PFO closure' What is coming soon

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PFO closure. What is coming soon ?

• Gian Paolo Anzola
• Service of Neurology
• S.Orsola Hospital FBF
• Brescia - Italy

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• Case control studies show PFO associated with
  stroke, especially cryptogenic stroke
• Epidemiological prospective studies ( NOMAS
  SPARC) indicate that PFO DOES NOT increase the
  risk of first ever in a life-time stroke

P Amarenco Heart 200591441-443
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• Case control studies show PFO associated with
  stroke, especially cryptogenic stroke
• Epidemiological prospective studies ( NOMAS
  SPARC) indicate that PFO DOES NOT increase the
  risk of first ever in a life-time stroke
• The PICCS study failed to show an increased risk
  of recurrent stroke in patients with PFO

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PICCS study (Homma et al 2002)
The PFO in Cryptogenic Stroke Study was a
42-center study that evaluated transesophageal
echocardiographic findings in patients randomly
assigned to warfarin or aspirin in the
Warfarin-Aspirin Recurrent Stroke Study. In this
study, 630 stroke patients were enrolled, of whom
312 (49.5) were randomized to warfarin and 318
(50.5) to aspirin. Of these, 265 patients
experienced cryptogenic stroke and 365
experienced known stroke subtypes. End points
were recurrent ischemic stroke or death. PFO was
present in 203 patients (33.8).
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PICCS study (Homma et al 2002)
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PICCS study (Homma et al 2002)
Limitations The assocition of PFO with
cryptogenic stroke has not been shown
consistently in all age groups. Thus, our
findings may not apply to all age groups or to
those who meet unambiguous criteria for
paradoxical embolism. Because the mean INR in our
warfarin-treated patients was 2.04, a higher INR
might have given different results. Finally, the
role of other antiplatelet agents remains
untested.
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• Case control studies show PFO associated with
  stroke, especially cryptogenic stroke
• Epidemiological prospective studies ( NOMAS
  SPARC) indicate that PFO DOES NOT increase the
  risk of first ever in a life-time stroke
• The PICCS study failed to show an increased risk
  of recurrent stroke in patients with PFO
• The French study, on the contrary, showed that
  the association PFO-ASA multiplies the risk of
  recurrence

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• Case control studies show PFO associated with
  stroke, especially cryptogenic stroke
• Epidemiological prospective studies ( NOMAS
  SPARC) indicate that PFO DOES NOT increase the
  risk of first ever in a life-time stroke
• The PICCS study failed to show an increased risk
  of recurrent stroke in patients with PFO
• The French study, on the contrary, showed that
  the association PFO-ASA multiplies the risk of
  recurrence
• Moreover, closing PFO might reduce the risk of
  recurrence compared with medical treatment

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Circulation 20051121063-1072
Percutaneus closure
Medical treatment
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• Case control studies show PFO associated with
  stroke, especially cryptogenic stroke
• Epidemiological prospective studies ( NOMAS
  SPARC) indicate that PFO DOES NOT increase the
  risk of first ever in a life-time stroke
• The PICCS study failed to show an increased risk
  of recurrent stroke in patients with PFO
• The French study, on the contrary, showed that
  the association PFO-ASA multiplies the risk of
  recurrence
• Moreover, closing PFO might reduce the risk of
  recurrence compared with medical treatment
• THEREFORE, WHERE DO WE GO FROM HERE?

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Practice Parameter Risk of Recurrent Stroke and
Secondary Stroke Prevention in Patients With
Interatrial Septal Abnormalities (An
Evidence-Based Review) Report of the Quality
Standards Subcommittee of the American Academy of
NeurologyNeurology 2004
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Recommendations

• Among patients with a cryptogenic stroke and
  atrial septal abnormalities, there is
  insufficient evidence to determine the
  superiority of aspirin or warfarin for prevention
  of recurrent stroke or death (Level U), but the
  risks of minor bleeding are possibly greater with
  warfarin (Level C).
• There is insufficient evidence regarding the
  effectiveness of either surgical or percutaneous
  closure of PFO (Level U).

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Planned RCTs
CLOSURE I
RESPECT
(n 1600, superiority trial) STARFlex (U.S.
Canada) 515 pts enrolled (350 pts in 2005)
(n 300, equivalence) AMPLATZER PFO Occluder U.S.
Results probably not to be expected soon..
CARDIA PFO STROKE Trial
PC Trial
(n 400, superiority) AMPLATZER PFO Occluder U.S.
(n 300, equivalence) Intrasept U.S.
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OVERALL RELAPSE RATE
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FACTORS INFLUENCING RELAPSE RATE
Low risk PFO PFO alone Small
PFO Single event Small PFO no
PFO High risk PFO PFO ASA
Large PFO Multiple events Large PFO
PFOgt 64 y.o. 3 years 4 years
annual annual 2years 2 years
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CRITICAL FACTORS FOR RELAPSE
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A DECISION MAKING STRATEGY TO CONFIRM MANDATORY
CLOSURE OF PATENT FORAMEN OVALE
PFO WITH LARGE SHUNT (shower or curtain)
PFO WITH SMALL SHUNT (lt 25 bubbles)
MULTIPLE
DISCUSS TRANSCATH. CLOSURE
TRANSCATHETER CLOSURE
MEDICAL TREATMENT
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ASYMPTOMATIC LARGE SHUNT
MRI
MRI-
MA -
MA
WAIT
???
DISCUSS TRANSCATH. CLOSURE
TRANSCATHETER CLOSURE
MEDICAL TREATMENT
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