Secondary Haemophagocytic Lymphohistiocytosis Syndrome (HLH) After Intravesical Instillation of Bacillus Calmette-Guérin (BCG): A Case Report and Review of the Literature.

Intravesical bacillus Calmette-Guérin (BCG) instillation is widely used for the treatment of superficial bladder cancer. BCGitis is a serious immune-mediated complication with systematic manifestations and a high mortality rate. Here, we describe a case of a 64-year-old male patient who presented with haemophagocytic lymphohistiocytosis syndrome (HLH) after BCG instillation and was effectively treated with high-dose dexamethasone, intravenous immunoglobulins and anti-tuberculosis treatment. LEARNING POINTS: BCGitis after intravesical BCG instillation is a rare, but potentially fatal complication.HLH syndrome associated with BCGitis should be suspected in patients with systematic symptoms, cytopenias and elevated inflammation markers.Prompt diagnosis and early treatment is essential for reducing the mortality rates of this rare clinical entity.

Validation of the InBody BPBIO210 manual auscultatory hybrid device for professional office use in a general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Universal Standard.

OBJECTIVE: To evaluate the accuracy of the InBody BPBIO210 manual auscultatory mercury-free hybrid blood pressure (BP) measuring device for professional office use in a general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060-2:2018). METHODS: Subjects were recruited to fulfil the age, sex, BP and cuff distribution criteria of the AAMI/ESH/ISO Universal Standard in a general population using the same arm sequential BP measurement method. Two cuffs of the test device were used for arm circumference 22-32 (medium) and 32-42 cm (large). RESULTS: A total of 94 subjects were recruited and 86 were analysed (mean age 53.7 ± 18.4 [SD] years, 50 men, arm circumference 32.5 ± 4.8 cm, range 22-42 cm). For the validation Criterion 1, the mean ± SD of the differences between the test device and reference BP readings was -1.0 ± 4.1/-0.7 ± 2.5 mmHg (systolic/diastolic). For Criterion 2, the SD of the averaged BP differences between the test device and reference BP per subject was 2.65/1.59 mmHg (systolic/diastolic). CONCLUSIONS: The InBody BPBIO210 manual auscultatory hybrid device for professional office BP measurement fulfilled all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) in a general population and can be recommended for clinical use.

Nighttime Home Blood Pressure in Children: Association with Ambulatory Blood Pressure and Preclinical Organ Damage.

[Figure: see text].

Reproducibility of Office and Out-of-Office Blood Pressure Measurements in Children: Implications for Clinical Practice and Research.

This study aimed to evaluate the reproducibility of office (OBP), ambulatory (ABP), and home blood pressure (HBP) measurements in children and adolescents, and their implications in diagnosing hypertension in clinical practice and in pediatric hypertension research. Apparently healthy children and adolescents referred for suspected hypertension were included. Measurements of 2-visit OBP, 7-day HBP, and 24-hour ABP were performed twice, 1 to 6 months apart. Reproducibility was quantified using the SD of differences between repeated measurements. The sample size of clinical trials comparing the efficacy of antihypertensive drugs using each method was calculated. Fifty-eight individuals were analyzed (mean age, 13.0±2.9 years, 60.3% boys). The reproducibility of 24-hour ABP (SD of differences 5.7/4.5 systolic/diastolic) and HBP (5.9/5.0 mm Hg) were comparable and superior to that of visit-2 OBP (9.2/7.8) and awake (6.7/5.5) or asleep ABP (7.6/6.1). As a consequence, a parallel-group comparative trial aiming to detect a difference in the effect of 2 drugs of 10 mm Hg systolic BP, would require 36 participants when using OBP measurements, 14 using 24-hour ABP, and 15 using HBP (102/34/42 respectively for detecting a 5 mm Hg difference in diastolic BP). For a crossover design trial, the corresponding sample sizes are 9/3/4 for systolic BP and 26/9/11 for diastolic, respectively. These data suggest that in children and adolescents 24-hour ABP and 7-day HBP have similar reproducibility, superior to OBP and daytime or asleep ABP. These findings have major implications in diagnosing hypertension in children in clinical practice and in designing clinical research trials in pediatric hypertension.

Automated blood pressure measurement in atrial fibrillation: validation process modification and evaluation of a novel professional device which detects atrial fibrillation and adapts its blood pressure measurement algorithm.

OBJECTIVES: Blood pressure (BP) measurement in atrial fibrillation (AF) patients is problematic and automated monitors are regarded as inaccurate. The optimal procedure for validating BP monitors in AF is questionable. This study evaluated the accuracy of a novel professional oscillometric upper-arm cuff device (Microlife WatchBP Office), which has an algorithm for detecting AF and then applies an AF-specific BP measurement algorithm. BP variability, which is inherently increased in AF patients, was considered in the analysis. METHODS: Subjects with sustained AF were included in a validation study using the same arm sequential measurement method of the Universal Standard (ISO 81060-2:2018) for special populations. Analysis was performed in all subjects and separately in those with and without high reference BP variability (>12/8 mmHg SBP/DBP). RESULTS: Thirty-five subjects with 105 paired test/reference BP measurements were included (mean age 76.3 ±â€Š8.4 years, reference SBP/DBP 128.2 ±â€Š19.5/72.5 ±â€Š12.1 mmHg, pulse rate 68.3 ±â€Š14.9 bpm). Validation Criterion 1 (mean difference ±â€ŠSD) was 0.0 ±â€Š7.7/0.2 ±â€Š7.0 mmHg in all 105 BP pairs (threshold ≤5 ±â€Š8 mmHg). Criterion 1 was 0.5 ±â€Š6.1/-0.2 ±â€Š6.8 mmHg in 18 subjects (54 BP pairs) with low reference BP variability and -0.6 ±â€Š9.2/0.6 ±â€Š7.3 mmHg in 17 (51 pairs) with high variability. Criterion 1 did not differ in pulse rate < 70 vs. ≥ 70 bpm Validation Criterion 2 (SD of differences for 35 individuals) was 5.38/6.20 mmHg (SBP/DBP; threshold ≤6.95/6.95). CONCLUSION: A technology which detects AF and activates an AF-specific BP measurement algorithm introduces a challenging solution for clinical practice. Validation of BP monitors in AF patients should not ignore their inherently high BP variability.

Validation of the single-cuff oscillometric blood pressure monitor InBody BPBIO750 for public spaces according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Universal Standard.

OBJECTIVE: The aim of this study was to evaluate the accuracy of the single upper-arm cuff oscillometric blood pressure (BP) monitor InBody BPBIO750 developed for self-measurement by adults in public spaces (kiosk) according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060-2:2018). METHODS: Subjects were recruited to fulfil the age, gender, BP and cuff distribution criteria of the AAMI/ESH/ISO Universal Standard in general population using the same arm sequential BP measurement method. RESULTS: A total of 102 subjects were recruited and 85 were analyzed [mean age 56.7 ± 15.4 (SD) years, 40 men, arm circumference 32.3 ± 5.3 cm, range 22-42 cm]. For validation criterion 1, the mean ± SD of the differences between the test device and reference BP readings was 2.2 ± 6.1/-2.2 ± 5.2 mmHg (systolic/diastolic). For criterion 2, the SD of the averaged BP differences between the test device and reference BP per subject was 5.00/4.63 mmHg (systolic/diastolic). CONCLUSION: The InBody BPBIO750 device fulfilled all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) in general population and can be recommended for clinical use in adults.

Twenty-four-hour ambulatory central blood pressure in adolescents and young adults: association with peripheral blood pressure and preclinical organ damage.

OBJECTIVES: To investigate the relationship of 24-h ambulatory central blood pressure (ABP) with preclinical organ damage in youth. METHODS: Individuals aged 10-25 years referred for suspected hypertension and healthy volunteers had simultaneous 24-h peripheral and central ABP monitoring (Mobil-O-Graph 24 h PWA). Central BP was calculated using two different calibration methods (c1 using oscillometric systolic/diastolic ABP; c2 using mean arterial/diastolic ABP). Their association with preclinical organ damage [left ventricular mass index (LVMI), carotid intima-media thickness (IMT), 24-h pulse wave velocity (PWV)] was investigated. RESULTS: A total of 136 participants were analyzed (age 17.9 ±â€Š4.7 years, 54% adolescents, 77% males, 34% with elevated ABP). Twenty-four-hour peripheral systolic ABP (pSBP) was higher than c1 systolic ABP (c1SBP) by 14.1 ±â€Š3.7 mmHg, but lower than c2SBP by 6.5 ±â€Š7.6 mmHg (all P < 0.01). c2SBP quartiles provided better stratification of preclinical organ damage than pSBP. Both c1SBP/c2SBP were significantly associated with LVMI (r = 0.35/0.33) and IMT (r = 0.23/0.42; all P < 0.01; primary endpoint). These associations were stronger for c2SBP compared with those of pSBP in adolescents but not in adults. PWV was more closely associated with pSBP than c2SBP (r = 0.94/0.83, P < 0.01). LVMI variation was best determined by c2SBP in adolescents and pSBP in adults; IMT by c2SBP and PWV by pSBP in both subgroups. CONCLUSION: These findings suggest that in young individuals, the calibration method for 24-h central ABP plays a major role in determining its association with preclinical organ damage. In adolescents, 24-h central ABP appears to be more strongly associated with early cardiac and carotid damage than peripheral BP.

Validation of the InBody BPBIO250 oscillometric blood pressure monitor for professional office use in general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Universal Standard.

OBJECTIVE: The aim of this study was to evaluate the accuracy of the InBody BPBIO250 oscillometric upper-arm professional office blood pressure (BP) monitor in general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060-2:2018). METHODS: Subjects were recruited to fulfil the age, gender, BP, and cuff distribution criteria of the AAMI/ESH/ISO Universal Standard in general population using the same arm sequential BP measurement method. Two cuffs of the test device were used for arm circumference 22-32 (medium) and 32-42 cm (large). RESULTS: Ninety-seven subjects were recruited and 88 were analyzed. For validation criterion 1, the mean ± SD of the differences between the test device and reference BP readings was 1.9 ± 5.9/0.9 ± 4.9 mmHg (systolic/diastolic). For criterion 2, the SD of the averaged BP differences between the test device and reference BP per subject was 4.78/4.31 mmHg (systolic/diastolic). CONCLUSION: The InBody BPBIO250 professional oscillometric device for office BP measurement fulfilled all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) in general population and can be recommended for clinical use.

Validation of the InBody BP170 oscillometric home blood pressure monitor in general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Universal Standard.

OBJECTIVE: To evaluate the accuracy of the InBody BP170 oscillometric upper-arm home blood pressure (BP) monitor in general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060-2:2018). METHODS: Subjects were recruited to fulfill the age, gender, BP and cuff distribution criteria of the AAMI/ESH/ISO Universal Standard in general population using the same arm sequential BP measurement method. Two cuffs of the test device were used for arm circumference 22-32 (medium) and 32-42 cm (large). RESULTS: One-hundred five subjects were recruited and 88 were analyzed. For validation Criterion 1, the mean ± SD of the differences between the test device and reference BP readings was 0.9 ± 6.9/0.5 ± 5.5 mmHg (systolic/diastolic). For Criterion 2, the SD of the averaged BP differences between the test device and reference BP per subject was 5.77/4.80 mmHg (systolic/diastolic). CONCLUSION: The InBody BP170 oscillometric home BP monitor fulfilled all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) in general population and can be recommended for clinical use.

STRIDE BP international initiative for accurate blood pressure measurement: Systematic review of published validation studies of blood pressure measuring devices.

Blood pressure (BP) is a vital sign, and its measurement is essential for diagnosing and treating hypertension. The accuracy of BP monitors is therefore essential, but unfortunately very few devices available on the market have been validated using an established protocol. STRIDE BP (www.stridebp.org) is an international nonprofit organization with the mission to improve the accuracy of BP measurement and the diagnosis of hypertension. It has a prestigious Scientific Advisory Board and operates in affiliation with the European Society of Hypertension, the International Society of Hypertension, and the World Hypertension League. STRIDE BP provides lists of accurate office, ambulatory, and home BP monitors. STRIDE BP performed a systematic review of 419 published validations (270 articles and 260 devices). In these publications, 50 (12%) of the validations were rejected compared with 129 (31%) rejected by STRIDE BP (P < .001). Of 79 validations approved in publications but rejected by STRIDE BP, 7 (9%) were rejected due to device inaccuracy and 72 (91%) due to inadequate study quality (execution, analysis, and reporting). Errors in conducting and reporting published validations must be avoided. Peer review must ascertain that a comprehensive checklist of all aspects of a validation study have been adhered to. The implementation of a Universal Standard for device validation and the global dissemination of information on accurate devices by STRIDE BP are expected to improve the quality and accuracy of BP measurement, which should have a positive impact on the diagnosis and management of hypertension globally.

Home Blood Pressure Monitoring in Children and Adolescents: Systematic Review of Evidence on Clinical Utility.

PURPOSE OF REVIEW: For the accurate diagnosis and management of hypertension, out-of-office blood pressure evaluation using ambulatory (ABPM) or home monitoring (HBPM) is currently recommended. In children, there is considerable evidence on the clinical utility of ABPM, whereas the evidence on HBPM is limited. This systematic review presents (i) the benefits of HBPM in children; (ii) the evidence on normal range, diagnostic accuracy, and relationship with preclinical organ damage; and (iii) guidance for devices, monitoring schedule, and interpretation. RECENT FINDINGS: HBPM is a useful adjunct to the conventional office measurements for the evaluation of children with suspected or treated hypertension. HBPM is feasible in children and has good reproducibility, diagnostic accuracy and acceptability by users, and relatively low cost. Thus, it has greater potential for widespread and long-term use than ABPM, which is more expensive and often not available or not tolerated. Automated monitors that have been clinically validated specifically in children should be used with appropriate cuff size. HBPM for 7 days (minimum 3) with duplicate morning and evening measurements (minimum 12 readings) should be performed in children with suspected or treated hypertension before each office visit. Until more data become available, in case of diagnostic disagreement between office blood pressure and HBPM, treatment decisions should be based on ABPM. HBPM is clinically useful in children with hypertension. More research is needed on its clinical application, and more automated devices need to be clinically validated in this population.