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. THANOPOULOS MD, PhD Associate Professor Honorary Consultant, RBH, London, UK Proctor Vascular Innovations
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.
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?
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
ASD OCCLUDERS Self-centering 1996 ASO Repositionable No angles-spokes Easy loading-delivery Stenting effect Reusable? 2010 > 150000 Implants 100% closure rate % thrombus formation
Sizing technique Balloon sizing BSDD BSDD Stop flow
Sizing technique
Sizing technique
GUIDANCE OF THE PROCEDURE Fluoroscopy + 2D-3D TEE IVUS TTE Small-moderate defects (-2cm) with good rims Stand by TEE
Large ASDs( 3cm) with or insufficient one rim (3-4 mm)?-
LARGE ASDS( 3CM) WITH OR INSUFFICIENT ONE RIM (3-4 MM) Greek maneuver Thanopoulos et al IJC 2013
A B C D E F
Complex defects Multiple or fenestrated defects ASO,Cribiform A, SF, Helex Insufficient (3-4mm) PI rim Aneurysmal septum
*Procedural complications *Similar to those reported by other authors 27% 16% 41% 8% 8% device misplacement transient ST elevetion transient AV block embolization transient atrial arrhytmia
REPORTED LATE COMPLICATIONS Major (Rare): Atrial-aortic wall erosion(0.001%) Embolization of the device (0.55%)? Thromboembolism Endocarditis Minor: Mild AV valve regurgitation Atrial arrhythmias Transient migraine Complete AV block
REPORTED LATE COMPLICATIONS Atrial-aortic wall erosions EL-Said CCI, 2009 Amin et al,cci 2005 Dinekar et al JACC 2005 14/12000 (0.001%) 28 cases Deficient AS-rim 24 cases Anatomy of FO 29% Oversized occluder? 13% 68% 72h 1y 5d-8m 4% 4 Deaths? 67% 1,5h-6d un 3w-3y 21%
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
Sarris et al EJCVS 2010
Thanopoulos et al 1997-2014 N = 778 pts Age (years) = 12.8 ± 13.4 Defect diameter (TEE mm) = 15.5 ± 5.5mm Devise diameter (Dx2:24) = 19.3 ± 6.3mm Non attempted or failed procedure=8.6% (64/742). (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 (423pts-5y FU)
ASO ASD OCCLUDERS Occlutech Helex CSO Thanopoulos et al IJC 2014
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 ASO, careful monitoring of the procedure and closed patient follow-up will significantly reduce the risk of device-related complications
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.
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
PFO AND CRYPTOGENIC STROKE THROMBUS THROUPH
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
NOVEL DATA FOR PERCUTANEOUS PFO CLOSURE 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)
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.
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.
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:1.5-7.2% 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
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
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
NOVEL DATA FOR PERCUTANEOUS PFO CLOSURE
NOVEL DATA FOR PERCUTANEOUS PFO CLOSURE PFO AND CRYPTOGENIC STROKE Randomized Control Trials Sample sizes are small (410-1500 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%)
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
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
NOVEL DATA FOR PERCUTANEOUS PFO CLOSURE PFO occluders Amplatzer CS SF Helex Occlutech PFO Star BS Nitocclud PFO Coherex FS
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
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
NOVEL DATA FOR PERCUTANEOUS PFO CLOSURE CONCLUSIONS ΙI Additional indications may be include professional divers, high altitude pilots, the rare cases of platypnea orthodeoxia and patients with indwelling Hickman catheters. Migraine is not yet an indication but it may be in the near future.