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Leeds Thesis Template Optimisation of Pacemaker Therapy for Cardiac Function John Gierula BSc (Hons) NIHR Doctoral Research Fellow, Lecturer in Clinical Physiology and Cardiac Physiologist Submitted in accordance with the requirements for the degree of Doctor of Philosophy The University of Leeds Leeds Institute of Cardiovascular and Metabolic Medicine School of Medicine January 2017 - ii - Intellectual Property and Publication Statements: The candidate confirms that the work submitted is his own and that appropriate credit has been given where reference has been made to the work of others. This copy has been supplied on the understanding that it is copyright material and that no quotation from the thesis may be published without proper acknowledgement. The right of John Gierula to be identified as Author of this work has been asserted by him in accordance with the Copyright, Designs and Patents Act 1988. © 2017 The University of Leeds and John Gierula - iii - Dedication This thesis is dedicated to my wife and children; Emma, Samuel and Lily Gierula, for their unfaltering love, support and welcome distraction whilst writing this thesis and throughout my career. Also to my parents Margaret and Zygmunt Gierula, for their unfailing love and guidance, and without whom my career would not have been possible. A special mention must also go to my great friend, and supervisor, Dr Klaus Witte. Without his unrelenting enthusiasm, support and guidance I would not be in the fortunate position I am in today. - iv - Acknowledgements I would like to start by thanking my supervisors, Dr Klaus Witte and Professor Mark Kearney for recognising and having faith in my potential, providing inspiration, guidance, encouragement and support and providing me with the opportunity to undertake research at the Leeds Institute for Cardiovascular and Metabolic Medicine (LICAMM). I would also like to sincerely thank the LICAMM research team and all the staff at the Leeds Cardiovascular Clinical Research Facility and Cardiac Investigations Unit, for their assistance and support. This research has been carried out by a multi-disciplinary team, and could not have been completed without the tireless and enthusiastic help and support of Dr Klaus Witte, Maria Paton, Judith Lowry, Rowena Byrom, Dr Haqeel Jamil and Dr Richard Cubbon. My own contributions have been to supervise, design, coordinate and carry out the research studies, as well as the subsequent analyses and discussions. The other members of the group and their contributions have been: exercise test supervision, echocardiography, randomisation, data collection, blinding, assistance with statistical analysis and advice on writing papers. The time, and funding, to complete this series of investigations has been made available through a number of sources. A special mention must go to the staff of the Cardiac Investigations Unit, the Cardiology CSU, and in particular Gina McGawley, at Leeds Teaching Hospitals NHS Trust. The - v - generous allocation of time, equipment and facilities made this research possible. From 2012 my salary was funded by the REM-HF study, a British Heart Foundation (BHF), multi-centre, UK wide, randomised-control trial of weekly remote monitoring v usual care, in 1800 patients with heart failure and an implantable cardiac pacemaker or defibrillator. In 2015 I was awarded a National Institute of Health Research (NIHR) Healthcare Scientist Doctoral Fellowship £300,685 which enabled me to focus on the final data analysis, writing of this thesis and to perform further work investigating how optimising the rate response function, based on left ventricular contractility, in patients with heart failure and pacemakers affects exercise capacity. Finally, I would like to thank all the patients who volunteered for these studies - helping to advance our understanding of the adverse effects of pacemaker therapy on heart function, and how we may optimise pacemaker therapy to halt or indeed reverse decline. - vi - Abstract Patients with right ventricular (RV) pacemakers are at increased risk of left ventricular (LV) systolic dysfunction (LVSD) and chronic heart failure (CHF). I aimed 1) to establish the prevalence of LVSD in patients with long-term RV pacemakers listed for pulse generator replacement (PGR), 2) to evaluate the effects on LV function of reprogramming existing pacemakers to reduce RV pacing (RVP) and 3) to investigate whether upgrade to cardiac resynchronization therapy (CRT) at the time of PGR is beneficial in patients with unavoidable RV pacing and LVSD. Data were collected on 491 patients listed for PGR. Reduced left ventricular ejection fraction (LVEF) <50% was observed in 40%. Multivariable analysis revealed %RVP, serum creatinine and previous myocardial infarction (MI) to be independently related to the presence of LVSD. An audit was performed to investigate the effects of optimising pacemaker programming to avoid RV pacing in 66 patients. At 6m, RV pacing was reduced by a mean of 49%, with a mean improvement in LVEF of 6% and no reduction in exercise capacity, NT-pro-BNP or quality of life. Fifty patients with unavoidable RV pacing, LVSD, and mild symptoms of CHF, listed for PGR were randomized 1:1 to either standard RV-PGR or CRT. At 6 months there was a difference in change in median LVEF, improvements in exercise capacity, quality of life, and NT-proBNP in those - vii - randomized to CRT. After 809 days, 17 patients had died or been hospitalized (6 CRT and 11 PGR) and two patients in the PGR arm required CRT for deteriorating CHF. In summary, LVSD is common in patients with standard RV pacemakers and relates to cardiovascular co-morbidities, careful reprogramming to avoid unnecessary RV pacing can improve LVEF without adversely affecting exercise capacity and quality of life and upgrading patients with unavoidable RV pacing to CRT at PGR improves LV function, and exercise tolerance and may reduce admissions and further upgrades. - viii - Table of Contents Dedication ................................................................................................... iii Acknowledgements .................................................................................... iv Abstract ....................................................................................................... vi Table of Contents ..................................................................................... viii List of Tables ............................................................................................. xii List of Figures .......................................................................................... xiii Preface ....................................................................................................... xv Bibliography ............................................................................................ xvii Chapter 1. Introduction to Pacemaker therapy ......................................... 1 1.1 Introduction ................................................................................... 1 1.2 History of heart rhythm, pacemaker therapy and electrophysiology .......................................................................... 3 1.3 Epidemiology of pacemakers in the UK ......................................... 36 1.4 Effects of RV pacing on cardiac function ....................................... 36 1.5 Alternate right ventricular pacing sites ........................................... 51 1.5.1 RV outflow tract pacing ...................................................... 51 1.5.2 RV septal pacing ................................................................ 52 1.5.3 His Bundle pacing .............................................................. 53 1.6 Cardiac Resynchronisation Therapy (CRT) ................................... 54 Chapter 2. Introduction to Chronic Heart Failure (CHF) and its treatment ............................................................................................ 55 2.2 Terminology of CHF ...................................................................... 55 2.3 Epidemiology of CHF .................................................................... 56 2.4 Diagnosis of CHF .......................................................................... 58 2.5 Pathophysiology and aetiology of CHF ......................................... 60 2.5.1 The Haemodynamic Model ................................................ 63 2.5.2 Cardio-renal model ............................................................. 64 2.5.3 Neuro-hormonal model ....................................................... 64 2.5.4 Abnormal Ca2+ cycling model ............................................. 65 2.5.4 Cell death model ................................................................ 66 2.5.5 Genetic model .................................................................... 66 2.6 Management of CHF ..................................................................... 66 2.6.1 General Management of CHF ............................................ 67 - ix - 2.6.1.1 Diet .......................................................................... 67 2.6.1.2 Exercise .................................................................. 67 2.6.1.3 Travel ...................................................................... 69 2.6.1.4 Smoking .................................................................. 69 2.6.1.5 Alcohol consumption ............................................... 69 2.6.2 Modification of risk factors to prevent CHF ........................
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