Safety and Feasibility of Impella CP Decannulation With a Preclosure Technique in Myocardial Infarction With Cardiogenic Shock

2] Over the past decade, there has been an increase in the use of veno-arterial extracorporeal membrane oxygenation (VA-ECMO) in the management of refractory cardiogenic shock, because it offers not only a high cardiac output with biventricular support but also respiratory support. 5 However, peripheral VA-ECMO is limited by the significant increase in afterload because of retrograde aortic flow, which may be deleterious in CS, especially from AMI. The IABP has remained the most commonly used modality of LV decompression studied in literature because of its ubiquitous availability, ease of insertion, relatively small arteriotomy, theoretical benefit of diastolic augmentation and therefore coronary perfusion, and lastly, the ease of maintenance in the cardiac intensive care unit.

IntroductionIn ST-elevated myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention (PPCI), door-to-balloon (DTB) time is an important metric of the quality of care. Shorter DTB times are associated with...

ELSO Interim Guidelines for Venoarterial Extracorporeal Membrane Oxygenation in Adult Cardiac Patients.

The article entitled “Effects of Door-to-Balloon Times on Outcomes in Taiwanese Patients Receiving Primary Percutaneous Coronary Intervention: A Report of Taiwan Acute Coronary Syndrome Full Spectrum Registry” was published in the Journal of Acta Cardiologica Sinica in early 2015.1 This is the first large-scale (> 1000 patients) domestic report which investigated whether or not increasingly lower door-to-balloon (DTB) time correspondingly improves clinical outcomes. One expert(s) wrote a Letter to the Editor and questioned whether the significant relationship between 1-year major adverse cardiac events and DTB time < 45 minutes was statistically adjusted by use of drug-eluting stent (DES). The letter also referenced our previous study to reinforce that the DES-treated group had fewer cardiovascular events as compared to the BMS (bare-metal stent)-treated group.2 In fact, we selected all variables with a statistical trend or significance (p < 0.15), as listed in Table 1 and 2, including stent type, for univariate analysis. The variable of stent type did not reach a statistical significance using univariate analysis. Importantly, it is necessary to highlight here that such statistical processing remains insufficient to exclude the potential effects of the different stent types on cardiovascular outcome. In addition, the expert(s) shared data about a 5-year cohort study involving 951 patients with ST-segment elevation myocardial infarction (STEMI) showing that DTB time was strongly associated with annual mortality (1.001-1.004; p < 0.001). They suggest that DTB time is an important prognostic factor for annual mortality. Of course we will unquestionably review the entire available domestic data. On the other hand, the article concludes that DTB time is not a good determinant for 1-year cardiovascular outcome. It is consistent with the fact that current evidence remains conflicting about the association between mortality rate and DTB time.3,4 We believe that the impact of DTB time on clinical outcome, especially on long-term outcome, is very complicated due to numerous confounders. Irrespective of the impact of DTB time on long-term outcome, we have emphasized in our study that a D2B time must be aggressively shortened to minimize myocardial damage based upon the belief that “time is muscle” in STEMI patients. In other words, coronary interventionalists should expedite the process of revascularizing the infarct-related coronary artery without delay to most efficaciously manage patients with STEMI.

Guidelines for patients with ST-elevation myocardial infarction include a door-to-balloon time (DTBT) of ≤90 min for primary percutaneous coronary intervention. The aim of this study was to assess temporal trends (2006-2010) in DTBT and determine if a reduction in DTBT was associated with improved clinical outcomes. We compared annual median DTBT in 1926 STEMI patients undergoing primary percutaneous coronary intervention from the Melbourne Interventional Group registry. ST-elevation myocardial infarction presenting >12 h and rescue percutaneous coronary intervention was excluded. Major adverse cardiac events were analysed according to DTBT (dichotomised as ≤90 min vs >90 min). A multivariable analysis for predictors of mortality (including DTBT) was performed. Baseline demographics, clinical and procedural characteristics were similar in the STEMI cohort across the 5 years, apart from an increase in out-of-hospital cardiac arrest (3.6% in 2006 vs 9.4% in 2010, P < 0.0001) and cardiogenic shock (7.7-9.6%, P = 0.07). The median DTBT (interquartile range) was reduced from 95 (74-130) min in 2006 to 75 (51-100) min in 2010 (P < 0.01). In this period, the proportion of patients achieving a DTBT of ≤90 min increased from 45% to 67% (P < 0.01). Lower mortality and major adverse cardiac event rates were observed with DTBT ≤90 min (all P < 0.01). Multivariable analysis showed that a DTBT of ≤90 min was associated with improved clinical outcomes at 12 months (odds ratio 0.48; 95% confidence interval 0.33-0.73, P < 0.01). There has been a decline in median DTBT in the Melbourne Interventional Group registry over 5 years. DTBT of ≤90 min is associated with improved clinical outcomes at 12 months.

Commentary: Preparation is half the battle-preclosure devices for peripheral venoarterial extracorporeal oxygenation.

Introduction: Observational studies have consistently demonstrated a strong association between longer door-to-balloon (DTB) times and increased mortality in patients presenting with ST-elevation myocardial infarction (STEMI). However, the extent to which this association is attributable to unmeasured differences between patients with different DTB times (i.e., confounding), as opposed to a causal impact of longer DTBs is unclear. Aim: In this study, we exploit a natural experiment using an instrumental variable (IV) approach based on weekday vs weekend presentation to evaluate whether incremental delays in DTB times have a causal effect on patient outcomes. Methods: We performed a retrospective analysis of patients undergoing immediate percutaneous coronary intervention (PCI) for STEMI in the CathPCI Registry from 1/2010 to 12/2021 at 1,422 sites. Time of presentation with STEMI (weekday daytime vs weekend daytime) was used as an IV to address potential confounding. A 2-stage IV analysis was used. In-hospital all-cause mortality was the primary outcome. Results: A total of 447,355 patients presented with STEMI during the study period. The average difference in weekend (N=125,787) minus weekday (N=321,568) daytime DTB times was 10.5 minutes. Patient, procedural, and hospital characteristics were well balanced between groups. Overall, in-hospital mortality was 3.5%. In the IV analysis, delays in DTB time were not associated with increased odds of in-hospital mortality (OR 0.99, 95% CI 0.95 to 1.03, P = 0.70). This null association was also observed when limited to hospitals with larger differences (19.5 minutes) between weekend and weekday DTB time (OR 1.00, 95% CI 0.96 to 1.03, P = 0.85) and among patients predicted to have the longest (mean 70.8 minutes) DTB times (OR 1.00, 95% CI 0.94 to 1.07, P = 0.96). Conclusions: Contrary to prior findings, incremental delays in DTB time for patients presenting with STEMI are not associated with increased in-hospital mortality when analyzed using quasi-experimental methods less likely to be influenced by unmeasured confounding. Efforts to further reduce DTB times in patients presenting to hospitals with STEMI are unlikely to improve outcomes. In the current era, policies intended to incentivize better care for STEMI patients should prioritize other measures of quality beyond DTB.

Effect on Door-to-Balloon Time of Immediate Transradial Percutaneous Coronary Intervention on Culprit Lesion in ST-Elevation Myocardial Infarction Compared to Diagnostic Angiography Followed by Primary Percutaneous Coronary Intervention

BackgroundIn ST-segment elevation myocardial infarction (STEMI), even in presence of short door to balloon time (DTBT), timely reperfusion with percutaneous coronary intervention (PCI) is hampered by pre-hospital delays. Travel time (TT) constitutes a relevant part of these delays and may contribute to worse outcomes.ObjectiveTo evaluate the relationship between TT from home to hospital and DTBT on 30-day mortality after PCI among patients with STEMI.MethodsWe enrolled a cohort of 3,608 STEMI patients with a DTBT within 120 minutes who underwent PCI between years 2009 and 2013 in Lazio Region (Italy). We calculated the minimum travel time from residential address to emergency department where the first medical contact occurred. We defined system delay as the sum of travel time and DTBT time. Logistic regression models, including clinical and demographic characteristics were used to estimate the effect of TT and DTBT on mortality.ResultsAmong patients with 0–90 minutes of system delay, TT above the median value is positively associated with mortality (OR = 2.46; P = 0.009). Survival benefit associated with DTBT below the median results only among patients with TT below the median (OR for DTBT below the median = 0.39; P = 0.013), (OR for interaction between TT and DTBT = 2.36; p = 0.076).ConclusionTT affects survival after PCI for STEMI, even in the presence of health care systems compliant with current guidelines. Results emphasize the importance of health system initiatives to reduce pre-hospital delay. Utilization of TT can contribute to a better estimate of patient mortality risk in the evaluation of quality of care.

Cardiac energetics and end-organ perfusion with veno-arterial extracorporeal membrane oxygenation versus ecmella for cardiogenic shock in a large animal model

Coronavirus disease 2019 (COVID-19) is a global pandemic impacting nearly 170 countries/regions and millions of patients worldwide. Patients with acute myocardial infarction (AMI) still need to be treated at percutaneous coronary intervention (PCI) centers with relevant safety measures. This retrospective study was conducted to assess the therapeutic outcomes of PCI performed under the safety measures and normal conditions. AMI patients undergoing PCI between January 24 to April 30, 2020 were performed under safety measures for COVID-19. Patients received pulmonary computed tomography (CT) and underwent PCI in negative pressure ICU. Cardiac catheterization laboratory (CCL) staff and physicians worked with level III personal protection. Demographic and clinical data, such as door-to-balloon (DTB) time, operation time, complications for patients in this period (COVID-19 group) and the same period in 2019 (2019 group) were retrieved and analyzed. COVID-19 and 2019 groups had 37 and 96 patients, respectively. There was no significant difference in age, gender, BMI and comorbidity between the two groups. DTB time and operation time were similar between the two groups (60.0 ± 12.39 vs 58.83 ± 12.85 min, p = 0.636; 61.46 ± 9.91 vs 62.55 ± 10.72 min, p = 0.592). Hospital stay time in COVID-19 group was significantly shorter (6.78 ± 2.14 vs 8.85 ± 2.64 days, p < 0.001). The incidences of malignant arrhythmia and Takotsubo Syndrome in COVID-19 group were higher than 2019 group significantly (16.22% vs 5.21%, p = 0.039; 10.81% vs 1.04% p = 0.008). During hospitalization and 3-month follow-up, the incidence of major adverse cardiovascular events and mortality in the two groups were statistically similar (35.13% vs 14.58%, p = 0.094; 16.22% vs 8.33%, p = 0.184). The risk of major adverse cardiac events (MACE) was associated with cardiogenic shock (OR, 11.53; 95% CI, 2.888–46.036; p = 0.001), malignant arrhythmias (OR, 7.176; 95% CI, 1.893–27.203; p = 0.004) and advanced age (≥ 75 years) (OR, 6.718; 95% CI, 1.738–25.964; p = 0.006). Cardiogenic shock (OR, 17.663; 95% CI, 5.5–56.762; p < 0.001) and malignant arrhythmias (OR, 4.659; 95% CI, 1.481–14.653; p = 0.008) were also associated with death of 3 months. Our analysis showed that safety measures undertaken in this hospital, including screening of COVID-19 infection and use of personal protection equipment for conducting PCI did not compromise the surgical outcome as compared with PCI under normal condition, although there were slight increases in incidence of malignant arrhythmia and Takotsubo Syndrome.

IntroductionEarly detection and treatment of cardiogenic shock (CS) is crucial to avoid irreparable multiorgan damage and mortality. Impella CP® is a novel temporary mechanical circulatory support (MCS) device associated with greater hemodynamic support and significantly fewer device-related complications compared with other MCS devices, e.g., intra-aortic balloon pumps (IABP) and venoarterial extracorporeal membrane oxygenation (VA-ECMO). The present study evaluated the budget impact of introducing Impella CP versus IABP and VA-ECMO in patients with CS following an acute myocardial infarction (MI) in France.MethodsA budget impact model was developed to compare the cost of introducing Impella CP with continuing IABP and VA-ECMO treatment from a Mandatory Health Insurance (MHI) perspective in France over a 5-year time horizon, with 700 patients with refractory CS assumed to be eligible for treatment per year. Costs associated with Impella CP and device-related complications for all interventions were captured and clinical input data were based on published sources. Scenario analyses were performed around key parameters.ResultsIntroducing Impella CP was associated with cumulative cost savings of EUR 2.7 million over 5 years, versus continuing current clinical practice with IABP and VA-ECMO. Cost savings were achieved in every year of the analysis and driven by the lower incidence of device-related complications with Impella CP, with estimated 5-year cost savings of EUR 22.4 million due to avoidance of complications. Total cost savings of more than EUR 250,000 were projected in the first year of the analysis, which increased as the market share of Impella CP was increased. Scenario analyses indicated that the findings of the analysis were robust.ConclusionTreatment with Impella CP in adult patients aged less than 75 years in a state of refractory CS following an MI was projected to lead to substantial cost savings from an MHI perspective in France, compared with continuing current clinical practice.

Ambulatory simultaneous venoarterial extracorporeal membrane oxygenation and temporary percutaneous left ventricular assist device bridge to heart transplantation

To assess the impact of triage initiatives for rapid 12-lead electrocardiogram (ECG) acquisition on door-to-ECG (DTE), door-to-balloon (DTB), length of stay (LOS), and in-hospital mortality for self-presenting emergency department (ED) patients with ST-elevation myocardial infarction. This systematic review encompassed cohort studies, controlled trials, one-group pre-test-post-test studies, interventional, observational, and randomized controlled trials assessing rapid acquisition of ECG for patients above 18 years experiencing symptoms of ST-elevation myocardial infarction in ED. Data from seven databases underwent screening, extraction, and quality appraisals by two independent reviewers. Employing a random-effects model, meta-analyses were conducted for primary outcomes: DTE, DTB, LOS, and in-hospital mortality. Subgroup analyses and meta-regression were performed for meta-analyses with over 10 studies. This review included 25 studies with 19 475 ST-elevation myocardial infarction patients. All were cohort studies with acceptable evidence quality. Our findings revealed enhanced triage initiatives for ECG related to significant reductions in DTE (MD -6.45 min, P < 0.001) and DTB (MD -24.40 min, P < 0.001) times. More institutions met benchmarked goals for DTE (MD 22.2%, P < 0.001) and DTB (MD 15.6%, P < 0.001) times. Improvements reported in LOS and in-hospital mortality were not significant. Subgroup and meta-regression analyses revealed significant differences in DTE times, but not in DTB times. Positive impacts of such initiatives on ST-elevation myocardial infarction patient outcomes offer institutions opportunities to improve triage processes and training. Future research should focus on extended follow-up and larger sample sizes for a comprehensive understanding of sustained impacts. PROSPERO: CRD42023472392.

In patients with acute ST-elevation myocardial infarction (STEMI) who are undergoing percutaneous coronary intervention, current guidelines for reperfusion therapy recommend a door-to-balloon (DTB) time of less than 90 minutes. Considerable effort has focused on reducing DTB time with the assumption that a reduction in DTB time translates into a significant reduction in mortality; however, the clinical impact of this effort has not been evaluated. Therefore, our objective was to determine whether a decline in DTB time in patients with STEMI was associated with an improvement in clinical outcomes. We assessed the yearly trend in DTB time for 8771 patients with STEMI who were undergoing primary percutaneous coronary intervention from 2003 to 2008 as part of the Blue Cross Blue Shield of Michigan Cardiovascular Consortium and correlated it with trends in in-hospital mortality. Patients were stratified according to risk of death using a mortality model to evaluate whether patient risk factors affect the relationship between DTB time and mortality. Median DTB time decreased each year from 113 minutes in 2003 to 76 minutes in 2008 (P < .001), and the percentage of patients who were revascularized with a DTB time of less than 90 minutes increased from 28.5% in 2003 to 67.2% in 2008 (P < .001). In-hospital mortality remained unchanged at 4.10% in 2003, 4.02% in 2004, 4.40% in 2005, 4.42% in 2006, 4.73% in 2007, and 3.62% in 2008 (P = .69). After the differences in baseline characteristics were adjusted for, there was no difference in the standardized mortality ratios (SMRs) across the study period (SMR, 1.00; 95% confidence interval [CI], 0.74-1.26 in 2003 compared with SMR, 0.95; 95% CI, 0.77-1.13 in 2008). There has been a dramatic reduction in median DTB time and increased compliance with the related national guideline. Despite these improvements, in-hospital mortality was unchanged over the study period. Our results suggest that a successful implementation of efforts to reduce DTB time has not resulted in the expected survival benefit.