(Hypertension. 2000;35:1037.)
© 2000 American Heart Association, Inc.
Scientific Contributions |
Blood Pressure–Measuring Devices
Time to Open Pandora’s Box and Regulate
From the Study Coordinating Center, Hypertension and Cardiovascular Rehabilitation Unit, Department of Molecular and Cardiovascular Research, University of Leuven (Belgium).
Correspondence to Jan A. Staessen, MD, PhD, Study Coordinating Center, Hypertension and Cardiovascular Rehabilitation Unit, Department of Molecular and Cardiovascular Research, University of Leuven, Campus Gasthuisberg, Herestraat 49, B-3000 Leuven, Belgium. E-mail jan.staessen{at}med.kuleuven.ac.be
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 Top Introduction References |
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Rose and colleagues1 found that the DINAMAP models 1846-SX and 1846-SX/P (Critikon Corp) systematically skip 14 values of systolic blood pressure, of which some (140 and 160 mm Hg) are critical in the diagnosis and treatment of hypertension. The findings of Rose and colleagues1 come as no surprise. The DINAMAP 8100 failed to pass validation.2 Furthermore, to protect their intellectual and commercial interests, most-if not all-manufacturers of blood pressure monitors operate in secrecy. Against current recommendations,3 they modify the technical specifications and software of devices without notice or fail to subject new or modified devices to independent peer-reviewed validation in a timely manner.4 Guideline committees3 5 6 have repeatedly demanded that producers submit their algorithms to expert panels, so that the underlying physiological and physical principles can be verified and so that the proprietary software can be checked for accuracy. Too many companies mislead doctors and the general public by marketing nonvalidated devices, which sometimes measure blood pressure at anatomic sites other than the brachial artery, a procedure that is prone to error and far from generally endorsed.6 Other commercial groups, regardless of validation, sell machines for blood pressure self-measurement through public outlets without providing buyers any proper training or information on the limitations of their use. Instructions for professionals as well as other consumers also should be better standardized; they should include guidelines for calibration and state a guaranteed lifetime of accurate use.
Over the past decade, blood pressure measurement by ambulatory monitoring or self-measurement gained wide acceptance in clinical and experimental medicine.6 7 The banning of the mercury sphygmomanometer will make clinical decisions even more dependent on devices for automated blood pressure measurement.8 These machines are most useful in identifying patients with white-coat hypertension6 7 9 and will increasingly be used to avert or postpone antihypertensive drug treatment.6 7 9 Because, so to speak, they will become substitutes for pharmacological treatment, they should adhere to the same quality standards and licensing procedures. Regulatory organizations should guarantee the accuracy of blood pressure–measuring devices, oversee their independent verification and certification, and provide rules for their distribution and use. Such regulations are equally needed for professional and lay consumers and for clinical practice and medical research. Ultimately, a doctor’s or a patient’s perception of cardiovascular risk and consequently the quality and the duration of life of many people rely on the correct assessment of blood pressure, not only in the medical environment but also at home or under ambulatory conditions.
Long-term outcome studies with a design similar to that of the Ambulatory Blood Pressure Monitoring and Treatment of Hypertension (APTH) Trial9 should firmly establish the advantage of further integrating ambulatory blood pressure monitoring or the self-measurement of blood pressure into the routine care of hypertensive patients. These studies would also provide much-needed information on the long-term cost-effectiveness of these techniques. Because such trials are unlikely to be funded by the pharmaceutical industry, governments, health insurance companies, and above all, manufacturers, should assume responsibility in this regard. It would be of particular interest to hear the opinion of the Food and Drug Administration on these issues.
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Footnotes |
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The opinions expressed in this editorial are not necessarily those of the editors or of the American Heart Association.
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References |
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TopIntroductionReferences |
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1. Rose KM, Arnett DK, Curtis Ellison C, Heiss G. Skip patterns in DINAMAP-measured blood pressure in 3 epidemiologic studies. Hypertension.. 2000;35:1032–1036.
2. O’Brien E, Em F, Atkins N, O’Malley K. Short report: Accuracy of the DINAMAP portable monitor, model 8100 determined by the British Hypertension Society protocol. J Hypertens. 1993;11:761–763.[Medline] [Order article via Infotrieve]
3. O’Brien E, Petrie J, Littler WA, de Swiet M, Padfield PL, Altman D, Bland M, Coats A, Atkins N. The British Hypertension Society protocol for the evaluation of blood pressure measuring devices. J Hypertens. 1993;11(suppl 2):S43–S63.
4. Hansen KW, Orskov H. A plea for consistent reliability in ambulatory blood pressure monitors: a reminder. J Hypertens. 1992;10:1313–1315.[Medline] [Order article via Infotrieve]
5.
Staessen JA, Fagard R, Thijs L, Amery A,
Participants in The Fourth International Consensus Conference on
24-Hour Ambulatory Blood Pressure Monitoring. A consensus view on the
technique of ambulatory blood pressure monitoring.
Hypertension. 1995;26:912–918.
6.
Joint National Committee on Prevention Detection
Evaluation, and Treatment of High Blood Pressure. The Sixth report of
the Joint National Committee on Prevention, Detection, Evaluation, and
Treatment of High Blood Pressure. Arch Intern Med. 1997;157:2413–2446.
7. Staessen JA, Beilin L, Parati G, Waeber B, White W, and Participants of the 1999 Consensus Conference on Ambulatory Blood Pressure Monitoring. Clinical use of ambulatory blood pressure monitoring. Blood Press Monit.. 1999;4:319–331.[Medline] [Order article via Infotrieve]
8. O’Brien E. Will the millimeter of mercury be replaced by the kilopascal? J Hypertens. 1998;16:259–261.[Medline] [Order article via Infotrieve]
9.
Staessen JA, Byttebier G, Buntinx F, Celis H,
O’Brien ET, Fagard R, for the Ambulatory Blood Pressure Monitoring and
Treatment of Hypertension Investigators. Antihypertensive treatment
based on conventional or ambulatory blood pressure measurement: a
randomized controlled trial. JAMA. 1997;278:1065–1072.
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