PERCUTANEOUS CLOSURE OF PFO: State of the art Gian Paolo Anzola Service of Neurology S.Orsola...

PERCUTANEOUS CLOSURE OF PFO: PERCUTANEOUS CLOSURE OF PFO: State of the artState of the art

Gian Paolo AnzolaGian Paolo AnzolaService of NeurologyService of Neurology

S.Orsola Hospital FBFS.Orsola Hospital FBFBrescia - ItalyBrescia - Italy

Why should a neurologist talk Why should a neurologist talk about PFO closure ?about PFO closure ?

For a number of reasonsFor a number of reasons

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

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

The team

Francesco Casilli“Tao” Onorato

Marco Berti

Nicola Refatti

This is what happens in ourHeart and Brain Department

Which was initiated as a Multidisciplinary Clinic Which was initiated as a Multidisciplinary Clinic several years ago mainly for the study of patients with several years ago mainly for the study of patients with ASD and has since “blossomed” up to the ASD and has since “blossomed” up to the establishment of a true Cardio-Neurological Dept. establishment of a true Cardio-Neurological Dept. where patients with affections that may potentially where patients with affections that may potentially involve both brain and heart are admitted and involve both brain and heart are admitted and managed in a comprehensive way according to managed in a comprehensive way according to shared guidelines. shared guidelines. This may happen because main diagnostic facilities This may happen because main diagnostic facilities (TTE, TEE, Treadmill, ECHO cardiography (TTE, TEE, Treadmill, ECHO cardiography provocative tests, Carotid US, Transcranial Doppler, provocative tests, Carotid US, Transcranial Doppler, IADSA) as well as therapeutic options (invasive [e.g. IADSA) as well as therapeutic options (invasive [e.g. CAS – PTCA]vs. non-invasive) are CAS – PTCA]vs. non-invasive) are DIRECTLY DIRECTLY PERFORMED by the team.PERFORMED by the team.

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

And conversely, pts with primarily suspected CVD undergo a comprehensive cardiological assessment with e.g ECHO, treadmill etc up to coronary angiography

The practical consequence of this The practical consequence of this organisation is a substantial improvement inorganisation is a substantial improvement in

Efficacy of therapeutical interventionsEfficacy of therapeutical interventions

Sparing of time and moneySparing of time and money

Patients satisfactionPatients satisfaction

Expected long term outcomeExpected long term outcome

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 <70% carotid stenosis• Unexplained multi-infarct encephalopathy• Migraine with aura• Undeserved decompression sickness• Platypnea-orthodeoxia syndrome• Posterior fossa surgery

AspirinAspirin

WarfarinWarfarin

ClosureClosure

PFO WITH LARGE SHUNT (shower or curtain)

MULTIPLE

ASA + ASA -

SINGLE

THROMB. +

THROMB -

TRANSCATHETER CLOSURETRANSCATHETER CLOSURE

DISCUSSTRANSCATH. CLOSURE

MEDICAL TREATMENTMEDICAL TREATMENT

THROMB -THROMB -THROMB. + THROMB. +

MULTIPLE SINGLE

PFO WITH SMALL SHUNT (< 25 bubbles)

Transcranial Doppler in Cryptogenic Stroke

A DECISION MAKING STRATEGY TO CONFIRM A DECISION MAKING STRATEGY TO CONFIRM “MANDATORY” CLOSURE OF PATENT FORAMEN OVALE“MANDATORY” CLOSURE OF PATENT FORAMEN OVALE

Guidelines 2005Guidelines 2005

MRI +

Test for CADASIL

+ -

TRANSCATHETER CLOSURETRANSCATHETER CLOSURE

DISCUSSTRANSCATH. CLOSURE

MEDICAL TREATMENTMEDICAL TREATMENT

THROMB -THROMB -THROMB. + THROMB. +

MULTIPLE SINGLE

MRI-

ASYMPTOMATIC LARGE SHUNTASYMPTOMATIC LARGE SHUNT

WAITWAIT

??????

MA+ MA -

Procedural Data

E Onorato, F Casilli, M Berti, N Refatti, GP AnzolaHeart & Brain Department, FBF S.Orsola Hospital, Brescia

Percutaneous PFO Closure: Heart & Brain Guidelines


n. of patients (female/male n. of patients (female/male ratio)ratio)

(1.44)(1.44)

Age range (mean)Age range (mean) 14-75y14-75y (48 ± 15)(48 ± 15)

Atrial septal aneurysm (%)Atrial septal aneurysm (%) 272272 (42.3%)(42.3%)

Prominent Eustachian Valve Prominent Eustachian Valve (%)(%) 103103 (16%)(16%)

Thromboembolic events (%)Thromboembolic events (%)

StrokeStroke

TIATIA

Peripheral & coronary Peripheral & coronary

embolismembolism

38%38%

54%54%

5%5%

653653

Demographics


1999-2007


nn (%)(%)

Procedure successfulProcedure successful

ICE Monitoring aloneICE Monitoring alone

Fluoro time (median)Fluoro time (median) 2-30 min2-30 min (9.5 ± 4.7)(9.5 ± 4.7)

Procedure time Procedure time (median)(median)

10-135 min10-135 min (56 ± 21)(56 ± 21)

653 100653 100

588 89588 89

Procedural Data



LALA

RARA

RUPVRUPV

RAWRAW

FOFO

Ultra ICE

Radial 360° Imaging Plane

INTRACARDIAC ECHOCARDIOGRAPHY (ICE)INTRACARDIAC ECHOCARDIOGRAPHY (ICE)

AXIAL AND LONGITUDINAL PLANESAXIAL AND LONGITUDINAL PLANES

Fossa ovalis diameterFossa ovalis diameter PFO tunnelPFO tunnel Rims: SA, IP, SP & IA rimRims: SA, IP, SP & IA rim Cardiac structuresCardiac structures

5

3

4

1

2

3

5


Intra-Procedural Complications nn (%)(%)

Atrial Fibrillation (intra-p)Atrial Fibrillation (intra-p)Sinus rhythm at the end of procedureSinus rhythm at the end of procedure

1414 2.172.17

Transient ST-segment Transient ST-segment elevationelevation 1010 1.51.5

Groin HematomaGroin Hematoma 1212 1.81.8

TIA/StrokeTIA/Stroke 00 00

Device EmbolizationDevice Embolization 00 00

Surgical InterventionSurgical Intervention 00 00

Myocardial InfarctionMyocardial Infarction 00 00

Pericardial EffusionPericardial Effusion 00 00

00%%

1999-2007

n: 645n: 645


0

5

10

15

20

25

30

35

femoral cath atrial cath septal probing sizing left opening right opening

ce-Transcranial Dopplerce-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. 2006;27:328-331


Long-term follow-up Data

Recurrent eventsRecurrent events

TIATIA 11 0.10.1

StrokeStroke 00 00

Peripheral embolizationPeripheral embolization 11 0.10.1

n %n %n: 310n: 310

1999-2007How we manage f-up

TT/TE Echocardiography

Ce-TCD

Clinical & Neurological Evaluation

1, 3, 6, 12 mos post-procedure

Post-Implantation Management


Follow-up Data

DeathDeath 66 1.91.9

Perforation/ErosionPerforation/Erosion 11 0.30.3

ThrombusThrombus 11 0.30.3

n %n %n: 310n: 310

1999-2007

TT/TE Echocardiography

Ce-TCD

Clinical & Neurological Evaluation

1, 3, 6, 12 mos post-procedure

Post-Implantation Management

• Early death due to massive pulm. thromboemb.Early death due to massive pulm. thromboemb.11

• Late death:Late death:55

Respiratory FailureRespiratory Failure22

Fatal massive pulm. thromboemb.Fatal massive pulm. thromboemb.11

Sudden deathSudden death11

SuicideSuicide11

• Small shunt between Ao and LASmall shunt between Ao and LA11late erosion surgically corrected (electively)

• Thrombus on the right-side of the disc (APO 25)Thrombus on the right-side of the disc (APO 25)11

LAC syndrome (post-op 14 months)Resolution on medical therapy

Transient AF (8%)Transient AF (8%)

Scintillating scotoma Scintillating scotoma (6%)(6%)

Significant residual Significant residual shunt in about 10%shunt in about 10%

Early identification of Early identification of patients with residual patients with residual shuntshuntUsefulness of combined f-up

CURRENTLY AVAILABLE CURRENTLY AVAILABLE DEVICES IN EUROPEDEVICES IN EUROPE

CardioSEAL

STARFlex

PFO CLOSURE DEVICES: present and future perspectives

PremerePremereTMTM PFO Closure PFO Closure DeviceDevice

Solysafe Solysafe Septal Septal OccluderOccluder

•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.

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


CARDCARDIIAA PFO PFO DeviceDevice

Generations I, I, III,…

PFO StarPFO Star Cardia StarCardia Star Cardia PFOCardia PFO

2 mm center posts2 mm Ivalon sailstitanium caps

Left-sided sail attached outside of frame3-5 mm center postsstranded wiresthinner Ivalon sails

6 arms per sailfirmer wires

GIGI GIIGII GIIIGIII

The Cardia Intrasept DeviceThe Cardia Intrasept Device


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

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

CARDCARDIIAA PFO PFO DeviceDevice

Generation IV Advancing Septal Closure Advancing Septal Closure TechnologyTechnology

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

The Cardia Intrasept DeviceThe Cardia Intrasept Device


ContraindicationsContraindications

? Nickel allergyNickel allergyNitinol-based alloys in ASD devices= 55% nickel + 45% titanium


ContraindicationsContraindications

? Nickel allergyNickel 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

Ries MW et al. Am Heart J 2003; 145: 737-741

0.47 ng/ml

1.50 ng/ml


? Nickel allergy … OR TOXICITY ?Nickel allergy … OR TOXICITY ?

J Thoracic CV Surg 2003; 125: 213-214Fukahara K et al.

CARDIA PFO device

Systemic allergic reaction (high fever, edema) following PFO

occluder

RemovedSymptoms completely resolved

J Thoracic CV Surg 2003; 2112Dasika UK et al.

HELEX Septal Occluder

4 months after ASD closure

RemovedBut did not

improve!!

Catheter CV Interv. 2005 Nov; 66: 424-426Lai DW et al.

Amplatzer PFO Occluder

Pericarditis, atrial fibrillation, and

migraine headaches with

aura

Oral prednisone

J Am Coll Cardiol. 2006 Mar 21; 47 (6): 1226-7

Wertman B et al.

Septal & PFO Amplatzer Occluder

n: 37 pts• MHA was

associated with nickel allergy

• Pericarditis

ASA + Clopidogrel (MHA)Prednisone


Main

Com

plicatio

ns

Main C

omplic

ations

Late erosions or perforations of the left and Late erosions or perforations of the left and right atrial roof have been reported with right atrial roof have been reported with each device implanteach device implant

Late Device ErosionLate Device Erosion

Post-implant Post-implant device thrombosis device thrombosis has been reported has been reported with each device with each device

implantimplant

Device Device ThrombosisThrombosis


Device Device ThrombosiThrombosi

ss


• The incidence of thrombus formation on closure The incidence of thrombus formation on closure device is LOWdevice is LOW

• The thrombus usually resolves under The thrombus usually resolves under anticoagulation therapyanticoagulation therapy

Device ErosionDevice Erosion

The atria are moving/contracting The atria are moving/contracting friction and wall distortion occur friction and wall distortion occur at site of device contact:at site of device contact:

- contact surface area- contact surface area- abrasiveness of device - abrasiveness of device surfacesurface- conformability of the device - conformability of the device

36 erosions 36 erosions

reportedreported

60.000 total 60.000 total

implantsimplants

Cryptogenic Stroke

(n= 1600, superiority trial)

STARFlex

U.S. & Canada

515 pts enrolled (350 pts in 2005)

CLOSURE ICLOSURE I

(n= 300, equivalence)

AMPLATZER PFO Occluder

U.S.

RESPECTRESPECT

(n= 300, equivalence)

Intrasept

U.S.

CARDIA PFO STROKE TrialCARDIA PFO STROKE Trial

(n= 450, superiority)

AMPLATZER PFO Occluder

U.S. 279/450 pts279/450 pts

PC TrialPC Trial

On

goin

g T

rials


UPCOMING DEVICES

BESTBEST BioSTAR™Evaluation STudy BioSTAR™Evaluation 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)NMT Medical,

Inc.

““Upcoming” PFO Closure DevicesUpcoming” PFO Closure Devices

COHEREXCOHEREXCOHEREX FlatStent PFO Closure SystemCOHEREX FlatStent PFO Closure System

““Upcoming” PFO Closure Upcoming” PFO Closure WITHOUTWITHOUT Devices Devices

• 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

Now there is a new Now there is a new way to close itway to close it

without without leaving leaving

anything anything behindbehind

Cierra PFXCierra PFXTMTM Closure System Closure System

This is the first technology which allows closure of an intracardiac defect without leaving anything behind

• Non-implantable system

• Performed entirely from right side

• Employs monopolar radiofrequency energy

• Welds the tissues of the septum primum and secundum together


Sutura completes successful PFO test of HeartStitch suturing deviceSutura completes successful PFO test of HeartStitch suturing device


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 efficacyefficacy but also for durabilitydurability

Conclusions

1. Evaluate the balance of the risk/benefit ratio in every individual case (experience & patient selection)

2. Technological progress: biocompatibility & “less” material

3. Persistent vacuum for at least one or more years for Evidence Based Medicine indications

Conclusions

Take Home Take Home Message Message Plannings should begin for the

development of a network of centers of excellence for patient care and physician training


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

Take Home Take Home Message Message

The teamFrancesco Casilli

“Tao” Onorato

The warmest thanks to the colleagues and friends of the Heart and Brain Department

Nicola Refatti

Marco Berti

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PERCUTANEOUS CLOSURE OF PFO: State of the art Gian Paolo Anzola Service of Neurology S.Orsola...

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