-Diagnosis of a PFO -New devices for PFO closure

The 3rd international meeting of Pediatric Cardiologyand Cardiac Surgery, Cairo, 29 Nov- 21 Dec 2010-Diagnosis of a PFO-New devices for PFO closureNina Wunderlich, Horst SievertCardiovasculäres Centrum Frankfurt

What isa PFO?• In utero, theforamen ovaleallows blood toflow from theright atrium tothe left,bypassing thelung• Usually it closesafter birth• But in ~25% ofpeople it staysopen→ Patent Foramen Ovale

Role of Echo:How to diagnose a PFO• Diagnosis• Anatomy and Morphology• Shunt assessment• Associated atrial septumaneurysms and Eustachian Valve

Role of Echo:How to diagnose a PFO• Diagnosis• Anatomy and Morphology• Shunt assessment• Associated atrial septumaneurysms and Eustachian Valve

Diagnosis of PFO• TEE Transesophageal Echo- "Gold standard"• TTE Transthoracic Echo• TCD Transcranial Doppler

Echo ContrastAgitated salinewith microbubbleswhich do not survivepulmonary passageAgitated saline~60 micron (40-100)Agitated saline + blood~52 micron (24-75)

Diagnosis PFOTTE

So you can diagnose a PFOby transthoracic echo …… but you can not exclude it!No shunt on TTEdoes not mean that there is no PFO

Transcranial Doppler→ significant shunt: > 10 bubbles*Single HITSShowerCurtain(uncountable)*Consensus Conference of Venice - Jauss, Zanette ;Cerebrovasc Dis 2000; 10: 490-6

You can exclude aPFO by transcranialdoppler …… but you can notdiagnose it!

Why no diagnosis of PFOby transcranial doppler?• TCD is unable to locate the source ofthe right-to left shunt- PFO or ASD or intrapulmonary shunt?• However, TCD and TTE in combinationcan detect a PFO accurate and reliablein comparison to TEE ** Souteyrand,G et al. Eur J Echocardiography 2006; 7: 147- 154

… and intracardiac echo?• imaging is almost as good as TEE- sometimes better especially in the inferiorpart of the septum• usually more time consuming than TEE• more convenient for the patient• less convenient for the hospitaladministration- because it is much more expensive

The ideal PFO approach• For diagnosis‣ TCD for sreening‣ TTE (PFO or ASD?)• In the cath lab‣ TEE or ICE• To confirm the diagnosis• To exclude intrapulmonary shunts• To assess anatomical characteristics• To guide PFO closure

Intrapulmonary Shunting• Echo contrast appears late in the LA- But this may also happen in PFOs• More important is where in the LAthe contrast appears• Intrapulmonary shunting isconfirmed by echo contrast injectioninto the pulmonary artery

Intrapulmonary ShuntingContrast via femoral veinContrast via A. pulmonalis

Role of Echo:How to diagnose a PFO• Diagnosis• Anatomy and Morphology• Shunt assessment• Associated atrial septumaneurysms and Eustachian Valve

Anatomy and MorphologyWhich information do we need?• Shape of defect• Size of defect• Rim size• Relation of device to other cardiacstructures during deployment- AV- Valves- Pulmonary veins- Coronary sinus

Right Atrium ViewLeft Atrium View

Typical PFO

Multifenestrated Septum2D TEE115˚ and 3D LA view

Rim assessment in 2DTEEsuperiorLAAV rim(inferior)posteriorLAaortic rim(anterior)IVC(caudal)LASVC rim(cranial)RALVRAAoRARV0 ˚ SAX 45 ˚ LAX 90 ˚

No anterior rim6 Month FU, Amplatzer Occluder

Role of Echo:How to diagnose a PFO• Diagnosis• Anatomy and Morphology• Shunt assessment• Associated atrial septumaneurysms and Eustachian Valve

Right to Left Shuntdepends upon• Size of PFO• Pressure RA - LA• Femoral or brachial echocontrast injection• Quality of Valsalva

Injection via cubital vein + Valsalva Injection via femoral vein +ValsalvaInjection via cubital vein + Valsalva:K no shunt!Injection V. fem + Valsalva

Shunt detection by echoworks but quantitativeassessment does not!!No need to countthe bubbles!

Sensitivity for Detection of PFOA descriptive study with contrast TEEJASE May 2008, 419 - 23

Role of Echo:How to diagnose a PFO• Diagnosis• Anatomy and Morphology• Shunt assessment• Associated atrial septumaneurysms and Eustachian Valve

Septal AneurysmBase diameterAneurysm( total excursion > 10mm)

PFO and septum aneurysmAneurysmLAPFOLARAAoRAAoExcursion to LAExcursion to RA

What's that?Large Eustachian Valve

Atypical LA Membrane16 mm Amplatzer ASD Occluder

How to close aPFO?

Implantation technique todayis straight forward:• Local anesthesia• Transvenous 8-11 F sheath• 10,000 E Heparin• Multipurpose catheter left upper pulmonaryvein• Balloon sizing• Device implantation• < 30 min door to door• < 24 hours hospital stay

Most frequently used PFO devicesAmplatzerCardioSEAL andCardioSEAL-STARflexHelex

BioSTAR (NMT)• CardioSEAL®framework• STARFlex® selfcenteringmechanism• Bioresorbable collagenmatrix- derived from thesubmucosal layer of theporcine small intestine(ICL)- Heparin coating

Solysafe ® (Carag)• Self-centering• Two foldable Polyesterpatches- attached to eight Phynox wires• Streched device fits into 10 Fintroducer• In the defect, wire-holdersare moved towards eachother• Clicking mechanism keepsthe wire-holders together

Premere PFO Closure DeviceSt. JudeeliveryystemLockRight AtrialAnchorCE-MarkUS: Clinical trialsTetherDelivery SystemRelease MechanismLeft AtrialAnchor• No fabric on theleft side• Flexible tetherholds anchorstogether• Variable distancebetween theanchors

New developments• New double- disc devices• In-tunnel devices• Suture based techniques

Nit-Occlud® PFO• Double umbrella occluderwith single-layer left atrial disc• Occluder is knitted from asingle Nitinol wire• Low profile• No protrudingclamps• CE Mark since July 20103 sizes: 20 mm, 26 mm ,30 mm

The Spider TM PFOOccluder• Self-expandable, doubledisc device• Right atrial disc: ceramiccoated Nitinol wire mesh.• Left atrial disc: ePTFEpatch and ceramic coatedbraided nitinol anchors• Joint between the left atrialdisc allows free rotation foradaption to PFOmorphology• Sizes 18mm, 25mm,30mm.

SeptRx PFO Closure Device• Closes the PFO tunnelfrom within• Nitinol frame andNitinol wire mesh• Small left and rightatrial anchors- Minimal material in leftand right atrium

CoherexDesigned to "Stent" the PFO tunnel

CoherexPig Model – 30 daysRA ViewLA View

Coherex• PFO closure from inside

Suture Closure of PFO• The suture closure of a PFO isintuitively attractive- No device left behind- No risk for device erosion- No risk of embolisation- Minimal risk of thrombosis- No need for aggressive antiplatelet regimen- No obstruction of atrial septum

The Sutura SuperStitch ® EL• Profile: 12 Fr• Working length: 90 cm• Suture type:- Polypropolene 4-0• Knot type:- PolypropoleneArms and NeedlesCE marked

Take Home Messages• PFO Screening →TTE and TCD• Confirming of the diagnosis andintraprocedural Guidance → TEE or ICE• Follow-up → TTE, TCD and TEE• PFO closure is a straightforward procedure• New devices are available or underdevelopment and may have someadvantages

Thank You

Profile: 12 FrWorking length: 90 cmSuture type: Polypropylene 4-0Knot type: Polypropylene

The Sutura SuperStitch ® ELArms and Needles•Profile: 12 Fr•Working length: 90 cm•Suture type: Polypropolene 4-0•Knot type: PolypropoleneCourtesy C. Ruiz

Morphology in TEESeptum secundumSeptumprimumSeptumsecundumLong axis view 109˚

Thrombi on devicesAmplatzer Device- RA

ThrombusTTE after PFO closure with radiofrequency

Thrombi on devicesAmplatzer Device (LA)

The Spider TM PFOOccluder• 1) ceramic coat – lessthrombus formation, fasterendothelialization andimproved biocompatibility.• 2) left atrial disc:only anchors and patch• joint between the left atrialdisc allows free rotation sooccluder can adapt to theunique morphology of thePFO, therefore no majordeformation of the PFOtunnel.

Large PFO close to aortic root16mm Amplatzer Occluder

??Atypical RA Membrane

• TEE allows to identify patients at higherrisk requiring closer follow- up- significantly larger device than ASDdiameter- small pericardial effusion at 24 hr follow-up- deformation of device at aortic root- high defect• A high quality transesophagealechocardiography helps to avoid most ofthe potential pitfalls and complicationsStandard equipment in the Cath Lab

Device Embolization LA24 mm Amplatzer Occluder- too small

Thank you!

SeptRx PFO Closure Device• Closes the PFO tunnelfrom within• Nitinol frame andNitinol wire mesh• Small left and rightatrial anchors- Minimal material in leftand right atriumRALA sideLARA side

The SeptRx- SystemOnly the left anchorsare liberatedHole device liberated

Echocardiographic AnatomyWhere to look for rims in TEE?• Aortic short- axis(~55-70˚)- Aortic rim- Posterior rim• Bicaval view (~ 90-120˚)- SVC and IVC rims• Four chamber view (~0˚)- Superior and AV valve rim

TEE alone is “not suitable” forquantification of RLS• PFO right to left shunting varies considerably• The amount of right to left shunt is a matter ofexpiratory pressure during the ValsalvaManeuver (1)• The magnitude of contrast shunting does notnecessarily correlate with the true anatomicalsize of the PFO(1) Devuyst G et al.Stroke 2004;35:859-63(2) Schuchlenz HW et al. AM J Med.2000; 109: 456-62/(3) Schuchlenz HW et al.Stroke 2002;33:293-6

Captured Starflex Occluder

What isa PFO?

Prolapse of a VelocimedOccluder

Residual Shunt…Why?• Occluder system type• Inappropriate device selection- Undersized device- Device malposition (partial)• Multifenestrated Septum primum

Potential Complications of deviceclosure of septal defects• Occluder embolization/ Malpositioning• Atrial arrythmia• Thrombi on devices• Pericardial effusion• Interference with AV Valve function• Perforation of atrial wall or aorta• Pulmonary vein obstruction (RUPV)• Stroke/TIA/peripheral Embolism• Frame fracture

Concordance of ICE and TEE24 devices in 23 patientsPre- release device position• All devices were deployed with a satisfactoryassessment of septal capture using ICE→ 99% concordance with TOE• No complications associated with ICE- Additional defects N= 2- Malpositions N= 5- PAPVD N= 1- Clot N= 1Mullen et al; JACC 2002

Do we need ICE?Acunav® catheter• 10 F 90 cm; 8F 100 cm• Miniaturized, 64 channel Multi Herz (5-10Mhz)transducer• Full color flow and Doppler capabilities• Quadridirectional steering• Inserted via seperate sheath into the femoral vein

Embolized occluder- distal Aorta

TCD vs TTEReference C.M. (i.v.) TTETCDSens/Spec % Sens/Spec %Nemec et al 1991 saline-air-blood 54/94 100/100Di Tullio et al 1993 aeroated saline 47/100 68/100Jauss et al 1994galactosemicrobubblesn.d. 93/100Anzola et al 1995 aeroated saline n.d. 90/100Droste et al 1999 aeroated saline - 95/75Droste et al 2000 aeroated saline - 100/100

And ICE?

ICE may be helpful inspecific casesTEEICE

Role of Echo in PFO closure• Diagnosis• Anatomy and Morphology• Shunt assessment• Associated atrial septumaneurysms and Eustachian Valve• Monitoring and guiding catheterclosure• Follow-up after closure/ Occlusionrate monitoring

ImplantationTEE supports a correct device positioning anddetecting of acute complicationsAmplatzer OccluderTEE 150˚

Occluder slippingthrough defect in RACardioseal- Starflex Occluder

Rim assessmentPVsLALAA

Thrombus RAAfter balloon sizing

PFO and Atrial Septum Aneurysm) 25mm Helex (suboptimal) 2) 30mm Cardioseal (correct)

Role of Echo in PFO closure• Diagnosis• Anatomy and Morphology• Shunt assessment• Associated atrial septumaneurysms and Eustachian Valve• Monitoring and guiding catheterclosure• Follow-up after closure/ occlusionrate monitoring

Follow up after closureWhat we are looking for?• Device position• Monitoring for potential complications- Pericardial effusion- Surrounding cardiac structures- Thrombi• Residual shunt

Residual Shunt• 90 % residual shunt immediatelyafter device implantation• 10 % after 6 months- Gaps between device and septum- Device not covered by tissue?- Additional defects

Residual shunt afterdevice implantation3-D Echo

Thrombi on devicesASDOS Device (RA)Starflex Occluder (LA +RA)

2247 Patients with atrial septal device closure,9 different devices,Incidence of thrombi evaluated using TEE (1+6 month)%(85% in the1 st month, 15% after 1 month)5432101.2%PFO0.9%ASDBaranowski et al; presented Mannheim 2007

Material• Nitinol framework• 2 Dacron patches• 2 Platinum markers• Polypropylene (Prolene®)• Idea and development:Dr. F. Freudenthal, Bolivia

What is different?• Occluder is knitted from a singleNitinol wire• Low profile• No protruding clamps• Pre-mounted device

What is different?• Occluder is knitted from a singleNitinol wire• Low profile• No protruding clamps• Pre-mounted device• Different release mechanism• Animal studies showed• Good adaption to septal wall• No protrusion into LA• Accelerated endothelialisationFreudenthal et al. 2004

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How does a PFO differ from an ASD?ASD and PFO are different types of interatrial defects• The septumprimum formsfirst• It leaves awindow, theostiumsecundum• The septumsecundum formslater, and usuallycovers theostiumsecundum

• If the septumsecundumfailes to coverthe ostiumsecundum,blood can flowin eitherdirection• This causes acontinuousshunt→ Atrial Septum Defect

Left AtriumSeptumPrimumSeptumSecundumSeptumSecundumRight Atrium

PFO TrackLeft AtriumSeptumSecundumSeptumSecundumRight Atrium

ilderDiagnosis:TTERestValsalva

CardioSEAL and CardioSEAL-STARflexTwo rectangular discseach consisting of four wire spring armsCovered with a polyester patchMicrospring system (CardioSEAL-STARflex)23, 28, 33, 40 mm

Amplatzer18, 25, 35 mmNitinol wire frame mesh with Dacron patches insideThe two discs are linked together by a short connecting waist

HelexTwo discsformed by one continuous Nitinolwire in the shape of a spiralePTFE patch is attached to the wire15-35 mm

30 Day Outcome of PFO Closure660 PFO-Patients, Randomized to 3 Devices5432%53.6101.40 00.9 01.4Amplatzer Helex CardioSEAL-STARflexAtrial fibrillation Thrombus Device embolisation0Am J Cardiol. 2008;101:1353-8

TEE 100 ˚ASD/ PFO/ ASA

Why is anatomy important?• For device selection• To decide which implantationtechnique- Through the PFO tunnel ortransseptal puncture?• To prevent complications

What does that mean?Injections, Injections,Injections….