Clinical Trials & Case Studies
Journal of Primary Care & Community Health Twenty-Four-Hour Ambulatory Blood Pressure Monitoring
The diagnosis, management, and estimated mortality risk in patients with hypertension have been historically based on clinic or office blood pressure readings. •The most widely used criteria for 24-hour measurements are from the American Heart Association 2017 guidelines and the European Society of Hypertension 2018 guidelines. •Two (2) important scenarios described in this document are white coat hypertension (patients have normal blood pressures at home but high blood pressures during office visits) and masked hypertension, (patients are normotensive in the clinic but have high blood pressures outside of the office). •The Centers for Medicare and Medicaid Services has changed its policy to allow reimbursement for a broader use of 24-hour ambulatory blood pressure monitoring within some specific guidelines.
Automated Ambulatory Blood Pressure Monitoring: Clinical Utility in the Family Practice Setting
Although the percentage of patients treated for hypertension has increased, the percentage who demonstrate control of blood pressure has declined.
Studies confirm that ambulatory blood pressure monitoring devices reflect a patient’s blood pressure more accurately and correlate more closely with end-organ complications than blood pressure levels measured in the physician’s office.
Ambulatory blood pressure monitoring is useful in the following scenarios: borderline hypertension, white-coat hypertension, apparent drug resistance, hypotensive symptoms from medications or autonomic dysfunction, episodic hypertension, and evaluation of antihypertensive efficacy.
It is also useful in the evaluation of drug resistance and medication compliance.
Four (4) recent studies indicate that ABP data may more accurately reflect a patient’s actual blood pressure than casual or in-office blood pressure measurements and may improve the physician’s ability to predict cardiovascular risk.
Comparative Cost-Effectiveness of Clinic, Home, or Ambulatory Blood Pressure Measurement for Hypertension Diagnosis in US Adults A Modeling Study
The findings of this study suggest that using ABPM is the strategy of choice for hypertension diagnosis and treatment initiation for most adults in primary care settings in the United States.
We predict that correctly diagnosing white-coat and masked hypertension by ABPM reduces the overall cost of treatment for hypertension and future cardiovascular and cerebrovascular disease events.
Our findings have policy significance in the sense that expanding the reimbursement of ABPM as a diagnostic strategy for hypertension in primary care settings may reduce healthcare costs and improve health outcomes by getting hypertension treatment to the correct patients.
Implementing Ambulatory Blood Pressure Monitoring in Primary Care Practice
In-office blood pressure readings are often inaccurate or insufficient. Here’s a way to better understand how your patients are doing and get paid for it. Key Points:
ABPM is more accurate than in-office BP readings because it excludes white coat hypertension and masked hypertension.
ABPM also allows for the evolution of patients’ blood pressure while awake versus asleep, which can be valuable for risk assessment.
Start-up costs are a barrier to adding ABPM to primary care practices, but clinicians with a significant number of commercially insured patients can recoup those costs relatively quickly.
CMS coverage indications for ABPM* For diagnosis of suspected white coat hypertension, elevated average office BP (per new American Heart Association guideline) on two separate visits with at least two separate measurements made at each visit and with at least two BP measurements outside the office < 130/80 mm Hg For diagnosis of suspected masked hypertension, average office systolic BP 120-129 mm Hg or diastolic BP 75-79 mm Hg on two separate office visits with at least two separate measurements made at each visit and with at least two BP measurements outside the office ≥ 130/80 mm Hg.
Predicting Out-of-Office Blood Pressure in the Clinic for the Diagnosis of Hypertension in Primary Care,
Clinical guidelines in the United States and United Kingdom recommend that individuals with suspected hypertension should have ambulatory blood pressure (BP) monitoring to confirm the diagnosis. This approach reduces misdiagnosis because of white coat hypertension but will not identify people with masked hypertension who may benefit from treatment.
The Predicting Out-of-Office Blood Pressure (PROOF-BP) algorithm predicts masked and white coat hypertension based on patient characteristics and clinic BP, improving the accuracy of diagnosis while limiting subsequent ambulatory BP monitoring.
This study assessed the cost-effectiveness of using this tool in diagnosing hypertension in primary care.
A Markov cost-utility cohort model was developed to compare diagnostic strategies: the PROOF-BP approach, including those with clinic BP ≥130/80 mm Hg who receive ambulatory BP monitoring as guided by the algorithm, compared with current standard diagnostic strategies, including those with clinic BP ≥140/90 mm Hg combined with further monitoring (ambulatory BP monitoring as a reference, clinic, and home monitoring also assessed).
Proportion of US Adults Recommended Out-of-Clinic Blood Pressure Monitoring According to the 2017 Hypertension Clinical Practice Guidelines
“The 2017 Hypertension Clinical Practice Guidelines recommend out-of-clinic BP monitoring to screen for white coat and masked hypertension among adults not taking antihypertensive medication and white coat effect and masked uncontrolled hypertension among adults taking antihypertensive medication.
Among US adults not taking antihypertensive medication, 92.6% (95% CI, 90.7%–94.1%) with systolic/diastolic BP ≥130/80 mm Hg met criteria for out-of-clinic BP monitoring to screen for white coat hypertension and 32.8% (95% CI, 30.4%–35.3%) with systolic/diastolic BP<130/80 mm Hg met criteria to screen for masked hypertension.
The proportion meeting criteria for out-of-clinic BP monitoring to screen for masked hypertension was higher at an older age, among men versus women and non-Hispanic blacks and whites versus non-Hispanic Asians or Hispanics.
Among US adults taking antihypertensive medication, 12.5% (95% CI, 10.5%–14.9%) with systolic/diastolic BP ≥130/80 mm Hg met criteria to screen for white coat effect and 57.4% (95% CI, 52.7%–62.1%) with systolic/diastolic BP<130/80 mm Hg met criteria to screen for masked uncontrolled hypertension.
Validated BP Monitors for For Specialist Use
Comprehensive list of BP Monitors validated by the British and Irish Hypertension Society
Ambulatory Tonometric Blood Pressure Measurements in Patients with Diabetes
Background: Arterial tonometry is a novel technique for measuring ambulatory blood pressure (AMBP). The watch-like device BPro (HealthSTATS International, Singapore) captures radial pulse wave reflection and calculates brachial blood pressure (BP). In this study we investigate if arterial tonometry is applicable and reliable in patients with diabetes.
Oscillometric devices are less accurate in measuring BP in persons with increased arterial stiffness. Patients with Diabetes have increased arterial stiffness.
There was no significant difference in agreement between devices [BPro & Cuff-Based BP] when comparing normo-versus micro- and macro- albuminuric patients, men versus women, or patients with type 1 versus type 2 (P>0.05).
Only one patient [in the study] (4%) declined to repeat the AMBP. The discomfort associated with the tonometric AMBP was acceptable for the remaining patients, and AMBP measurements were successful according to the present guidelines.
Aside from brachial arterial BP, the BPro device measures various arterial stiffness indices, including augmentation index, central BP, and MAP. Brachial arterial BP is an inferior risk marker of cardiovascular outcome compared with markers of arterial stiffness.
The absence of an inflatable cuff and the inaudibility of the device prevent anticipation rise of BP and nighttime awakening in connection with measurements.
The BPro device offers frequent and undisturbed BP measurements, along with additional information on arterial state. Furthermore, tonometric measurements appear to be feasible and possibly more convenient for the patients. We, therefore, propose that in patients with diabetes tonometric BPs may be preferable to sphygmomanometric measurements.
Comparison of Wrist-type And Arm-type 24-h Blood Pressure Monitoring Devices for Ambulatory Use
Wrist monitors do not require the removal of clothing for a cuff application, and they are easy to wear, particularly in the winter, because long-sleeved clothing can be used with a wrist monitor, but not with an arm-cuff monitor.
Another advantage of wrist monitors is that they can even be used for obese patients for whom an appropriate arm-cuff size is not available.
The algorithm of the wrist-type ABPM monitor we used in the present study is an arterial tonometric algorithm. The principle is that a single transducer that is held manually over the radial artery records the waveform of SBP and DBP when an artery is partially compressed against the radius bone.
Physical Exercise, Fitness and Dietary Pattern and Their Relationship with Circadian Blood Pressure Pattern, Augmentation Index and Endothelial Dysfunction Biological Markers : EVIDENT Study Protocol
The accepted gold standard to assess arterial stiffness is currently femoral, carotid pulse wave velocity (PWV) , and it has been related to increased morbidity and mortality in both patients with cardiovascular disease and healthy subjects.
The use of a new tool such as the Radial Pulse Wave Acquisition Device (BPro) and Pulse Wave Application Software (A-Pulse), and verification of their feasibility and convenience of use may help generalize the evaluation of certain cardiovascular parameters that increase vascular risk and are not routinely assessed. If our hypotheses are confirmed, molecules such as OPG or endoglin could be used as early markers of endothelial dysfunction.
Sustained Blood Pressure–Lowering Effect of Aliskiren Compared With Telmisartan After a Single Missed Dose
“Poor adherence to prescribed medication is one of the major factors affecting the efficacy of antihypertensive treatment in clinical practice.”
In a large proportion of treated patients with hypertension, BP remains uncontrolled despite the wide availability of antihypertensive agents that have proven clinical efficacy in controlled trials.
24-hour Central Blood Pressure and Intermediate Cardiovascular Phenotypes in Unrelated Subjects
When used for 24-hour central SBP, the BPro device (calibrated once at the beginning) captures BP waveforms every 15 minutes (for 8-10 seconds for each measurement) over 24 hours, allowing for peripheral BP monitoring. This method was validated against invasive measurements as well as against validated noninvasive methods of central pressure determination.
Discrepancy Between Tonometric Ambulatory and Cuff-Based Office Blood Pressure Measurements in Patients with Type 1 Diabetes
HTN is often solely diagnosed by OBP rather than ABP, despite ABP being superior to OBP in predicting risk of adverse outcome.
However, masked HTN is associated with increased end-organ damage and adverse cardiovascular disease (CVD) outcome.
Tonometry has proved valuable in risk prediction in various populations, as it provides information on various parameters of arterial stiffness along with specific BP measurements.
ABP provides information on circadian BP, including nocturnal BP, which has been shown to predict the development of microalbuminuria in patients with type 1 diabetes and mortality in type 2 diabetes. Treatment of nocturnal hypertension may be important and has been shown to reduce CVD mortality and morbidity in patients with type 2 diabetes.
Validation of the BPro Radial Pulse Waveform Acquisition Device in Pregnancy and Gestational Hypertensive Disorders
Hypertension complicates approximately 10% of pregnancies and is responsible for significant maternal and perinatal morbidities.
Took 45 pregnant women (15 with preeclampsia, 15 with gestational hypertension, 15 normotensives)
The mean BP differences between the BPro and mercury sphygmomanometer in the total cohort was −1.7±6.1 and 0.1±4.6 mmHg for SBP and DBP, respectively, therefore, fulfilling the criteria of the AAMI.
The absolute differences within 5, 10, and 15 mmHg between the BPro and the mercury sphygmomanometer meet the criteria to achieve validation for use in pregnancy as required by the ESH-IP.
Increased arterial stiffness is a common finding both in those at risk of preeclampsia due to underlying comorbidities such as chronic hypertension or due to the disease itself.
Our study has confirmed that BPro is accurate for use in pregnancy and may have an important role to play in HBPM in this population, particularly in women with chronic and gestational hypertension.
Differential Impact of Blood Pressure–Lowering Drugs on Central Aortic Pressure and Clinical Outcomes Principal Results of the Conduit Artery Function Evaluation (CAFE) Study
BP-lowering drugs can have substantially different effects on central aortic pressures and hemodynamics despite a similar impact on brachial BP. Moreover, central aortic pulse pressure may be a determinant of clinical outcomes, and differences in central aortic pressures may be a potential mechanism to explain the different clinical outcomes between the 2 BP treatment arms in ASCOT.
Development and Validation of a Novel Method to Derive Central Aortic Systolic Pressure from the Radial Pressure Waveform Using an N-point Moving Average Method
We show that an NPMA with a denominator of one-quarter of the tonometer sampling frequency accurately defines CASP when applied to noninvasively acquired RAPWFs in man. These novel findings have important implications for the simplification of noninvasive CASP measurement and its wider application in clinical trials and clinical practice.
The Role of Central Blood Pressure Monitoring in the Management of Hypertension
Central blood pressure is a novel predictor of cardiovascular risk that can be measured in the clinical setting using currently available technology. This paper will review current available methods of central blood pressure monitoring as well as its impact in cardiac and renal disease.
Acc Scientific Expert Panel
Blood Pressure Assessment in Adults in Clinical Practice and Clinic-Based Research
Current limitations with clinic BP measurement include lack of standardization, infrequent technician/clinician training and retraining, use of devices that have not been validated and/or regularly calibrated, not using an appropriately sized cuff, improper conditions and technique, and inadequate documentation of the procedure. Also, despite guideline recommendations, the averaging of BP within and across visits is rarely done. There is substantial evidence demonstrating that out of clinic BP measurements, using ABPM and HBPM, have stronger associations with risk for CVD events than clinic BP measurements (129).
Association Between Central Blood Pressure and Subclinical Cerebrovascular Disease in Older Adults
Elevated blood pressure (BP) level is one of the most consistently identified risk factors for silent brain disease. BP values obtained at the proximal segment of the aorta (central BP) are more directly involved than brachial BP in the pathogenesis of cardiovascular disease. However, the association between central BP and silent cerebrovascular disease has not been clearly established.
Both central systolic BP (P<0.001) and central pulse pressure (P<0.001) were significantly associated with upper quartile of white matter hyperintensity volume in multivariable analysis, even after adjustment for brachial BP. Higher central systolic BP and central pulse pressure, but not brachial BP, were significantly associated with white matter hyperintensity volume.
This study identified that both brachial and central PP were in-dependently associated with SBI, whereas higher central SBP and PP, but not brachial BP, were significantly associated with WMHV in a predominantly older population-based cohort without history of stroke.
Central BP, estimated noninvasively by radial applanation tonometry, has the potential to be clinically useful as an indicator subclinical brain damage from high BP.
A Cohort Evaluation on Arterial Stiffness and Hypertensive Disorders in Pregnancy
HTN disorders occur in 10-15% of pregnancies, mainly with gestational HTN at 10-12%, followed by preeclampsia at 3-5% and severe preeclampsia at less than 1%. About 15% of women with gestational HTN may progress to preeclampsia and 9% to severe diseases.
Arterial stiffness or reduced arterial compliance occurs with diffuse vasoconstriction and increased peripheral vascular resistance arising from endothelial dysfunction. This led to profound changes in hemodynamic measures such as the central aortic and peripheral blood pressures. Higher arterial stiffness is associated with preeclampsia compared with gestational HTN or those with normal pregnancies.
Raised arterial pressure is a manifestation of endothelial dysfunction, targeted measurement of central aortic pressures may yield important information on how these aberrant responses occur and its role in early detection and prediction of HTN disorders in pregnancy.
Arterial Stiffness is Associated with Cardiovascular, Renal, Retinal, and Autonomic Disease in
Type 1 Diabetes
Arterial stiffness predicts cardiovascular disease events in the general population in hypertension and diabetes. A recent meta-analysis showed pulse wave velocity to predict both CVD and all-cause mortality. The gold standard for measurement of arterial stiffness is aortic PWV measurements.
In hypertension, PWV is a marker of subclinical organ damage. Recent studies have shown PWV to be predictive of future changes in systolic blood pressure development of hypertension to potentially improve CVD risk.
In patients with end-stage renal disease, elevated PWV is an independent predictor of all-cause mortality and lowering PWV by AHT reduced the mortality independently of the blood pressure reduction.
Type 1 diabetes, kidney impairment, CVD, elevated BP, retinopathy, and automatic neuropathy are all associated with increased arterial stiffness.
National Hypertension Guidelines & Recommendations
U.S. Preventative Services Task Force Recommendation on Hypertension Screening
The USPSTF recommends screening for hypertension in adults 18 years or older with office blood pressure measurement (OBPM). The USPSTF recommends obtaining blood pressure measurements outside of the clinical setting for diagnostic confirmation before starting treatment.
2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults
A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines
US Surgeon General Call to Action to Control Hypertension
US Surgeon General Call to Action to Control Hypertension
ABPM Reimbursement Guidelines
2019 CMS National Coverage Determination for Ambulatory Blood Pressure Monitoring
2019 CMS National Coverage Determination for Ambulatory Blood Pressure Monitoring
Reimbursement of ambulatory blood pressure monitoring in the US commercial insurance marketplace Eric Dietrich PharmD1,2
AETNA: Automated Ambulatory Blood Pressure Monitoring