This document discusses potential treatments for mitral regurgitation beyond the MitraClip procedure. It notes that while the MitraClip is effective for selected patients, other options are needed to treat a wider range of patients. These include open heart surgery, combining approaches synergistically, and new technologies such as annuloplasty, neochordae implantation, and mitral valve replacement. Several new transcatheter techniques are discussed such as devices to implant neochordae or reshape the coronary sinus. The document emphasizes tailoring the treatment approach to each individual patient based on their anatomy, comorbidities, and goals of care.

1. Cosa possiamo fare, nella insufficienza
mitralica, oltre la MitraClip.
Francesco Maisano MD, FESC
Ospedale San Raffaele
DipartimentoCardiotoracovascolare

2. MitraClip in the clinicalpractice
Opportunity Challenges
– Largeunmetneed – Lackofevidence, parti
– Reportedclinical cularlyfor FMR
benefit in – Limitedclinicalexperi
selectedpatients ence, concentrated
in high volume
centers
– Limitedapplicability

3. MitraClip anatomical
patient selection considerations
Recommended criteria1
• 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 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).

5. Anatomic Measurements
P=0.05 P=0.1
San Raffaele Preliminary data

6. Tenting area and QRS duration
p=0.002
P=0.01
San Raffaele Preliminary data

7. Jet extension (%)
p=0.01
Jet extension/IC diameter

8. What to do in patients beyond
MitraClip feasibility
• Surgery
• Synergistic approaches
• New technologies
– Annuloplasty
– Neochordae implantation
– Mitral valve replacement

9. The Mitraclip is
applicable only in
selected patients
Surgeons use many
different techniques to
individualize treatment
2008-Hugo Vanermen

10. Current transcatheter technologies
to treat MR at the leaflet level
technique device status
Edge-to-edge MitraClip CE mark
Mobius Earlyclinical
Mitraflex preclinical
neochordae Neochord Early clinical
Babic preclinical
Mobius preclinical
Valtech - vchordal preclinical
Tissue reduction Thermocool preclinical
Spacer Percupro Early clinical

11. Neochord Inc.

12. FB, 85 yo, high surgical risk

13. Neochord
Good Bad
• “Anatomical” off • Limited applicability
pump correction of • Apical attachment of
prolapse the neochorda
• Minimally invasive • Need for
approach annuloplasty
• Beating heart
adjustment of
chordae

14. Beyond Mitraclip - Annuloplasty
• Lackof annuloplasty isassociatedtoacceleratedfailure
in the overallsurgicalpopulation
Maisano F, et al Eur J CardiothoracSurg. 1999;15:419-25
Gillinov et al J ThoracCardiovascSurg 1998;116:734-43

15. Transcatheter annuloplasty
Coronary sinus remodeling
SL dimensions cinching
RF/Ultrasound remodeling
External compression
Direct annuloplasty

16. Coronary sinus devices
MONARC Two-anchor design EVOLUTION
(Edwards with chronic trial
Lifesciences reshaping (6weeks) (69 pts
LLC) by a foreshortening enrolled)
bridge
CARILLON Acute reshaping AMADEUS trial
(Cardiac device acting in (43 pts
Dimensions P2P3, repositionable, enrolled )
Inc) retrievable
PTMA Tri-lumen catheter, PTOLEMY
(Viacor Inc) reshapable, (24 pts
possibility of enrolled)
multiple long term
adjustment

17. Direct annuloplasty
the only approach with a proven surgical background
Mitralign GDS Valtech
Bident Accucinch Cardioband
• Arterial access • Arterial access • Venous access
• Transannular • Subannular • Annular fixation
cinchin cinching

18. Valtech Cardio - CARDIOBAND
• A surgical ring implanted percutaneously

19. Transcatheter MVR
• Larger device
• Anchoring
• Asymmetric anatomy
• Interaction with the aortic valve
and LVOT
• PVL more problematic

21. Trattamento della valvola tricuspide

22. Treating valve disease in the future
today
Patient-optimized care
Minimally
Transcatheter Open heart
invasive
interventions procedures
surgery
Tailored approach – the best option
for the patient

23. Individualizethe 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