Percutaneous Mitral Repair The Truth

SICCH 2010, Technocollegepercutaneous mitralrepair
…TheTruth
F. Maisano MD, FESC
San Raffaele Institute
Milano, Italy

Current status of surgical repair of MR
Mitral repair is a surgical success story
Low operative risk
Recovery of life expectancy
Low rate of recurrence when appropriate procedures are performed
Minimally 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 mitralinterventions
Cinchingdevices
Internal (PS3)
External (Coapsys, BACE)
Other
Hybriddevices (MitralSolutions, Micardia, Valtech)
Occluder (CardiacSolutions)
Transcatheter MVR (Endovalve, CardiaQ, Mitraltech)
Perivalvularleakclosure
Balloon commissurotomy
Annularrepair
Sinoplasty (Monarc, Carillon, PTMA)
Directreshaping (Mitralign, GDS)
Surgicallike annuloplasty (ValtechCArdio)
Leafletrepair
Edge-to-edgerepair (Mitraclip)
Others (plicatingclips, chordal repair)

From surgery to catheter interventionsSurgical E2E, open heart, sternotomy

From surgery to catheter interventionsRobotic E2E, open heart, closed chest

From surgery to catheter interventionstranscathter 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 CollCardiol 2009;54:686–94

FMR, Log ES 45%, REDO post CABG, recent AMI, EF 20%, CRT-AICD
Before treatment
After mitraclip
The patientwastransferredfrom ICU to the generalward in day1 and discharged home 4daysafter the procedure
At1year the MR reductionisstablewithmildresidual MR, reductionof LV volumes, and the patientis in NYHA classI

European Experience:Number of Patients Treated Per Month
N = 1060 Total Patients
* Includes first-time procedures only – not 2nd Clip interventions
*Data as of 8/31/2010. Source: EU Case Observation Reports
Confidential

22
ACCESS Europe – MitraClip Arm Baseline Echocardiographic Measurements

European/HSR ExperienceOverall Results
1Does not include time to perform the transseptal puncture
2Includes 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
*Data as of 8/31/2010. Source: EU Case Observation Reports

ACCESS Europe – MitraClip Arm Baseline Demographics
24

Baseline Co-morbidities

Discharge Status
26

ACCESS Europe – MitraClip Arm MR Severity at Baseline & Discharge
San Raffaele – Milan
ACCESS-EU STUDY
Baseline & Discharge MR Severity
Matched Data
(n = 205)
Baseline & Discharge MR Severity
Matched Data
(n = 40)
Degenerative
(n = 14)
Functional
(n = 26)
27

NYHA Class
San Raffaele Milan
DMR
FMR
Functional

Beyond Mitraclip - Annuloplasty
Lackof annuloplasty isassociatedtoacceleratedfailure in the overallsurgicalpopulation
Current transcatheter annuloplasty solutions are suboptimal
New technologies are developing (GDS, Mitralign, Valtech Cardioband)
Maisano F, et al Eur J CardiothoracSurg. 1999;15:419-25
Gillinov et al J ThoracCardiovascSurg 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

Surgery vs Mitraclip
Risk of Mitraclip procedure
Risk of surgery
Low High
Risk of Mitraclip procedure
Preservation of surgical option
Long term results of Mitraclip
Low High
Chance of correcting
MR with Mitraclip

Individualizethe therapy
We need data !!!
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

Percutaneous Mitral Repair The Truth

by drmaisano on Nov 07, 2010

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Percutaneous Mitral Repair The Truth — Presentation Transcript