Percutaneous Mitral Interventions Alec Vahanian, FESC, FRCP (Edin.) Bichat Hospital, Paris University Paris VII
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
The «Mitral Complex» The annulus, the leaflets, the chordae, the papillary muscles, the inflow and outflow of the ventricle, the aortic valve
Percutaneous mitral commissurotomy Percutaneous mitral valve repair Transcatheter mitral valve implantation
Percutaneous Mitral Commissurotomy The Proof of Concept for Percutaneous Valve Intervention
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
The Role of PMC 5001 Patients admitted in 92 centres from April to July 2001 N = 512 119 112 155 100% 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)
Mitral Valve Implantation in Native Mitral Annular Calcification (Himbert. J Am Coll Cardiol 2014)
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
Percutaneous mitral commissurotomy Percutaneous mitral valve repair Transcatheter mitral valve implantation
Percutaneous Repair Techniques with Approval in Europe Mitralign
Line of coaptation
Current status of MitraClip > 35000 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
Registries on MitraClip
(Feldman ACC 2014)
(Feldman ACC 2014)
Survival and Need for Rehospitalisation Survival Need for Rehospitalisation MitraClip treated patients Medically treated patients (Source: CERGAS Dr Tarricone)
Predictors of 1-Yr Mortality in TRAMI (Puls M et al, Eur Heart J 2016;37:703-12)
MitraClip in Patients with Low EF (Schafer ACCESS EU Registry EuroPCR 2015)
Timing of Intervention is Key (Rudolph V et al. Eur J Heart Fail 2013;15:796-807)
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) www.escardio.org/guidelines European Heart Journal 2012 - doi:10.1093/eurheartj/ehs109 & European Journal of Cardio-Thoracic Surgery 2012 - doi:10.1093/ejcts/ezs455).
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: 10.1016/j.jacc.2014.02.537)
Degenerative MR (Feldman T et al JACC 2009;54: 686-94) Flail gap Flail width
Ideal morphologies for a MitraClip implantation (Wunderlich NC, Eur Heart J Cardiovasc Imag 2013;14:935-949)
Secondary MR (Feldman T et al JACC 2009; 54 :686-94) Coaptation length Coaptation depth
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)
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)
Edge-to-edge surgical mitral valve repair what if the annuloplasty ring is missed? Without annuloplasty With annuloplasty (De Bonis Curr Op Cardiol. 2014 30:155-160 - J Thorac Cardiovasc Surg 2012;144:1019-1026)
(Courtesy S Von Bardeleben)
Percutaneous Repair Techniques with Approval in Europe Mitralign
Percutaneous Coronary Sinus Annuloplasty Mitral valve Tricuspid valve Coronary sinus
Percutaneous Repair Techniques with Approval in Europe Mitralign
Mitral Ring Annuloplasty Surgery Cardioband
Fluoro and echo guidance Cardioband implantation Implantation completed Annular reduction
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, 33:2403-2414) ** Part of the Death case One additional death case within 40 days per ITT - compassionate 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% 0-1+ 0-1+ 0-1+ 0-1+ 0-1+ 40% 3-4+ 20% 2+ 2+ 2+ 2+ 2+ 0% Baseline N=59 3-4+ 3-4+ Discharge N=56 *Dr. Paul Grayburn Baylor University 30 days N=52 3-4+ 3-4+ 3-4+ 6 Months N=38 12 Months N=28 24 Months N=12 39
Septo Lateral Dimension [mm] A-P Dismension [mm] Annular Reconstruction by Significant Reduction in Septo Lateral (A-P) Dimension (N=45) 47 42 37 32 27 22 17 Baseline 30% average reduction in A-P Discharge 38 36 34 32 30 28 26 24 22 20 37±4 (29-46) Baseline 26±4 (18-35) Discharge *P<0.01 11
Meters Walked MLHFQ Score % of population Functional Improvement at 24 Months 340 320 300 280 260 325 6MWT P<0.5 Δ = 8 333 40 35 30 25 20 15 MLHFQ score P<0.02 Δ = 16 38 22 100 80 60 40 NYHA Class P<0.01 II III I II 77% N1YHA I/II 240 220 10 5 20 III 200 Baseline 24 Months 0 Baseline 24 Months 0 baseline 24 months N = 9 N = 11 N = 13 41
Percutaneous Repair Techniques with Approval in Europe Mitralign
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)
Percutaneous Repair Techniques with Approval in Europe Mitralign
The TACT Study (Seeburger. J Am Coll Cardiol 2014;63:914 9)
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
Freedom From Return of MR By Patient Type 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 96% 81% 58% 0 30 60 90 120 150 180 Type A Type B Type C At Risk: Type A 25 24 18 Type B 36 29 15 Type C 23 15 7 (Courtesy Dr Gerosa)
Combining Annuloplasty + Mitraclip (Courtesy of F Maisano)
MitraClip after Annuloplasty Failure (Courtesy of KH Kuck)
Percutaneous mitral commissurotomy Percutaneous mitral valve repair Transcatheter mitral valve implantation
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).
Transcatheter «Valve in Valve» for Mitral Bioprosthesis Failure Transapical Transseptal
Transcatheter «Valve in a Ring» Transseptal Transapical
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
Challenges LVOT obstruction mostly with Mitral Valve in Ring Residual gradient in small prosthesis Long-term outcomes : delay and mode of failure, thrombosis
MitraClip after Annuloplasty Failure (Courtesy of KH Kuck)
Transcatheter Valve Implanation
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.
Valve in a «Docking Device «(Courtesy of R Lange) (Courtesy of M Butchbinder )
Challenges (Courtesy of F Maisano)
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?
annuloplasty replacement chordal replacement
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) /
Final Comments
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)
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;28:1358-1365) www.escardio.org/guidelines European Heart Journal 2012 - doi:10.1093/eurheartj/ehs109 & European Journal of Cardio-Thoracic Surgery 2012 - doi:10.1093/ejcts/ezs455).
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)
The «Heart Team» SURGEONS CARDIOLOGISTS (General, HF, EP, Interventionists) Anesthesiologists Treatment of Mitral Valve disease Other specialists: Geriatricians Imaging specialists (Echo, CT, MRI)
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
HiRiDeTrial High and Intermediate Risk Degenerative Mitral Regurgitation Treatment: a Randomized Controlled Trial Comparing MitraClip to Surgical Therapy HiRiDe Trial Francesco Maisano
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
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
The new ESC/EACTS Guidelines on VHD will be presented in August 2017!!!
The ESC Virtous circle on VHD In August 2017, we will have the «full picture» of the management of VHD in Europe 2017 2012 2017 EURObservational Research Programme
Variation in MitraClip Utilization/ Health Policy and Reimbursement
«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 2020-2025 : Mitral trans-catheter techniques will represent a satisfactory palliation in patients who are at high surgical risk or inoperable 2008-Hugo Vanermen
10.000 extra hours Talent & Innovation Engagement
Merci