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1.
J Hypertens ; 2024 Apr 12.
Article in English | MEDLINE | ID: mdl-38690949

ABSTRACT

Hypertensive disorders in pregnancy (HDP), remain the leading cause of adverse maternal, fetal, and neonatal outcomes. Epidemiological factors, comorbidities, assisted reproduction techniques, placental disorders, and genetic predisposition determine the burden of the disease. The pathophysiological substrate and the clinical presentation of HDP are multifarious. The latter and the lack of well designed clinical trials in the field explain the absence of consensus on disease management among relevant international societies. Thus, the usual clinical management of HDP is largely empirical. The current position statement of the Working Group 'Hypertension in Women' of the European Society of Hypertension (ESH) aims to employ the current evidence for the management of HDP, discuss the recommendations made in the 2023 ESH guidelines for the management of hypertension, and shed light on controversial issues in the field to stimulate future research.

4.
Hypertension ; 80(7): 1417-1426, 2023 07.
Article in English | MEDLINE | ID: mdl-37315119

ABSTRACT

BACKGROUND: Sex differences in blood pressure control are recognized. We systematically investigated sex differences in specific components of ambulatory blood pressure (ABP), including variability, day-night changes, morning surge, and hypertension types. METHODS: We analyzed ABPs of 52 911 participants (45.6% male, 54.4% female, 37.0% treated for hypertension) visiting 860 Italian community pharmacies. Sex differences in ABP levels and patterns were evaluated in the whole group and 4 risk groups (antihypertensive-treated patients, patients with diabetes, dyslipidemia, or cardiovascular disease). RESULTS: Average 24-hour, day-time, and night-time blood pressure values were consistently higher in males than females (P<0.001). Variability in ABP was higher in females, except during the night. Nondippers and an abnormal morning surge were more common among males (odds ratio and 95% CI, 1.282 [1.230-1.335] and 1.244 [1.159-1.335]; P<0.001). The prevalence of 24-hour and masked hypertension was higher in males (odds ratio and 95% CI, 2.093 [2.019-2.170] and 1.347 [1.283-1.415]; P<0.001) and that of white-coat hypertension in females (0.719 [0.684-0.755]; P<0.001). Ambulatory heart rate mean values were higher (P<0.001) in females. Day-time HR variability was higher and night-time heart rate variability lower in females (P<0.001). Sex differences in ABP levels and patterns detected in the whole population were replicated in all risk groups, except for the prevalence of abnormal morning surge (between sexes difference in antihypertensive-treated participants only). CONCLUSIONS: Females show better ABP control than males, but with an increased blood pressure variability and a greater prevalence of white-coat hypertension. These findings support tailored management of hypertension. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT03781401.


Subject(s)
Hypertension , Masked Hypertension , White Coat Hypertension , Female , Humans , Male , Antihypertensive Agents/therapeutic use , Blood Pressure , Blood Pressure Monitoring, Ambulatory , Hypertension/diagnosis , Hypertension/drug therapy , Hypertension/epidemiology , Sex Characteristics , White Coat Hypertension/diagnosis , White Coat Hypertension/epidemiology
5.
J Hypertens ; 41(12): 2088-2094, 2023 12 01.
Article in English | MEDLINE | ID: mdl-37303225

ABSTRACT

OBJECTIVE: To develop scientific consensus recommendations for the optimal design and functions of different types of blood pressure (BP) measuring devices used in clinical practice for the detection, management, and long-term follow-up of hypertension. METHODS: A scientific consensus meeting was performed by the European Society of Hypertension (ESH) Working Group on BP Monitoring and Cardiovascular Variability and STRIDE BP (Science and Technology for Regional Innovation and Development in Europe) during the 2022 Scientific Meeting of the ESH in Athens, Greece. Manufacturers were also invited to provide their feedback on BP device design and development. Thirty-one international experts in clinical hypertension and BP monitoring contributed to the development of consensus recommendations on the optimal design of BP devices. STATEMENT: International consensus was reached on the requirements for the design and features of five types of BP monitors, including office (or clinic) BP monitors, ambulatory BP monitors, home BP monitors, home BP telemonitors, and kiosk BP monitors for public spaces. For each device type "essential" requirements (must have), and "optional" ones (may have) are presented, as well as additional comments on the optimal device design and features. CONCLUSIONS: These consensus recommendations aim at providing manufacturers of BP devices with the requirements that are considered mandatory, or optional, by clinical experts involved in the detection and management of hypertension. They are also directed to administrative healthcare personnel involved in the provision and purchase of BP devices so that they can recommend the most appropriate ones.


Subject(s)
Blood Pressure Determination , Hypertension , Humans , Blood Pressure , Reproducibility of Results , Hypertension/diagnosis , Hypertension/therapy , Sphygmomanometers , Blood Pressure Monitoring, Ambulatory
6.
J Med Syst ; 47(1): 34, 2023 Mar 11.
Article in English | MEDLINE | ID: mdl-36905441

ABSTRACT

Hypertension (HT) continues to be a leading cause of cardiovascular death and an enormous burden on the healthcare system. Although telemedicine may provide improved blood pressure (BP) monitoring and control, it remains unclear whether it could replace face-to-face consultations in patients with optimal BP control. We hypothesized that an automatic drug refill coupled with a telemedicine system tailored to patients with optimal BP would lead to non-inferior BP control. In this pilot, multicenter, randomized control trial (RCT), participants receiving anti-HT medications were randomly assigned (1:1) to either the telemedicine or usual care group. Patients in the telemedicine group measured and transmitted their home BP readings to the clinic. The medications were refilled without consultation when optimal control (BP < 135/85 mmHg) was confirmed. The primary outcome of this trial was the feasibility of using the telemedicine app. Office and ambulatory BP readings were compared between the two groups at the study endpoint. Acceptability was assessed through interviews with the telemedicine study participants. Overall, 49 participants were recruited in 6 months and retention rate was 98%. Participants from both groups had similar BP control (daytime systolic BP: 128.2 versus 126.9 mmHg [telemedicine vs. usual care], p = 0.41) and no adverse events. Participants in the telemedicine group had fewer general outpatient clinic attendances (0.8 vs. 2, p < 0.001). Interviewees reported that the system was convenient, timesaving, cost saving, and educational. The system could be safely used. However, the results must be verified in an adequately powered RCT. Trial registration: NCT04542564.


Subject(s)
Hypertension , Telemedicine , Humans , Pilot Projects , Feasibility Studies , Hypertension/drug therapy , Telemedicine/methods , Blood Pressure , Primary Health Care , Blood Pressure Monitoring, Ambulatory/methods
7.
J Hypertens ; 41(4): 527-544, 2023 04 01.
Article in English | MEDLINE | ID: mdl-36723481

ABSTRACT

Blood pressure is not a static parameter, but rather undergoes continuous fluctuations over time, as a result of the interaction between environmental and behavioural factors on one side and intrinsic cardiovascular regulatory mechanisms on the other side. Increased blood pressure variability (BPV) may indicate an impaired cardiovascular regulation and may represent a cardiovascular risk factor itself, having been associated with increased all-cause and cardiovascular mortality, stroke, coronary artery disease, heart failure, end-stage renal disease, and dementia incidence. Nonetheless, BPV was considered only a research issue in previous hypertension management guidelines, because the available evidence on its clinical relevance presents several gaps and is based on heterogeneous studies with limited standardization of methods for BPV assessment. The aim of this position paper, with contributions from members of the European Society of Hypertension Working Group on Blood Pressure Monitoring and Cardiovascular Variability and from a number of international experts, is to summarize the available evidence in the field of BPV assessment methodology and clinical applications and to provide practical indications on how to measure and interpret BPV in research and clinical settings based on currently available data. Pending issues and clinical and methodological recommendations supported by available evidence are also reported. The information provided by this paper should contribute to a better standardization of future studies on BPV, but should also provide clinicians with some indications on how BPV can be managed based on currently available data.


Subject(s)
Coronary Artery Disease , Hypertension , Humans , Blood Pressure , Clinical Relevance , Hypertension/diagnosis , Hypertension/drug therapy , Hypertension/complications , Blood Pressure Determination , Coronary Artery Disease/complications , Blood Pressure Monitoring, Ambulatory
9.
Eur Heart J ; 43(46): 4777-4788, 2022 12 07.
Article in English | MEDLINE | ID: mdl-36136303

ABSTRACT

There is strong evidence that sex chromosomes and sex hormones influence blood pressure (BP) regulation, distribution of cardiovascular (CV) risk factors and co-morbidities differentially in females and males with essential arterial hypertension. The risk for CV disease increases at a lower BP level in females than in males, suggesting that sex-specific thresholds for diagnosis of hypertension may be reasonable. However, due to paucity of data, in particularly from specifically designed clinical trials, it is not yet known whether hypertension should be differently managed in females and males, including treatment goals and choice and dosages of antihypertensive drugs. Accordingly, this consensus document was conceived to provide a comprehensive overview of current knowledge on sex differences in essential hypertension including BP development over the life course, development of hypertension, pathophysiologic mechanisms regulating BP, interaction of BP with CV risk factors and co-morbidities, hypertension-mediated organ damage in the heart and the arteries, impact on incident CV disease, and differences in the effect of antihypertensive treatment. The consensus document also highlights areas where focused research is needed to advance sex-specific prevention and management of hypertension.


Subject(s)
Hypertension , Sex Characteristics , Female , Humans , Male , Hypertension/epidemiology
10.
Heart Lung Circ ; 31(10): 1333-1340, 2022 Oct.
Article in English | MEDLINE | ID: mdl-35934633

ABSTRACT

Hypertension continues to be the leading modifiable risk factor for stroke, kidney disease and cardiovascular disease, and it also plays a key role in a significant proportion of preventable deaths globally. Ambulatory blood pressure monitoring (ABPM) is an underutilised tool that augments the accurate diagnosis of hypertension. Out-of-office blood pressure measurements such as ABPM, permits the diagnosis of white coat hypertension and masked hypertension as well as determining a patient's nocturnal dipping status. These common clinical phenotypes have relevance with regard to clinical outcomes and may impact management. Overall, the diagnosis and management of hypertension presents numerous challenges, requiring the complementary use of multimodal blood pressure monitoring. Familiarity with the use of ABPM is important in the optimal management of patients, particularly as it becomes more accessible with the recent introduction of a Medicare Benefits Schedule item number.


Subject(s)
Hypertension , Masked Hypertension , Aged , Blood Pressure , Blood Pressure Monitoring, Ambulatory , Humans , Masked Hypertension/diagnosis , Medicare , Risk Factors , United States
11.
Minerva Cardiol Angiol ; 70(6): 641-651, 2022 Dec.
Article in English | MEDLINE | ID: mdl-35212510

ABSTRACT

The challenges to academic and professional development and career advancement of women in cardiology (WIC), imposed by the pandemic, not only impinge the female cardiologists' "leaky pipeline" but also make the "leakiness" more obvious. This consensus document aims to highlight the pandemic challenges WIC face, raise awareness of the gender equity gap, and propose mitigating actionable solutions derived from the data and experiences of an international group of female cardiovascular clinicians and researchers. This changing landscape has led to the need for highly specialized cardiologists who may have additional training in critical care, imaging, advanced heart failure, or interventional cardiology. Although women account for most medical school graduates, the number of WIC, particularly in mentioned sub-specialties, remains low. Moreover, women have been more affected by systemic issues within these challenging work environments, limiting their professional progression, career advancement, and economic potential. Therefore, it is imperative that tangible action points be noted and undertaken to ensure the representation of women in leadership, advocacy, and decision-making, and increase diversity in academia. Strategies to mitigate the negative impacts of the pandemic need to be taken during this COVID-19 pandemic to ensure WIC have a place in the field of Cardiology.


Subject(s)
COVID-19 , Cardiologists , Cardiology , Heart Failure , Humans , Female , Pandemics/prevention & control , Cardiology/education , Cardiologists/education
13.
J Hypertens ; 39(9): 1742-1767, 2021 09 01.
Article in English | MEDLINE | ID: mdl-34269334

ABSTRACT

The present paper provides an update of previous recommendations on Home Blood Pressure Monitoring from the European Society of Hypertension (ESH) Working Group on Blood Pressure Monitoring and Cardiovascular Variability sequentially published in years 2000, 2008 and 2010. This update has taken into account new evidence in this field, including a recent statement by the American Heart association, as well as technological developments, which have occurred over the past 20 years. The present document has been developed by the same ESH Working Group with inputs from an international team of experts, and has been endorsed by the ESH.


Subject(s)
Blood Pressure Monitoring, Ambulatory , Hypertension , Blood Pressure , Blood Pressure Determination , Humans , Hypertension/diagnosis , Societies, Medical
14.
Lancet ; 397(10292): 2385-2438, 2021 06 19.
Article in English | MEDLINE | ID: mdl-34010613

ABSTRACT

Cardiovascular disease is the leading cause of death in women. Decades of grassroots campaigns have helped to raise awareness about the impact of cardiovascular disease in women, and positive changes affecting women and their health have gained momentum. Despite these efforts, there has been stagnation in the overall reduction of cardiovascular disease burden for women in the past decade. Cardiovascular disease in women remains understudied, under-recognised, underdiagnosed, and undertreated. This Commission summarises existing evidence and identifies knowledge gaps in research, prevention, treatment, and access to care for women. Recommendations from an international team of experts and leaders in the field have been generated with a clear focus to reduce the global burden of cardiovascular disease in women by 2030. This Commission represents the first effort of its kind to connect stakeholders, to ignite global awareness of sex-related and gender-related disparities in cardiovascular disease, and to provide a springboard for future research.


Subject(s)
Cardiovascular Diseases , Cost of Illness , Goals , Internationality , Women's Health , Awareness , Cardiovascular Diseases/epidemiology , Cardiovascular Diseases/mortality , Female , Humans , Risk Factors , Socioeconomic Factors , Women's Health/statistics & numerical data , Women's Health/trends
16.
Sleep Med ; 80: 294-300, 2021 04.
Article in English | MEDLINE | ID: mdl-33610954

ABSTRACT

BACKGROUND: Obstructive sleep apnoea (OSA) is associated with increased blood pressure variability (BPV) and are risk factors for cardiovascular disease. We aimed to assess the comparative effects of two OSA therapies, continuous positive airway pressure (CPAP) and mandibular advancement splint (MAS), on BPV. METHODS: This is a secondary analysis of data collected as part of a previously published randomised crossover trial of one month each of CPAP and MAS therapy. BPV was determined from 24-h-ambulatory blood pressure recordings in 92 patients with moderate to severe OSA at baseline and after one month of optimised treatment with each modality. BPV was assessed by three measures: Standard deviation of the mean (SD), Coefficient of variation (CoV), and the Average Real Variability (ARV) index. RESULTS: Neither CPAP nor MAS therapy improved BPV, with no difference between treatments. BPV did not change in hypertensive OSA patients, however, there was a reduction in ARV of diastolic blood pressure in the effectively treated compared to ineffectively treated CPAP patients, Δ ARV 24-h-DBP (mmHg), -0.72 ± 2.14, 0.34 ± 1.52, P = 0.02, respectively. There was no difference between effective versus ineffective MAS treatment, Δ ARV 24-h-DBP (mmHg), -0.04 ± 2.4, 0.02 ± 1.9, P = 1.00, respectively. CONCLUSIONS: One month of optimised CPAP or MAS therapy did not improve short term BPV in patients with moderate to severe OSA. The subgroup of patients on effective CPAP showed some improvement in BPV with CPAP but not MAS. Further work on the effect of OSA therapy on BPV following long-term therapy is needed.


Subject(s)
Blood Pressure , Continuous Positive Airway Pressure , Mandibular Advancement , Occlusal Splints , Sleep Apnea, Obstructive , Blood Pressure Monitoring, Ambulatory , Cross-Over Studies , Humans , Sleep Apnea, Obstructive/therapy
17.
J Clin Hypertens (Greenwich) ; 22(11): 1995-2003, 2020 11.
Article in English | MEDLINE | ID: mdl-32941678

ABSTRACT

Clinic blood pressure (BP) measurement remains a crucial step in managing hypertension. While the number of measures recorded in different settings varies, with typically 1-3 measures, there has been no prior justification for the actual number of measures required. We investigated the pattern of BP variability over 5 consecutive automated readings (R1-R5) and the influence of patient characteristics on this pattern to identify the phenotype of hypertension in a Middle Eastern population. There were 1389 outpatients (51% men, 49% women), age range (18-87 y) who had 5 unattended automated consecutive BP measurements with one-minute intervals using the validated Datascope Mindray Passport V Monitor with the patient blinded from the results. Mean (±SEM) SBP for R1 (136.0 ± 2 mm Hg) was similar to R2 (136.2 ± 2 mm Hg). Thereafter SBP progressively declined till R5 by total of 5.5 mm Hg. The SBP decline was less (4.2 mm Hg) in older (>50 years) vs younger participants (8.1 mm Hg; P < .001) and was blunted in diabetic and hypertensive participants. Overall, 43% of participants had R2 > R1, and 24% additionally had R5 > R1. Age was a strong independent predictor of having both R2 > R1 and R5 > R1, as well as diabetes. Diastolic blood pressure (DBP) decreased by average 2.8 mm Hg from R1 to R5. Females had a 5-fold greater total decline in DBP vs males (P < .001). Using the mean of 5 BP measures resulted in fewer participants being classified as hypertensive (36% of the population) compared to using one measurement (46%), or established BP guidelines which use different combinations of R1-R3 (37%-42%). Our findings in a Middle Eastern population highlight the importance of the BP measurement protocol in combination with patient characteristics in determining whether a patient is diagnosed with hypertension. Protocols that rely on different combinations of only 3 measures (R1-3) will classify more participants as hypertensive, compared to using 5 measures or disregarding a high R2.


Subject(s)
Hypertension , Adolescent , Adult , Aged , Aged, 80 and over , Blood Pressure , Blood Pressure Determination , Female , Humans , Hypertension/diagnosis , Hypertension/epidemiology , Male , Middle Aged , Phenotype , Young Adult
18.
Clin J Am Soc Nephrol ; 15(8): 1129-1138, 2020 08 07.
Article in English | MEDLINE | ID: mdl-32675281

ABSTRACT

BACKGROUND AND OBJECTIVES: Elevated BP is an important risk factor for cardiovascular disease, with a prevalence of over 80% in patients undergoing maintenance dialysis. We assessed the comparative BP-lowering efficacy and the safety of BP-lowering drugs in patients undergoing maintenance dialysis. DESIGN, SETTINGS, PARTICIPANTS, & MEASUREMENTS: We performed a frequentist random effects network meta-analysis of randomized, controlled trials evaluating BP-lowering agents in adult patients undergoing maintenance dialysis. Electronic databases (CENTRAL, MEDLINE, and Embase) were systematically searched (up to August 2018) for relevant trials. The main outcome was systolic BP reduction. RESULTS: Forty trials (4283 participants) met our inclusion criteria. Angiotensin-converting enzyme inhibitors, ß-blockers, calcium-channel blockers, and aldosterone antagonists lowered systolic BP to a greater extent than placebo, with effect sizes ranging from -10.8 mm Hg (95% confidence interval, -14.8 to -6.7 mm Hg) for the aldosterone antagonists to -4.3 mm Hg (95% confidence interval, -7.2 to -1.5 mm Hg) for angiotensin-converting enzyme inhibitors. Aldosterone antagonists and ß-blockers were superior to angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, calcium-channel blockers, and renin inhibitors at lowering systolic BP. Compared with angiotensin-converting enzyme inhibitors, aldosterone antagonists and ß-blockers lowered systolic BP by 6.4 mm Hg (95% confidence interval, -11.4 to -1.4 mm Hg) and 4.4 mm Hg (95% confidence interval, -7.4 to -1.3 mm Hg), respectively. Systolic BP reduction was not different with angiotensin receptor blockers, α-blockers, and calcium-channel blockers compared with angiotensin-converting enzyme inhibitors. Renin inhibitors were less effective. Angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, and aldosterone antagonists incurred risks of drug discontinuation due to adverse events and hypotension. CONCLUSIONS: BP-lowering agents significantly reduced systolic BP in patients undergoing maintenance dialysis. ß-Blockers and aldosterone antagonists may confer larger reductions, although treatment with aldosterone antagonists may be limited by adverse events.


Subject(s)
Antihypertensive Agents/therapeutic use , Blood Pressure/drug effects , Hypertension/drug therapy , Kidney/physiopathology , Renal Insufficiency, Chronic/therapy , Adult , Aged , Antihypertensive Agents/adverse effects , Antihypertensive Agents/classification , Comparative Effectiveness Research , Female , Humans , Hypertension/diagnosis , Hypertension/epidemiology , Hypertension/physiopathology , Male , Middle Aged , Network Meta-Analysis , Randomized Controlled Trials as Topic , Renal Insufficiency, Chronic/diagnosis , Renal Insufficiency, Chronic/epidemiology , Renal Insufficiency, Chronic/physiopathology , Time Factors , Treatment Outcome
19.
Rev Panam Salud Publica ; 44: e21, 2020.
Article in Spanish | MEDLINE | ID: mdl-32117468

ABSTRACT

The Lancet Commission on Hypertension identified that a key action to address the worldwide burden of high blood pressure (BP) was to improve the quality of BP measurements by using BP devices that have been validated for accuracy. Currently, there are over 3 000 commercially available BP devices, but many do not have published data on accuracy testing according to established scientific standards. This problem is enabled through weak or absent regulations that allow clearance of devices for commercial use without formal validation. In addition, new BP technologies have emerged (e.g. cuffless sensors) for which there is no scientific consensus regarding BP measurement accuracy standards. Altogether, these issues contribute to the widespread availability of clinic and home BP devices with limited or uncertain accuracy, leading to inappropriate hypertension diagnosis, management and drug treatment on a global scale. The most significant problems relating to the accuracy of BP devices can be resolved by the regulatory requirement for mandatory independent validation of BP devices according to the universally-accepted International Organization for Standardization Standard. This is a primary recommendation for which there is an urgent international need. Other key recommendations are development of validation standards specifically for new BP technologies and online lists of accurate devices that are accessible to consumers and health professionals. Recommendations are aligned with WHO policies on medical devices and universal healthcare. Adherence to recommendations would increase the global availability of accurate BP devices and result in better diagnosis and treatment of hypertension, thus decreasing the worldwide burden from high BP.


A Comissão Lancet sobre Hipertensão Arterial identificou que uma iniciativa central para enfrentar a carga mundial da hipertensão arterial seria a melhoria na qualidade da mensuração da pressão arterial pelo uso aparelhos de pressão arterial validados quanto à acurácia. Atualmente, existem mais de 3 000 aparelhos de pressão arterial disponíveis comercialmente; entretanto, muitos não têm dados publicados sobre testes de acurácia realizados de acordo com padrões científicos estabelecidos. Este problema resulta de regulamentação fraca ou inexistente, o que permite a aprovação para uso comercial de dispositivos sem validação formal. Além disso, surgiram novas tecnologias de mensuração da pressão arterial (por exemplo, sensores sem algemas) sem consenso científico quanto aos padrões de acurácia. No conjunto, essas questões contribuem para a oferta generalizada de dispositivos de pressão arterial clínica e domiciliar com acurácia limitada ou incerta, levando a diagnóstico, gerenciamento e tratamento inadequados da hipertensão em escala global. Os problemas mais significativos relacionados com a acurácia dos dispositivos de pressão arterial podem ser resolvidos por regulamentação que imponha a obrigatoriedade de validação independente dos aparelhos de pressão arterial, de acordo com a norma universalmente aceita pela Organização Internacional de Normalização. Esta é uma recomendação fundamental para a qual existe uma necessidade internacional urgente. Outras recomendações essenciais incluem o desenvolvimento de padrões de validação especificamente para novas tecnologias de mensuração da pressão arterial e listas on-line de aparelhos com acurácia adequada que sejam acessíveis aos consumidores e profissionais de saúde. As recomendações estão alinhadas com as políticas da Organização Mundial da Saúde (OMS) sobre dispositivos médicos e atenção universal à saúde. A adesão às recomendações aumentaria a oferta global de dispositivos de pressão arterial com acurácia adequada e resultaria em melhor diagnóstico e tratamento da hipertensão arterial, diminuindo assim a carga mundial dessa doença.

20.
Article in Spanish | PAHO-IRIS | ID: phr-51862

ABSTRACT

[RESUMEN]. La Comisión Lancet de Hipertensión determinó que una medida clave para responder a la carga mundial que representa la hipertensión arterial era mejorar la calidad de las mediciones de la presión arterial, mediante la utilización de dispositivos cuya exactitud haya sido validada. En la actualidad existen 3000 dispositivos comercializados, pero muchos no tienen datos publicados sobre pruebas de exactitud conformes a las normas científicas establecidas. La falta de regulación o su ineficiencia, que permiten la autorización de dispositivos para uso comercial sin una validación oficial, posibilitan este problema. Además, han surgido tecnologías nuevas de medición de la presión arterial (por ejemplo, los sensores sin brazalete) sobre las cuales no existe unanimidad en la comunidad científica con respecto a las normas de exactitud de la medición. En conjunto, estos aspectos contribuyen a la disponibilidad generalizada de tensiómetros de consultorio o domiciliarios que ofrecen una exactitud limitada o incierta, que llevan a diagnósticos, manejo y farmacoterapia inapropiados de la hipertensión a escala mundial. Los problemas más importantes relacionados con la exactitud de los dispositivos de medición de la presión arterial se pueden resolver mediante el requisito regulatorio de una validación independiente obligatoria de los dispositivos, en consonancia con la norma ISO universalmente aceptada. Esta es una recomendación básica y constituye una necesidad internacional acuciante. Otras recomendaciones clave son la elaboración de normas de validación específicas para las tecnologías nuevas de medición de la presión arterial y la publicación en línea de listas de los dispositivos nuevos exactos que están a la disposición de los usuarios y los profesionales de salud. Las recomendaciones están en consonancia con las políticas de la Organización Mundial de la Salud sobre los dispositivos médicos y la atención universal de la salud. El cumplimiento de las recomendaciones aumentará la disponibilidad mundial de dispositivos de medición de la presión arterial que sean exactos y tendrá como efecto un mejor diagnóstico y tratamiento, reduciendo así la carga mundial de la hipertensión.


[ABSTRACT]. The Lancet Commission on Hypertension identified that a key action to address the worldwide burden of high blood pressure (BP) was to improve the quality of BP measurements by using BP devices that have been validated for accuracy. Currently, there are over 3 000 commercially available BP devices, but many do not have published data on accuracy testing according to established scientific standards. This problem is enabled through weak or absent regulations that allow clearance of devices for commercial use without formal validation. In addition, new BP technologies have emerged (e.g. cuffless sensors) for which there is no scientific consensus regarding BP measurement accuracy standards. Altogether, these issues contribute to the widespread availability of clinic and home BP devices with limited or uncertain accuracy, leading to inappropriate hypertension diagnosis, management and drug treatment on a global scale. The most significant problems relating to the accuracy of BP devices can be resolved by the regulatory requirement for mandatory independent validation of BP devices according to the universally-accepted International Organization for Standardization Standard. This is a primary recommendation for which there is an urgent international need. Other key recommendations are development of validation standards specifically for new BP technologies and online lists of accurate devices that are accessible to consumers and health professionals. Recommendations are aligned with WHO policies on medical devices and universal healthcare. Adherence to recommendations would increase the global availability of accurate BP devices and result in better diagnosis and treatment of hypertension, thus decreasing the worldwide burden from high BP.


[RESUMO]. A Comissão Lancet sobre Hipertensão Arterial identificou que uma iniciativa central para enfrentar a carga mundial da hipertensão arterial seria a melhoria na qualidade da mensuração da pressão arterial pelo uso aparelhos de pressão arterial validados quanto à acurácia. Atualmente, existem mais de 3 000 aparelhos de pressão arterial disponíveis comercialmente; entretanto, muitos não têm dados publicados sobre testes de acurácia realizados de acordo com padrões científicos estabelecidos. Este problema resulta de regulamentação fraca ou inexistente, o que permite a aprovação para uso comercial de dispositivos sem validação formal. Além disso, surgiram novas tecnologias de mensuração da pressão arterial (por exemplo, sensores sem algemas) sem consenso científico quanto aos padrões de acurácia. No conjunto, essas questões contribuem para a oferta generalizada de dispositivos de pressão arterial clínica e domiciliar com acurácia limitada ou incerta, levando a diagnóstico, gerenciamento e tratamento inadequados da hipertensão em escala global. Os problemas mais significativos relacionados com a acurácia dos dispositivos de pressão arterial podem ser resolvidos por regulamentação que imponha a obrigatoriedade de validação independente dos aparelhos de pressão arterial, de acordo com a norma universalmente aceita pela Organização Internacional de Normalização. Esta é uma recomendação fundamental para a qual existe uma necessidade internacional urgente. Outras recomendações essenciais incluem o desenvolvimento de padrões de validação especificamente para novas tecnologias de mensuração da pressão arterial e listas on-line de aparelhos com acurácia adequada que sejam acessíveis aos consumidores e profissionais de saúde. As recomendações estão alinhadas com as políticas da Organização Mundial da Saúde (OMS) sobre dispositivos médicos e atenção universal à saúde. A adesão às recomendações aumentaria a oferta global de dispositivos de pressão arterial com acurácia adequada e resultaria em melhor diagnóstico e tratamento da hipertensão arterial, diminuindo assim a carga mundial dessa doença.


Subject(s)
Global Health , Biomedical Technology , Reference Standards , Diagnostic Equipment , Global Health , Biomedical Technology , Reference Standards , Diagnostic Equipment , Global Health , Biomedical Technology , Reference Standards , Diagnostic Equipment
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