PERCUTANEOUS CLOSURE OF PFO: State of the art

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PERCUTANEOUS CLOSURE OF PFO State of the art

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

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Why should a neurologist talk about PFO closure ?

• For a number of reasons

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• Cryptogenic stroke
• Migraine
• Neurological decompression sickness
• Obstructive sleep apnoea

• Because a PFO (better RLS) may be diagnosed with
  TCD ( a neurological tool)
• Because PFO is implicated in neurological more
  than cardiological conditions
• Because a multidisciplinary assessment should be
  performed even when the patient is primarily
  referred to the cardiologist.
• Because, in the absence of strong evidence, the
  decision so as to close should only be taken
  following a consensus of specialists including
  the neurologist
• Because the neurologist may be involved in
  monitoring the procedure and in follow-up.

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The team
This is what happens in our Heart and Brain
Department
Marco Berti
Francesco Casilli
Nicola Refatti
Tao Onorato
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• Which was initiated as a Multidisciplinary Clinic
  several years ago mainly for the study of
  patients with ASD and has since blossomed up to
  the establishment of a true Cardio-Neurological
  Dept. where patients with affections that may
  potentially involve both brain and heart are
  admitted and managed in a comprehensive way
  according to shared guidelines.
• This may happen because main diagnostic
  facilities (TTE, TEE, Treadmill, ECHO
  cardiography provocative tests, Carotid US,
  Transcranial Doppler, IADSA) as well as
  therapeutic options (invasive e.g. CAS
  PTCAvs. non-invasive) are DIRECTLY PERFORMED by
  the team.

And conversely, pts with primarily suspected CVD
undergo a comprehensive cardiological assessment
with e.g ECHO, treadmill etc up to coronary
angiography
Thus patients with primarily suspected CAD are
assessed also from the neurological point of view
, both clinically and, whenever deemed necessary,
also instrumentally with U.S., neuroimaging and
so on
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The practical consequence of this organisation is
a substantial improvement in

• Efficacy of therapeutical interventions
• Sparing of time and money
• Patients satisfaction
• Expected long term outcome

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It is in this general framework that patients
with PFO are diagnosed and looked after. The
cardio-neurological cooperation has first of all
led to the establishment of local guidelines for
PFO search and management

• Conditions in which PFO is systematically looked
  for
• Cryptoghenic styroke or TIA
• Minor stroke with no major cardioembolic source
  or lt70 carotid stenosis
• Unexplained multi-infarct encephalopathy
• Migraine with aura
• Undeserved decompression sickness
• Platypnea-orthodeoxia syndrome
• Posterior fossa surgery

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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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Percutaneous PFO Closure Heart Brain Guidelines
Procedural Data
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Percutaneous PFO Closure Heart Brain Guidelines
Demographics
653
1999-2007
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Percutaneous PFO Closure Heart Brain Guidelines
Procedural Data
653 100 588 89
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Percutaneous PFO Closure Heart Brain Guidelines
INTRACARDIAC ECHOCARDIOGRAPHY (ICE)
Ultra ICE
RAW
RA
FO
LA
RUPV
Radial 360 Imaging Plane
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Percutaneous PFO Closure Heart Brain Guidelines
Intra-Procedural Complications
n 645
1999-2007
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ce-Transcranial Doppler
SILENT BRAIN EMBOLISM DURING TRANSCATHETER
CLOSURE OF PATENT FORAMEN OVALE A TRANSCRANIAL
DOPPLER STUDY E. Morandi 1 M.D., G.P. Anzola 2
M.D., F. Casilli 3 M.D., E. Onorato 3
M.D. Neurol. Sci. 200627328-331
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Percutaneous PFO Closure Heart Brain Guidelines
Long-term follow-up Data
n 310
n
Post-Implantation Management
1, 3, 6, 12 mos post-procedure
1999-2007

• How we manage f-up
• TT/TE Echocardiography
• Ce-TCD
• Clinical Neurological Evaluation

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Percutaneous PFO Closure Heart Brain Guidelines
Follow-up Data
n 310
n
Post-Implantation Management

• TT/TE Echocardiography
• Ce-TCD
• Clinical Neurological Evaluation

• Early death due to massive pulm. thromboemb. 1
• Late death 5
• Respiratory Failure 2
• Fatal massive pulm. thromboemb. 1
• Sudden death 1
• Suicide 1
• Small shunt between Ao and LA 1
• late erosion surgically corrected (electively)
• Thrombus on the right-side of the disc (APO 25) 1
• LAC syndrome (post-op 14 months)
• Resolution on medical therapy

1, 3, 6, 12 mos post-procedure
1999-2007
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• Transient AF (8)
• Scintillating scotoma (6)
• Significant residual shunt in about 10
• Early identification of patients with residual
  shunt

Usefulness of combined f-up
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CURRENTLY AVAILABLE DEVICES IN EUROPE
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PFO CLOSURE DEVICES present and future
perspectives
CardioSEAL?
STARFlex?
PremereTM PFO Closure Device
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PFO CLOSURE DEVICES present and future
perspectives
Solysafe Septal Occluder

• The implant is based on an idea of Dr. Laszlo
  Solymar,
• (Gothenburg, Sweden) and has been developed by
  CARAG
• AG, a Swiss engineering company

• Self-centering device with two foldable patches
  which are attached to eight metal wires. The
  wires are united in a wireholder
• The device can be stretched and fits into a 10 F
  introducer
• Once placed in the defect, the two wire-holders
  are moved towards each other until the wires snap
  into a second stable position and form the
  flower-like shape as shown
• A major advantage is that it is delivered over a
  guidewire as opposed to a long transseptal
  sheath.

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PFO CLOSURE DEVICES present and future
perspectives
The Cardia Intrasept Device
CARDIA PFO Device Generations I, I, III,
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PFO CLOSURE DEVICES present and future
perspectives
CARDIA PFO DeviceGeneration IV
Advancing Septal Closure Technology

• 2 same size sails made of polyvinyl alcohol foam
  -Ivalon - (PVA) attached to a Nitinol Frame

• Generation IV device has grade 1 PVA sails (0.5
  mm thick)

• The nitinol struts secure the device in place
  (sails are attached to the struts with
  polypropylene suture)

The Cardia Intrasept Device
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PFO CLOSURE DEVICES present and future
perspectives
Contraindications

• Nickel allergy
• Nitinol-based alloys in ASD devices 55 nickel
  45 titanium

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PFO CLOSURE DEVICES present and future
perspectives
Contraindications

• Nickel allergy

• Patch testing is currently the gold standard for
  evaluating pts with allergic contact dermatitis

• The relationship between cutaneous allergy and
  endocardial reaction is unknown
• Increase in serum nickel levels after ASD device
  closure (Amplatzer) in pts without nickel allergy

1.50 ng/ml
0.47 ng/ml
Ries MW et al. Am Heart J 2003 145 737-741
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PFO CLOSURE DEVICES present and future
perspectives

• Nickel allergy OR TOXICITY ?

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PFO CLOSURE DEVICES present and future
perspectives
Main Complications
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PFO CLOSURE DEVICES present and future
perspectives
Device Thrombosis
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• The incidence of thrombus formation on closure
  device is LOW
• The thrombus usually resolves under
  anticoagulation therapy

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The atria are moving/contracting ? friction and
wall distortion occur at site of device
contact - contact surface area - abrasiveness of
device surface - conformability of the device
Device Erosion
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PFO CLOSURE DEVICES present and future
perspectives
Cryptogenic Stroke
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.
Ongoing Trials
CARDIA PFO STROKE Trial
PC Trial
(n 450, superiority) AMPLATZER PFO Occluder U.S.
279/450 pts
(n 300, equivalence) Intrasept U.S.
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UPCOMING DEVICES
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BEST BioSTAREvaluation STudy

• BioSTAR is the first bioadsorbable septal repair
  implant (bioadsorbable acellular collagen matrix
  mounted on low-profile STARFlex alloy framework)
• Drug-eluting capability (elitable heparin
  substrate)

• Potential for improve biological seal on atrial
  surface
• Rapidly adsorbed and replaced with host tissue
• Platform for biological response modifiers
  (genes, cells, proteins, drugs)

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COHEREX
COHEREX FlatStent PFO Closure System

• Designed to combine the familiarity and
  ease-of-use of a self-expanding vascular stent
  with a unique fusion of PFO closure technologies
• New RF closure technique

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Now there is a new way to close it

• without leaving anything behind

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Cierra PFXTM Closure System

• Non-implantable system
• Performed entirely from right side
• Employs monopolar radiofrequency energy
• Welds the tissues of the septum primum and
  secundum together

This is the first technology which allows
closure of an intracardiac defect without
leaving anything behind
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Sutura completes successful PFO test of
HeartStitch suturing device
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Conclusions

• Randomized trials need to be completed !
• FDA is working closely with industry for a
  solution
• More devices are entering the market and they
  need to be rigorously tested for not only
  efficacy but also for durability

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Conclusions

• Evaluate the balance of the risk/benefit ratio in
  every individual case (experience patient
  selection)
• Technological progress biocompatibility less
  material
• Persistent vacuum for at least one or more years
  for Evidence Based Medicine indications

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Take Home Message

• Plannings should begin for the development of a
  network of centers of excellence for patient care
  and physician training

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Percutaneous PFO Closure Heart Brain Guidelines
Take Home Message

• Cardiologists need to forge relationships with
  neurologists to channel potential candidates to
  PFO closure

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The warmest thanks to the colleagues and friends
of the Heart and Brain Department
Francesco Casilli
Marco Berti
The team
Tao Onorato
Nicola Refatti
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