Background/Objectives: Aortic pulse wave velocity (aPWV) is a well-established surrogate marker of arterial stiffness. The Antares algorithm offers a method for determining aPWV from oscillometric blood pressure waveforms without requiring additional inputs. This prospective study aimed to evaluate the association and prognostic value of aPWV, determined by Antares, in predicting major adverse cardiovascular events (MACE). Methods: In total, 240 patients (median age 69, 25.4% female) underwent oscillometric blood pressure measurements, from which aPWV was calculated using the Antares algorithm. MACE, comprising myocardial infarction, stroke, or all-cause mortality, occurred in 19.2% of patients during a median follow-up of 43 months. Survival analyses were performed using continuous aPWV values, a 10 m/s threshold, and aPWV quartiles. Kaplan–Meier curves and log-rank tests were used to compare survival across aPWV groups. Cox proportional hazards models were applied to assess the independent predictive value of aPWV. Results: Patients with aPWV < 10 m/s showed significantly higher event-free survival compared to those with aPWV ≥ 10 m/s (log-rank p = 0.044). Quartile analysis reinforced this, with the highest event rate in the highest aPWV quartile (log-rank p < 0.01). Multivariable analysis confirmed aPWV as an independent predictor of MACE (HR per 1 m/s: 1.24, 95% CI: 1.08–1.41; HR per 1 SD: 1.53, 95% CI: 1.17–2.00, p = 0.002). Adding aPWV to a risk model improved predictive accuracy (C-index 0.68 to 0.71). Conclusions: In the investigated cohort, aPWV derived using the Antares algorithm is an independent predictor of cardiovascular events. This non-invasive approach is promising for improving simple outpatient risk stratification and targeting preventive measures.

Objective: Evaluation of cardiac output (CO) is crucial for understanding cardiac function and diagnosis of heart failure. While invasive thermodilution procedures serve as the gold standard for CO assessment, routine clinical practice has widely adopted transthoracic Doppler echocardiography (TTE) as the established non-invasive method. Nevertheless, there is a persistent demand for alternative non-invasive approaches, aiming to improve the efficiency of CO estimation, mitigate complications associated with invasive methods, and extend its application to non-intensive care settings, all of which potentially can be offered by oscillometric pulse wave analysis (PWA). This study aims to compare the non-invasive estimation of CO using TTE and the oscillometric PWA algorithm Antares. Design and method: We compared non-invasive cardiac output data obtained through two-dimensional transthoracic echocardiography with data obtained from an oscillometric blood pressure device (custo med GmbH, Ottobrunn, Germany) utilizing the integrated Antares algorithm (Redwave Medical GmbH, Jena, Germany). A total of 59 patients, undergoing elective cardiac catheterization for clinical reasons, were included in the study (mean age 71±10 years, 24% females), but only echocardiography-data with CO were used for analysis. Agreement between the two CO measurement methods (TTE versus Antares) was evaluated through Bland-Altman analysis, Student's t-test, and Pearson correlations. Results: The mean difference in CO was 0.04 ± 1.03 l/min. No statistically significant difference in means was observed between the two CO measurement methods. Significant correlations between transthoracic echocardiography (TTE) and Antares CO were evident in the overall population (r=0.71), as well as in both, female (r=0.80) and male patients (r=0.67; all p<0.001). Conclusions: The oscillometric PWA algorithm Antares and the established TTE exhibit strong correlations for non-invasive CO estimation in both male and female patients, with no statistically significant differences between the two approaches. This study opens the door to a valid and simple detection of heart failure that is seamlessly integrated into a quick and easy-to-perform upper arm blood pressure measurement.

Background In cardiology, cardiac output (CO) is an important parameter for assessing cardiac function. While invasive thermodilution procedures are the gold standard for CO assessment, transthoracic Doppler echocardiography (TTE) has become the established method for routine CO assessment in daily clinical practice. However, a demand persists for non-invasive approaches, including oscillometric pulse wave analysis (PWA), to enhance the accuracy of CO estimation, reduce complications associated with invasive procedures, and facilitate its application in non-intensive care settings. Here, we aimed to compare the TTE and oscillometric PWA algorithm Antares for a non-invasive estimation of CO. Methods Non-invasive CO data obtained by two-dimensional TTE were compared with those from an oscillometric blood pressure device (custo med GmbH, Ottobrunn, Germany) using the integrated algorithm Antares (Redwave Medical GmbH, Jena, Germany). In total, 59 patients undergoing elective cardiac catheterization for clinical reasons (71±10 years old, 76% males) were included. Agreement between both CO measures were assessed by Bland-Altman analysis, Student’s t-test, and Pearson correlations. Results The mean difference in CO was 0.04 ± 1.03 l/min (95% confidence interval for the mean difference: -0.23 to 0.30 l/min) for the overall group, with lower and upper limits of agreement at -1.98 and 2.05 l/min, respectively. There was no statistically significant difference in means between both CO measures (P = 0.785). Statistically significant correlations between TTE and Antares CO were observed in the entire cohort (r = 0.705, P<0.001) as well as in female (r = 0.802, P<0.001) and male patients (r = 0.669, P<0.001). Conclusions The oscillometric PWA algorithm Antares and established TTE for a non-invasive estimation of CO are highly correlated in male and female patients, with no statistically significant difference between both approaches. Future validation studies of the Antares CO are necessary before a clinical application can be considered.

BACKGROUND:Obesity is a global health concern and risk factor for cardiovascular disease. The assessment of central blood pressure (cBP) has been shown to improve prediction of cardiovascular events. However, few studies have investigated the impact of obesity on cBP in adults, and invasive data on this issue are lacking. This study aimed to evaluate cBP differences between patients with and without obesity, identify cBP determinants, and evaluate the accuracy of the algorithm Antares for non-invasive cBP estimation. METHODS:A total of 190 patients (25% female; 39% with BMI ≥30kg/m2; age: 67±12 years) undergoing elective cardiac catheterization were included. cBP was measured invasively and simultaneously estimated non-invasively using the custo screen 400 device with integrated Antares algorithm. RESULTS:No significant cBP differences were found between obese and non-obese patients. However, females, especially those with obesity, had higher systolic cBP compared to males (P<0.05). Multiple regression analysis showed that brachial mean arterial pressure, pulse pressure, BMI, and heart rate predicted cBP significantly (adjusted R2 = 0.82, P<0.001). Estimated cBP correlated strongly with invasive cBP for systolic, mean arterial, and diastolic cBP (r = 0.74-0.93, P<0.001) and demonstrated excellent accuracy (mean difference <5 and SD <8 mmHg). CONCLUSIONS:This study discovered no significant difference in cBP between obese and non-obese patients. However, it revealed higher cBP values in women, especially those with obesity, which requires further investigation. Additionally, the study highlights Antares' effectiveness in non-invasively determining cBP in obese individuals. This could improve the diagnosis and treatment of hypertension in this special patient population.

Objective: Chronic kidney disease (CKD) is characterized by decreased renal autoregulatory capacity, increased proteinuria, and direct transmission of systemic blood pressure to the glomeruli. Thereby, an increase in central (aortic) blood pressure (cBP) accelerates the progression of CKD. Antares is a pulse wave analysis algorithm designed to allow a non-invasive estimation of cBP using automated oscillometric blood pressure devices. We aimed to compare the invasively measured cBP with the estimated cBP using the Antares algorithm in patients with CKD. Design and method: 26 patients with stages 3-5 CKD (eGFR <60 ml/min/1.73m2, 88% stage 3 CKD, age 78±9 years, BMI 29±5 kg/m2, 65% male) were included and cBP was measured invasively during elective coronary angiography and simultaneously non-invasively using the custo screen 400 device (custo med GmbH, Ottobrunn, Germany) with the integrated Antares algorithm (Redwave Medical GmbH, Jena, Germany). Results: The mean difference for cBP was -0.7 ± 6.3 mmHg for central systolic BP (cSBP), -2.0 ± 5.1 mmHg for central mean arterial pressure (cMAP) and -4.2 ± 7.2 mmHg for central diastolic BP (cDBP). High correlations were found between estimated and invasively measured cBP (cSBP, r = 0.96; cMAP, r = 0.92; cDBP, r = 0.77; all p<0.001). Conclusions: The present study demonstrates that the Antares algorithm can estimate cBP with high accuracy in patients with CKD. Measurement of cBP and subsequent therapeutic interventions could improve renal and cardiovascular prognosis in these patients.

Objective: In 2013 the German Society of Hypertension and Prevention initiated a hypertension education program (HEP) - Mein Blutdruck - OK! (https://www.hochdruckliga.de/hypertonie-schulung-fuer-patienten.html). The objective of this study was to evaluate the blood pressure lowering efficacy of the HEP. Design and method: The HEP consists of 5 modules (blood pressure regulation, non-pharmacological treatment 1 and 2, pharmacological treatment, adherence) of group (4–6 patients) teaching, held by trained physicians and medical staff who underwent a specially designed train the trainer program. Each module consisted of 90 minutes training and patients underwent all 5 modules within 4 weeks. The validation study was performed in 8 hypertension outpatient clinics. Patients with mild (stage 1) hypertension, treated or untreated were included, and pharmacologic antihypertensive treatment was not altered during 6 months. The clinics were randomized to HEP or standard care. Blood pressure was monitored at baseline and after 6 months by standardized office measurements, home measurements (automatic oscillometric device, patients training) and 24 h ABPM. Primary endpoint was an at least 5 mmHg greater reduction of systolic office blood pressure by HEP compared to usual care. Results: 4 hypertension outpatient clinics were randomized to HEP, including 35 patients, 4 hypertension outpatient clinics were randomized to usual care, including 53 patients in the study. ABPM data were available in only 71 out of 88 patients. Data are presented in tables 1 and 2. Conclusion: The HEP resulted in significantly greater reductions of office and home blood pressure values as compared to usual care. The primary endpoint was met. Changes in ABPM daytime means did not differ significantly between groups, possibly due to insufficient available data. These results were obtained in patients with mild hypertension, either treated or untreated, and may differ in patients with severe or resistant hypertension.

INTRODUCTION:Antares is a pulse wave analysis (PWA) algorithm designed to allow a non-invasive estimation of central (aortic) blood pressure (cBP) using automated oscillometric blood pressure (BP) devices. Diabetes may affect elastic and muscular arteries differently, resulting in disparate pulse wave characteristics in central and peripheral arteries, which may limit the accuracy of PWA devices. The aim of our study was to evaluate the accuracy of Antares for estimating cBP as compared with invasively measured cBP in patients with type 2 diabetes. RESEARCH DESIGN AND METHODS:In this study, consecutive patients undergoing elective coronary angiography were recruited between November 2017 and September 2020. In 119 patients with type 2 diabetes, cBP was measured invasively and simultaneously determined non-invasively using the custo screen 400 device with the integrated Antares algorithm. RESULTS:The mean difference between the estimated and invasively measured cBP was 1.2±6.3 mmHg for central systolic BP (cSBP), 1.0±4.3 mmHg for central mean arterial pressure (cMAP) and 3.6±5.7 mmHg for central diastolic BP (cDBP). High correlations were found between estimated cBP and invasively measured cBP (cSBP: r=0.916; cMAP: r=0.882; cDBP: r=0.791; all p<0.001). CONCLUSIONS:The present study suggests that the Antares algorithm incorporated into the custo screen 400 device can estimate cBP with high accuracy turning a conventional oscillometric BP device into a type II device for the non-invasive estimation of cBP, which is applicable in patients with type 2 diabetes. Integration of Antares into commercially available BP devices could facilitate the introduction of cBP into routine clinical practice as a part of disease and risk management.

Antares is an algorithm for oscillometric blood pressure (BP) monitors to determine aortic pulse wave velocity (PWV) solely using oscillometric pulse waves without dependence of any other input. The aim of this study is to test Antares PWV for feasibility and whether the known age and blood pressure dependence of PWV can be shown with Antares PWV. In total, 259 patients were investigated for PWV as sub-study of the invasive validation of Antares algorithm, of which 219 entered analyses. Non-invasive PWV determination by Antares algorithm, integrated into an oscillometric BP monitor (custo screen 400) was compared to five different ePWV equations based on age, BP, or both. Additionally, in a subset of 27 patients, comparison of ARCSolver PWV algorithm (Mobil-O-Graph) with Antares PWV and ePWV was conducted. Mean differences ± SD between Antares PWV and (A) ePWV (based on age and systolic BP) was − 0.05 ± 1.06 m/s (Spearman’s rank correlation coefficient, rS = 0.805); (B) ePWV (based on age) was − 1.75 ± 1.17 m/s (rS = 0.829); (C) ePWV (based on mean BP) was − 1.35 ± 1.24 m/s (rS = 0.763), and (D) ePWV (based on age and mean BP) was − 1.64 ± 1.22 m/s (rS = 0.810) and − 1.69 ± 1.18 m/s (rS = 0.802). Comparison of Antares PWV with ARCSolver PWV revealed a mean difference of − 0.65 ± 1.31 m/s (rS = 0.854). The Antares algorithm confirmed its feasibility to use an oscillometric BP monitor as a single-point measurement device to calculate aortic PWV with acceptable comparability and high correlation to both estimated PWV and ARCSolver PWV. Antares achieves these results solely based on analysis of waveform features without requiring any secondary input, like BP or age.

BACKGROUND:Contrast-induced nephropathy (CIN) can occur after cardiovascular procedures using contrast media, which is associated with increased morbidity and mortality. RenalGuard is a closed-loop system designed to match intravenous hydration with diuretic-induced diuresis that has shown mixed results in the prevention of CIN in previous randomized controlled trials. OBJECTIVES:The STRENGTH (Study Evaluating the Use of RenalGuard to Protect Patients at High Risk of AKI) study assessed whether RenalGuard (PLC Medical Systems) is superior to standard intravenous hydration for CIN prevention in patients with chronic kidney disease undergoing complex cardiovascular procedures. METHODS:STRENGTH is a multicenter, international, open-label, postmarket, prospective, randomized (1:1) study monitored by the Cardiovascular European Research Center (Massy, France) that included a total of 259 patients with moderate to severe chronic kidney disease (estimated glomerular filtration 15-40 mL/min/m2) requiring a complex coronary, structural, or peripheral procedure with an expected contrast injection of at least 3 times the estimated glomerular filtration rate. Patients were randomized to either RenalGuard or intravenous saline hydration according to current guidelines. RESULTS:The primary endpoint, the incidence of CIN at day 3 after the procedure, was similar between the 2 groups (17/107 [15.9%] in the RG group vs 15/110 [13.9%] in the control group; P = 0.62). In addition, none of the secondary endpoints differed between the 2 groups. CONCLUSIONS:In high-risk patients undergoing complex cardiovascular interventions in experienced centers, furosemide-induced high urine output with matched hydration using the RenalGuard system did not reduce the risk of CIN and adverse outcomes at 12 months compared with conventional intravenous hydration.

Background: The Covid-19 pandemic caused a shutdown of healthcare systems in many countries. We explored the impact on hypertension care in the Excellence Center (EC) network of the European Society of Hypertension. Methods: We conducted a 17-question electronic survey among ECs. Results: Overall, 52 ECs from 20 European and three non-European countries participated, providing hypertension service for a median of 1500 hypertensive patients per center per year. Eighty-five percent of the ECs reported a shutdown lasting for 9 weeks (range 0–16). The number of patients treated per week decreased by 90%: from a median of 50 (range 10–400) before the pandemic to a median of 5.0 (range 0–150) during the pandemic (P < 0.0001). 60% of patients (range 0–100%) declared limited access to medical consultations. The majority of ECs (57%) could not provide 24-h ambulatory BP monitoring, whereas a median of 63% (range 0–100%) of the patients were regularly performing home BP monitoring. In the majority (75%) of the ECs, hypertension service returned to normal after the first wave of the pandemic. In 66% of the ECs, the physicians received many questions regarding the use of renin–angiotensin system (RAS) blockers. Stopping RAS-blocker therapy (in a few patients) either by patients or physicians was reported in 27 and 36.5% of the ECs. Conclusion: Patient care in hypertension ECs was compromised during the Covid-19-related shutdown. These data highlight the necessity to develop new strategies for hypertension care including virtual clinics to maintain services during challenging times.

Arterial baroreflex activation through electrical carotid sinus stimulation has been developed for the treatment of resistant hypertension. Previous studies suggested that the peripheral chemoreflex is tonically active in hypertensive patients and may inhibit baroreflex responses. We hypothesized that peripheral chemoreflex activation attenuates baroreflex efficacy evoked by electrical carotid sinus stimulation. We screened 35 patients with an implanted electrical carotid sinus stimulator. Of those, 11 patients with consistent acute depressor response were selected (7 men/4 women, age: 67±8 years, body mass index: 31.6±5.2 kg/m2, 6±2 antihypertensive drug classes). We assessed responses to electrical baroreflex stimulation during normoxia, isocapnic hypoxia (SpO2: 79.0±1.5%), and hyperoxia (40% end-tidal O2 fraction) by measuring heart rate, blood pressure, ventilation, oxygen saturation, end-tidal CO2 and O2 fractions, and muscle sympathetic nerve activity. During normoxia, baroreflex activation reduced systolic blood pressure from 164±27 to 151±25 mm Hg (mean±SD, P<0.001), heart rate from 64±13 to 61±13 bpm (P=0.002), and muscle sympathetic nerve activity from 42±12 to 36±12 bursts/min (P=0.004). Hypoxia increased systolic blood pressure 8±12 mm Hg (P=0.057), heart rate 10±6 bpm (P<0.001), muscle sympathetic nerve activity 7±7 bursts/min (P=0.031), and ventilation 10±7 L/min (P=0.002). However, responses to electrical carotid sinus stimulation did not differ between hypoxic and hyperoxic conditions: systolic blood pressure: -15±7 versus -14±8 mm Hg (P=0.938), heart rate: -2±3 versus -2±2 bpm (P=0.701), and muscle sympathetic nerve activity: -6±4 versus -4±3 bursts/min (P=0.531). We conclude that moderate peripheral chemoreflex activation does not attenuate acute responses to electrical baroreflex activation therapy in patients with resistant hypertension. These patients provided insight into human baroreflex-chemoreflex interactions that could not be gained otherwise.

Background: Antares is an algorithm for pulse wave analysis (PWA) by oscillometric blood pressure (BP) monitors in order to estimate central (aortic) blood pressure (cBP). Antares aims to enable brachial cuff-based BP monitors to be type II-devices, determining absolute cBP values independently of potential peripheral BP inaccuracies. The present study is an invasive validation of the Antares algorithm in the custo screen 400. Methods: We followed entirely the 2017 ARTERY protocol for validation of non-invasive cBP devices, the 2013 American National Standards Institute, Inc./Association for the Advancement of Medical Instrumentation/International Organization for Standardization (ANSI/AAMI/ISO) 81060-2 and 2018 AAMI/European Society of Hypertension (ESH)/ISO validation standard protocols. In total, 191 patients undergoing cardiac catheterization were included, of which 145 patients entered analysis. Invasive cBP recordings were compared to simultaneous non-invasive cBP estimations using the Antares algorithm, integrated into an oscillometric BP monitor. Results: Mean difference between invasive and non-invasively estimated systolic cBP was 0.71 mmHg with standard deviation of 5.95 mmHg, fulfilling highest validation criteria. Conclusion: Antares is the first algorithm for estimation of cBP that entirely fulfills the 2017 ARTERY and AAMI/ESH/ISO validation protocols. The Antares algorithm turns the custo screen 400 BP monitor into a type II-device. Integration of Antares into commercially available BP monitors could make it possible to measure PWA parameters in virtually every practice in future.

Abstract Aim Radio-contrast agents are widely used in coronary, peripheral and structural interventions. Use of these iodine-containing agents can be associated with contrast-induced acute kidney injury (CI-AKI) that can cause substantial morbidity and mortality. The RenalGuard system induces a forced diuresis with a matched hydration and has been shown beneficial in patients requiring coronary angiogram and PCI. Methods STRENGTH is a prospective, randomised (1:1), open-labeled, parallel-group, multicenter (10 centers in Germany and France) study where patients at high risk of CI-AKI were randomly assigned to RenalGuard® therapy or conventional strategy including preventive hydration before complex percutaneous cardiovascular intervention (PCI, peripheral and structural). In the RenalGuard arm, matched fluid replacement was started 60 minutes pre-procedure and maintained for up to 4 hours afterwards. Patients were given an initial i.v. bolus of up to 250 ml of normal saline over 30 minutes and then an i.v. bolus of furosemide (0.5 mg/kg). To be enrolled, patients had to have moderate to severe renal failure (defined as 15≤eGFR≤40 mL/min/m2) and a high-volume contrast requiring cardiovascular procedure (estimated contrast volume>3 times eGFR value). The main exclusion criterion was administration of iodine contrast media within 5 days before index procedure. The primary endpoint was CI-AKI defined as an increase in sCr ≥0.3 mg/dL or an increase of 25% of basal value or requiring dialysis within 5 days after procedure. The primary analysis for efficacy is performed in a modified intention-to-treat basis. The trial was designed and monitored by an independent CRO (Cardiovascular European Research Center, CERC, Massy, France). Results A total of 259 patients aged 79.1±8.8 yrs were included in the study. Among them, 129 were assigned to RenalGuard therapy and 130 to preventive saline hydration. Their mean baseline eGFR was 32 (25; 37) vs. 33 (25; 39) mL/min/m2, respectively (p=0.88). Total fluid intake volume within 24hrs before the procedure was 2383±1146 vs. 1386±842mL, respectively (p<0.0001). Procedure type was complex PCI (48%), TAVI (25%), peripheral intervention (18%), other structural intervention (9%) with no difference between groups (p=0.56). The total amount of contrast used for the procedure was 116.3±68.2mL in the RenalGuard arm vs. 104.1±56.7 mL in the conventional arm (p=0.26). A staged procedure was performed in 24 patients, including 16 in the RenalGuard and 8 in the control arm with a mean interval from the first intervention of 43±29 days and 24±19 days, respectively. For this second procedure, the total amount of contrast was 80±59 vs. 87±73mL. Conclusion The primary and secondary endpoints of the Study To evaluate the use of RENalGuard to proTect patients at High risk of CI-AKI comparing RenalGuard therapy to conventional hydration in 259 patients requiring complex percutaneous cardiovascular intervention will be presented. Funding Acknowledgement Type of funding source: Private grant(s) and/or Sponsorship. Main funding source(s): CERC

ZusammenfassungDer erhöhte Blutdruck (arterielle Hypertonie) ist eine der häufigsten chronischen Erkrankungen und der Hauptrisikofaktor für die Entstehung von Herz-Kreislauf-Erkrankungen. Die in der Praxis/Klinik gängige Blutdruckmessung hat unter standardisierten Bedingungen zu erfolgen. Ansonsten ist eine Fehleinschätzung der tatsächlichen Blutdruckhöhe mit konsekutiv sowohl schlechter Blutdruckkontrolle als auch Fehldiagnosen die Folge. Der Umsetzung/Einhaltung dieser Standards in der täglichen Routine durch einen geschulten Untersucher kommt hierbei die entscheidende Rolle für eine akkurate und zuverlässige Blutdruckmessung zu. Neben der rein technischen/standardisierten Durchführung ist jedoch auch zu beachten, dass viele im Handel erhältliche Blutdruckmessgeräte den Blutdruck nicht genau messen. Daher ist weiterhin auf die Verwendung von validierten Blutdruckmessgeräten (z. B. Prüfsiegel der DHL®) zu achten. Neben der Ruheblutdruckmessung in der Praxis und Klinik erlauben ambulante bzw. häusliche Blutdruckmessungen wichtige Informationen zur Einschätzung des kardiovaskulären Risikos.

Arterial hypertension is one of the most prevalent chronic diseases, and a major risk factor for cardiovascular diseases. It is essential to perform the blood pressure measurement under standardized conditions in the office/clinical setting, otherwise inaccuracy of blood pressure values may lead to poor blood pressure control or misdiagnosis. Compliance with these standards by a trained observer is of crucial importance for a reliable and accurate blood pressure measurement in clinical practice. Regardless of the standardized assessment, it has to be kept in mind that available devices on the market may not measure blood pressure accurate enough. Therefore, a validated (e. g. German Hypertension League Quality Seal) blood pressure monitor should be used. Out-of-office (home and ambulatory) blood pressure measurements provide important information beyond determining resting office/clinical BP.

In the past 30 years, several organizations, such as the US Association for the Advancement of Medical Instrumentation (AAMI), the British Hypertension Society, the European Society of Hypertension (ESH) Working Group on Blood Pressure (BP) Monitoring, and the International Organization for Standardization (ISO), have developed protocols for clinical validation of BP measuring devices. However, it is recognized that science, as well as patients, consumers, and manufacturers, would be best served if all BP measuring devices were assessed for accuracy according to an agreed single validation protocol that had global acceptance. Therefore, an international initiative was taken by the AAMI, ESH, and ISO experts who agreed to develop a universal standard for device validation. This statement presents the key aspects of a validation procedure, which were agreed by the AAMI, ESH, and ISO representatives as the basis for a single universal validation protocol. As soon as the AAMI/ESH/ISO standard is fully developed, this will be regarded as the single universal standard and will replace all other previous standards/protocols.

: In the past 30 years, several organizations have developed protocols for clinical validation of blood pressure measuring devices. An international initiative was recently launched by the US Association for the Advancement of Medical Instrumentation (AAMI), the European Society of Hypertension Working Group on Blood Pressure Monitoring (ESH) and the International Organization for Standardization (ISO), aiming to reach consensus on a universal AAMI/ESH/ISO validation standard. The purpose of this statement by the ESH Working Group on Blood Pressure Monitoring is to provide practical guidance for investigators performing validation studies according to the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018), to ensure that its stipulations are meticulously implemented and data are fully reported. Thus, this statement provides: a list of key recommendations for validation studies of intermittent non-invasive automated blood pressure measuring devices according to the AAMI/ESH/ISO Universal Standard; practical stepwise guidance for researchers performing these validation studies; a checklist for authors and reviewers of such studies; an example of a complete validation study report.

Die standardisierte indirekte Blutdruckmessung ist die Grundlage der Diagnostik und Therapie einer arteriellen Hypertonie. Lesen Sie hier, wo sich Fehler in der Routine einschleichen könnten.

SummaryIn elderly patients with diabetes mellitus and mild deterioration of the lower extremities, peripheral artery disease and diabetic peripheral neuropathy may contribute to the development of a diabetic foot syndrome. Early diagnosis and intervention can help to preserve the foot and thus significantly increase quality of life with diagnostic and therapeutic procedures being the same in elderly and in young patients.Non-invasive diagnosis is possible in most bed-ridden patients and should take into account reasonable therapeutic options against the background of overall morbidity, physical performance and quality of life, which should be discussed with the patient and his relatives. Multidisciplinary care structures facilitate treatment and might lead to reduced amputation rates and an improved well-being.

Objective The German Hypertension League (Deutsche Hochdruckliga) established a program to assess the accuracy and reliability of blood pressure (BP)-measuring devices in 1999 (Quality Seal Protocol). Here, we report on the results of a testing series of 105 devices designed for BP self-measurement. Methods The test protocol for the validation of upper-arm, wrist, and finger devices was developed to compare device to conventional Riva-Rocci measurements based on five criteria: mean systolic and mean diastolic differences, their standard deviations, and a point score representing the correlation of systolic and diastolic errors of individual comparisons. The results of this testing are summarized. Results From 1999 to 2014, a total of 105 BP devices for self-measurement were tested according to the Quality Seal Protocol. Of these, 47.6% fulfilled all five validation criteria, 55.7% of the upper-arm devices (39 of 71) and 32.4% (11 of 34) of the wrist devices. Finger devices were not offered for testing. Forty-four devices (41.9%) failed multiple test criteria of the validation procedure. A subanalysis with 51 devices tested showed that a stricter definition of the passing point score with a limit of at least 55% would slightly increase the consistency with the conventional criteria in comparison with a point score criterion of at least 50%. It was therefore introduced in 2007. Conclusion The results indicate the importance of a rigorous testing of a BP-measuring device used for home BP measurement to prevent patients from making erroneous treatment decisions.