Blood Pressure Monitoring in Cardiovascular Medicine and Therapeutics Second Edition EEDDIITTEEDD BBYY William B. White, MMDD B P M C M LOOD RESSURE ONITORING IN ARDIOVASCULAR EDICINE T AND HERAPEUTICS C H LINICAL YPERTENSION V D AND ASCULAR ISEASES W B. W , ILLIAM HITE MD SERIESEDITOR Blood Pressure Monitoring in Cardiovascular Medicine and Therapeutics,Second Edition,edited by William B. White,MD, 2007 Hypertension in the Elderly,edited by L. Michael Prisant, MD, 2005 Lower Extremity Arterial Disease, edited by Dennis G. Caralis, MD, PhD, MPH, and George L. Bakris, MD, 2005 Secondary Hypertension, Clinical Presentation, Diagnosis, and Treatment, edited by George A. Mansoor, MD, 2004 Pediatric Hypertension, edited by Ronald J. Portman, MD, Jonathan M. Sorof, MD, and Julie R. Ingelfinger, MD, 2004 B P LOOD RESSURE M ONITORING C IN ARDIOVASCULAR M EDICINE T AND HERAPEUTICS Second Edition Edited by W B. W , ILLIAM HITE MD Section of Hypertension and Clinical Pharmacology, University of Connecticut School of Medicine, Farmington, CT ©2007 Humana Press Inc. 999 Riverview Drive,Suite 208 Totowa,New Jersey 07512 humanapress.com For additional copies, pricing for bulk purchases, and/or information about other Humana titles, contact Humana at the above address or at any of the following numbers: Tel.: 973-256-1699; Fax:973-256-8341,E-mail:[email protected]; or visit our Website:www.humanapress.com All rights reserved. No part of this book may be reproduced,stored in a retrieval system,or transmitted in any form or by any means, electronic,mechanical,photocopying,microfilming,recording,or otherwise without written permission from the Publisher. All articles,comments,opinions,conclusions,or recommendations are those of the author(s),and do not necessarily reflect the views of the publisher. 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Further it is the responsibility of the health care provider to ascertain the Food and Drug Administration status of each drug or device used in their clinical practice. The publisher,editors,and authors are not responsible for errors or omissions or for any consequences from the application of the information presented in this book and make no warranty,express or implied,with respect to the contents in this publication. Production Editor:Jennifer Hackworth. This publication is printed on acid-free paper. ∞ ANSI Z39.48-1984 (American National Standards Institute) Permanence of Paper for Printed Library Materials. Photocopy Authorization Policy: Authorization to photocopy items for internal or personal use,or the internal or personal use of specific clients, is granted by Humana Press Inc.,provided that the base fee of US $30.00 per copy is paid directly to the Copyright Clearance Center at 222 Rosewood Drive,Danvers,MA 01923. For those organizations that have been granted a photocopy license from the CCC,a separate system of payment has been arranged and is acceptable to Humana Press Inc. The fee code for users of the Transactional Reporting Service is:[1-58829- 512-5/07 $30.00]. Printed in the United States of America. 10 9 8 7 6 5 4 3 2 1 eISBN:1-59259-978-8 ISBN13:978-1-58829-512-5 Library of Congress Control Number:2007926032 Foreword It is about 30 years since the development of the first practical non- invasive devices for repetitively measuring blood pressures in people undertaking their usual daily activities. For those of us involved at the beginning of this technology, this important new book—comprehensively detailing the current state of the art—inevitably brings back memories of the early days when moni- toring devices were large, complicated and uncertain. One of the first supporters of this science was NASA’s manned space program. I still vividly recall engineers from a nearby device company borrowing my laboratory as they labored intently to prepare a blood pressure monitor- ing instrument, aided by the highly motivated astronaut who was to wear it during his forthcoming space mission. Remarkably, the proto- type appeared to work at least as well in orbit as it did on the ground. The concept of ambulatory blood pressure monitoring has always been beguiling. It certainly has provided insights into the physiology of blood pressure, including its diurnal changes. During the last several years the monitoring equipment has improved in important ways:it has become far simpler to use,more reliable in its operation and more flex- ible in gathering data. From the point of view of the patient, reductions in the size and weight of the devices have added greatly to their practicality. Despite this progress, however, not all available automated technologies for monitoring blood pressure provide acceptable accuracy and repro- ducibility, and appropriately a major section of this text deals with the processes for validating and recommending these instruments. This highly authoritative publication is the Second Edition of a work first published by Dr William White in 2000. Like its predecessor, it will become an indispensable source of information and reference in the field of ambulatory monitoring. Dr White is uniquely qualified for the task of bringing together and editing the contributions of the renowned group of experts who have joined him in writing this book. Not only has his own personal research contributed strongly to the knowledge that guides this discipline, but for many years he has been the Editor-in-Chief of Blood Pressure Monitoring, the principal peer- reviewed publication dealing with this area of clinical science. v vi Foreword There continues to be a notable expansion in the applications of blood pressure monitoring. Its use in clinical practice has grown signi- ficantly, particularly as official hypertension guidelines have now acknowledged its value for the accurate diagnosis of hypertension. This technology can be valuable in detecting white-coat hypertension,a con- dition where blood pressure is misleadingly high in the office or clinic, but normal when measured elsewhere. As well, patients with so-called masked hypertension, whose blood pressures are atypically low in the clinical setting, can be identified by this method. One of the charms of ambulatory blood pressure monitoring is that it is one of the few medical tests that patients can largely interpret for themselves. Reviewing blood pressure values obtained over the 24 hour period allows patients, together with their physicians, to understand clearly whether or not they are hypertensive. And, if the evidence hap- pens to point to the existence of hypertension, these informed patients will often become just as committed as their professional advisors to achieving effective treatment. Whole-day monitoring data have also emerged as strong tools for exploring epidemiology. As the book discusses in detail, these meas- urements are more powerful in predicting major cardiovascular out- comes than conventional blood pressure readings. What’s more,certain periods of the 24 hour pattern—for instance, the night-time readings, and whether they exhibit the expected physiologic reductions during sleep—can be of strong prognostic value. Even the rate-of-rise in blood pressure during the morning arousal period may be linked to the likeli- hood of major cardiovascular events. Research into the factors that regu- late blood pressure profiles during the different portions of the day could ultimately lead to better-directed therapeutic strategies in hyper- tensive patients at risk. Ambulatory blood pressure monitoring has become an indispensable part of studying drugs and potentially other treatments of hypertension. For a start, by ensuring that only truly hypertensive patients are included in clinical trials—thereby avoiding the dilutional effects on data of including patients with white coat hypertension—monitoring enhances the accuracy of quantifying blood pressure changes. Importantly, this technique virtually abolishes placebo effects. Additionally,its reproducibility reduces the number of patients needed to provide the statistical power for discriminating differences in achieved blood pressures among comparative treatment groups. Foreword vii In many ways this book documents the maturing of ambulatory monitoring into an integral and vital part of clinical practice and research in hypertension. But it is far more than just a celebration of the great progress made in the field during recent years. Dr White brings us up to date with the insight and knowledge that can only come from one of the true pioneers and leaders in this work. For those who seek infor- mation about ambulatory blood pressure monitoring, and certainly for those who plan to use it, reading this new edition of William White’s book will be an invaluable experience. Michael A. Weber, MD State University of New York Downstate College of Medicine Brooklyn, New York Preface The second edition of Blood Pressure Monitoring in Cardiovascular Medicine and Therapeutics is devoted to the topic of circadian variation in cardiovascular disease,with a special emphasis on the evaluation and treatment of hypertension. Clinical and device research related to self and ambulatory monitoring of the blood pressure and heart rate have led to significant advances in our ability to detect various clinical enti- ties in patients with hypertension and its vascular complications. This research is important not only because hypertension is such a common problem among adults in industrialized countries, but also because the cardiovascular morbidity and mortality associated with the hyperten- sive disease process is so great. Since the first edition of this book in 2000, research efforts in basic and clinical hypertension have continued to accelerate and work devoted to the measurement of blood pressure and blood pressure vari- ability has also remained productive with new evaluations of devices, novel drug therapies, and outcomes research in cohort and population studies. During the past 6 years,numerous important research papers in the field of ambulatory blood pressure monitoring have been published and annual international consensus conferences have been held at the European and International Society of Hypertension meetings. Thus,it remains important and clinically relevant to devote a second edition of this book that updates research findings involving blood pressure mon- itoring and cardiovascular therapeutics. The five chapters in Part I describe the methodology of self and ambulatory blood pressure monitoring in research and clinical practice. Dr. Pickering presents a comprehensive assessment of the utility of self blood pressure measurement for clinical practice by evaluating the validity of the devices, reviewing the epidemiologic data that are avail- able,and discussing the potential for this technique in clinical trials and for the general management of patients. Drs. James and Mansoor describe the importance of diaries and physical activity recordings in cardiovascular disease. These techniques are crucial for obtaining mean- ingful data during ambulatory blood pressure recordings in clinical trials. Advances in actigraphy research have allowed investigators to pinpoint changes in physical activity that may directly impact on blood pressure ix x Preface variability. Dr. Krishnan and I have written an overview of ambulatory monitoring of the blood pressure,including descriptions of device vali- dation, patterns of blood pressure variation discovered with the advent of this technique, and usefulness of the methodology in clinical hyper- tension. Drs. O’Brien and Atkins have written a chapter on the impor- tance of device validation and their reliability. The importance of device validation cannot be over-estimated as it eventually can have an effect on the overall validity of clinical trials using the recorders. The seven chapters in Part II describe a number of advances in our understanding of the pathophysiology of the circadian biology of car- diovascular disorders. Drs. Portaluppi and Smolensky begin with an overview of the chronobiology of blood pressure regulation in humans. This chapter lays the groundwork for the rest of this section with its comprehensive discussion of the progress that has been made in research involving the chronophysiology of human disease with major emphases on hypertension, coronary artery disease, and stroke. Drs. Celis, Staessen, Palatini, Angeli, Schillaci and Verdecchia present a number of epidemiologic and prognostic studies that examine the importance of blood pressure and heart rate ability as determinants of cardiovascular morbidity and mortality. During the past decade, the field of ambulatory blood pressure monitoring has advanced dramati- cally owing to the completion and publication of major prospective studies that relate circadian blood pressure to cardiovascular outcomes. These studies show convincingly that ambulatory blood pressure values are independent predictors of cardiovascular morbidity and mortality. Drs. Sica and Wilson have examined the available data on the role of neurohormonal activity, salt sensitivity, and the renin–angiotensin sys- tem on blood pressure variability,especially as it relates to the blunting of the nocturnal decline in pressure. Drs. Shea and Muller have reported on the circadian variation of myocardial infarction and cardiovascular death. These authors remind us of the need to identify acute causes of sudden death and myocardial infarction since coronary disease remains the leading cause of death in so many countries around the globe. Drs. Vagaonescu and Phillips con- clude this section by providing a review of the data on the relationship between blood pressure variability and stroke,as well as discussing the seasonal and daily variations in the incidence of stroke. The 4 chapters in Part III are all new in this Edition and focus on ambulatory blood pressure in special populations of patients with hypertension: Dr. Prisant covers the older patient who has systolic