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Anatomical, Biomechanical, and End-Of-Life Considerations for Emergent Cardiac Pacing Technologies

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Anatomical, Biomechanical, and End-Of-Life Considerations for Emergent Cardiac Pacing Technologies Anatomical, Biomechanical, and End-of-Life Considerations for Emergent Cardiac Pacing Technologies A DISSERTATION SUBMITTED TO THE FACULTY OF UNIVERSITY OF MINNESOTA BY ALEXANDER R MATTSON IN PARTIAL FULFILLMENT OF THE REQUIREMENTS FOR THE DEGREE OF DOCTOR OF PHILOSOPHY IN BIOMEDICAL ENGINEERING ADVISOR: PAUL A. IAIZZO, PHD July 2018 © Alexander R Mattson 2018 Acknowledgements My most sincere thanks to the PhD students whose passion, dedication, and friendship defined my graduate life: Lars Mattison, Megan Schmidt, Erik Gaasedelen, Mikayle Holm, Jorge Zhingre-Sanchez, Brian Howard, Steve Quallich, David Ramirez. I am beyond fortunate to have worked with such a talented group of people. Thanks to the lab staff, scientists, and Medtronic collaborators who’ve provided countless hours of work on my behalf: Mike Eggen, Monica Mahre, Tinen Iles, Alex Deakyne, Mike Bateman, Alison Weyer, Charles Soule, Weston Upchurch. A special thanks to Paul Iaizzo for taking a chance on the quiet student. Your mentorship was and is invaluable. You’ve helped me put the tools in my toolbox to become the best scientist I can be. i Dedication This thesis is dedicated to my parents: Dave and Gloria Mattson. I could write a blurb about how much you’ve done for me, but it wouldn’t say nearly enough. Thank you for everything. ii Abstract Over 600,000 permanent pacing systems are implanted each calendar year as the primary therapy for symptomatic bradycardia. Innovations in pacing technology have rapidly expanded the indications for this life-saving therapy, while reducing complication rates. This thesis examined three prongs of emergent pacing technologies: leadless pacing, epicardial/extravascular pacing, and physiologic pacing through the bundle of His. First, I quantitatively evaluated the likely target anatomies for next-generation pacing systems. Then, anatomic data was supplemented with biomechanics, to provide the foundation upon which next-generation leadless pacemaker fixation mechanisms may be built. Finally, I investigated some of the challenges of extracting leadless pacing systems. The data in this thesis provided a substrate for the design and implementation of next-generation pacing systems. iii Table of Contents List of Tables………………………………………………………………………...…vii List of Figures ………………………………………..………….…………………..viii Section I. An Introduction to Cardiac Pacemakers: Where have we been? Where are we now? What’s next on the Horizon? ................................................ 1 Chapter 1: The Cardiac Pacemaker: A Crossroads of Engineering and Medicine 2 1.1 Preface .................................................................................................... 3 1.2 Looking back: A brief history of cardiac pacing ....................................... 4 1.3 Lillehei and Zoll: World War II Innovators ................................................ 5 1.4 Earl Bakken and the Birth of a Medical Device Industry .......................... 9 1.5 Innovation Fuels Innovation ................................................................... 11 1.6 Modern Implantable Pacing Systems .................................................... 16 1.7 Implantable Pulse Generators (IPGs) .................................................... 18 1.8 Sensing Algorithms................................................................................ 19 1.9 Pacemaker Leads ................................................................................. 20 1.10 Clinical Pacing Categories ................................................................... 24 1.11 Future Pacing Directions ..................................................................... 30 1.12 Conclusion ........................................................................................... 42 Section II. Anatomic Considerations for Next-Generation Pacemakers .......... 43 Chapter 2: The Quantitative Assessment of Epicardial Fat Distributions on Human Hearts: Implications for Epicardial Electrophysiology ......................... 45 2.1 Preface .................................................................................................. 46 2.2 Synopsis ................................................................................................ 47 2.3 Introduction ............................................................................................ 49 2.4 Objective ............................................................................................... 51 2.5 Methods ................................................................................................. 51 2.6 Results .................................................................................................. 54 2.7 Discussion ............................................................................................. 58 2.8 Conclusion ............................................................................................. 61 Chapter 3: 3-Dimensional Reconstruction and Quantitative Assessment of Ventricular Epicardial Fat Tissue on Human Hearts ....................................... 63 3.1 Preface .................................................................................................. 64 3.2 Synopsis ................................................................................................ 65 3.3 Introduction ............................................................................................ 67 3.4 Methods ................................................................................................. 69 3.5 Results .................................................................................................. 73 3.6 Discussion ............................................................................................. 82 3.7 Conclusion ............................................................................................. 87 Chapter 4: Electrical Parameters of Physiologic His-Purkinje Pacing Vary by Implant Location in a Canine Model ................................................................ 88 4.1 Preface .................................................................................................. 89 iv 4.2 Synopsis ................................................................................................ 90 4.3 Introduction ............................................................................................ 92 4.4 Methods ................................................................................................. 93 4.5 Results .................................................................................................. 95 4.6 Discussion ........................................................................................... 101 4.7 Conclusion ........................................................................................... 109 Chapter 5: Visible Heart Visualization of Physiologic His-Bundle Pacing and Surrounding Anatomy within Reanimated Human Hearts ............................. 110 5.1 Preface ................................................................................................ 111 5.2 Synopsis .............................................................................................. 111 5.3 Introduction .......................................................................................... 113 5.4 Case Report ........................................................................................ 114 5.5 Discussion and Conclusions ................................................................ 119 Chapter 6: 3-Dimensional Anatomic Assessment of the Human Right Atrial Appendage: Implications for Atrial Fixation Mechanisms .............................. 122 6.1 Preface ................................................................................................ 123 6.2 Synopsis .............................................................................................. 123 6.3 Background ......................................................................................... 125 6.4 Methods ............................................................................................... 126 6.5 Results ................................................................................................ 130 6.6 Discussion ........................................................................................... 135 6.7 Conclusions ......................................................................................... 136 Section III. Biomechanics Informing Fixation of Next-Generation Pacing Systems 137 Chapter 7: Perforation Properties of the Right Atrial Appendage ............. 138 7.1 Preface ................................................................................................ 139 7.2 Synopsis .............................................................................................. 140 7.3 Introduction and Background ............................................................... 142 7.4 Methods ............................................................................................... 143 7.5 Results ................................................................................................ 144 7.6 Discussion ........................................................................................... 148 7.7 Conclusion ........................................................................................... 149 Chapter 8: Assessing the Relationship between Right Atrial Stiffness and Chamber Pressure to Quantitatively Define Myocardial Tensile Properties
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