Advanced Mitral Valve Therapies

Transcription

1 Advanced Mitral Valve Therapies Mahesh Ramchandani MD, FRCS Chief, Section of Cardiac Surgery

2 A Largely Untreated Patient Population Mitral Regurgitation 2009 U.S. Prevalence Total MR Patients 1,2 4,100,000 Eligible for Treatment 3,4 (MR Grade 3+) Annual Incidence 3 (MR Grade 3+) Annual MV Surgery 5 1,700,000 1,670, ,000 30,000 Untreated Large and Growing Clinical Unmet Need 14% Newly Diagnosed Each Year 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 2010.

3 Mitral Valve Surgery in the US STS database Jan Dec 30, 2012 Risk stratified 82% Low risk, 10% intermediate, 4% high, 4% extreme Operative mortality 1.3% among low risk and 9.2% among high risk Gammie. Ann Thor Surg. 2013;96:1587

4 Classification of MR 2 Types Incompetent mitral valve closure Systolic retrograde blood flow from the LV into the LA Primary: Anatomic abnormality the mitral valve Leaflets Subvalvular apparatus Chordae and papillary muscles Secondary : LV dilation; often secondary to ischemic heart disease Leads to mitral annular dilation Incomplete coaptation of the mitral valve Mayo Clinic (

5 Classification of MR Primary The Valve Secondary The Ventricle Usually myxomatous Ischemic or not Sorajja, Paul, MD; Abbott Northwestern Hospital

6 Trans-catheter MV Repair 6

7 Suture-Based Designs History of MitraClip Percutaneous Edge-to-Edge prototype First MitraClip Implantation Minor Changes for Safety MitraClip XT MitraClip Momentum Evalve Company MitraClip CE Mark Approval MitraClip NT Clip-Based Designs 7

8 MitraClip System

9 Catheter-Based Mitral Valve Repair MitraClip System Clip toward MV Clip across MV Leaflets grasped 9

10 Mitraclip for degenerative MR A2/P2 prolapse

11 Guiding MitraClip A B C LV D D E LV 11

12 Guiding MitraClip Placement 12

13 EVEREST 2 NEJM patients 2:1 184 Mitraclip 95 Surgery CONCLUSIONS Although percutaneous repair was less effective at reducing mitral regurgitation than conventional surgery, the procedure was associated with superior safety and similar improvements in clinical outcomes.

14 Kaplan-Meier Freedom From Mortality EVEREST II RCT MitraClip (N=178) 93.7% 92.3% 1 year Surgery (N=80) 81.2% 79.0% 5 years Baseline 6 Months 12 Months 18 Months 2 Years 3 Years 4 Years 5 Years MitraClip # At Risk Surgery # At Risk

15 Kaplan-Meier Freedom From MV Surgery in MitraClip Group or Re-operation in Surgery Group Surgery (N=80) MitraClip (N=178) 78.9% 97.4% 1 year 74.3% 92.5% 5 years Baseline 6 Months 12 Months 18 Months 2 Years 3 Years 4 Years 5 Years MitraClip # At Risk Surgery # At Risk EVEREST II RCT

16 Mitraclip indications For Symptomatic MR > 3+ Primary abnormality of mitral valve Degenerative MR A2/P2 prolapse (EVEREST 2 anatomic criteria) Prohibitive risk for surgery Heart team decision Surgeon and Cardiologist Reasonable life expectancy No other serious comorbidities

17 77 y male, frail, previous CABG Class 3/4 CHF 19

18 Flail posterior MV leaflet; Severe MR 20

19 Now 2 month post-mitraclip x 2 NYHA Class 1; Feels great 21

20 Mitraclip for eccentric degenerative MR 86yo male referred for evaluation of surgical mitral valve repair vs. replacement Recurrent chest pain, worsening dyspnea- NYHA III -, progressive functional decline. Recent Evaluations: Cath : Mild to moderate, diffuse CAD. TTE: severe eccentric MR possible prolapse of the anterior leaflet ; hyperdynamic, moderately enlarged left ventricle ; severe bi-atrial dilatation. TEE : severe mitral regurgitation, flail anterior leaflet. The Valve Team deemed the patient more suitable for a trans catheter approach STS 7.834% Risk of Mortality 1 22

21 Flail of the medial commissural area, with evident ruptured chordae, creating severe regurgitation The standard echo views and clip placement techniques did not work. A modified approach using an off axis view allowed optimal visualization 3 23

22 5 24

23 EFFICACY EVALUATION A C B D 7 25

24 RELEASING THE DEVICE A B C D 8 26

25 CLINICAL IMPLICATION Eccentric Mitral Regurgitation can be successfully treated with a transcatheter approach. Indication for MitraClip implantation may be expanded to non-central MR. 27

26 CoApt Trial Design Goals: 430 patients at up to 85 sites in US/Canada Significant FMR ( 3+ by core lab) Symptomatic heart failure subjects who are treated per standard of care Determined by the site s local heart team as not appropriate for mitral valve surgery Specific valve anatomic criteria Randomize 1:1 MitraClip N=215 Control group Standard of care N=215 Clinical and TTE follow-up: Baseline, Treatment, 1-week (phone) 1, 6, 12, 18, 24, 36, 48, 60 months Clinical Investigational Plan : Version 5.1, November 11, COAPT protocol approved by FDA July 27,

27 Transcatheter MVR Potential advantages 1. Applicable to primary and secondary MR, regardless of anatomy or etiology 2. Complete elimination of MR (and durable result)! 3. Ease of implantation (more generalizable in the future)

28 The Mitral Valve Complex is Complex! It s not round nor D shaped it s asymmetric It s not flat it s saddle-shaped (3D) Its annulus is not rigid it s dynamic It s not passive it contracts, reducing valve area during systole It s a high pressure closure valve, not a high pressure opening valve It has 24+ chords; it calcifies with age (MAC) It s relatively easy to block aortic outflow It s easier to form thrombus on than the AV It has a much larger annulus than the AV Its annulus changes size as the heart fails MR is not one disease! Adapted from Meredith I, TCT 2015

29 Challenges for TMVR Complex annular geometry D shape saddle, dynamic Unknown optimal device sizing Large annulus dimensions LV may be too large or too small Effect on Annular-Chordal interaction unknown Adjacent structures LCx, CS, AVB, papillary muscles LVOT obstruction mitral inflow-ao outflow angles, septal hypertrophy, SAM Optimal fixation annulus, atrial rim, sub annulus structures PV leak poorly tolerated, esp hemolysis

30 RISK of LVOT OBSTRUCTION 34

31 Challenges for TMVR MV annulus calcification affects fixation and PV leak Increased risk of thrombosis duration of anticoagulation Increased afterload worsening HF in severe FMR pts Imaging requirements non standardized Preplanning CTA and intraprocedural TEE Device profile and access Trans septal problematic due to size and stiffness Durability unknown for valve and frame (?strut fracture) Valve in Valve may not be possible

32 FIM TMVR Timeline 37

33 TMVR Landscape 38

34 TMVR Explosion Unprecedented Early Acquisition Frenzy Combined (fully realized) acquisition value ~ $ 2 BILLION!

35 Other Transcatheter strategies For mitral valve Existing Transcatheter valve (commercial) in surgical valve or ring MAC (for MS/MR)

36 VIVID Registry (Valve In Valve International Directory) Transcatheter Mitral implants in failed valves post surgery (n=437) Mitral Valve in Valve (n=349) Mitral Valve in Ring (n=88) Most procedures in very high-risk patients and clinically effective; However, small surgical valves (label 25) associated with elevated post-procedural gradients. Mitral Valve-in-Ring worse clinical results compared with Valve-in- Valve, including more post-procedural MR and LVOT obstruction. Almost one third of patients with Valve-in-Ring procedures experienced the composite adverse event end point at 30-days. Courtesy of D. Dvir

37 Intrepid TMVR Houston Methodist Structural Heart Team

38 INTREPID DIFFERENTIATED DUAL STENT DESIGN Conformable Outer Stent engages the annulus providing fixation & sealing while isolating the inner stent from the dynamic anatomy Circular Inner Stent houses a 27 mm tricuspid bovine pericardium valve (EOA = 2.4cm2) Flexible Brim aids imaging during delivery One valve size significantly reduces development & manufacturing complexity/cost One implant platform regardless of delivery approach: trans-apical or trans-septal

39 MEDTRONIC INTREPID TM TMVI FIXATION AND SEALING Primary fixation from cork effect produced by variable stiffness along height of the Outer Stent, then in time in-growth becomes dominant No need for rotational alignment or to search for leaflets Accommodates tilt & lateral misalignment CAUTION: INVESTIGATIONAL DEVICE. LIMITED BY FEDERAL LAW (USA) TO INVESTIGATIONAL USE. THESE TESTS MAY NOT BE INDICATIVE OF CLINICAL PERFORMANCE. THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FDA AND ARE NOT INTENDED TO REPRESENT CLAIMS OF HUMAN CLINICAL PERFORMANCE OR SERVE AS A SUBSTITUTE FOR MEDICAL JUDGMENT. 5

40 MEDTRONIC INTREPID TM TMVI DELIVERY SYSTEM AND DEPLOYMENT Working length ~32.9cm OD 11.7mm / 35Fr 2cm ~19.1cm CAUTION: INVESTIGATIONAL DEVICE. LIMITED BY FEDERAL LAW (USA) TO INVESTIGATIONAL USE. THESE TESTS MAY NOT BE INDICATIVE OF CLINICAL PERFORMANCE. THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FDA AND ARE NOT INTENDED TO REPRESENT CLAIMS OF HUMAN CLINICAL PERFORMANCE OR SERVE AS A SUBSTITUTE FOR MEDICAL JUDGMENT. 5

41 INTREPID STRAIGHTFORWARD DELIVERY Advance across mitral valve Deploy brim Retract to desired position Expand fixation ring Release Hydraulic mechanism provides for controlled, precise deployment No need for rotational alignment No need to hunt for leaflets Accommodates tilt & lateral misalignment

42 Severe Functional MR 54

43 Positioning & Deployment Positioning Rapid Pace Deployment 55

44 Final Position & Function 56

45 Trans-Apical TMVR Before After 57

46 TMVR near future Longer device development and testing phases due to increased complexity of mitral valve and delivery issues Will need to be integrated with transcatheter repair strategies and More refined, minimally invasive surgical techniques with enhanced recovery protocols

47 Re Evolution Summit April 6-8, 2017 Learn Minimally Invasive Cardiac Surgery Didactic Hands on instruction World class faculty World class facility Robotic and non robotic PA Track TEAM APPROACH Excellent social program Big Texas Welcome! Save the date Register early as numbers limited Google Re Evolution Summit for details 59

48 Re Evolution some faculty

49 MITIE Methodist Institute for Technology Innovation and Education 61

50 Thank you