[Medical societies in Germany call for a ban on flavors in e-cigarettes - A Position Paper of the German Respiratory Society (DGP) in cooperation with other professional associations and organizations]. / Medizinische Fachgesellschaften fordern ein Verbot von Aromen in E-Zigaretten.

E-cigarettes are primarily used by teenagers and young adults. Flavors in e-cigarettes increase their attractiveness and encourage young people and adults to start using them. This exposes young people in particular to the risk of nicotine addiction and various toxic substances from the aerosol of e-cigarettes. There are indications that various flavors in e-cigarettes are harmful to health, although toxicological studies are still lacking for the majority of flavors. There is a need for independent scientific investigations in this area. The scientific societies involved are calling for a ban on flavors in e-cigarettes, a ban on disposable e-cigarettes, effective regulation of the sale of e-cigarettes and effective control and implementation of the provisions for the protection of minors.

Impact of Access Site on Periprocedural Bleeding and Cerebral and Coronary Events in High-Bleeding-Risk Percutaneous Coronary Intervention: Findings from the RIVA-PCI Trial.

INTRODUCTION: The preference for using transradial access (TRA) over transfemoral access (TFA) in patients requiring percutaneous coronary intervention (PCI) is based on evidence suggesting that TRA is associated with less bleeding and fewer vascular complications, shorter hospital stays, improved quality of life, and a potential beneficial effect on mortality. We have limited study data comparing the two access routes in a patient population with atrial fibrillation (AF) undergoing PCI, who have a particular increased risk of bleeding, while AF itself is associated with an increased risk of thromboembolism. METHODS: Using data from the RIVA-PCI registry, which includes patients with AF undergoing PCI, we analyzed a high-bleeding-risk (HBR) cohort. These patients were predominantly on oral anticoagulants (OAC) for AF, and the PCI was performed via radial or femoral access. Endpoints examined were in-hospital bleeding (BARC 2-5), cerebral events (TIA, hemorrhagic or ischemic stroke) and coronary events (stent thrombosis and myocardial infarction). RESULTS: Out of 1636 patients, 854 (52.2%) underwent TFA, while 782 (47.8%) underwent the procedure via TRA, including nine patients with brachial artery puncture. The mean age was 75.5 years. Groups were similar in terms of age, sex distribution, AF type, cardiovascular history, risk factors, and comorbidities, except for a higher incidence of previous bypass surgeries, heart failure, hyperlipidemia, and chronic kidney disease (CKD) with a glomerular filtration rate (GFR) < 60 ml/min in the TFA group. No clinically relevant differences in antithrombotic therapy and combinations were present at the time of PCI. However, upon discharge, transradial PCI patients had a higher rate of triple therapy, while dual therapy was preferred after transfemoral procedures. Radial access was more frequently chosen for non-ST-segment elevation myocardial infarction (NSTEMI) and unstable angina pectoris (UAP) cases (NSTEMI 26.6% vs. 17.0%, p < 0.0001; UAP 21.5% vs. 14.5%, p < 0.001), while femoral access was more common for elective PCI (60.3% vs. 44.1%, p < 0.0001). No differences were observed for ST-segment elevation myocardial infarction (STEMI). Both groups had similar rates of cerebral events (TFA 0.2% vs. TRA 0.3%, p = 0.93), but the TFA group had a higher incidence of bleeding (BARC 2-5) (4.2% vs. 1.5%, p < 0.01), mainly driven by BARC 3 bleeding (1.5% vs. 0.4%, p < 0.05). No significant differences were found for stent thrombosis and myocardial infarction (TFA 0.2% vs. TRA 0.3%, p = 0.93; TFA 0.4% vs. TRA 0.1%, p = 0.36). CONCLUSIONS: In HBR patients with AF undergoing PCI for acute or chronic coronary syndrome, the use of TRA might be associated with a decrease in in-hospital bleeding, while not increasing the risk of embolic or ischemic events compared to femoral access. Further studies are required to confirm these preliminary findings.

[General Estimation of Cardiovascular Risk]. / Allgemeine Abschätzung des kardiovaskulären Risikos.

The assessment of individual cardiovascular disease risk (CVD) is essential for a cost-effective prevention of cardiovascular morbidity and mortality. While almost half of the population have a very low CVD risk approximately 1/5th of the population have a CVD risk >20% over the next 10 years.Modern risk scores like the ESC-SCORE2 help to identify those in need of intensified preventive efforts based on basic risk factors like smoking, systolic blood pressure, total cholesterol, age, and sex. According to current ESC-guidelines all men >45 years and all women >55 years should be assessed with SCORE2, which is the best calibrated and validated scoring system for Europe.The calculation of total cardiovascular risk also permits to calculate an individual heart-age, which makes it easier for the individual patient to understand his own risk profile. Most current risk estimation systems can be accessed online under u-prevent.com/calculators.

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.

Right Ventricular Cardiac Power Index Predicts 1 Year Outcome After Transcatheter Edge-to-Edge-Repair for Severe Tricuspid Valve Regurgitation.

Tricuspid transcatheter edge-to-edge repair (T-TEER) for severe tricuspid regurgitation (TR) emerged as a novel treatment option for patients not amenable to surgery. However, knowledge regarding independent risk factors for a worse prognosis is rarely available. The study sought to investigate the impact of right ventricular cardiac power index (RVCPi) on 1-year outcomes in patients with severe symptomatic TR who underwent T-TEER. Consecutive patients with severe TR who underwent T-TEER from August 2020 to March 2022 were included and followed prospectively. Baseline clinical and invasive hemodynamic variables, changes in echocardiographic parameters and New York Heart Association functional class, and periprocedural and in-hospital major adverse events were assessed. Primary end point was defined as a composite of all-cause mortality and heart failure hospitalization at 1 year after T-TEER. A multivariable Cox proportional-hazards regression analysis was performed to identify independent risk factors for combined primary end point. RVCPi was calculated as: (cardiac index × mean pulmonary pressure) × K (conversion factor 2.22 × 10-3) = W/m². Receiver operator characteristic analysis was used to determine discriminative capacity of RVCPi. The prognostic value of RVCPi threshold was tested using Kaplan-Meier analysis. In total, 102 patients (mean age 81 ± 6 years, 51% women) at high operative risk underwent T-TEER for severe TR. Primary end point occurred in 30 patients (32%). Receiver operator characteristic curve analysis demonstrated that RVCPi was associated with an area under the curve of 0.69 (95% confidence interval 0.56 to 0.82; p = 0.003). With a RVCPi threshold of 0.17 W/m² (maximally selected rank statistics), the event-free survival was significantly higher in the RVCPi <0.17 W/m² group compared with those with RVCPi ≥0.17 W/m² (71% vs 35%, log-rank p <0.001). In the multivariable Cox regression analysis, RVCPi was an independent predictor for the combined primary end point (hazard ratio 2.6, 95% confidence interval 1.4 to 5.1, p = 0.003). In conclusion, RVCPi is associated with outcome in patients who underwent T-TEER for severe TR and this hemodynamic predictor is useful in risk stratification of T-TEER candidates.

Rivaroxaban in Patients With Atrial Fibrillation Who Underwent Percutaneous Coronary Intervention in Clinical Practice.

Little is known about the efficacy and safety of rivaroxaban in patients with atrial fibrillation (AF) who underwent percutaneous coronary intervention (PCI) in clinical practice. We therefore conducted a prospective observational study to determine the rate of ischemic, embolic, and bleeding events in patients with AF and PCI treated with rivaroxaban in a real-world experience. The RIVA-PCI ("rivaroxaban in patients with AF who underwent PCI") (clinicaltrials.gov NCT03315650) is a prospective, noninterventional, multicenter study with a follow-up until 14 months, including patients with AF who underwent PCI discharged with rivaroxaban. Between January 2018 and March 2020, 700 patients with PCI treated with rivaroxaban (elective in 50.1%, non-ST-elevation acute coronary syndrome 43.0%, ST-elevation myocardial infarction in 6.9%) were enrolled at 51 German hospitals. After PCI, a dual antithrombotic therapy consisting of rivaroxaban and a P2Y12 inhibitor was administered in 70.7% and triple antithrombotic therapy in 27.9%, respectively. Follow-up information could be obtained in 695 patients (99.3%). Rivaroxaban has been stopped prematurely in 21.6% of patients. Clinical events under rivaroxaban during the 14-month follow-up compared with those observed in the PIONEER-AF PCI trial included cardiovascular death (2.0% % vs 2.0%), myocardial infarction (0.9% vs 3.0%), stent thrombosis (0.2% vs 0.8%), stroke (1.3% vs 1.3%), International Society on Thrombosis and Haemostasis major (4.2% vs 3.9%), and International Society on Thrombosis and Haemostasis nonmajor clinically relevant bleeding (15.3% vs 12.9%). Therefore, in this real-world experience, rivaroxaban in patients with AF who underwent PCI is associated with ischemic and bleeding event rates comparable with those observed in the randomized PIONEER-AF PCI trial.

German Cardiac Arrest Registry: rationale and design of G-CAR.

BACKGROUND: In Germany, 70,000-100,000 persons per year suffer from out-of-hospital cardiac arrest (OHCA). Despite medical progress, survival rates with good neurological outcome remain low. For many important clinical issues, no or only insufficient evidence from randomised trials is available. Therefore, a systemic and standardised acquisition of the treatment course and of the outcome of OHCA patients is warranted. STUDY DESIGN: The German Cardiac Arrest Registry (G-CAR) is an observational, prospective, multicentre registry. It will determine the characteristics, initial treatment strategies, invasive procedures, revascularisation therapies and the use of mechanical circulatory support devices with a focus on extracorporeal cardiopulmonary resuscitation. A special feature is the prospective 12-month follow-up evaluating mortality, neurological outcomes and several patient-reported outcomes in the psychosocial domain (health-related quality of life, cognitive impairment, depression/anxiety, post-traumatic stress disorder and social reintegration). In a pilot phase of 24 months, 15 centres will include approximately 400 consecutive OHCA patients ≥ 18 years. Parallel to and after the pilot phase, scaling up of G-CAR to a national level is envisaged. CONCLUSION: G-CAR is the first national registry including a long-term follow-up for adult OHCA patients. Primary aim is a better understanding of the determinants of acute and long-term outcomes with the perspective of an optimised treatment. TRIAL REGISTRY: NCT05142124. German Cardiac Arrest Registry (G-CAR).

Current status of antithrombotic therapy and in-hospital outcomes in patients with atrial fibrillation undergoing percutaneous coronary intervention in Germany.

BACKGROUND: Little is known about current patterns of antithrombotic therapy in patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI) in clinical practice in Germany. METHODS: The RIVA-PCI is a prospective, non-interventional, multicenter study with follow-up until hospital discharge including consecutive patients with AF undergoing PCI. RESULTS: Between January 2018 and March 2020, 1636 patients (elective in 52.6%, non-ST elevation acute coronary syndrome [NSTE-ACS] in 39.3%, ST-elevation myocardial infarction in 8.2%) from 51 German hospitals were enrolled in the study. After PCI a dual antithrombotic therapy (DAT) consisting of OAC and a P2Y12 inhibitor was given to 66.0%, triple antithrombotic therapy (TAT) to 26.0%, dual antiplatelet therapy to 5.5%, and a mono-therapy to 2.5% of the patients. Non-vitamin K antagonist oral anticoagulants (NOACs) were given to 82.4% and vitamin K antagonists to 11.5% of the patients. In-hospital events included death in 12 cases (0.7%), myocardial infarction, stent thrombosis, and ischemic stroke in four (0.2%) patients each, while 2.8% of patients had bleeding complications. The recommended durations for DAT or TAT at discharge were 1 month (1.5%), 3 months (2.1%), 6 months (43.1%), and 12 months (45.6%), with a 6-month course of DAT (47.7%) most often recommended after elective PCI and a 12-month course of DAT (40.1%) after ACS. CONCLUSION: The preferred therapy after PCI in patients with AF is DAT with a NOAC and clopidogrel. In-hospital ischemic and bleeding events were rare. The recommended durations for combination therapy vary considerably.

Impact of moderate or severe left ventricular outflow tract calcification on clinical outcomes of patients with severe aortic stenosis undergoing transcatheter aortic valve implantation with self- and balloon-expandable valves: a post hoc analysis from the SOLVE-TAVI trial.

BACKGROUND: Left ventricular outflow tract (LVOT) calcification has been associated with worse outcomes in patients undergoing transcatheter aortic valve implantation (TAVI) and may influence the selection of prosthetic valve type. AIMS: We aimed to evaluate the impact of LVOT calcification on outcomes after TAVI with a self-expanding valve (SEV) versus a balloon-expandable valve (BEV). METHODS: Patients of the SOLVE-TAVI trial, randomised to Edwards SAPIEN 3 or Medtronic Evolut R, were divided according to LVOT calcification into no/mild (≤1 calcium nodule extending <5 mm and covering <10% of the LVOT perimeter) and moderate/severe LVOT calcification groups. The primary endpoint was a composite of death, stroke, moderate/severe paravalvular regurgitation, permanent pacemaker implantation and annulus rupture at 30 days. Additional endpoints included all-cause and cardiovascular mortality at 1 year. RESULTS: Out of 416 eligible patients, moderate/severe LVOT calcification was present in 143 (34.4%). Moderate/severe LVOT calcification was associated with significantly longer fluoroscopy time and higher rates of pre- and post-dilation. Regardless of the LVOT calcification group, there was no significant difference in the primary endpoint associated with the valve type (no/mild LVOT calcification group: SEV 25.0% vs BEV 27.0%; hazard ratio [HR] 1.10, 95% confidence interval [95% CI]: 0.68-1.73; p=0.73 and moderate/severe LVOT calcification group: SEV 25.0% vs BEV 19.4%; HR 0.76, 95% CI: 0.38-1.61; p=0.49), no significant interaction between LVOT calcification and valve type (pint=0.29) and no differences between SEV vs BEV within LVOT calcification groups regarding 1-year all-cause and cardiovascular mortality. CONCLUSIONS: Moderate/severe LVOT calcification was associated with longer fluoroscopy time and an increased need for pre- and post-dilation, but not with a higher incidence of early and mid-term adverse clinical outcomes, regardless of valve type. (ClinicalTrials.gov: NCT02737150).

Lifestyle and metabolic risk factors in patients with early-onset myocardial infarction: a case-control study.

AIMS: Family history is a known risk factor for early-onset myocardial infarction (EOMI). However, the role of modifiable lifestyle and metabolic factors in EOMI risk is unclear and may differ from that of older adults. METHODS: This case-control study included myocardial infarction (MI) patients aged ≤45 years from the Bremen ST-elevation MI Registry and matched controls randomly selected from the general population (German National Cohort) at the same geographical region. Multiple logistic regression was used to estimate odds ratios (ORs) and 95% confidence intervals (CIs) for the individual and combined associations of lifestyle and metabolic factors with EOMI risk, overall and according to family history for premature MI. RESULTS: A total of 522 cases and 1191 controls were included. Hypertension, current smoking, elevated waist-to-hip ratio, and diabetes mellitus were strongly associated with the occurrence of EOMI. By contrast, higher frequency of alcohol consumption was associated with decreased EOMI risk. In a combined analysis of the risk factors hypertension, current smoking, body mass index ≥25.0 kg/sqm, and diabetes mellitus, participants having one (OR = 5.4, 95%CI = 2.9-10.1) and two or more risk factors (OR = 42.3, 95%CI = 22.3-80.4) had substantially higher odds of EOMI compared to those with none of these risk factors, regardless of their family history. CONCLUSION: This study demonstrates a strong association of smoking and metabolic risk factors with the occurrence of EOMI. The data suggest that the risk of EOMI goes beyond family history and underlines the importance of primary prevention efforts to reduce smoking and metabolic syndrome in young persons.

Temporal trends in treatment strategies and clinical outcomes among patients with advanced chronic kidney disease and ST-elevation myocardial infarctions: results from the Bremen STEMI registry.

BACKGROUND: Although the detrimental effects of advanced chronic kidney disease (CKD) on prognosis in coronary artery disease is known, there are few data on the efficacy and safety of modern interventional therapies and medications in patients with advanced CKD, because this special patient cohort is often excluded or underrepresented in randomized trials. METHODS: In the present study all patients admitted with ST-elevation myocardial infarctions (STEMI) from the region of Bremen/Germany treated between 2006 and 2019 were analyzed. Advanced CKD was defined as glomerular filtration rate < 45 ml/min. RESULTS: Of 9605 STEMI-patients, 1018 (10.6%) had advanced CKD with a serum creatinine of 2.22 ± 4.2 mg/dl at admission and with lower rates of primary percutaneous coronary intervention (pPCI) (84.1 vs. 94.1%, p < 0.01) and higher all-cause-mortality (44.4 vs. 3.6%, p < 0.01). Over time, advanced CKD-patients were more likely to be treated with pPCI (2015-2019: 90.3% vs. 2006-2010:75.8%, p < 0.01) and with ticagrelor/prasugrel (59.6% vs. 1.7%, p < 0.01) and drug eluting stents (90.7% vs. 1.3%, p < 0.01). During the study period a decline in adverse ischemic events (OR 0.3, 95% CI 0.1-0.7) and an increase in bleedings (OR 2.2, 95% CI 1.3-3.8) within 1 year after the index event could be observed in patients with advanced CKD while 1-year-mortality (OR 1.0, 95% CI 0.7-1.4) and rates of acute kidney injury (OR 1.2, 95% CI 0.8-1.7) did not change in a multivariate model. Both, ticagrelor/prasugrel (OR 0.48, 95% CI 0.2-0.98) and DES (OR 0.38, 95% CI 0.2-0.8) were associated with a decrease in ischemic events at 1 year. CONCLUSIONS: During the observed time period STEMI-patients with advanced CKD were more likely to be treated with primary PCI, ticagrelor or prasugrel and DE-stents. These changes probably have contributed to the decline in ischemic events and the increase in bleedings within 1 year after STEMI while overall mortality at 1-year remained unchanged for this high-risk patient group.

Influence of the ratio of mean arterial pressure to right atrial pressure on outcome after successful percutaneous edge-to-edge repair for severe mitral valve regurgitation.

BACKGROUND: It is important to identify further predictors of outcome after successful transcatheter mitral valve repair (TMVR), as optimal patient selection remains difficult. OBJECTIVE: The study investigates the prognostic benefit of the mean arterial pressure (MAP) to right atrial pressure (RAP) ratio (MAP/RAP ratio) after successful TMVR in patients with congestive heart failure (CHF) and severe mitral regurgitation (MR). METHOD: Patients with CHF and severe MR were enrolled after successful TMVR (MR ≤ 2+ at discharge). The primary endpoint was a composite of all-cause mortality or hospitalisation for heart failure. The median follow-up time was 16 ± 9 months. Receiver Operating Characteristic (ROC) analysis was applied to assess the discriminatory power of the MAP/RAP ratio. The predictive value of the MAP/RAP ratio threshold was investigated using a Kaplan-Meier analysis. Multivariable logistic regression analysis was conducted to evaluate independent risk factors for the combined primary endpoint. RESULTS: 145 patients (median age 76 [69-80 years], 60.3% male) were included. ROC curve analysis showed that MAP/RAP ratio was associated with an area under the curve of 0.62 (95% confidence interval (CI) 0.53-0.71; p = 0.01). A MAP/RAP ratio threshold of 7.13 was associated with 67.4% sensitivity and 57.0% specificity for the combined primary endpoint. Event-free survival was significantly lower in the MAP/RAP ratio < 7.13 group compared to those with MAP/RAP ratio ≥ 7.13 (62.2% versus 39.4%; log-rank p = 0.022). In logistic regression analysis MAP/RAP ratio was an independent predictor for the combined primary endpoint (odds ratio 0.75; 95% CI 0.62-0.90; p = 0.002). CONCLUSIONS: The MAP/RAP ratio is associated with an unfavorable outcome in patients undergoing successful TMVR. Therefore, this new index could improve prognostic assessment of TMVR candidates.

Efficacy of Drug-Eluting Stents in Diabetic Patients Admitted with ST-Elevation Myocardial Infarctions Treated with Primary Percutaneous Coronary Intervention.

BACKGROUND: Diabetic patients show higher adverse ischemic event rates and mortality when undergoing percutaneous coronary intervention (PCI) in acute myocardial infarctions. Therefore, diabetic patients might benefit even more from modern-generation drug-eluting stents (DES). The aim of the present study was to compare adverse ischemic events and mortality rates between bare-metal stents (BMS) and DES in diabetic patients admitted with ST-elevation-myocardial infarction (STEMI) with non-diabetic patients as the control group. METHODS: All STEMI patients undergoing emergency PCI and stent implantation documented between 2006 and 2019 in the Bremen STEMI registry entered the analysis. Efficacy was defined as a combination of in-stent thrombosis, myocardial re-infarction or additional target lesion revascularization at one year. RESULTS: Of 8356 patients which entered analysis, 1554 (19%) were diabetics, while 6802 (81%) were not. 879 (57%) of the diabetics received a DES. In a multivariate model, DES implantation in diabetics compared to BMS was associated with lower rates of in-stent thrombosis (OR 0.16, 95% CI 0.05-0.6), myocardial re-infarctions (OR 0.35, 95%CI, 0.2-0.7, p < 0.01) and of the combined endpoint at 1 year ((ST + MI + TLR): OR 0.31, 95% CI 0.2-0.6, p < 0.01), with a trend towards lower 5-year mortality (OR 0.56, 95% CI 0.3-1.0, p = 0.058). When comparing diabetic to non-diabetic patients, an elevation in event rates for diabetics was only detectable in BMS (OR 1.78, 95% CI 0.5-0.7, p < 0.01); however, this did not persist when treated with a DES (OR 1.03 95% CI 0.7-1.6, p = 0.9). CONCLUSIONS: In STEMI patients with diabetes, the use of DES significantly reduced ischemic event rates and, unlike with BMS, adverse ischemic event rates became similar to non-diabetic patients.

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.

Prevalence and clinical characteristics of prediabetes and diabetes mellitus in young patients with ST-segment elevation myocardial infarction.

BACKGROUND: Only few data on the prevalence of DM in young patients with ST-elevation myocardial infarction (STEMI) exist. Aim of the present study was to analyse this prevalence, its association to other cardiovascular risk factors and its impact on severity of CAD. In a substudy, consecutive HbA1c measurements in each patient were evaluated. METHODS: All patients ≤ 45 years old, admitted with STEMI to an overregional German Heart Centre and treated with primary coronary intervention between 2006 and 2019, entered analysis. Since 2015 HbA1c measurements were performed to detect unknown dysglycaemia. RESULTS: Out of 776 young patients of the total cohort, 88 patients (11.4%) had a DM, while 688 (88.6%) did not. Diabetics were more likely to be obese (BMI ≥ 30 kg/m2, OR 2.4, 95%CI 1.4-4.0, p < 0.01) and very obese (BMI ≥ 40 kg/m2, OR 5.1, 95%CI 2.1-12.2, p < 0.01). In diabetics, a higher likelihood of subacute STEMI (OR 2.2, 95% CI 1.1-4.5, p < 0.05) and more advanced CAD (OR 1.6, 95% CI 1.0-2.6, p < 0.05) compared to non-diabetics was observed. 208 patients were included in the substudy with HbA1c measurements. Out of those, 26 patients (12%) had known DM, while 17 patients (8%) had newly diagnosed DM and 49 patients (24%) preDM. The combined prevalence of any type of dysglycaemia was 44%. CONCLUSION: DM in young patients with STEMI was associated with (severe) obesity, a higher likelihood of subacute STEMI and more advanced CAD compared to non-diabetics. Measurement of HbA1c in every consecutive STEMI-patient increased the rate of detected dysglycaemias more than three times higher than in general population.

Impact of COVID-19 Pandemic on Presentation and Outcome of Consecutive Patients Admitted to Hospital Due to ST-Elevation Myocardial Infarction.

Impact of COVID-19 pandemic and pandemic-related social restrictions on clinical course of patients treated for acute ST-elevation myocardial infarction (STEMI) is unclear. In the present study presentation and outcome of patients with STEMI in the year 2020 were compared with the years before in a German registry that includes all patients hospitalized for acute STEMI in a region with approximately 1 million inhabitants. In the year 2020 726 patients with STEMI were registered compared with 10.226 patients in the years 2006 to 2019 (730 ± 57 patients per year). No significant differences were observed between the groups regarding age, gender and medical history of patients. However, in the year 2020 a significantly higher rate of patients admitted with cardiogenic shock (21.9% vs 14.2%, p <0.01) and out-of-hospital cardiac arrest (OHCA) (14.3% vs 11.1%, p <0.01) was observed. The rate of patients with subacute myocardial infarction (14.3% vs 11.6%, p <0.05) was elevated in 2020. Hospital mortality increased by 52% from the years 2006 to 2019 (8.4%) to the year 2020 (12.8%, p <0.01). Only 4 patients (0.6%) with STEMI in the year 2020 had SARS-CoV-2 infection, none of those died in-hospital. In conclusion, in the year 2020 a highly significant increase of STEMI-patients admitted to hospital with advanced infarction and poor prognosis was observed. As the structure of the emergency network to treat patients with STEMI was unchanged during the study period, the most obvious reason for these changes was COVID-19 pandemic-related lockdown and the fear of many people to contact medical staff during the pandemic.

Impact of Anesthesia Strategy and Valve Type on Clinical Outcomes After Transcatheter Aortic Valve Replacement.

BACKGROUND: The randomized SOLVE-TAVI (compariSon of secOnd-generation seLf-expandable vs. balloon-expandable Valves and gEneral vs. local anesthesia in Transcatheter Aortic Valve Implantation) trial compared newer-generation self-expanding valves (SEV) and balloon-expandable valves (BEV) as well as local anesthesia with conscious sedation (CS) and general anesthesia (GA) in patients undergoing transfemoral transcatheter aortic valve replacement (TAVR). Both strategies showed similar outcomes at 30 days. OBJECTIVES: The purpose of this study was to compare clinical outcomes during 1-year follow-up in the randomized SOLVE-TAVI trial. METHODS: Using a 2 × 2 factorial design 447 intermediate- to high-risk patients with severe, symptomatic aortic stenosis were randomly assigned to transfemoral TAVR using either the SEV (Evolut R, Medtronic Inc., Minneapolis, Minnesota) or the BEV (Sapien 3, Edwards Lifesciences, Irvine, California) as well as CS or GA at 7 sites. RESULTS: In the valve-comparison strategy, rates of the combined endpoint of all-cause mortality, stroke, moderate or severe paravalvular leakage, and permanent pacemaker implantation were similar between the BEV and SEV group (n = 84, 38.3% vs. n = 87, 40.4%; hazard ratio: 0.94; 95% confidence interval: 0.70 to 1.26; p = 0.66) at 1 year. Regarding the anesthesia comparison, the combined endpoint of all-cause mortality, stroke, myocardial infarction, and acute kidney injury occurred with similar rates in the GA and CS groups (n = 61, 25.7% vs. n = 54, 23.8%; hazard ratio: 1.09; 95% confidence interval: 0.76 to 1.57; p = 0.63). CONCLUSIONS: In intermediate- to high-risk patients undergoing transfemoral TAVR, newer-generation SEV and BEV as well as CS and GA showed similar clinical outcomes at 1 year using a combined clinical endpoint. (SecOnd-generation seLf-expandable Versus Balloon-expandable Valves and gEneral Versus Local Anesthesia in TAVI [SOLVE-TAVI]; NCT02737150).

Impact of Ventricular Stroke Work Indices on Mortality in Heart Failure Patients After Percutaneous Mitral Valve Repair.

Optimal patient selection for transcatheter mitral valve repair (TMVR) remains challenging. The aim of the study was to assess the impact of left and right ventricular stroke work index (LVSWi, RVSWi) on mortality in patients with chronic heart failure (CHF) undergoing TMVR. One hundred-forty patients (median age 74 ± 9.9 years, 67.9% male) with CHF who underwent successful TMVR were included. Primary end point was defined as all-cause mortality after 16 ± 9 months of follow-up. LVSWi was calculated as: Stroke volume index (SVi) * (mean arterial pressure - postcapillary wedge pressure) * 0.0136 = g/m-1/m2. RVSWi was calculated as: SVi * (mean pulmonary artery pressure - right atrial pressure) * 0.0136 = g/m-1/m2. Receiver operating characteristic (ROC) analysis determined an optimal threshold of 24.8 g/m-1/m2 for LVSWi (sensitivity 80.4%, specificity 40.2%, area under the curve (AUC) 0.71 [0.60 to 0.81]; p = 0.001) and 8.3 g/m-1/m2 for RVSWi (sensitivity 67.4%, specificity 57.0%, AUC 0.67 [0.56 to 0.78]; p = 0.006), respectively. Kaplan-Meier analysis showed significantly lower survival in patients with LVSWi ≤24.8 g/m-1/m2 (20.0% vs 39.4%; log-rank p = 0.038) and in patients with RVSWi ≤8.3 g/m-1/m2 (22.1% vs 43.7%; log-rank p = 0.026), respectively. LVSWi of ≤24.8 g/m-1/m2 and RVSWi of ≤8.3 g/m-1/m2 were independent predictors for all-cause mortality (hazard ratio (HR) 2.83; 95% confidence interval (CI) 1.1 to 7.6; p = 0.04; HR 2.52; 95% CI 1.04 to 6.1; p = 0.041). A risk-score incorporating LVSWi and RVSWi cut-off values from ROC analysis powerfully predicts long-term survival after successful TMVR (log-rank p = 0.02). In conclusion, LVSWi and RVSWi independently predict mortality in patients with CHF undergoing TMVR and might be useful in risk stratification of TMVR candidates.

New technologies for intensive prevention programs after myocardial infarction: rationale and design of the NET-IPP trial.

INTRODUCTION: Current health care data reveal suboptimal prevention in patients with coronary artery disease and an unmet need to develop effective preventive strategies. The New Technologies for Intensive Prevention Programs (NET-IPP) Trial will investigate if a long-term web-based prevention program after myocardial infarction (MI) will reduce clinical events and risk factors. In a genetic sub study the impact of disclosure of genetic risk using polygenic risk scores (PRS) will be assessed. STUDY DESIGN: Patients hospitalized for MI will be prospectively enrolled and assigned to either a 12-months web-based intensive prevention program or standard care. The web-based program will include telemetric transmission of risk factor data, e-learning and electronic contacts between a prevention assistant and the patients. The combined primary study endpoint will comprise severe adverse cardiovascular events after 2 years. Secondary endpoints will be risk factor control, adherence to medication and quality of life. In a genetic sub study genetic risk will be assessed in all patients of the web-based intensive prevention program group by PRS and patients will be randomly assigned to genetic risk disclosure vs. no disclosure. The study question will be if disclosure of genetic risk has an impact on patient motivation and cardiovascular risk factor control. CONCLUSIONS: The randomized multicenter NET-IPP study will evaluate for the first time the effects of a long-term web-based prevention program after MI on clinical events and risk factor control. In a genetic sub study the impact of disclosure of genetic risk using PRS will be investigated.