clinical pearls: takeaway points for aortic stenosis and...

Clinical Pearls:

Takeaway Points for Aortic

Stenosis and Mitral

Regurgitation Management

in 2014

Hemal Gada, MD, MBA

Assistant Professor of Medicine

Rutgers Robert Wood Johnson Medical School

A Hot 20 Minutes

Aortic Stenosis

Indications for valve replacement are expanding

Access requirements for TF TAVR are getting smaller

Multiple TAVR devices mean more options and better patient care

Mitral Regurgitation

Degenerative (primary) mitral regurgitation needs early surgical referral

Repair vs replace for medically-optimized symptomatic ischemic mitral regurgitation will be driven by surgeon expertise

Percutaneous mitral valve repair indications will continue to evolve and expand into the realm of functional mitral regurgitation

INDICATIONS FOR

AORTIC VALVE

REPLACEMENT ARE

EXPANDING

ACC/AHA Valve Guidelines

Surgery for AS

Asymptomatic(Stage C)

Vmax ≥ 4.0 m/sec-OR-

MG ≥ 40 mmHg

LVEF < 50%(Stage C2)

AVR (I)

Symptomatic(Stage D1)

Other Cardiac Surgery

Vmax ≥ 5 m/sec-OR-

MG ≥ 60 mmHgLow surgical risk

(Stage C1)

Abnormal ETTΔVmax > 0.3 m/sec/y

Low surgical risk(Stage C1)

AVR (IIa)

AVR (IIb)

Nishimura RA et al. J Am Coll Cardiol 2014;63:e57–185


TAVR for AS

COR LOE

For patients in whom TAVR or high-risk

surgical AVR is being considered, members

of a Heart Valve Team should collaborate to

provide optimal patient care

I C

TAVR is recommended in patients who meet

an indication for AVR for AS who have a

prohibitive surgical risk and a predicted

post-TAVR survival > 12 mos

I B

TAVR is a reasonable alternative to surgical

AVR in patients who meet an indication for

AVR and who have high surgical riskIIa B

Percutaneous aortic balloon dilation may

be considered as a bridge to surgical or

transcatheter AVR in severely symptomatic

patients with severe AS

IIb CNishimura RA et al. J Am Coll Cardiol 2014;63:e57–185

Patient

Surgeon

Cardiologist

Imaging

SpecialistAnesthesia

Consultants

Heart Valve Team

• Cath lab/OR staff

• Nurses, NPs, PAs

• Research staff

• Social work, PT

• Geriatricians

• Coordinators

• Hospital

administrators

• Valve clinic

• Case selection

• Multi-modality imaging

(access site, valve size)

• TAVR procedure

(cath lab/OR)

• Post-op care and FU

All-Cause Mortality (ITT) Crossover Patients Censored at Crossover

71.8%

93.6%

All

-Cau

se M

ort

ality

(%

)

Months

HR [95% CI] = 0.50 [0.39, 0.65]

p (log rank) < 0.0001

Standard Rx (n = 179)

TAVR (n = 179)

30.7%

50.8%

43.0%

68.0%

64.1%

87.5%

53.9%

80.9%

* In an age and gender matched US population without comorbidities,

the mortality at 5 years is 40.5%.

Kapadia S. TCT 2014

Evolution in Patient Selection

in U.S. TAVR Clinical Trials

11.2% 11.0%10.3% 10.3%

9.0%

7.0%

11.8%10.9%

7.3%

5.0%

0%

2%

4%

6%

8%

10%

12%

14%

PARTNER BTAVR

PARTNERIIB

SAPIEN

PARTNERIIB

SAPIEN XT

CoreValveER

Iliofemoral

CoreValveER

ContinuedAccess

TVTRegistry

SAPIEN TF

PARTNER ATAVR

PARTNERTF

ContinuedAccess

CoreValveHR

TVTRegistry

SAPIEN TF

STS

Sco

re

Inoperable (extreme risk) High-Risk

Frailty Assessment

Frailty

Characteristic

Cardiovascular

Health Study –

Fried Measure

PARTNER

Measure

Shrinking: Weight

loss, sarcopenia

Self-report 10lb

weight loss

Albumin less

than 3.5 g/dL

Weakness Grip strength:

lowest 20% (by

gender, BMI)

Same

Poor endurance:

Slowness

Exhaustion

Walking time/15

feet: slowest 20%

(by gender, height)

“Exhaustion” report

Same

Symptomatic AS

Low activity Kcal/week: by

activity

Katz ADL

impairment

Positive for frailty

phenotype

3 or more criteria

present

Same

P. Green, TVT 2012 Courtesy of J. Popma

The Role for TAVR

Operable AS patients

TAVR in 2014

Low

Risk

Surgery (AVR)

irresponsible,

reckless

~65%

Intermed

Risk

¿

“equipoise”

~25%

High

Risk

TAVRor

AVR

OK

~10%

Futile

No

Too

Sick

TAVR

Extr

Risk*

Current TAVR

Clinical Use

* Extreme risk = “inoperable”


Surgery for AS

Asymptomatic(Stage B)

Vmax 3 m/sec-3.9 m/sec-OR-

MG 20-39 mmHg

LVEF < 50%

Symptomatic

DSE with AVA ≤ 1 cm2

and Vmax ≥ 4 m/sec(Stage D2)

Other cardiac surgery

AVR (IIa)


Ye

s

No

AVA ≤ 1 cm2 and LVEF ≥ 50% (Stage D3*)

AS likely cause of symptoms

Paradoxical Low-Flow

Low-Gradient AS

AVR is reasonable in symptomatic patients with

LVEF ≥ 50%

Calcified aortic valve with significantly reduced

leaflet motion

Vmax < 4 m/sec or MG < 40 mmHg

AVA ≤ 1.0 cm2

Provided that:

Stroke volume index < 35 mL/m2

Indexed AVA ≤ 0.6 cm2/m2

Treatment Comparison inNormal EF (NEF), Low-flow (LF), Low-gradient (LG) AS

0%

10%

20%

30%

40%

50%

60%

80%

90%

60 120 180 240 300 360 420 480 540 600 660 720

70%

2-Y

ea

r D

ea

th (

%)

39.7%

41.1%

56.5%

76.9%

0

log rank p= 0.003

Numbers at Risk

A – TAVR 43 39 38 34 34 33 29 26 22A – Surgery 44 33 30 30 28 27 27 26 23B – TAVR 23 21 19 17 15 13 11 10 10B – Std Rx 29 22 15 10 9 9 6 5 4

LF NEF LG – A - TAVR

LF NEF LG – A - Surgery

LF NEF LG – B - TAVR

LF NEF LG – B - Std Rx

Days

Herrmann HC et al. Circulation 2013;127:2316–26

ACCESS

REQUIREMENTS

FOR TF TAVR ARE

GETTING SMALLER

Larger Sheath Size Can Contribute to

Major Vascular Complications

A Sheath to Femoral Artery Ratio (SFAR) ≥ 1.05 is a Predictor of both

VARC Major Vascular Complications and 30-Day Mortality

Sapien or Sapien XT (n = 102)CoreValve (n = 28)

100

80

60

40

20

00.7 0.8 0.9 1.0 1.1 1.2

1.05

Sensitivity

Specificity

(%)

Hayashida K et al. J Am Coll Cardiol CV Int 2011;4:851-8

Vascular Complications/Bleeding:

PARTNER 2B Sheath Size

Comparison

ValveValve

Size

Sheath

ID

Sheath

OD

Minimum

Vessel

Diameter

SAPIEN THV 23mm 22F25F

(8.4mm)7.0mm

SAPIEN XT THV 23mm 18F22F

(7.2mm)6.0mm

SAPIEN THV 26mm 24F28F

(9.2mm)8.0mm

SAPIEN XT THV 26mm 19F23F

(7.5mm)6.5mm

33% reduction in CSA

Leon M. ACC 2013

Events

SAPIEN

(n=271)

SAPIEN XT

(n=282)

n % n % p-value

Vascular:

Major 42 15.5 27 9.6 0.04

Minor 20 7.4 14 5.0 0.23

Bleeding:

Disabling 34 12.6 22 7.8 0.06

Major 44 16.4 44 15.7 0.84

Patients with transfusions 80 29.5 73 25.9 0.40

Vascular

Complications/Bleeding:

PARTNER 2B – at 30 days (AT)

Leon M. ACC 2013

Edwards eSheath

The Edwards expandable sheath (1) features a fold that

expands as the NovaFlex catheter moves through (2,3).

Toggweiler S et al. J Am Coll Cardiol CV Int 2013;6:643-53

Edwards eSheath

14F 16F 18F 20F

Valve SAPIEN 3

26 mm

SAPIEN XT

23 mm

SAPIEN XT

26 mm

SAPIEN XT

29 mm

Sheath ID Unexpanded 4.7 mm 5.3 mm 6.0 mm 6.7 mm

Sheath OD

Unexpanded 6.0 mm 6.7 mm 7.2 mm 8.0 mm

Expanded w/valve 8.0 mm 8.9 mm 8.9 mm 9.9 mm

Rec Minimum Diameter 5.5 mm 6.0 mm 6.5 mm 7.0 mm

SFAR

Unexpanded 1.0 1.12 1.11 1.14

Expanded w/ valve 1.45 1.48 1.37 1.41

Binder RK et al. J Am Coll Cardiol CV Int 2013;3:293-300

Terumo SoloPath

Dimitriadis Z et al. J Am Coll Cardiol CV Int 2013;26:84-9

Terumo SoloPath

Re-collapsible

Sheath Size (Based

on Expanded ID)

19Fr

22Fr

24Fr

Insertion Profile OD

13.5Fr

15Fr

15Fr

23Fr

26Fr

28.5Fr

Features

• 5.3Fr tip diameter

• 25 or 35 cm

working length

• 20 or 30 cm

expandable length

• ~30% reduction in

profile once re-

collapsed

Increasing TF Options for

the Future

SFAR <= 1.05 1.05<SFAR<=1.2 SFAR>1.2

Vessel Diameter in mm 5.0 6.00 6.25 6.50 6.75 7.00 7.25 7.50 7.75 8.00

18 Fr Sheath1.5 1.2 1.2 1.1 1.1 1.0 1 1.0 0.9 0.9

14 Fr Sheath1.2 1 1.0 0.9 0.9 0.9 0.8 0.8 0.8 0.8

13 Fr Sheath1.1 0.9 0.9 0.9 0.8 0.8 0.8 0.7 0.7 0.7

Babaliaros V. TVT 2013

MULTIPLE TAVR

DEVICES MEAN

MORE OPTIONS

AND BETTER

PATIENT CARE

Edwards Lifesciences Medtronic CoreValve

Current Generation Devices

The Great TAVR Device Debate

>100,000 patients treated thru 2014

in >750 interventional centers

around the world!

>95% of TAVR patients have been

treated with either of these

two (very different) devices!

The Great TAVR Device Debate

What’s important?

Differences in major clinical outcomes (definitely death and stroke; possibly PVR, bleeding, and vascular complications)

Differences in softer secondary clinical endpoints (e.g. conduction disturbances)

Preferences based upon specific anatomic situations (e.g. horizontal Ao, high rupture risk), technical device differences, and operator ease-of-use issues

I use it because I know it well, I like it, and I get good outcomes!

No Differences in Mortality at 1 Year

in High Risk and Inoperable Patients

TV

T R

eg

istr

y

FR

AN

CE

2

SO

UR

CE

XT

SO

UR

CE

Co

h2

SO

UR

CE

Co

h1

AD

VA

NC

E

UK

Ita

lia

n

CV

Ex

trem

e R

isk

PR

AG

MA

TIC

CV

Hig

h R

isk

PA

RT

NE

R 1

A

PA

RT

NE

R 2

B

PR

EV

AIL

TA

PR

EV

AIL

EU

PA

RT

NE

R 1

B

PR

EV

AIL

JA

PA

N

26.2, 7710

24.0, 2107

19.5, 2688

23.0, 126924.3, 1038

20.6, 410

12.3, 204

24.2, 348

22.5, 284

23.0, 218

20.5, 214

30.7, 179

14.7, 64

23.7, 104317.9, 996

21.7, 452

15.0, 663

24.3, 489

16.2, 20414.2, 390

0

5

10

15

20

25

30

35

40

SAPIEN Family CoreValve

Mo

rtali

ty (

%)

Rate, Number of Patients

Leon M. TVT 2014

TV

T R

eg

istr

y

SO

UR

CE

XT

SO

UR

CE

Co

h2

SO

UR

CE

Co

h1

AD

VA

NC

E

UK

Ita

lia

n-T

A

CV

Ex

trem

e R

isk

PR

AG

MA

TIC

CV

Hig

h R

isk

PA

RT

NE

R1

A

PA

RT

NE

R 2

B

PR

EV

AIL

EU

AD

VA

NC

E I

I

Ita

lia

n

PA

RT

NE

R 1

B

PR

EV

AIL

TA

S3

TF

PR

EV

AIL

JA

PA

N

Str

oke

* (%

)

Rate, Number of Patients

2.8, 3528

3.6, 2688

2.8, 1269

2.7, 1038

4.1, 870

3.0, 504

1.0, 204

4.7, 348

4.3, 284

3.9, 214

6.7, 179

1.9, 218

1.0, 96

1.6, 643.0, 996

4.0, 489

2.9, 204

4.9, 390

2.1, 194

2.8, 181

0

2

4

6

8

10

SAPIEN Family CoreValve

No Differences in All Strokes at 30 days

in High Risk and Inoperable Patients

*Rate of All Stroke or Major Stroke + Minor Stroke

Leon M. TVT 2014

Dissimilarities in clinical outcomes after TAVR using SAPIEN XT or

CoreValve in different annular zones*

* Favorable aortic annulus zones were defined as those that may enable 5-20% area

oversizing or 2.5-9.5% perimeter oversizing in SAPIEN XT procedures and 20-35% area

oversizing or 9.5-16.2% perimeter oversizing in CoreValve procedures.

Individualized Device Approach in

TAVR: SAPIEN XT or CoreValve

Dvir D, et al. TVT 2014

250 300 350 400 450 500 550 600 650

SAPIEN XT zone

CoreValve zone

26

1.8

29

9.2

30

7.8

34

6.2

39

3.3

39

5.7

44

2.4

48

9.3

50

5.6

55

0.4

55

9.1

CoreValve

23 mm

SAPIEN XT

23 mmSAPIEN XT

26 mm

SAPIEN XT

29 mm

CoreValve

26 mm

CoreValve

29 mm

CoreValve

31 mm

SAPIEN XT

20 mm

Aortic Valve Annulus Area (mm2)

Dvir D, et al. TVT 2014

DEGENERATIVE

MITRAL

REGURGITATION

NEEDS EARLY

SURGICAL

REFERRAL

ACC/AHA 2014 Valve Guidelines

Treatment of MR

First decision



PrimaryMR

SecondaryMR


Primary vs. Secondary MR

Definition of Severe MR

Primary MR Secondary MR

EROA ≥0.4 cm2 ≥0.2 cm2*

Regurgitant volume ≥60 ml ≥30 ml

Regurgitant fraction ≥50% ≥50%

Vena contracta ≥0.7 cm -

Jet areaCentral jet >40% LA or

holosystolic eccentric jet-

* Measurement of the proximal isovelocity surface area by 2D TTE in secondary MR

underestimates the true ERO due to the crescentic shape of the proximal convergence



Surgery for Primary MR


Progressive MR(stage B)

Vena contracta <0.7 cmR Vol <60 mL

RF <50%ERO <0.4 cm2

Primary MR

YES NO

Asymptomatic(stage C)

MV Surgery(llb)

MV Surgery(l)

MV Repair(lla)

Periodic Monitoring

NO YES

Likelihood of successfulRepair >95% and

Expected mortality <1%

LVEF >30%LVEF 30% to ≤60%or LVESD ≥40 mm

(stage C2)

LVEF >60% andLVESD <40 mm

(stage C1)

New onset AF orPASP >50 mm Hg

(stage C1)

Symptomatic(stage D)

Severe MRVena contracta ≥0.7 cm

R Vol <60 mLRF ≥50%

ERO ≥0.4 cm2

LV dilation

Surgery in Asymptomatic Severe

Chronic Primary MR

• MIDA registry (6 international centers) between 1980 and 2004

• 1,021 asymptomatic pts with flail leaflets causing severe MR with LVEF>60% and LVESD<40

mm

• MV surgery w/i 3 mos (median 14 d; 93% repair; 22% concomitant CABG) vs. med Rx (with MV

surgery in 59% at median of 1.65 years, 87% repair); 10 yr median FU

• Outcomes in 324 propensity matched pairs were compared

Suri et al. JAMA. 2013;310:609-16

HR [95%CI] =

0.52 [0.35-0.79]

P=0.002

HR [95%CI] =

0.44 [0.26-0.76]

P=0.003

Survival CHF

11%

24%

53%

60%

Su

rviv

al (%

)

100

80

60

40

20

0

Follow-up (years)

0 5 10 15 20

Medical management

Early surgery

324

324

276

295

157

160

53

35

8

10

Ris

k o

f C

HF

(%

)

50

40

30

20

10

0

Follow-up (years)

0 5 10 15 20

Medical management

Early surgery

324

324

253

289

142

149

48

31

3

9

HR (95%CI) =

0.51 (0.24-1.08)

P=0.08

HR (95%CI) =

0.22 (0.08-0.56)

P=0.002

HR (95%CI) =

0.11 (0.01-0.84)

P=0.03

MA

CE

(%

)

Ca

rdia

c M

ort

ality

(%

)

All

-ca

us

e M

ort

ality

(%

)

Time after Baseline, yearsNo. at risk

CONV

OP

50

40

30

20

10

0

0 2 4 6 8 10 12

207

207

199

203

174

179

138

137

108

94

58

00

38

32


CONV

OP

50

40

30

20

10

0

0 2 4 6 8 10 12

207

207

199

203

174

179

138

137

108

94

58

00

36

32

Conservative

MV surgery


CONV

OP

50

40

30

20

10

0

0 2 4 6 8 10 12

207

207

199

202

172

170

136

134

108

93

54

00

31

31

19%

1%

6%6%

15%

4%

Conservative

MV surgery

Conservative

MV surgery

Kang et al. J Am Coll Cardiol. 2014;63:2398-407

Surgery in Asymptomatic Severe

Chronic Primary MR

• 2 S. Korean centers from 1996-2009

• 610 asymptomatic pts ≤85 yo with severe MR (ERO ≥0.4 cm2) with LVEF>60%, LVESD<40 mm

• Treated with MV surgery w/i 6 mos (94% repair; 10% concomitant CABG) vs. med Rx (with

censoring when indications for surgery developed)

• Outcomes in 207 propensity matched pairs were compared (median 8 yr FU)

MACE = cardiac death, repeat MV surgery, and HF hospitalization

FDA MitraClip Approval

October 24, 2013

The MitraClip is approved

for treatment of patients with

3+-4+ primary (degenerative) MR

(DMR) who are at “prohibitive risk” for

mitral valve surgery and are likely to

benefit from MR reduction

MitraClip in Prohibitive-risk

DMR

Relationship between Discharge MR Grade

and 1-year HF Hospitalizations*

Lim SD et al. J Am Coll Cardiol 2014;64:182–92

* with death

counted as a HF

hospitalization

28%

increase

HF

Ho

sp

italizati

on

Rate

per

Pati

en

t-Y

ear

1.0

0.8

0.6

0.4

0.2

0.0

0.50

MR ≤1+

N=65

0.35

MR = 2+N=35

MR = 3+-4+N=18

0.97

0.68

0.87

0.39

60%

reduction

30%

reduction

Su

rviv

al

1.0

0.9

0.8

0.3

0.2

0.1

0.7

0.6

0.5

0.4

0.0

0 40 80 120 160 200 240 280 320 360 400

83.3%80.0%

52.4%

Survival at

1 year

MR severity

at discharge: Survival at 1 year (unadjusted):

≤1+ (n=66)

2+ (n=35)

3+/4+(n=22)

p=0.61 for ≤1 vs 2+ at discharge

p=0.001 for ≤1 vs 3+/4+ at discharge

p=0.02 for 2+ vs 3+/4+ at discharge

MitraClip in Prohibitive-risk

DMR

• 127 pts from EVEREST studies• Mean age 82 yrs, 87% NYHA III/IV, mean STS score 13.2%. MitraClip success 95.3%• 1-year survival 75.2%; survival according to d/c MR:

Days

Lim SD et al. J Am Coll Cardiol 2014;64:182–92


TMVR for DMR

COR LOE

Transcatheter MV repair may be

considered for severely

symptomatic pts (NYHA class

III/IV) with chronic severe primary

MR (stage D) who have a

reasonable life expectancy but a

prohibitive surgical risk because

of severe comorbidities


REPAIR VS REPLACE

FOR MEDICALLY-

OPTIMIZED

SYMPTOMATIC

ISCHEMIC MR WILL BE

DRIVEN BY SURGEON

EXPERTISE

Secondary MR

CAD RxHF Rx

Consider CRT

Symptomatic severe MR (Stage D)

Asymptomatic severe MR (Stage C)

Progressive MR (Stage B)

Persistent NYHA Class III-IV symptoms

MV Surgery (IIb)



Surgery for Secondary MR

Periodic Monitoring

Medical treatment

PCI

CABG only

CABG + MVr/R

Is MV Surgery Beneficial in

FMR?• 4,989 pts with CAD and mod/sev ischemic MR at Duke between 1990-2009 • Treated with MED only (1,800; 36%), PCI only (1,295; 26%), CABG only (1,651; 33%) and

CABG + MV repair or replacement (243; 5%) • Propensity adjusted multivariable outcomes at median FU 5.4 yrs:

PCI vs Med: Adj HR (95%CI) = 0.83 (0.76 - 0.92), P=0.0002

CABG vs. Med: Adj HR (95%CI) = 0.56 (0.52 - 0.62), P<0.0001

CABG+MVRR vs. Med: Adj HR (95%CI) = 0.69 (0.57 - 0.82), P<0.0001

P for interaction for MR severity = 0.61

Median adj

survival

5.6 years

6.8 years

9.7 years

8.1 years

Su

rviv

al

1.0

0.9

0.8

0.3

0.2

0.1

0.7

0.6

0.5

0.4

0.0

No. at risk0

Medical treatmentPCICABG onlyCABG + MVRR

180012951651243

1 2

119810381402181

3 4

8778581160144

5 6

633677901103

7 8

46148667372

9 10

33235240248

Castleberry AW et al. Circulation 2014;129:2547-56

Meta-analysis of Repair vs.

Replacement for Ischemic MR

12 non-randomized studies, 2,508 pts, 64% repair, 36%

replacement

Random effects meta-analysis:Repair vs. replacement

Endpoint (n studies) HR (or OR) [95%CI] P value

Hospital death (11) 0.56 [0.38, 0.85] 0.006

- Studies after 1988 (7) 0.70 [0.44, 1.12] 0.14

Long-term death (11) 0.86 [0.66, 1.13] 0.28

- Propensity adjusted (4) 1.05 [0.92, 1.19] 0.46

Recurrent MR ≥2+ (5) 7.51 [3.70, 15.23] <0.0001

Reoperation (4) 1.49 [0.91, 2.46] 0.16

Dayan V et al. Ann Thorac Surg 2014;97:758–66

Severe MR (SMR) Trial Design

• 251 pts with severe ischemic FMR

• Randomized to MV repair with complete rings vs. chordal-sparing MV replacement

• Mean EROA ~0.40 cm2; 86% concomitant procedures (75% CABG, TV repair, Maze)

En

rollm

en

t

Excluded (n=3207)

• Did not meet inclusion criteria (n=3011)

• Refused to participate (n=131)

• Other (n=65)

All

oc

ati

on

An

aly

sis

Fo

llo

w-u

p

Allocated to Mitral Valve Repair (n=126)

• Received MV Repair (n=115)

• Received MV Replacement (n=11)

Assessed for Eligibility

(n=3458)

Allocated to Mitral Valve Replacement (n=125)

• Received MV Replacement (n=124)

• Received MV Repair (n=1)

Randomized

(n=251)

• Withdrawal before month 12 (n=3)

• Death before month 12 (n=18)

• Withdrawal before month 12 (n=1)

• Death before month 12 (n=22)

Primary Endpoint Analysis (n=126)

Excluded from Analysis (n=0)

Primary Endpoint Analysis (n=125)

Excluded from Analysis (n=0)

2 year FU planned

Acker MA et al. NEJM 2013;45:381-387

SMR Trial: 1° Endpoint





1 EP = Median Change in LVESVI from baseline to 1 year

P=0.18

Med

ian

Ch

an

ge in

LV

ES

VI

(mm

/m2)

Repair

(All pts)

Replacement

(All pts)

Repair

(Survivors)

Replacement

(Survivors)

10.0

7.5

5.0

2.5

0.0

-2.5

-5.0

SMR Trial: Recurrent MR





Recurrent MR at 1 year

28.4 2.3

4.2

2.3%

0

10

20

30

40

Repair (n=126) Replacement (n=125)

Rec

urr

en

t M

R (

%) Severe

Moderate

32.6%

There were no

significant 1-year

differences in:

• LVESVI

• NYHA

• SF-36 scores

• MLwHF scores

• MV reoperation

• Death

• MACE

P<0.001

SMR Trial: Impact of Recurrent MR





Mean Change in LVESVI

P<0.001

Mean

LV

ES

VI

70

50

40

30

20

10

0

60

Repair with

recurrent MR

Repair without

recurrent MR

Replacement

Δ=6.8 ml

Baseline 12 mos

PERCUTANEOUS MV

REPAIR INDICATIONS

WILL CONTINUE TO

EVOLVE AND EXPAND

INTO THE REALM OF

FUNCTIONAL MR

• 1,095 pts* with 3+/4+ MR and HF between 2000 and 2008 (74% FMR, 21% DMR). Rx before 10/2011:

DMR pts (n=226): 84% MV surgery, 16% med RxFMR pts (n=814): 36% MV surgery (77% w/CABG), 64% med Rx

Un-operated pts had lower LVEF (mean 27% vs. 42%, p<0.0001 and higher STS score (median 5.8 vs. 4.0, p<0.001) compared with operated pts.

* Excluded MVA ≤2 cm2, AR ≥2+, aortic peak velocity ≥2.5 m/s, HCM, endocarditis, concomitant AV, Ao or pericardial surgeries, LVAD or OHT.

Prognosis

of un-

operated

pts with 3-

4+ MR and

HF

171 of 474 (36%)

un-operated pts

with FMR and good

echos would have

been eligible for

MitraClip based on

published criteria

Goel SS et al. JACC 2014;63,:185–90

% o

f P

ati

en

ts

100

80

60

40

20

0

Mortality

Surviving pts hospitalized for HF

Years

1

20

2 3 4 5

41

50

29

37

58

68

4650

90

Management of 3-4+ MR with HF

What are the anatomic

criteria for MitraClip?

>2mm

<11mm

<10mm

≤15mm

Non-rheumatic MR originating

from the central 2/3 of the valve

Etiology: degenerative or

functional

Sufficient leaflet tissue for

mechanical coaptation

Protocol anatomic exclusions

Flail gap >10mm

Flail width >15mm

LVIDs >55mm

MVA <4 cm2

Data as of 08/31/2014. Source: Abbott Vascular

Study Population N*

EVEREST I (feasibility) Feasibility 55

EVEREST II (pivotal) Roll-in 60

EVEREST II (pivotal) Randomized 184

EVEREST II (pivotal) Non-randomized high-risk 78

REALISM continued access Non-randomized 899

Compassionate/emergency Non-randomized 66

ACCESS Europe Phase I Non-randomized 567

ACCESS Europe Phase II Non-randomized 286

Commercial Use Commercial 14,232

Total 16,427

Worldwide MitraClip Experience

MitraClip RCTs in Functional MRCOAPT RESHAPE-HF Mitra-Fr

N patients, sites 430 @ 75 US sites 800 @ 50 EU sites 288 @ 18 French sites

Control arm Medical Rx Medical Rx Medical Rx

FMR grade≥3+ (EROA ≥30 mm² and/or Rvol >45

mL by ECL)

≥3+ (EROA ≥30 mm² and/or Rvol >45

mL by ECL)

Sev (EROA >20 mm² + Rvol

>30 mL) by ECL

NYHA class II, III, or ambulatory IV III or ambulatory IV II - IV

Other inclusion criteria

HF hosp within 12 months or BNP

≥300 pg/ml or nT-proBNP ≥1500

pg/ml within 12 months; MV surgery

is not local standard of care

HF hosp within 12 months or BNP ≥350

pg/ml or nT-proBNP ≥1400 pg/ml within

90 days; not eligible for MV surgery

HF hosp within 12 months;

not eligible for MV surgery

LVEF ≥20% - ≤50% ≥15% - ≤40% ≥15% - ≤40%

LV volumes LVESD ≤70 mm LVEDD ≥55 mm -

Primary efficacy

endpoint (superiority)

Recurrent HF hospitalization at 12

months

Death or recurrent HF hospitalization at

12 months

Death or recurrent HF

hospitalization at 12 months

Primary safety

endpoint

(noninferiority)

SLDA, device embolizations,

endocarditis/MS/device-related

complications requiring non-elective

CV surgery, LVAD, OHT

- -

Health economics Assessed Assessed -

Follow-up 5 years 2 years 2 years

• 3 trials randomizing 1,518 patients with

heart failure and secondary (functional) MR

to MitraClip vs. GDMT

• As of September 10th, 2014,

207 patients had been randomized:

- COAPT - 124 pts

- RESHAPE-HF - 37 pts

- Mitra-Fr - 46 pts

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