Effects of baroreflex activation therapy on cardiac function and morphology.

AIMS: Arterial hypertension (aHTN) plays a fundamental role in the pathogenesis and prognosis of heart failure with preserved ejection fraction (HFpEF). The risk of heart failure increases with therapy-resistant arterial hypertension (trHTN), defined as inadequate blood pressure (BP) control ≥140/90 mmHg despite taking ≥3 antihypertensive medications including a diuretic. This study investigates the effects of the BP lowering baroreflex activation therapy (BAT) on cardiac function and morphology in patients with trHTN with and without HFpEF. METHODS: Sixty-four consecutive patients who had been diagnosed with trHTN and received BAT implantation between 2012 and 2016 were prospectively observed. Office BP, electrocardiographic and echocardiographic data were collected before and after BAT implantation. RESULTS: Mean patients' age was 59.1 years, 46.9% were male, and mean body mass index (BMI) was 33.2 kg/m2. The prevalence of diabetes mellitus was 38.8%, atrial fibrillation was 12.2%, and chronic kidney disease (CKD) stage ≥3 was 40.8%. Twenty-eight patients had trHTN with HFpEF, and 21 patients had trHTN without HFpEF. Patients with HFpEF were significantly older (64.7 vs. 51.6 years, P < 0.0001), had a lower BMI (30.0 vs. 37.2 kg/m2, P < 0.0001), and suffered more often from CKD-stage ≥3 (64 vs. 20%, P = 0.0032). After BAT implantation, mean office BP dropped in patients with and without HFpEF (from 169 ± 5/86 ± 4 to 143 ± 4/77 ± 3 mmHg [P = 0.0019 for systolic BP and 0.0403 for diastolic BP] and from 170 ± 5/95 ± 4 to 149 ± 6/88 ± 5 mmHg [P = 0.0019 for systolic BP and 0.0763 for diastolic BP]), while a significant reduction of the intake of calcium-antagonists, α2-agonists and direct vasodilators, as well as a decrease in average dosage of ACE-inhibitors and α2-agonists could be seen. Within the study population, a decrease in heart rate from 74 ± 2 to 67 ± 2 min-1 (P = 0.0062) and lengthening of QRS-time from 96 ± 3 to 106 ± 4 ms (P = 0.0027) and QTc-duration from 422 ± 5 to 432 ± 5 ms (P = 0.0184) were detectable. The PQ duration was virtually unchanged. In patients without HF, no significant changes of echocardiographic parameters could be seen. In patients with HFpEF, posterior wall diameter decreased significantly from 14.0 ± 0.5 to 12.7 ± 0.3 mm (P = 0.0125), left ventricular mass (LVM) declined from 278.1 ± 15.8 to 243.9 ± 13.4 g (P = 0.0203), and e' lateral increased from 8.2 ± 0.4 to 9.0 ± 0.4 cm/s (P = 0.0471). CONCLUSIONS: BAT reduced systolic and diastolic BP and was associated with morphological and functional improvement of HFpEF.

[Influence of the Corona pandemic on cardiovascular risk factors - Data from 1775 participants of the ELITE study before and during the Corona pandemic]. / Einfluss der Corona-Pandemie auf kardiovaskuläre Risikofaktoren ­ Daten von 1775 Teilnehmern der ELITE Studie vor und während der Corona Pandemie.

BACKGROUND: The COVID-19 pandemic and its interventions have led to a deficit in medical care and changes in people's lifestyles, which has consequently changed cardio- and cerebrovascular primary and secondary prevention. The existing data are mainly based on surveys. In addition to the problem of the accuracy of self-assessments, the pandemic per se and the massive public reporting may have biased the data.Only a few publications have compared data collected before the pandemic with results during the pandemic. The ELITE study has regularly monitored risk factors (RF) and psychosocial parameters (stress, depression, well-being, diet, brain performance, exercise) in over 5000 participants for years. From this study, data were analyzed from 1775 individuals collected before the onset and again during the pandemic (06/05/2020-25/01/2022). Thus, baseline values were unaffected by the pandemic. RESULTS: As expected, both improvements and worsening of the collected parameters were found. Blood pressure and depressive symptoms worsened significantly more often, with women more frequently affected. Weight and stress levels also increased more often than they improved. Only physical activity showed a slight increase. 24.1 % showed only deteriorations and no improvements in these parameters. In contrast, 19.6 % showed improvements exclusively. In the group with only worsening, there was a significant increase in individuals with the risk factors (RF) hypertension, obesity, elevated LDL cholesterol, nicotine, and diabetes mellitus. This resulted in an increase in individuals with 2 or more RF. In contrast, the number of individuals with 2 and more RF decreased in the group with only improvements. Strikingly, individuals with risk factors improved more frequently. CONCLUSION: A not insignificant part of the population experienced significant worsening of RF during the pandemic. This particularly affected blood pressure and depressive symptoms, and more often women.

Urinary Dickkopf-3 (DKK3) Is Associated with Greater eGFR Loss in Patients with Resistant Hypertension.

Patients with resistant hypertension (HTN) demonstrate an increased risk of chronic kidney disease and progression to end-stage renal disease; however, the individual course of progression is hard to predict. Assessing the stress-induced, urinary glycoprotein Dickkopf-3 (uDKK3) may indicate ongoing renal damage and consecutive estimated glomerular filtration rate (eGFR) decline. The present study aimed to determine the association between uDKK3 levels and further eGFR changes in patients with resistant HTN. In total, 31 patients with resistant HTN were included. Blood pressure and renal function were measured at baseline and up to 24 months after (at months 12 and 24). uDKK3 levels were determined exclusively from the first available spot urine sample at baseline or up to a period of 6 months after, using a commercial ELISA kit. Distinctions between different patient groups were analyzed using the unpaired t-test or Mann-Whitney test. Correlation analysis was performed using Spearman's correlation. The median uDKK3 level was 303 (interquartile range (IQR) 150-865) pg/mg creatinine. Patients were divided into those with high and low eGFR loss (≥3 vs. <3 mL/min/1.73 m²/year). Patients with high eGFR loss showed a significantly higher median baseline uDKK3 level (646 (IQR 249-2555) (n = 13) vs. 180 (IQR 123-365) pg/mg creatinine (n = 18), p = 0.0412 (Mann-Whitney U)). Alternatively, patients could be classified into those with high and low uDKK3 levels (≥400 vs. <400 pg/mg creatinine). Patients with high uDKK3 levels showed significantly higher eGFR loss (-6.4 ± 4.7 (n = 11) vs. 0.0 ± 7.6 mL/min/1.73 m2/year (n = 20), p = 0.0172 (2-sided, independent t-test)). Within the entire cohort, there was a significant correlation between the uDKK3 levels and change in eGFR at the latest follow-up (Spearman's r = -0.3714, p = 0.0397). In patients with resistant HTN, high levels of uDKK3 are associated with higher eGFR loss up to 24 months later.

Health football beats them all: subgroup analysis of the 3F (Fit&Fun with Football) study on white-coat hypertension, sustained hypertension, dippers, nondippers, and on pharmacologically un(treated) arterial hypertension.

BACKGROUND: The 3F study (Fit&Fun with Football) demonstrated a significant reduction in blood pressure, antihypertensive medication, body weight, stress and depression through health football. Health football could be a popular tool to unleash the full preventive potential of physical activity. This work analyses the effect of health football on hypertensive subgroups: dipper, nondipper, white-coat hypertension (WCH), sustained hypertension, (un)treated hypertensive patients (UH, TH). METHODS: A prospective interventional study with 1-year follow-up. Football group (FG): n  = 103, 'health'-football training (1×/week, 90 min) led by licensed football coaches. Physical inactive, hypertensive patients older than 45 years were compared with a control group (CG) ( n  = 105). Subgroups were divided by ambulatory blood pressure monitoring (ABPM), casual blood pressure (CBP), medication schedule and compared by blood pressure (BP), laboratory results and weight. RESULTS: In all three subgroups (WCH vs. sustained hypertension, TH vs. UH, D vs. ND), health football reduced BP and weight significantly compared with the CG, and compared with the admission. An even greater effect in CBP was found in people with WCH than in sustained hypertension (FG: WCH: 141-127 mmHg, sustained Hypertension (SH): 142-132 mmHg; CG: WCH: 141-143 mmHg, SH: 140-141 mmHg). In contrast, the significant reduction in CBP and ABPM was comparable in treated and untreated patients, although antihypertensive drugs were reduced significantly more frequently in FG than in CG. BP reduction in nondippers and dippers was also comparable. In the nondipper group, nocturnal BP was significantly reduced in the FB (122.0-111.5 mmHg), but not in the CG or the dippers. CONCLUSION: All evaluated football subgroups achieved a significant BP reduction (compared with CG). This applied to dipper, nondipper, (un)treated hypertension, WCH and SH. All mentioned subgroups displayed a clear benefit. The even greater reduction in BP in WCH demonstrates the importance of physical activity before the additional prescription of antihypertensive medications, underscoring the recommendations of the ESC and ISH in WCH.

Impact of medication adherence on the efficacy of Baroreflex activation therapy.

Therapy adherence significantly determines the success of antihypertensive therapy, especially in patients with resistant hypertension. Our study investigates the impact of drug adherence on the efficacy of Baroreflex-activation-therapy (BAT). In this retrospective analysis, the authors measured blood pressure (BP) and antihypertensive medication adherence (by gas chromatography-mass spectrometry [GC-MS] urine analysis) before and 6 months after BAT initiation. Adherence was defined as detection of ≥80% intake of prescribed medication at the time of follow-up. Response to BAT was defined as BP drop ≥5 mmHg in systolic 24 h-ambulatory BP (ABP) after 6 months. Overall patients (n = 38) median medication adherence was low, but rose from 60% (IQR 25%-100%) to 75% (IQR 38%-100%; p = .0194). After 6 months of BAT, mean systolic and diastolic office BP (-21 ± 25 mmHg and -9 ± 15 mmHg; p < .0001 and .0004) as well as 24 h-ABP dropped significantly (-9 ± 17 mmHg and -5 ± 12 mmHg; p = .0049 and .0280). After 6 months of BAT, 21 patients (60%) could be classified as responders. There was neither significant difference in mean office systolic (-21 ± 23 mmHg vs. -21 ± 28 mmHg; p = .9581) nor in 24 h-systolic ABP decrease (-11 ± 19 mmHg vs. -7 ± 15 mmHg; p = .4450) comparing adherent and non-adherent patients. Whereas Antihypertensive Therapeutic Index (ATI) was unchanged in non-responders, it significantly decreased in responders (from 50 ± 16 to 46 ± 16; p = .0477). These data are the first to show that BAT-initiation leads to a clear BP reduction independently of patients´ medication adherence. Response to BAT is associated with a significant lowering of ATI, which might contribute to an underestimation of BAT efficacy.

Regular Exercise is Associated with a More Favorable Cardiovascular Risk Profile, Better Quality of Life, Less Depression and Less Psychological Stress.

INTRODUCTION: It is well documented that insufficient physical activity (PA) contributes substantially to cardiovascular diseases. The number of physically active people in Germany is still too low. METHODS: In ELITE study in Germany, 4602 participants are regularly examined for cardiovascular risk factors (CVRF). The aim is to motivate participants to improve their CVRF through individual recommendations and regular follow-up. Here, the PA data are presented in correlation with CVRF at baseline. A feature of this presentation is that the usual CVRF but also the effects on psychosocial factors were recorded simultaneously. RESULTS: Participants were divided into 3 groups based on their PA: 1. frequent exercise (FE): daily to 2-3x per week (41.4%), 2. moderate exercise (ME): 1x/week to 2x/month (28.8%), 3. rarely exercise (RE): 1x/month to not at all (29.8%). Age did not differ in the 3 groups. The most common CVRF was arterial hypertension, which decreased significantly with an increase in PA. Diabetes, nicotine, and increased BMI were also significantly less frequent in group 1. Antihypertensives were taken less frequently in this group 1. Less physically active participants were significantly more likely to have 3 or more additional CVRF. While group 1 consumed more fruit (64%) and considerably less pork, in group 2 and 3 only 58.3% and 50.3% respectively included fruit in their diet. FE also had a favorable effect on stress, depression and general well-being, all of which were significantly better in group 1. CONCLUSION: Results confirm the beneficial influences of exercise on known CVRF and on psychosocial parameters. The prevalence of several CVRF per person at low levels of sport is of particular concern, as these participants would benefit most. During a 5-year follow-up, participants will receive intensive education on the need to increase PA. It remains to be seen how successful the effort will be.

Relationship between Lipoprotein(a) and cardiovascular risk factors-data from 4602 participants of the ELITE study.

Lipoprotein(a) (Lp(a)) is becoming increasingly important as an independent risk factor for cardiovascular disease. Since no effective therapy currently exists other than lipid apheresis, the recommendation remains to optimally adjust all other cardiovascular risk factors (CVRF). In a Northwest German population study, the frequency of elevated Lp(a) levels and all other CVRF was investigated. The aim was to investigate whether individuals with elevated Lp(a) levels were also more likely to have other CVRFs. To date, 4602 individuals have been enrolled in the study, and blood pressure, weight, lipids, diabetes, medications, and pre-existing conditions were recorded in addition to Lp(a). In addition, questionnaires assessed physical activity, psychological stress, depression, and brain dysfunction. All participants received detailed individual recommendation about their CVRF and its treatment. In the further follow-up of 5 years, it will be examined how persons with elevated Lp(a) implemented these recommendations in comparison with participants without elevated Lp(a). The first group Lp(a) <75 nmol/L consisted of 3550 (80.2%), the Lp(a) 75-120 nmol/L group of 341 (7.4%) and the Lp(a) >120 nmol/L of 538 (11.7%). 81.6% of all participants had one or more CVRF. Age, sex, and prevalence of hypertension, diabetes, smoking, obesity, and exercise did not differ among the 3 groups. As expected, LDL-Cholesterol was significantly elevated in the Lp(a) >120 nmol/L group despite significantly more frequent use of statins. Significantly more often hypertensive patients were found in the Lp(a) >120 nmol/L group who were inadequately controlled by medication and significantly less often persons without further CVRF. No differences existed in the frequency of psychological stress, depression, and mild cognitive impairment. CVRF occur with comparable frequency in individuals with elevated Lp(a) levels. However, individuals with Lp(a) above 120 nmol/L were more likely to have poorly controlled blood pressure, elevated LDL-C, and less likely to have no other risk factors. This underlines that in case of Lp(a) elevation all further CVRF should be intensively adjusted, especially in case of strongly elevated values >120 nmol/L. However, these recommendations have not been adequately implemented in clinical care in this population to date.

Football beats hypertension: results of the 3F (Fit&Fun with Football) study.

OBJECTIVES: Football as the most popular sport could improve insufficient physical activity in patients with cardiovascular risk factors. A modified 'healthy' football training format could motivate hypertensive patients to return to sport and improve risk factors. METHODS: The 3F study: 'Fit and Fun with Football' a prospective interventional study with 1 year follow-up. Football group: n = 103, structured 'health'-football training (1×/week, 90 min) led by Deutscher Fußball Bund-licensed football coaches. Hypertensive patients at least 45 years who have not exercised for several years were compared with a control group (n = 105). PRIMARY STUDY OBJECTIVE: Reduction of office (OBP) and/or 24-h ambulatory blood pressure (BP) monitoring (ABPM) and/or reduction of number or dosage of antihypertensive medication. MAIN RESULTS: OBP values decreased significantly in the football group from 142.6/87.9 to 130.8/81.8 mmHg (P < 0.001), in the control group the values increased slightly (NS). ABPM values decreased significantly in the football group, while a slight increase was found in the control group. At the end of the study, the mean values in the football group of both OPB (P < 0.001) and ABPM (systolic P < 0.001, diastolic P = 0.017) were significantly lower than in the control group. Significantly more people in the football group were able to reduce antihypertensive patients than in the control group (football group:16, control group:6), while more participants in the control group intensified antihypertensive therapy (football group:3, control group:14) (P < 0.001). Among the secondary endpoints, there was a weight loss of 3 kg in the football group and an increase of 1.7 kg in the control group (P < 0.001). CONCLUSION: Offering modified 'healthy' football-training to middle-aged hypertensive patients can lead to better BP control and a reduction of antihypertensive medication. Therefore, the offer of 'health football' should be established and supported by clubs, insurances and authorities.

Influence of individualized prevention recommendations after one year on the control of hypertension in 3,868 follow-up participants of the ELITE study.

OBJECTIVES: The ELITE study (German acronym for "Nutrition, lifestyle and individual information for prevention of heart attack, stroke and dementia") prospectively collects data on hypertension, cardiovascular risk factors (RF), dietary habits, physical activity, cognitive function, and quality of life in North-West Germany, which will then be improved through targeted individual information. The aim of the study is to improve the health of the participants in the long term and to identify reasons for a lack of implementation of prevention measures. METHODS: Of 4,602 included subjects, 3,868 could be studied so far at one-year follow-up. Blood pressure (BP) was measured according to the guidelines at admission and blood pressure history, premedication, sports behaviour and BMI were recorded by means of questionnaires and compared with the data collected in the follow-up examination after one year. RESULTS: The participants were evaluated in 4 groups (G): G1 - normotensive patients (n = 1,558), G2 - controlled hypertensive patients (n = 502), G3 - untreated uncontrolled hypertensive patients (n = 1,080), G4 - treated uncontrolled hypertensive patients (n = 728). In G1 blood pressure (RR) remained unchanged from 126.3/77.8 to 127.8/78.5, in G2 there was a significant (p < 0.001) RR increase from 128.1/77.0 to 134.9/79.8. In G3 and G4 RR decreased significantly (p < 0.001) from 149.9/90.0 to 143.5/86.9 and from 153.1/87.5 to 146.2 84.1 mmHg, respectively. In G3 and G4, RR decreased in 56.1% and 56.3% of subjects and increased in 18% and 21%, respectively. In contrast, RR increase was found more frequently in G1 and G2 (34.3% and 51%, respectively), and RR decrease less frequently (25.4 and 20.7%, respectively). The main reasons for RR decrease were weight loss, more exercise, and more antihypertensives. Frequently, improved compliance and dietary changes were given as reasons. As expected, the opposite often led to RR increase. CONCLUSION: 56% of the hypertensive participants succeeded in lowering their blood pressure, whereas there was a significant increase in blood pressure, especially in those who were well controlled with antihypertensives. This underlines the need to further motivate normotensive patients to maintain their normotension. The results show that the combination of individual written education and lifestyle interventions are an effective tool for the public health sector to combat hypertension. In our participants, lifestyle interventions have a significant impact on BP change. It should be noted critically that there are still too many patients who have not been reached.

Influence of cardiovascular risk factors on arterial hypertension and mild cognitive impairment in 4602 participants of the ELITE study.

BACKGROUND: In ELITE (Ernährung, Lebensstil und individuelle Information zur Verhinderung von Herzinfarkt, Schlaganfall und Demenz; german for: Nutrition, Lifestyle and Individual Information for the Prevention of Heart Attack, Stroke and Dementia) data on cardiovascular risk factors, cognitive function and quality of life are prospectively collected, which will be improved through targeted individual information. The aim is to improve the health of the participants and identify the reasons for the lack of implementation. METHODS: Risk factors of 4602 participants were linked to (controlled) hypertension and mild cognitive impairment (MCI). Blood pressure was measured according to the guidelines and the DEMTECT- test was used to detect MCI. RESULTS: The most common risk factor was hypertension (60%). Hypertensive patients were older (56.1 and 44.7 years), had a higher BMI (28 and 24.8 kg/m), frequently physical inactive (26 and 32.4%), diabetes (9.3 and 1.3%), higher LDL (134.7 and 124.1 mg/dl), higher triglycerides (169.6 and 124.8 mg/dl) and lower HDL (57.9 and 65.5 mg/dl) compared with normotensives (P < 0.001). Controlled hypertensive patients are less common men (46.1 and 52.1%, P < 0.001), have a lower BMI (28.3 and 29.1 kg/m, P < 0.001), lower LDL (129.0 and 135.6 mg/dl, P = 0.004) and lower triglycerides (162.5 and 182.3 mg/dl, P = 0.001) compared with treated uncontrolled hypertensive patients. Antihypertensives per person (2.015; 2.017) do not differ. The prevalence of MCI is highly significantly associated with the number of risk factors. in participants without risk factors, the prevalence is 3.9%, in participants with 4 risk factors, 16.3%. In hypertensive patients, the frequency is 11.8% compared with 4.8% for normotensives (P < 0.001). The occurrence of MCI depends significantly from age, blood pressure and diabetes CONCLUSION:: The frequency of MCI is highly significantly associated with the number of cardiovascular risk factors, regardless of age. The prevalence was particularly high among hypertensive patients, which is not often described. The occurrence of MCI depends significantly from age, blood pressure and diabetes. The metabolic syndrome and lack of exercise complicate blood pressure control.

Long-term effects of baroreflex activation therapy: 2-year follow-up data of the BAT Neo system.

OBJECTIVE: Baroreflex activation therapy (BAT) reduces office blood pressure (BP) in patients with resistant hypertension (HTN). Whereas sustained effects from the BAT Rheos device have already been reported, no long-term data on 24-h ambulatory BP (ABP) are currently available for the unilateral BAT Neo device. METHODS: Patients treated with the BAT neo device for resistant hypertension were prospectively included into this observational study. Office and ABP measurements were performed before BAT implantation as well as 6, 12 and 24 months after initiation of BAT. RESULTS: A total of 60 patients with resistant HTN (office BP 172 ± 25/90 ± 17 mmHg, 24-h ABP 150 ± 16/80 ± 12 mmHg, median of antihypertensive drugs 7 (IQR 6-8)) were included. After 24 months, there was a significant reduction of - 25 ± 33/- 9 ± 18 mmHg (n = 50, both p < 0.01) in office BP and - 8 ± 23/- 5 ± 13 mmHg (n = 46, both p = 0.02) in 24-h ABP, while the number of antihypertensive medications was reduced to a median of 5 (4-6) drugs (p < 0.01). Patients with isolated systolic HTN (ISH) experienced a BP-lowering effect in office BP, but not in ABPM at month 24. Using unadjusted BP values, BAT seems to be more effective in combined hypertension (CH) than in ISH. After adjustment for baseline BP values, there was no significant difference in BP reduction between ISH and CH patients. Ambulatory SBP at baseline was the only independent correlate of BP response at month 24. CONCLUSION: BAT reduced office BP and improved relevant parameters of ABP, which is associated with a high cardiovascular risk, in patients with resistant HTN, whereas, after adjustment for baseline BP, BP reduction was not different in patients with CH compared with patients with ISH. However, randomized controlled trials are needed to confirm the effects of BAT on 24-h ABP.

[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.

Effect of baroreflex activation therapy on renal sodium excretion in patients with resistant hypertension.

OBJECTIVE: Activation of the sympathetic nervous system increases sodium retention in resistant hypertension. Baroreflex activation therapy (BAT) is an interventional method to reduce sympathetic overactivity in patients with resistant hypertension. This study aimed to assess the effect of BAT on urinary sodium excretion. METHODS: From 2012 to 2015, consecutive patients with resistant hypertension and blood pressure (BP) above target despite polypharmacy strategies were consecutively included in this observational study. BAT was provided with the individual adaption of programmed parameters over the first months. 24-h urinary sodium excretion (UNa) was estimated at baseline and after 6 months using the Kawasaki formula in patients undergoing BAT. Additionally, the fractional sodium excretion, plasma renin activity, and aldosterone levels were assessed. RESULTS: Forty-two patients completed the 6-month follow-up period. Office systolic and ambulatory 24-h systolic BP at baseline were 169 ± 27 mmHg and 148 ± 16 mmHg despite a median intake of 7(3-9) antihypertensive drugs. After 6 months of BAT, systolic office BP decreased to 150 ± 29 mmHg (p < 0.01), 24-h systolic BP to 142 ± 22 mmHg (p = 0.04) and 24-h UNa increased by 37% compared to baseline (128 ± 66 vs. 155 ± 83 mmol/day, p < 0.01). These findings were accompanied by a significant increase in fractional sodium excretion (0.74% [0.43-1.47] to 0.92% [0.61-1.92]; p = 0.02). However, in contrast to the significant BP reduction, eGFR, plasma sodium, renin activity and aldosterone levels did not change during BAT. The increase in sodium excretion was correlated with the change in eGFR (r = 0.371; p = 0.015). CONCLUSION: The present study revealed a significant increase of estimated 24-h UNa which may contribute to the long-term BP-lowering effects of this interventional method.

[ELITE study - Nutrition, lifestyle and individual information for the prevention of stroke, dementia and heart attack - Study design and cardiovascular status]. / ELITE-Studie ­ Ernährung, Lebensstil und individuelle Information zur Verhinderung von Schlaganfall, Demenz und Herzinfarkt ­ Studiendesign und kardiovaskuläre Aufnahmedate.

BACKGROUND: For the prevention of cardiovascular risk factors (RF) there are numerous recommendations of professional societies, which relate to the personal way of life of individuals (for example nutrition/diet, physical activity, stress reduction etc.). The implementation of these recommendations is so far poor. In the ELITE study, data on RF, nutritional behavior, physical activity and quality of life in the Oldenburger Münsterland region are to be collected prospectively and improved by individual information. Reasons for the lack of implementation of preventive measures should be recognized. METHODS: The study is conducted as an interventional cohort study (DRKS-No.: 00 006 813, Ethics vote University of Göttingen). Up to 5000 people (with or without pre-existing RF) are aimed to be included. All participants receive a computer-generated report of their personal risk profile with detailed recommendations based on current guidelines. In addition, it is recommended to visit the family doctor to discuss the findings and, if necessary, initiate diagnostic or therapeutic measures. Every year, follow-up examinations take place for up to 5 years. RESULTS: By 31.12.2017 4602 participants (mean age 51.5 (±â€Š15.7) years, 53.7 % female) were admitted. Overweight were 39 % of the participants, obese 20.4 %. Most frequent anamnestic RF is hypertension (31.4 %), mean blood pressure was 138.4 ±â€Š16.6/83.0 ±â€Š9.9 mmHg. 2165 (47.0 %) participants show hypertensive blood pressure values. The second most frequent anamnestic RF are lipid metabolism disorders (16.6 %). CONCLUSION: The incidence of participants with at least one cardiovascular RF is very high (49.5 %, 16.6 % multiple RF). The incidence of RF is similar to other epidemiological data in Germany, so the ELITE collective allows a good comparison with other surveys.

[New American Guidelines on Hypertension: New Consequences for German Patients?] / Neue amerikanische Leitlinien zur Hypertonie: neue Konsequenzen für uns?

Following the publication of the new US guidelines, especially the new classifications of hypertension and the general reduction in treatment targets were discussed worldwide. Applying the US guidelines to a recent German cohort study would in practice lead to a significant increase in the diagnosis of "hypertension" in untreated patients. The number of under-adjusted patients would also increase sharply, increasing more than those predicted in the US Guidelines. Affected by an intensified antihypertensive therapy would be particularly elderly patients, in which adverse drug reactions but also occur more frequently. It seems doubtful whether the massive increase in the diagnosis "hypertension" can improve the supply situation: the opposite effect of avoiding therapists and patients could occur. Determining the individual risk with suitable, evaluated instruments certainly makes sense to treat more targeted patients. More important than new blood pressure limits is a more accurate classification of blood pressure. Repeated self-measurements and ambulatory blood pressure measurement lead to a better selection of patients benefiting from a therapy.

Safety profile of baroreflex activation therapy (NEO) in patients with resistant hypertension.

OBJECTIVE: Unlike safety data of baroreflex activation therapy device (Rheos), only few data of the currently used second device (Barostim neo) are available and little is reported about common side effects. METHODS: We prospectively analyzed patients with resistant hypertension treated with Barostim neo. A standardized interview regarding side effects of the therapy was performed in routine follow-up visits after device implantation in 42 patients to determine adverse events staged into three degrees. RESULTS: Within 6 months of baroreflex activation therapy, the office mean arterial blood pressure decreased from 169 ±â€Š27 to 148 ±â€Š29 mmHg systolic (P < 0.001), respectively, to 145 ±â€Š24 mmHg after 1 year (P < 0.001), whereas the number of prescribed antihypertensive classes decreased from 6.6 ±â€Š1.5 to 5.6 ±â€Š1.8 (P < 0.001). Adverse events were combination of the following field depending on the severity (I° mild: local discomfort, clinical observation only, no intervention indicated; II° moderate: medically significant such as occurrence of hypertensive crisis, syncope, arrhythmias; III° severe: life-threatening events or urgent medical intervention indicated). Adverse events I° were present in almost all patients (97.6%), and occurred mainly within first 6 months after device activation. Device-related events were most frequently and could be resolved by optimization of device parameters. Most procedure-related adverse events were directly related to the incision or anesthetic procedure. Adverse events II° occurred in 28.6% patients treated with Barostim neo, whereas patients' elevated individual risks might be potential triggers. Because of individual diversity of blood pressure response and the occurrence of adverse events, no standardization of parameters of implantable pulse generator could be found. By adapting the pulse generator settings individually, most of adverse events I° resolved without sequel. CONCLUSION: Though there are common side effects, Barostim neo significantly lowers blood pressure in resistant hypertension and provides an adequate safety profile. Regular patient visits are necessary to register side effects.

Management of cardiovascular risk factors in patients with ANCA-associated vasculitis.

OBJECTIVES: Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) is accompanied by increased cardiovascular (CV) risk. Treatment of AAV patients includes the management of conventional CV risk factors, primarily hypertension and hypercholesterolemia, while lipoprotein(a) (LP(a)) is an emerging potential target. METHODS: We performed a multicenter, retrospective study in Germany. Patients were considered if they were between 18 and 90 years old and presented with AAV. Patients with arterial hypertension but no autoimmune disease were used as a control group (HTN reference group). RESULTS: Compared to the reference group (n = 52), CV disease burden was significantly greater in patients with AAV (n = 53). Hypercholesterolemia was also more common in the AAV patients (71.7% vs 46.2% for the HTN; P = .008). Lipoprotein(a) levels were elevated in both groups, with 11.3% and 17.3% of the AAV and HTN groups, respectively, displaying a level above 0.6 g/l (P = .083). Guideline-recommended targets for low-density lipoprotein cholesterol and blood pressure levels were rarely met. According to Kidney Disease: Improving Global Outcomes guidelines, 72.5% of the patients with AAV should have been taking statins and/or ezetimibe for treatment of hyperlipidemia; however, only 24.3% of them were receiving such treatment. Blood pressure below ≤140/90 mmHg was reached in 78.6% of the patients with chronic kidney disease. However, for patients with chronic kidney disease and an albumin excretion rate of >30 mg/day, the recommended blood pressure is ≤130/80 mmHg, a value that was not reached in 65% of the AAV patients. CONCLUSION: Patients with AAV are at high CV risk, but management of the associated risk factors is poor. In addition to improving the treatment of hypercholesterolemia and hypertension, lipoprotein(a) is a further potential target for reducing CV risk in individuals with AAV.

Baroreflex activation therapy in patients with prior renal denervation.

BACKGROUND: Both baroreflex activation therapy (BAT) and renal denervation modulate sympathetic activity. The aim of this study was to systematically investigate whether additive modulation of autonomic nervous system by BAT lowers blood pressure (BP) in patients who still suffer from uncontrolled resistant hypertension despite prior renal denervation. METHODS: From 2012 to January 2015, patients treated with BAT for uncontrolled resistant hypertension, who prior received renal denervation were consecutively analyzed in four German centers for hypertension. Analyses of office BP, 24-h ambulatory BP, central hemodynamics, parameters of renal function were performed. RESULTS: A total of 28 patients, who underwent renal denervation at least 5 months before and still suffer from uncontrolled BP, were subsequently treated with BAT. The office SBP decreased from 182 ±â€Š28 to 163 ±â€Š27 mmHg (P < 0.01) with a responder rate of 68% (office SBP reduction ≥10 mmHg) at month 6, whereas the number of prescribed antihypertensive drug classes remained unchanged (6.2 ±â€Š1.5 vs. 6.0 ±â€Š1.7, P = 0.30). Serum creatinine, estimated glomerular filtration rate and cystatin C remained stable (P = 1.00, P = 0.41 and P = 0.22, respectively), whereas albuminuria was significantly reduced by a median of -29% (P = 0.02). Central SBP (-15 ±â€Š24 mmHg, P = 0.047) and end systolic pressure (-14 ±â€Š20 mmHg, P = 0.03) were significantly reduced. CONCLUSION: The present data demonstrate that BAT may exert BP-lowering as well as antiproteinuric effects in patients with prior renal denervation. However, precise evaluation of BAT effects in patients with prior renal denervation will need randomized controlled trials using sham procedures.