter mitral valve implantation

50 Valve in Valve International Registry Patients undergoing procedures in 94 sites in Europe, North-America, Australia, New Zealand, South Africa, South America and the Middle-East (n=1,671) Aortic Valve in Valve (n= 1,074) Tricuspid Valve in Valve / Valve in Ring (n=156) Transcatheter Mitral implants in failed valves post surgery (n=437) (Dvir TVT 2015).

51 Transcatheter «Valve in Valve» for Mitral Bioprosthesis Failure Transapical Transseptal

52 Transcatheter «Valve in a Ring» Transseptal Transapical

53 Current Status Current experience in 500 patients suggests that the procedure is feasible,with a high success rate and allows for a clinical and hemodynamic at mid term. Valve in a Ring implantation is more challenging than Valve in a Valve

54 Challenges LVOT obstruction mostly with Mitral Valve in Ring Residual gradient in small prosthesis Long-term outcomes : delay and mode of failure, thrombosis

55 MitraClip after Annuloplasty Failure (Courtesy of KH Kuck)

56 Transcatheter Valve Implanation

57

58 Transcatheter Mitral Valve Implantation The feasibility of TMV replacement has been recently reported in a limited number of extreme risk patients (<100) with native mitral valve disease. Over 10 devices are currently in development. Four are in early feasibility trials in the US including Neovasc Tiara, Tendyne Mitral Valve System, CardiAQ TMVI System and Twelve Transcatheter Mitral Valve Replacement. In 2015, > 2 Billion Dollars were invested in TMVR.

59 Valve in a «Docking Device «(Courtesy of R Lange) (Courtesy of M Butchbinder )

60 Challenges (Courtesy of F Maisano)

61 Transcatheter Mitral Replacement vs Repair? Replacement Simpler Versatility (?) Reproducibility Predictable MR reduction BUT High profile of the devices Durability? PV leak? Artifact hemodynamics Repair More natural hemodynamics Safe BUT More complex Works only in selected patients Learning curve MR reduction is less predictable Durability?

62 annuloplasty replacement chordal replacement

63 The Complementary Role of Transcatheter Techniques replacement annuloplasty mitraclip Stand-alone Annuloplasty: early treatment FMR Stand-alone Mitraclip: FMR with asymmetric tethering (IMR) Stand-alone Mitraclip: DMR Combined Annuloplasty and MitraClip: DMR and Advanced FMR MV Replacement: advanced DMR and Advanced FMR (Courtesy of F Maisano) /

64 Final Comments

65 Knowledge and gaps in the care of MR 297 US physicians (PCP,general cardiologists,cardiovascular subspecialists ) Qualitative and quantitative survey Gaps in : Recognition of primary or sencinary MR Quantitative assessment Reporting of echo results Knowledge of Guidelines Assessment of quality and appropriatness of interventions (Wang,Am Heart J 2016;172:709)

66 Current Management of Severe MR Isolated MR (n=887) No Severe MR (n=347) Severe MR (n=540) No Symptoms (n=144) Symptoms (n=396) No Intervention (n=193) 49% Intervention (n=203) 51% (Mirabel et al. Eur Heart J 2007;28: ) European Heart Journal doi: /eurheartj/ehs109 & European Journal of Cardio-Thoracic Surgery doi: /ejcts/ezs455).

67 Heart Valve Centres of Excellence «The optimal care of patients with complex heart valve disease is best performed in centres that can provide all available options for diagnosis and management, including the expertise for complex aortic or mitral valve repair, aortic surgery, and transcatheter therapies.» This has led to the development of «Heart valve Centres of Excellence «Mitral Heart team (Nishimura et al. J Am Coll Cardiol 2014;63:e57 e185)

68 The «Heart Team» SURGEONS CARDIOLOGISTS (General, HF, EP, Interventionists) Anesthesiologists Treatment of Mitral Valve disease Other specialists: Geriatricians Imaging specialists (Echo, CT, MRI)

69 Patient Selection for Intervention on the Mitral Valve Medical Rx «Futility > Utility» Because of cardiac and extra-cardiac factors PMVR Surgery (Repair, Replacement, LVAD, Transplantation) Need for a team discussion with HF and EP specialists and transplant team to evaluate respective indications of transcatheter therapy or surgery or LV assist as a destination therapy or transplant

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74 HiRiDeTrial High and Intermediate Risk Degenerative Mitral Regurgitation Treatment: a Randomized Controlled Trial Comparing MitraClip to Surgical Therapy HiRiDe Trial Francesco Maisano

75 Raising Awareness in Mitral Regurgitation Project led by : - ESC Education Committee,ESC WG on Valvular Heart Disease, EAPCI, ACCA, EHRA, HFA, EACVI,ESC WG on Cardiac Surgery, Council for Cardiology Practice; AXEDEV Goals Qualitative phase is completed - Assessment of current Guidelines implementation (Qualitative Quantitative) - Design an educational programme - - Continued Quantitative roll out of the educational phase programme ongoing and its measurement. Participants - GPs,General cardiologists,arrhytmia specialists,hf specialists, Interventionists, Cardiac surgeons

76 VHD II Registry January-March 2017 Primary objectives: to analyse existing practices in the management of patients with heart valve disease to compare these practices with existing guidelines and with the first European survey on valvular disease performed in 2001 Secondary objectives: In-hospital and 6-month mortality & morbidity according to the differences in management strategies Other Objectives: Use of diagnostic procedures Use and results of valve procedures Management of patients after a valve procedure Assessment of specific subgroups of patients of interest because of their increasing incidence EURObservational Research Programme

77 The new ESC/EACTS Guidelines on VHD will be presented in August 2017!!!

78 The ESC Virtous circle on VHD In August 2017, we will have the «full picture» of the management of VHD in Europe EURObservational Research Programme

79 Variation in MitraClip Utilization/ Health Policy and Reimbursement

80 «The duty of any valvular surgeon today is no longer to correct a mitral valve regurgitation, but to correct a mitral valve regurgitation for the rest of the patient s life A.Carpentier My Rosy Prophecy for : Mitral trans-catheter techniques will represent a satisfactory palliation in patients who are at high surgical risk or inoperable 2008-Hugo Vanermen

81 extra hours Talent & Innovation Engagement

82 Merci