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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 !!!