Evaluation of frailty in geriatric patients undergoing cardiac rehabilitation after cardiac procedure: results of a prospective, cross-sectional study.

BACKGROUND: Frailty is an indicator of a decline in quality of life and functional capacity in cardiac rehabilitation (CR) patients. Currently, there is no standardized assessment tool for frailty used in CR. The aim of this study was to determine if the Clinical Frailty Scale (CFS) is feasible for assessing frailty in CR. METHODS: Prospective, cross-sectional study within the framework of the ongoing multicenter prehabilitation study "PRECOVERY". Patients ≥75 years undergoing CR after cardiac procedure (n=122) were recruited in four German inpatient CR facilities. Assessments included: CFS, Katz-Index, hand grip strength (HGS), Short Physical Performance Battery (SPPB) and six-minute-walk test (6MWT). Outcomes were frailty (CFS≥4) and the correlation of frailty with assessments of functional capacity, activities of daily living and clinical parameters. Statistical analysis included descriptive statistics and correlations, using the spearman correlation coefficient and chi-square test to test for significance. RESULTS: Data from 101 patients (79.9±4.0 years; 63% male) were analyzed. The mean CFS score was 3.2±1.4; 41.6% were defined as frail (CFS≥4). The mean time required to assess the CFS was 0.20 minutes. The findings show that CFS correlates significantly (p<0.001) with the following factors: Katz-Index, HGS, SPPB-Score and 6MWT (r≤-0.575). In addition, CFS correlated with small to moderate effects with co-morbidities (r=0.250), as-needed medications and need for nursing assistance (r≤0.248). CONCLUSIONS: The CFS assessment can be performed in under one minute and it correlates significantly with assessments of functional capacity, activities of daily living and clinical parameters in the CR setting. TRIAL REGISTRATION: German Clinical Trials Register (DRKS; http:// www. drks. de; DRKS00032256). Retrospectively registered on 13 July 2023.

Non-invasive pulse arrival time as a surrogate for oscillometric systolic blood pressure changes during non-pharmacological intervention.

Background.Non-invasive continuous blood pressure (BP) monitoring is of longstanding interest in various cardiovascular scenarios. In this context, pulse arrival time (PAT), i.e., a surrogate parameter for systolic BP (change), became very popular recently, especially in the context of cuffless BP measurement and dedicated lifestyle interventions. Nevertheless, there is also understandable doubt on its reliability in uncontrolled and mobile settings.Objective.The aim of this work is therefore the investigation whether PAT follows oscillometric systolic BP readings during moderate interventions by physical or mental activity using a medical grade handheld device for non-invasive PAT assessment.Approach.A study was conducted featuring an experimental group performing a physical and a mental task, and a control group. Oscillometric BP and PAT were assessed at baseline and after each intervention. Interventions were selected randomly but then performed sequentially in a counterbalanced order. Multivariate analyses of variance were used to test within-subject and between-subject effects for the dependent variables, followed by univariate analyses for post-hoc testing. Furthermore, correlation analysis was performed to assess the association of intervention effects between BP and PAT.Mainresults.The study included 51 subjects (31 females). Multivariate analysis of variances showed that effects in BP, heart rate, PAT and pulse wave parameters were consistent and significantly different between experimental and control groups. After physical activity, heart rate and systolic BP increased significantly whereas PAT decreased significantly. Mental activity leads to a decrease in systolic BP at stable heart rate. Pulse wave parameters follow accordingly by an increase of PAT and mainly unchanged pulse wave analysis features due to constant heart rate. Finally, also the control group behaviour was accurately registered by the PAT method compared to oscillometric cuff. Correlation analyses revealed significant negative associations between changes of systolic BP and changes of PAT from baseline to the physical task (-0.33 [-0.63, 0.01],p< 0.048), and from physical to mental task (-0.51 [-0.77, -0.14],p= 0.001), but not for baseline to mental task (-0.12 [-0,43,0,20],p= 0.50) in the experimental group.Significance.PAT and the used digital, handheld device proved to register changes in BP and heart rate reliably compared to oscillometric measurements during intervention. Therefore, it might add benefit to future mobile health solutions to support BP management by tracking relative, not absolute, BP changes during non-pharmacological interventions.

The prevalence and impact of sarcopenia in older cardiac patients undergoing inpatient cardiac rehabilitation - results from a prospective, observational cohort pre-study.

BACKGROUND: The prevalence of sarcopenia and its impact in older patients undergoing inpatient cardiac rehabilitation (iCR) after cardiac procedure has been insufficiently studied. The main aim of this study was to evaluate the prevalence of sarcopenia and quantify the functional capacity of older sarcopenic and non-sarcopenic patients participating in iCR. METHODS: Prospective, observational cohort study within the framework of the ongoing multicenter prehabilitation study "PRECOVERY". A sample of 122 patients ≥75 years undergoing iCR after cardiac procedure were recruited in four German iCR facilities and followed up 3 months later by telephone. At iCR (baseline), the Strength, Assistance with walking, Rise from a chair, Climb stairs and Falls (SARC-F) questionnaire was used to identify sarcopenic patients. In addition, Katz-Index, Clinical Frailty Scale (CFS), handgrip strength (HGS), Short Physical Performance Battery (SPPB) and 6-minute walk distance (6MWD) measured functional capacity and frailty at baseline. Outcomes were prevalence of sarcopenia and the correlation of sarcopenia to functional capacity and frailty at baseline as well as the SARC-F score at follow-up. The Wilcoxon test was applied for pre-post-test analysis. Correlation between sarcopenia and 6MWD, SPPB score and HGS was tested with the eta coefficient with one-way ANOVA. RESULTS: Complete assessments were collected from 101 patients (79.9 ± 4.0 years; 63% male). At baseline, the mean SARC-F score was 2.7 ± 2.1; 35% with sarcopenia. Other baseline results were Katz-Index 5.7 ± 0.9, CFS 3.2 ± 1.4, HGS 24.9 ± 9.9 kg, SPPB score 7.5 ± 3.3 and 6MWD 288.8 ± 136.5 m. Compared to baseline, fewer patients were sarcopenic (23% versus 35%) at follow-up. In the subgroup of sarcopenic patients at baseline (n = 35), pre-post comparison resulted in a significant SARC-F improvement (p = 0.017). There was a significant correlation between sarcopenia measured by SARC-F and poor results in the assessments of functional capacity (p < 0.001; r > 0.546). CONCLUSIONS: The prevalence of sarcopenia in older patients at iCR after cardiac procedure is high (35%) and remains high at follow-up (23%). Sarcopenia screening is important since the diagnosis of sarcopenia in these patients correlates significantly with poor functional capacity. The results indicate that these patients may benefit from prehabilitation aimed at improving perioperative outcomes, increasing functional capacity and mitigating adverse effects. TRIAL REGISTRATION: German Clinical Trials Register (DRKS; http://www.drks.de ; DRKS00032256). Retrospectively registered on 13 July 2023.

Twelve-month follow-up effects of cognitive training after heart valve surgery on cognitive functions and health-related quality of life: a randomised clinical trial.

OBJECTIVES: Postoperative cognitive decline (POCD) or decreased health-related quality of life (HQL) have been reported after cardiac surgery. A previous investigation showed beneficial effects of postoperative cognitive training on POCD and HQL 3 months after heart surgery. Here, we present the 12-month follow-up results. METHODS: This bicentric, 1:1 randomised and treatment-as-usual controlled trial included elderly patients scheduled for elective heart valve surgery. The training consisted of paper-and-pencil-based exercises practising multiple cognitive functions for 36 min/day 6 days/week over a period of 3 weeks. Neuropsychological tests and questionnaires assessing HQL (36-Item Short Form Health Survey (SF-36)) and cognitive failures in daily living (Cognitive Failures Questionnaire) were performed presurgery and 12 months after training. RESULTS: Twelve months post training, the training group (n=30) showed improvements in HQL compared with the control group (n=28), especially in role limitations due to physical health (U=-2.447, p=0.015, η2=0.109), role limitations due to emotional problems (U=-2.245, p=0.025, η2=0.092), pain (U=-1.979, p=0.049, η2=0.068), average of all SF-36 factors (U=-3.237, p<0.001, η2=0.181), health change from the past year to the present time (U=-2.091, p=0.037, η2=0.075), physical component summary (U=-2.803, p=0.005, η2=0.138), and mental component summary (U=-2.350, p=0.018, η2=0.095). Furthermore, the training group (n=19) showed an improvement compared with the control group (n=27) in visual recognition memory (U=-2.137, p=0.034, η2=0.099). POCD frequency was 22% (n=6) in the control group and 11% (n=2) in the training group (χ²(1) =1.06, p=0.440; OR=2.43, 95% CI 0.43 to 13.61). CONCLUSION: In conclusion, postoperative cognitive training shows enhancing effects on HQL in cardiac surgery patients after 12 months.

The impact of postoperative cognitive training on health-related quality of life and cognitive failures in daily living after heart valve surgery: A randomized clinical trial.

BACKGROUND: Heart surgery is a risk factor for objectively and subjectively assessable postoperative cognitive decline (POCD), which is relevant for everyday life. The aim of this study was to investigate whether early postoperative cognitive training has an impact on health-related quality of life and cognitive failures in daily living after cardiac surgery. METHODS: The study was a two-arm, randomized, controlled, outcome-blinded trial involving older patients undergoing elective heart valve surgery with extracorporeal circulation (ECC). Recruitment took place at the Departments of Cardiac Surgery of the Kerckhoff Clinic in Bad Nauheim (Germany) and the University Hospital in Giessen (Germany). The patients were randomized (1:1 ratio) to either a paper-and-pencil-based cognitive training group or a control group. We applied the Short Form Health Survey (SF-36) and the Cognitive Failures Questionnaire (CFQ) prior to surgery and 3 months after the cognitive training. Data were analyzed in a per-protocol fashion. RESULTS: Three months after discharge from rehabilitation, the training group (n = 31) showed improvement in health-related quality of life compared to the control group (n = 29), especially in role limitations due to emotional problems (U = -2.649, p = .008, η2  = 0.121), energy and fatigue (F[2.55] = 5.72, p = .020, η2  = 0.062), social functioning (U = -2.137, p = .033, η2  = 0.076), the average of all SF-36 factors (U = -2.374, p = .018, η2  = 0.094), health change from the past year to the present time (U = -2.378, p = .017, η2  = 0.094), and the mental component summary (U = -2.470, p = .013, η2  = 0.102). CONCLUSION: As our cognitive training has shown beneficial effects, this intervention could be a promising method to enhance health-related quality of life after cardiac surgery.

Device-guided slow breathing with direct biofeedback of pulse wave velocity - acute effects on pulse arrival time and self-measured blood pressure.

BACKGROUND: There isevidence that device-guided slow breathing using biofeedback acutely reduces blood pressure (BP) and pulse wave velocity [i.e. increased pulse arrival time (PAT)]. OBJECTIVES: The objectives of the study presented here were to test whether the results of changes observed in PAT in earlier studies are reproducible over 1 week and how changes in pulse wave velocity/PAT translate into absolute self-measured BP changes. METHODS: Patients with a systolic BP 130-160 mmHg or treated essential hypertension (21 females/23 males) were trained to perform unattended device-guided slow breathing exercises for 10 min daily over 5 days. Furthermore, they were skilled to perform self-measurement of BP before and after the breathing exercise using a validated upper-arm device. RESULTS: Office BP at screening [median (1, 3. Q)] was 137 (132, 142)/83 (79, 87) mmHg. We observed a significant ( P < 0.05) increase in PAT of 5 ms (SD 12.5 ms) on average after 10 min of guided breathing and an additional 1 ms ( P < 0.05, SD 8 ms) during the following 5 min of spontaneous breathing compared to baseline. PAT before the exercise remained constant over 5 days paralleled by constant self-measured BP before the exercise. Device-guided breathing was associated with a significant reduction of self-measured SBP of 5 mmHg ( P < 0.01, SD 8 mmHg). Data furthermore demonstrated that these changes were highly reproducible over 1 week. CONCLUSIONS: Device-guided slow breathing and biofeedback lead to reproducible and favorable changes (increase) in PAT and SBP (decrease).

Attractor Reconstruction for Quantifying the Arterial Pulse Wave Morphology During Device-Guided Slow Breathing.

Attractor reconstruction is a new way to quantify the morphology of a cardiovascular waveform by plotting all data points in the three-dimensional phase space, generating a trajectory of overlapping loops. The aim of this study is to show the feasibility of an automatic approach to quantify pulse wave attractors from a device-guided breathing study, and to link attractor features to pulse waveform features. The recently developed feature extraction technique is applied to arterial pulse waveform data of 30 patients with treated hypertension. The patients performed a device-guided slow breathing exercise. The generated attractors were categorized into three different shapes: triangular attractors, bent attractors and attractors with overlapping arms. The average height of the attractors continuously and progressively dropped from 41.8 [35.4, 55.1] AU to 34.5 [25.4, 47.3] AU (p < 0.001) during the breathing exercise. We have shown that the novel approach to quantify pulse wave attractors is feasible and can be used to detect changes in the morphology of arterial pulse waveforms. Device-guided slow breathing exercise has a shrinking effect on the average height of the attractors, which may indicate a reduction in blood pressure.

Effects of postoperative cognitive training on neurocognitive decline after heart surgery: a randomized clinical trial.

OBJECTIVES: Following cardiac surgery, postoperative cognitive decline (POCD) is a common complication that can impair the quality of life and increase mortality. The aim of this study was to investigate whether early postoperative cognitive training can decrease POCD after cardiac surgery. METHODS: The study was a multi-centred, two-arm, randomized (1:1 ratio), controlled trial involving older patients undergoing elective heart valve surgery with extracorporeal circulation. Recruitment took place at the Department of Cardiac Surgery of the Kerckhoff-Clinic in Bad Nauheim (Germany) and the University-Hospital in Giessen (Germany). The patients were randomized to either a paper-and-pencil-based cognitive training group or a standard rehabilitation care control group. The cognitive training started 1 week after surgery and lasted about 3 weeks until discharge from rehabilitation. To detect POCD, neuropsychological functions were assessed prior to surgery, upon discharge from rehabilitation (primary outcome), and 3 months after discharge (secondary outcome). Data were primarily analysed in a per-protocol fashion. RESULTS: The frequency of POCD at discharge from rehabilitation (training group, n = 37; control group, n = 44) was 50% in the control group and 19% in the training group (χ2[1] = 8.45, P = 0.004; odds ratio = 4.29, 95% confidence interval [1.56-11.80]). Three months after the cognitive training (training group, n = 33; control group, n = 34), POCD frequency was 29% in the control group and 6% in the training group (χ2[1] = 6.21, P = 0.013; odds ratio = 6.46, 95% confidence interval [1.29-32.28]). CONCLUSIONS: Since our cognitive training showed beneficial effects, it could be a promising method to prevent POCD.

Home blood pressure monitoring: methodology, clinical relevance and practical application: a 2021 position paper by the Working Group on Blood Pressure Monitoring and Cardiovascular Variability of the European Society of Hypertension.

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.

Monitoring of Treatment for Arterial Hypertension­The Role of Office, Home, and 24 h Ambulatory Blood Pressure Measurement.

BACKGROUND: The treatment of arterial hypertension can be monitored by office blood pressure (office BP), home blood pressure (home BP), or 24 hours ambulatory blood pressure (ABPM). In this review, we present current recommendations from Germany and from international guidelines as well as the findings of the main studies on the use of these methods to guide treatment. METHODS: This review is based on pertinent publications retrieved by a selective search in PubMed up to and including March 2020. Special attention was paid to guidelines and position papers. RESULTS: The guidelines offer heterogeneous recommendations for treatment monitoring. Home BP is the most reproducible method, with test-retest correlation coefficients of 0.91/0.86 (systolic/diastolic), in comparison to office BP (0.77/0.76). Two meta-analyses revealed better blood pressure control with home measurement than with usual care (systolic, -3.2 to -8.9 mmHg). A meta-analysis of randomized controlled trials also suggests that home measurement promotes adherence. In the randomized and controlled TASMINH4 trial, the home BP group with telemetric surveillance achieved better blood pressure control than the group with treatment titration based on office BP (systolic -4.7 [CI: -7; -2.4] mmHg, diastolic -1.3 [-2.5; 0.02] mmHg). With ABPM, patients frequently reported moderate to severe discomfort, limiting its practical applicability. CONCLUSION: Blood pressure measurement at home is recommended for treatment monitoring, using validated, automatic upper arm devices with data storage and trend analysis. Changes of treatment should be based on average values (28 home measurements) from seven days (two morning and two evening measurements per day). Office BP is mainly used for for screening purposes. There have not yet been any randomized trials comparing the three measuring methods in terms of hard cardiovascular endpoints.

Non-invasive quantification of the effect of device-guided slow breathing with direct feedback to the patient to reduce blood pressure.

OBJECTIVE: Slow breathing is a relaxation exercise recommended for lowering blood pressure (BP). Biofeedback may improve patient adherence and enhance BP lowering effects. Since the pulse arrival time (PAT) is inversely proportional to BP, it can be used to estimate BP changes. APPROACH: In this pilot study, 30 patients (age 62.9 (SD 7.7) years, 11 F/19 M, Sys. BP 133.0 (SD 17.1) mmHg, Dia. BP 83.8 (SD 10.6) mmHg) performed a device-guided slow breathing exercise. PAT was measured by ECG and plethysmography and immediately presented to the patient, and respiratory sinus arrhythmia (RSA) was calculated retrospectively to measure the adherence to the instructed respiratory rate. MAIN RESULTS: Respiratory rate was 13.6 (SD 1.9) bpm at baseline and 5.4 (SD 1.0) bpm during guided breathing. PAT continuously and progressively increased from 231.5 (SD 20.3) to 237.3 (SD 18.5) ms (p [Formula: see text] 0.001). The median deviation of RSA from the guided respiratory rate was 0.06 (IQR 0.19) bpm. In three patients, a deviation of > 0.20 bpm was detected, and two of them showed no increase in PAT. In total, 25 patients responded with increase in PAT. SIGNIFICANCE: In this pilot study we have shown that biofeedback of PAT and RSA are feasible and can further improve motivation and adherence. Furthermore, we have shown that the exercise increased PAT, which indicates a reduction in BP. Due to its ease of use, this method is ideal for home use and self-monitoring.

Prehabilitation in patients awaiting elective coronary artery bypass graft surgery - effects on functional capacity and quality of life: a randomized controlled trial.

OBJECTIVE: To determine the impact of an exercise-based prehabilitation (EBPrehab) program on pre- and postoperative exercise capacity, functional capacity (FC) and quality of life (QoL) in patients awaiting elective coronary artery bypass graft surgery (CABG). DESIGN: A two-group randomized controlled trail. SETTING: Ambulatory prehabilitation. SUBJECTS: Overall 230 preoperative elective CABG-surgery patients were randomly assigned to an intervention (IG, n = 88; n = 27 withdrew after randomization) or control group (CG, n = 115). INTERVENTION: IG: two-week EBPrehab including supervised aerobic exercise. CG: usual care. MAIN MEASURES: At baseline (T1), one day before surgery (T2), at the beginning (T3) and at the end of cardiac rehabilitation (T4) the following measurements were performed: cardiopulmonary exercise test, six-minute walk test (6MWT), Timed-Up-and-Go Test (TUG) and QoL (MacNew questionnaire). RESULTS: A total of 171 patients (IG, n = 81; CG, n = 90) completed the study. During EBPrehab no complications occurred. Preoperatively FC (6MWTIG: 443.0 ± 80.1 m to 493.5 ± 75.5 m, P = 0.003; TUGIG: 6.9 ± 2.0 s to 6.1 ± 1.8 s, P = 0.018) and QoL (IG: 5.1 ± 0.9 to 5.4 ± 0.9, P < 0.001) improved significantly more in IG compared to CG. Similar effects were observed postoperatively in FC (6MWDIG: Δ-64.7 m, pT1-T3 = 0.013; Δ+47.2 m, pT1-T4 < 0.001; TUGIG: Δ+1.4 s, pT1-T3 = 0.003). CONCLUSIONS: A short-term EBPrehab is effective to improve perioperative FC and preoperative QoL in patients with stable coronary artery disease awaiting CABG-surgery.ID: NCT04111744 (www.ClinicalTrials.gov; Preoperative Exercise Training for Patients Undergoing Coronary Artery Bypass Graft Surgery- A Prospective Randomized Trial).

Decreasing postoperative cognitive deficits after heart surgery: protocol for a randomized controlled trial on cognitive training.

BACKGROUND: The occurrence of postoperative cognitive deficits, especially after heart surgery, has been demonstrated in several studies. These deficits can clearly be noticed by the patients and by their close relatives in daily life. Furthermore, postoperative cognitive deficits can decrease quality of life in social functioning and earning capacity. The aim of this study is to investigate whether early postoperative cognitive training can reduce subjective and objective postoperative cognitive deficits. METHODS: The proposed study is a multicenter, two-arm, randomized controlled trial involving 144 elderly patients undergoing elective heart-valve surgery with extracorporeal circulation. Patients will be assigned to either a training group or a control group. The intervention involves paper-and-pencil-based cognitive training, which is conducted for 36 min over a period of 18 days. The training starts about 1 week after surgery and is carried out during the hospitalized rehabilitation phase. The control group will not receive cognitive training or a placebo intervention. A detailed assessment of psychological functions and health-related quality of life prior to surgery at discharge from rehabilitation and 3 and 12 months after discharge will be performed. The primary outcome of this trial is the training effect on objective cognitive functions at discharge from rehabilitation. Secondary outcomes are the training effect on objective and subjective cognitive functions (3 and 12 months after discharge), depression, health-related quality of life, and the impact of perioperative cerebral ischemia on the training effect. Perioperative cerebral ischemia will be measured with postoperative magnetic resonance imaging including diffusion-weighted sequences. DISCUSSION: Should it be shown that our cognitive training can improve postoperative cognitive deficits and quality of life, one possibility could be to integrate this intervention into early rehabilitation. Furthermore, we hope that the investigation of perioperative ischemia by diffusion-weighted magnetic resonance imaging will improve our understanding of neurobiological factors influencing the course of postoperative cognitive plasticity. TRIAL REGISTRATION: German Clinical Trials Register (DRKS), DRKS00015512. Retrospectively registered on 21 September 2018.

[Actual Standard of Blood Pressure Measurement - Statement of the German High Blood Pressure League]. / Aktueller Standard der Blutdruckmessung ­ Stellungnahme der Deutschen Hochdruckliga e. V. DHL® ­ Deutsche Gesellschaft für Hypertonie und Prävention.

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.

["Little Old Ladies' Heart" - Ventriculoarterial Coupling in Women With Isolated Systolic Hypertension and Diastolic Dysfunction]. / Little Old Ladies' Heart.

The term "ventricular-arterial coupling" (va-coupling) describes the close interaction of the left ventricle with the arterial system during systole. Increased arterial stiffness in conditions such as isolated systolic hypertension (ISH) or increases in pulse wave reflection may lead to disturbed va-coupling. Pathological pulse wave reflection is closely related to increased left ventricular late systolic load, diastolic dysfunction and, in the long-term, the risk of new-onset HFpEF. Non-invasive technologies for pulse wave analysis may identify patients at increased risk for the development of diastolic dysfunction or HFpEF. Women are approximately two times more likely than men to develop HFpEF which may be explained by sex differences in cardiovascular pathophysiology. Elderly women with ISH show sex-specific alterations of pulse wave reflection, LV remodelling and va-coupling which may increase the risk of HFpEF.

Blood pressure control and cardiovascular risk in hypertensive patients with type 2 diabetes: The German T2Target registry.

Blood pressure control in patients with type 2 diabetes and hypertension is poor. It is unclear how effectively general practitioners assess and treat such patients. T2Target included hypertensive patients with type 2 diabetes mellitus who had undergone ambulatory blood pressure monitoring within the past 3 months. Recordings were analyzed by the general practitioner and an independent center and the conclusions were compared. Nighttime hypertension was reported less frequently by the general practitioner in comparison with central assessment (43.9% vs 77.9%, P<.001), as were masked (4.0% vs 13.1%, P<.001) and isolated office (4.4% vs 8.8%, P<.001) hypertension. A total of 13.9% of patients were deemed to have controlled blood pressure (ambulatory blood pressure monitoring). For the 784 patients with uncontrolled blood pressure, 40.7% underwent no change to their antihypertensive treatment. Cardiovascular risk was underestimated, with 11.1% deemed to be at very high risk, in contrast to the 97.0% of patients by central assessment. In conclusion, blood pressure control in hypertensive patients with type 2 diabetes mellitus is poor and not accurately assessed by office-based general practitioners, despite the use of ambulatory blood pressure monitoring.

Methodology and technology for peripheral and central blood pressure and blood pressure variability measurement: current status and future directions - Position statement of the European Society of Hypertension Working Group on blood pressure monitoring and cardiovascular variability.

Office blood pressure measurement has been the basis for hypertension evaluation for almost a century. However, the evaluation of blood pressure out of the office using ambulatory or self-home monitoring is now strongly recommended for the accurate diagnosis in many, if not all, cases with suspected hypertension. Moreover, there is evidence that the variability of blood pressure might offer prognostic information that is independent of the average blood pressure level. Recently, advancement in technology has provided noninvasive evaluation of central (aortic) blood pressure, which might have attributes that are additive to the conventional brachial blood pressure measurement. This position statement, developed by international experts, deals with key research and practical issues in regard to peripheral blood pressure measurement (office, home, and ambulatory), blood pressure variability, and central blood pressure measurement. The objective is to present current achievements, identify gaps in knowledge and issues concerning clinical application, and present relevant research questions and directions to investigators and manufacturers for future research and development (primary goal).

The German Hypertension League (Deutsche Hochdruckliga) Quality Seal Protocol for blood pressure-measuring devices: 15-year experience and results from 105 devices for home blood pressure control.

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.

Validation protocols for blood pressure-measuring devices: status quo and development needs.

Hypertension is a major risk factor for cardiovascular morbidity and mortality. Therefore, blood pressure self-measuring devices have emerged as valuable tools in patient care and the accuracy of these instruments is of fundamental importance. For this reason, several validation procedures for assessing the efficacy of blood pressure monitoring devices have been developed, including protocols by the Association for the Advancement of Medical Instrumentation, the British Hypertension Society, the German Hypertension League (Prüfsiegelprotokoll), and the International Protocol of the Working Group on Blood Pressure Monitoring of the European Society of Hypertension. In the past, most of the protocols have been reviewed and modified because of experiences gained during the validation studies carried out. However, each shows distinct differences, that is number and characteristics of patients required, blood pressure ranges, and the length of the validation procedure, which may result in unique advantages and/or limitations associated with their use. The continued standardization and evolution of these guidelines is essential to ensure the efficacy of blood pressure-measuring devices marketed for clinical and home use. Here, we aimed to compare four currently used validation protocols and to initiate a discussion on potential future improvements.

European Society of Hypertension practice guidelines for ambulatory blood pressure monitoring.

Given the increasing use of ambulatory blood pressure monitoring (ABPM) in both clinical practice and hypertension research, a group of scientists, participating in the European Society of Hypertension Working Group on blood pressure monitoring and cardiovascular variability, in year 2013 published a comprehensive position paper dealing with all aspects of the technique, based on the available scientific evidence for ABPM. The present work represents an updated schematic summary of the most important aspects related to the use of ABPM in daily practice, and is aimed at providing recommendations for proper use of this technique in a clinical setting by both specialists and practicing physicians. The present article details the requirements and the methodological issues to be addressed for using ABPM in clinical practice, The clinical indications for ABPM suggested by the available studies, among which white-coat phenomena, masked hypertension, and nocturnal hypertension, are outlined in detail, and the place of home measurement of blood pressure in relation to ABPM is discussed. The role of ABPM in pharmacological, epidemiological, and clinical research is also briefly mentioned. Finally, the implementation of ABPM in practice is considered in relation to the situation of different countries with regard to the reimbursement and the availability of ABPM in primary care practices, hospital clinics, and pharmacies.