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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.

BackgroundRobotically 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 summaryHere 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.DiscussionIn 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.

We report a case of a large thrombus entrapped in a patent foramen ovale after bariatric surgery and pulmonary embolism. The 60-year-old female patient was admitted to hospital as an emergency after syncope. She suffered from metabolic syndrome with obesity (height: 180 cm, weight: 170 kg, BMI: 49.4 kg/m2) and an insulin-dependent diabetes mellitus type 2. She had had bariatric surgery (implantation of a gastric balloon) 4 weeks prior to hospitalization. A transthoracic echocardiography was performed which indicated a large entrapped thrombus in the patent foramen ovale with extensions of approximately 10 cm in both the right and the left heart. Surgical embolectomy was performed to remove the circa 20-cm-long thrombus.At the time of surgery, only 2 cm of the transit thrombus remained in the right atrium. Thus, during the time between diagnosis and emergency surgery, the thrombus had gradually migrated 8 cm. Pulmonary embolectomy and closure of the patent foramen ovale were performed during the same procedure. The patient recovered completely without any complications and was discharged 11 postoperatively. This case demonstrates the importance of urgent medical decision-making with transit thrombi — time is running out.

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.

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.

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.

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.

Graphical abstract Electronic supplementary material The online version of this article (10.1007/s00392-020-01756-0) contains supplementary material, which is available to authorized users.

Background Bioresorbable scaffolds (BRS) have been shown to be inferior to drug-eluting stents in randomized trials. Nevertheless, patients treated during daily routine differ from those treated within randomized trials and thus need further long-term evaluation. The present investigation aims to address this lack. Methods Consecutive patients with coronary artery disease treated with implantation of everolimus-eluting BRS at 5 centers in Germany were included. Clinical follow-up was assessed up to 3 years. Analysis of clinical outcomes was performed by pooling of the individual patient data sets of each center. The major clinical endpoints of interest was target lesion failure (TLF) a composite of cardiac death, target vessel myocardial infarction and target lesion revascularization. Furthermore occurrence of definite scaffold thrombosis was evaluated. A multivariable Cox regression analysis was applied to identify independent predictors of TLF. Results A total of 1614 patients treated with BRS were analyzed (mean age 64.0 ± 10.9 years, 75.8% male, 28.3% diabetics). A total 1817 lesions were treated with BRS and 56.0% were considered to be complex. At 3 years, the rate of TLF was 17.1% and definite scaffold thrombosis was noted in 2.6%. Independent predictors of TLF were a higher age, diabetes, bifurcation, complex lesions and the use of small BRS. Conclusions In this large-scale analysis of patients undergoing BRS implantation in daily routine, event rates were high, but in line with randomized studies. Predictors of TLF were identified which may optimize patient and lesion selection for BRS.

Bastian Schrader,1 Anna-Maria Bünker,2,3 Charis Conradi,1 Stephan Lüders,2,4 Bernhard Vaske,5 Michael Koziolek,3 Hermann Haller,6 Albrecht Elsässer,1 Joachim Schrader1,2 1Department of Cardiology in Klinikum Oldenburg, University of Oldenburg, Oldenburg, Germany; 2Institute for Hypertension and Cardiovascular Research (INFO), Cloppenburg, Germany; 3Department of Nephrology and Rheumatology, University Medical Center Göttingen, Göttingen, Germany; 4Department of Nephrology, St.-Josefs-Hospital, Cloppenburg, Germany; 5Department of Statistics, Institute for Hypertension and Cardiovascular Research (INFO), Cloppenburg, Germany; 6Clinic for Renal and Hypertensive Diseases, Hannover Medical School, Hanover, GermanyCorrespondence: Bastian Schrader Email bastian.schrader@uni-Oldenburg.deIntroduction: 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.Keywords: sport, exercise, cardiovascular risk factors, hypertension, diabetes, hypercholesterolemia, stress, ELITE, nutrition

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-1β, 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.

Interventional cardiovascular medicine has seen constant progress over the last few decades. Since the first angiograms and percutaneous transluminal coronary angioplasty were carried out, this progress has been tremendous and has led to a substantial decline in cardiovascular morbidity and mortality. The purpose of this article is to report and review the latest developments and evidence in robotics-assisted percutaneous coronary intervention (rPCI) and its potential future applications, opportunities, and limitations. Contemporary evidence shows that rPCI can lead to a significant reduction in radiation exposure as well as medical hazards for cardiologists. Rates of device and procedural success remain high and there is no evidence of a disadvantage for the patient. The accuracy of implantation with a reduced geographic mismatch is a further advantage that can result in a higher quality of treatment. Even in complex coronary lesions and procedures, rPCI seems to be safe and efficient. The latest developments include telestenting over hundreds of kilometers from a remote platform. Currently, the main limitations are the absence of large-scale randomized trials for the valid assessment of the benefits and disadvantages of rPCI as well as the technical limitations of the currently available rPCI systems. rPCI is a forward-looking innovation in cardiology that is applicable to a wide range of coronary interventions. Despite the present lack of knowledge and the limited data concerning the outcome for the patient, the available literature reveals promising results that should lead to improvements for physicians and patients.

Transcatheter aortic valve implantation (TAVI) is emerging as the standard of care for patients with severe aortic stenosis. Recent results have been favourable even for patients with low periprocedural risk. We analysed the number of procedures, complications, and in-hospital mortality rates of all patients undergoing isolated aortic valve replacement in 2017 in Germany, focussing especially on transvascular (TV) TAVI. Patients were stratified according the German Aortic Valve Score (AKL) into the risk classes low, intermediate, high and very high (≥ 10%). A total of 17,956 TV-TAVI and 9011 isolated surgical aortic valve replacements (iSAVR) were performed in Germany in 2017. Although the total rate of intraprocedural complications after TV-TAVI was the same as in 2016 (both 7.4%), fewer patients experienced an arterial vascular complication in 2017 (2017: 6.0%; 2016: 7.1%; p

OBJECTIVE This study of patients treated with novolimus-eluting bioresorbable scaffold (BRS) investigated the impact of plaque burden on the acute mechanical performance of the BRS and the short-term outcome. METHODS A total of 15 patients were enrolled. The following parameters were derived from optical coherence tomography (OCT) during the final pullback: mean and minimum area, residual area stenosis, incomplete strut apposition, tissue prolapse, scaffold expansion index (SEI), scaffold eccentricity index (SEC), symmetry index, strut fracture, and edge dissection. Fibrous plaque (FP) and calcific plaque (CP) characteristics were measured at each 200 μm longitudinal cross-section. The patients were divided into two groups based on their medians of the respective plaque characteristics. RESULTS OCT analysis showed a lumen area of 11.4 ± 1.9 mm2 and a scaffold area of 11.5 ± 2.1 mm2. The mean eccentricity index overall was 0.65 ± 0.16 and mean symmetry index 0.39 ± 0.25. Statistically, scaffold expansion was not significantly influenced by a greater plaque burden as represented by greater CP area (SEI in group with CP area

The ELITE study (German acronym for "Nutrition, lifestyle and individual information for prevention of heart attack, stroke and dementia") prospectively collects data on hypertension, cardiovascular risk factors (RF), dietary habits, physical activity, cognitive function, and quality of life in North-West Germany, which will then be improved through targeted individual information. The aim of the study is to improve the health of the participants in the long term and to identify reasons for a lack of implementation of prevention measures.Of 4,602 included subjects, 3,868 could be studied so far at one-year follow-up. Blood pressure (BP) was measured according to the guidelines at admission and blood pressure history, premedication, sports behaviour and BMI were recorded by means of questionnaires and compared with the data collected in the follow-up examination after one year.The participants were evaluated in 4 groups (G): G1 - normotensive patients (n = 1,558), G2 - controlled hypertensive patients (n = 502), G3 - untreated uncontrolled hypertensive patients (n = 1,080), G4 - treated uncontrolled hypertensive patients (n = 728). In G1 blood pressure (RR) remained unchanged from 126.3/77.8 to 127.8/78.5, in G2 there was a significant (p0.001) RR increase from 128.1/77.0 to 134.9/79.8. In G3 and G4 RR decreased significantly (p0.001) from 149.9/90.0 to 143.5/86.9 and from 153.1/87.5 to 146.2 84.1 mmHg, respectively. In G3 and G4, RR decreased in 56.1% and 56.3% of subjects and increased in 18% and 21%, respectively. In contrast, RR increase was found more frequently in G1 and G2 (34.3% and 51%, respectively), and RR decrease less frequently (25.4 and 20.7%, respectively). The main reasons for RR decrease were weight loss, more exercise, and more antihypertensives. Frequently, improved compliance and dietary changes were given as reasons. As expected, the opposite often led to RR increase.56% of the hypertensive participants succeeded in lowering their blood pressure, whereas there was a significant increase in blood pressure, especially in those who were well controlled with antihypertensives. This underlines the need to further motivate normotensive patients to maintain their normotension. The results show that the combination of individual written education and lifestyle interventions are an effective tool for the public health sector to combat hypertension. In our participants, lifestyle interventions have a significant impact on BP change. It should be noted critically that there are still too many patients who have not been reached.

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.

Both surgical aortic valve replacement (SAVR) and transcatheter aortic valve implantation (TAVI) are established options to treat aortic valve stenosis. We present the outcome of the complete cohort of all patients undergoing SAVR or TAVI in Germany during the calendar year 2019.Data concerning all isolated aortic valve procedures performed in Germany in 2019 were retrieved from the mandatory nationwide quality control program: 22,973 transvascular (TV)-TAVI procedures, 7905 isolated SAVR (iSAVR), and 1413 transapical (TA)-TAVI. Data was complete in 99.9% (n = 32,156). In-hospital mortality after TV-TAVI (2.3%) was significantly lower when compared with iSAVR (2.8%, p = 0.007) or TA-TAVI (6.3%; p 0.001). Expected mortality was calculated with a new version of the German Aortic valve score (AKL Score) based on the data of either catheter-based (AKL-CATH) or surgical (AKL-CHIR) aortic valve replacements in Germany in 2018. TV-TAVI and iSAVR both showed lower observed mortality in 2019 than expected based on their respective performance in 2018, yielding an observed/expected (O/E) mortality ratio 1. This was particularly apparent for patients at low risk. After exclusion of emergency procedures, in-hospital mortality after TV-TAVI (2.1%) and after iSAVR (2.1%) was identical, even though patients undergoing TV-TAVI showed a considerably higher perioperative risk profile.After excluding emergency procedures, in-hospital mortality of TV-TAVI and iSAVR in 2019 in Germany was identical. In 2019, TV-TAVI and iSAVR both show lower matched mortality ratios compared with 2018, which suggests technical improvements of both therapies.

Leukocyte recruitment is a fundamental step in the inflammatory response during ischemia/reperfusion injury (IRI). Rolling and adhesion of leukocytes to activated endothelium promote tissue inflammation after IRI and require presentation of adhesion molecules E-selectin and ICAM-1 on the endothelial surface. Bone morphogenetic protein (BMP) 4 is a prominent member of the BMP family expressed and secreted by endothelial cells. BMP4 derived from endothelial cells has important functions in vascular disease but its influence on the leukocyte adhesion cascade during inflammation is incompletely understood. In the present study, we challenged mice with an inducible endothelial-specific BMP4 deletion (referred to as EC-BMP4-/- mice) and their control littermates (EC-BMP4+/+) with thioglycollate i.p. and assessed extravasation of different leukocyte subsets during peritonitis. Peritoneal lavages were performed and peritoneal cells were counted. Total cell count in lavages of EC-BMP4-/- mice was markedly reduced compared with lavages of EC-BMP4+/+ mice. FACS analyses of thioglycollate-elicited peritoneal cells revealed that diverse leukocyte subsets were reduced in EC-BMP4-/- mice. Intravital microscopy of cremaster venules demonstrated that rolling and adhesion of leukocytes were significantly diminished in EC-BMP4-/- mice in comparison with control mice in response to TNFα. These observations indicate that endothelial BMP4 is essential for rolling, adhesion, and extravasation of leukocytes in vivo. To understand the underlying mechanisms, levels of endothelial adhesion molecules E-selectin and ICAM-1 were quantified in EC-BMP4-/- and EC-BMP4+/+ mice by quantitative PCR and Western blotting. Interestingly, ICAM-1 and E-selectin expressions were reduced in the hearts of EC-BMP4-/- mice. Next we confirmed pro-inflammatory properties of BMP4 in a gain of function experiments and found that administration of recombinant BMP4 in male C57BL/6 mice increased leukocyte rolling and adhesion in cremaster venules in vivo. To assess the regulation of BMP4 in inflammatory disease in humans, we collected plasma samples of patients from day 0 to day 7 after survived out-of-hospital cardiac arrest (OHCA, n = 42). Remarkably, plasma of OHCA patients contained significantly higher BMP4 protein levels compared with patients with coronary artery disease (CAD, n = 12) or healthy volunteers (n = 11). Subgroup analysis revealed that elevated plasma BMP4 levels after ROSC are associated with decreased survival and unfavorable neurological outcome. Collectively, endothelial BMP4 is a potent activator of inflammation in vivo that promotes rolling, adhesion, and extravasation of leukocyte subsets by induction of E-selectin and ICAM-1. Elevation of plasma BMP4 levels in the post-resuscitation period suggests that BMP4 contributes to pathophysiology and poor outcome of post-cardiac arrest syndrome.

Objectives The aim of this study was to evaluate very long-term results after unrestricted everolimus-eluting bioresorbable scaffolds (BRS) implantation. Background Previous randomized studies mainly included selected patients differing from those seen during daily routine and long-term data from all-comers registries are sparse. Methods Consecutive patients undergoing BRS implantation were included in this observational, single center study. Clinical follow-up was conducted up to 5 years. Endpoint of interest was the composite of target lesion failure (TLF), including target-vessel myocardial infarction and target lesion revascularization and cardiac death. Furthermore, ARC-defined scaffold thrombosis (ScT) were assessed. Results A total of 176 patients with a median age of 64 (55 - 72) years were analyzed, of which 59.6% presented an acute coronary syndrome. A total of 183 mainly complex lesions (55.8%) were treated. At 5 years, the rate for TLF was 21.6%. Definite or probable ScT rate was 4.1%. The rate of ScT within the first year was 2.8% and afterwards 1.2%. Notably, no ScT was seen later than 2 years. Conclusions Although this real-world registry displays high rates of clinical events during long-term follow-up, no ScT was seen after 2 years.

Inappropriate implantable cardioverter-defibrillator (ICD) shocks are associated with greater healthcare resource utilization, poorer quality-of-life, and higher mortality. We aimed to investigate the performance of enhanced supraventricular tachycardia (SVT) discrimination algorithms (morphology discrimination, rate stability, and sudden or chamber onset) for reducing inappropriate ICD therapies in patients with ICD/cardiac resynchronization therapy devices.This prospective, non-randomized, multicenter study (ReduceIT) study took place at 56 sites across Germany and Estonia. Adults at risk of sudden cardiac death undergoing St. Jude Medical™ ICD or CRT-D implantation were included. The primary endpoint was freedom from inappropriate ICD shock at 12 months and was analyzed in the intention to treat (ITT) and per-protocol population.Overall, 733 patients (65.9 ± 11.4 years) were included, of which 40.9% and 59.1% received a single- and dual-chamber detection device, respectively. During follow-up (median 11.9 [0-21.6] months), 96.3% of patients experienced no inappropriate therapy (ITT). The sensitivity, specificity, and accuracy for VT/VF were 91.9%, 95.5%, and 94.7%, respectively. In the per-protocol population (n = 620), the proportion of patients free from inappropriate shock at 12 months was 98.4% (n = 610; 95% CI 97.1-99.2%) and exceeded the expected value of 93% (p 0.0001) which was derived from the rates in the SPICE, ATPonFastVT, and DECREASE studies. A total of 44 patients (6.0%) died during follow-up, 19 deaths were cardiac-related which is consistent with a meta-analysis of EMPIRIC, MADIT-RIT, ADVANCE III, and PROVIDE. Serious device and procedure-related adverse effects occurred in 9.8% of patients.In ICD/CRT-D devices with advanced SVT discriminators, device programming according to clinical setting and detection chamber significantly reduces the rate of inappropriate ICD shocks without compromising patient safety. The algorithms and settings described herein have particular clinical importance and their employment may be of benefit to ICD recipients.

In der interventionellen Kardiologie ist eine stetig zunehmende Zahl an Patienten zu verzeichnen, die aufgrund ihres Alters und ihrer Komorbiditäten trotz eindeutiger prognoserelevanter Koronarstenosen nicht einer leitliniengerechten operativen Myokardrevaskularisation zugeführt werden können. Insbesondere Patienten mit relevanter, ischämisch bedingter Einschränkung der linksventrikulären Pumpfunktion profitieren von einer interventionellen Revaskularisation. Gefürchtete Komplikationen bei diesen Patienten sind die Kreislaufdepression bei prolongierter Koronarischämie, z. B. aufgrund länger andauernder Ballondilatationen, die akute Nierenschädigung aufgrund einer passageren Kreislaufdepression, Ischämie-getriggerte Herzrhythmusstörungen und inkomplette Revaskularisierung aufgrund einer Kreislaufinstabilität während der zumeist komplexen Prozeduren. Im Beitrag werden die Rationale, die Indikationen, die Datenlage, das praktische Vorgehen und die potenziellen Komplikationen dargestellt, die dem Konzept der geschützten Hochrisiko-Koronarintervention („protected percutaneous coronary intervention“, „protected PCI“) zugrunde liegen. A correction to this article is available online at https://doi.org/10.1007/s12181-017-0213-6

Hypercholesterolaemia is a major cardiovascular risk factor. A healthy diet and a healthy lifestyle reduces cardiovascular risk. ‘Functional foods’ supplemented with phytosterols are recommended for the management of hypercholesterolaemia and have become a widely used non-prescription approach to lower plasma cholesterol levels. Two billion euros are spent world-wide each year on various functional foods, which have regulator-approved health claims for the management of elevated cholesterol levels. While international societies, such as the European Atherosclerosis Society or the National Heart Foundation in Australia, still advise phytosterols as an additional dietary option in the management of hypercholesterolaemia, recently released guidelines such as those from the National Institute of Health and Clinical Excellence in the United Kingdom are more critical of food supplementation with phytosterols and draw attention to significant safety issues. This review challenges whether an intervention with phytosterol supplements is beneficial. We summarize the current evidence from genetic diseases, genetic association studies, clinical trial data and data from animal studies. Linked Articles This article is part of a themed section on Principles of Pharmacological Research of Nutraceuticals. To view the other articles in this section visit http://onlinelibrary.wiley.com/doi/10.1111/bph.v174.11/issuetoc

Objectives To examine ischemic and bleeding outcomes in patients on triple antithrombotic therapy (TAT) compared with dual antiplatelet therapy (DAPT) after the implantation of bioresorbable scaffolds (BRS). Background The optimal antithrombotic regimen in patients undergoing percutaneous coronary intervention that have an indication for oral anticoagulation is unclear, in particular among those undergoing BRS implantation. Methods Consecutive patients of a single-center, all-comers BRS registry were included. Patients were followed up after 30days, 6 and 12months, and thereafter yearly. Outcome parameters were target vessel failure (TVF), major adverse cardiac events (MACE) including target lesion revascularization (TLR), scaffold thrombosis (ST), death, myocardial infarction, and any bleeding as defined by BARC. Patients on TAT were matched to patients on DAPT. Results A total of 607 patients were included. Fifty-five patients receiving TAT were matched with 165 patients treated with DAPT. Acute coronary syndrome was an indication for coronary angiography in 50.9% vs 50.4% groups ( p =0.97). Major adverse cardiac events occurred in 16.4% of TAT patients vs. 8.9% DAPT patients ( p =0.12), TLR in 5.5% vs. 1.9% ( p =0.17), ST in 3.6% vs. 1.9% ( p =0.46), and TVF in 3.6 vs. 1.9% ( p =0.46). Patients died in 7.3% in the TAT group vs. 5.1% in the DAPT group ( p =0.26). No severe bleeding was recorded in either of the groups. Conclusion There was no difference in bleeding or ischemic events between the patients on TAT and those on DAPT after BRS implantation. The high rate of scaffold thrombosis in all of these patients, however, is not negligible.

We analysed the number of procedures, indications, and in-hospital mortality rates of all patients undergoing isolated surgical aortic valve replacement (sAVR) or transvascular (TV-) and transapical (TA-) transcatheter aortic valve implantation (TAVI) from 2012 to 2015 in Germany.More than 31,000 aortic valve procedures were performed in 2015 in Germany, representing a total increase of 4.5% over 2014. TV-TAVI accounts for 13,108 of these procedures, with an increase of 21%, whereas the numbers of isolated sAVR and TA-TAVI decreased slightly. Age, frailty, high risk, and patients' choice were the main reasons for a catheter-based intervention. In 2015, the in-hospital mortality rate after TV-TAVI decreased to 3.4%, approaching that of sAVR (2.9%), despite a considerably higher baseline risk. A stratified analysis according to the German aortic valve (AKL) score demonstrated a further decrease of the in-hospital mortality for TV-TAVI, showing a lower in-hospital mortality rate than expected in all risk groups. Importantly, this also accounts for the lowest risk group with an AKL score3% showing an in-hospital mortality rate of 1.7%, which is now comparable to that of sAVR (1.5%). In all other risk groups, the in-hospital mortality in patients undergoing TV-TAVI was lower than in patients undergoing sAVR.Mortality after TV-TAVI keeps decreasing over the last years and equals that of SAVR in the lowest risk cohort in the meanwhile. All TV-TAVI patients have significantly lower observed than expected mortality, which will further lead to a redefinition of standard of care.

Das Manual dient als Anlage zum Curriculum „Interventionelle Kardiologie“, das den Ausbildungsprozess fur die Zusatzqualifikation Interventionelle Kardiologie der DGK beschreibt. Die fur die Zusatzqualifikation erforderlichen Fertigkeiten konnen auch im Rahmen von Simulationskursen unterstutzend erworben werden, sofern die Kurse definierte Qualitatskriterien erfullen. Das vorliegende Manual beschreibt diese Kriterien, die sich auf die Mindestausstattung der Kurse mit Simulatoren und Modellen, den zeitlichen Anteil an praktischem Training, die Einbindung geschulter Trainer usw. beziehen. Mit diesen Vorgaben wird gewahrleistet, dass Simulationskurse die Zusatzausbildung zum Interventionellen Kardiologen in sinnvoller und effektiver Weise erganzen. Sofern die Anforderungen an Kurskonzept und -inhalte erfullt werden, kann die DGK bzw. die „Arbeitsgruppe Interventionelle Kardiologie“ (AGIK) die Schirmherrschaft fur den Kurs ubernehmen („Curriculum-begleitender AGIK-Simulationskurs“).

Resumen Introduccion y objetivos El implante de armazones bioabsorbibles (AB) es una tecnica emergente que se utiliza en las intervenciones coronarias percutaneas. Su aplicacion se ha extendido a las lesiones mas complejas, aunque solo se dispone de evidencia respecto a las lesiones simples. En el presente estudio se evaluo el implante del AB en lesiones largas atendiendo al solapamiento de los AB. Metodos Se llevo a cabo un analisis retrospectivo de todos los pacientes consecutivos considerados aptos para el implante de un AB de acido poli-L-lactico liberador de everolimus con una longitud total minima de 28 mm, con independencia del numero de AB implantados. Los objetivos principales fueron los eventos adversos cardiacos mayores (que incluyen la muerte cardiaca, cualquier infarto de miocardio y la revascularizacion de la lesion diana) y el fallo de la lesion diana (que incluye la muerte cardiaca, el infarto de miocardio del vaso diana y la revascularizacion de la lesion diana). Se realizo un analisis de subgrupos para la evaluacion de los pacientes con AB solapados. Resultados Se incluyo en total a 250 pacientes. El motivo de la angiografia fue enfermedad coronaria estable en el 36,4% de los pacientes (91 de 250), un sindrome coronario agudo en el 61,6% (154 de 250) y otros en el 2,0% (5 de 250). Se alcanzo exito de la intervencion en el 97,8% (267 de 273) de las lesiones. En el seguimiento de 12 meses, las tasas de eventos cardiacos adversos mayores, fallos de la lesion diana y trombosis del armazon fueron del 8,5, el 6,6 y el 2,3% respectivamente. El analisis del subgrupo de 239 pacientes puso de manifiesto que no habia diferencias estadisticamente significativas entre los pacientes con y sin solapamiento de AB despues de un seguimiento de 12 meses. Conclusiones El implante de stents en segmentos largos empleando un solo armazon o multiples armazones solapados es factible tecnicamente, y los resultados a medio plazo son adecuados. Sin embargo, seran necesarios estudios aleatorizados a gran escala para confirmar la prueba de concepto.

Within the last years TAVI—especially transfemoral/transvascular TAVI—has proven to be a valuable therapeutic option for most patients suffering from AS. Here, we present the outcome of a complete dataset of all patients undergoing aortic valve replacement in Germany in 2018. The data of all aortic valve procedures performed in Germany in 2018 derive from the mandatory nationwide quality control program. Patients were stratified with a new version of the German Aortic valve score (AKL Score) divided in different risk stratification depending on the treatment with either a catheter based (TV-TAVI) or surgical (iSAVR) approach. In-hospital outcomes have been compared between the two approaches. 19,317 transvascular (TV)–TAVI procedures were carried out. In contrast to this steady growth, the number of iSAVR andtransapical (TA) -TAVI procedures declined. In-hospital mortality after TV-TAVI (2.5%) was lower when compared to iSAVR (3.1%) as well as TA-TAVI (5.7%) in-hospital mortality after TV-TAVI was significantly lowest (Fig. 2) with an in-hospital mortality rate of 2.5%. TV-TAVI was the only approach with an observed vs. expected mortality ratio

For the prevention of cardiovascular risk factors (RF) there are numerous recommendations of professional societies, which relate to the personal way of life of individuals (for example nutrition/diet, physical activity, stress reduction etc.). The implementation of these recommendations is so far poor. In the ELITE study, data on RF, nutritional behavior, physical activity and quality of life in the Oldenburger Münsterland region are to be collected prospectively and improved by individual information. Reasons for the lack of implementation of preventive measures should be recognized.The study is conducted as an interventional cohort study (DRKS-No.: 00 006 813, Ethics vote University of Göttingen). Up to 5000 people (with or without pre-existing RF) are aimed to be included. All participants receive a computer-generated report of their personal risk profile with detailed recommendations based on current guidelines. In addition, it is recommended to visit the family doctor to discuss the findings and, if necessary, initiate diagnostic or therapeutic measures. Every year, follow-up examinations take place for up to 5 years.By 31.12.2017 4602 participants (mean age 51.5 (± 15.7) years, 53.7 % female) were admitted. Overweight were 39 % of the participants, obese 20.4 %. Most frequent anamnestic RF is hypertension (31.4 %), mean blood pressure was 138.4 ± 16.6/83.0 ± 9.9 mmHg. 2165 (47.0 %) participants show hypertensive blood pressure values. The second most frequent anamnestic RF are lipid metabolism disorders (16.6 %).The incidence of participants with at least one cardiovascular RF is very high (49.5 %, 16.6 % multiple RF). The incidence of RF is similar to other epidemiological data in Germany, so the ELITE collective allows a good comparison with other surveys.Zur Prävention kardiovaskulärer Risikofaktoren (RF) existieren zahlreiche Empfehlungen von Fachgesellschaften, die sich auf die persönliche Lebensweise von Menschen beziehen (z. B. Ernährung/Diät, körperliche Aktivität, Stressabbau etc.). Die Umsetzung dieser Empfehlungen ist bislang mangelhaft. In der ELITE-Studie sollen in der Region Oldenburger Münsterland prospektiv Daten zu RF, Ernährungsverhalten, körperlicher Aktivität und Lebensqualität erhoben und durch individuelle Information verbessert werden. Gründe für fehlende Umsetzung von Präventionsmaßnahmen sollen erkannt werden.Die Studie wird als interventionelle Kohorten-Untersuchung durchgeführt (DRKS-Nr.: 00 006 813; Ethikvotum Universität Göttingen). Bis zu 5000 Personen (mit oder ohne Vorerkrankungen) sollten eingeschlossen werden. Alle Teilnehmer erhalten einen computergenerierten Report ihres persönlichen Risikoprofils mit hieraus resultierenden ausführlichen Empfehlungen, die sich an den aktuellen Leitlinien orientieren. Ergänzend wird empfohlen, den Hausarzt aufzusuchen, um die Befunde zu besprechen und ggf. diagnostische oder therapeutische Maßnahmen einzuleiten. Im Jahresabstand erfolgen über bis zu 5 Jahre Follow-Up-Untersuchungen.Bis zum 31.12.2017 wurden 4602 Teilnehmer (mittleres Alter 51,5 (± 15,7) Jahre; 53,7 % weiblich) aufgenommen. Übergewichtig sind 39 % der Teilnehmer, adipös 20,4 %. Häufigster anamnestischer RF ist Bluthochdruck (31,4 %), mittlerer Blutdruck 138,4 ± 16,6/83,0 ± 9,9 mmHg. 2165 (47,0 %) Teilnehmer weisen hypertone Blutdruckwerte auf. Zweithäufigster anamnestischer RF sind Fettstoffwechselstörungen (16,6 %).Die Häufigkeit von Teilnehmern mit mindestens einem anamnestisch angegebenen kardiovaskulären RF ist sehr hoch (49,5 %; 16,6 % mehrere RF). Die Häufigkeit von RF entspricht anderen epidemiologischen Daten in Deutschland, sodass das ELITE-Kollektiv einen guten Vergleich mit anderen Erhebungen zulässt.

Aims To evaluate the acute performance of a novolimus-eluting bioresorbable scaffold (BRS) with a nominal diameter of 4.0mm (DESolve® XL) using optical coherence tomography (OCT) in terms of appropriate scaffold deployment. Methods and results Ten patients (55.6% male, mean age 60.0 y) undergoing OCT-guided scaffold implantation were enrolled consecutively in this retrospective study. Using data from the final pullback, the following indexes were calculated: mean and minimum area, residual area stenosis, incomplete strut apposition, tissue prolapse, eccentricity and symmetry indexes, strut fracture, and edge dissection. The clinical indication for the procedure was acute coronary syndrome in roughly half (55.5%) of the cases. All three main vessels were affected equally. The maximum post-dilatation balloon inflation pressure was 14.7±4.2atm. OCT analysis showed a lumen area of 11.4±1.9mm 2 and a scaffold area of 11.5±2.1mm 2 . Mean residual area stenosis was 28.6%. No strut fractures or edge dissections were apparent. The mean eccentricity index was 0.65±0.16 and the mean symmetry index 0.39±0.25. Conclusion The size of large vessels does not adversely influence acute mechanical performance as assessed by the eccentricity and symmetry indexes. No adverse cardiac event occurred during the hospital stay or the 30-day follow-up. It is feasible to treat large vessels with the DESolve® XL BRS.

Background: In ST-segment elevation myocardial infarction (STEMI) patients treated with percutaneous coronary intervention, direct transport from the scene to the catheterisation laboratory bypassing the emergency department has been shown to shorten times to reperfusion. The aim of this study was to investigate the effects of emergency department bypass on mortality in both haemodynamically stable and unstable STEMI patients. Methods: The analysis is based on a large cohort of STEMI patients prospectively included in the German multicentre Feedback Intervention and Treatment Times in ST-Elevation Myocardial Infarction (FITT-STEMI) trial. Results: Out of 13,219 STEMI patients who were brought directly from the scene by emergency medical service transportation and were treated with percutaneous coronary intervention, the majority were transported directly to the catheterisation laboratory bypassing the emergency department ( n=6740, 51% with emergency department bypass). These patients had a significantly lower in-hospital mortality than their counterparts with no emergency department bypass (6.2% vs. 10.0%, PConclusion: In STEMI patients, emergency department bypass is associated with a significant reduction in mortality, which is most pronounced in patients presenting with cardiogenic shock. Our data encourage treatment protocols for emergency department bypass to improve the survival of both haemodynamically stable patients and, in particular, unstable patients. Clinical Trial Registration: NCT00794001 ClinicalTrials.gov: NCT00794001

It is known that patients with acute coronary syndromes (ACS) and diabetes mellitus (DM) are at higher risk for in-hospital adverse events. However, we hypothesized that the higher event rate is due to the patients' subgroup with renal failure (RF), a common sequel of DM.We used data of the prospective ALKK-PCI registry including all consecutive percutaneous coronary interventions (PCI) for ACS of 48 hospitals between 2008 and 2013. We divided 69,651 patients in four groups according to their history of DM and RF (GFR 60 ml/min). All-cause, in-hospital mortality of the following four groups: noDM/noRF, DM/noRF, DM/RF, RF/noDM, was: 3.5%, 6.6%, 21.9%, and 14.1% for STEMI and 1.5%, 2.1%, 7.2%, and 5.4% for NSTE-ACS. In a multivariate analysis we looked for independent mortality-predictors. Odds ratios with confidence intervals for the following variables: DM without RF, DM with RF, RF without DM were: 1.62 (1.37-1.90), 3.02 (2.43-3.76), and 2.13 (1.80-2.52) for STEMI and 1.20 (0.99-1.45), 2.72 (2.18-3.88), and 2.08 (1.69-2.56) for NSTE-ACS. We also calculated mortality in four groups (60-90, 45-60, 45-30,30 ml/min) according to the estimated glomerular filtration rate (eGFR). Mortality rates were: 5.0%, 12.8%, 17.7%, and 31.5% for STEMI and 2.1%, 3.8%, 7.1%, and 12.0% for NSTE-ACS (p for trend0.0001 for both).In-hospital death after PCI in patients with ACS and DM is mainly observed in the subgroup with co-existing RF. In a multivariate analysis, DM without RF was a significant mortality-predictor in STEMI, but not in NSTE-ACS. RF, irrespective of co-existent DM, was a stronger predictor than DM alone for both ACS-types (OR 3) and mortality increased with decreasing eGFR.

BackgroundLong-term risk factor control after myocardial infarction (MI) is currently inadequate and there is an unmet need for effective secondary prevention programmes.Design and methodsIt was the aim of the study to compare a 12-month intensive prevention programme (IPP), coordinated by prevention assistants and including education sessions, telephone visits and telemetric risk factor control, with usual care after MI. Three hundred and ten patients were randomized to IPP vs. usual care one month after hospital discharge for MI in two German heart centres. Primary study endpoint was the IPP Prevention Score (0–15 points) quantifying global risk factor control.ResultsGlobal risk factor control was strongly improved directly after MI before the beginning of the randomized study (30% increase IPP Prevention Score). During the 12-month course of the randomized trial the IPP Prevention Score was improved by a further 14.3% in the IPP group ( p ConclusionsA novel intensive prevention programme after MI, coordinated by prevention assistants and using personal teachings and telemetric strategies for 12 months, was significantly superior to usual care in providing sustainable risk factor control and better quality of life.

Clinical management of patients with ST-elevation myocardial infarction (STEMI) is an emergency situation. Primary aim is urgent reestablishment of reperfusion by means of percutaneous coronary intervention (PCI). The European society of cardiology recently published the latest version of the guideline for management of patients with STEMI. A clear recommendation now exists for radial approach as access side for PCI as well as an intervention including the implantation of a drug eluting stent (DES). In patients with STEMI and multi vessel disease a complete revascularization should be planned on an individual basis either as part of the index procedure or as staged procedure. Heparin remains the routinely used anticoagulant and it remains unchanged that dual antiplatelet therapy is recommended after STEMI - duration of DAPT should be planned according to individual ischemic and bleeding risk.Die aktualisierte Leitlinie zum ST-Hebungsinfarkt (STEMI) der Europäischen Gesellschaft für Kardiologie (ESC) definiert den ersten qualifizierten medizinischen Kontakt genauer: Hierunter versteht man die Anwesenheit von medizinischem Personal, welches in der Lage ist, ein EKG zu schreiben und zu interpretieren. Von diesem sollte die Arbeitsdiagnose STEMI gestellt und die definierten Maßnahmen zur schnellstmöglichen Revaskularisation organisiert werden (ideal 90Minuten). In der EKG-Beurteilung wurde der Nachweis eines neu aufgetretenen kompletten Rechtsschenkelblocks in der Bewertung dem eines entsprechenden Linksschenkelblocks gleichgestellt.Die perkutane Koronarintervention (PCI) ohne vorherige Lysetherapie ist als Standardversorgung etabliert. Eine Versorgungszeit von Diagnosestellung bis PCI von unter 90 Minuten ist zu gewährleisten, in einem PCI-Zentrum binnen 60 Minuten. Die medikamentöse Notfallversorgung besteht aus unfraktioniertem Heparin, ASS und ggf. Sedativa und Analgetika. Aufgrund aktueller Studienergebnisse sollte eine Sauerstoffgabe via Nasenbrille nur bei Hypoxämie (Sauerstoffsättigung 90 %) erfolgen.Die Versorgungsstrategie der Wahl ist die perkutane Koronarintervention mit der dezidierten Präferenz des radialen Zugangsweges. Der Einsatz von Drug-eluting-Stents sollte uneingeschränkt erfolgen, die Thrombusaspiration spielt in der Routinebehandlung keine Rolle mehr. Bei stabilen Patienten mit STEMI und Mehrgefäßerkrankung sollte eine komplette Revaskularisation angestrebt werden. In der Index-Prozedur steht die Versorgung der „culprit lesion“ im Mittelpunkt, der Interventionszeitpunkt der weiteren relevanten Stenosierungen in den Nicht-Infarkt-Gefäßen ist patienten- und prozedurabhängig. MEDIKAMENTöSE THERAPIE: Die periprozedurale Standardantikoagulation erfolgt mittels Heparin, die Bedeutung von Bivalirudin wurde hier abgewertet. Standard bleibt ebenso weiterhin eine duale Thrombozytenaggregationshemmung (DAPT), bevorzugt mit den Präparaten Ticagrelor oder Prasugrel in Kombination mit ASS. Die Dauer der DAPT sollte im Kontext des Ischämie- und Blutungsrisikos festgelegt werden, grundsätzlich wird eine Dauer von 12 Monaten empfohlen. Ein Fokus in der Nachsorge der Patienten liegt in der Reduktion des LDL-Cholesterins mit einem Zielwert 70 mg/dl.Neu in den Leilinien aufgenommen ist unter dem Thema unklarer STEMI ein Kapitel zu Myokardinfarkt mit nicht obstruktiven Koronararterien (MINOCA). Hier werden die möglichen Differenzialdiagnosen vorgestellt sowie deren Verifizierung diskutiert.

The instantaneous wave-free ratio (iFR) is a new adenosine-independent index of coronary stenosis severity. Most published data have been based on off-line analyses of pressure recordings in a core laboratory. We prospectively compared real-time iFR and fractional flow reserve (FFR) measurements.iFR and FFR were measured in 151 coronary stenoses in 108 patients. Repeated iFR measurements were technically simple, showed excellent agreement [rs=0.99; p0.0001], and the mean difference between consecutive iFR values was 0.0035 (limits of agreement: -0.019, 0.026). Mean iFR showed a significant correlation with FFR [rs=0.81; p0.0001]. Receiver-operating characteristic analysis identified an optimal iFR cut-off value of 0.896 for categorization based on an FFR cut-off value 0.8. We compared two different iFR-based diagnostic strategies (iFR-only and hybrid iFR-FFR) with standard FFR: The iFR-only strategy showed good classification agreement (83.4%) with standard FFR. Use of the hybrid iFR-FFR strategy, assessing lesions in an iFR-gray zone of 0.86-0.93 by FFR, improved classification accuracy to 94.7%, and diagnosis would have been established in 61% of patients without adenosine-induced hyperemia. Notably, both iFR and FFR values were significantly higher in the posterior coronary vessels.Real-time iFR measurements are easily performed, have excellent diagnostic performance and confirm available off-line core laboratory data. The excellent agreement between repeated iFR measurements demonstrates the reliability of single measurements. Combining iFR with FFR in a hybrid strategy enhances diagnostic accuracy, exposing fewer patients to adenosine. Overall, iFR is a promising method, but still requires prospective clinical endpoint trial evaluation.

Background Diabetes is associated with aggressive atherosclerosis, leading to an increased risk of in-stent restenosis and stent thrombosis. Bioresorbable scaffolds (BRS) are a new technology for the treatment of coronary lesions that might be beneficial due to their dissolving character, especially in diabetic patients. Objective This study was designed to evaluate feasibility and mid-term clinical outcome of the implantation of PLLA-based, everolimus-eluting BRS for the treatment of coronary lesions in a diabetic all-comers population. Methods All patients of an all-comers registry with diabetes eligible for BRS implantation were included. Outcome parameters were target vessel failure (TVF), major adverse cardiac events (MACE) including target lesion revascularization (TLR), cardiac death, and myocardial infarction. Follow-up was conducted via telephone and/or office visit. Results A total of 120 diabetic patients were included. Of all diabetics, 35.0% had insulin-dependent diabetes, and all other patients were treated with oral antidiabetics or dietary modification. The median age was 67 (59–72) years and 26.7% were female. Patients underwent coronary angiography due to acute coronary syndrome in 50.8%. Of 127 lesions, 60.6% were B2/C lesions according to ACC/AHA classification. The 6-month rates of TVF, TLR, and MACE were 8.9, 2.7, and 8.4%, respectively. Conclusion This evaluation confirms reasonable clinical outcome of bioresorbable vascular scaffold implantation in a high-risk diabetic population with predominately complex lesions during daily clinical practice. Nevertheless, long-term data are required for final evaluation. © 2015 Wiley Periodicals, Inc.

Objectives We present our experience with an inflatable, non-metallic, fully retrievable, and repositionable transcatheter aortic valve [Direct Flow® Medical (DFM)] focusing on technical features adopted during implantation. Background Implantation techniques of new generation percutaneous aortic valves are still developing and with experience implementations are described. Methods The “low pressure” (initial valve inflation at 4 ATM, lower than the recommended 12 ATM) and the “alternate aortic curve” techniques (initial valve pulling either from the wire running on the side of the inner or from the one on the outer aortic curve) are part of our modified protocol for DFM® implantation. Results Forty-two consecutive patients underwent TAVI with DFM. The “low pressure” technique was used in all patients. In 27 (64.3%) patients the bulkiest calcifications were on the inner aortic curve side, and an inner curve technique was used to initiate valve pulling toward the annular hinge point. In the remaining 15 (35.7%) patients, an outer curve technique was used. Neither pull-through nor re-valving was reported. Valve performance showed mean gradient of 8.9 mm Hg. Mild paravalvular leak was reported in seven (16%) patients. No one experienced moderate or severe aortic insufficiency. Thirty-day mortality was 9.5% (4/42). Conclusion The “low pressure technique” and the “alternate curve technique” guarantee an anatomy and patient tailored approach to achieve controlled and finely tuned valve seating. © 2015 Wiley Periodicals, Inc.

Objective This study evaluates the feasibility of percutaneous coronary intervention with bioresorbable vascular scaffolds (BVSs) in chronic total occlusion (CTO) lesions. Background Everolimus-eluting BVSs represent a new approach to treating coronary artery disease, but experience with CTO is limited. Methods Patients with a previously diagnosed CTO who had been treated with BVS were included. Patients with unsuccessful CTO procedures and patients treated with drug-eluting stents were excluded. Difficulty of the CTO procedure was assessed by the J-score. Results A total of 23 patients were included. Mean age was 60.4±9.0years, 17.4% were female, 91.3% suffered from hypertension and 34.8% from diabetes. Mean J-score was 1.7±1.0. Median procedure time was 70min (54–85), mean contrast volume was 213.5mL (±94.2) and median fluoroscopy time was 19.1min (13.1–30.0). A total of 64 BVSs were implanted with a mean number of 2.8±1.0 BVSs per patient, a mean total BVS length of 64.8±24.2mm per lesion, and a mean BVS diameter of 3.1±0.2mm. Neither a scaffold-related dissection nor any other intra-procedural complication occurred. During a follow-up of 108 (79.5–214.5) days one in-scaffold thrombosis was noted 4days after the CTO procedure due to a lack of dual antiplatelet therapy. No further major adverse cardiac events occurred. Conclusion These results suggest that BVS implantation in CTO lesions can be performed with good procedural success and reasonable clinical short-term outcome in highly selected cases.

Aims Conduction abnormalities (CA), in particular complete atrioventricular block (CAVB), requiring permanent pacemaker (PPM) implantation, are frequent complications after transcatheter aortic valve implantation (TAVI) in patients with severe aortic stenosis (AS). However, the potential mechanisms are still incompletely understood. The objective of this retrospective study was to determine further predictors of CAVB after TAVI in patients without the known predictors. Methods and results This study included patients without prior CA/PPM who underwent TAVI of a balloon-expandable valve (Sapien or Sapien XT or Sapien 3). Of 563 patients (81.2 ± 6.9 years, 245 men [43.5%], logistic EuroSCORE 22.2 ± 14.1%, STS PROM 5.9 [3.4–8.0]) who were treated by TAVI at our institution between July 2008 and January 2016, 61 (10.8%) developed a permanent CAVB after the procedure. In a multivariable logistic regression analysis moderate/severe tricuspid regurgitation (TR) (OR 2.05; 95% CI 1.18–3.55; p = 0.010) was identified as an independent predictor for new CAVB after TAVI. Moreover, patients with more pronounced TR presented with increased left and right ventricular overload (left ventricular (LV) end-diastolic diameter, LV end-diastolic pressure), pulmonary pressures, NT-proBNP, and prevalence of mitral regurgitation ≥II, whereas LV ejection fraction, TAPSE and cardiac output were decreased. Conclusions PPM implantation is a frequent complication in patients undergoing TAVI. Increasing severity of TR seems to be a consequence of left and right ventricular overload caused by severe AS and is a significant predictor of new CAVB after TAVI. Condensed abstract Conduction abnormalities (CA) requiring permanent pacemaker (PPM) implantation, are frequent complications after transcatheter aortic valve implantation (TAVI). This study included patients without prior CA/PPM who underwent TAVI. Of 563 patients 61 (10.8%) developed a permanent CAVB after the procedure. In a multivariable logistic regression analysis moderate/severe tricuspid regurgitation (TR) (OR 2.05; 95% CI 1.18–3.55; p = 0.010) was identified as an independent predictor for new CAVB. Therefore, in patients with moderate/severe TR utmost care should be taken to avoid procedural factors conducive to mechanical irritation of the conduction system, resulting in pacemaker dependency.

OBJECTIVE The objective of the study was to retrospectively evaluate the long-term clinical outcome after implantation of the self-expandable (SE) STENTYS stent in a large multicenter cohort. BACKGROUND Incomplete stent apposition is known to cause higher rates of myocardial infarction (MI) and stent thrombosis. Because of its self-expanding features, the SE STENTYS stent adapts to the vessel wall and is therefore expected to minimize malapposition and therefore the rates of MI and stent thrombosis. PATIENTS AND METHODS Treatment with a total of 351 SE coronary stents was attempted in 314 patients of a cohort from three German institutions between 2011 and 2015. Technical success was achieved with 331/351 (94%) stents. Patients treated successfully with SE stents (n=298) were followed up using the primary outcome measure of target lesion failure (TLF), a combined endpoint of cardiac mortality, recurrent target vessel MI, acute stent thrombosis, and clinically driven target lesion revascularization. Follow-up was complete in 268/298 (90%) patients with a median follow-up period of 2.5 (interquartile range: 1.4-3.3) years. RESULTS TLF occurred in 54/298 (18%) patients. Event rates were 7.5% for cardiac mortality, 11.6% for target vessel MI, and 5.2% for clinically driven target lesion revascularization. Acute stent thrombosis occurred in 2/298 (0.7%). Overall, stent thrombosis had an incidence of 2.6% within the follow-up period. ST-elevation MI at baseline (P=0.02) and a dual antiplatelet therapy with clopidogrel for only 6 months (P=0.04) were the only clinical factors linked to the absence of TLF. CONCLUSION Technical success of SE coronary stent implantation in an all-comer cohort of patients was high, although the rate of TLF and stent thrombosis during long-term follow-up was also relatively high.