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PERCUTANEOUS CLOSURE OF PFO: State of the art

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Presentation on theme: "PERCUTANEOUS CLOSURE OF PFO: State of the art"— Presentation transcript:

1 PERCUTANEOUS CLOSURE OF PFO: State of the art
Gian Paolo Anzola Service of Neurology S.Orsola Hospital FBF Brescia - Italy

2 Why should a neurologist talk about PFO closure ?
For a number of reasons

3 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.

4 This is what happens in our Heart and Brain Department
The team This is what happens in our Heart and Brain Department Marco Berti Francesco Casilli Nicola Refatti “Tao” Onorato

5 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 – PTCA]vs. 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

6 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

7 Cryptoghenic styroke or TIA
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

8 TRANSCATHETER CLOSURE MEDICAL TREATMENT
Aspirin Warfarin Closure A DECISION MAKING STRATEGY TO CONFIRM “MANDATORY” CLOSURE OF PATENT FORAMEN OVALE Transcranial Doppler in Cryptogenic Stroke PFO WITH LARGE SHUNT (shower or curtain) PFO WITH SMALL SHUNT (< 25 bubbles) ASA + ASA - SINGLE MULTIPLE SINGLE MULTIPLE THROMB - THROMB. + THROMB. + THROMB - DISCUSS TRANSCATH. CLOSURE TRANSCATHETER CLOSURE Guidelines 2005 MEDICAL TREATMENT

9 ASYMPTOMATIC LARGE SHUNT
MRI + MRI- MA - MA+ WAIT MULTIPLE SINGLE THROMB - THROMB. + Test for CADASIL + - ??? DISCUSS TRANSCATH. CLOSURE TRANSCATHETER CLOSURE MEDICAL TREATMENT

10 Procedural Data E Onorato, F Casilli, M Berti, N Refatti, GP Anzola
Percutaneous PFO Closure: Heart & Brain Guidelines Procedural Data E Onorato, F Casilli, M Berti, N Refatti, GP Anzola Heart & Brain Department, FBF S.Orsola Hospital, Brescia

11 Percutaneous PFO Closure: Heart & Brain Guidelines
Demographics 653 n. of patients (female/male ratio) (1.44) Age range (mean) 14-75y (48 ± 15) Atrial septal aneurysm (%) 272 (42.3%) Prominent Eustachian Valve (%) 103 (16%) Thromboembolic events (%) Stroke TIA Peripheral & coronary embolism 38% 54% 5% E Onorato, F Casilli, M Berti, N Refatti, GP Anzola Heart & Brain Department, FBF S.Orsola Hospital, Brescia

12 Procedural Data 653 100 588 89 n (%) Procedure successful
Percutaneous PFO Closure: Heart & Brain Guidelines Procedural Data n (%) Procedure successful ICE Monitoring alone Fluoro time (median) 2-30 min (9.5 ± 4.7) Procedure time (median) min (56 ± 21) E Onorato, F Casilli, M Berti, N Refatti, GP Anzola Heart & Brain Department, FBF S.Orsola Hospital, Brescia

13 AXIAL AND LONGITUDINAL PLANES
Percutaneous PFO Closure: Heart & Brain Guidelines INTRACARDIAC ECHOCARDIOGRAPHY (ICE) AXIAL AND LONGITUDINAL PLANES Fossa ovalis diameter PFO tunnel Rims: SA, IP, SP & IA rim Cardiac structures 5 3 4 1 2 Ultra ICE RAW RA FO RUPV LA Radial 360° Imaging Plane

14 Intra-Procedural Complications
Percutaneous PFO Closure: Heart & Brain Guidelines Intra-Procedural Complications n: 645 n (%) Atrial Fibrillation (intra-p) Sinus rhythm at the end of procedure 14 2.17 Transient ST-segment elevation 10 1.5 Groin Hematoma 12 1.8 TIA/Stroke Device Embolization Surgical Intervention Myocardial Infarction Pericardial Effusion 0% E Onorato, F Casilli, M Berti, N Refatti, GP Anzola Heart & Brain Department, FBF S.Orsola Hospital, Brescia

15 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 ;27:

16 Long-term follow-up Data
Percutaneous PFO Closure: Heart & Brain Guidelines Long-term follow-up Data n: 310 n % Post-Implantation Management Recurrent events TIA 1 0.1 Stroke Peripheral embolization 1, 3, 6, 12 mos post-procedure How we manage f-up TT/TE Echocardiography Ce-TCD Clinical & Neurological Evaluation

17 Percutaneous PFO Closure: Heart & Brain Guidelines
Follow-up Data n: 310 n % Post-Implantation Management Death 6 1.9 Perforation/Erosion 1 0.3 Thrombus 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

18 Scintillating scotoma (6%) Significant residual shunt in about 10%
Transient AF (8%) Scintillating scotoma (6%) Significant residual shunt in about 10% Early identification of patients with residual shunt Usefulness of combined f-up

19 CURRENTLY AVAILABLE DEVICES IN EUROPE

20 PFO CLOSURE DEVICES: present and future perspectives
CardioSEAL STARFlex PremereTM PFO Closure Device 20

21 Solysafe Septal Occluder
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.

22 CARDIA PFO Device Generations I, I, III,…
PFO CLOSURE DEVICES: present and future perspectives The Cardia Intrasept Device PFO Star Cardia Star Cardia PFO 2 mm center posts 2 mm Ivalon sails titanium caps Left-sided sail attached outside of frame 3-5 mm center posts stranded wires thinner Ivalon sails 6 arms per sail firmer wires GI GII GIII CARDIA PFO Device Generations I, I, III,…

23 CARDIA PFO Device Generation IV
PFO CLOSURE DEVICES: present and future perspectives CARDIA PFO Device Generation 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

24 PFO CLOSURE DEVICES: present and future perspectives
Contraindications Nickel allergy Nitinol-based alloys in ASD devices= 55% nickel + 45% titanium

25 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:

26 PFO CLOSURE DEVICES: present and future perspectives
Nickel allergy … OR TOXICITY ? J Thoracic CV Surg 2003; 125: Fukahara K et al. CARDIA PFO device Systemic allergic reaction (high fever, edema) following PFO occluder Removed Symptoms completely resolved J Thoracic CV Surg 2003; 2112 Dasika UK et al. HELEX Septal Occluder 4 months after ASD closure But did not improve!! Catheter CV Interv Nov; 66: Lai DW et al. Amplatzer PFO Occluder Pericarditis, atrial fibrillation, and  migraine headaches with aura Oral prednisone J Am Coll Cardiol Mar 21; 47 (6): Wertman B et al. Septal & PFO Amplatzer Occluder n: 37 pts MHA was associated with nickel allergy Pericarditis ASA + Clopidogrel (MHA) Prednisone

27 PFO CLOSURE DEVICES: present and future perspectives
Post-implant device thrombosis has been reported with each device implant Device Thrombosis Main Complications Late erosions or perforations of the left and right atrial roof have been reported with each device implant Late Device Erosion 27

28 PFO CLOSURE DEVICES: present and future perspectives
Device Thrombosis 28

29 The incidence of thrombus formation on closure device is LOW
The thrombus usually resolves under anticoagulation therapy 29

30 Device Erosion 36 erosions reported 60.000 total implants
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 36 erosions reported total implants 30

31 Cryptogenic Stroke Ongoing Trials CLOSURE I RESPECT
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.

32 UPCOMING DEVICES

33 “Upcoming” PFO Closure Devices
BEST 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) NMT Medical, Inc. Potential for improve biological seal on atrial surface Rapidly adsorbed and replaced with host tissue Platform for biological response modifiers (genes, cells, proteins, drugs) 33

34 COHEREX “Upcoming” PFO Closure WITHOUT Devices
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 34

35 Now there is a new way to close it
without leaving anything behind but now there is a new way to close it- without leaving anything behind 35

36 Cierra PFXTM Closure System
“Upcoming” PFO Closure WITHOUT Devices 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 36

37 “Upcoming” PFO Closure WITHOUT Devices
Sutura completes successful PFO test of HeartStitch suturing device 37

38 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

39 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

40 Take Home Message Plannings should begin for the development of a network of centers of excellence for patient care and physician training

41 Percutaneous PFO Closure: Heart & Brain Guidelines
Take Home Message Cardiologists need to forge relationships with neurologists to channel potential candidates to PFO closure

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

43


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