MITRACLIP

Introduccion

La insuficiencia mitral moderada o

severa es la segunda valvulopatia
que mas frecuentemente requiere
tratamiento quirúrgico en Europa.
 Introduccion
• Los pacientes con IM severa sintomática
tienen un pobre pronostico, con mortalidad
anual del 5% sin tto quirurgico.

• La mortalidad asciende al 60% a los 5 años

cuando hay disfuncion ventricular.
Epidemiologia
Distribución de la enfermedad Valvular en el
Euro Heart Survey
 Euro Heart Survey: 50% de pacientes
sintomáticos con IMS se contraindicó cirugía
Isolated MR
(n=877)

No Severe
Severe MR
MR
(n=546)
(n=331)

No
Symptoms
Symptoms
(n=396)
(n=144)

No
Intervention
Intervention
(n=203) 51%
(n=193) 49%

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

 El sistema
• La terapia con Mitraclip esta basada en la
reparacion valvular quirúrgica “edge to edge”
descripta por Alfieri.

• El dispositivo Mitraclip, diseñado para simular la

reparacion “edge to edge”, consiste en un implante
con dos brazos y dos broches para agarrar los dos
bordes oponentes de las valvas anterior y porterior,
con el objetivo de mejorar la coaptacion y
generando una válvula con doble orificio.
 El sistema
• La encapsulacion del dispositivo ocurre en 12
semanas en modelos porcinos.

• El dispositivo es enviado vía transeptal, y es

dirigido con guia ecocardiografica al VI hasta el
punto de regurgitacion.

• Si se confirma la insecion adecuada a las valvas,

el Mitraclip es ajustado para asegurar la eficacia.
 El Sistema
• Si el agarre se considera suboptimo, las valvas
pueden ser liberadas y el procedimiento
puede ser repetido.

• Se han descripto la insecion de hasta cuatro

dispositivos en un solo paciente.
Transcatheter Mitral Valve Repair.
Opportunity Challenges
– Unmet need – Lack of evidence,
– Reported clinical particularly for FMR
benefit in selected – Limited clinical
patients experience,
concentrated in high
volume centers
 Patient selection – a teamwork effort
• Confirm severity of MR + ?
?
evaluate symptoms ? ? ?
• Analize risk of surgery and ? ?
evaluate life-expectancy ? ?
? ? ?
and quality of life ?
?
?
• Assess feasibility of
?
Mitraclip.
Evidence
+ ?
Risk scores
• DMR vs FMR +
Guidelines
 Mitraclip for DMR
• In experienced centers, DMR is
treated with surgical repair at low risk,
long term durability of repair is
achieved in the majority of patients
– 50% of Euro Heart Survey patients were
not referred to surgery (Mirabel EHJ
2007)
– Age and comorbidity increase the risk of
surgery (STS database, 2010)
– Surgery is not associated with improved
QoL in most elderly patients (Maisano et
al EJCTS 2009)
 Mitraclip for FMR
• Surgical treatment of FMR is associated
with
– High hospital mortality
– High recurrence rate
– Long hospital stay
– Unproven survival benefit
• Mitraclip for FMR
– Procedure more simple than for DMR
– Improvement of symptoms at low risk
– HRR suggests survival benefit
– Failure does not modify the surgical option
 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).
 Surgery vs Mitraclip
Risk of
Mitraclip High
procedure
Risk of surgery

•Risk of Mitraclip
procedure
•Preservation of
surgical option
Low

•Long term results of

Mitraclip

Bad anatomy Good

for Mitraclip
 Individualize the therapy waiting for more
actual randomized trials
• Anatomy and function
• Comorbidities, Life
expectancy
• Compare risk and
probability of success
• Preservation of surgical
option
• Patient informed consent
for therapy
• collaboration
Gracias