Cosa possiamo fare, nella insufficienza mitralica, oltre la MitraClip.

Francesco Maisano MD, FESCOspedale San Raffaele

Dipartimento Cardiotoracovascolare

MitraClip in the clinical practice

Opportunity– Large unmet need – Reported clinical

benefit in selected patients

Challenges– Lack of evidence,

particularly for FMR– Limited clinical

experience, concentrated in high volume centers

– Limited applicability

MitraClip anatomical patient selection considerations

• Moderate to severe MR (Grade 3 or more out of 4 grades)

• Pathology in A2-P2 area• Coaptation length > 2 mm

(depending on leaflet mobility)• Coaptation depth < 11 mm• Flail gap < 10 mm• Flail width < 15 mm• Mitral valve orifice area > 4cm2

(depending on leaflet mobility)• Mobile leaflet length > 1 cm

Recommended criteria1

1. The current patient considerations are based on EVEREST II and commercial European experience to date. The MitraClip Patient Selection Coniderations document has been endorsed by Expert Opinion (Crossroads institute).

Anatomic Measurements

P=0.05 P=0.1

San Raffaele Preliminary data

Tenting area and QRS duration

p=0.002

P=0.01

San Raffaele Preliminary data

Jet extension (%)

Jet extension/IC diameter

p=0.01

What to do in patients beyond MitraClip feasibility

• Surgery• Synergistic approaches• New technologies

– Annuloplasty– Neochordae implantation– Mitral valve replacement

2008-Hugo Vanermen

The Mitraclip is applicable only in selected patients

Surgeons use many different techniques to individualize treatment

Current transcatheter technologies to treat MR at the leaflet level

technique device status

Edge-to-edge MitraClip CE mark

Mobius Early clinical

Mitraflex preclinical

neochordae Neochord Early clinical

Babic preclinical

Mobius preclinical

Valtech - vchordal preclinical

Tissue reduction Thermocool preclinical

Spacer Percupro Early clinical

Neochord Inc.

FB, 85 yo, high surgical risk

Neochord

Good• “Anatomical” off

pump correction of prolapse

• Minimally invasive approach

• Beating heart adjustment of chordae

Bad• Limited applicability • Apical attachment of

the neochorda• Need for

annuloplasty

Beyond Mitraclip - Annuloplasty

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

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

Transcatheter annuloplasty

MONARC (Edwards Lifesciences LLC)

Two-anchor design with chronic reshaping (6weeks) by a foreshortening bridge

EVOLUTION trial (69 pts enrolled)

CARILLON (Cardiac Dimensions Inc)

Acute reshaping device acting in P2P3, repositionable, retrievable

AMADEUS trial(43 pts enrolled )

PTMA (Viacor Inc)

Tri-lumen catheter, reshapable, possibility of multiple long term adjustment

PTOLEMY(24 pts enrolled)

Coronary sinus devices

Direct annuloplasty

the only approach with a proven surgical background

Valtech Cardio - CARDIOBAND

• A surgical ring implanted percutaneously

Transcatheter MVR

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

and LVOT• PVL more problematic

Valve in Valve and Valve in Ring

Trattamento della valvola tricuspide

Treating valve disease in the future

Tailored approach – the best option for the patient

today

Individualize the therapy waiting for more evidence

• Anatomy and function• Comorbidities, Life

expectancy• Compare risk and

probability of success• Preservation of surgical

option• Patient informed consent

for therapy• collaboration