Influence of prior myocardial infarction on outcome in patients with ischaemic HFrEF: insights from the EVIdence based TreAtment in Heart Failure (EVITA-HF) registry.

BACKGROUND: There is scarce information about the influence of prior myocardial infarction (pMI) on outcomes in patients (pts) with ischaemic HFrEF. We analysed data from the EVIdence based TreAtment in Heart Failure (EVITA-HF) registry. METHODS: EVITA-HF comprises web-based case report data on demography, diagnostic measures, adverse events and 1-year follow-up of patients hospitalized for chronic heart failure ≥ 3 months (CHF) and an ejection fraction ≤ 40%. In the present study, we focused on the outcomes of pts with and without pMI in ischaemic HFrEF. RESULTS: Between February 2009 and November 2015, a total of 2075 consecutive pts with ischaemic HFrEF were included from 16 centres in Germany. A total of 81.2% were male, and the mean age was 71 years. A total of 61.5% of the pts with ischaemic HFrEF had a history of pMI. These pts were treated less often with PCI (20.0 vs. 31.0%, p < 0.001) or CABG (3.8 vs. 7.7%, p < 0.001). They more often received an ICD (40.9 vs. 28.7%, p < 0.001), but less often a CRT-D (11.3 vs. 19.4%, p < 0.001). After multivariate adjustment, pts with pMI had a greater all-cause mortality after 1 year than those without pMI (hazard ratio 1.4; 95% CI, 1.10-1.79, p = 0.007). The combined endpoint of death, resuscitation or ICD shock after 1 year was greater in patients with pMI (20.8 vs. 16.4%, p = 0.03). Mobility was more often reduced in pts with pMI (46.8% vs. 40.1%, p = 0.03), and overall health status was more frequently worse in patients with pMI than in those 12 months ago (23.1 vs. 15.9%, p = 0.01). More than a quarter of the pts with ischaemic HFrEF were anxious or depressive. CONCLUSION: pMI in patients with CHF and ischaemic HFrEF was associated with increased mortality, increased event rates, and worsened health status. Hence, the subgroup of pts with ischaemic HFrEF and pMI is at higher risk and deserves special attention.

Patient knowledge about risk factors, achievement of target values and guideline adherent secondary prevention therapies 12 months after acute myocardial infarction.

AIMS: The prospective GULLIVE-R study aimed to evaluate adherence to guideline recommended secondary prevention, physicians' and patients' estimation of cardiac risk, and patients' knowledge about target values of risk factors after acute myocardial infarction (AMI). METHODS: We performed a prospective study enrolling patients 9-12 months after AMI. Guideline recommended secondary prevention therapies and physicians as well as patients' estimation about their risk, and patients' knowledge about target values were prospectively collected. RESULTS: Between 07/2019 and 06/2021 a total of 2509 outpatients were enrolled in 150 German centers 10 months after AMI. The mean age was 66 years, 26.4% were women, 45.3% had STEMI, 54.7% had NSTEMI, 93.6% had revascularization (84.0% PCI, 7.4% CABG, 1.8% both). Guideline recommended secondary drug therapies were prescribed in over 80% of patients, while only about 50% received all five recommended drugs (aspirin, P2Y12 inhibitors, statins, beta-blockers, RAAS inhibitors) and regular exercise was performed by only one third. About 90% of patients felt well informed about secondary prevention, but the correct target value for blood pressure was known in only 37.9% and for LDL-C in only 8.2%. Both, physicians and patients underestimated the objective risk for future AMIs as determined by the TIMI risk score for secondary prevention. CONCLUSIONS: There is still room for improvement in patient education and implementation of guideline recommended non-pharmacological and pharmacological secondary prevention therapies in patients in the chronic phase after AMI.

Bullet points: Between 07/2019 and 06/2021 a total of 2509 outpatients were enrolled in 150 German centers 10 months after AMI. Guideline recommended secondary drug therapies were applied in over 80% of patients, while only about 50% received all five recommended drugs (aspirin, P2Y12 inhibitors, statins, beta-blockers, RAAS inhibitors) and regular exercise was performed by only one third. About 90% of patients felt well informed about secondary prevention, but the correct target value for blood pressure was known in only 37.9% and for LDL-C in only 8.2%. ESC recommended target values for systolic blood pressure and LDL-cholesterol were achieved in 38.8% and 36.0%, respectively. There was an underestimation of risk for future AMIs as determined by the TIMI Risk Score for Secondary Prevention (TRS2P) both by physicians and patients.

Why VA-ECMO should not be used routinely in AMI-Cardiogenic Shock.

This review summarizes the current evidence regarding efficacy and safety of venoarterial extracorporeal membrane oxygenation (VA-ECMO) in the setting of cardiogenic shock. Currently, there is evidence from 4 randomized controlled trials which all do not support a mortality benefit and increased complication rates by VA-ECMO. Based on current evidence, possible subgroups will be discussed and indications in selected very small patient groups be discussed.

Use of sacubitril/valsartan in patients with heart failure in primary care in Germany: the AURORA-HF noninterventional study.

BACKGROUND: Sacubitril/valsartan (Sac/Val) is the first angiotensin receptor-neprilysin inhibitor indicated for symptomatic chronic heart failure (HF) with reduced ejection fraction (HFrEF). Given most patients with HF in Germany are managed by general practitioners, AURORA-HF investigated the baseline characteristics and 1­year follow-up of patients starting Sac/Val in primary care in Germany. METHODS: This was a prospective, multicenter, observational study, with all treatment decisions independent of participation. The only inclusion criteria were adults (age ≥ 18 years) with symptomatic HFrEF. The study comprised four groups, depending on therapy on entry: initiation of (1) Sac/Val or (2) other HF therapy; and no change in HF regimen that (3) included or (4) did not include Sac/Val. Baseline data were captured for all groups; 1­year follow-up was recorded in groups 1 and 2. RESULTS: Of 1278 patients in the baseline analyses, 513 (40.1%) had newly started Sac/Val (449 [87.5%] completing the 1­year follow-up), 265 (20.7%) had newly started other HF regimens (245, 92.5%) with 1­year follow-up, while 249 with Sac/Val (19.5%) and 251 without Sac/Val (19.6%) patients had unchanged therapies. Patients treated with Sac/Val had a higher New York Heart Association (NYHA) class at baseline and more often a left ventricular ejection fraction (LVEF) < 35%. The only baseline parameter significantly correlating with Sac/Val discontinuation during the 1­year follow-up was diabetes mellitus (odds ratio: 2.44; 95% confidence interval: 1.14-5.24). In the Sac/Val group, 30.7% of patients were in NYHA class I/II on study entry, improving to 51.0% at 1­year follow-up. In the no Sac/Val group, the corresponding rates of NYHA I and II classes were 49.8% and 58.2%, respectively. The overall adverse event profile of Sac/Val was good, with only 6.0% patients experiencing serious adverse events leading to permanent discontinuation. CONCLUSION: In patients with symptomatic HFrEF treated in primary care, the group in whom Sac/Val was initiated was characterized by a higher NYHA class and lower LVEF compared to patients in whom Sac/Val was not initiated. Sac/Val was well tolerated, with a high proportion completing 1 year of therapy.

Scrutinizing the Role of Venoarterial Extracorporeal Membrane Oxygenation: Has Clinical Practice Outpaced the Evidence?

The use of venoarterial extracorporeal membrane oxygenation (VA-ECMO) for temporary mechanical circulatory support in various clinical scenarios has been increasing consistently, despite the lack of sufficient evidence regarding its benefit and safety from adequately powered randomized controlled trials. Although the ARREST trial (Advanced Reperfusion Strategies for Patients with Out-of-Hospital Cardiac Arrest and Refractory Ventricular Fibrillation) and a secondary analysis of the PRAGUE OHCA trial (Prague Out-of-Hospital Cardiac Arrest) provided some evidence in favor of VA-ECMO in the setting of out-of-hospital cardiac arrest, the INCEPTION trial (Early Initiation of Extracorporeal Life Support in Refractory Out-of-Hospital Cardiac Arrest) has not found a relevant improvement of short-term mortality with extracorporeal cardiopulmonary resuscitation. In addition, the results of the recently published ECLS-SHOCK trial (Extracorporeal Life Support in Cardiogenic Shock) and ECMO-CS trial (Extracorporeal Membrane Oxygenation in the Therapy of Cardiogenic Shock) discourage the routine use of VA-ECMO in patients with infarct-related cardiogenic shock. Ongoing clinical trials (ANCHOR [Assessment of ECMO in Acute Myocardial Infarction Cardiogenic Shock, NCT04184635], REVERSE [Impella CP With VA ECMO for Cardiogenic Shock, NCT03431467], UNLOAD ECMO [Left Ventricular Unloading to Improve Outcome in Cardiogenic Shock Patients on VA-ECMO, NCT05577195], PIONEER [Hemodynamic Support With ECMO and IABP in Elective Complex High-risk PCI, NCT04045873]) may clarify the usefulness of VA-ECMO in specific patient subpopulations and the efficacy of combined mechanical circulatory support strategies. Pending further data to refine patient selection and management recommendations for VA-ECMO, it remains uncertain whether the present usage of this device improves outcomes.

A contemporary training concept in critical care cardiology.

Critical care cardiology (CCC) in the modern era is shaped by a multitude of innovative treatment options and an increasingly complex, ageing patient population. Generating high-quality evidence for novel interventions and devices in an intensive care setting is exceptionally challenging. As a result, formulating the best possible therapeutic approach continues to rely predominantly on expert opinion and local standard operating procedures. Fostering the full potential of CCC and the maturation of the next generation of decision-makers in this field calls for an updated training concept, that encompasses the extensive knowledge and skills required to care for critically ill cardiac patients while remaining adaptable to the trainee's individual career planning and existing educational programs. In the present manuscript, we suggest a standardized training phase in preparation of the first ICU rotation, propose a modular CCC core curriculum, and outline how training components could be conceptualized within three sub-specialization tracks for aspiring cardiac intensivists.

Current spectrum and outcomes of infarct-related cardiogenic shock: insights from the CULPRIT-SHOCK registry and randomized controlled trial.

AIMS: We analysed consecutive patients with acute myocardial infarction complicated by cardiogenic shock (CS) who were enrolled into the CULPRIT-SHOCK randomized controlled trial (RCT) and those with exclusion criteria who were included into the accompanying registry. METHODS AND RESULTS: In total, 1075 patients with infarct-related CS were screened for CULPRIT-SHOCK in 83 specialized centres in Europe; 369 of them had exclusion criteria for the RCT and were enrolled into the registry. Patients were followed over 1 year. The mean age was 68 years and 260 (25%) were women. 13.5%, 30.9%, and 55.6% had one-vessel, two-vessel, and three-vessel coronary artery disease (CAD), respectively. Significant left main (LM) coronary artery stenosis was present in 8.0%. 54.2% of the patients had cardiac arrest before admission. Thrombolysis in myocardial infarction (TIMI) 3 patency of the infarct vessel after percutaneous coronary intervention was achieved in 83.6% of all patients. Mechanical circulatory support was applied in one-third of patients. Total mortality after 30 days and 1 year was 47.6% and 52.9%. Mortality after 1 year was highest in patients with LM coronary artery stenosis (63.5%), followed by three-vessel (56.6%), two-vessel (49.8%), and one-vessel CAD (38.6%), respectively. Mechanical complications were rare (21/1008; 2.1%) but associated with a high mortality of 66.7% after 1 year. CONCLUSION: In specialized centres in Europe, short- and long-term mortality of patients with infarct-related CS treated with an invasive strategy is still high and mainly depends on the extent of CAD. Therefore, there is still a need for improvement of care to improve the prognosis of infarct-related CS.

LAA occlusion is effective and safe in very high-risk atrial fibrillation patients with prior stroke: results from the multicentre German LAARGE registry.

BACKGROUND: Interventional left atrial appendage occlusion (LAAO) mitigates the risk of thromboembolic events in nonvalvular atrial fibrillation (AF) patients with contraindication for long-term oral anticoagulation (OAC). Patients with prior stroke have a relevantly increased risk of recurrent stroke, so the effectiveness of LAAO could be reduced in this specific very high-risk patient group. AIM: This sub-study of the LAARGE registry investigates the effectiveness and safety of LAAO for secondary prevention in nonvalvular AF patients with a history of stroke. METHODS: LAARGE is a prospective, non-randomised registry on the clinical reality of LAAO. The current sub-study employs data from index procedure and 1-year follow-up. Effectiveness and safety were assessed by documentation of all-cause mortality, non-fatal thromboembolism, procedure-related complications, and bleeding events. RESULTS: A total of 638 patients were consecutively included from 38 hospitals in Germany and divided into two groups: 137 patients with a history of stroke (21.5%) and 501 patients without. Successful implantation was consistent between both groups (98.5% vs. 97.4%, p = NS), while peri-procedural MACCE and other complications were rare (0% vs. 0.6% and 4.4% vs. 4.0%, respectively; each p = NS). Kaplan-Meier estimate showed no significant difference in primary effectiveness outcome measure (freedom from all-cause death or non-fatal stroke) between both groups at follow-up (87.8% vs. 87.7%, p = NS). The incidence of transient ischemic attack or systemic embolism at follow-up was low (0% vs. 0.5% and 0.9% vs. 0%, respectively; each p = NS). Severe bleeding events after hospital discharge were rare (0% vs. 0.7%, p = NS). CONCLUSIONS: Patients with prior stroke demonstrated similar effectiveness and safety profile for LAAO as compared to patients without prior stroke. LAAO could serve as a feasible alternative to OAC for secondary stroke prevention in this selected group of nonvalvular AF patients. GOV IDENTIFIER: NCT02230748.

GLP-1 in patients with myocardial infarction complicated by cardiogenic shock-an IABP-SHOCK II-substudy.

BACKGROUND: Glucagon-like peptide-1 (GLP-1) is a gut-derived peptide secreted in response to nutritional and inflammatory stimuli. Elevated GLP-1 levels predict adverse outcome in patients with acute myocardial infarction or sepsis. GLP-1 holds cardioprotective effects and GLP-1 receptor agonists reduce cardiovascular events in high-risk patients with diabetes. In this study, we aimed to investigate the capacity of GLP-1 to predict outcome in patients with cardiogenic shock (CS) complicating myocardial infarction. METHODS: Circulating GLP-1 levels were serially assessed in 172 individuals during index PCI and day 2 in a prospectively planned biomarker substudy of the IABP-SHOCK II trial. All-cause mortality at short- (30 days), intermediate- (1 year), and long-term (6 years) follow-up was used for outcome assessment. RESULTS: Patients with fatal short-term outcome (n = 70) exhibited higher GLP-1 levels [86 (interquartile range 45-130) pM] at ICU admission in comparison to patients with 30-day survival [48 (interquartile range 33-78) pM; p < 0.001] (n = 102). Repeated measures ANOVA revealed a significant interaction of GLP-1 dynamics from baseline to day 2 between survivors and non-survivors (p = 0.04). GLP-1 levels above vs. below the median proved to be predictive for short- [hazard ratio (HR) 2.43; 95% confidence interval (CI) 1.50-3.94; p < 0.001], intermediate- [HR 2.46; 95% CI 1.62-3.76; p < 0.001] and long-term [HR 2.12; 95% CI 1.44-3.11; p < 0.001] outcome by multivariate Cox-regression analysis. CONCLUSION: Elevated plasma levels of GLP-1 are an independent predictor for impaired prognosis in patients with myocardial infarction complicated by CS. The functional relevance of GLP-1 in this context is currently unknown and needs further investigations. TRIAL REGISTRATION: www. CLINICALTRIALS: gov Identifier: NCT00491036.

Identifying the highest risk vascular patients: Insights from the XATOA registry.

BACKGROUND: Patients with coronary and peripheral artery disease (PAD) have a residual risk of major adverse cardiovascular and limb events despite standards of care. Among patients with coronary artery disease (CAD) and/or PAD selected for low dose rivaroxaban (2.5 mg BID) and aspirin, we sought to determine the highest risk vascular patients. METHODS: Xarelto pluc Acetylsalicylic acid: Treatment patterns and Outcomes in patients with Atherosclerosis (XATOA) is a single-arm registry of CAD and/or PAD patients. All participants were initiated on low dose rivaroxaban (2.5 mg BID) and aspirin. We report the incidence risk of major adverse cardiovascular events (MACE) or major adverse limb events (MALE) and major bleeding. A classification and regression tree analysis determined independent subgroups. RESULTS: Between November 2018 and May 2020, 5,808 participants were enrolled in XATOA; 5,532 were included in the full analysis. The median follow-up (interquartile range) was 462 (371-577) days. The incidence risk per 100 patient-years of MACE or MALE was highest among participants with polyvascular disease (2 or more vascular beds affected, n = 2,889). The incidence risk was 9.16 versus 2.48 per 100 patient-years in polyvascular and nonpolyvascular patients respectively. Other subgroups of high-risk patients included participants 75 years or older, with a history of diabetes, heart failure, or chronic renal insufficiency (CRI). Rates of major bleeding were low overall. A classification and regression tree analysis showed that polyvascular disease was the most dominant factor separating higher from lower risk participants, and this was heightened with CRI or diabetes. CONCLUSION: Patients with polyvascular disease represent a substantial subset of patients in clinical practice and should be prioritized to receive maximal medical therapy including low dose rivaroxaban (2.5 mg BID) and aspirin.

Impact of anaemia and iron deficiency on outcomes in cardiogenic shock complicating acute myocardial infarction.

AIMS: Anaemia and iron deficiency (ID) are common comorbidities in cardiovascular patients and are associated with a poor clinical status, as well as a worse outcome in patients with heart failure and acute myocardial infarction (AMI). Nevertheless, data concerning the impact of anaemia and ID on clinical outcomes in patients with cardiogenic shock (CS) are scarce. This study aimed to assess the impact of anaemia and ID on clinical outcomes in patients with CS complicating AMI. METHODS AND RESULTS: The presence of anaemia (haemoglobin <13 g/dl in men and <12 g/dl in women) or ID (ferritin <100 ng/ml or transferrin saturation <20%) was determined in patients with CS due to AMI from the CULPRIT-SHOCK trial. Blood samples were collected in the catheterization laboratory during initial percutaneous coronary intervention. Clinical outcomes were compared in four groups of patients having neither anaemia nor ID, against patients with anaemia with or without ID and patients with ID only. A total of 427 CS patients were included in this analysis. Anaemia without ID was diagnosed in 93 (21.7%), anaemia with ID in 54 study participants (12.6%), ID without anaemia in 72 patients (16.8%), whereas in 208 patients neither anaemia nor ID was present (48.9%). CS patients with anaemia without ID were older (73 ± 10 years, p = 0.001), had more frequently a history of arterial hypertension (72.8%, p = 0.01), diabetes mellitus (47.8%, p = 0.001), as well as chronic kidney disease (14.1%, p = 0.004) compared to CS patients in other groups. Anaemic CS patients without ID presence were at higher risk to develop a composite from all-cause death or renal replacement therapy at 30-day follow-up (odds ratio [OR] 3.83, 95% confidence interval [CI] 2.23-6.62, p < 0.001) than CS patients without anaemia/ID. The presence of ID in CS patients, with and without concomitant anaemia, did not increase the risk for the primary outcome (OR 1.17, 95% CI 0.64-2.13, p = 0.64; and OR 1.01, 95% CI 0.59-1.73, p = 0.54; respectively) within 30 days of follow-up. In time-to-event Kaplan-Meier analysis, anaemic CS patients without ID had a significantly higher hazard ratio (HR) for the primary outcome (HR 2.11, 95% CI 1.52-2.89, p < 0.001), as well as for death from any cause (HR 1.90, 95% CI 1.36-2.65, p < 0.001) and renal replacement therapy during 30-day follow-up (HR 2.99, 95% CI 1.69-5.31, p < 0.001). CONCLUSION: Concomitant anaemia without ID presence in patients with CS at hospital presentation is associated with higher risk for death from any cause or renal replacement therapy and the individual components of this composite endpoint within 30 days after hospitalization. ID has no relevant impact on clinical outcomes in patients with CS.

Is spontaneous echo contrast associated with device-related thrombus or embolic events after left atrial appendage occlusion? - Insights from the multicenter German LAARGE registry.

BACKGROUND: Interventional left atrial appendage occlusion (LAAO) provides an alternative to oral anticoagulation (OAC) for prophylaxis of thromboembolic events (TEs) in nonvalvular atrial fibrillation patients, predominantly in those with high bleeding risk and contraindications for long-term OAC. Although spontaneous echo contrast (SEC) is a well-known risk factor for atrial thrombus formation, little is known about whether this means an increased risk of device-related thrombus (DRT) or TEs following LAAO. METHODS: This substudy of the prospective, multicenter German LAARGE registry assessed two groups according to absence (SEC -) or presence of SEC (SEC +) in preprocedural cardiac imaging. Clinical and echocardiographic parameters were registered up to 1 year after LAAO. RESULTS: Five hundred eighty-eight patients (SEC - 85.5 vs. SEC + 14.5%) were included. More SEC + patients were implanted for OAC non-compliance (11.8 vs. 4.6%, p = 0.008) and a higher proportion received only antiplatelet therapy without OAC at hospital discharge (96.5 vs. 86.0%, p = 0.007). The SEC + patients had larger LA diameters (50 (47; 54) vs. 47 (43; 51) mm, p < 0.001), wider LAA ostia (21 (19; 23) vs. 20 (17; 22) mm at 45°, p = 0.011), and lower left ventricular ejection fraction (50 (45; 60) vs. 60 (50; 60) %, p < 0.001) on admission. Procedural success was very high in both groups (98.1%, p = 1.00). Periprocedural major adverse cardiac and cerebrovascular events and other major complications were rare in both groups (3.8 vs. 4.7%, p = 0.76). At follow-up, DRT was only detected in the SEC - group (3.8 vs. 0%, p = 1.00). The rates of TEs (SEC - 1.2 vs. SEC + 0%, p = 1.00) after hospital discharge and 1-year mortality (SEC - 12.0 vs. SEC + 11.8%, p = 0.96) were not significantly different between the two groups. CONCLUSIONS: Presence of SEC at baseline was not associated with an increased rate of DRT or TEs at 1-year follow-up after LAAO in LAARGE.

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.

Standardized Definitions for Cardiogenic Shock Research and Mechanical Circulatory Support Devices: Scientific Expert Panel From the Shock Academic Research Consortium (SHARC).

The Shock Academic Research Consortium is a multi-stakeholder group, including representatives from the US Food and Drug Administration and other government agencies, industry, and payers, convened to develop pragmatic consensus definitions useful for the evaluation of clinical trials enrolling patients with cardiogenic shock, including trials evaluating mechanical circulatory support devices. Several in-person and virtual meetings were convened between 2020 and 2022 to discuss the need for developing the standardized definitions required for evaluation of mechanical circulatory support devices in clinical trials for cardiogenic shock patients. The expert panel identified key concepts and topics by performing literature reviews, including previous clinical trials, while recognizing current challenges and the need to advance evidence-based practice and statistical analysis to support future clinical trials. For each category, a lead (primary) author was assigned to perform a literature search and draft a proposed definition, which was presented to the subgroup. These definitions were further modified after feedback from the expert panel meetings until a consensus was reached. This manuscript summarizes the expert panel recommendations focused on outcome definitions, including efficacy and safety.

[Prehospital resuscitation : Current status, results and strategies for improvement in Germany]. / Prähospitale Reanimationen : Aktueller Stand, Ergebnisse und Verbesserungsansätze in Deutschland.

Out-of-hospital cardiac arrest (OHCA) is one of the most frequent causes of death in Europe and is associated with a dismal prognosis. The annual incidence in Germany is approximately 100-120 per 100,000 inhabitants (ca. 80,000-100,000 cases). With the use of cardiopulmonary resuscitation (CPR) about 40% of patients have a return of spontaneous circulation (ROSC); however, after OHCA only 15% of patients survive for 30 days and less than 10% survive with no or only minor neurological deficits. Data from the German Resuscitation Register demonstrate that there was no change in the results over the last 15 years, despite all medical innovations, higher rates of coronary interventions, higher use of mechanical support systems and improvement in intensive care treatment. A high proportion of patients with OHCA have a cardiac or coronary cause. As shown by the data from the German Cardiac Arrest Register (G-CAR) an early coronary angiography is often carried out after CPR in Germany; however, in randomized clinical studies an immediate coronary angiography in patients with non-ST segment elevation in the electrocardiogram (ECG) was not associated with an improvement in the prognosis. In large randomized studies the use of mechanical CPR systems and the implantation of mechanical circulatory support devices after OHCA also did not lead to a reduction in mortality. The most important impact factor for the success of CPR is the time interval between collapse and start of CPR, if possible also by bystander resuscitation. Therefore, the focus of efforts for improving CPR should be on increasing the rate of patients with early CPR. Experiences from Denmark and The Netherlands indicate that this can be successful by education and training of the general population, telephone resuscitation and apps for alerting lay persons.

Breathing pattern and pulmonary gas exchange in elderly patients with and without left ventricular dysfunction-modification with exercise-based cardiac rehabilitation and prognostic value.

Background: Inefficient ventilation is an established prognostic marker in patients with heart failure. It is not known whether inefficient ventilation is also linked to poor prognosis in patients with left ventricular dysfunction (LVD) but without overt heart failure. Objectives: To investigate whether inefficient ventilation in elderly patients with LVD is more common than in patients without LVD, whether it improves with exercise-based cardiac rehabilitation (exCR), and whether it is associated with major adverse cardiovascular events (MACE). Methods: In this large multicentre observational longitudinal study, patients aged ≥65 years with acute or chronic coronary syndromes (ACS, CCS) without cardiac surgery who participated in a study on the effectiveness of exCR in seven European countries were included. Cardiopulmonary exercise testing (CPET) was performed before, at the termination of exCR, and at 12 months follow-up. Ventilation (VE), breathing frequency (BF), tidal volume (VT), and end-expiratory carbon dioxide pressure (PETCO2) were measured at rest, at the first ventilatory threshold, and at peak exercise. Ventilatory parameters were compared between patients with and without LVD (based on cardio-echography) and related to MACE at 12 month follow-up. Results: In 818 patients, age was 72.5 ± 5.4 years, 21.9% were women, 79.8% had ACS, and 151 (18%) had LVD. Compared to noLVD, in LVD resting VE was increased by 8%, resting BF by 6%, peak VE, peak VT, and peak PETCO2 reduced by 6%, 8%, and 5%, respectively, and VE/VCO2 slope increased by 11%. From before to after exCR, resting VE decreased and peak PETCO2 increased significantly more in patients with compared to without LVD. In LVD, higher resting BF, higher nadir VE/VCO2, and lower peak PETCO2 at baseline were associated with MACE. Conclusions: Similarly to patients with HF, in elderly patients with ischemic LVD, inefficient resting and exercise ventilation was associated with worse outcomes, and ExCR alleviated abnormal breathing patterns and gas exchange parameters.

OECD indicator 'AMI 30-day mortality' is neither comparable between countries nor suitable as indicator for quality of acute care.

BACKGROUND: Hospital mortality after acute myocardial infarction (AMI, ICD-10: I21-I22) is used as OECD indicator of the quality of acute care. The reported AMI hospital mortality in Germany is more than twice as high as in the Netherlands or Scandinavia. Yet, in Europe, Germany ranks high in health spending and availability of cardiac procedures. We provide insights into this contradictory situation. METHODS: Information was collected on possible factors causing the reported differences in AMI mortality such as prevalence of risk factors or comorbidities, guideline conform treatment, patient registration, and health system structures of European countries. International experts were interviewed. Data on OECD indicators 'AMI 30-day mortality using unlinked data' and 'average length of stay after AMI' were used to describe the association between these variables graphically and by linear regression. RESULTS: Differences in prevalence of risk factors or comorbidities or in guideline conform acute care account only to a smaller extent for the reported differences in AMI hospital mortality. It is influenced mainly by patient registration rules and organization of health care. Non-reporting of day cases as patients and centralization of AMI care-with more frequent inter-hospital patient transfers-artificially lead to lower calculated hospital mortality. Frequency of patient transfers and national reimbursement policies affect the average length of stay in hospital which is strongly associated with AMI hospital mortality (adj R2 = 0.56). AMI mortality reported from registries is distorted by different underlying populations. CONCLUSION: Most of the variation in AMI hospital mortality is explained by differences in patient registration and organization of care instead of differences in quality of care, which hinders cross-country comparisons of AMI mortality. Europe-wide sentinel regions with comparable registries are necessary to compare (acute) care after myocardial infarction.