Transcatheter Closure of Septal Defects

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Transcatheter Closure of Septal Defects

• Carl Y. Owada, MD
• Director, Cardiac Catheterization Laboratory
• Childrens Hospital Central California

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Case Presentation

• Hx 30 y.o. presents with left sided numbness,
  weakness, expressive aphasia, and dizziness.
  Symptoms resolved after 1 week. Several months
  later patient experienced a second TIA on aspirin
  and clopidogrel. Patient has since been
  maintained on warfarin.
• W/u Carotid ultrasound normal
• EKG normal
• Coag evaluation no identifiable coagulopathy
• Echo suggestion of PFO with spontaneous right
  to left shunt during bubble study.
• Dx Recurrent cryptogenic stroke and PFO

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PFO is accused but not convicted

• Prevalence of PFO in the general population is 15
  25
• Prevalence of PFO in patients lt 55 yrs with
  cryptogenic stroke 50
• PFO size in patients with stroke are larger (2.1
  ? 1.7mm vs. 0.6 ? 0.8 mm in controls)
• Right to left shunt by bubble contrast study is
  larger (14 ? 11 bubbles seen in the left atrium
  in stroke patients vs. 2 ? 1 bubbles in patients
  with PFO but no stroke)
• The presence of a PFO has not been conclusively
  proven to be causative

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PFO and StrokeTheorized causal relationship
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PFO and StrokeTheorized causal relationship
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Treatment Options

• Medical management
• Aspirin, clopidogrel, warfarin
• Surgical closure
• Percutaneous device closure
• Amplatzer PFO occluder
• CardioSEAL/STARFlex septal occluder
• Helex septal occluder
• Helex septal occluder
• PFO Star Device
• Available under HDE, Remains investigational

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Indications for device closure

• Humanitarian Device Exemption (HDE) approval
  under the Humanitarian Use Device (HUD)
  regulations.
• PFO occlusion is indicated in patients with
  recurrent cryptogenic stroke or TIA due to
  presumed paradoxical embolism through a PFO AND
  who have failed conventional drug therapy.

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Evaluation of cryptogenic stroke

• Ultrasound of carotid and cerebral arteries
• Head CT or MRI
• Screening for hypercoagulability
• Factor V Leiden
• Protein C, S deficiency
• Anticardiolipin antibodies
• Prothrombin mutation
• Antithrombin III
• Cardiac Echocardiogram with contrast study
• TEE
• Transcranial Doppler

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Indications for closure

• Primary indications
• History of unequivocal and unexplained ischemic
  stroke or TIA confirmed clinically and
  radiographically AND recurrent event on
  conventional anticoagulation
• History of stoke or TIA and conventional
  anticoagulation is contraindicated

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Indications for closure

• Secondary indications
• Diving and decompression
• Migraine headache with aura
• Risk of material embolization during orthopedic,
  neurovascular or cardiovascular surgery

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Early outcomes

• Procedural success 95 100
• Complete occlusion
• 50 60 immediate occlusion
• 70 80 at 1 month
• 80 90 at 6 months
• 93 97 at 12 months
• Recurrent stroke or TIA 1.5 2.0 per year (cf.
  Medical management 3- 4 per year)
• Recurrence rate is higher in patients gt 55 years.
• 60 reduction in migraine headaches

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Complications

• Procedural 3
• Transient ST elevation
• AV fistulae at the catheter insertion site
• TIA
• Device dislodgement
• Late 1 2
• Device embolization
• Device related thrombus
• Device arm fracture

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Back up patient case presentation

• Hx 67 y.o. recently presented with increasing
  exercise intolerance and a cardiac murmur
• W/u EKG NSR, RVCD, possible RVH
• TEE moderate sized anterior ASD measuring 11
  mm with RVE
• Diagnostic cath QpQs ratio of 1.91, mean PA
  pressure was 22 mmHg
• Dx Hemodynamically significant ASD

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Indications for Intervention

• Atrial Septal Defect
• Symptoms of exercise intolerance, recurrent
  respiratory illnesses, difficult to treat RAD,
  atrial or ventricular arrhythmia related to
  chamber enlargement
• Evidence of large left-to-right shunt or minimal
  shunt with symptoms
• RVH on EKG
• RVE on echocardiogram

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Treatment Options

• Surgical closure of septal defects
• Relative exclusion criteria include
• Pulmonary vascular disease
• Unstable angina or decompensated CHF
• Recent MI
• LV ejection fraction lt 30
• Transcatheter device closure of the septal
  defects
• Additional exclusion criteria
• Defect size greater than 38mm
• Defect rim lt 5mm from margin of CS, AV valves,
  RUPV
• Primum, sinus venosus ASD, or PAPVR

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History

• 1976 - King and Mills device (23F delivery
  system)
• 1987 - Rashkind double umbrella (15F)
• 1991 - Clamshell device (11-13F, arm fracture
  rate 20)
• 1999 - CardioSEAL approved under HDE for
  fenestrated Fontans, PFOs, selected VSDs
• 2001 - Amplatzer septal occluder is FDA approved
• 2002 - Amplatzer PFO occluder approved under HDE