SICCH 2010, Technocollege

percutaneous mitral repair

F. Maisano MD, FESC

San Raffaele Institute

Milano, Italy

…The Truth

Current status of surgical repair of MR

• Mitral repair is a surgical success storyLow operative riskRecovery of life expectancyLow rate of recurrence when appropriate

procedures are performedMinimally invasive techniques increasingly

performed

Everest Peak, Himalaya complex

Euro Heart Survey: 50% symptomatic patients with severe MR are denied surgery

Isolated MR

(n=877)

Severe MR

(n=546)

No Severe MR

(n=331)

No Symptoms

(n=144)

Symptoms

(n=396)

No Intervention

(n=193) 49%

Intervention

(n=203) 51%

Mirabel et al, European Heart J 2007;28:1358-1365

Transcatheter mitral interventions

• Balloon commissurotomy• Annular repair

Sinoplasty (Monarc, Carillon, PTMA)

Direct reshaping (Mitralign, GDS)

Surgical like annuloplasty (ValtechCArdio)

• Leaflet repair Edge-to-edge repair (Mitraclip) Others (plicating clips, chordal

repair)

Cinching devices Internal (PS3) External (Coapsys,

BACE)

Other Hybrid devices (Mitral

Solutions, Micardia, Valtech)

Occluder (Cardiac Solutions)

Transcatheter MVR (Endovalve, CardiaQ, Mitraltech)

Perivalvular leak closure

From surgery to catheter interventions

Surgical E2E, open heart, sternotomy

From surgery to catheter interventions

Robotic E2E, open heart, closed chest

From surgery to catheter interventions

transcathter E2E, beating heart, closed chest

Mitraclip

Versatility

Functional MR Degenerative MR

EVEREST Trial Anatomic Eligibility

• Sufficient leaflet tissue for mechanical coaptation

• Non-rheumatic/endocarditic valve morphology

• Protocol anatomic exclusions Flail gap >10mm Flail width >15mm LVIDs > 55mm Coaptation depth >11mm Coaptation length < 2mm

Feldman T et al., J Am Coll Cardiol 2009;54:686–94

FMR, Log ES 45%, REDO post CABG, recent AMI, EF 20%, CRT-AICD

• Before treatment • After mitraclip

• The patient was transferred from ICU to the general ward in day 1 and discharged home 4 days after the procedure

• At 1 year the MR reduction is stable with mild residual MR, reduction of LV volumes, and the patient is in NYHA class I

Confidential

European Experience:Number of Patients Treated Per Month

4

10 912

7

1614

19

26 25

30 28

35 35

47

53 54

70

7880

87

112

97

112

0

20

40

60

80

100

120

Sep08

Oct Nov Dec Jan09

Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan10

Feb Mar Apr May Jun Jul Aug

Co

un

t

# of Patients Treated # of Sites # of Sites Treating Patients

* Includes first-time procedures only – not 2nd Clip interventions*Data as of 8/31/2010. Source: EU Case Observation Reports

N = 1060 Total Patients

GISE Mitraclip User Meeting22

ACCESS Europe – MitraClip Arm Baseline Echocardiographic Measurements

Co-morbidities (MitraClip N)

ACCESS MitraClip Patients

EVEREST II RCT Device Group

(N = 184)

MR,% (n=246)

None (0) 0.0% 0.0%

Mild (1+) 0.0% 0.0%

Mild to Moderate (1+-2+) 0.0% 0.0%

Moderate (2+) 2.8% 4.3%

Moderate to Moderate to Severe (2-3+) 4.1% 0.0%

Moderate to Severe (3+) 30.9% 70.7%

Moderate to Severe to Severe (3-4+) 26.4% 0.0%

Severe (4+) 35.8% 25.0%

MR Etiology, % (n=216)

DMR 12.5% 73.4%

FMR Ischemic 43.1% 26.6%

CombinedFMR Non-ischemic 44.4%

European/HSR ExperienceOverall Results

*Data as of 8/31/2010. Source: EU Case Observation Reports

Overall European experience

All Patients – HSR Milan

Patients Treated 1060 48

Hospitals/Sites 56 1

Etiology: FMR/DMR/Mixed (%) 64%/29%/8% 64% / 29% / 8%

Average Device Time1,2 (hr:min) 1:51 1:23

Clip Implant Rate2 (%) 96% 98%

1 Clip/2 Clip/3 Clip/4 Clip2,3 (%) 67%/30%/2%/<1% 32% / 62% /4% / 0%

Site Reported MR Reduction2,3 (%) 98% 100%

Clip Embolization (%) 0.01% 0.0%

1Does not include time to perform the transseptal puncture2Includes first procedures only – not 2nd Clip interventions.3Applies only to successful implants – does not include non-implants.4Applies to two patients one clip partial detached each

24

ACCESS Europe – MitraClip Arm Baseline Demographics

Characteristic (MitraClip N)

ACCESS MitraClip Patients

EVEREST II RCT Device Group

(N = 184)

San Raffaele Milan(N=41)

Age, years (n=278)

Age, Mean ± SD 72.8 ± 10.2 67.3 ± 12.8 70.7 ± 13.2F 68.3 ± 10.8

D 75.4 ± 16.4

Patients > 75 years (%)

41.4% 29.9% 43.6%F 33.3% - D 71.4%

Gender, % (n=282)

Male 65.6% 62.5% 75.6%F 88.9% - D 50.0%

Female 34.4% 37.5% 24.4%F 11.1% - D 50.0%

Baseline Co-morbidities

Co-morbidities (MitraClip N)

ACCESS MitraClip Patients

EVEREST II RCTDevice Group

(N = 184)

San Raffaele - Milan(N=41)

Age, Mean ± SD 72.8 ± 10.2 67.3 ± 12.8 70.7 ± 13.2

F 68.3 ± 10.8 D 75.4 ± 16.4

Logistic EuroSCORE (n=243) 19.8 ± 18.2 NA 25.1 ± 15.7

F 27.9±17.1 - D 19.5±11.1

Coronary Artery Disease (n=248) 62.1% 47.0 % 65.8% (F 81.5% - D 35.7%)

Atrial Fibrillation (n=240) 62.1% 33.7% 41.9% (F 50% - D 27.3%)

Diabetes (n=251) 28.7% 7.6% 24.0% (F 29.4% - D 12.5%)

Previous Cardiovascular Surgery (n=247)

37.7% 22.3% 32.5% (F 33.4% - D 30.1%)

Previous Percutaneous Intervention (n=245)

39.6% 24.0% 55.0% (F 70.4% - D 23.1%)

ICD 22.7% 7.1% 20% (F 28.6% - D 0.0%)

AICD-CRT 18.2% (F 30.0% - D 0.0%)

LVEF 10-20% 12.0%

Mean EF

60.0%

7.3% (F 11.2% - D 0.0%)

LVEF 20-30% 29.3% 29.3% (F 44.4% -D 0.0%)

LVEF 30-40% 17.4% 17.1% (37.0% - D 0.0%)

LVEF > 40% 41.3% 36.6% (7.4% -D 100%)

Discharge Status

26

Discharge Location

(n = 238)MitraClip Patients

San Raffaele Milan

Discharged home without home healthcare

81.1% 82.9%

Discharged home with home health care

0.8% 0.0%

Discharged to nursing home/skilled nursing facility/hospital

16.0%17.1%

Death prior to discharge 2.1% 2.0%

Death prior to 30 days or discharge 3.4% 2.0%

27

Degenerative (n = 14)

Functional (n = 26)

ACCESS Europe – MitraClip Arm MR Severity at Baseline & Discharge

50%

43%

36%

2%

5%

1%

62%

0%

20%

40%

60%

80%

100%

Pre-Clip Discharge

Pe

rce

nt

4+ MR

3+ MR

2+ MR

1+ MR

0+ MR

Baseline & Discharge MR SeverityMatched Data

(n = 205)

Baseline & Discharge MR SeverityMatched Data

(n = 40)

San Raffaele – MilanACCESS-EU STUDY

NYHA Class

Functional

DMR

San Raffaele Milan

FMR

Beyond Mitraclip - Annuloplasty

• Lack of annuloplasty is associated to accelerated failure in the overall surgical population

• Current transcatheter annuloplasty solutions are suboptimal

• New technologies are developing (GDS, Mitralign, Valtech Cardioband)

Maisano F, et al Eur J Cardiothorac Surg. 1999;15:419-25Gillinov et al J Thorac Cardiovasc Surg 1998;116:734-43

Transcatheter annuloplasty

Direct annular remodeling

• Mitralign• GDS• ValtechCardio

• The closest devices to conventional suture annuloplasty

• Initial clinical trials

Neochord Inc.

Transcatheter MVR

• Larger device• Anchoring• Asymmetric anatomy• Interaction with the aortic valve

and LVOT• PVL more problematic

Surgery vs percutaneous treatemtnWhere are we?... The truth…

• Surgical mitral repair can provide excellent results in most patients

• Interventional MR repair is a great opportunity for expanding current treatment options

• We need data Everest trial results are encouraging but not reflecting real world

scenario

70

30EVEREST

DMRFMR

10

90

ACCESS

DMRFMR

Surgery vs Mitraclip

Chance of correcting MR with Mitraclip

Ris

k

of

su

rge

ryL

ow

H

igh

Low High

Risk of Mitraclip

procedure

• Risk of Mitraclip procedure

• Preservation of surgical option

• Long term results of Mitraclip

Individualize the therapy

• Anatomy and function• Comorbidities, Life expectancy• Compare risk and probability of

success• Preservation of surgical option• Patient informed consent for

therapy• Transcatheter mitral repair is here

to stay• Surgeons will do procedures

We need data !!!