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The Nuts and Bolts of Cardiac Resynchronization Therapy Tom Kenny Vice President Clinical Education & Training St Jude Medical, Austin, Texas © 2007 St Jude Medical Published by Blackwell Publishing Blackwell Futura is an imprint of Blackwell Publishing Blackwell Publishing, Inc., 350 Main Street, Malden, Massachusetts 02148-5020, USA Blackwell Publishing Ltd, 9600 Garsington Road, Oxford OX4 2DQ, UK Blackwell Science Asia Pty Ltd, 550 Swanston Street, Carlton, Victoria 3053, Australia All rights reserved. No part of this publication may be reproduced in any form or by any electronic or mechanical means, including information storage and retrieval systems, without permission in writing from the publisher, except by a reviewer who may quote brief passages in a review. First published 2007 1 2007 ISBN: 978-1-4051-5372-0 Library of Congress Cataloging-in-Publication Data Kenny, Tom, 1954- The nuts and bolts of cardiac resynchronization therapy / Tom Kenny. p. ; cm. Includes bibliographical references and index. ISBN 978-1-4051-5372-0 (alk. paper) 1. Heart failure--Treatment. 2. Cardiac pacing. I. Title. [DNLM: 1. Heart Failure, Congestive--therapy. 2. Cardiac Pacing, Artifi cial. 3. Defi brillators, Implantable. 4. Pacemaker, Artifi cial. WG 370 K36n 2007] RC685.C53K46 2007 616.1’23025--dc22 2006035499 A catalogue record for this title is available from the British Library Commissioning Editor: Gina Almond Development Editor: Fiona Pattison Editorial Assistant:Victoria Pitman Set in 9.5/12 pt Minion by Sparks, Oxford – www.sparks.co.uk Printed and bound in Singapore by COS Printers Pte Ltd For further information on Blackwell Publishing, visit our website: www.blackwellcardiology.com The publisher’s policy is to use permanent paper from mills that operate a sustainable forestry policy, and which has been manufactured from pulp processed using acid-free and elementary chlorine-free practices. Furthermore, the publisher ensures that the text paper and cover board used have met acceptable environmental accreditation standards. Blackwell Publishing makes no representation, express or implied, that the drug dosages in this book are correct. Readers must therefore always check that any product mentioned in this publication is used in accordance with the prescribing information prepared by the manufacturers. The author and the publishers do not accept responsibility or legal liability for any errors in the text or for the misuse or misapplication of material in this book. Contents Preface, v 14 Basic ECG Interpretation for CRT Systems, 93 1 Understanding Heart Failure, 1 15 CRT System Optimization, 103 2 Cardiovascular Anatomy of the Healthy 16 Troubleshooting the Non-Responder, 109 Heart, 6 17 Defi brillation Basics, 116 3 Cardiac Physiology and Heart Failure, 11 18 Advanced Defi brillation Functions, 125 4 Causes of Heart Failure, 17 19 Advanced CRT ECG Analysis, 135 5 The Neurohormonal Model of Heart 20 DFT Management in CRT-D Patients, 144 Failure, 23 21 Atrial Fibrillation, 150 6 An Overview of Heart Failure Drugs, 27 22 CRT in Post-AV Nodal Ablation Patients, 158 7 Ventricular Dyssynchrony, 34 23 Special CRT Device Features, 163 8 Arrhythmias in Heart Failure Patients, 38 24 Diagnostics, 169 9 Indications for CRT, 54 25 A Systematic Guide to CRT Follow-Up, 177 10 Types of CRT Systems, 64 26 Troubleshooting, 186 11 Implant Procedures, 72 Glossary, 191 12 Basic Programming, 79 Index, 213 13 Advanced Programming, 87 iii Preface A lot has happened since the day I was involved in cal application of these devices, writing about CRT caring for my fi rst patient with an implanted car- is a little like writing about the future. diac rhythm management device. Back then, about There are aspects to these devices that we still do the only devices available were fairly simple VVI not understand. Algorithms and features are still pacemakers – at least, they look simple today. Back evolving. In fact, even a few years from now, this then, we thought adjustable programmable rates book may seem out of date. Manufacturers have and output inhibition were very sophisticated con- evidenced a strong commitment to put the most cepts. I can remember how incredible the fi rst dual- advanced and useful tools into the hands of clini- chamber pacemakers seemed, and can still recall cians. That means a steady stream of new products learning about AV delays and other dual-chamber and features! timing cycles. My main concern is that clinicians from all types When implantable defi brillators were intro- of practices understand the basics – the nuts and duced, they were just that: implantable defi brilla- bolts – of these CRT devices. It is hard to imagine tors. Some of those fi rst patients who needed both any sort of clinical practice that will not encounter pacing and defi brillation ended up with two devic- CRT systems sooner or later. But while these sys- es! Today, you cannot fi nd an implanted defi bril- tems may be new and even a bit complicated, they lator on the market without very advanced pacing work on some fundamental concepts that clini- functionality. cians can readily understand. It is my goal to try to The cardiac resynchronization therapy (CRT) make these concepts and the device functions that system is a device I would never have foreseen back address them as simple and understandable as pos- in my rookie year as a clinician. Comparing those sible. simple single-chamber pacemakers I worked with This book could not have been written without then with today’s CRT devices is like comparing a the outstanding contributions of many of my col- wagon with a space ship. leagues. I want to particularly recognize the work This is by far the longest and most complex book of Dr Angelo Carboni of the University of Parma, I have ever written. Spurred by the success of The Italy, for his pioneering educational efforts in CRT Nuts & Bolts of Cardiac Pacing and The Nuts & Bolts training. I would also like to thank Dr. Mark Kroll of ICD Therapy, I wanted to tackle the latest type for his insights into the nature of defi brillation. In of device that is turning up in clinics around the my own offi ce, I must thank David Andreasen for world. The CRT device is the most promising, most assisting me in a review of the manuscript. I am also powerful and most complicated implantable car- grateful to the ‘behind-the-scenes’ team of Jo Ann diac device available today. LeQuang, who helped prepare the manuscript, Be- For that reason, I want to go on the record by linda Kinkade who handled the art work, and my saying that this book was written at the advent of gracious editor, Fiona Pattison. CRT devices. Unlike my books on pacing and ICDs, Of course, the biggest debt of gratitude I owe is which were written after decades of successful clini- to my family, all of whom have more or less come v vi Preface to terms with having an author in the family. They and opinions, and I appreciate the tremendous have generously given me time to devote to my new support and confi dence that readers have shown passion of writing and have been my best critics me. and strongest allies. Tom Kenny It is my sincere hope that you fi nd this book of October, 2006 immediate practical use. I welcome your comments Austin, Texas The Nuts and Bolts of Cardiac Resynchronization Therapy Tom Kenny Copyright © 2007 St Jude Medical 1 Chapter 1 Understanding Heart Failure Although heart failure (HF) was observed in ancient curred was similar to waiting for metastasis rather times (ancient physicians called it ‘dropsy’), medical than screening for a primary tumor.2 science has been slow to respond to its challenge. The American College of Cardiology and Ameri- Unlike other things that concern cardiologists, HF can Heart Association defi ne heart failure as ‘a is a syndrome rather than a disease, i.e. it is a constel- complex clinical syndrome that can result from lation of symptoms. There remains no straightfor- any structural or functional cardiac disorder that ward way to diagnose the disease; classifi cation sys- impairs the ability of the ventricle to fi ll with or tems are more subjective than objective and we are eject blood’.3 There is no objective defi nition of HF only recently beginning really to understand what because there are no currently agreed-upon cut- goes on when the human heart begins to fail. off values in terms of cardiac dysfunction, such as The name of the syndrome itself is something change in fl ow, pressure, dimension or volume. The of a misnomer. The heart does not ‘fail’ in a sud- main symptoms are shortness of breath and fatigue, den spasm. The failure is a gradual, stepwise degen- which often manifests as exercise intolerance. Fluid eration. Not too many years ago, all we clinicians retention may be observed and, even if present, may could do in the face of progressive HF was keep the not dominate the clinical presentation. A straight- patient comfortable in the face of the inevitable forward diagnosis is not possible and, when diag- decline. Even today, the prognosis for HF patients nosed, HF should not be the sole fi nding. is not good. However, new treatment options are HF impairs the heart’s ability to pump blood and changing how we think about HF and that includes that, in turn, causes an inadequate blood supply to not just trying to stop the progressive deterioration the body’s main organs. This lack of oxygen-rich but actually to fi ght to reverse it. As clinicians, we blood fl ow to the brain, liver and kidneys is respon- are not always successful in the fi ght against HF, but sible for some of the symptoms of HF. As the heart’s every year we become better and better equipped. pump becomes less effective, blood can pool in the In fact, Dr John G. F. Cleland stated recently in an heart and stagnate. It can back up into the veins interview that at this point in medical history, ‘I or clots may form, increasing the patient’s risk of think it’s realistic to talk in terms of remission of stroke. The symptoms relate to an inadequate oxy- heart failure’.1 genated blood supply to the body, including: Most clinicians have heard the term congestive • Dyspnea (shortness of breath) heart failure (CHF). Although you still hear it, it is • Fatigue, feeling overtired starting to sound old-fashioned. Congestion is a • Edema or fl uid accumulation. troublesome and extremely obvious symptom of advanced HF. Today we know that patients can have Types of heart failure HF without congestion. In fact, by the time fl uids start to accumulate, the heart has withstood con- Since the defi nition of HF is vast, it is not unusual siderable assault. Early treatment of HF involves for clinicians to describe HF further to help describe diagnosing and managing the syndrome long be- the type and stage of the condition. Some of the ad- fore fl uid overload becomes a problem. In fact, Dr. jectives used with HF include: chronic, acute, con- Jonathan Sackner-Bernstein wrote that not treating gestive, decompensated, systolic, diastolic, right- a heart failure patient until fl uid accumulation oc- sided and left-sided. 1 2 The Nuts and Bolts of Cardiac Resynchronization Therapy Acute heart failure (AHF) is used to describe two paired right-ventricular pumping action, causing different things. Sometimes the term is heard for congestion in systemic circulation. Left-sided HF new-onset cases of HF. However, the term is often is by far the more common type, although cases of applied when a patient with heart failure experienc- ‘true right-sided HF’ have been documented. Over es a sudden and dangerous worsening of symptoms, the long term, patients may develop both forms of typically characterized by pulmonary or peripheral HF, in that left-ventricular dysfunction eventually congestion (or both). Patients with chronic heart causes right-sided failure. failure may have bouts of AHF, sometimes requir- ing emergency hospitalization. Classifi cation of HF Decompensation is a term that means ‘failure to compensate’. It describes quite well what happens as When classifying heart failure, the most commonly heart failure progresses. In the early stages of HF, the used method is not necessarily the most elegant. The heart develops some radical methods to compen- New York Heart Association (NYHA) came up with sate for its failings and still provide the body with an a four-level classifi cation scale which is still in broad adequate supply of oxygenated blood. As the heart use around the world today.4 Although subjective continues to fail, the heart loses its ability to com- and based on symptoms, the NYHA scale has prov- pensate and starts to pump inadequately. Decom- en to be exceedingly useful in helping to quantify a pensated HF is an advanced form of HF. syndrome that seems to defy hard defi nitions. The Chronic HF (which confusingly sometimes uses NYHA scale maps the degree of exertion required to the same acronym as congestive heart failure or elicit symptoms (see Table 1.1). CHF) describes most of what we clinicians know as The American College of Cardiology (ACC) and HF. Not long ago, it was common to talk about pa- American Heart Association (AHA) proposed an tients being ‘in heart failure’ or ‘out of heart failure’ alternative classifi cation system for HF which is as if HF was something that might clear up. While not in widespread use despite its obvious clinical symptoms can be alleviated, today we recognize that value. This system allows for the classifi cation of the HF is a chronic condition. asymptomatic and mildly symptomatic patient as Systolic and diastolic HF will be discussed in more well as those with more advanced cases of HF with- detail in a later chapter, but they refer to the portion out relying on exertion to provoke symptoms. One of the cardiac cycle where the heart can no longer reason for this new classifi cation system is that we pump effectively. Systolic HF may be thought of as truly do not understand why exercise should pro- the inability to eject blood effectively during the car- voke symptoms. For instance, it has been observed diac cycle (aligning with systole), while diastolic HF that some patients with markedly impaired left- generally refers to the heart’s inability to fi ll effective- ventricular function may be asymptomatic during ly with blood prior to pumping (matching diastole). exercise. Other patients may have symptoms with While these terms and conditions are important to exercise because of mitral valve regurgitation, pul- know, systolic and diastolic HF are not mutually ex- monary disease or general poor condition. Thus, clusive. Many patients have both together and, over the presence of dyspnea with exercise is not neces- the long term, it is diffi cult to imagine a patient with sarily a reliable yardstick. systolic HF who does not have impaired diastolic The ACC and AHA have proposed another clas- function and vice versa. Thus, when the adjectives sifi cation system3 (see Table 1.2) which offers the ‘systolic’ or ‘diastolic’ appear together with HF, they tend to describe what is more dominant and observ- able in the patient at that particular point in time. Table 1.1 New York Heart Association classifi cation system Left-sided and right-sided HF are sometimes NYHA class Effort required to elicit symptoms used, but these terms do not indicate which ven- tricle is the more damaged. Left-sided HF does in- I Exertion that would limit normal individuals deed refer to the left ventricle’s ineffective pump- II Ordinary exertion ing action of blood and manifests as congestion in III Less than ordinary exertion the pulmonary veins. Right-sided HF involves im- IV Rest CHAPTER 1 Understanding Heart Failure 3 Table 1.2 American College of Cardiology (ACC)/American 1970 to 400 000 annually in 1990.5 The AHA says Heart Association (AHA) classifi cation the number in the year 2000 is 550 000 new cases a year.6 HF is one of the few forms of heart disease ACC/AHA Defi nition actually increasing in incidence. In the population class of Americans < 75 years old, men are more likely to A Patients at high risk of developing left- develop HF than women. At age ≥ 75 years, the inci- ventricular (LV) dysfunction dence becomes more balanced between the genders. B Patients with LV dysfunction who have not Hospital discharges (patients alive or dead at time developed symptoms of discharge) show that heart failure is increasing C Patients with LV dysfunction with current or over time, more than doubling from 1980 to 2003 prior symptoms D Patients with refractory end-stage HF (see Fig. 1.1). Prevalence is another public health term used to describe the number of people who have a condi- advantage of including asymptomatic (actually, it tion at any given time. HF is increasing in preva- would be more accurate to say pre-symptomatic) lence mainly because the population, overall, is patients without neglecting the progressive nature aging and HF is a chronic condition. Of people of the condition. above the age of 65, about 6–10% have some form While the presence of left-ventricular (LV) dys- of HF7 (see Fig. 1.2). As better medical treatment function is common in HF patients and is the basis allows people to live longer and as we know how to of the ACC/AHA classifi cation scale, the presence manage HF better, the prevalence of the syndrome of LV dysfunction does not defi ne HF, nor does its will continue to increase. While the incidence of HF absence preclude it. is higher among men (at least up until age 75), the prevalence statistics show that in the USA, more fe- males have HF than males. That is partly due to the Incidence, prevalence, populations fact that women live longer and that many women Incidence is a public health term used to defi ne have a less severe form of HF known as diastolic the number of new cases of a disease each year in dysfunction. a particular population. The incidence of HF has HF contributes to more than 287 000 deaths an- been growing steadily from 250 000 annually in nually. The real extent of the devastation caused by Hospital Discharges for Heart Failure by Sex 700 (United States: 1979-2003) ds 600 n a us 500 o h n T 400 es i 300 g har 200 c s Di 100 0 79 80 85 90 95 00 03 Ages Male Note: Hospital discharges include people discharged alive and dead. Female Source: National Hospital Discharge Survey, CDC/NCHS and NHLBI. Figure 1.1 Hospital discharge rates for heart failure. The number of discharges of people from US hospitals with the diagnosis of heart failure has increased steadily since 1979. The gap between male and female patients has widened over time. 4 The Nuts and Bolts of Cardiac Resynchronization Therapy Prevalence of Heart Failure by Age and Sex 10.9 11 (NHANES: 1999-2002) 9.8 9 n o ati 7 5.8 6.2 ul p o P 5 of 4.1 Percent 3 1.8 1.5 2.3 1 0.3 0.3 0.5 0.4 -1 20-34 35-44 45-54 55-64 65-74 75+ Ages Male Source: CDC/NCHS and NHLBI. Female Figure 1.2 Heart failure prevalence by age and sex. The prevalence of heart failure increases sharply with advancing age. Up to age 74, more men than women have heart failure. This reverses at ages above 75, when slightly more females have heart failure than males. Women tend to develop heart failure later in life and to live longer than men. HF is probably better captured in what it costs so- References ciety. HF costs the world about $60 billion a year and accounts for 12–15 million offi ce visits and 6.5 1 Stiles S. CARE-HF: CRT improves survival, symptoms million hospital days.8 In the USA, HF is the single and remodeling—and sometimes achieves HF “remis- most common Medicare diagnosis-related group sion”. Available at http://theheart.org/printArticle. (DRG) and Medicare spends more on HF than on do?primaryKey=399895. Accessed March 22, 2005. any other disease.9 2 Sackner-Bernstein J. Heart failure treatment options. In: Resynchronization and Defi brillation for Heart Fail- HF is a progressive disorder that can affect more ure: A Practical Approach. Hayes DL, Wang PJ, Sackner- than just the heart: it often affects the lungs, liver Bernstein J, Asirvatham SJ, eds. Oxford, UK: Blackwell and kidneys. As a patient’s functional status deterio- Futura (Blackwell Publishing) 2004:2. rates, his or her chance of survival decreases. In the 3 Hunt SJ, Baker DW, Chin MH et al. ACC/AHA Guide- earlier stages of the disease, HF is associated with a lines for the evaluation and management of chronic higher incidence of sudden cardiac death, while in heart failure in the adult: executive summary. Circula- later stages, worsening HF is more likely to be the tion 2001; 104:2996–3007. cause of death. The main objective in treating HF 4 The Criteria Committee of the New York Heart Asso- patients has been to improve symptoms, reduce the ciation. Diseases of the Heart and Blood Vessels: No- risk of death and disease progression and enhance menclature and Criteria for Diagnosis, 6th edn. Boston, MA: Little Brown 1964. the patient’s quality of life. 5 Jaski BE. Basics of Heart Failure: A Problem-Solving One of the latest innovations for HF treatment Approach. Norwell, MA: Kluwer Academic Publishers is cardiac resynchronization therapy, which is a de- 2000. vice-based treatment. However, HF requires a mul- 6 American Heart Association. 2002 Heart and Stroke tidisciplinary approach and rarely is any HF patient Statistical Update. Dallas, TX: American Heart Associa- well served by one drug or even one therapeutic tion 2001. approach. It is a complex syndrome which requires 7 ACC/AHA Guidelines for the Evaluation and Manage- careful management. ment of Heart Failure, October 24, 2002. CHAPTER 1 Understanding Heart Failure 5 8 Zevitz ME. Heart Failure. Available at http://www. 9 Weintraub NL, Chaitman BR. Newer concepts in the emedicine.com/med/topic3552.htm. Accessed April 23, medical management of patients with congestive heart 2003. failure. Clin Cardiol 1993; 16:380–390. The nuts and bolts of understanding heart failure • Heart failure (HF) is not a disease with a specifi c classifi cation system, it is not as widely used as diagnostic test. It is a complex syndrome of the NYHA classes. symptoms and conditions. • In populations < 75 years old, more men • HF is increasing in incidence and prevalence. In than women get HF every year (incidence). the USA, Medicare spends more on HF than on At ≥ 76 years old, the incidence is about equal any other condition. Worldwide, HF costs about for men and women. However, more women $60 billion annually. than men have HF at any given point in time • While there are many ‘types’ of HF, the main (prevalence), partly because women live longer one of concern for device-based therapy is and partly because they are more likely to have chronic HF. It may or may not be accompanied less severe diastolic forms of HF. by signifi cant congestion. • The hallmark symptoms of HF include • HF affects the heart’s ability to pump blood shortness of breath, fatigue and fl uid effectively. It can be systolic (impairs ability to accumulation. Exercise intolerance is frequently pump blood out) or diastolic (impairs ability of the way patients are classifi ed (the NYHA heart to fi ll with blood). Having one form of HF classifi cation system is based on symptoms that does not preclude the other. Some patients have occur based on levels of exertion). While left- both systolic and diastolic HF. ventricular (LV) dysfunction and congestion are • The most commonly used system to rank HF common in HF patients, neither one defi nes HF. patients is the New York Heart Association In fact, many people with HF may have neither (NYHA) classifi cation, where Class I is the LV dysfunction nor congestion. least symptomatic and Class IV is the most • On the other hand, LV dysfunction cannot symptomatic. These classes are not static and are occur without some degree of HF being present, based on somewhat subjective criteria. even if the patient is not (yet) symptomatic. • The American College of Cardiology (ACC)/ • The best way to think of HF is as a deterioration American Heart Association (AHA) have of the heart’s ability to pump blood effectively. proposed an alternative classifi cation system of • Many other organs can be affected by HF four stages, A–D, where A indicates patients at besides the heart, mainly the lungs, liver and high risk of developing HF and Class D end- kidneys. stage refractory HF patients. The ACC/AHA • HF is associated with many other conditions scale is based on degree of left-ventricular (co-morbidities), including diabetes, dysfunction. Although this is an important hypertension and atrial fi brillation.

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