The selection of the optimal antithrombotic regimen in patients with atrial fibrillation and acute coronary syndrome remains challenging. Previous trials have demonstrated that dual antithrombotic therapy (DAT), consisting of direct oral anticoagulants (DOACs) plus a P2Y12 inhibitor, reduces bleeding compared to a triple-therapy regimen using vitamin K antagonists. However, subsequent meta-analyses have suggested an increased risk of ischemic events with DAT, particularly within the first month of treatment. Clopidogrel has been the predominant P2Y12 inhibitor used across these studies, despite the risk of high on-treatment platelet reactivity when using this drug. In this study, we conducted an open-label, randomized controlled trial (EPIDAURUS) in patients with atrial fibrillation and acute coronary syndrome, designed to assess the efficacy and safety of a 1-month regimen of DOAC plus potent P2Y12 inhibitor (prasugrel or ticagrelor) compared to DOAC plus clopidogrel and in-hospital aspirin. The primary outcomes of the trial were an efficacy endpoint, recurrent ischemic events and safety endpoints, including death and major bleeding, which were evaluated 6 weeks after randomization using separate win-loss ratio analyses. The study was prematurely terminated after enrollment of 602 patients (154 female) of an expected 1,474 patients, owing to safety concerns raised by the Data and Safety Monitoring Board. Exploratory analyses of secondary safety endpoints, including bleeding type ≥2 and ≥3 according to the Bleeding Academic Research Consortium scale, revealed that, compared to clopidogrel and in-hospital aspirin, treatment with a potent P2Y12 inhibitor was associated with higher bleeding rates without a clear reduction in the risk of ischemic complications. These findings do not support the routine use of potent P2Y12 inhibitors in combination with DOACs in this patient population. ClinicalTrials.gov identifier: NCT04981041 .
AIMS:Cardiogenic shock (CS) is often treated with catecholamines titrated to an adequate target mean arterial pressure (MAP) while minimizing adverse effects. We aim to assess the optimal catecholamine dose/MAP balance in heart failure-associated CS (HF-CS). METHODS:Patients with HF-CS were retrospectively enrolled from 16 tertiary centres in 5 European countries (2016-2021; NCT03313687). Dosage was quantified by inotropic scores (epinephrine, norepinephrine, and dobutamine). Associations of baseline and seven-day summarized dosage with intensive care unit (ICU) discharge (mixed-effects logistic regression) and 30-day mortality (Cox regression) were analysed. Potential catecholamine/MAP target ratios for optimized outcomes were assessed in models adjusted for age, sex, pH, lactate and prior resuscitation, stratified by centre. RESULTS:N = 704 patients: median age 63 years, 74% male, 34% post-resuscitation, median lactate 5.2 mmol/l. Of these, 53% were discharged from ICU, 48% died within 30 days. Higher inotropic scores independently predicted a lower probability of ICU discharge (baseline score: OR 0.78 [95%-CI 0.69-0.88]; summarized score: OR 0.46 [0.38-0.56]; both P < .001) and higher risk of 30-day mortality (baseline score: HR 1.27 [1.15-1.40], summarized score HR 1.83 [1.60-2.09]; both P < .001). A score/MAP ratio <0.403 µg/kg/min/mmHg was associated with higher ICU discharge odds (ceiling effect); a < 0.426 µg/kg/min/mmHg with lower 30-day mortality hazards (no ceiling effect). Lowering catecholamine doses by accepting reduced MAP targets was linked to better outcomes. CONCLUSION:In HF-CS, higher catecholamine support independently associates with worse outcomes. Accepting lower blood pressure targets to reduce catecholamine dosage may improve outcomes. Validation in randomized controlled trials is urgently needed.
Delayed complications may occur up to weeks after atrial fibrillation (AF) ablation and are usually a consequence of initial injury during ablation and ongoing processes progressing to severe symptomatic but late-onset events. A structured clinical follow-up of patients to appraise for late complications is therefore imperative for all centers performing AF ablations. Late complications should also be reported when testing new ablation technologies. Red flag symptoms like fever, neurological events, and syncope but also delayed onset thoracic pain, dyspnea, exercise intolerance or gastrointestinal symptoms within the first months after AF ablation should trigger standardized diagnostic testing to evaluate for complications like esophageal injury/esophagoatrial fistula, gastroparesis, pulmonary vein stenosis (can become symptomatic even later), diaphragmatic paralysis, or late pericarditis/pericardial effusion. Whereas severe late complications are rare, the remote onset of associated symptoms warrants a high degree of awareness of all medical disciplines involved in the follow-up and also on the patient side to assure appropriate management without further delay. Indicative symptoms, incidences, and standardized management workflows for late complications like esophagoatrial fistula, gastroparesis, pulmonary vein stenosis, phrenic nerve injury/diaphragmatic palsy, and late pericarditis/pericardial effusion are discussed. Different imaging modalities have been used to clarify diagnosis and clinical relevance of these complications. Treatment options may range from wait-and-watch to emergency surgical interventions.
Background: Because of demographic changes, the number of older patients undergoing cardiac interventions has increased. The most common indication in this group is aortic valve stenosis, treated with either surgical aortic valve replacement (SAVR) or transcatheter aortic valve implantation (TAVR), with good outcomes. Our study investigated whether the heart team's choice of intervention (TAVI, SAVR, or conservative) is influenced by geriatric assessment results. Methods: This study was a single-centre, prospective, longitudinal case-control study conducted over 12 months and did not affect routine diagnostic examinations or clinical decisions. After risk stratification and clinical evaluation, patients were assigned to undergo TAVI, SAVR, or conservative management. Cardiological evaluation and geriatric assessment were performed for up to 12 months. Results: Of 135 patients (mean age 81 ± 4.6 years), 60% underwent TAVI, 29% SAVR, and 11% conservative therapy. Age, Frailty Score, cognition, and nutritional status were significantly associated with the heart team's decision, whereas EuroSCORE II remained the only independent predictor of one-year mortality (OR 1.58, 95% CI 1.13-2.19, p = 0.007). One-year mortality was 9.9% (n = 11). Compared to the literature, one-year mortality was lower than expected, particularly in the intervention group. Conclusions: Single assessment tools did not have the power to predict mortality. Similar to other trials, a combination of different scores can assess the risk of mortality.
Cardiovascular diseases such as arteriosclerosis, arterial hypertension, heart failure or atrial fibrillation are most prevalent in advanced age and usually occur in combination with multimorbidity and functional deficits. Recommendations from guidelines can therefore only be applied to these patient groups to a limited extent. Due to the complexity and vulnerability of multimorbid, older adults, an interdisciplinary approach to care is required. For the future, there is a great need for studies that include these patient groups, also taking into account other outcome parameters.
Cardiovascular diseases such as arteriosclerosis, arterial hypertension, heart failure or atrial fibrillation are most prevalent in advanced age and usually occur in combination with multimorbidity and functional deficits. Recommendations from guidelines can therefore only be applied to these patient groups to a limited extent. Due to the complexity and vulnerability of multimorbid, older adults, an interdisciplinary approach to care is required. For the future, there is a great need for studies that include these patient groups, also taking into account other outcome parameters.
Background: In patients with cardiogenic shock (CS), predicting risk of mortality may improve treatment allocation beyond intensive care admission and thereby outcomes. Troponin appears to be a suitable biomarker but has primarily been evaluated in the setting of infarct-related CS, not in heart failure-related CS (HF-CS), which accounts for almost 50% of cases. Objectives: To assess the association of Troponin T with shock severity and mortality in HF-CS patients. Methods: Heart failure-related CS patients treated in 15 tertiary care centres (5 European countries, 2016–2021) were retrospectively enrolled (NCT03313687). Association of baseline high-sensitive Troponin T and its 24-h kinetics with shock severity according to the SCAI classification and with in-hospital mortality was assessed by fitting multivariable adjusted regression models. Results: N = 477 patients (mean age 62 years, 30.2% women). High-sensitive Troponin T at baseline (median 164 ng/l) was significantly associated with in-hospital mortality (HR 1.008, 95%CI 1.002–1.013, p < 0.01). Increasing Troponin within 24 h from baseline indicated a 2.4-fold higher risk of death vs. decreasing Troponin levels (HR 2.439, 95% CI 1.070–5.558, p = 0.03). In addition, higher Troponin T levels correlate with higher SCAI stages (e.g., baseline Troponin T per 250 ng/l increase: OR 5.268, 95%CI: 1.637, 16.953, p < 0.01 for SCAI stage D vs. C). Conclusions: Troponin T, a marker of myocardial injury, associates with shock severity in patients with heart failure-related CS. It predicts mortality both with its baseline value as well as with its 24-h kinetics. Thus, Troponin may be a suitable marker to guide therapy or clinical trial enrolment in these patients. Graphical abstract Central Illustration. Baseline Troponin and its 24-hour kinetics predict all-cause in-hospital mortality in patients with heart failure-related cardiogenic shock. In addition, Troponin associates with shock severity according to the SCAI classification. SCAI: Society for Cardiovascular Angiography and Interventions.
AIMS:Heart failure-related cardiogenic shock (HF-CS) accounts for about half of CS cases, with a paucity of data regarding the role of kidney injury in this subset. This study aims to evaluate patient characteristics and outcome associated with renal function in patients with HF-CS. METHODS AND RESULTS:In this multicentre, international, retrospective study, patients with HF-CS from 16 tertiary care centres in five countries were enrolled between 2010 and 2021. To investigate differences in clinical presentation, complications, and 30-day mortality, based on renal function, adjusted logistic and Cox regression models were fitted. Among 1010 HF-CS patients, the median age was 64 (interquartile range [IQR] 52-75) years, with 71.7% being male. Median baseline creatinine was 1.7 (IQR 1.2-2.5) mg/dl, corresponding to an estimated glomerular filtration rate (eGFR) of 41.0 (IQR 25.2-62.2) ml/min/1.73 m2. In patients with acute kidney injury (AKI), 30-day mortality increased with AKI stages (no AKI 41.7%, AKI stage 1 43.3%, AKI stage 2 50.0%, AKI stage 3 63.7%; adjusted hazard ratio [HR] for AKI stage 3 1.97, 95% confidence interval [CI] 1.56-2.48, p < 0.001). Similarly, severe renal dysfunction (eGFR ≤ median) was associated with a 21% higher 30-day mortality risk (61.0% vs. 40.1%; adjusted HR 1.48, 95% CI 1.20-1.84, p < 0.001). Sepsis and bleeding were associated with both AKI and renal dysfunction, even after adjustment. CONCLUSIONS:In HF-CS, kidney injury is associated with higher 30-day mortality, potentially mediated by bleeding and sepsis. These findings support the consideration of kidney function as a prognostic marker and call for the development and evaluation of kidney-restoring adjunct interventions in HF-CS.
AIMS:This study aimed to investigate incidence and predictors of weaning failure and in-hospital death after successful weaning from veno-arterial extracorporeal membrane oxygenation (VA-ECMO) in patients with cardiogenic shock (CS). METHODS AND RESULTS:Overall, 685 patients with CS treated with VA-ECMO from 23 tertiary care centres in 7 countries were analysed (median age 57 [interquartile range 49-66] years, 542 [79.1%] male, median lactate 7.6 [interquartile range 4.1-12.7] mmol/L). The cause of CS was acute myocardial infarction in 438 (63.9%) patients, and 431 (62.9%) patients presented with cardiac arrest. A total of 410 patients (59.9%) were successfully weaned from VA-ECMO, whereas in 275 patients (40.1%) weaning failed (i.e. patients died on or within 48 h after VA-ECMO support). Of the successfully weaned patients, 150 (36.6%) died before hospital discharge. On multivariable logistic regression, predictors for both patient groups varied: age (per 10 years, odds ratio [OR] 1.49, 95% confidence interval [CI] 1.25-1.76; p < 0.001) and cardiac arrest before VA-ECMO implantation (OR 1.64, 95% CI 1.01-2.64; p = 0.04) were associated with weaning failure, whereas lactate clearance within 24 h after VA-ECMO initiation was associated with successful weaning (OR 0.21, 95% CI 0.1-0.44; p < 0.001). In-hospital death after successful weaning was more likely with higher age (per 10 years, OR 1.56, 95% CI 1.24-1.97; p < 0.001), renal replacement therapy (OR 2.56, 95% CI 1.4-4.68; p = 0.002) and bleeding events (OR 2.93, 95% CI 1.4-6.14; p = 0.004). CONCLUSION:Weaning from VA-ECMO fails in 40% of patients treated with VA-ECMO for CS. When successful, survival after VA-ECMO weaning mostly depends on age and the incidence of device- and shock-related complications.
Vorhofflimmern ist die häufigste Herzrhythmusstörung im Alter. Als Folge der positiven Daten zur Katheterablation hat sich der Fokus in der symptomatischen Therapie auf die Rhythmuskontrolle gelegt. Auch ältere Patienten können von einer Katheterablation profitieren. Die orale Antikoagulation bleibt wesentlicher Bestandteil der pharmakologischen Therapie beim Vorhofflimmern. Neue Studienergebnisse belegen, dass geriatrische Patienten eines individuellen Behandlungsansatzes bedürfen; dieser sollte auf den Empfehlungen der aktuellen Leitlinien und einschließlich dem Einsatz ergänzender Hilfsmittel basieren. Die Beurteilung der Funktionalität sollte in der Therapie und der Therapiezielplanung Berücksichtigung finden ebenso wie die mit dem Vorhofflimmern assoziierten Beschwerden. Zur Rhythmuskontrolle stehen akut die Kardioversion und langfristig eine medikamentöse oder interventionelle (Katheterablation) rhythmusstabilisierende Therapie zur Verfügung.
BACKGROUND:New-onset heart failure with reduced ejection fraction (HFrEF) requires further diagnostic evaluation to determine its underlying cause. Despite the potential of cardiac magnetic resonance (CMR) imaging to identify ischemic and nonischemic causes, percutaneous invasive coronary angiography (CATH) remains the preferred tool for diagnosing ischemic cardiomyopathy (ICM). OBJECTIVES:This study aimed to determine whether a CMR-first strategy could diagnose ICM as effectively as CATH (primary endpoint) and potentially reduce the number of invasive procedures (secondary endpoint). METHODS:In this multicenter 2-armed diagnostic trial (Magnetic Resonance Imaging vs Invasive Coronary Angiography as First-Line Diagnostic Modality in New-Onset Heart Failure), 229 adults with new-onset HFrEF were randomized to undergo CMR or CATH first and the other modality second. Separate expert panels evaluated both modalities, blinded to each other's results. The cardiologist-in-charge was blinded to the panel results and served as the reference standard. RESULTS:A total of 203 patients (mean age: 62 ± 14 years, 28% women) had evaluable pairs of diagnostic modalities (108 CATH-first). For diagnosing ICM, the panels considered CATH to be sufficient in 100% (105/105) and CMR in 80% (76/95; P < 0.001). Compared with the reference, sensitivity for diagnosing ICM was high for both (CATH 91%, CMR 90%; P = 1.00), but CMR had lower specificity (98% vs 74%; P < 0.001). According to the CMR panel, 48% (46/95) of CATH procedures could have been avoided with a CMR-first strategy, dropping to 45% when excluding patients who underwent coronary interventions. CONCLUSIONS:Although CATH was superior for diagnosing ICM, CMR showed similar sensitivity and could significantly reduce CATH procedures without increasing the risk of missing critical coronary interventions. Longitudinal studies are needed to assess whether a CMR-first strategy confers prognostic benefit. (Magnetic Resonance Imaging vs Invasive Coronary Angiography as First-Line Diagnostic Modality in New-Onset Heart Failure; ISRCTN16515058).
Despite the recommendation of coronary physiology to guide revascularization in angiographically intermediate stenoses without established correlation to ischemia, its uptake in clinical practice is slow. This study aimed to analyze the use of coronary physiology in clinical practice. Based on a multicenter registry (Fractional Flow Reserve Fax Registry, F(FR)2, ClinicalTrials.gov identifier NCT03055910), clinical use, consequences, and complications of coronary physiology were systematically analyzed. F(FR)2 enrolled 2,000 patients with 3,378 intracoronary pressure measurements. Most measurements (96.8
Background Heart failure–related cardiogenic shock (HF-CS) accounts for a significant proportion of all CS cases. Nevertheless, there is a lack of evidence on sex-related differences in HF-CS, especially regarding use of treatment and mortality risk in women vs. men. This study aimed to investigate potential differences in clinical presentation, use of treatments, and mortality between women and men with HF-CS. Methods In this international observational study, patients with HF-CS (without acute myocardial infarction) from 16 tertiary-care centers in five countries were enrolled between 2010 and 2021. Logistic and Cox regression models were used to assess differences in clinical presentation, use of treatments, and 30-day mortality in women vs. men with HF-CS. Results N = 1030 patients with HF-CS were analyzed, of whom 290 (28.2%) were women. Compared to men, women were more likely to be older, less likely to have a known history of heart failure or cardiovascular risk factors, and lower rates of highly depressed left ventricular ejection fraction and renal dysfunction. Nevertheless, CS severity as well as use of treatments were comparable, and female sex was not independently associated with 30-day mortality (53.0% vs. 50.8%; adjusted HR 0.94, 95% CI 0.75–1.19). Conclusions In this large HF-CS registry, sex disparities in risk factors and clinical presentation were observed. Despite these differences, the use of treatments was comparable, and both sexes exhibited similarly high mortality rates. Further research is necessary to evaluate if sex-tailored treatment, accounting for the differences in cardiovascular risk factors and clinical presentation, might improve outcomes in HF-CS. Graphical abstract Sex-related differences in clinical characteristics, shock severity, and mortality in patients with heart failure–related cardiogenic shock. Summary for the main study findings. AMI, acute myocardial infarction; CI, confidence interval; HF-CS, heart failure–related cardiogenic shock; LVEF, left ventricular ejection fraction; MCS, mechanical circulatory support; SCAI, Society for Cardiovascular Angiography & Interventions.
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. 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
Atrial fibrillation is the most frequent cardiac arrhythmia in old age. As a result of the positive data on ablation, the focus has shifted to rhythm control. Older adults can also benefit from catheter ablation. Oral anticoagulation remains an essential part of the pharmacological treatment of atrial fibrillation. Recent study results show that geriatric patients require an individual treatment approach, which should be based on the recommendations of the current guidelines and the use of supplementary aids. The assessment of functionality should be taken into account in the treatment and the treatment goal planning as well as symptoms associated with atrial fibrillation. In acute situations cardioversion and long-term drug or interventional (catheter ablation) rhythm-stabilizing treatment are available for rhythm control.