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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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Presentation on theme: "PERCUTANEOUS CLOSURE OF PFO: State of the art Gian Paolo Anzola Service of Neurology S.Orsola Hospital FBF Brescia - Italy."— 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 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. Cryptogenic stroke Migraine Neurological decompression sickness Obstructive sleep apnoea

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

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. 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

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

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

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

11 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 (%) StrokeTIA Peripheral & coronary embolism 38% 54% 5% 653 Demographics E Onorato, F Casilli, M Berti, N Refatti, GP Anzola Heart & Brain Department, FBF S.Orsola Hospital, Brescia 1999-2007

12 Percutaneous PFO Closure: Heart & Brain Guidelinesn(%) Procedure successful ICE Monitoring alone Fluoro time (median) 2-30 min (9.5 ± 4.7) Procedure time (median) 10-135 min (56 ± 21) 653 100 588 89 Procedural Data E Onorato, F Casilli, M Berti, N Refatti, GP Anzola Heart & Brain Department, FBF S.Orsola Hospital, Brescia

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

14 Percutaneous PFO Closure: Heart & Brain Guidelines Intra-Procedural Complicationsn(%) Atrial Fibrillation (intra-p) Sinus rhythm at the end of procedure 142.17 Transient ST-segment elevation 101.5 Groin Hematoma 121.8 TIA/Stroke00 Device Embolization 00 Surgical Intervention 00 Myocardial Infarction 00 Pericardial Effusion 00 0% 1999-2007 n: 645 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. 2006;27:328-331

16 Percutaneous PFO Closure: Heart & Brain Guidelines Long-term follow-up Data Recurrent events TIA10.1 Stroke00 Peripheral embolization 10.1 n % n: 310 1999-2007 How we manage f-up TT/TE Echocardiography Ce-TCD Clinical & Neurological Evaluation 1, 3, 6, 12 mos post-procedure Post-Implantation Management

17 Percutaneous PFO Closure: Heart & Brain Guidelines Follow-up DataDeath61.9Perforation/Erosion10.3 Thrombus10.3 n % n: 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.1Early death due to massive pulm. thromboemb.1 Late death:5Late death:5 Respiratory Failure2 Fatal massive pulm. thromboemb.1 Sudden death1 Suicide1 Small shunt between Ao and LA1Small shunt between Ao and LA1 late erosion surgically corrected (electively) Thrombus on the right-side of the disc (APO 25)1Thrombus on the right-side of the disc (APO 25)1 LAC syndrome (post-op 14 months) Resolution on medical therapy

18 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 CardioSEAL STARFlex PFO CLOSURE DEVICES: present and future perspectives Premere TM PFO Closure Device

21 Solysafe Septal Occluder 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 PFO CLOSURE DEVICES: present and future perspectives

22 CARDIA PFO Device CARDIA PFO Device Generations I, I, III,… 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 GIGIIGIII The Cardia Intrasept Device PFO CLOSURE DEVICES: present and future perspectives

23 polyvinyl alcohol foam Ivalon 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) CARDIA PFO Device CARDIA PFO Device Generation IV Advancing Septal Closure Technology The nitinol struts secure the device in place (sails are attached to the struts with polypropylene suture) The Cardia Intrasept Device PFO CLOSURE DEVICES: present and future perspectives

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

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

26 ? Nickel allergy … OR TOXICITY ? J Thoracic CV Surg 2003; 125: 213-214 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 Removed But did not improve!! Catheter CV Interv. 2005 Nov; 66: 424-426 Lai 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 PFO CLOSURE DEVICES: present and future perspectives

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

28 Device Thrombosis PFO CLOSURE DEVICES: present and future perspectives

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

30 Device Erosion 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 36 erosions reported 60.000 total implants

31 Cryptogenic Stroke (n= 1600, superiority trial) STARFlex U.S. & Canada 515 pts enrolled (350 pts in 2005) CLOSURE I (n= 300, equivalence) AMPLATZER PFO Occluder U.S. RESPECT (n= 300, equivalence) Intrasept U.S. CARDIA PFO STROKE Trial (n= 450, superiority) AMPLATZER PFO Occluder 279/450 pts U.S. 279/450 pts PC Trial O n g o i n g T r i a l s PFO CLOSURE DEVICES: present and future perspectives

32 UPCOMING DEVICES

33 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) NMT Medical, Inc. Upcoming PFO Closure Devices

34 COHEREX COHEREX FlatStent PFO Closure System Upcoming PFO Closure WITHOUT 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

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

36 Cierra PFX TM 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 Upcoming PFO Closure WITHOUT Devices

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

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

39 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

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

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

43


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