Beneficial impacts of physical activity on heart rate variability: A systematic review and meta-analysis.

BACKGROUND: Cardiovascular diseases (CVD) are the leading causes of morbidity and mortality. Heart rate variability (HRV) represents the modulatory capacity of the autonomous nervous system and influences mortality. By surveying this meta-analysis, we investigated the impact of physical activity on HRV. METHODS: Databases, online journal libraries and clinical trial registries were searched for publications of randomized controlled and non-randomized controlled trials concerning adults with coronary artery disease (CAD)/ischemic heart disease (IHD), congestive heart failure (CHF), peripheral arterial disease (PAD) or after acute coronary syndrome (ACS) joining an intervention group with physical activity or a control group with usual care or no intervention. Extracted time-domain and frequency-domain parameter of HRV were analyzed in a meta-analysis using a random effect model. Subgroup analyses concerning intervention type, study design and type of heart disease and sensitivity analysis were performed. RESULTS: Significant results were obtained for RR-Interval (p = 0.05) and standard deviation of Normal-to-Normal intervals (SDNN) (p = 0.01) for short-term assessment and for the ratio of low-frequency power (LF) to high-frequency power (HF) (p = 0.05) for 24-hour assessment. Subgroup analyses also resulted significant: root-mean-square difference of successive normal R-R intervals (RMSSD) (p = 0.01), SDNN (p = 0.02) and HF (p < 0.01) concerning CHF. CONCLUSION: We were able to demonstrate the positive impact of physical activity on HRV, especially in patients with CHF. Cardiac rehabilitation exercise programs need to be individualized to identify the most beneficial method of training for improving the prognosis of patients with CVD.

Underutilization of guideline-recommended therapy in patients 80 years and older with peripheral artery diseases.

Background: Ageing is a major cardiovascular risk factor with detrimental changes that culminate in a high atherosclerotic burden. Peripheral artery disease (PAD) is a major manifestation of atherosclerosis with high mortality. Guideline-recommended treatment is essential, however implementation is inadequate. With an ageing society, age-related inequalities are important and have not been elucidated in a high-risk PAD population on a nation-wide scale. We sought to analyse outpatient treatment structures and guideline adherence in treatment of PAD patients older than 80 years. Patients and methods: The study is based on ambulatory claims data comprising 70.1 million statutorily insured patients per year in Germany from 2009 to 2018. We analysed age-related differences in prevalence, pharmacotherapy and specialized outpatient care in PAD patients. Results: Of 17,633,970 PAD patients included, 28% were older than 80 years. PAD prevalence increased between 2008 and 2018 (1.85% vs. 3.14%), with the proportion of older patients increasing by a third (24.4% vs. 31.2%). Octogenarians were undertreated regarding guideline-recommended statin pharmacotherapy compared to younger patients while antiplatelets were prescribed more often (statins 2016: 46.5% vs. 52.4%; antiplatelets 2016 30.6% vs. 29.3%; p<.05). Furthermore, octogenarians received less specialized outpatient care (angiology: 6.4% vs. 9.5%, vascular surgery: 8.1% vs. 11.8%, cardiology: 25.2% vs. 29.2%, p<.05). Conclusions: Our results demonstrate that age-related differences in pharmacotherapy and specialized outpatient care of PAD patients are evident. While overall guideline-recommended outpatient treatment is low, patients 80 years and older are less likely to receive both, leaving age-related health inequalities a challenge of our future.

Needs and demands for mHealth cardiac health promotion among individuals with cardiac diseases: a patient-centred design approach.

Aims: Cardiovascular diseases are one of the main contributors to disability and mortality worldwide. Meanwhile, risk factors can be modified by lifestyle changes. mHealth is an innovative and effective way to deliver cardiac health promotion. This study aims to examine the needs and demands regarding the design and contents of an mHealth intervention for cardiac health promotion among individuals with cardiac diseases. Different clusters were determined and analysed in terms of the intention to use an mHealth intervention. Methods and results: A cross-sectional study was conducted via a web-based survey. Three hundred and four individuals with coronary artery diseases (CADs) and/or congestive heart failure (CHF) were included in the data analysis. Descriptive statistics were applied to evaluate needs and demands regarding an mHealth intervention. A k-medoids cluster analysis was performed. Individuals with CAD and CHF favoured an mHealth intervention that supports its users permanently and is easily integrated into everyday life. Handheld devices and content formats that involve active user participation and regular updates were preferred. Three clusters were observed and labelled high, moderate, and low burden, according to their psychometric properties. The high burden cluster indicated higher behavioural intention towards use of an mHealth intervention than the other clusters. Conclusion: The results of the study are a valuable foundation for the development of an mHealth intervention for cardiac health promotion following a user-centred design approach. Individuals with cardiac diseases report positive attitudes in the form of high usage intention regarding mHealth. Highly burdened individuals report a high intention to use such interventions.

A mHealth intervention to reduce perceived stress in patients with ischemic heart disease: study protocol of the randomized, controlled confirmatory intervention "mStress-IHD" trial.

BACKGROUND: Stress is highly prevalent in patients with ischemic heart disease (IHD) and is associated with lower health-related quality of life and impaired cardiovascular outcome. The importance of stress management is now recognized in recent guidelines for the management of cardiovascular disease. However, effective stress management interventions are not implemented in clinical routine yet. The development of easily disseminated eHealth interventions, particularly mHealth, may offer a cost-effective and scalable solution to this problem. The aim of the proposed trial is to assess the efficiency and cost-effectiveness of the mHealth intervention "mindfulHeart" in terms of reducing stress in patients with IHD. METHODS AND ANALYSIS: This randomized controlled confirmatory interventional trial with two parallel arms has assessments at six measurement time points: baseline (T0, prior randomization), post-treatment (T1), and four follow-ups at months 1, 3, 6, and 12 after intervention (T2, T3, T4, and T5). We will include patients with confirmed diagnosis of IHD, high-perceived stress, and use of an internet-enabled smartphone. Patients will be randomized into two groups (intervention vs. control). The proposed sample size calculation allocates 128 participants in total. The primary analysis will be performed in the intention-to-treat population, with missing data imputed. An ANCOVA with the outcome at T1, a between-subject factor (intervention vs. control), and the participants' pre-intervention baseline values as a covariate will be used. Different ANOVAs, regression, and descriptive approaches will be performed for secondary analyses. ETHICS: The Ethics Committee of the Medical Faculty of the University of Duisburg-Essen approved the study (22-11,015-BO). TRIAL REGISTRATION: ClinicalTrials NCT05846334. Release 26.04.2023.

Psychometric properties of the German revised version of the eHealth literacy scale in individuals with cardiac diseases: Validation and test of measurement invariance.

Background: The internet is most people's primary source of (health) information. However, no validated instrument exists to assess eHealth literacy in the group of patient with cardiac diseases. Objective: The objective of this study was the evaluation of the psychometric properties of the German revised version of the eHealth literacy scale (GR-eHEALS) in individuals with coronary artery disease (CAD) and congestive heart failure (CHF). Methods: A cross-sectional study was conducted. N = 455 were included in the statistical analyses. The assessment compromised the GR-eHEALS, medical history, sociodemographic data, and technology-related data. Confirmatory factor analyses, correlational analyses, and tests of measurement invariance were performed. Results: The two-factorial model reached a good model fit. The sub-scales information seeking and information appraisal, as well as the eHealth literacy total score, reached high reliability coefficients. Construct and criterion validity was fully confirmed For the two-factorial model, measurement invariance up to the scalar level could be confirmed regarding the sociodemographic characteristics sex, age, and educational level. Conclusions: This study confirmed the two-factor structure, construct, and criterion validity as well as measurement invariance at the scalar level for sex, age, and educational level of the GR-eHEALS scale in a sample of individuals with CAD and CHF.

Differences in treatment strategies for LDL-cholesterol reduction in a university lipid clinic vs. standard care apart from the use of PCSK9 inhibitors.

BACKGROUND: Lipid-lowering therapy (LLT) in patients with cardiovascular disease (CVD) is insufficient despite clear guideline recommendations. Lipid clinics have specialized in patients with dyslipidemia, but the magnitude and reduction of low-density lipoprotein cholesterol (LDL-C) in lipid clinics has not yet been studied in depth. OBJECTIVE: To assess LDL-C reduction in very high-risk CVD patients achieved in a lipid clinic through different forms of LLT in comparison to standard care without the initiation of PSCK9 inhibitors. METHODS: Data from 96 lipid clinic patients were analyzed retrospectively and compared to 84 standard care patients. Very high-risk patients were defined according to the European Society of Cardiology (ESC). Different combinations of LLT focusing on statins and ezetimibe were investigated. Achievement of LDL-C treatment goals according to ESC guidelines as well as LDL-C reduction were assessed. RESULTS: Baseline and follow-up data of 180 very high-risk CVD patients (mean age 67.7 (±9.8) y; 60.6% male) were used. Achievement of the LDL-C goal in lipid clinic patients increased significantly from 14.6% at baseline to 41.7% at the latest visit (p<0.001) while standard care patients improved from 21.4% to 33.3% (p=0.08). The largest relative LDL-C reduction via an adjustment in LLT was achieved by initiation of high-intensity statins (50.8 ± 4.9%, n = 5, p < 0.05). CONCLUSION: Treatment in a lipid clinic leads to a superior LDL-C goal achievement in very high-risk CVD patients as compared to standard care with the highest reduction under LLT with high-intensity statins and ezetimibe. Referral algorithms have to be established for high-risk patients.

Percutaneous left atrial appendage closure for stroke prevention in patients with chronic renal disease.

Introduction: Atrial fibrillation (AF) is the most common cardiac arrhythmia in the general population. Atrial fibrillation is associated with an increased risk of thromboembolic events, particularly stroke. Chronic kidney disease (CKD) is associated with a higher prevalence of AF and is an independent risk factor of increased mortality and stroke in AF patients. Left atrial appendage closure (LAAC) for stroke prevention plays an important role in the treatment of patients with AF and increased bleeding risk. The impact of CKD on outcomes after LAAC has not been deeply investigated. We assessed whether percutaneous LAAC is safe and feasible in CKD patients. Material and methods: Ninety-seven patients (mean age: 73.9 ±8.5 years) with AF and contraindications for oral anticoagulation (OAC) or complications under OAC underwent LAAC with the Amplatzer Cardiac Plug and the Amplatzer Amulet Occluder in an open-label observational single-center study. We classified patients as having normal to mild (KDOQI stage I-II) or moderate to severe (KDOQI stage III-V) CKD. Results: Patients with moderate to severe CKD (n = 49) had increased CHA2DS2-VASc and HAS-BLED scores and were at higher thromboembolic and bleeding risk (CHA2DS2-VASc: 4.08 ±0.79, HAS-BLED: 4.76 ±0.69) than patients with mild to moderate CKD (n = 48, CHA2DS2-VASc: 3.69 ±1.1, HAS-BLED: 4.06 ±0.66; p < 0.001 for both). In both groups, procedural and occlusion success was similar (97.9% vs. 95.9%; p = 0.479). Follow-up of 6 months and from 12 to 36 months revealed effective stroke prevention and no bleeding complication in both groups. Conclusions: In spite of a higher thromboembolic and bleeding risk in patients with severe CKD, LAAC is a safe and feasible option for stroke prevention.

Determining the Acceptance of Digital Cardiac Rehabilitation and Its Influencing Factors among Patients Affected by Cardiac Diseases.

BACKGROUND: Cardiac diseases are a major global health issue with an increasing prevalence of affected people. Rehabilitation following cardiac events is underutilized, despite its proven effectiveness. Digital interventions might present a useful addition to traditional cardiac rehabilitation. AIMS: This study aims to assess the acceptance of mobile health (mHealth) cardiac rehabilitation and to investigate the underlying factors of acceptance in patients with ischemic heart disease and congestive heart failure. METHODS: A cross-sectional study was conducted from November 2021 to September 2022 with N = 290 patients. Sociodemographic, medical, and eHealth-related data were assessed. The Unified Theory of Acceptance and Use of Technology (UTAUT) was applied. Group differences in acceptance were examined and a multiple hierarchical regression analysis was conducted. RESULTS: The overall acceptance of mHealth cardiac rehabilitation was high (M = 4.05, SD = 0.93). Individuals with mental illness reported significantly higher acceptance (t(288) = 3.15, padj = 0.007, d = 0.43). Depressive symptoms (ß = 0.34, p < 0.001); digital confidence (ß = 0.19, p = 0.003); and the UTAUT predictors of performance expectancy (ß = 0.34, p < 0.001), effort expectancy (ß = 0.34, p < 0.001), and social influence (ß = 0.26, p < 0.001) significantly predicted acceptance. The extended UTAUT model explained 69.5% of the variance in acceptance. CONCLUSIONS: As acceptance is associated with the actual use of mHealth, the high level of acceptance found in this study is a promising basis for the future implementation of innovative mHealth offers in cardiac rehabilitation.

Complications in Patients with Chronic Type B Aortic Dissection (cTBAD)-A Long-Term Analysis.

Chronic type B aortic dissection (cTBAD) is a rare but challenging condition that requires individual treatment strategies. Especially the long-term therapy impacts prognosis. In this single-center retrospective study, we evaluated patients with cTBAD in our vascular outpatient clinic over 10 years. Follow-up consultations included contrast-enhanced, electrocardiogram-triggered, high-resolution CT angiography (CTA) covering the entire aorta. Evaluated characteristics went beyond demographic characteristics combining the treatment approach and the timing and occurrence of potential complications. We analyzed 133 patients in total (n = 92, 69.2% male) with cTBAD with a mean follow-up of 67.7 months. Most of them underwent invasive treatment (n = 102, 76.7%), the majority received thoracic endovascular aortic repair (TEVAR) (n = 82, 61.7%). A total of 80 patients (60.2%) had major complications, whereas over a third was free of complications even after 5 years. Most common complications were progress of dissection and endoleaks, aneurysms of true (TL) and false lumen (FL) were more common in the later time periods. The treatment of cTBAD in terms of timing, therapy approach, and complications is still challenging for the entire aortic team. Nevertheless, the early recognition of complications permits promising treatment options and highlights the importance of frequent follow-up examinations especially within the first years.

Income-Related Peripheral Artery Disease Treatment: A Nation-Wide Analysis from 2009-2018.

Economic status has a measurable and significant effect on cardiovascular health. Socioeconomic- and income-related disparities worsen cardiovascular risk factors. Peripheral artery disease (PAD) remains a major risk factor for morbidity and mortality. Not all patients benefit equally from recent advances in outpatient healthcare. The implementation of guideline recommendations regarding treatment is inadequate. Income-related disparities for PAD treatment are unknown. We aimed to analyse income-stratified PAD prevalence, outpatient treatment and pharmacotherapy. Associations of statutory health insurance physicians at the regional level, income-stratified PAD prevalence and differences in outpatient care and pharmacotherapy were analysed in 70.1 million statutorily insured patients/year between 2009 and 2018. Analysis was based on claims data (§295 of the social code (SGB V)) and drug-prescription data (§300 SGB V). The diagnosis of PAD was defined by ICD I70.2-9. Regional income data were derived from the German Census Bureau. PAD prevalence was higher in low-income than in high-income areas. Low-income patients more often presented to angiology outpatient care and more frequently received guideline recommended pharmacotherapy. High-income patients more often presented to outpatient vascular surgery. This was true for statins, antiplatelets, intermittent claudication and critical limb ischemia alike. These data indicate that PAD and income are associated. Regional income is related to insufficiencies in guideline-recommended treatment and contact to vascular specialists. Our results aim to encourage medical professionals to implement PAD guideline recommendations, especially in high-income areas. Further studies on associations between spatial-level income and healthcare in PAD are needed.

Mechanical atherothrombectomy improves endothelial function through plaque burden reduction in PAD.

Background: Endothelial dysfunction defines outcomes and serves as a surrogate parameter for the progression of cardiovascular disease. For symptomatic peripheral artery disease (PAD) endovascular treatment is the primary revascularization strategy, which affects endothelial function. Interventional mechanical atherothrombectomy (MATH) provides advantages when treating complex atherosclerotic and thrombotic lesions. We now aimed to determine the impact and mechanisms of MATH on endothelial function. Patients and methods: Endothelial function was determined using flow-mediated dilation (FMD) before and after lower limb intervention with a six-month follow-up in the target and control vessel in 15 PAD MATH+DCB treated patients and compared to 15 non-Math controls. In a further cohort of 20 patients the impact of MATH and DCB on vascular structure and virtual histology was assessed through intravascular ultrasound (IVUS) and compared to DCB treatment alone. Results: Improved endothelial function after 6 months was observed in both groups for the target and nontarget vessel. When comparing the changes from baseline endothelial function, treatment with MATH+DCB was superior to DCB treatment in the target vessel. IVUS revealed a greater improvement in luminal area and plaque burden reduction after MATH treatment. Virtual histology disclosed MATH-associated changes in plaque composition evidenced by alterations in fibrous volume and reductions in superficial calcium. Conclusions: We demonstrate an improved endothelial function after MATH treatment as compared to DCB treatment. The improved vessel function is evidenced by MATH-related plaque burden reduction, improved luminal gain and a decrease in superficial calcification. Clinicaltrials.gov: NCT04092972.

Determinants of Acceptance of Weight Management Applications in Overweight and Obese Individuals: Using an Extended Unified Theory of Acceptance and Use of Technology Model.

Overweight and obesity carry a tremendous burden in terms of physiological and psychological comorbidities. There is a great variety of weight management applications to support weight reduction, but a systematical analysis of individuals' needs and requirements to adopt sustaining lifestyle changes is missing so far. This study aimed to assess the acceptance of such applications and its underlying predictors in individuals with overweight/obesity. A cross-sectional study was conducted, including 439 overweight/obese individuals. Health-related internet use and acceptance of weight management applications were examined using a modified questionnaire based on the Unified Theory of Acceptance and Use of Technology (UTAUT). The general acceptance of weight management applications was high, with significant age differences. Compared to older individuals, younger ones showed a higher acceptance. BMI was not significantly associated with acceptance. Besides psychometric data and eHealth-related data, performance expectancy, effort expectancy, and social influence proved to be significant predictors for acceptance. The total variance explanation provided by the extended UTAUT model was 61.2%. The knowledge of the influencing factors on acceptance might be useful in developing, optimizing, and establishing weight management applications. For determining acceptance and its predictors of weight management applications, the UTAUT model is a valid approach.

Gender Differences in Outpatient Peripheral Artery Disease Management in Germany: A Population Based Study 2009-2018.

OBJECTIVE: Peripheral artery disease (PAD) is a major risk factor for morbidity and death. Despite clear guideline recommendations regarding outpatient treatment and pharmacotherapy, implementation is inadequate. Gender differences are becoming increasingly important, especially in patients with atherosclerosis. METHODS: Gender stratified PAD prevalence and differences in treatment by specialised outpatient care and pharmacotherapy were analysed in 70.1 million statutorily insured patients/year in Germany between 2009 and 2018. This was based on claims data according to §295 of the social code (SGB V) and drug prescription data according to §300 SGB V. Diagnosis of PAD was defined according to ICD I70.2-9 coding. Statistical analysis was performed with the chi square test for trend and two way ANOVA. RESULTS: In total, 17 633 970 patients with PAD were identified, of whom 47% were female. Prevalence of PAD in Germany increased between 2009 and 2018 and was higher in male patients. Only a minority of 37.1% presented to a vascular specialist. Interestingly, female patients were both less likely to present to a vascular specialist and to receive guideline recommended pharmacotherapy. Overall prescription rates of statins and antiplatelet drugs increased between 2009 and 2018, however. PAD stages were stratified by intermittent claudication (IC) and chronic limb threatening ischaemia (CLTI). In CLTI even fewer patients received a statin, with the gender gap increasing. CONCLUSION: The results demonstrate gender based differences in pharmacotherapy and specialised outpatient care of patients with PAD. While overall outpatient treatment by vascular specialists and guideline recommended medical therapy of PAD are low, women and patients with CLTI remain undertreated.

Changes in Health Perception among Patients with Aortic Diseases in a Severe COVID-19 Area in the West of Germany: A Longitudinal Study between the First and Second Wave of the COVID-19 Pandemic.

Background and Objectives: The rapid spread of the novel coronavirus disease (COVID-19) has become the most challenging global health pandemic since the 1918 flu. In Germany, more than 3.4 million cases are confirmed so far, including 83,000 deaths. Increased fatality rates among patients with pre-existing cardiovascular diseases (CVD) represent this group at particular risk. The aim of this study was to evaluate changes in health perception among patients with aortic diseases during the first (w1) and second wave (w2) of the COVID-19 pandemic in Germany. Material and Methods: Patients (n = 262) diagnosed with aortic disease participated in telephone interviews during w1 and w2. The perception of COVID-19 as a threat was examined using relevant items of the Brief Illness Perception (BIP) questionnaire. Results: The BIP score increased from 9.18 (SD = 7.132) to 14.58 (SD = 6.956) between w1 and w2 (p < 0.001). Although this population is at high risk their overall perception of COVID-19 as a threat was low in the beginning, but surged during w2. Main reasons were increased effects on personal life and elevated concerns about the pandemic, but did not include the educational aspect of COVID-19. Conclusions: Tailored risk communication strengthens the mental health of people in a public health crisis and ensures the success of governmental guidelines.

Peripheral artery disease in Germany (2009-2018): Prevalence, frequency of specialized ambulatory care and use of guideline-recommended therapy - A population-based study.

BACKGROUND: Peripheral artery disease (PAD) patients have high morbidity and mortality rates, demonstrating a need for improved treatment strategies. While underuse and undertreatment have been reported, there is no clear picture of patterns in population-level disease prevalence, prescription of guideline-recommended pharmacotherapy, or frequency of contact with dedicated specialists. We present population-level data on changes in prevalence, care and treatment of PAD from 2009 to 2018 in Germany. METHODS: We analyzed the ambulatory claims data for all statutorily insured patients comprising 70.1 million patients each year and 87% of the German population. Prevalence was assessed by documentation of PAD and stratified by age and sex within the 10-year study timeframe. In addition, current ambulatory care, stratified by vascular specialists (vascular surgeons or angiologists), internists, cardiologists and primary care physicians, were examined. FINDINGS: Prevalence increased from 1·85% in 2009 to 3·14% in 2018, affecting 2·3 million patients in 2018 and more males (55%) than females (45%). A low level of visits to vascular specialists, with 11·1% receiving care from vascular surgeons and 8·1% from angiologists, was shown. Moreover, analysis of guideline-recommended prescriptions revealed increasing, but still insufficient, prescription frequencies among PAD patients between 2009 and 2016, from 42·6% to 56% for statins and from 40·2% to 48·0% for antiplatelets. INTERPRETATION: Our results show that the prevalence of PAD in Germany, as assessed by outpatient PAD documentation, is increasing and PAD patients are underutilizing specialized vascular care; moreover, the prescription frequency of guideline-recommended therapies remains low. There is a clear need to improve the referral and treatment algorithms in the high-risk PAD population. FUNDING: None.

Risk stratification and mortality prediction in octo- and nonagenarians with peripheral artery disease: a retrospective analysis.

OBJECTIVES: Among changes in demographics, aging is the most relevant cardiovascular risk factor. The prevalence of peripheral artery disease (PAD) is high in elderly patients and is associated with a worse prognosis. Despite optimal treatments, mortality in the high-risk population of octo- and nonagenarians with PAD remains excessive, and predictive factors need to be identified. The objective of this study was to investigate predictors of mortality in octo- and nonagenarians with PAD. METHODS: Cases of treated octo- and nonagenarians, including the clinical characteristics and markers of myocardial injury and heart failure, were studied retrospectively with respect to all-cause mortality. Hazard ratios [HR] were calculated and survival was analyzed by Kaplan-Meyer curves and receiver operating characteristic curved were assessed for troponin-ultra and N-terminal pro-brain natriuretic peptide (NT-proBNP) levels and chronic limb-threatening ischemia (CLTI). RESULTS: A total of 123 octo- and nonagenarians admitted for PAD were eligible. The troponin level was the major predictor of all-cause mortality (HR: 4.6, 95% confidence interval [CI]: 1.4-15.3), followed by the NT-proBNP level (HR: 3.9, 95% CI 1.8-8.8) and CLTI (HR: 3.1, 95% CI 1.6-5.9). Multivariate regression revealed that each increment of 1 standard deviation in log troponin and log NT-proBNP was associated with a 2.7-fold (95% CI 1.8-4.1) and a 1.9-fold (95% CI 1.2-2.9) increased risk of all-cause death. Receiver operating characteristic curve analysis using a combination of all predictors yielded an improved area under the curve of 0.888. In a control group of an equal number of younger individuals, only NT-proBNP (HR: 4.2, 95% CI 1.2-14.1) and CLTI (HR: 6.1, 95% CI 1.6-23.4) were predictive of mortality. CONCLUSION: Our study demonstrates that cardiovascular biomarkers and CLTI are the primary predictors of increased mortality in elderly PAD patients. Further risk stratification through biomarkers in this high-risk population of octo- and nonagenarians with PAD is necessary.

Supervised Exercise Therapy Using Mobile Health Technology in Patients With Peripheral Arterial Disease: Pilot Randomized Controlled Trial.

BACKGROUND: Mobile health interventions are intended to support complex health care needs in chronic diseases digitally, but they are mainly targeted at general health improvement and neglect disease-specific requirements. Therefore, we designed TrackPAD, a smartphone app to support supervised exercise training in patients with peripheral arterial disease. OBJECTIVE: This pilot study aimed to evaluate changes in the 6-minute walking distance (meters) as a primary outcome measure. The secondary outcome measures included changes in physical activity and assessing the patients' peripheral arterial disease-related quality of life. METHODS: This was a pilot two-arm, single-blinded, randomized controlled trial. Patients with symptomatic PAD (Fontaine stage IIa/b) and access to smartphones were eligible. Eligible participants were randomly assigned to the study, with the control group stratified by the distance covered in the 6-minute walking test using the TENALEA software. Participants randomized to the intervention group received usual care and the mobile intervention (TrackPAD) for the follow-up period of 3 months, whereas participants randomized to the control group received routine care only. TrackPAD records the frequency and duration of training sessions and pain levels using manual user input. Clinical outcome data were collected at the baseline and after 3 months via validated tools (the 6-minute walk test and self-reported quality of life). The usability and quality of the app were determined using the Mobile Application Rating Scale user version. RESULTS: The intervention group (n=19) increased their mean 6-minute walking distance (83 meters, SD 72.2), while the control group (n=20) decreased their mean distance after 3 months of follow-up (-38.8 meters, SD 53.7; P=.01). The peripheral arterial disease-related quality of life increased significantly in terms of "symptom perception" and "limitations in physical functioning." Users' feedback showed increased motivation and a changed attitude toward performing supervised exercise training. CONCLUSIONS: Besides the rating providing a valuable support tool for the user group, the mobile intervention TrackPAD was linked to a change in prognosis-relevant outcome measures combined with enhanced coping with the disease. The influence of mobile interventions on long-term prognosis must be evaluated in the future. TRIAL REGISTRATION: ClinicalTrials.gov NCT04947228; https://clinicaltrials.gov/ct2/show/NCT04947228.

The impact of percutaneous peripheral interventions on endothelial function.

Background: Treatment of symptomatic peripheral artery disease (PAD) through endovascular interventions is the primary revascularization strategy. Interventions restore perfusion but may cause severe injury to the vascular endothelium, which regulates vascular tone. Endothelial dysfunction is involved in the progression of cardiovascular disease, with higher incidences of vascular events. We aimed to determine the impact of percutaneous interventions on change in endothelial function. Patients and methods: Endothelial function was determined using flow-mediated dilation (FMD) before, the day after lower limb intervention with paclitaxel-coated balloons or stent guided interventions and after a six-month follow-up in the target limb, control limb and the systemic circulation in 42 PAD patients aged 70.2±9 years and 66% men. Additionally, macro- and microvascular function were assessed. Results: In PAD patients aged 70.2±9 years and 66% men, we observed an immediate enhancement of macro-, microvascular and endothelial function after endovascular treatment (FMD of superficial femoral artery (SFA) 3.7±0.2% to 4.1±0.1%, n=42, p=0.02), a sustained long-term improvement after 6-months (FMD SFA 3.7±0.2% to 4.2±0.1%, n=42, p=0.01), and moreover an improved systemic endothelial function (FMD brachial artery 4.3±0.1% to 4.7±0.2, n=42, p=0.01) following peripheral interventions. Subgroup analysis however revealed that following paclitaxel-based percutaneous intervention, the paclitaxel dosage applied was inversely related to the chronic improvement in local endothelial function (r=-0.6, n=22, p=0.005) without evidence for systemic effects (r=-0.25, p=0.27). Conclusions: We demonstrate an improved local and systemic endothelial function after treatment of atherosclerotic peripheral disease with a distinguished response after endovascular intervention with higher dosage of applied paclitaxel restraining the benefits. Further studies have to determine the optimal interventional strategy with respect to different treatment modalities to maintain vessel functions.

Clinical process optimization of transfemoral transcatheter aortic valve implantation.

Background: The avoidance of prolonged hospital stay is a major goal in the management of transcatheter aortic valve implantation (TAVI) - medically and economically. Materials & methods: We compared the time range of the preprocedural length of stay in 2014/2015 with 2016/2017, after the implementation of the TAVI coordinator in 2016. This included restructured pathways for screening and pre-interventional diagnosis, performed examinations during the inpatient stay and major outcome variables. Results: After 2016, we observed a significant reduction in preprocedural length of stay (admission to procedure) compared with 2014/2015 (11.3 ± 7.9 vs 7.5 ± 5.6 days, p = 0.001). There was no difference in other major outcome variables. Conclusion: The introduction of the TAVI coordinator caused a shortening of preprocedural length of stay.

Radial artery occlusion after cardiac catheterization and impact of medical treatment.

Background: The transradial artery approach is the preferred access for cardiac catheterization according to current guidelines. However, the most common complication is radial artery occlusion (RAO). Despite the rare indication for surgical reopening, the occluded radial artery is not available for further procedures or as a potential bypass graft. Still, treatment regimens for RAO are scarce. We now determined whether the addition of antithrombotic to antiplatelet therapy improves the rate of partial or complete regain of patency in RAO following transradial cardiac catheterization in a retrospective analysis. Patients and methods: In a two-center tertiary referral hospital retrospective analysis 4135 files of patients who had undergone transradial catheterization were screened for documented RAO. 141 patients were identified and 138 patients with complete information on the medical regimen and ultrasound examinations for a maximum of 3 months were included in the analysis, whereas 3 patients were excluded due to missing or incomplete follow-up information. Results: 3.3% of all patients that had undergone transradial catheterization featured an oligosymptomatic RAO, confirmed by color-coded duplex sonography. 21% of patients with additional anticoagulation regained full patency vs. 9% without additional anticoagulation (p = 0.07). 40% of patients with anticoagulation featured a partial or full regain of patency vs. 16% of patients without additional anticoagulation for a maximum of 3 months treatment (p = 0.006). No major bleedings were reported during the follow-up visits. Conclusions: RAO remains a rare complication of cardiac catheterization. The addition of antithrombotic therapy for 3 months appears to safely improve the partial or even full regain of radial patency in case of postinterventional RAO.