Disclosures Atrial Septal Defect and Patent Foramen Ovale: Not the - PDF document

10/1/16 Disclosures Atrial Septal Defect and Patent Foramen Ovale: Not the Same Thing — No financial disclosures Jared Oyama, MD — Off-label device use will be discussed Interventional Cardiology The Queen’s Medical Center Assistant Clinical Professor of Medicine University of Hawaii John A Burns School of Medicine Overview Overview — Development of the interatrial septum — Development of the interatrial septum — Pathophysiology in atrial septal defect — Pathophysiology in atrial septal defect — Pathophysiology in patent foramen ovale — Pathophysiology in patent foramen ovale — Imaging the interatrial septum — Imaging the interatrial septum — Treatment of atrial septal defect — Treatment of atrial septal defect — Treatment of patent foramen ovale — Treatment of patent foramen ovale 1

10/1/16 Septal Development Adapted from Nat Rev Cardiol. 2011;8:148-60 Septal Development Septal Development OS OS OP OP Adapted from Nat Rev Cardiol. 2011;8:148-60 Adapted from Nat Rev Cardiol. 2011;8:148-60 2

10/1/16 Septal Development Septal Development SS SS Adapted from Nat Rev Cardiol. 2011;8:148-60 Adapted from Nat Rev Cardiol. 2011;8:148-60 J Am Soc Echocardiogr 2015;28:910-58 J Am Soc Echocardiogr 2015;28:910-58 3

10/1/16 Overview — Development of the interatrial septum — Pathophysiology in atrial septal defect — Pathophysiology in patent foramen ovale — Imaging the interatrial septum — Treatment of atrial septal defect — Treatment of patent foramen ovale Consequences Overview — Right-sided chamber enlargement and HF — Development of the interatrial septum — Atrial arrhythmias — Pathophysiology in atrial septal defect — Elevation in pulmonary pressures — Pathophysiology in patent foramen ovale — Imaging the interatrial septum — Treatment of atrial septal defect — Treatment of patent foramen ovale 4

10/1/16 PFO-Associated Conditions — Paradoxical embolism including cryptogenic stroke — Platypnea/orthodeoxia — Decompression sickness — Migraines Overview — Development of the interatrial septum — Pathophysiology in atrial septal defect — Pathophysiology in patent foramen ovale — Imaging the interatrial septum — Treatment of atrial septal defect — Treatment of patent foramen ovale 5

10/1/16 Transthoracic Echocardiography Transthoracic Echocardiography — Good for: — Not adequate for: ◦ Gross visualization of defect ◦ Accurate assessment of dimensions ◦ Doppler evaluation of flow ◦ Determining if multiple defects present ◦ Evaluation of right-to-left shunt ◦ Presence/absence of adequate rims ◦ Evaluation of chamber sizes ◦ Intraprocedural guidance ◦ Estimation of pulmonary pressures ◦ Assessment of device stability post-procedure 6

10/1/16 Transesophageal Echocardiography — Good for: ◦ Detailed visualization of defect – Dimensions, number of defects, fenestrations – Adequacy of rims ◦ Doppler evaluation of flow ◦ Evaluation of right-to-left shunt ◦ Evaluation of chamber sizes ◦ Intraprocedural guidance J Am Soc Echocardiogr 2015;28:910-58 7

10/1/16 J Am Coll Cardiol Img. 2010;3:749-60 Catheter Cardiovasc Interv. 2010;75:570-77 8

10/1/16 Intracardiac Echocardiography — Good for: ◦ Intraprocedural guidance ◦ Reasonable visualization of defect – Fewer views compared to TEE ◦ Doppler evaluation of flow ◦ Evaluation of right-to-left shunt 9

10/1/16 Overview — Development of the interatrial septum — Pathophysiology in atrial septal defect — Pathophysiology in patent foramen ovale — Imaging the interatrial septum — Treatment of atrial septal defect — Treatment of patent foramen ovale Indications for Closure — Class I ◦ Right sided chamber enlargement with or without symptoms — Class IIa ◦ Paradoxical embolism ◦ Orthodeoxia-platypnea Circulation. 2008;118:2395-2451 10

10/1/16 Percutaneous Closure Devices Available — Only for secundum ASDs Amplatzer Septal Occluder — Need TEE evaluation of size and rims — Most closures can be performed with sedation and ICE guidance Devices Available Technique Gore Cardioform Septal Occluder 11

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10/1/16 Overview — Development of the interatrial septum — Pathophysiology in atrial septal defect — Pathophysiology in patent foramen ovale — Imaging the interatrial septum — Treatment of atrial septal defect — Treatment of patent foramen ovale PFO Closure Percutaneous Closure — No FDA approved device for PFO closure — PFO closure is currently off label — Continues to be investigated — Remains a contentious issue 15

10/1/16 Devices Being Used Devices Being Used Amplatzer Cribriform Septal Occluder Gore Cardioform Septal Occluder 16

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10/1/16 PFO Closure in Cryptogenic Stroke PFO Closure in Cryptogenic Stroke — CLOSURE I (NEJM 2012) — PC Trial (NEJM 2013) ◦ 909 patients, STARFlex vs ASA or OAC ◦ 414 patients, Amplatzer vs medical therapy ◦ Composite endpoint: ◦ Composite endpoint: – Stroke/TIA at 2 years – Death – 30 day mortality – Nonfatal stroke – Neurologic mortality past 30 days – TIA ◦ No significant difference – Peripheral embolism ◦ No significant difference 18

10/1/16 PFO Closure in Cryptogenic Stroke — RESPECT Trial (NEJM 2013) ◦ 980 patients, Amplatzer vs medical therapy ◦ Composite endpoint: – Recurrent nonfatal ischemic stroke – Fatal ischemic stroke – Early death ◦ No significant difference in intention to treat ◦ However, as-treated analysis favored closure Stroke. 2014;45:2160-2236 Stroke. 2014;45:2160-2236 Stroke. 2014;45:2160-2236 19

10/1/16 HOWEVER… Stroke. 2014;45:2160-2236 — Device safety: 15 to 1 yes — Effectiveness: 9 to 7 yes — Benefits outweigh risks: 11 to 5 yes 20

10/1/16 Conclusion Thank You! — Embryology is boring but important in understanding the interatrial septum — Echocardiographic imaging is critical to evaluation of ASD and PFO — Percutaneous closure of secundum ASDs is first line therapy in most cases — Percutaneous closure of PFOs remains controversial but may be gaining ground 21