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Mitraclip : Actual data and perspectives

Jean-François OBADIA Hôpital Louis Pradel

- LYON -

Worldwide Clinical Experience *Data as of 21/3/2012.

Source: Abbott Vascular

Study Population N*

EVEREST I (Feasibility) Feasibility patients 55

EVEREST II (Pivotal) Pre-randomized patients 60

EVEREST II (Pivotal) Non-randomized patients

(High Risk Study)

78

EVEREST II (Pivotal) Randomized patients

(2:1 Clip to Surgery)

279

184 Clip

95 Surgery

REALISM (Continued Access) Non-randomized patients 650

Compassionate/Emergency Use Non-randomized patients 35

ACCESS Europe Phase I Non-randomized patients 566

ACCESS Europe Phase II Non-randomized patients 90

Commercial Use Commercial patients 3,284

Total 5,002

2011

2011

2003

2002

Randomized

Classical

Indicatios

Counter

Indication

Per-cutaneous Valve treatment

Cohort B

Cohort A All indications MR

HR Pts, Funct.MR

Percutaneous Valve Repair – MITRACLIP

EVEREST II April 4, 2011, at NEJM.org

EVEREST II Results at 2 years

7

MitraClip > Surgery “Safety”

30 Day Modified * MAE Intent to Treat, Hierarchical Events

Safety endpoint met with a wide margin

0

10

20

30

40

50

Device Control

30 D

ay

Modifie

d M

AE (

%)

Major Bleeding Complication*

GI Complication

New Onset Atrial Fibrillation

Ventilation >48hrs

Urgent CV Surgery

Stroke

Death8.3%

42.6%

*Major bleeding requiring transfusion ≥ 2U, or surgical intervention.

p<0.0001

(MitraClip)Devicen=180

(Surgery)Controln=94

Surgery > Mitraclip “Residual MR at 1 year”

MR Severity, Preliminary 24 Month Results

Per Protocol Cohort, Matched Baseline and 12 Months

0

20

40

60

80

100

Baseline 12 Months 24 Months

Pe

rcen

t P

atie

nts

1+

1+ - 2+

2+

4+

(n=119) (n=119) (n=75)

Device Control

p<0.0001

3+

2+

4+

3+

1+

1+ - 2+

2+

4+

3+

0

20

40

60

80

100

Baseline 12 Months 24 Months

Pe

rcen

t P

atie

nts

1+

1+ - 2+

2+

4+

(n=69) (n=69) (n=39)

p<0.0001

3+

2+

3+

0+

1+

1+ - 2+

2+

4+

0+ 1+ - 2+

p - value compares the distribution of MR grade in device with the distribution of MR grade in control at 12 months

(Fishers ’ Exact test)

Regurg.

LV NYHA

2 Years Follow-up

Surgery > Mitraclip “Residual MR at 2 years”

0 grade > 2

2 Re-op.

23 % grade III/IV

15 repair / 13 Replac

4

10 912

7

1614

19

26 25

3028

35 35

47

53 54

70

7880

87

112

97

112

0

20

40

60

80

100

120

Sep

08

Oct Nov Dec Jan

09

Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan

10

Feb Mar Apr May Jun Jul Aug

Co

un

t

# of Patients Treated

# of Sites

# of Sites Treating Patients

* Mitraclip is a safe technique (less blood transfusion)

* Surgery provides better Valve repair

- 96% versus 78 % at 2 years (free from reop.)

* Both Mitraclip and surgery

- Reduce Regurgitation

- Improve LV volumes and NYHA class

• This encouraging but sub-optimal results :

• Cannot deal with dystrophic surgical results

• Could be an elegant option for FMR

Everest II Conclusions Safer - Transfusion

Equivalent to Surgery ???

Everest Conclusions Safer - Transfusion

Equivalent to Surgery ???

See Disclaimer on Slide 2

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

HRR: Freedom from Death

P=0.037

HRR

HRR Control30 day mortality in HRR

MitraClip patients is similar

to patients managed with

standard of care treatment

MitraClip Therapy vs. High Risk Control

Everest II HRR (from everest) Access Europ

Demographics and Co-morbidities EVEREST II RCT Device Patients

N=178

High Surgical Risk Cohort

N=211

ACCESS EU – MitraClip Patients

N=566

Age (mean ± SD), years 67 ± 13 76 ± 10 74 ± 10

Logistic EuroSCORE, (%)

Mean ± SD NA NA 23 ± 18

Logistic EuroSCORE ≥ 20%, (%) NA NA 45

Mitral Regurgitation Grade ≥ 3+, (%) 96 86 98

NYHA Functional Class III or IV, (%) 50 86 85

Ejection Fraction < 40%, (%) 6 28 53

Functional MR, (%) 27 71 77

Ischemic NA NA 42

Non-ischemic NA NA 58

Degenerative MR, (%) 73 29 23

“Access Eu” Registry

99.6% Implant Rate N=566

2,7%

37%

60%

0,4%

0%

20%

40%

60%

80%

100%

Perc

ent

0 MitraClips (N=2)

1 MitraClip (N=340)

2 MitraClips(N=208)3 MitraClips (N=15)

4 MitraClips (N=1)

0.2%

Procedural and Post-procedural Results ACCESS EU – MitraClip Patients

N=566

Procedural, (mean ± SD)

Procedure time, (min) 117 ± 69

Contrast volume, (ml) 17 ± 40

Fluoroscopy duration, (min) 29 ± 20

Post-procedural, (mean ± SD)

ICU/CCU duration, (days) 2.5 ± 6.5

Length of hospital stay, (days) 7.7 ± 8.2

Discharge to, (%)

Home 80% (447/561)

Skilled nursing home/nursing facility 18% (103/561)

Died prior to discharge 2% (11/561)


30 Day Events*

Patients Experiencing Event, # (%)

All Patients N=566

Logistic EuroSCORE ≥20%

N=252

Logistic EuroSCORE <20%

N=314

Death 19 (3.4%) 11 (4.4%) 8 (2.5%)

Stroke 4 (0.7%) 3 (1.2%) 1 (0.3%)

Myocardial Infarction 4 (0.7%) 2 (0.8%) 2 (0.6%)

Renal Failure 24 (4.2%) 16 (6.3%) 8 (2.5%)

Respiratory Failure 4 (0.7%) 3 (1.2%) 1 (0.3%)

Need for Resuscitation 10 (1.8%) 7 (2.8%) 3 (1.0%)

Cardiac Tamponade 6 (1.1%) 3 (1.2%) 3 (1.0%)

Bleeding Complications 21 (3.7%) 12 (4.8%) 9 (2.9%)

* As reported by sites as of January 12, 2012


At Risk 0 Day 30 Days 180 Days

N 566 540 486

88.8%

at 6 Months

96.6%

at 30 Days


Reported by Site* ACCESS EU – MitraClip Patients

N=566

MitraClip Device Embolization 0% (0/566)

Single Leaflet Device Attachment (SLDA) 4.6% (26/566)

Mitral Valve Surgery Within 6 Months Post-Index Implant Procedure

4.6% (26/566)

Second Intervention to Place an Additional MitraClip Device 3.4% (19/566)

* As of January 12, 2012


N = 392 Matched Cases

80% MR ≤ 2+ at 6 Months

0

20

40

60

80

100

Baseline 6 months

Perc

ent

Patients

3+

4+

3+

2+

1+

0

p<0.0001

2+

4+

* As assessed by the sites

“Access Eu” Residual MR

Access EU NYHA Functional Class

71% NYHA Class I or II at 6 Months

0

20

40

60

80

100

Baseline 6 months

Perc

ent

Patients

II

III

IV

II

III

IV

I


p<0.0001

I

Access EU Quality of Life Score (MLWHF)

0

15

30

45

60

Mean Q

oL S

core

(M

LWH

F)

p<0.0001

Baseline 6 Months


41.4

28.9

Mean improvement

-12.5 points

95% CI: (-14.9, -10.1)

Access EU 6-Minute Walk Distance

0

100

200

300

400

Mean M

ete

rs W

alk

ed

Baseline 6 Months


p=0.0007 Mean improvement

58 meters 95% CI: (44.0, 72.1)

265

323

Conclusions > 5000 procedures

EVEREST II

178 Pts

RCT

ACCESS EU 566 Pts

REALISM 650 Pts

EVEREST II HR 211 Pts

Registries

Franzen, Schillinger, Sven,

Treede, Auricchio

Large cohorts*

Less Transfusion

Surgery Better

Safety Confirmed Functional MR

Post-Conclusion Mitraclip in France 2011…2012……..

Reimbursement STIC 2011 rejected

in France PHRC 2012 ?

Bichat 12

Lyon CHU 11

Massy 7

Nantes J.Cartier 5

Toulouse CHU 2

--------------------------

Total 37

37 Patients : 10 females, 27 Males 75 ans

Etiology :

26 Functional, 8 Dystrophic, 6 Mixed

Procedure :

2 Failures

2 Clips in 5 pts

Morbi-Mortality :

1 Clip Detachment Surgery

1 pericardial effusion

1 Esophagus Perf. DCD at 1 month

Results

MR Grade Patients

-1 1

-1,5 2

-2 4

-2,5 13

-3 6

-3,5 4

Country comparison (patients / million inhabitants)

Source : Abbott Vascular Data on file – Sept 2011

0

5

10

15

20

25

30

35

40

Spa

in

Cze

ch R

epubl

ic

Finland

Turke

y

Polan

d

Belgium

Franc

e

Denm

ark

Aus

tria

Swed

en

Neth

erland

s

Switz

erland

Unite

d Kingd

om Italy

Ger

man

y

Nb

er

of

mo

nth

s o

n t

he m

ark

et

0

5

10

15

20

25

Nb

er

of

PM

VR

per

1000 0

00 o

f In

hab

.

Wich one will give us Mitraclip ?????

“ Wu, Bolling et al JACC 2005 “

ESC 2007 Guidelines

MV Repair Indications for FMR and Results

Mitraclip Candidates and Results

ISSN: 1524-4539 Copyright © 2005 American Heart Association. All rights reserved. Print ISSN: 0009-7322. Online

72514Circulation is published by the American Heart Association. 7272 Greenville Avenue, Dallas, TX

DOI: 10.1161/CIRCULATIONAHA.104.525188 2005;112;I-402-I-408 Circulation

Pagliaro, Lucia Torracca, Francesco Maisano and Ottavio Alfieri Michele De Bonis, Elisabetta Lapenna, Giovanni La Canna, Eleonora Ficarra, Marco

Cardiomyopathy: Role of the "Edge-to-Edge" TechniqueMitral Valve Repair for Functional Mitral Regurgitation in End-Stage Dilated

http://circ.ahajournals.org/cgi/content/full/112/9_suppl/I-402located on the World Wide Web at:

The online version of this article, along with updated information and services, is

http://www.lww.com/reprintsReprints: Information about reprints can be found online at

[email protected]. E-mail:

Fax:Kluwer Health, 351 West Camden Street, Baltimore, MD 21202-2436. Phone: 410-528-4050. Permissions: Permissions & Rights Desk, Lippincott Williams & Wilkins, a division of Wolters

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MV Repair Indications for FMR and Results

Mitraclip Candidates and Results

Hôpital Louis Pradel - LYON - congres-ebr.com€¦ · Conflit d’intérêt : Consultant :...

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