The top 10 <i>European Heart Journal: Acute Cardiovascular Care</i> papers in cardiogenic shock and resuscitation of 2024

The 2024 calendar year provided cardiovascular intensive care unit practitioners the first randomized controlled trial (RCT) evidence to reduce cardiogenic shock (CS) mortality in 25 years, and an individual patient meta-analysis of RCTs that showed patients with in-patients ST-elevation myocardial infarction (STEMI) complicated by CS managed with temporary mechanical circulatory support (tMCS) without risk of hypoxic brain injury may reduce mortality, but at the expense of a higher risk of major bleeding and vascular complications.1,2 While major resuscitation cardiac arrest trials were negative,3 international societies published practice guidelines on post-cardiac arrest best care practices that integrated a recent deluge of RCTs in this field.4–6The European Heart Journal: Acute Cardiovascular Care (EHJ: ACVC) has emerged as a leading repository for informative secondary analysis of RCTs and well-conducted observation analyses in acute cardiovascular care.7 This manuscript highlights and summarized the top 10 manuscripts in CS and resuscitation published in the journal in 2024. A critique of CS RCTs is that the patients enrolled may not represent patients cared for in routine clinical practice. In an effort to address this potential selection bias, in the April issue of EHJ: ACVC, Zeymer et al.8 compared patients in the Culprit Lesion Only PCI vs. Multi-vessel PCI in Cardiogenic Shock trial with those who were screened but had a trial exclusion criteria and were enrolled into the trial’s registry. Patients included in the registry with angiographic multi-vessel disease (n = 235) more frequently had an anterior STEMI, received fibrinolysis, had higher median creatinine levels, had lower frequency of culprit lesion stenting, and had lower post-intervention thrombolysis in myocardial infarction 3 flow. Notably, registry patients had higher use of intra-aortic balloon pumps, but lower use of ImpellaTM support. Unadjusted all-cause death at 30 days was ∼5% higher in the registry arm, although this did not achieve statistical significance. This study confirms our collective recognition that there are clinically important differences between patients enrolled in RCTs and those encountered in clinical practice, and there are differences in patient characteristics and treatments, which may be associated with survival. Perhaps, reassuringly, the incremental mortality is only modestly higher, but these results should be interpreted with caution given patients may be selected from high-volume academic trial centres and may be limited to patients consenting to be part of the registry. The study emphasizes the potential need for registry-embedded randomized trials with novel consent mechanisms that may help mitigate some of external validity concerts that are germane to all well-conducted randomized trials.9,10 Whether the negative results of extracorporeal membrane oxygenation (ECMO) trials compared with ImpellaTM trials were due to different patient selection criteria has been an area of ongoing debate.1,2 In an individual patient meta-analysis of the four ECMO CS randomized trials completed to date, the authors restricted the population to a ‘DanGer-Shock’ (Danish-German Cardiogenic Shock Trial) patient-like cohort (e.g. STEMI with a low risk of anoxic brain injury).11 The study included 202 patients, and the authors report that 6-month mortality was numerically lower in the ECMO cohort (45 vs. 50%; hazard ratio 0.84; 95% confidence interval 0.56–1.26); however, major bleeding and peripheral vascular complications were significantly higher. While this study suggests that there is no large benefit of ECMO in patients with a low risk of anoxic bran injury, it is important to consider the limitations of underlying trials predominantly enrolled patients with Society for Cardiovascular Angiography and Interventions (SCAI) Stage ‘C’, and this meta-analysis may be underpowered to detect a smaller clinical difference. Future ECMO trials focusing on evaluating the efficacy and safety of ECMO in patients with more advanced SCAI stages, a low risk of anoxic brain injury, biventricular dysfunction, and in-care systems with routine evaluation for destination therapies would be welcomed by the cardiovascular community.12 The complication rates in this study are also mirrored by a retrospective multinational study of 501 patients treated with ECMO.13 Beer et al.13 reported that 52% of patients had one or more neurologic, bleeding, and/or ischaemic complications, and all complications were associated with higher mortality. Inasmuch as we are learning which patients will benefit from these potentially lifesaving but costly and resource-intensive therapies, in parallel, the cardiovascular community should be exploring how to make the routine use of these technologies safer with a view towards improving patient outcomes. Invasive haemodynamic assessment is routinely used to haemodynamically phenotyping CS and may help guiding therapeutic management. Moreover, increasing observational evidence shows an association between pulmonary arterial catheter use and improved survival in patients with CS.14,15 The use of echocardiography for haemodynamic assessment is intriguing because of its non-invasiveness and rapid applicability. Most of the studies exploring the correlation between invasive haemodynamic assessment and echocardiography were conducted in clinically stable patients, thus limiting their applicability to patients with CS. In an innovative study, Frea et al.16 prospectively explored the correlation between echocardiographic and invasive assessment of haemodynamics in 101 consecutive patients with acute decompensated heart failure–related CS (ADHF-CS) with SCAI shock Stage ≥B. The results reveal a strong correlation for cardiac index, systolic pulmonary artery pressure, right atrial pressure, and cardiac power output, underscoring the potential of echocardiographic haemodynamic assessment to offer fast and reliable haemodynamic profiling in the acute setting. Notably, the study introduces the first prospective validation of echocardiographic estimation of pulmonary artery pulsatility index, affirming its potential prognostic significance and advocating for broader use of echocardiography in assessing haemodynamics in patients with ADHF-CS. Limitations acknowledged by the authors include single-centre design in an institution with broad expertise in echocardiographic haemodynamic assessment and the relatively small sample size and the lack of external validation. There has been a growing international trend of transcatheter therapies for patient with CS due to underlying severe valvular disease, but high-quality evidence in this field has been lacking. Ismayl et al.17 used the US Healthcare Cost and Utilization Project to identify 16 161 patients with aortic stenosis complicated by CS between 2016 and 2021, among whom 40% underwent isolated transcatheter aortic valve replacement (TAVR) and 60% underwent isolated survival valve replacement. The authors report a shift away from a traditional surgical approach with a rise in TAVR from 29.5 to 46.5% over the 5-year study period. In a propensity-matched analysis, TAVR was associated with a lower risk of acute kidney injury, major bleeding, stroke, hospital costs, and shorter hospital length of stay, with higher observed risk of vascular complications. The strengths of the study include the size of the population, the propensity analysis that may help potentially mitigate known and unknown confounders, and the temporal analysis. The limitations, as acknowledged by both the authors and the editorialists, include the very real potential for selection bias, lack of haemodynamic information including CS severity and degree of hypoperfusion, lack of valvular and ventricular echocardiographic data, surgical risk scores, and the principle indication for valve replacement (e.g. degenerative, congenital, or infective endocarditis).18,19 While the paper helps inform us of the epidemiology of current management of aortic stenosis complicated by CS and the potential associated outcomes, the results also highlight the need for randomized studies to help inform best practices. Little information has been published about the utility of ImpellaTM support in patients with or without STEMI and associated CS. Nasu et al.20 added to our collective international knowledge by using the Japan Registry for Percutaneous Ventricular Assist Device registry to identify 260 patients with fulminant myocarditis supported with an ImpellaTM between 2020 and 2021. The authors report that 107 patients were treated with ImpellaTM alone and 162 were supported with ImpellaTM in combination with venoarterial EMCO (e.g. ECPella). The authors report a 74.3% overall 30-day survival. The ImpellaTM alone cohort had an 83.2% survival with a 23.4% major bleeding rate, while the ECPella cohort had a 68.5% 30-day survival with an 37.7% major bleeding rate. The strengths of the study include the national scope of the registry and relatively large number of patient with an uncommon CS aetiology. The good survival rate is promising and provides the best data for tMCS support in fulminant myocarditis to date, but the lack of a control group and inability to dissect selection and acuity biases between the ECMPella and ImpellaTM cohorts are limitations. Collectively, these promising registry reports reinforce the growing off-label use of ImpellaTM for aetiologies beyond STEMI and highlights the need to properly evaluate the efficacy and safety of ImpellaTM in distinct CS phenotypes the role beyond the narrow scope of DanGer trial inclusion criteria21,22 in future trials. Finally, the most informative clinical practice paper of the year was written my Arrigo et al.23 in an EHJ: ACVC consensus paper focuses on right ventricular failure secondary to acute cor pulmonale. The strengths of this paper are that it consolidates expert consensus practices on the diagnosis and physiology of this acute, but less commonly encountered, condition that is largely void of high-quality studies to guide acute management. The authors provide a focused and pithy summary of early stabilization, volume management, inopressor principles, ventilation strategies, and tMCS selection criteria together with haemodynamic monitoring principles. The document will likely serve as an educational—and middle of the night—resource for trainees and non-experts alike. Performing RCTs in out-of-hospital cardiac arrest patients is challenging. The difficulty in enrolling patients in this pre-hospital setting often results in numerically smaller trials that are systematically underpowered with an often-unrealistic treatment effect. Negative trials utilizing this construct may either be due to true lack of treatment effect or may simply be underpowered to detect a clinically impactful treatment effect. The use of a Bayesian approach over the conventional frequentist statistical analysis may help shed added light on the utility of an experimental intervention in this setting. In this context, The Early Initiation of Extracorporeal Life Support in Refractory OHCA trial (n = 134) failed to show a clinical benefit of incorporating extracorporeal cardiopulmonary resuscitation (eCPR) in adult patients aged <70 years, without return of spontaneous circulation following witnessed ventricular tachycardia/ventricular fibrillation arrest undergoing bystander cardiopulmonary resuscitation (CPR) and defibrillation when compared with conventional CPR (CCPR).24 Of note, the investigators assumed an ambitious survival with favourable neurological outcome of 30% compared with 8% in the CCPR arm. A novel paper utilizing Bayesian analysis in this dataset sheds unique light on the potential of eCPR to be associated with a meaningful favourable clinical outcome in this experiment.25 Using an expert consensus-derived minimum clinically importance difference of 5%, the investigators report a mean favourable absolute risk benefit of 3.6% in favour of eCPR intervention in this setting with probability of 42% that the eCPR intervention was associated with a 30-day favourable neurological outcome of 5%. Instead of simply labelling eCPR as ineffective, this analysis provides clinicians with unique insight into the potential benefits of the intervention in this setting and provides valuable insight for trialists planning for future studies in this area.26 Finally, the same trial provided us with the first cost-effectiveness analysis of eCPR and reported the 1-year mean quality-adjusted life year (QALY) was 0.15 and 0.11 in the eCPR and CCPR groups, respectively, with an incremental cost-effectiveness ratio of €121 643 per additional QALY.27 These costs are above the traditional threshold of €80 000 per QALY. Importantly, while both sub-studies provide additional valuable information, they do not address potential limitations of the underlying trial, including the lack of eCPR experience at some enrolling sites. European Society of Cardiology guidelines suggest that percutaneous stellate ganglion blocks (PSGBs) can be considered when anti-arrhythmic, sedation, and beta-blockade therapies are ineffective, or not tolerated, but high-quality evidence is lacking.28 A 2017 meta-analysis of 38 patients from 23 studies reported that ventricular arrhythmias were reduced from a mean of 12.4 to 1.0 episodes per day after PSGB.29 In a retrospective analysis of 280 patients from the STellate ganglion block for Arrhythmic stoRm registry, the authors examined 180 patients with electrical storm defined as 3 or more episodes of ventricular tachycardia or fibrillation in 24 h.30 They compared 26 (14%) patients who had an early sympathetic block prior to intravenous anti-arrythmia drugs vs. delayed PSGB defined as having received at least one intravenous anti-arrhythmic drug. The early PSGB cohort more frequently had refractory ventricular fibrillation and more oral amiodarone and mexiletine use. The authors report no differences in the rates of recurrent ventricular arrhythmias in the first hour (81 vs. 84%), 3 h (77 vs. 89%), or 12 h (65 vs. 69%) after initial therapy. Complications and in-hospital mortality were similar between the cohorts. Given the potential toxicities of anti-arrhythmic drugs, the findings suggest the potential role for earlies PSBG, but the use of this approach may be limited to high-volume centres with procedure experience and case volume. This clinical question may be answered by the ongoing GANGlion Stellate Block for Treatment of Electric storm trial (ClinicalTrials.gov NCT05078684).31 With the 2024 calendar year in the review mirror, EHJ: ACVC will continue to build on our collective understanding of CS and resuscitation best practices by serving as an important repository for original manuscripts and educational papers centred around critically ill patients with cardiovascular disease. We gratefully acknowledge Ms L. Soulard for copy-editing the manuscript. None. No new data were generated or analysed in support of this research.

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