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Zahid Amin Jonathan M. Tobis Horst Sievert John D. Carroll Editors Patent Foramen Ovale 123 Patent Foramen Ovale Zahid Amin (cid:129) J onathan M. Tobis Horst Sievert (cid:129) John D. Carroll Editors Patent Foramen Ovale Editors Zahid Amin Horst Sievert Children's Hospital of Georgia CardioVascular Center Augusta , GA Frankfurt USA Germany Jonathan M. Tobis John D. Carroll UCLA University of Colorado Denver Anschutz Los Angeles , CA Medical Campus USA Aurora , CO USA ISBN 978-1-4471-4986-6 ISBN 978-1-4471-4987-3 (eBook) DOI 10.1007/978-1-4471-4987-3 Springer London Heidelberg New York Dordrecht Library of Congress Control Number: 2014957317 © Springer-Verlag London 2015 This work is subject to copyright. All rights are reserved by the Publisher, whether the whole or part of the material is concerned, specifi cally the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfi lms or in any other physical way, and transmission or information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed. Exempted from this legal reservation are brief excerpts in connection with reviews or scholarly analysis or material supplied specifi cally for the purpose of being entered and executed on a computer system, for exclusive use by the purchaser of the work. Duplication of this publication or parts thereof is permitted only under the provisions of the Copyright Law of the Publisher's location, in its current version, and permission for use must always be obtained from Springer. Permissions for use may be obtained through RightsLink at the Copyright Clearance Center. Violations are liable to prosecution under the respective Copyright Law. T he use of general descriptive names, registered names, trademarks, service marks, etc. in this publication does not imply, even in the absence of a specifi c statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. While the advice and information in this book are believed to be true and accurate at the date of publication, neither the authors nor the editors nor the publisher can accept any legal responsibility for any errors or omissions that may be made. The publisher makes no warranty, express or implied, with respect to the material contained herein. Printed on acid-free paper Springer is part of Springer Science+Business Media (www.springer.com) Contents Part I Background and Anatomy 1 Historical Perspective and Importance of PFO . . . . . . . . . . . . . . . . . . . . . . . . . 3 John F. Rhodes Jr. and Amanda Green 2 Embryology, Neonatal Circulation and Anatomy of PFO. . . . . . . . . . . . . . . . . 7 John L. Bass 3 Anatomical Variations of Patent Foramen Ovale. . . . . . . . . . . . . . . . . . . . . . . . 15 Hussam Suradi and Zahid Amin 4 Aging and Patent Foramen Ovale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 Robert J. Sommer and Barbara T. Spencer Part II Methods and Techniques for Detection and Characterization of PFO 5 Echocardiographic Detection and Transcranial Doppler Quantifi cation of Right-to-Left Shunting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 Eustaquio Maria Onorato, Francesco Casilli, and Gian Paolo Anzola 6 ICE: Intra-Procedural Evaluation and Guidance During Closure of PFO. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49 Noa Holoshitz and Ziyad M. Hijazi 7 A Comparison of Methods to Detect and Quantitate PFO: TCD, TTE, ICE and TEE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55 M. Khalid Mojadidi, Rubine Gevorgyan, and Jonathan M. Tobis 8 Angiographic Evaluation for PFO and Pulmonary AVMs . . . . . . . . . . . . . . . . 67 Daniel R. Turner and Thomas J. Forbes Part III PFO and Clinical Syndromes 9 An Overview of Clinical Syndromes (Keeping the Heart in Mind). . . . . . . . . . 77 James Orford and Brian Whisenant 10 The Association of Patent Foramen Ovale and Migraine Headache . . . . . . . . 81 M. Khalid Mojadidi, Nimit Dave, Rubine Gevorgyan, and Jonathan M. Tobis 11 Current Patient Management Issues, Clinical Trial Design Challenges, and the Pathway Forward . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95 John D. Carroll, Sharon Poisson, and Michael S. Kim 12 Patent Foramen Ovale and Divers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107 Carla Canniffe and Kevin P. Walsh v vi Contents 13 Orthodeoxia and Platypnea . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113 Omar Ali and Ted Feldman 14 Obstructive Sleep Apnea and Patent Foramen Ovale . . . . . . . . . . . . . . . . . . . . 119 Tomas Konecny, Guy S. Reeder, and Virend K. Somers 15 PFO and Various Types of Surgery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123 John D. Carroll 16 When a PFO Is Discovered Incidentally . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129 Robert J. Sommer and Barbara T. Spencer Part IV Closure Methods 17 The GORE® Septal Occluder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137 Gary Cheung and Lars Søndergaard 18 The Novel PFO Specifi c Closure Devices: Why Did They Fail? . . . . . . . . . . . . 145 Brian Whisenant 19 Optimal Device for Children and Closure Indications in Pediatric Population . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151 Damien Kenny 20 Occlutech, PFM, Lifetech and Other New Devices. What’s on the Horizon?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157 Jennifer Franke, Sameer Gafoor, and Horst Sievert 21 Complications of PFO Closure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163 Khaled Mansoor and Zahid Amin Part V Statistical Methods, Trials and Tribulations 22 Device Closure of Patent Foramen Ovale or Medical Therapy for Cryptogenic Stroke: The CLOSURE I Trial. . . . . . . . . . . . . . . . . . . . . . . . . 173 M. Khalid Mojadidi, Rubine Gevorgyan, and Jonathan M. Tobis 23 The Gore REDUCE Clinical Study . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 181 John F. Rhodes Jr, and Scott E. Kasner 24 The PC Trial: An Effective Treatment Not Demonstrating Effective Power. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 185 Ahmed A. Khattab and Bernhard Meier 25 From FDAs Point of View: What Is Needed to Move PFO Closure for Stroke Prevention Forward?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 189 Donald J. Hagler 26 The Medical Device Manufacturer’s Perspective: W.L. Gore and Associates, Inc.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 193 Jake A. Goble 27 PFO-Patient’s Perspective. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 199 Bray Patrick-Lake Contents vii 28 Clinical Trials to Assess the Relationship Between Patent Foramen Ovale and Migraine Headaches. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203 M. Khalid Mojadidi, Rubine Gevorgyan, and Jonathan M. Tobis 29 Do We Need More PFO Trials: Hypercoaguable Syndromes, Obstructive Sleep Apnea, and Arrhythmias . . . . . . . . . . . . . . . . . . . . . . . . . . . . 211 Harsimran Sachdeva Singh and Eric M. Horlick Part VI Diffi culties/Obstacles in Starting PFO Closure Practice 30 Obstacles in Starting a PFO Closure Program. How I Did It . . . . . . . . . . . . . . 225 Christian Spies and Brittney Patterson-Lazzaro 31 Developing a Successful Integrated PFO Closure Program . . . . . . . . . . . . . . . 229 Sherman G. Sorensen Online Videos E lectronic supplementary material is available on Springer Extra Materials h ttp://extras. springer.com/ Chapter 7 Video 7.1 Positive bubble study in a patient with pulmonary shunt (X-plane) Video 7.2 Positive bubble study in a patient with pulmonary shunt (LA view) Video 7.3 Negative bubble study, bicaval view Video 7.4 Hypermobile septum on TEE (X plane) Video 7.5 PFO closure device image in 3-D V ideo 7.6 Transthoracic echocardiography in a 33-year old patient suffering from severe migraine with visual aura (apical four-chamber view) ix

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Zahid Amin Jonathan M. Tobis Horst Sievert John D. Carroll Editors Patent Foramen Ovale 123 Patent Foramen Ovale Zahid Amin (cid:129) J onathan M. Tobis Horst Sievert (cid:129) John D. Carroll Editors Patent Foramen Ovale Editors Zahid Amin Horst Sievert Children's Hospital of Georgia CardioVascular Center Augusta , GA Frankfurt USA Germany Jonathan M. Tobis John D. Carroll UCLA University of Colorado Denver Anschutz Los Angeles , CA Medical Campus USA Aurora , CO USA ISBN 978-1-4471-4986-6 ISBN 978-1-4471-4987-3 (eBook) DOI 10.1007/978-1-4471-4987-3 Springer London Heidelberg New York Dordrecht Library of Congress Control Number: 2014957317 © Springer-Verlag London 2015 This work is subject to copyright. All rights are reserved by the Publisher, whether the whole or part of the material is concerned, specifi cally the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfi lms or in any other physical way, and transmission or information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed. Exempted from this legal reservation are brief excerpts in connection with reviews or scholarly analysis or material supplied specifi cally for the purpose of being entered and executed on a computer system, for exclusive use by the purchaser of the work. Duplication of this publication or parts thereof is permitted only under the provisions of the Copyright Law of the Publisher's location, in its current version, and permission for use must always be obtained from Springer. Permissions for use may be obtained through RightsLink at the Copyright Clearance Center. Violations are liable to prosecution under the respective Copyright Law. T he use of general descriptive names, registered names, trademarks, service marks, etc. in this publication does not imply, even in the absence of a specifi c statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. While the advice and information in this book are believed to be true and accurate at the date of publication, neither the authors nor the editors nor the publisher can accept any legal responsibility for any errors or omissions that may be made. The publisher makes no warranty, express or implied, with respect to the material contained herein. Printed on acid-free paper Springer is part of Springer Science+Business Media (www.springer.com) Contents Part I Background and Anatomy 1 Historical Perspective and Importance of PFO . . . . . . . . . . . . . . . . . . . . . . . . . 3 John F. Rhodes Jr. and Amanda Green 2 Embryology, Neonatal Circulation and Anatomy of PFO. . . . . . . . . . . . . . . . . 7 John L. Bass 3 Anatomical Variations of Patent Foramen Ovale. . . . . . . . . . . . . . . . . . . . . . . . 15 Hussam Suradi and Zahid Amin 4 Aging and Patent Foramen Ovale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 Robert J. Sommer and Barbara T. Spencer Part II Methods and Techniques for Detection and Characterization of PFO 5 Echocardiographic Detection and Transcranial Doppler Quantifi cation of Right-to-Left Shunting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 Eustaquio Maria Onorato, Francesco Casilli, and Gian Paolo Anzola 6 ICE: Intra-Procedural Evaluation and Guidance During Closure of PFO. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49 Noa Holoshitz and Ziyad M. Hijazi 7 A Comparison of Methods to Detect and Quantitate PFO: TCD, TTE, ICE and TEE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55 M. Khalid Mojadidi, Rubine Gevorgyan, and Jonathan M. Tobis 8 Angiographic Evaluation for PFO and Pulmonary AVMs . . . . . . . . . . . . . . . . 67 Daniel R. Turner and Thomas J. Forbes Part III PFO and Clinical Syndromes 9 An Overview of Clinical Syndromes (Keeping the Heart in Mind). . . . . . . . . . 77 James Orford and Brian Whisenant 10 The Association of Patent Foramen Ovale and Migraine Headache . . . . . . . . 81 M. Khalid Mojadidi, Nimit Dave, Rubine Gevorgyan, and Jonathan M. Tobis 11 Current Patient Management Issues, Clinical Trial Design Challenges, and the Pathway Forward . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95 John D. Carroll, Sharon Poisson, and Michael S. Kim 12 Patent Foramen Ovale and Divers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107 Carla Canniffe and Kevin P. Walsh v vi Contents 13 Orthodeoxia and Platypnea . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113 Omar Ali and Ted Feldman 14 Obstructive Sleep Apnea and Patent Foramen Ovale . . . . . . . . . . . . . . . . . . . . 119 Tomas Konecny, Guy S. Reeder, and Virend K. Somers 15 PFO and Various Types of Surgery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123 John D. Carroll 16 When a PFO Is Discovered Incidentally . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129 Robert J. Sommer and Barbara T. Spencer Part IV Closure Methods 17 The GORE® Septal Occluder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137 Gary Cheung and Lars Søndergaard 18 The Novel PFO Specifi c Closure Devices: Why Did They Fail? . . . . . . . . . . . . 145 Brian Whisenant 19 Optimal Device for Children and Closure Indications in Pediatric Population . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151 Damien Kenny 20 Occlutech, PFM, Lifetech and Other New Devices. What’s on the Horizon?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157 Jennifer Franke, Sameer Gafoor, and Horst Sievert 21 Complications of PFO Closure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163 Khaled Mansoor and Zahid Amin Part V Statistical Methods, Trials and Tribulations 22 Device Closure of Patent Foramen Ovale or Medical Therapy for Cryptogenic Stroke: The CLOSURE I Trial. . . . . . . . . . . . . . . . . . . . . . . . . 173 M. Khalid Mojadidi, Rubine Gevorgyan, and Jonathan M. Tobis 23 The Gore REDUCE Clinical Study . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 181 John F. Rhodes Jr, and Scott E. Kasner 24 The PC Trial: An Effective Treatment Not Demonstrating Effective Power. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 185 Ahmed A. Khattab and Bernhard Meier 25 From FDAs Point of View: What Is Needed to Move PFO Closure for Stroke Prevention Forward?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 189 Donald J. Hagler 26 The Medical Device Manufacturer’s Perspective: W.L. Gore and Associates, Inc.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 193 Jake A. Goble 27 PFO-Patient’s Perspective. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 199 Bray Patrick-Lake Contents vii 28 Clinical Trials to Assess the Relationship Between Patent Foramen Ovale and Migraine Headaches. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203 M. Khalid Mojadidi, Rubine Gevorgyan, and Jonathan M. Tobis 29 Do We Need More PFO Trials: Hypercoaguable Syndromes, Obstructive Sleep Apnea, and Arrhythmias . . . . . . . . . . . . . . . . . . . . . . . . . . . . 211 Harsimran Sachdeva Singh and Eric M. Horlick Part VI Diffi culties/Obstacles in Starting PFO Closure Practice 30 Obstacles in Starting a PFO Closure Program. How I Did It . . . . . . . . . . . . . . 225 Christian Spies and Brittney Patterson-Lazzaro 31 Developing a Successful Integrated PFO Closure Program . . . . . . . . . . . . . . . 229 Sherman G. Sorensen Online Videos E lectronic supplementary material is available on Springer Extra Materials h ttp://extras. springer.com/ Chapter 7 Video 7.1 Positive bubble study in a patient with pulmonary shunt (X-plane) Video 7.2 Positive bubble study in a patient with pulmonary shunt (LA view) Video 7.3 Negative bubble study, bicaval view Video 7.4 Hypermobile septum on TEE (X plane) Video 7.5 PFO closure device image in 3-D V ideo 7.6 Transthoracic echocardiography in a 33-year old patient suffering from severe migraine with visual aura (apical four-chamber view) ix

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