Percutaneous Therapy for Mitral Regurgitation: Current and Future Options: Could we do better today? Peter S. Fail, MD, FACC, FACP, FSCAI Director of the Cardiac Catheterization Laboratories and Interventional Research Cardiovascular Institute of the South
Peter S. Fail, MD FACC, FACC, FSCAI Disclosure Statement of Financial Interest Grant Research Support Abbott Vascular Medtronic CardioKinetix Boston Scientific Stock CardioSolutions Off label use of products and investigational devices will be discussed in this presentation
Relative Sizes of Clinical Needs Primary vs Functional MR Expected WW Ann. Incidence Primary MR ~650,000 Functional MR ~2,570,000 ~2,570,000 Functional MR
Bulging Mechanisms Mitral Regurgitation Degenerative Functional Redundant / Broken Chordea Sick Valve Papillary muscle traction Sick Heart Increased tethering Flail or Degenerative Leaflets Decreased closing force MR MR Annular dilatation
Transcatheter MV Repair: Device Landscape 2015 Edge-to-edge MitraClip* MitraFlex irect annuloplasty and basal ventriculoplasty Mitralign Bident* GDS Accucinch* Valtech Cardioband* Quantum Cor (RF) Micardia encor *In patients Coronary sinus annuloplasty Cardiac Dimensions Carillon* Cerclage annuloplasty MV replacement CardiAQ* Neovasc * Edwards Fortis* Micro Interventional Valtech Cardiovalve ValveXchange Lutter Valve Medtronic Tendyne* MitrAssist MValve Other approaches MitraSpacer* St. Jude leaflet plication* Cardiac Implant perc ring NeoChord* Babic chords Valtech Vchordal Middle Peak Medical Mardil BACE Mitralis Millipede
Percutaneous Mitral Valve Therapies Evalve leaflet repair n >20,000 Annular & chamber remodleing Replacement icoapsys Vaicor Ample PS3 Monarc Cardiac Dimensions Mitralign
Catheter-Based Mitral Valve Repair MitraClip System Investigational Device only in the US; Not available for sale in the US
Surgical isolated edge-to-edge mitral repair without annuloplasty Clinical proof of principle for endovascular approach Freedom from re-operation and 2+ MR Maisano F, Vigano G, Blasio A, Columbo A, Calabrese C, Alfieri O Eurointervention 2:181-186, 2006
Grasping
Results from 2 clip Case Degenerative MR
Functional MR with Severe Cardiomyopathy Pre Following 1 Clip
Functional MR with Significant Cardiomyopathy Post CRT
% Patients Mitral Regurgitation Severity All Treated Patients (N=258) MitraClip (N=178) 84% MR 2+ at 3 Years Surgery (N=80) 96% MR 2+ at 3 Years 100% 100% 80% 80% 0+ 60% 1+ 2+ 60% 3+ 40% 4+ 40% 20% 20% 15 0% Matched N = BL 1Y BL 2Y BL 3Y 149 126 119 0% BL 1Y BL 2Y BL 3Y 66 57 50
Kaplan-Meier Freedom from MV Surgery in MitraClip group or Re-operation in Surgery group All Treated Patients (N = 258) Surgery (N = 80) MitraClip (N = 178) 98.7% 97.2% 97.1% 96.3% 1 year 2 years 95.6% 95.5% 3 years Surgery Non-High Risk (N = 80) RCT MitraClip Non-High Risk (N = 178) MitraClip Non-High Risk (N = 178) RCT Surgery Non-High Risk (N = 80) 0 180 360 540 720 Days Post Index Procedure 900 1080 TCT 2012
Kaplan-Meier Freedom From Mortality All Treated At Risk: Percutaneous FMR Percutaneous DMR Surgery FMR Surgery DMR 0 Days 1Y 2Y 3Y 48 39 33 31 130 119 111 102 18 15 13 11 62 55 52 47
Endovascular Valve Edge-to-Edge REpair STudy Subgroup Analyses for the Primary End Point at 12 Months Feldman T et al. N Engl J Med 2011;364:1395-1406
C-19 Improved LV Dimensions at 1 Year Left Ventricular Internal Diastolic Diameter -0.2 cm p < 0.001 Paired Analysis Left Ventricular Internal Systolic Diameter -0.1 cm p < 0.002 0 0 N = 221 N = 210 HRR: p < 0.001, REALISM: p < 0.001 HRR: p = 0.09, REALISM: p = 0.006
HRR: p = 0.02, REALISM: p < 0.001 Significant Reduction in HF Hospitalization Rate 48% Reduction p < 0.001 All Treated C-20
Lets take a closer look: Could have we done better?
MitraClip vs Surgery Learning Curve 2 clip limit +2 MR as an acceptable endpoint Making MR the end point and not the clinical response Surgeons were able to the best procedure to achieve MR Reduction
Learning Curve EVEREST Investigators Roll-in with 3 case then able to randomize??? Can you really understand a new procedure with 3 cases? Against surgeons the had a average to 15years experience at MVR
Learning Curve 200 100 180 90 160 80 140 70 120 60 100 80 60 40 20 0 Procedural Time Device Time 50 40 30 20 10 0 APS 6 Month Durability First 25 Last 25 European Journal of Heart Failure (2011) 13, 1331 1339
Learning Curve 140 60 120 50 100 80 40 60 30 40 20 20 10 0 Time First Cohort Second Cohort 50 26 0 Multiple Clips % European Journal of Heart Failure: 2011, 13;5 569 576
2 Clip Limit (+2MR as an Acceptable endpoint)
2 Clip Limit After 2 Clips Did the insertion of the 3 rd clip improve this patients long term survival? After 3 Clips
Reduction in HF Hospitalization Rate by MR Reduction - - Is this Trial Effect? All Treated MR Grade 1+ or 2+ MR Grade 3+ or 4+ C-28 54% Reduction Exploratory analysis 1 Year Prior to MitraClip 1 Year Post Discharge 1 Year Prior to MitraClip 1 Year Post Discharge
Freedom from Death and MR >2+ or MR > 1+ at 1 Year C-29 1 0.8 Freedom from death and MR > 2+ 1 Year Freedom from death and MR at 1 year 0.6 0.4 Freedom from death and MR > 1+ 62.6% 29.5% 0.2 0 0 100 200 300 400 Days Post Index Procedure
MR versus NYHA
Left Ventricular Volume Per Protocol Cohort
Left Ventricular Dimension Per Protocol Cohort
NYHA Functional Class Ask your patient what matters more to him/her. How he or she feels or what their MR is?
Think back to the PTCA vs CABG Trials Endpoints Death Angina MI Hospitalizations MI Angina Repeat angioplasty/cabg
Isolated procedure vs Multiple Procedures SURGERY (Control) prosthetic ring annuloplasty Full or partial leaflet resection chordal shortening Neo-chords leaflet mobilization papillary muscle reimplantation Alferei Stitch VS DEVICE 1 or 2 clip
Is this REALY expected to be equivalent
Despite the previous criticism, the MitraClip remains the first in-class device of many, many more to come. Those of us that have witnessed the results of those patients we have treated with the MitraClip have been nothing short of amazing Where are we today?
19,000 patients
MitraClip Approved for Degenerative MR High surgical risk as reported by 2 CT surgeons experienced in mitral valve surgery 2 Trials underway to look at Functional MR COAPT RESHAPE HF (EU)
Conclusion and Questions No lack of creativity and device iteration Thresholds remain difficult to determine for percutaneous treatment as well as assessment of the outcomes Will the threshold for success be the same for surgery Will percutaneous procedures have the ability to treat less severe patients what is the optimal time to alter the course of the natural history of the disease. Will there be optimally a hybridization of techniques and how will they be adequately tested.
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