TRANSCATHETER CLOSURE OF ATRIAL SEPTAL DEFECT AND PFO

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1 TRANSCATHETER CLOSURE OF ATRIAL SEPTAL DEFECT AND PFO BASIL D. THANOPOULOS MD, PhD Associate Professor Agios Loukas Clinic, Thessaloniki, Greece Ares Heart Center, Bucharest, Romania Honorary Consultant, RBH, London, UK

2 Transcatheter closure with a device delivered transvenously is currently the procedure of choice for the majority of patients with hemodynamically significant secundum atrial septal defects. Complete closure rate approaches 100% and the results are comparable to those of surgical closure.

3 However even in nowadays several questions come to mind about transcatheter closure of ASDs-namely, What ASDs are not suitable for device closure? Which is the best currently available occluder? Which is the best sizing technique? Guidance of the procedure? How to close large ( 3cm) and Complex ASDs?, What are the risks? Late follow-up? Device related erosions.

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5 TRANSCATHETER CLOSURE OF ATRIAL SEPTAL DEFECT AND PFO ASDs that are not suitable for device closure Large ASDs ( 30 mm) requiring a oversized occluder encroaching the adjacent cardiac structures (e.g. MV, SVC, PVs) ASDs with deficient 1 rim (usually PI <3 mm) deficient or absent aortic rim ASDs with an echo diameter 35 mm

6 ASD OCCLUDERS Self-centering 1996 ASO Repositionable No angles-spokes Easy loading-delivery 2010 Stenting effect Reusable? Implants 100% closure rate % thrombus formation

7 ASD OCCLUDERS ASO Helex Occlutech CSO Thanopoulos et al IJC Thanopoulos et al PICS 2015

8

9 Sizing technique Balloon sizing BSDD BSDD Stop flow

10 Sizing technique

11 Sizing technique

12 GUIDANCE OF THE PROCEDURE Fluoroscopy + 2D-3D TEE IVUS TTE Small-moderate defects (-2cm) with good rims Stand by TEE

13 Large ASDs( 3cm) with or insufficient one rim (3-4 mm)?-

14 LARGE ASDS( 3CM) WITH OR INSUFFICIENT ONE RIM (3-4 MM) Greek maneuver Thanopoulos et al IJC 2013

15 A B C D E F

16 Complex defects Multiple or fenestrated defects ASO,Cribiform A, SF, Helex Insufficient (3-4mm) PI rim Aneurysmal septum

17 *Similar to those reported by other authors 10 (27%) *Procedural complications 6 (22%) 15 (56%) 3 (11%) 3(11%) device misplacement transient ST elevetion transient AV block embolization transient atrial arrhytmia

18 REPORTED LATE COMPLICATIONS Major (Rare): Atrial-aortic wall erosion(0.001%) Embolization of the device (0.55%)? Thromboembolism Endocarditis Complete AV block Minor: Mild AV valve regurgitation Atrial arrhythmias Transient migraine

19 REPORTED LATE COMPLICATIONS Atrial-aortic wall erosions Z.Amin PICS 2015: 0.3% EL-Said CCI, 2009 Amin et al,cci 2005 Dinekar et al JACC /12000 (0.001%?) 19 67% 28 cases Deficient AS-rim 24 cases 8 Anatomy of FO 29% 1 4% Oversized occluder? 16 66% 3 13% 5 21% 72h 5d-8m 1y 4 Deaths? 1,5h-6d un 3w-3y

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21 Figure 2 Trans-thoracic echocardiogram (TTE): Short axis view. J D R Thomson, and S A Qureshi Echo Res Pract 2015;2:R73-R The authors

22 REPORTED LATE COMPLICATIONS Atrial-aortic wall erosions Device position with lower risk for erosion Devices that straddle the aorta somewhat oversized, and which do not move relative to the heart? EL-Said-Moore, CCI, 2009

23 Thanopoulos et al N = 1256 pts Age (years) = Defect diameter (TEE mm) = mm Devise diameter (Dx2:24) = mm Non attempted or failed procedure=8.6% (65/1156). (ASDs 35 mm, Complex defects: deficient PI rim, Swiss type) Major complications: 3 device embolization 1 catheter retrieved,-2 surgically removed-no device related erosion (723pts 5y FU)

24 Ooi et al JACC 2016

25 CONCLUSIONS I Transcatheter device closure s is a safe and effective alternative to surgical treatment for the great majority of patients with secundum ASDs. Precise selection of suitable patients, use of a properly sized occluder, careful monitoring of the procedure and closed patient follow-up will significantly reduce the risk of device-related complications

26 CONCLUSIONS II The Cocoon Septal Occluder is an effective and safe double disc ASD occluder that has certain design features which make it potentially attractive for catheter closure of secundum ASDs.

27 TRANSCATHETER CLOSURE OF ATRIAL SEPTAL DEFECT AND PFO PFO AND CRYPTOGENIC STROKE There is still controversy? in the literature regarding the optimal treatment for secondary stroke prevention in patients with cryptogenic stroke (CS) and patent foramen ovale

28 TRANSCATHETER CLOSURE OF ATRIAL SEPTAL DEFECT AND PFO PFO AND CRYPTOGENIC STROKE THROMBUS THROUPH

29 NOVEL DATA FOR PERCUTANEOUS PFO CLOSURE CATHETER V MEDICAL TREATMENT Stroke recurrence under ATT QSS-AAN, Messe et al Neurology 2004 Lausanne study, Bogousslavsky et all, Neurology 1996 French PFO/ASA Study, Mass et al, NEJM 2001 PICSS-RCT, Homma et al, Circulation 2002 AR: % PFO alone does not portend an increased risk for recurrent CS in medically treated patients PFO-SA: HR=4.17/Mass et al NEJM 2001

30 NOVEL DATA FOR PERCUTANEOUS PFO CLOSURE CATHETER V MEDICAL TREATMENT Stroke recurrence after PFO closure Most recent studies Windecker et all, JACC 2004 Von Bardeleben et all, IJC 2008 Wohrle et all, Lancet 2006 Cutty et al, AJC 2008 Wahl et all, Heart 2008 Ford et all, JACC-CI 2009 Pineda et all, CCI 2013 Catheter PFO closure may be (is) more beneficial the medical therapy RA:0-3.4% Khan et all, JACC 2013

31 NOVEL DATA FOR PERCUTANEOUS PFO CLOSURE PFO AND CRYPTOGENIC STROKE Randomized Control Trials Meier et al N Engl J Med 2013 (PC 404 pts) - NS Carrol et al N Engl J Med 2013 (Respect 980 pts) + Furlan et al N Engl J Med 2013 (909 pts) - NS

32 NOVEL DATA FOR PERCUTANEOUS PFO CLOSURE PFO AND CRYPTOGENIC STROKE Randomized Control Trials Sample sizes are small ( pts) to give significant statistical differences CLOSURE I NMT 17/6/2010 (SF) Small non statistically significant benefit from device closure Criticism Eligibility criteria too broad Low shunt free CR (86%)

33 NOVEL DATA FOR PERCUTANEOUS PFO CLOSURE

34 TRANSCATHETER CLOSURE OF ATRIAL SEPTAL DEFECT AND PFO Additionally, PFO closure reduced the relative risk of recurrent cryptogenic stroke by 70% compared with medical therapy (1.5% to 4.3%; P =.004 Carrol et al TCT 2015: Extended Follow-up Respect trial

35 TRANSCATHETER CLOSURE OF ATRIAL SEPTAL DEFECT AND PFO

36 PFO AND CRYPTOGENIC STROKE RISK FACTORS Large RLS (unprovoked shunt) Septal aneurysm General population: 1.2% PFO-CS: 50-89%% De Castro et al Stroke 2000 Mass et al NEJM 2001 Messer et al Neurology 2004 Wohrle et all, Lancet 2006 Eustachian valve? Hypercoagulable state? Pulmonary embolism OR: CS (6.6%)-Death (11.4%) RR:4x Konstadinides el, Circulation 1988

37 TRANSCATHETER CLOSURE OF ATRIAL SEPTAL DEFECT AND PFO CATHETER CLOSURE Procedure 1/2 day hospitalization Local-general anaesthesia ΤΕΕ guidance IVE (AcuNav) - Fluoroscopy 8-9F sheath- device size: 18, 25, 35 mm - APFOO Αντιβίωση: 2 δόσεις TTE 1,3 months (ΤΕΕ 6 months)

38 TRANSCATHETER CLOSURE OF ATRIAL SEPTAL DEFECT AND PFO

39 NOVEL DATA FOR PERCUTANEOUS PFO CLOSURE GUIDANCE Fluoroscopy Wahl et al JACC 2009 CC: 91% Compl: 0.8% Thanopoulos et al ESC (Abstr) 2009 Echo: CC: 98% Min RS Fluoro: CC: 98% Mod RS(4pts): RCS Catheter closure of PFO using the APFOO can be safely and effectively performed in the majority of the cases without ultrasonic guidance. However, echocardiographically guided PFO closure is associated with lower incidence of residual shunting and recurrent embolic events.

40 NOVEL DATA FOR PERCUTANEOUS PFO CLOSURE CATHETER CLOSURE GUIDANCE Echo v Fluoroscopy Thanopoulos et al ESC(Abstr) 2009

41 NOVEL DATA FOR PERCUTANEOUS PFO CLOSURE PFO AND CRYPTOGENIC STROKE Asymptomatic PFO SPARC Study : Meissner et al JACC 2006 NOMAS Study : Di Tullio et al JACC 2007 Risk of stroke from a PFO in the general population is low

42 NOVEL DATA FOR PERCUTANEOUS PFO CLOSURE PFO AND CRYPTOGENIC STROKE Severity of first CS Thanopoulos et al (unpublished data) 17/234 pts (7.2%) 3: Hemianopsia 6: Hemiparesis- 2: Severe MI 3: Severe Brain damage 3: aphasia Al with large RLS and SA

43 NOVEL DATA FOR PERCUTANEOUS PFO CLOSURE PFO occluders Amplatzer CS SF Helex Occlutech PFO Star BS Nitocclud PFO Coherex FS

44 NOVEL DATA FOR PERCUTANEOUS PFO CLOSURE CATHETER CLOSURE Current guidelines PFO closure may be considered for patients with recurrent cryptogenic stroke despite medical therapy (Class IIb, Level C). AHA/ASA,Sacco et al, Stroke 2006 PFO closure may be considered for high risk patients; ES0, Cerebrovasc Dis 2008 Our institutional guidelines High risk patients 1 CS, ASA,LRS (Asymptomatic;) Severe hypoxemia Major CS: Pilots, Divers

45 NOVEL DATA FOR PERCUTANEOUS PFO CLOSURE CONCLUSIONS I Patent foramen ovale is commonly associated with cryptogenic stroke, particularly in young patients All patients with cryptogenic stroke should have transesophageal echo evaluation with color Doppler and bubble test during Valsava maneuver Meta-analysis, comparative and randomized data suggest that device closure of PFO improves the outcomes compared to medical treatment

46 NOVEL DATA FOR PERCUTANEOUS PFO CLOSURE CONCLUSIONS ΙI Additional indications may be include professional divers, high altitude pilots, the rare cases of platypnea orthodeoxia HAPE and patients with indwelling Hickman catheters. Migraine is not yet an indication but it may be in the near future.

47 Sarris et al EJCVS 2010

48

49

50 Late complications 1 9% 1 9% 1 9% 2 18% embolization atrial fibrillation 6 55% transient atrial arrhytmia intermittent Mobitz II Block death (Ebstein)

51 % Comparison of normalization of RV size according to age at implantation pts pts pts pts h 1 month 6 months 1 year 3 years 5 years <4y 5 to 10y 11 to 18y adults

52 LONG-TERM FOLLOW-UP OF ASD CLOSURE WITH THE AMPLATZER Normalization of RV size during follow-up / /35 (60%) % 70 15/35 (62.8%) (43%) /35 (31%) pts:60-72y 30 ASDd cm /35 (0%) 0 24h 1 month 20/35 (57%) pts:nyha II 8/35 (22%) pts-af: NYHA III 7/35 (20%) pts: NYHA I 6 months 1 years 2 years 3 years 5 years adults

53 LONG-TERM FOLLOW-UP OF ASD CLOSURE WITH THE AMPLATZER Post-procedural migraine 10 31/336(9.2%) 8 % /336(0.6%) * 24h 1m 3m 6m 1y Migraine 24h 1m 3m 6m 1y * Mild

54 LONG-TERM FOLLOW-UP OF ASD CLOSURE WITH THE AMPLATZER OCCLUDER 5-y-FU Mitral valve regurgitation (MVP) % ,8 Mild Moderate 8,3 7,4 7,5 6,5 6 2,4 1,8 1,5 before 1 y 5 y

BASIL D. THANOPOULOS MD, PhD Associate Professor Honorary Consultant, RBH, London, UK

BASIL D. THANOPOULOS MD, PhD Associate Professor Honorary Consultant, RBH, London, UK TRANSCATHETER CLOSURE OF ATRIAL SEPTAL DEFECT AND PFO BASIL D. THANOPOULOS MD, PhD Associate Professor Honorary Consultant, RBH, London, UK TRANSCATHETER CLOSURE OF ATRIAL SEPTAL DEFECT AND PFO BASIL D.

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