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IntroductionAtrial 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 methodsNinety-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.ResultsPatients 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.ConclusionsIn spite of a higher thromboembolic and bleeding risk in patients with severe CKD, LAAC is a safe and feasible option for stroke prevention.

Summary: 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.

Summary: 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.

BACKGROUND There were gaps between guidelines and practice when surgery was the only treatment for aortic stenosis (AS). OBJECTIVES This study analyzed the decision to intervene in patients with severe AS in the EORP VHD (EURObservational Research Programme Valvular Heart Disease) II survey. METHODS Among 2,152 patients with severe AS, 1,271 patients with high-gradient AS who were symptomatic fulfilled a Class I recommendation for intervention according to the 2012 European Society of Cardiology guidelines; the primary end point was the decision for intervention. RESULTS A decision not to intervene was taken in 262 patients (20.6%). In multivariate analysis, the decision not to intervene was associated with older age (odds ratio [OR]: 1.34 per 10-year increase; 95% CI: 1.11 to 1.61; P = 0.002), New York Heart Association functional classes I and II versus III (OR: 1.63; 95% CI: 1.16 to 2.30; P = 0.005), higher age adjusted Charlson comorbidity index (OR: 1.09 per 1-point increase; 95% CI: 1.01 to 1.17; P = 0.03), and a lower transaortic mean gradient (OR: 0.81 per 10-mm Hg decrease; 95% CI: 0.71 to 0.92; P < 0.001). During the study period, 346 patients (40.2%, median age 84 years, median EuroSCORE II [European System for Cardiac Operative Risk Evaluation II] 3.1%) underwent transcatheter intervention and 515 (59.8%, median age 69 years, median EuroSCORE II 1.5%) underwent surgery. A decision not to intervene versus intervention was associated with lower 6-month survival (87.4%; 95% CI: 82.0 to 91.3 vs 94.6%; 95% CI: 92.8 to 95.9; P < 0.001). CONCLUSIONS A decision not to intervene was taken in 1 in 5 patients with severe symptomatic AS despite a Class I recommendation for intervention and the decision was particularly associated with older age and combined comorbidities. Transcatheter intervention was extensively used in octogenarians. (J Am Coll Cardiol 2021;78:2131-2143) (c) 2021 by the American College of Cardiology Foundation.

Background The rapidly spread of the novel coronavirus disease (COVID-19) worldwide has become the most challenging global health pandemic since the 1918 flu. In Germany, more than 2.5 million cases are confirmed so far, with more than 70,000 deaths. An increased fatality rate was seen among patients with preexisting comorbid conditions, especially with cardiovascular diseases, representing this group at particular risk. Purpose Risk perceptions of public health crises like the COVID-19 pandemic can affect people's mental health, reveal gaps in support, and influences the adherence to regulatory requirements. The aim of this study was to evaluate changes in health perception among patients with aortic diseases during the first and second wave of the COVID-19 pandemic in Germany. Methods Patients (n=262) diagnosed with aortic disease participated in telephone interviews during the first (w1, April 6–April 29, 2020) and second wave (w2, January 11–January 29, 2021) of the pandemic in Germany. The perception of COVID-19 as a threat was examined using relevant items of the Brief Illness Perception (BIP) questionnaire to address four dimensions (consequences, control, personal control, and understanding). Relevant data focusing on different aortic diseases and cardiovascular risk factors were taken from patient records. Results Aortic diseases included mainly aortic aneurysm of the ascending (n=164, 62.6%) and the descending aorta (n=37, 14.1%). Patients with acute or chronic aortic dissection made up a third (n=41, 15.6%, and n=48, 18.3%, respectively). At baseline (w1), none of the participants had neither been quarantined nor were taken ill with COVID-19. At the second survey (w2), 24 participants (n=252, 9.5%) had already been quarantined and five (n=252, 2%) were diagnosed with COVID-19. The BIP score increased 9.18 (SD=7.132) to 14.58 (SD = 6.956) between w1 and w2 (p Conclusion Although patients with aortic diseases are highly at risk of having worse outcomes from COVID-19, their overall perception of COVID-19 as a threat was low in the beginning, but rising during the second wave. The main reasons were the increased effects on personal life and elevated concerns about the COVID-19 pandemic, but concerns did not include the educational aspect of COVID-19. Tailored risk communication strengthens the mental health of people in a public health crisis and ensures the success of governmental guidelines and policies. Funding Acknowledgement Type of funding sources: None. Course of COVID-19 pandemic in Germany

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.

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.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.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.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.

Summary: 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.

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.

Background Cardiovascular diseases are the leading causes of death in the industrialized world. In addition to coronary heart disease, PAD defines morbidity and is associated with increased mortality. Guideline-recommended therapy and specialized ambulatory care is essential for optimal treatment. Knowledge of the treatment structures, contact with dedicated specialists and pharmacotherapy in the outpatient area are essential for improving treatment, reducing symptoms and finally improve mortality in this high-risk population. Methods The study is based on the ambulatory claims data of the panel doctors services according to § 295 SGB V and drug prescription data according to § 300 SGB V. The prevalence of PAD in Germany (medical diagnoses of PAD ICD I70.2–9) was analyzed by age and gender-specific characteristics with a timeframe of 10 years (2009–2018). In addition, the current ambulatory care structure was examined subdivided by vascular specialist (vascular surgeons or angiologists) and primary care physicians (internal medicine or general practitioners). Additionally, the prescription of guideline-recommended pharmacotherapy like statins and antiplatelet inhibitors was analyzed for the years 2009–2016. Results An increase of PAD diagnosis was observed with a maximum in 2018 with 2.280.000 patients in Germany. The rise of PAD patients strongly correlates with increased age (age group 50–59: 243.000, age group 60–69: 533.000, age group 70–79: 735.000, age group 75–79: 438.000, age group 80–89: 710.000) and more commonly affects males (55%) than females (45%). Access to vascular specialist was low for all age groups with only 11% of patients receiving care from vascular surgeons and only 9% from angiologists. However, 99% received care by a primary care physician. The prescription of lipid-lowering drugs and platelet aggregation inhibitors in the current analysis period from 2009–2016 is insufficient, with only 46% receiving statins and 29% receiving antiplatelets and 15% oral anticoagulation, Conclusion There are relevant differences in age and gender-specific prevalence of PAD in Germany. In addition to the regular care provided by primary care physicians, PAD patients are in need for specialized vascular care. Guideline recommended prescriptions are alarmingly low in PAD patients. There is a clear need to improve the treatment algorithms in the high-risk PAD population. Funding Acknowledgement Type of funding source: None

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. CLINICALTRIAL ClinicalTrials.gov NCT04947228; https://clinicaltrials.gov/ct2/show/NCT04947228

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

Background The Reveal LINQ™ implantable cardiac monitor (ICM; Medtronic, Minneapolis, MN, USA) is obviously smaller than its precursor (the Reveal XT™), but little is known about its long-term safety. Here, we investigated the long-term R-wave sensing reliability of the Reveal LINQ™ ICM. Methods We analyzed the sensing quality of the Reveal LINQ™ ICM over time between March 2014 and January 2015. Results A total of 30 patients underwent Reveal LINQ™ implantation. The main reason for implantation was unexplained syncope (60%). We evaluated a total of 305.8 patient-months (median, 10.7 months) of R-wave sensing quality. A comparison of baseline and follow-up R-wave sensing values revealed no difference (0.401 mV ± 0.244 mV vs 0.447 mV ± 0.323 mV; P = 0.225). Conclusions The consistent detection of events is an important safety feature of an ICM and linked to secure R-wave sensing. Despite the noticeable size reduction, the Reveal LINQ™ ICM retains reliable sensing quality over time.

Cardiovascular disease and its complications such as myocardial infarction in particular, but also cerebrovascular disease with resulting stroke or peripheral arterial disease with acute limb ischemia or amputation are the leading causes of morbidity and mortality in the high-income countries world-wide [1]. In Europe, cardiovascular disease causes almost 4 million deaths per year, which accounts for almost 50% of all deaths [2]. Importantly, 30–40% of all patients who die from cardiovascular disease are younger than 75 years. Primary and secondary prevention aims at the efficient treatment of the modifiable risk factors, i.e. hypercholesteremia, diabetes mellitus, obesity and the fully established metabolic syndrome, arterial hypertension and smoking. Besides drug and interventional treatment, a healthy diet and an active lifestyle with at least modest regular exercise help reduce or even avoid cardiovascular complications. (See Table 1). Table 1 Studies with digital health interventions.

Background Distal stent graft induced new entry (dSINE) is a rare complication occurring in acute and chronic dissections after thoracic endovascular aortic repair (TEVAR) and is linked to a high reintervention rate. We analyzed potential predicting risk factors for dSINE and analyzed the long-term outcome in patients after reintervention. Methods In this single-center, retrospective study we evaluated patients after TEVAR and investigated possible predictors for dSINE development. Therefore, we used a multivariate analysis to test important interventional parameters such as distal oversizing (dOS), taper ratio (TR), angle between distal stent graft and aorta, acute dissection and stent graft length. Reinterventional characteristics were analyzed and further long-term follow-ups after reintervention evaluated. Results We analyzed 185 patients with acute (n=77) and chronic (n=108) dissections after TEVAR with a follow-up of 68.9±32.5 months. Within the follow-up period, 12 (6.5%) patients developed dSINE after a median time of 22.2±20.7 months. We identified acute dissection as a major predicting factor for dSINE development with a 15.8 times higher odds, followed by an increased dOS and TR. The reintervention rate was higher in the dSINE group (83% vs. 20%, p=0.001), but reinterventional results were mostly satisfying, including further freedom from reintervention and/or new endoleak development up to a mean follow-up of 60.7±54.8 months. No dSINE was seen in association to tapered stent grafts. Conclusion We found acute aortic dissection as a major predicting factor for dSINE development, followed by increased dOS and TR. The use of tapered stent grafts might be beneficial in cases with expected high dOS and TR. In rare cases with dSINE occurrence, reintervention is often required, but has a good prognosis even after years.

Background and aims Aortic stiffness is an independent predictor of cardiovascular morbidity and mortality and thus simple, rapid and preferably automated techniques are indispensableto persue a global approach in risk statification. A novel oscillometric based carotido-femoral pulse-wave velocity (cfPWV) was investigated, regarding diagnostic accuracy, sensitivity and specificity and with emphasis on costs, training curves and procedural time effort. Methods In a single-center crossover study, we evaluated subjects free of known cardiovascular disease (CVD) and CVD subjects and a subgroup with peripheral artery disease (PAD) undergoing ankle-brachial index (ABI) and PWV measurements using oscillometry (BoSo, Bosch + Sohn, Germany) compared to tonometry (SphymoCor, Atcor Australia). Pearson's correlation analysis was used to assess the relationship of PWV measurements for both methods. Moreover, examination times and costs were compared. Results A total of 174 study subjects underwent assessment of oscillometric and tonometric PWV measurements. CVD-free subjects (n=57) were younger (60.4±15.6 vs. 67±12.9 years, p=0.003) compared to CVD subjects (n=117). PWV measurements showed significant correlations in CVD-free subjects (r=0.797, p Conclusion Using a simple and rapid automated oscillometric method, we provide good diagnostic accuracy for the determination of aortic stiffness through PWV, both in CVD-free and in CVD subjects. This might help in terms of cost-effectiveness and simplification in daily practice to screen for cardiovascular morbidity and for vascular damage in atherosclerosis.

BACKGROUND The development of mobile interventions for noncommunicable diseases has increased in recent years. However, there is a dearth of apps for patients with peripheral arterial disease (PAD), who frequently have an impaired ability to walk. OBJECTIVE Using a patient-centered approach for the development of mobile interventions, we aim to describe the needs and requirements of patients with PAD regarding the overall care situation and the use of mobile interventions to perform supervised exercise therapy (SET). METHODS A questionnaire survey was conducted in addition to a clinical examination at the vascular outpatient clinic of the West-German Heart and Vascular Center of the University Clinic Essen in Germany. Patients with diagnosed PAD were asked to answer questions on sociodemographic characteristics, PAD-related need for support, satisfaction with their health care situation, smartphone and app use, and requirements for the design of mobile interventions to support SET. RESULTS Overall, a need for better support of patients with diagnosed PAD was identified. In total, 59.2% (n=180) expressed their desire for more support for their disease. Patients (n=304) had a mean age of 67 years and half of them (n=157, 51.6%) were smartphone users. We noted an interest in smartphone-supported SET, even for people who did not currently use a smartphone. “Information,” “feedback,” “choosing goals,” and “interaction with physicians and therapists” were rated the most relevant components of a potential app. CONCLUSIONS A need for the support of patients with PAD was determined. This was particularly evident with regard to disease literacy and the performance of SET. Based on a detailed description of patient characteristics, proposals for the design of mobile interventions adapted to the needs and requirements of patients can be derived.

BACKGROUND Peripheral arterial disease (PAD) is a common and severe disease with a highly increased cardiovascular morbidity and mortality. Through the circulatory disorder and the linked undersupply of oxygen carriers in the lower limbs, the ongoing decrease of the pain-free walking distance occurs with a significant reduction in patients’ quality of life. Studies including activity monitoring for patients with PAD are rare and digital support to increase activity via mobile health technologies is mainly targeted at patients with cardiovascular disease in general. The special requirement of patients with PAD is the need to reach a certain pain level to improve the pain-free walking distance. Unfortunately, both poor adherence and availability of institutional resources are major problems in patient-centered care. OBJECTIVE The objective of this trackPAD pilot study is to evaluate the feasibility of a mobile phone–based self tracking app to promote physical activity and supervised exercise therapy (SET) in particular. We also aim for a subsequent patient centered adjustment of the app prototype based on the results of the app evaluation and process evaluation. METHODS This study was designed as a closed user group trial, with assessors blinded, and parallel group study with face-to-face components for assessment with a follow-up of 3 months. Patients with symptomatic PAD (Fontaine stage IIa or IIb) and possession of a mobile phone were eligible. Eligible participants were randomly assigned into study and control group, stratified by their distance covered in the 6-min walk test, using the software TENALEA. Participants randomized to the study 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 only usual care. TrackPAD records the frequency and duration of training sessions and pain level using manual user input. Clinical outcome data were collected at the baseline and after 3 months via validated tools (6-min walk test, ankle-brachial index, and duplex ultrasound at the lower arteries) and self-reported quality of life. Usability and quality of the app was determined using the user version of the Mobile Application Rating Scale. RESULTS The study enrolled 45 participants with symptomatic PAD (44% male). Of these participants, 21 (47%) were randomized to the study group and 24 (53%) were randomized to the control group. The distance walked in the 6-min walk test was comparable in both groups at baseline (study group: mean 368.1m [SD 77.6] vs control group: mean 394.6m [SD 100.6]). CONCLUSIONS This is the first trial to test a mobile intervention called trackPAD that was designed especially for patients with PAD. Its results will provide important insights in terms of feasibility, effectiveness, and patient preferences of an app-based mobile intervention supporting SET for the conservative treatment of PAD. INTERNATIONAL REGISTERED REPOR DERR1-10.2196/13651

Objectives Distal stent graft induced new entry (dSINE) is a rare complication associated with acute and chronic dissections after thoracic endovascular aortic repair (TEVAR) and is linked to a high re-intervention rate. The potential predicting risk factors for dSINE and long term outcome of patients after re-intervention were analysed. Methods This single centre, retrospective study included patients undergoing TEVAR. Multivariable analysis was used to test important interventional parameters such as distal oversizing (dOS), taper ratio (TR), angle between distal stent graft and aorta, acute dissection and stent graft length. Re-intervention characteristics were analysed and further long term follow up after re-intervention were evaluated. Results One hundred and eighty-five patients were analysed with acute (n = 77) and chronic (n = 108) dissections after TEVAR with an average follow up of 68.9 ± 32.5 months. During follow up, 12 (6.5%) patients developed dSINE after a median of 22.2 ± 20.7 months. Acute dissection was identified as a major predicting factor for dSINE development (15.8 fold increased odds), followed by increased dOS and TR. The re-intervention rate was higher in the dSINE group (83% vs. 20%, p = .001), but results indicated that no further re-intervention was needed and no new endoleak development occurred up to a mean follow up of 60.7 ± 54.8 months. No dSINE was seen in association with tapered stent grafts. Conclusions Acute aortic dissection was found to be the major predicting factor for dSINE development, followed by increased dOS and TR. The use of tapered stent grafts might be beneficial for patients with high expected dOS and TR. In the rare case of dSINE occurrence, even when re-intervention is required, the long term prognosis is good.

OA Förderung 2018 Background: Precise stent graft sizing in Thoracic endovascular aortic repair (TEVAR) is crucial to receive optimal long-term results. Computed tomography (CT), as the current standard in assessing aortic diameters (ADs), is often performed at initial diagnosis. Since several acute aortic diseases are associated with blood loss and/or volume re-distribution, assessed AD might be influenced by impaired hemodynamic conditions. Intravascular ultrasound (IVUS) offers real-time assessment, especially after hemodynamic restoration, and might help for stent graft choice. Methods: We investigated the correlation between CT and later IVUS measurements in elective (n=83) and emergency patients (n=32) at the level distal to the left subclavian artery (LSA), a frequent proximal landing zone in TEVAR. Patients were grouped depending on their shock index (heart rate/systolic blood pressure): emergency patients with diagnosis of acute aortic syndrome, urgently required treatment after admission and had a shock index >1, otherwise were grouped as elective. Basic hemodynamics were assessed for both groups at admission and at definite IVUS-procedure. Results: At time of admission the emergency group showed lower blood pressure (99±19.8 vs. 141±24 mmHg; P=0.001) and higher heart rate (98±13 vs. 70±12 bpm; P=0.001) compared to elective patients. By hemodynamic stabilization comparable blood pressure and heart rate were achieved in both groups at time of IVUS. In the emergency group, we found a significantly increase in AD after hemodynamic stabilization, whereas the diameters did not change in the elective group (IVUSmean vs. CTmean: 5.1±1.0 vs. 0.4±2.2 mm; P=0.001 and IVUSmin vs. CTmean: 3.9±1.3 vs. −0.3±2.2 mm; P=0.011). Conclusions: IVUS for stent graft sizing is a valuable approach during TEVAR, especially in the light of emergency treatment by offering real-time assistance. Impaired hemodynamic conditions might lead to relevant changes in AD and may strongly influence stent graft choice. In these cases, careful stent graft selection might contribute to avoidance of stent graft related complication.

Background: Radial artery access is the primary approach for coronary interventions due to higher safety profile in comparison to femoral access. Radial artery occlusion (RAO) is the main complication of transradial catheterization that can lead to severe symptoms and a permanent artery occlusion. The incidence of RAO after transradial access ranges from 5 to 38% and data regarding treatment is scarce. Whether anticoagulation and vasoactive medication provides an additional benefit in recovery of radial artery patency (RAP) after catheterization has not been investigated in detail. Aim: The objective was to investigate the impact of anticoagulation and vasoactive medication on regained patency after documented RAO following transradial catheterization. Patients and methods: Overall 2635 patients were screened. 2215 (84%) catheterizations were performed by femoral and 420 (16%) by radial access. In 30 patients RAO was observed. In case of RAO patients were classified in three groups: Anticoagulation, anticoagulation added with alprostadil and controls. Follow-up was conducted after 3 months with ultrasound and clinical examination. Results: Eight patients received anticoagulation and 11 patients anticoagulation together with alprostadil. Eleven patients served as controls. Recovery of RAP after catheterization was higher following either treatment (79.5%) compared to controls (0%, p = 0.006). Subgroup analysis yielded a higher RAP recovery in patients treated with anticoagulation (62.5%) as compared to controls (0%, p = 0.002). No effect on regained RAP was found with additional alprostadil therapy (33.3%) compared to anticoagulation therapy (62.5%, p = 0.229). Conclusion: RAO should be treated with anticoagulation to regain patency. Addition of vasoactive medication does not lead to further beneficial effects. Further research is needed regarding preventive and therapeutic strategies following RAO. CA Rammos

BackgroundAortic stiffness is an independent predictor of cardiovascular morbidity and mortality; thus, simple, rapid and preferably automated techniques are indispensable for pursuing a global risk stratification approach. We present an oscillometric technique for determination of the carotid-femoral pulse wave velocity (cfPWV), including the diagnostic accuracy, sensitivity and specificity, with emphasis on the training curve and procedural duration.MethodsIn a single-centre crossover study, we evaluated subjects free of known cardiovascular disease (CVD), subjects with CVD and a subgroup of subjects with peripheral artery disease (PAD) in terms of ankle-brachial index (ABI) and PWV measurements determined by oscillometry compared to tonometry. Pearson's correlation analysis was used to assess the relationship of the PWV measurements determined by both methods. Moreover, the time and cost of the examinations were compared.ResultsA total of 176 study subjects underwent assessments to obtain oscillometric and tonometric PWV measurements. The CVD-free subjects (n = 59) were younger (60.4±15.6 vs. 67.5±12.9 years, p = 0.003) than the subjects with CVD (n = 117). The PWV measurements showed significant correlations in CVD-free subjects (r = 0.797, pConclusionUsing a simple and rapid automated oscillometric method, we achieved good diagnostic accuracy for the determination of aortic stiffness through the PWV in both subjects with and without CVD. This method might be helpful in daily practice in terms of saving time and reducing procedural complexity for screening for cardiovascular morbidities and vascular damage in cases of atherosclerosis.

The Reveal LINQ™ implantable cardiac monitor (ICM; Medtronic, Minneapolis, MN, USA) is obviously smaller than its precursor (the Reveal XT™), but little is known about its long-term safety. Here, we investigated the long-term R-wave sensing reliability of the Reveal LINQ™ ICM.We analyzed the sensing quality of the Reveal LINQ™ ICM over time between March 2014 and January 2015.A total of 30 patients underwent Reveal LINQ™ implantation. The main reason for implantation was unexplained syncope (60%). We evaluated a total of 305.8 patient-months (median, 10.7 months) of R-wave sensing quality. A comparison of baseline and follow-up R-wave sensing values revealed no difference (0.401 mV ± 0.244 mV vs 0.447 mV ± 0.323 mV; P = 0.225).The consistent detection of events is an important safety feature of an ICM and linked to secure R-wave sensing. Despite the noticeable size reduction, the Reveal LINQ™ ICM retains reliable sensing quality over time.

Computed tomography (CT) for emergency thoracic endovascular aortic repair (TEVAR) in patients with acute aortic syndrome (AAS) often yields poor quality images for optimal stent graft sizing. Intravascular ultrasound (IVUS) provides an accurate measurement of the aortic diameter (AD) of the landing