Glycoprotein IIb/IIIa Inhibitors in Acute Myocardial Infarction and Angiographic Microvascular Obstruction: The REVERSE-FLOW Trial.

BACKGROUND AND AIMS: Glycoprotein (GP) IIb/IIIa inhibitors are recommended in acute myocardial infarction (AMI) for bailout treatment in case of angiographic microvascular obstruction (MVO), also termed no-reflow phenomenon, after percutaneous coronary intervention (PCI) with, however, lacking evidence (class IIa, level C). METHODS: The investigator-initiated, international, multicenter REVERSE-FLOW trial randomized 120 patients with AMI and Thrombolysis In Myocardial Infarction flow grade ≤2 after primary PCI to optimal medical therapy with or without GP IIb/IIIa inhibitor. The primary endpoint was infarct size (%LV) assessed by cardiac magnetic resonance (CMR). Secondary endpoints included CMR-derived MVO and 30-day adverse clinical events. The trial is registered with ClinicalTrials.gov: NCT02739711. RESULTS: The population was predominantly male (76.7%) with a median age of 66 years and ST-elevation myocardial infarction in 73.3% of patients. Clinical and angiographic characteristics were well balanced between the cohorts. Patients in the treatment group (n=62) received eptifibatide (n=41) or tirofiban (n=21). Infarct size assessed by CMR imaging was similar in both study groups (25.4% of left ventricular mass [LV] vs. 25.2%LV; p=0.386). However, the number of patients with evidence of CMR-derived MVO (74.5% vs. 92.2%; p=0.017) and the extent of MVO (2.1%LV vs. 3.4%LV; p=0.025) were significantly reduced in the GP IIb/IIIa inhibitor group compared to controls. Thirty-day outcome showed an increased bleeding risk after GP IIb/IIIa inhibitor administration restricted to non-life-threatening bleedings (22.6% vs. 6.9%; p=0.016) without differences in all-cause mortality (4.8% vs. 3.4%; p=0.703). CONCLUSIONS: Bailout GP IIb/IIIa inhibition in AMI patients with angiographic MVO failed to reduce the primary endpoint infarct size but decreased CMR-derived MVO and led to an increase in non-fatal bleeding events.

[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.

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.

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.

Prognostic Impact of the Pulmonary Artery Pulsatility Index in Patients with Chronic Heart Failure and Severe Mitral Regurgitation Undergoing Percutaneous Edge-to-Edge Repair.

BACKGROUND: Pulmonary artery (PA) pulsatility index (PAPi), calculated as (PA systolic pressure - PA diastolic pressure)/right atrial pressure, emerged as a novel predictor of right ventricular failure in patients with acute inferior myocardial infarction, advanced heart failure, and severe pulmonary hypertension. However, the prognostic utility of PAPi in transcatheter mitral valve repair (TMVR) using the MitraClip® system has never been tested. OBJECTIVE: To assess the prognostic impact of PAPi in patients with severe functional mitral regurgitation (MR) and chronic heart failure (CHF) undergoing TMVR. METHODS: Consecutive patients with severe functional MR (grade 3+ or 4+) and CHF who underwent successful TMVR (MR ≤2+ at discharge) were enrolled and divided into 3 groups according to PAPi (A: low PAPi ≤2.2; B: intermediate PAPi 2.21-3.99; C: high PAPi ≥4.0). The primary endpoint was a composite of all-cause mortality and rehospitalization due to CHF during a mean follow-up period of 16 ± 4 months. The impact of PAPi on prognosis was assessed by a receiver-operating characteristic (ROC) analysis and a multivariable Cox proportional hazard regression analysis investigating independent predictors for outcome. RESULTS: 78 patients (A: n = 27, B: n = 28, C: n = 23) at high operative risk (logistic EuroSCORE [European System for Cardiac Operative Risk Evaluation] 18.8 vs. 21.5 vs. 20.6%; nonsignificant) were enrolled. Mean PAPi was 1.6 ± 0.41 vs. 2.9 ± 0.53 vs. 6.8 ± 3.5; p < 0.001). Patients with low PAPi showed significantly higher rates of early rehospitalization for heart failure at the 30-day follow-up (14.9 vs. 7.1 vs. 4.3%; p = 0.04). In the long term, a significantly lower event-free survival for the combined primary endpoint was observed in the low PAPi group (44.4 vs. 25.0 vs. 20.3%; log-rank p = 0.016). ROC curve analysis revealed that optimal sensitivity and specificity were achieved using a PAPi cutoff of 2.46 (sensitivity 83%, specificity 78.3%, area under the curve 0.82 [0.64-0.99]; p = 0.01). In Cox regression analysis, PAPi ≤2.46 was an independent predictor for the combined primary endpoint (hazard ratio 2.85; 95% confidence interval 1.15-7.04; p = 0.023). CONCLUSIONS: PAPi is strongly associated with clinical outcome among patients with CHF and functional MR undergoing TMVR. A PAPi value ≤2.46 predicts a worse prognosis independent of other important clinical, echocardiographic, and hemodynamic factors. Therefore, PAPi may serve as a new parameter to improve patient selection for TMVR.

Comparison of newer generation self-expandable vs. balloon-expandable valves in transcatheter aortic valve implantation: the randomized SOLVE-TAVI trial.

AIMS: Transcatheter aortic valve implantation (TAVI) has emerged as established treatment option in patients with symptomatic aortic stenosis. Technical developments in valve design have addressed previous limitations such as suboptimal deployment, conduction disturbances, and paravalvular leakage. However, there are only limited data available for the comparison of newer generation self-expandable valve (SEV) and balloon-expandable valve (BEV). METHODS AND RESULTS: SOLVE-TAVI is a multicentre, open-label, 2 × 2 factorial, randomized trial of 447 patients with aortic stenosis undergoing transfemoral TAVI comparing SEV (Evolut R, Medtronic Inc., Minneapolis, MN, USA) with BEV (Sapien 3, Edwards Lifesciences, Irvine, CA, USA). The primary efficacy composite endpoint of all-cause mortality, stroke, moderate/severe prosthetic valve regurgitation, and permanent pacemaker implantation at 30 days was powered for equivalence (equivalence margin 10% with significance level 0.05). The primary composite endpoint occurred in 28.4% of SEV patients and 26.1% of BEV patients meeting the prespecified criteria of equivalence [rate difference -2.39 (90% confidence interval, CI -9.45 to 4.66); Pequivalence = 0.04]. Event rates for the individual components were as follows: all-cause mortality 3.2% vs. 2.3% [rate difference -0.93 (90% CI -4.78 to 2.92); Pequivalence < 0.001], stroke 0.5% vs. 4.7% [rate difference 4.20 (90% CI 0.12 to 8.27); Pequivalence = 0.003], moderate/severe paravalvular leak 3.4% vs. 1.5% [rate difference -1.89 (90% CI -5.86 to 2.08); Pequivalence = 0.0001], and permanent pacemaker implantation 23.0% vs. 19.2% [rate difference -3.85 (90% CI -10.41 to 2.72) in SEV vs. BEV patients; Pequivalence = 0.06]. CONCLUSION: In patients with aortic stenosis undergoing transfemoral TAVI, newer generation SEV and BEV are equivalent for the primary valve-related efficacy endpoint. These findings support the safe application of these newer generation percutaneous valves in the majority of patients with some specific preferences based on individual valve anatomy.

Impact of right heart function on outcome in patients with functional mitral regurgitation and chronic heart failure undergoing percutaneous edge-to-edge-repair.

AIMS: To evaluate the impact of right ventricular dysfunction (RVD) on outcome after transcatheter mitral valve repair (TMVR) in patients with chronic heart failure (CHF) and severe functional mitral regurgitation (FMR). METHODS AND RESULTS: One hundred thirty patients (median age 72.7 ± 10.7 years; 63.8% male) at high operative risk (LogEuroSCORE 23.8 ± 13.9%) with FMR and CHF (left ventricular ejection fraction 32 ± 7%) were enrolled and separated into two groups according to the RVD. RVD was assessed by the tricuspid annular plane systolic excursion (TAPSE) method (A: TAPSE ≤ 16 mm, n = 58; B: TAPSE > 16 mm, n = 72). The rate of successful reduction of mitral regurgitation (MR ≤2+) by TMVR was similar in both groups (94.6% vs 91.2%; P: n.s.) with low in-hospital major adverse event rates. During a median follow-up period of 10.5 ± 4 months, the Kaplan-Meier analysis revealed a significantly higher all-cause mortality in group A (43.1% vs 23.6%; log-rank P = 0.039) and a significantly higher rate of hospital readmission due to congestive heart failure (56.9% vs 26.4%; log-rank P < 0.001). At long-term follow-up, 25% of patients in group A remained in NYHA functional class IV (none in group B). Preexisting RVD as assessed by TAPSE and Doppler tissue imaging (DTI-S') was an independent predictor of all-cause mortality after TMVR (hazard ratio 2.84; 95% confidence interval 1.15-7.65; P = 0.039; hazard ratio 4.70; 95% confidence interval 1.14-20.21; P = 0.044, respectively). CONCLUSIONS: Patients with CHF and RVD were with regard to functional capacity less often responder and showed an unfavorable long-term outcome. Thus, patients with CHF and RVD seem to benefit less frequently from TMVR.

Bivalirudin versus heparin and provisional GP IIb/IIIa inhibitors in patients treated for ST-segment elevation myocardial infarctions: Comparison of outcomes in a "real-world" setting.

INTRODUCTION: The beneficial effects of bivalirudin during primary PCIs are controversially discussed, data on unselected patients are rare. It was the aim of the study to compare bivalirudin versus heparin and provisional glycoprotein IIb/IIIa inhibitors (GPIs) in a "real-world" study. METHODS: From 05/2013 until 11/2014, the STEMI-patients in the Bremen STEMI registry were treated with periinterventional bivalirudin; before and after this period the standard anticoagulative treatment was heparin and provisional GPIs. RESULTS: In 714 patients bivalirudin was used for PCI, this cohort was compared to 683 patients with heparin and provisional GPIs. In patients with bivalirudin a significantly lower rate of hospital bleedings was observed compared to patients with heparin (4.6% vs 8.1%, P < 0.01, multivariate HR 0.57, 95%CI 0.35-0.93), in an exclusive analysis of severe bleedings a trend toward less bleedings was found in patients with bivalirudin (2.0% vs 3.5%, P = 0.07, multivariate HR 0.66, 95%CI 0.30-1.42). The rate of stent thromboses reinfarctions and mortality was not different between the bivalirudin and the heparin group. During 1-year follow-up bivalirudin was associated with a lower rate of bleedings and no significant differences in stent thromboses, reinfarctions, and mortality. Bivalirudin was not associated with an excess of bleedings or stent thromboses in subgroups that are regularly underrepresented in randomized trials (older patients, women, cardiogenic shock). CONCLUSIONS: In this "real-world" cohort of patients with STEMI bivalirudin compared to heparin and GPIs was associated with less bleedings and no significant differences in stent thromboses, reinfarctions, and mortality during hospital and long-term course.

German Cardiac Arrest Registry (G-CAR)-results of the pilot phase.

BACKGROUND: In Europe, more than 300,000 persons per year experience out-of-hospital cardiac arrest (OHCA). Despite medical progress, only few patients survive with good neurological outcome. For many issues, evidence from randomized trials is scarce. OHCA often occurs for cardiac causes. Therefore, we established the national, prospective, multicentre German Cardiac Arrest Registry (G-CAR). Herein, we describe the first results of the pilot phase. RESULTS: Over a period of 16 months, 15 centres included 559 consecutive OHCA patients aged ≥ 18 years. The median age of the patients was 66 years (interquartile range 57;75). Layperson resuscitation was performed in 60.5% of all OHCA cases which were not observed by emergency medical services. The initial rhythm was shockable in 46.4%, and 29.1% of patients had ongoing CPR on hospital admission. Main presumed causes of OHCA were acute coronary syndromes (ACS) and/or cardiogenic shock in 54.8%, with ST-elevation myocardial infarction being the most common aetiology (34.6%). In total, 62.9% of the patients underwent coronary angiography; percutaneous coronary intervention (PCI) was performed in 61.4%. Targeted temperature management was performed in 44.5%. Overall in-hospital mortality was 70.5%, with anoxic brain damage being the main presumed cause of death (38.8%). Extracorporeal cardiopulmonary resuscitation (eCPR) was performed in 11.0%. In these patients, the in-hospital mortality rate was 85.2%. CONCLUSIONS: G-CAR is a multicentre German registry for adult OHCA patients with a focus on cardiac and interventional treatment aspects. The results of the 16-month pilot phase are shown herein. In parallel with further analyses, scaling up of G-CAR to a national level is envisaged. Trial registration ClinicalTrials.gov identifier: NCT05142124.

Long-term risk factor management and adverse events in patients with early-onset myocardial infarction-a "real-world" study.

BACKGROUND: International guidelines emphasize the importance of preventive efforts after early-onset myocardial infarction (EOMI); however, data on "real-world" long-term risk factor management and adverse event rates in this special patient group is scarce. METHODS: In this German registry study, 301 patients with MI aged ≤ 45 years were investigated. Risk factor control was assessed at the time of index MI and after 1 year. Major adverse cardiac and cerebrovascular events (MACCE) and its predictors were analyzed during long-term follow-up (median duration 49 months). RESULTS: A majority of patients with EOMI presented with insufficient risk factor control, even during 1-year follow-up. After 1-year 42% of patients were persistent smokers; 74% were physically inactive. The rate of obesity increased significantly from index MI (41%) to 1-year follow-up (46%, p = 0.03) as well as the rate of dysglycemia (index MI: 40%; 1-year follow-up: 51%, p < 0.01) and diabetes mellitus (index MI: 20%; 1-year follow-up: 24%, p < 0.01). 66% of the patients with diabetes mellitus had unsatisfactory HbA1c after 1 year; 69% of the patients did not attain guideline-recommended lipid targets. The rate of MACCE during long-term follow-up was 20% (incidence rate 0.05 per person-year). In a multivariable analysis smoking (HR 2.2, HR 1.3-3.7, p < 0.01) and physical inactivity (HR 2.8, HR 1.2-6.7, p = 0.02) were significant predictors for the occurrence of MACCE. CONCLUSION: Insufficient long-term risk factor control was common in patients with EOMI and was associated with an elevated rate of MACCE. The study reveals that better strategies for prevention in young patients are crucially needed.

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.

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.

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.

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).

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.

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).

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.

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.