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
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? Device related erosions.
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 2010 Stenting effect Reusable? 150000 Implants 100% closure rate % thrombus formation
ASD OCCLUDERS ASO Helex Occlutech CSO Thanopoulos et al IJC 2014 - Thanopoulos et al PICS 2015
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
*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
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
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 2005 14/12000 (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
Figure 2 Trans-thoracic echocardiogram (TTE): Short axis view. J D R Thomson, and S A Qureshi Echo Res Pract 2015;2:R73-R78 2015 The authors
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
Thanopoulos et al 1996-2016 N = 1256 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% (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)
Ooi et al JACC 2016
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
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
TRANSCATHETER CLOSURE OF ATRIAL SEPTAL DEFECT AND PFO PFO AND CRYPTOGENIC STROKE THROMBUS THROUPH
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 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
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
TRANSCATHETER CLOSURE OF ATRIAL SEPTAL DEFECT AND PFO
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
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)
TRANSCATHETER CLOSURE OF ATRIAL SEPTAL DEFECT AND PFO
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 CLOSURE GUIDANCE Echo v Fluoroscopy Thanopoulos et al ESC(Abstr) 2009
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 HAPE and patients with indwelling Hickman catheters. Migraine is not yet an indication but it may be in the near future.
Sarris et al EJCVS 2010
Late complications 1 9% 1 9% 1 9% 2 18% embolization atrial fibrillation 6 55% transient atrial arrhytmia intermittent Mobitz II Block death (Ebstein)
% Comparison of normalization of RV size according to age at implantation 100 90 52pts 80 108 pts 70 114 pts 60 50 40 62pts 30 20 10 0 24h 1 month 6 months 1 year 3 years 5 years <4y 5 to 10y 11 to 18y adults
LONG-TERM FOLLOW-UP OF ASD CLOSURE WITH THE AMPLATZER Normalization of RV size during follow-up 100 90 21/35 80 22/35 (60%) % 70 15/35 (62.8%) (43%) 60 50 11/35 (31%) 40 35 pts:60-72y 30 ASDd 2.7-3.5cm 20 10 0/35 (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
LONG-TERM FOLLOW-UP OF ASD CLOSURE WITH THE AMPLATZER Post-procedural migraine 10 31/336(9.2%) 8 % 6 4 2 0 2/336(0.6%) * 24h 1m 3m 6m 1y Migraine 24h 1m 3m 6m 1y * Mild
LONG-TERM FOLLOW-UP OF ASD CLOSURE WITH THE AMPLATZER OCCLUDER 5-y-FU Mitral valve regurgitation (MVP) % 11 9 7 5 3 1 9,8 Mild Moderate 8,3 7,4 7,5 6,5 6 2,4 1,8 1,5 before 1 y 5 y