Mitraclip Show me the data What patient would

Mitraclip : Show me the data ! What patient would a surgeon refer for clip? Steven F. Bolling, MD Professor of Cardiac Surgery University of Michigan COI : Edwards, Millipede, Abbott – IP / Royalty / Equity

Degenerative MR is not Functional MR

Mitraclip - Degenerative Patient selection : “Non - operable” “Prohibitive risk” Please don’t make me! Good vs. good enough

Functional MR : Clip?

Functional (2 o) MR : Ventricular Problem! Badhwar, Bolling , chapter in: Advances in Heart Failure, 2004

FMR…Not only a “late marker” ! It’s also a CAUSE ! Survival is still terrible ! FMR – worsens odds ratio of death Rossi A et al. Heart 2011; 97: 1675 -1680

Catheter-Based Mitral Repair – Mitral. Clip based on surgical concept !

MR Reduction to 1+ Surgery better than CLIP, but… p<0. 0001 2+ 1+ 1+-2+ 2+ 1+-2+ 3+ 36. 1% 3+ 0+ 75. 6 % 1+ 2+ 1+-2+ 3+ 4+ 2+ 4+ 3+ 4+ (n=124) Device (n=124) (n=67) Surgery p-value compares the distribution of MR grade in device with the distribution of MR grade in control at 12 months (Fishers’ Exact test)

Mitral Valve Repair Ring Annuloplasty alone with any or all of : Leaflet excision Leaflet plication Leaflet patch Artificial chordae Cleft closure Some other stuff More other stuff… Alfieri stitch

LV Volumes by MR Etiology THE CLIP LEAVES MR…But ? Baseline p<0. 0001 12 Months p=0. 0005 p=0. 0829 p=0. 0042 LVEDV LVESV Degen MR Subgroup n=88 LVEDV LVESV FMR Device Subgroup n=30

CRT : Less than half eligible, less than half “respond” Improvers: reduction in ≥ 1 grade of MR van Bommel R J et al. Circulation 2011; 124: 912 -919 Residual FMR is still BAD, but. . !! Copyright © American Heart Association

Residual / recurrent MR : if we do surgery repair badly Patients do badly ! Mc. Gee EC et al. JTCVS 2004; 128: 916 -24 Mihaljevic et al. J Am Coll Cardiol 2007; 49: 2191 -201 Crabtree TD et al. Ann Thorac 2008; 85: 1537 -43 Surg

Severe Ischemic Mitral Regurgitation NEJM 2014 MV repair vs. MV replacement LVESI Mortality CV events Functional status same 32% Recurrent MR! - MV repair

Severe Ischemic Mitral Regurgitation Operative Mortality Mitral repair operative mortality, 1. 6% vs “total valve sparing” MVR, 4. 2%

Remodeling - 67 mm LVESI Kron et al JTCVS 2015 “Good” repair - 46 mm Replacement - 61 mm “Bad” repair - 63 mm (45% - basal inferior “aneurysm” )

FMR : Gold Standard ! Undersized Rigid Ring Annuloplasty Must be a “Good repair”

Predictors of “Good vs. Bad” FMR Repair Mild annular dilatation Coaptation depth >1 cm Posterior leaflet angle >45° post/basal dyskinesia ! Distal anterior leaflet angle >25° Advanced LV remodelling – LVEDD > 65 mm – Systolic sphericity index > 0. 7 – End systolic interpapillary muscle distance >20 mm – LVESV ≥ 145 ml (or ≥ 100 ml/m 2) Lancellotti et al. Eur J Echo 2010 EAE recommendations for the assessment of valvular regurgitation

Mitraclip Functional MR Results “high risk” EF - 55 % 8% mort @ 30 d 25% mort @ 1 yr No controls Not random Left 2 -4+ MR ! DMR & FMR !

50 pts > 3+ FMR CRT failed - 21 Age 70; euro. SCORE 34; LVEDD 70 mm; LVEDV 252 ml; LVEF 19% Franzen et al Eur J Heart Fail 2011; 13: 569 -76

Mitral regurgitation at 6 months Half had significant residual MR …but? Franzen O et al. Eur J Heart Fail 2011; 13: 569 -576

Is there really LV “Remodeling” ? ? Franzen O et al. Eur J Heart Fail 2011; 13: 569 -576

Recurrence of FMR 3% at 6 months Conradi et al Eur J Cardiothor Surg 2015

How are pts with FMR ACTUALLY treated? Duke: 1, 538 pts 3 -4+ FMR LVEF ≥ 20%, 2000 -2010 not much surprise, NOT MUCH SURGERY ! N=1538 N=440 N=298 N=313 LVEF N=479

Mitra. Clip Therapy Changing Patient Demographics – PDP! EVEREST II (Randomized Controlled Trial) EVEREST ACCESS EU (Europe) (High Risk Cohort^) FMR • 178 patients • Device time— 146 minutes • Implant rate— 89% • Met safety & efficacy end points • 211 patients • Device time— 127 minutes • Implant rate— 95% = DMR > CE Mark 90 % FMR $$$$ EEE = FMR

Mitral. Clip and CHF / FMR n=78 1 year outcomes Decreased CHF rehosp by 45%: COAPT !

Functional MR : Clip?

Mitraclip - Functional Patient selection : TR, AF, CABG STS and “other factors” Anatomy - favor clip vs surgery COAPT eligible - GDMT

Mitraclip - Functional Patient selection : Be honest with patient Be honest with yourself Very little “data” !