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PFO Closure: clear and borderline indications and cases where there is no evidence of benefit. Michael Mullen Royal Brompton Hospital London. PFO Closure: clear and borderline indications and cases where there is no evidence of benefit. Research Grants NMT medical Edwards Life Science

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Pfo closure clear and borderline indications and cases where there is no evidence of benefit l.jpg

PFO Closure:clear and borderline indications and cases where there is no evidence of benefit

Michael Mullen

Royal Brompton Hospital

London


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PFO Closure:clear and borderline indications and cases where there is no evidence of benefit

Research Grants NMT medical

Edwards Life Science

Corevalve Inc

Medical Advisory Board Sutura Inc

Cardio-optics

Consultancy Sutura Inc

I have a PFO


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Stroke

DCI

Migraine

Cyanosis

OSA

Dementia

COPD


Prevalence of pfo l.jpg
Prevalence of PFO

CFS

Dementia

COPD

OSA

DCI

Migraine

Stroke/TIA

0

20

40

60

80

100

% with PFO


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PFO Closure:clear and borderline indications and cases where there is no evidence of benefit

“The only good PFO is a closed PFO” …..Dr Bernard Meier

“There is no clear indication for PFO closure” …..Most neurologists



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Patent Foramen OvaleCryptogenic stroke

  • Webster MW; Lancet 1988

    • 40 stroke patients < 40 yrs old + matched controls

    • Contrast echo +ve 50% of patients 15% controls

  • Lechat P; NEJM 1988

    • 60 stroke patients < 55 yrs old + 100 controls


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Patent Foramen OvaleCryptogenic stroke

60

50

40

% with PFO

30

20

10

0

All

Other

cause

RF

CS

Lechat P; NEJM 1988


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Patent Foramen OvaleMeta-analysis of risk of stroke

PFO

All

ASA

PFO +ASA

Age<55

PFO

ASA

PFO +ASA

Age>55

PFO

ASA

PFO +ASA

CS vs IC

PFO

ASA

PFO +ASA

1

5

10

15

20

25

30

Overell Neurology 2000


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Patent Foramen OvaleCS recurrence rate

  • Mas JL et al; NEJM 2001

  • 581 patients with CS followed for over 4 yrs

  • All patients received Aspirin 300mg/day

  • Recurrence rates

    • PFO 2.3% (95%CI: 0.3 to 4.3)

    • PFO+ASA 15.2% (95%CI: 1.8 to 28.6)

    • No PFO 4.2% (95%CI: 1.8 to 6.6)


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Device Closure of PFO

Windecker; JACC 2004


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Device Closure of PFODevice closure vs medical therapy

Khairy; Heart 2004


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Device Closure of PFORCTs in Stroke

  • RESPECT PFO (USA)

    • 500 patients

    • Amplatzer PFO vs standard medical therapy

    • Equivalence trial

    • Recruitment nearing completion

  • PC trial (Europe)

    • 410 patients

    • Amplatzer PFO device vs medical therapy

    • Recruitment nearing completion

  • Closure I trial (USA)

    • Starflex vs best medical therapy in CS with PFO

    • 800 patients powered to test superiority over medical treatment

    • Recruitment completed Q4 2008

    • Results Q4 2009???


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Device Closure of PFOIndications for closure

  • Clear

    • Proven cryptogenic stroke

    • Pathological PFO

    • Young age

    • Multiple events or recurrence on treatment

  • Borderline

    • First stroke

    • TIA

    • Small PFO

    • Older age with other RFs

  • Little evidence of benefit

    • Primary prevention of stroke

    • Trivial shunt

    • Other clear cause


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Stroke

DCI


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Decompression illness and PFO

  • First reported by Wilmshurst in BMJ 1986 postulated link between PFO and DCI

  • Risk of DCI increased x5 in divers with PFO

  • Increased incidence with size of defect

    Torti et al Eur H J 2004

  • No data on benefit of closure

  • Despite this closure recommended for professional divers

  • Social divers have the option of giving up, diving within safe limits or having PFO closure


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Stroke

DCI

Migraine


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PFO and migraine

  • Prevalence of migraine increased in patients with PFO

  • Prevalence of PFO increased in patients with migraine

  • PFO and migraine both associated with cryptogenic stroke

Shwedt Cephalgia 2006

Stang Neurology 2005


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Wilmshurst 2000

37 57%

86%

Morandi 2003

62 27%

88%

Schwerzmann 2004

215 22%

81%

Post 2004

66 39%

65% cured

Reisman 2004

120 42%

90%

Azarbal, 2005

89 42%

76%

Reisman 2005

162 35%

70%

Kimmelstein 2007

Luermans 2008

Giardini 2006

Dubiel 2008

191 24%

92 27%

131 27%

41 24%

91%

80%

70%

87%

Effect of PFO Closure on MigraineObservational studies

No

(%) migraine

% improved or cured


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8

Pre

7

Post

6

5

4

3

2

1

0

SS

SA

Ctrls

Effect of PFO Closure on Migraineprospective studies

  • N=77

  • All patients had migraine

  • PFO closure

    • SS - Previous stroke N=23

    • SA - No stroke N=27

      • DCI, TIA, migraine,MI

  • No PFO closure

    • Ctrls - N=27

  • Follow-up 1 year

  • Composite score of migraine frequency, severity and aura

Stroke 2006


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Contrast echo

TOE under GA and randomisation

PFO closure with Starflex

Sham procedure

3 month healing phase

3 month analysis phase by headache specialist

MIST I StudyProtocol

Assessment by headache specialist


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MIST I Study

  • 163/432 (38%) patients had right to left shunts consistent with a moderate or large PFO.

  • 147 patients were randomised.

  • No difference in the primary endpoint of migraine headache cessation between the implant and sham groups (3/74 versus 3/73 respectively).


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MIST I Study

  • What went wrong?

  • Why MIST I results so different from previous observational data?


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MIST I Study

  • RCTs often less positive than observational studies

    • Prospective and contemporaneous measurement of outcomes

    • Better recording of AEs

    • inclusion and exclusion criteria bias population so becomes non representative


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MIST I Study

  • MIST I patients were fundamentally different to those in the observational studies

    • Severe, migraine refractory to medical treatment

    • IHS guidelines lack precision and may include patients with CDH, depression

    • Patients with other indications for PFO closure excluded


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MIST I Study

  • Too short

  • Device performance

  • Confounding effects of aspirin and clopidogrel

  • Other shunts

  • Wrong endpoint


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Should PFO be closed for migraine

  • Results of MIST study do not support routine PFO closure for migraine alone –

  • however observational data still highly suggestive of link and in selected cases it is justified


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PFO and migraineCase History

13 yr old girl

Frequent incapacitating vertigo

Headache

Occ visual aura

Well between attacks

Normal neurological examination

Normal MRI and EEG

Missing significant amount of school

Large resting shunt on echo


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PFO and migraineCase History

  • Neurological opinion

  • Met with parents and patient on 2 occasions

  • Explained potential for benefit (~50%) and potential for complication (death <1:1000, embolization 1:200, tamponade 1:500, stroke 1:500, transient AF 1:10)

  • Catheterisation under GA July 2007

  • Large PFO – closed with 28 mm BioSTAR

  • No complications

  • FU Jan 08

    • Almost complete resolution of symptoms

    • No loss of school


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Stroke

DCI

Migraine

Cyanosis


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Stroke

DCI

Migraine

Cyanosis

OSA

Dementia

COPD


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Orthodeoxyia Platypnoea

  • Postural related hypoxia due to large PFO

    • Post pneumonectomy

    • Aortic root dilatation

  • Usually very large PFO

  • PFO closure results in immediate improvement

  • Anecdotal reports and small case series only


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PFO closure for respiratory disorders

  • Anecdotal reports of benefit in selected patients

  • Few small trials ongoing

  • Should not be part of routine practice

Hacievliyagil S et al. Respir Med 2006


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Indications for PFO closure

Benefit

Likelihood of causal relationship

Size of shunt

Risk

Size of defect

Experience of operator

Technological advances



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Conclusion

  • Large body of evidence for pathological link between PFO and a range of clinical syndromes where right to left shunt is a plausible mechanism

  • Increasing observational data suggests benefit in some patients

  • Results of RCTs awaited

  • In the meantime PFO closure indicated in selected patients with clinical syndrome and ‘pathological’ shunt if they understand and accept the potential for complications and potential for (or lack of) benefit