ACURATE neo2 Versus SAPIEN 3 Ultra Transcatheter Heart Valve in Severe Aortic Valve Calcification: A Propensity-Matched Analysis.

BACKGROUND: Comparative data on transcatheter self-expanding ACURATE neo2 (NEO2) and balloon-expandable SAPIEN 3 Ultra prostheses in technically challenging anatomy of severe aortic valve calcified aortic annuli are scarce. METHODS: A total of 1987 patients with severe native aortic stenosis treated with the self-expanding NEO2 (n=1457) or balloon-expandable SAPIEN 3 Ultra (n=530) from January 2017 to April 2023 were evaluated. The primary end point was procedural outcome according to the Valve Academic Research Consortium 3 definitions. Propensity matching defined 219 pairs with severe calcification (calcium density cutoff, 758 AU/cm2) of the native aortic valve. RESULTS: Technical success (90.4% versus 91.8%; risk difference, 1.4% [95% CI, -4.4 to -7.2]; P=0.737) and device success at 30 days (80.8% versus 75.8%; risk difference, -5.0% [95% CI, -13.2 to 3.1]; P=0.246) were comparable between NEO2 and SAPIEN 3 Ultra. The rate of severe prosthesis-patient mismatch (1.1% versus 10.1%; risk difference, 10.0% [95% CI, 4.0-13.9]; P<0.001) and mean transvalvular gradient ≥20 mm Hg (2.8% versus 14.3%; risk difference, 11.5% [95% CI, 5.8-17.1]; P<0.001) was lower with NEO2. The rate of more-than-mild paravalvular leakage or valve-in-valve due to paravalvular leakage was significantly higher (6.2% versus 0.0%; risk difference, 6.2% [95% CI, -10.1 to -2.7]; P=0.002), and there was a tendency for a higher rate of device embolization or migration (1.8% versus 0.0%; risk difference, -1.8% [95% CI, -4.1 to 0.4]; P=0.123) with NEO2. Multivarate regression revealed no independent impact of transcatheter heart valve selection on device success (odds ratio, 0.93 [95% CI, 0.48-1.77]; P=0.817). CONCLUSIONS: In patients with severely calcified annuli, supraannular implantation of NEO2 showed hemodynamic advantages. Nevertheless, NEO2 was associated with a higher incidence of relevant paravalvular leakage and a numerically higher rate of device embolization than SAPIEN 3 Ultra in this particular patient group.

[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.

Impact of educational attainment on preventive efforts after myocardial infarction: results of the IPP and NET-IPP trials.

AIMS: Educational attainment might impact secondary prevention after myocardial infarction (MI). The purpose of the present study was to compare the rate of risk factors and the efficacy of an intensive prevention program (IPP), performed by prevention assistants and supervised by physicians, in patients with MI and different levels of education. METHODS: In this post hoc analysis of the multicenter IPP and NET-IPP trials, patients with MI were stratified into two groups according to educational attainment: no "Abitur" (no A) vs. "Abitur" or university degree (AUD). The groups were compared at the time of index MI and after 12-month IPP vs. usual care. RESULTS: Out of n = 462 patients with MI, 76.0% had no A and 24.0% had AUD. At the time of index, MI rates of obesity (OR 2.4; 95%CI 1.4-4.0), smoking (OR 2.2, 95%CI 1.4-3.6), and physical inactivity (OR 1.6; 95%CI 1.0-2.5) were significantly elevated in patients with no A. At 12 months after index MI, larger improvements of the risk factors smoking and physical inactivity were observed in patients with IPP and no A than in patients with IPP and AUD or with usual care. LDL cholesterol levels were reduced by IPP compared to usual care, with no difference between no A vs. AUD. A matched-pair analysis revealed that high baseline risk was an important reason for the large risk factor reductions in patients with IPP and no A. CONCLUSION: The study demonstrates that patients with MI and lower educational level have an increased rate of lifestyle-related risk factors and a 12-month IPP, which is primarily performed by non-physician prevention assistants, is effective to improve prevention in this high-risk cohort.

Comparison of the New-Generation Self-Expanding NAVITOR Transcatheter Heart Valve with Its Predecessor, the PORTICO, in Severe Native Aortic Valve Stenosis.

BACKGROUND: Third-generation transcatheter heart valves (THVs) are designed to improve outcomes. Data on the new intra-annular self-expanding NAVITOR are scarce. AIMS: The aim of this analysis was to compare outcomes between the PORTICO and the NAVITOR systems. METHODS: Data from 782 patients with severe native aortic stenosis treated with PORTICO (n = 645) or NAVITOR (n = 137) from 05/2012 to 09/2022 were evaluated. The clinical and hemodynamic outcomes of 276 patients (PORTICO, n = 139; NAVITOR, n = 137) were evaluated according to VARC-3 recommendations. RESULTS: Rates of postprocedural more-than-mild paravalvular leakage (PVL) were significantly lower for NAVITOR than for PORTICO (7.2% vs. 1.5%, p = 0.041). In addition, severe bleeding rates (27.3% vs. 13.1%, p = 0.005) and major vascular complications (5.8% vs. 0.7%, p = 0.036) were lower in the NAVITOR group. The mean gradients (7 vs. 8 mmHg, p = 0.121) and calculated aortic valve areas (1.90 cm2 vs. 1.99 cm2, p = 0.235) were comparable. Rates of PPI were similarly high in both groups (15.3 vs. 21.6, p = 0.299). CONCLUSIONS: The NAVITOR demonstrated favorable in-hospital procedural outcome data, with lower rates of relevant PVL, major vascular complications, and severe bleeding than its predecessor the PORTICO and preserved favorable hemodynamic outcomes.

Prognostic Impact of the Get-with-the-Guidelines Heart-Failure Risk Score (GWTG-HF) after Transcatheter Aortic Valve Replacement in Patients with Low-Flow-Low-Gradient Aortic Valve Stenosis.

OBJECTIVES: This study examined the prognostic value of the get-with-the-guidelines heart-failure risk score (GWTG-HF) on mortality in patients with low-flow-low-gradient aortic valve stenosis (LFLG-AS) after transcatheter aortic valve implantation (TAVI). BACKGROUND: Data on feasibility of TAVI and mortality prediction in the LFLG-AS population are scarce. Clinical risk assessment in this particular population is difficult, and a score has not yet been established for this purpose. METHODS: A total of 212 heart failure (HF) patients with real LFLG-AS were enrolled. Patients were classified into low-risk (n = 108), intermediate-risk (n = 90) and high-risk (n = 14) groups calculated by the GWTG-HF score. Clinical outcomes of cardiovascular events according to Valve Academic Research Consortium (VARC-2) recommendations and composite endpoint of death and hospitalization for heart failure (HHF) were assessed at discharge and 1 year of follow-up. RESULTS: Baseline parameters of the groups showed a median age of 81.0 years [77.0; 84.0] (79.0 vs. 82.0 vs. 86.0, respectively p < 0.001), median EuroSCORE II of 6.6 [4.3; 10.7] (5.5 vs. 7.2 vs. 9.1, p = 0.004) and median indexed stroke volume of 26.7 mL/m2 [22.0; 31.0] (28.2 vs. 25.8 vs. 25.0, p = 0.004). The groups significantly differed at follow-up in terms of all-cause mortality (10.2 vs. 21.1 vs. 28.6%; p < 0.035). There was no difference in intrahospital event rate (VARC). Postprocedural mean gradients were lower in high-risk group (7.0 vs. 7.0 vs. 5.0 mmHg, p = 0.011). No differences in postprocedural aortic valve area (1.9 vs. 1.7 vs. 1.9 cm2, p = 0.518) or rate of device failure (5.6 vs. 6.8 vs. 7.7%, p = 0.731) could be observed. After adjustment for known predictors, the GWTG score (HR 1.07 [1.01-1.14], p = 0.030) as well as pacemaker implantation (HR 3.97 [1.34-11.75], p = 0.013) turned out to be possible predictors for mortality. An increase in stroke volume index (SVI) was, in contrast, protective (HR 0.90 [0.83-0.97]; p = 0.006). CONCLUSIONS: The GWTG score may predict mortality after TAVI in LFLG-AS HF patients. Interestingly, all groups showed similar intrahospital event and mortality rates, independent of calculated mortality risk. Low SVI and new conduction disturbances associated with PPI after THV implantation had negative impact on mid-term outcome in post-TAVI HF-patients.

Comparison of Coronary Intravascular Lithotripsy and Rotational Atherectomy in the Modification of Severely Calcified Stenoses.

Debulking techniques are often necessary for successful lesion preparation in percutaneous coronary intervention. The aim of this study was to compare plaque modification of severely calcified lesions by coronary intravascular lithotripsy (IVL) with that of rotational atherectomy (RA) using optical coherence tomography (OCT). ROTA.shock was a 1:1 randomized, prospective, double-arm, multicenter noninferiority trial designed to compare final minimal stent area after IVL with RA for lesion preparation in percutaneous coronary interventional treatment of severely calcified lesions. On the basis of OCT acquired before and immediately after IVL or RA in 21 of the 70 patients included, we performed a detailed analysis of the modification of the calcified plaque. After RA and IVL, calcified plaque fractures were present in 14 of the patients (67%), with a significantly greater number of fractures after IVL (3.23 ± 0.49) than after RA (1.67 ± 0.52; p < 0.001). Plaque fractures after IVL were longer than after RA (IVL: 1.67 ± 0.43 mm vs RA: 0.57 ± 0.55 mm; p = 0.01), resulting in a greater total volume of the fractures (IVL: 1.47 ± 0.40 mm3 vs RA: 0.48 ± 0.27 mm3; p = 0.003). Use of RA was associated with a greater acute lumen gain than was use of IVL (RA: 0.46 ± 0.16 mm2 vs IVL: 0.17 ± 0.14 mm2; p = 0.03). In conclusion, we were able to show differences in plaque modification of calcified coronary lesions by OCT: although RA leads to a greater acute lumen gain, IVL induces more and longer fractures of the calcified plaque.

Second-generation robotic angioplasty system use for the treatment of ST-elevation myocardial infarction: a first-in-man proof of concept case report.

Background: Robotically assisted remote-controlled PCI (rPCI) was introduced in the past decade as one of the latest enhancements in this rapidly evolving field. The use of a second-generation rPCI system in ST-elevation myocardial infarction (STEMI) is an effort to couple immediate revascularization with the accuracy of newer robotic assistance and software support. Case summary: Here we report on the safety and efficacy of rPCI applied to a 74-year-old female STEMI patient with persistent acute chest pain as well as regional wall motion abnormalities in the echocardiogram. The first medical contact-to-device time was 76 min, and door-to-balloon time was 33 min. The impatient course was uneventful, so the patient was discharged from hospital after 5 days. To the best of our knowledge, this is the first report of the successful application of second-generation rPCI in STEMI. Discussion: In the case presented, rPCI was feasible and safe even in acute coronary syndrome based on a single-centre experience. rPCI is a revolutionary new technique that may be applied to various types of clinical presentations.

High prevalence of incidental endoscopic findings at routine endoscopy after atrial fibrillation ablation: Do we need a screening endoscopy for the upper gastrointestinal tract in the general population?

INTRODUCTION: High-power short-duration ablation (HPSD) is an effective therapy for atrial fibrillation with thermal esophageal injury as a rare but relevant side effect. AIM AND METHODS: In this retrospective single-center analysis we evaluated the incidence and relevance of ablation-induced findings and the prevalence of ablation-independent incidental gastrointestinal findings. For 15 months all patients undergoing ablation were screened by postablation esophagogastroduodenoscopy. Pathological findings were followed up and treated if necessary. RESULTS: 286 consecutive patients (66±10 years; 54.9% male) were included. 19.6% of patients showed ablation-associated alterations (10.8% esophageal lesions, 10.8% gastroparesis, 1.7% both findings). Logistic multivariable regression analysis confirmed an influence of lower BMI on the occurrence of RFA-associated endoscopic findings (OR 0.936, 95% CI 0.878-0.997, p<0.05). 48.3% of patients demonstrated incidental gastrointestinal findings. In 1.0% neoplastic lesions were present, 9.4% showed precancerous lesions and in 4.2% neoplastic lesions of unknown dignity were found requiring further diagnostics or therapy. 18.1% of patients demonstrated findings associated with a potentially increased risk of bleeding under anticoagulation. Patients with clinically relevant incidental findings were significantly more often male, 68.8% vs. 49.5% (p<0.01). CONCLUSION: HPSD ablation is safe, no devasting complication occurred in any patient. It resulted in 19.6% ablation-induced thermal injury whereas incidental findings of the upper GI tract were found in 48.3% of patients. Due to the high prevalence of 14.7% of findings requiring further diagnostics, therapy, or surveillance in a cohort that is mimicking the general population, screening endoscopy of the upper GI tract seems to be reasonable in the general population.

Procedural Outcomes of a Self-Expanding Transcatheter Heart Valve in Patients with Porcelain Aorta.

BACKGROUND: Severe calcification of the ascending aorta increases the peri-operative risk for neurological complications in patients with severe aortic stenosis. Transcatheter aortic valve implantation (TAVI) seems to be an optimal treatment option in these patients. However, the impact of the extent of aortic calcification on procedural and neurological outcomes during TAVI is unclear. METHODS: Data from 3010 patients with severe native aortic valve stenosis treated with ACURATE neo/neo2 from May 2012 to July 2022 were evaluated and matched by 2-to-1 nearest-neighbor matching to identify one patient with porcelain aorta (PA) (n = 492) compared with two patients without PA (n = 984). PA was additionally subdivided into circumferential (classic PA) (n = 89; 3.0%) and non-circumferential (partial PA) (n = 403; 13.4%) calcification. We compared outcomes according to VARC-3 criteria among patients with and without PA and identified predictors for occurrence of stroke in the overall population. RESULTS: Technical success (88.5% vs. 87.4%, p = 0.589) and device success at 30 days (82.3% vs. 81.5%, p = 0.755) after transcatheter ACURATE neo/neo2 implantation according to VARC-3 definition was high and did not differ between non-calcified aortas or PA. The rate of in-hospital complications according to VARC-3-definitions was low in both groups. Rates of all stroke (3.2% (n = 31) vs. 2.6% (n = 13), p = 0.705) or transitory ischemic attacks (1.1% vs. 1.2%, p = 1.000) did not differ significantly. Thirty-day all-cause mortality did not differ (3.0% vs. 3.2%, RR 1.1; p = 0.775). Overall device migration/embolization (OR 5.0 [2.10;11.87]), severe bleeding (OR 1.79 [1.11;2.89]), and major structural cardiac complications (OR 3.37 [1.32;8.57]) were identified as independent predictors for in-hospital stroke in a multivariate analysis after implantation of ACURATE neo/neo2. CONCLUSION: A porcelain aorta does not increase the risk of neurological complications after transfemoral ACURATE neo/neo2 implantation. Based on these findings, transfemoral ACURATE neo/neo2 implantation is safe in these particularly vulnerable patients.

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.

First case report of fully robotically assisted lithotripsy in heavily calcified left main stenosis.

Background: Percutaneous coronary intervention (PCI) is the standard-of-care treatment for left main stenosis as an alternative to bypass surgery. In addition, severe coronary lesion calcification can be modified by intravascular lithotripsy (IVL). However, with PCI and debulking treatment options, there are inherent limitations. PCI poses an increased health burden for the treating physician that is associated with wearing a heavy, lead-lined apron and being exposed to radiation. To overcome these issues, a robotically assisted angioplasty system (rPCI) was established that enables the operator to perform PCI remotely in routine clinical procedures. Furthermore, IVL have not been used remotely. Case summary: Here, we report the use of this technique for treating a heavily calcified left main stenosis in an 82-year-old male with previously diagnosed two-vessel coronary artery disease, progressive symptoms of dyspnoea at high cardio-vascular risk profile. The decision of the local heart team declined surgery. To the best of our knowledge, this is the first report of successful rPCI combined with IVL. Discussion: In the case presented, rPCI was feasible and safe even in a complex lesion of the left main coronary artery requiring IVL. rPCI is a revolutionary new technique that may be applied to various types of coronary artery lesions.

Intramyocardial Inflammation after COVID-19 Vaccination: An Endomyocardial Biopsy-Proven Case Series.

Myocarditis in response to COVID-19 vaccination has been reported since early 2021. In particular, young male individuals have been identified to exhibit an increased risk of myocardial inflammation following the administration of mRNA-based vaccines. Even though the first epidemiological analyses and numerous case reports investigated potential relationships, endomyocardial biopsy (EMB)-proven cases are limited. Here, we present a comprehensive histopathological analysis of EMBs from 15 patients with reduced ejection fraction (LVEF = 30 (14-39)%) and the clinical suspicion of myocarditis following vaccination with Comirnaty® (Pfizer-BioNTech) (n = 11), Vaxzevria® (AstraZenica) (n = 2) and Janssen® (Johnson & Johnson) (n = 2). Immunohistochemical EMB analyses reveal myocardial inflammation in 14 of 15 patients, with the histopathological diagnosis of active myocarditis according the Dallas criteria (n = 2), severe giant cell myocarditis (n = 2) and inflammatory cardiomyopathy (n = 10). Importantly, infectious causes have been excluded in all patients. The SARS-CoV-2 spike protein has been detected sparsely on cardiomyocytes of nine patients, and differential analysis of inflammatory markers such as CD4+ and CD8+ T cells suggests that the inflammatory response triggered by the vaccine may be of autoimmunological origin. Although a definitive causal relationship between COVID-19 vaccination and the occurrence of myocardial inflammation cannot be demonstrated in this study, data suggest a temporal connection. The expression of SARS-CoV-2 spike protein within the heart and the dominance of CD4+ lymphocytic infiltrates indicate an autoimmunological response to the vaccination.

Heart Failure Relapses in Response to Acute Stresses - Role of Immunological and Inflammatory Pathways.

Cardiovascular diseases continue to be the most imminent health care problems in the western world, accounting for numerous deaths per year. Heart failure (HF), namely the reduction of left ventricular function, is one of the major cardiovascular disease entities. It is chronically progressing with relapsing acute decompensations and an overall grave prognosis that is little different if not worse than most malignant diseases. Interestingly acute metabolically and/or immunologically challenging events like infections or major surgical procedures will cause relapses in the course of preexisting chronic heart failure, decrease the patients wellbeing and worsen myocardial function. HF itself and or its progression has been demonstrated to be driven at least in part by inflammatory pathways that are similarly turned on by infectious or non-infectious stress responses. These thus add to HF progression or relapse. TNF-α plasma levels are associated with disease severity and progression in HF. In addition, several cytokines (e.g., IL-1ß, IL-6) are involved in deteriorating left ventricular function. Those observations are based on clinical studies using inhibitors of cytokines or their receptors or they stem from animal studies examining the effect of cytokine mediated inflammation on myocardial remodeling in models of heart failure. This short review summarizes the known underlying immunological processes that are shared by and drive all: chronic heart failure, select infectious diseases, and inflammatory stress responses. In conclusion the text provides a brief summary of the current development in immunomodulatory therapies for HF and their overlap with treatments of other disease entities.

Transcatheter-based aortic valve replacement vs. isolated surgical aortic valve replacement in 2020.

BACKGROUND: Based on the results of several recent randomized trials, European and American guidelines on valvular heart disease management have substantially expanded the indications for transcatheter aortic valve implantation (TAVI). We present an all-comer data on peri-operative risk profile and in-hospital outcomes from Germany for patients treated by TAVI or isolated surgical aortic valve replacement (iSAVR) in 2020, providing an opportunity to compare study data with data from daily clinical practice. METHODS: Data concerning all isolated aortic valve procedures performed in Germany in 2020 were retrieved from the mandatory nationwide quality control program. Expected mortality was calculated with the annually revised German Aortic valve score (AKL-score) based on the data of either catheter-based (AKL-CATH) or isolated surgical (AKL-CHIR) aortic valve replacement in Germany from the previous year (2019). RESULTS: In 2020 21,903 TAVI procedures (20,810 transvascular (TV; vs. 2019: 22.973; - 9.4%), 1093 transapical (TA; vs. 2019: 1413; - 22.6%)) and 6144 (vs. 2019 7905; - 22.5%) iSAVR were performed in Germany. Patients who received TAVI showed a significantly higher perioperative risk profile than patients undergoing iSAVR based on older age and more severe co-morbidities. While in-hospital mortality after TAVI (2.3%) was numerically lower than in 2019 (2.5%), this difference was not significant (p = 0.11). In-hospital mortality after iSAVR was identical in 2020 and 2019 (2.8%) and thus higher than after TAVI (p = 0.003), resulting in an observed expected mortality ratio of 1.02 after TAVI and 1.05 after iSAVR. After exclusion of the emergency procedures, in-hospital mortality did not differ significantly between the groups (TAVI 2.2% vs. iSAVR 1.9%, p = 0.26). CONCLUSION: Total numbers of both iSAVR and TAVI in Germany were lower in 2020 than in 2019, most likely due to the COVID-19 pandemic. However, the relative number of patients treated by TAVI as compared to iSAVR continues to increase. Despite older age and more severe comorbidities compared to patients undergoing iSAVR the in-hospital mortality after TAVI continued to decrease in 2020 and remains significantly lower than after iSAVR.

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.

Clinical presentation does not affect acute mechanical performance of the Novolimus-eluting bioresorbable vascular scaffold as assessed by optical coherence tomography.

INTRODUCTION: Initial trials of bioresorbable vascular scaffolds (BVS) have mostly excluded patients presenting with acute coronary syndrome (ACS). However, these patients might benefit from a BVS platform, in particular as they are often younger and have been less frequently treated than patients with chronic disease. AIM: To compare the acute performance of a Novolimus eluting BVS in ACS and non-ACS patients using optical coherence tomography (OCT) in patients presenting with acute or chronic coronary syndrome. MATERIAL AND METHODS: The final OCT pullback of 79 patients (34 with ACS, 45 non-ACS) was analysed at 1-mm intervals. The following indices were calculated: mean and minimal area, residual area stenosis, incomplete strut apposition, tissue prolapse, eccentricity index, symmetry index, strut fracture, and edge dissection. RESULTS: OCT showed a minimum lumen area (non-ACS vs. ACS) of 6.2 ±2.1 vs. 5.6 ±1.5 mm2 (p = 0.21). Mean residual area stenosis was 14.5% vs. 19.5% (p = 0.39). The mean eccentricity index did not differ significantly (0.78 ±0.13 vs. 0.78 ±0.06; p = 0.42). There was a non-significant tendency for more fractures in the non-ACS group (22.2% vs. 5.9%; p = 0.07). Prolapse area was comparable (4.4 ±7.4 mm2 vs. 5.2 ±10.9 mm2; p = 0.62). CONCLUSIONS: This is the first study to investigate the acute mechanical performance of a Novolimus-eluting BVS in patients with different clinical presentations using OCT. We found that clinical presentation did not determine acute mechanical performance as assessed by the final OCT pullback. There was evidence of more mechanical complications in terms of fractures and a higher percentage of incomplete strut apposition in the group of patients with chronic coronary syndrome.

Acute Mechanical Performance of Magmaris vs. DESolve Bioresorbable Scaffolds in a Real-World Scenario.

Background: After the bioresorbable PLLA-based vascular scaffold (Absorb BVS) was taken from the market due to its high adverse event rates, a magnesium-based scaffold (Magmaris) was introduced. Objective: To compare the acute performance of the sirolimus-eluting magnesium alloy Magmaris scaffold with that of the novolimus-eluting PLLA-based DESolve scaffold in terms of appropriate scaffold deployment using optical coherence tomography (OCT). Methods and Results: Data from the final OCT pullback of 98 patients were included (19 Magmaris, 79 DESolve) and analyzed at 1-mm intervals. The following indices were calculated: mean and minimal area, residual area stenosis, incomplete strut apposition, tissue prolapse, eccentricity index, symmetry index, strut fracture, and edge dissection. OCT showed a minimum lumen area for Magmaris vs. DESolve of 6.6 ± 1.6 vs. 6.0 ± 1.9 (p = 0.06). Scaffolds with residual area stenosis >20% were predominantly seen in the DESolve group (15.8 vs. 46.8%; p = 0.01). The mean eccentricity index did differ significantly (0.74 ± 0.06 vs. 0.63 ± 0.09; p < 0.001). No fractures were observed for Magmaris scaffolds, but 15.2% were documented for DESolve BRS (p < 0.001). Incomplete scaffold apposition area was significantly higher in the DESolve group (0.01 ± 0.02 vs. 1.05 ± 2.32 mm2; p < 0.001). Conclusion: This is the first study to compare the acute mechanical performance between Magmaris and DESolve in a real-world setting. The acute mechanical performance of Magmaris BRS seems to be superior to that of DESolve BRS, whereas OCT showed a good acute mechanical performance for both BRS in terms of generally accepted imaging criteria.

Long-Term Effects of an Intensive Prevention Program After Acute Myocardial Infarction.

Effective long-term prevention after myocardial infarction (MI) is crucial to reduce recurrent events. In this study the effects of a 12-months intensive prevention program (IPP), based on repetitive contacts between non-physician "prevention assistants" and patients, were evaluated. Patients after MI were randomly assigned to the IPP versus usual care (UC). Effects of IPP on risk factor control, clinical events and costs were investigated after 24 months. In a substudy efficacy of short reinterventions after more than 24 months ("Prevention Boosts") was analyzed. IPP was associated with a significantly better risk factor control compared to UC after 24 months and a trend towards less serious clinical events (12.5% vs 20.9%, log-rank p = 0.06). Economic analyses revealed that already after 24 months cost savings due to event reduction outweighted the costs of the prevention program (costs per patient 1,070 € in IPP vs 1,170 € in UC). Short reinterventions ("Prevention Boosts") more than 24 months after MI further improved risk factor control, such as LDL cholesterol and blood pressure lowering. In conclusion, IPP was associated with numerous beneficial effects on risk factor control, clinical events and costs. The study thereby demonstrates the efficacy of preventive long-term concepts after MI, based on repetitive contacts between non-physician coworkers and patients.

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.