MR2010:1

Who will Benefit from Percutaneous Management of Mitral Regurgitation?

An Imaging Guide to Management

James D. Thomas, M.D., F.A.C.C.

Department of Cardiovascular Medicine Heart and Vascular Institute Cleveland Clinic Foundation

Cleveland, Ohio, USA

Conflicts: None

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Guangzhou Guangzhou

Hong Kong

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Indications for MR Surgery Lessons from the Valve Guidelines

• Class 1

–Severe MR with symptoms and EF > 30%

–Asymptomatic severe MR with 30%<EF<60%

• Class 2a

–Asymptomatic severe MR with normal LV and either new onset AF or PA pressure > 50 mmHg

–Asymptomatic severe MR with normal LV and likelihood of repair > 90%

• Severe MR must be assessed quantitatively

–ROA>0.4 cm2, RF>50%, RV>60 mL

• Likelihood of repair

–Detailed anatomic assessment of valve

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Proximal Convergence Method Underlying Principle

Flow thru any isovelocity shell is

equal to instantaneous orifice flow

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Measurement of Mitral ROA Simplified PISA Formula

40

40

• Assume LV-LA p is 100 mmHg

• Set aliasing velocity to 40 cm/sec

• Then ROA = r2/2

r = 8 mm

ROA = 82/2 = 32 mm2

LA

LV

MV

Pu et al., JASE 2001;14:180-5

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Simplified PISA Method 5 Easy Steps

1. Optimize view of proximal convergence zone from apex

2. Baseline shift to ~40 cm/sec

3. Zoom on valve

4. Measure first aliasing radius

5. ROA = r2/2

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2. Baseline shift to ~40 cm/sec

Simplified PISA Method 5 Easy Steps

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3. Zoom on valve

Simplified PISA Method 5 Easy Steps

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Simplified PISA Method 5 Easy Steps

4. Measure 1st aliasing radius

5. ROA = r2/2 = 92/2 = 40 mm2

r = 9 mm

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Beware Late Systolic MR! 46 Year Old Woman Referred for Surgery

Large jet and proximal convergence zone, but BRIEF

Normal LV size, no PHTN

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Mitral CW Doppler Can Show This Easily

Significant MR only in latter half of systole

MV closure

MR

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Isolated Mitral Valve Repair Extremely Safe in Suitable Candidates

0

0.5

1

1.5

2

2.5

2001 2002 2003 2004 2005 2006 2007

Year

Mo

ra

lity

(%

)

STS benchmark

CCF

But some patients are too high risk for standard surgery

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Double Mitral Orifice after Surgical Alfieri Stitch

Percutaneous Mitral Valve Repair

Edge to Edge Repair

Echo short axis after Alfieri Animal Mitral Valve after Alfieri

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Percutaneous Mitral Repair

(PMR)

Evalve

Clip

The

Delivery

System

Catheter-based

Delivery

MR2010:18 Feldman et al. NEJM 2011; 364: 1395

MitraClip Technique

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Anatomic Exclusions for Mitral Clipping

Coaptation

too short

<2 mm

Coaptation

too deep

>11 mm

Flail gap

too large

10 mm

Flail too

wide

15 mm

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Mitral Valve Prolapse/Flail 89 yo man with 4+ MR and CHF

1.0 cm PISA radius, ROA~0.5 cm2

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Mitral Valve Prolapse/Flail

89 yo man with 4+ MR and CHF

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Clip trying to grasp both leaflets simultaneously

RAO

Percutaneous Edge-to-edge Technique

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Catheter Detached from Clip

Post MR

click

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RAO Left Ventriculogram

Baseline Post-device

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Mitral Valve Prolapse/Flail 89 yo man with 4+ MR and CHF

Follow-up, 1-2+ MR, no CHF

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3D TEE is Critical to Guiding MV Clipping

Guidance of trans-septal puncture

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Clip

Placement

LA side

LV side

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After Two Clips Placed

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N Engl J Med 2011;364:1395-406

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EVEREST II High Risk Registry Data

Kar, S., EuroPCR 2009 Symposium

Presentation

0%

20%

40%

60%

80%

100%

Baseline 30 day 12 month

0%

20%

40%

60%

80%

100%

Baseline 30 day 12 month

Percutaneous MV Repair Sustained MR Reduction

Grade 3+/ 4+

Grade 1+/ 2+

FMR, n=34

100% 80% 75%

20% 25%

Grade 1+ = Mild MR Grade 2+ = Moderate MR Grade 3+ = Moderate - Severe MR Grade 4+ = Severe MR

12 month Matched data

DMR, n=20

97%

18% 21%

82% 79%

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EVEREST II High Risk Registry Data Kar, S.,

EuroPCR 2009 Symposium Presentation

At Risk

High Risk (n) 78 72 65 53

Control (n) 36 34 27 22

76.4%

55.3%

Impl 30d 6m 12m

1.0

0.8

0.6

0.4

0.2

0.0

Fre

ed

om

fro

m D

eath

P=0.037

HRR

HRR Control

MitraClip Therapy vs. High Risk Control

Percutaneous MV Repair Significant Mortality Benefit

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Mitral Remodelling via Coronary Sinus

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Mitral Remodelling via Coronary Sinus

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Carillon Monarc Viacor

Coronary Sinus Devices

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Combined data from AMADEUS (EU), PERSEUS (SA), VERITAS (AU) feasibility studies

Goldberg S, ACC

Implantation of VIACOR Device

Baseline Post Implant

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CARILLON Device The AMADEUS Trial

Combined data from AMADEUS (EU), PERSEUS (SA), VERITAS (AU) feasibility studies

• Prospective, single-arm, 6-month, multi-center trial

• Primary Endpoint

Thirty day rate of Major Adverse Events

• Secondary Endpoints

•Long-term safety

•Hemodynamic and functional changes

•NYHA Class

•Exercise (6 minute walk test; Max Exercise Time)

•QOL (KCCQ)

•MR Reduction

Schofer et al, Circulation. 2009; 120:326-333

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MR Reduction

1.00

0.80

0.60

0.40

0.20

0.00

1.00

0.80

0.60

0.40

0.20

0.00

60 50 40 30 20 10 0

60 50 40 30 20 10 0

cm

m

l

ml

cm

Vena Contracta Vena Contracta

Regurgitant Volume Regurgitant Volume

Baseline

1 month

6 months

AMADEUS™ TITAN™

(Interim)

P<0.01 P<0.001

0.61 0.48

N=34 N=34

N=34 N=34

N=30 N=28 N=24

0.71 0.56 0.53

N=30

35.9 27.1

P<0.05 P<0.001

N=23

24

N=28

23

35

Schofer et al, Circulation. 2009 Jul 28;120(4):272-4.

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7.84±2.75 mm

10.35±1.96mm

Mitral Annulus-Coronary Sinus Relationship CS Often Far from the MA

• Variable p<0.001

• Shorter near to commisures Vertical distance between CS and MA at different sites.

Choure et al. JACC

2006;48:1938-1945

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LCX “under” CS

80%

LCX “Over” CS

20%

Coronary Sinus - Circumflex Relationship

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Many Wild Ideas… Direct Annuloplasty: QuantumCore

• QuantumCore

Catheter-based application of

RF energy at subablative

temperatures to the mitral

annulus will heat and

contract the collagen fibers,

thereby reducing mitral

annular circumference

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You get ALL the “special” bits…….

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Percutaneous MV Repair Current Approach

• Mitral clip

–Approved in Europe with over 6000 deployed

–Not approved in US with a few continued access pts

» Currently on hold for 2nd time (redesign)

– In high risk pts, good alternative to surgery

» Confirm severity of MR and anatomic suitability

• Annuloplasty devices

–Carillon device approved in Europe, none in US

–Limited survival data, but MR reduced by ~50% with improved QOL

–Echo for severity and functional nature of MR

–CT to assess CS-MA distance and relation to LCx

MR2010:46 Thanks, Steven!