Circulatory Support Devices Research Articles

Temporary mechanical circulatory support in infarct-related cardiogenic shock: an individual patient data meta-analysis of randomised trials with 6-month follow-up

Percutaneous active mechanical circulatory support (MCS) devices are being increasingly used in the treatment of acute myocardial infarction-related cardiogenic shock (AMICS) despite conflicting evidence regarding their effect on mortality. We aimed to ascertain the effect of early routine active percutaneous MCS versus control treatment on 6-month all-cause mortality in patients with AMICS. In this individual patient data meta-analysis, randomised controlled trials of potential interest were identified, without language restriction, by querying the electronic databases MEDLINE via PubMed, Cochrane Central Register of Controlled Trials, and Embase, as well as ClinicalTrials.gov, up to Jan 26, 2024. All randomised trials with 6-month mortality data comparing early routine active MCS (directly in the catheterisation laboratory after randomisation) versus control in patients with AMICS were included. The primary outcome was 6-month all-cause mortality in patients with AMICS treated with early routine active percutaneous MCS versus control, with a focus on device type (loading, such as venoarterial extracorporeal membrane oxygenation [VA-ECMO] vs unloading) and patient selection. Hazard ratios (HRs) of the primary outcome measure were calculated using Cox regression models. This study is registered with PROSPERO, CRD42024504295. Nine reports of randomised controlled trials (n=1114 patients) were evaluated in detail. Overall, four randomised controlled trials (n=611 patients) compared VA-ECMO with a control treatment and five randomised controlled trials (n=503 patients) compared left ventricular unloading devices with a control treatment. Two randomised controlled trials also included patients who did not have AMICS, who were excluded (55 patients [44 who were treated with VA-ECMO and 11 who were treated with a left ventricular unloading device]). The median patient age was 65 years (IQR 57-73); 845 (79·9%) of 1058 patients with data were male and 213 (20·1%) were female. No significant benefit of early unselected MCS use on 6-month mortality was noted (HR 0·87 [95% CI 0·74-1·03]; p=0·10). No significant differences were observed for left ventricular unloading devices versus control (0·80 [0·62-1·02]; p=0·075), and loading devices also had no effect on mortality (0·93 [0·75-1·17]; p=0·55). Patients with ST-elevation cardiogenic shock without risk of hypoxic brain injury had a reduction in mortality with MCS use (0·77 [0·61-0·97]; p=0·024). Major bleeding (odds ratio 2·64 [95% CI 1·91-3·65]) and vascular complications (4·43 [2·37-8·26]) were more frequent with MCS use than with control. The use of active MCS devices in patients with AMICS did not reduce 6-month mortality (regardless of the device used) and increased major bleeding and vascular complications. However, patients with ST-elevation cardiogenic shock without risk of hypoxic brain injury had a reduction in mortality after MCS use. Therefore, the use of MCS should be restricted to certain patients only. The Heart Center Leipzig at Leipzig University and the Foundation Institut für Herzinfarktforschung.

Optimal patient and mechanical circulatory support device selection in acute myocardial infarction cardiogenic shock

Optimal patient and mechanical circulatory support device selection in acute myocardial infarction cardiogenic shock

Effectiveness of Extracorporeal Cardiopulmonary Resuscitation for Non-Shockable Out-of-Hospital Cardiac Arrest: An Analysis From the SOS-KANTO 2017 Study.

Extracorporeal cardiopulmonary resuscitation (ECPR) using veno-arterial extracorporeal membrane oxygenation (V-A ECMO) has the potential as a viable treatment for refractory out-of-hospital cardiac arrest (OHCA). While mechanical circulatory support devices, such as Impella® and left ventricular assist devices, are being increasingly used, initial ECPR often relies on V-A ECMO. Previous studies, including randomized controlled trials, reported the prognostic benefits of ECPR for shockable OHCA (SOHCA); however, its effectiveness for non-SOHCA (NSOHCA) remains unclear, with poorer neurological outcomes and the lower return of spontaneous circulation rates than for SOHCA being reported. The present study utilized data from the SOS-KANTO 2017 study to examine the impact of ECPR on the neurological outcomes of NSOHCA. Data from 2,502 OHCA cases were analyzed, with a focus on the relationship between ECPR and 90-day neurological outcomes. The results obtained showed significantly higher survival rates at 30 and 90 days and significantly better 90-day neurological outcomes in the ECMO attempt group than in the non-ECMO attempt group. A multivariate analysis identified ECPR as one of the significant independent predictors of favorable neurological outcomes. The prognosis of NSOHCA cases with CA was improved by ECPR using V-A ECMO, particularly in those where CPR was initiated within one minute of onset and the patient arrived at the hospital within 45 minutes. Factors associated with a favorable prognosis included a shorter time from onset to hospital arrival and the likelihood of acute coronary syndrome being the cause of CA. The present results suggest the potential of ECPR to improve the survival and the 90-day prognosis of NSOHCA, particularly when bystander CPR is initiated quickly and hospital arrival is prompt.

Clinical outcomes of the post-closure technique for arteriotomy closure with the Impella cardiac power percutaneous left ventricular assist device.

With the increasing utilization of endovascular mechanical circulatory support devices, such as the Impella CP (Abiomed), there is a need for standardized guidelines for its safe removal. Development of the Perclose post-closure technique was facilitated by the introduction of a new Impella repositioning sheath in 2019, which enabled re-access to the sidearm and stylet, rewiring of the access artery, and Impella sheath removal. Our retrospective single-center study included all patients undergoing Perclose post-closure technique for vascular access closure after Impella removal between 2018 and 2024. Forty-six patients, with a mean age of 63.8 years, predominantly male (82.6%), were included in the analysis. Indications for Impella placement included complex percutaneous coronary intervention (34.8%) and cardiogenic shock (CS) (heart failure-CS: 32.6%, myocardial infarction-CS: 21.7%). Clinically relevant complications were encountered in less than 5% of cases. No instances of covered stent placement, fasciotomy, amputation, or access site infections were reported. Our study underscores the safety of the Perclose post-closure technique following Impella removal in a diverse cohort of patients, with an overall clinically significant complication rate of less than 5%. The Perclose post-closure technique is a reliable and well-tolerated method for vascular access closure in patients undergoing Impella support.

Role of Mechanical Circulatory Support in Complex High-Risk and Indicated Percutaneous Coronary Intervention: Current Indications, Device Options, and Potential Complications.

Improved expertise and technological advancements have enabled the safe and effective performance of complex and high-risk-indicated percutaneous coronary intervention (CHIP) in patients previously considered inoperable or high-risk. Mechanical circulatory support (MCS) devices play a crucial role in stabilizing hemodynamics during percutaneous coronary intervention (PCI) -related ischemia, thereby reducing the risk of major adverse events and achieving a more complete revascularization. However, the use of MCS devices in protected PCI is not without risks, including peri-procedural myocardial infarction (MI), bleeding, and access-related complications. Despite numerous observational studies, there is a significant lack of randomized clinical trials comparing different MCS devices in various CHIP scenarios and evaluating their long-term safety and efficacy profiles. This review aims to summarize the current evidence regarding the benefits of MCS devices during CHIPs, offer a practical guide for selecting appropriate devices based on clinical scenarios, and highlight the unanswered questions that future trials need to address.

Review of Advancements in Managing Cardiogenic Shock: From Emergency Care Protocols to Long-Term Therapeutic Strategies.

Cardiogenic shock (CS) is a complex multifactorial clinical syndrome of end-organ hypoperfusion that could be associated with multisystem organ failure, presenting a diverse range of causes and symptoms. Despite improving survival in recent years due to new advancements, CS still carries a high risk of severe morbidity and mortality. Recent research has focused on improving early detection and understanding of CS through standardized team approaches, detailed hemodynamic assessment, and selective use of temporary mechanical circulatory support devices, leading to better patient outcomes. This review examines CS pathophysiology, emerging classifications, current drug and device therapies, standardized team management strategies, and regionalized care systems aimed at optimizing shock outcomes. Furthermore, we identify gaps in knowledge and outline future research needs.

Anaesthesia considerations in heart transplantation: A comprehensive review

In over 56 years since the first heart transplant, the science of heart transplantation has evolved from an experimental procedure to an established standard of care for end-stage heart failure. The process involves appropriate patient selection, the listing of recipients, pre-operative optimization, intraoperative management, post-operative care, and follow-up. A robust transplant team, strong government backing, and positive support from the population are essential criteria for the success of any transplant program. Management of heart transplant recipients from the Anaesthesia perspective is challenging due to a myriad of patient risk factors; and the urgent nature of surgery due to the unpredictable nature of donor heart availability. The intraoperative aim is safe induction of anaesthesia, strict asepsis, immunosuppressive therapy, anticipation of major vascular injury, managing pulmonary vascular resistance, ventricular support, optimal ventilatory strategy, and good haemostasis. The postoperative goal is preventing infection, haemodynamic management, gradual weaning of supports, adequate analgesia, monitoring for complications, physiotherapy, and early discharge of the patient from the intensive care unit. There is an increased complexity of heart transplant recipients, due to the increasing use of pre-transplantation mechanical circulatory support devices. The cardiac anaesthesiologist needs to have knowledge of the modern changes in the field of Heart Transplant. The goal of this paper is to provide an overview of the heart transplant origins in India, donor pre-operative workup, intra-operative anaesthesia care, and early post-operative management of heart transplant patients.

Extracorporeal membrane oxygenation in the therapy of cardiogenic shock: 1-year outcomes of the multicentre, randomized ECMO-CS trial.

Among patients with cardiogenic shock, immediate initiation of extracorporeal membrane oxygenation (ECMO) did not demonstrate any benefit at 30 days. The present study evaluated 1-year clinical outcomes of the Extracorporeal Membrane Oxygenation in the therapy of Cardiogenic Shock (ECMO-CS) trial. The ECMO-CS trial randomized 117 patients with severe or rapidly progressing cardiogenic shock to immediate initiation of ECMO or early conservative strategy. The primary endpoint for this analysis was 1-year all-cause mortality. Secondary endpoints included a composite of death, resuscitated cardiac arrest or implantation of another mechanical circulatory support device, duration of mechanical ventilation, and the length of intensive care unit (ICU) and hospital stays. In addition, an unplanned post-hoc subgroup analysis was performed. At 1 year, all-cause death occurred in 40 of 58 (69.0%) patients in the ECMO arm and in 40 of 59 (67.8%) in the early conservative arm (hazard ratio [HR] 1.02, 95% confidence interval [CI] 0.66-1.58; p = 0.93). The composite endpoint occurred in 43 (74.1%) patients in the ECMO group and in 47 (79.7%) patients in the early conservative group (HR 0.83, 95% CI 0.55-1.25; p = 0.29). The durations of mechanical ventilation, ICU stay and hospital stay were comparable between groups. Significant interaction with treatment strategy and 1-year mortality was observed in subgroups according to baseline mean arterial pressure (MAP) indicating lower mortality in the subgroup with low baseline MAP (<63 mmHg: HR 0.58, 95% CI 0.29-1.16; pinteraction = 0.017). Among patients with severe or rapidly progressing cardiogenic shock, immediate initiation of ECMO did not improve clinical outcomes at 1 year compared to the early conservative strategy. However, immediate ECMO initiation might be beneficial in patients with advanced haemodynamic compromise.

Mechanical circulatory support devices in adults with congenital heart disease.

Mechanical circulatory support is used frequently as a method of stabilizing patients with end stage heart failure who are unable to safely await allograft availability. While this technology has been fundamentally important in supporting patients with normal cardiac anatomy, it is still used infrequently in adult patients with congenital heart disease and end-stage heart failure. Here, we review the data on mechanical circulatory support technology in this small but growing population of patients with chronic heart disease prone to the development of circulatory failure. Mechanical circulatory support (MCS) has been increasingly employed in adults with congenital heart disease (ACHD) as a bridge to transplant. The new United Network for Organ Sharing listing system favoring temporary MCS use with a higher listing status offers another tool to stabilize ACHD patients and potentially shorten wait times. Both temporary and Durable MCS could help improve transplant candidacy and posttransplant outcomes in select groups of ACHD patients. Durable and temporary MCS have the potential to significantly improve access to transplant and overall transplant outcomes in ACHD patients.

Simulation of the effect of hemolysis on thrombosis in blood-contacting medical devices

Heart failure, broadly characterized by the gradual decline of the ability of the heart to maintain adequate blood flow throughout the body's vascular network of veins and arteries, is one of the leading causes of death worldwide. Mechanical Circulatory Support is one of the few available alternative interventions for late-stage heart failure with reduced ejection fraction. A ventricular assist device is surgically implanted and connected to the left and or right heart ventricles to provide additional bloodflow, off-loading the work required by the heart to maintain circulation. Modern mechanical circulatory support devices generate non-physiological flow conditions that can lead to the damage and rupture of blood cells (hemolysis), and the formation of blood clots (thrombosis), which pose severe health risks to the patient. It is essential to improve prediction tools for blood damage to reduce the risk of hemolysis and thrombosis. A simulation-based approach examines the interaction between hemolysis and thrombosis. Incompressible finite-volume computational fluid dynamics simulations are executed on an open-hub axial flow ventricular assist device. A continuum model of thrombosis and the intrinsic coagulation process is extended to include the effect of hemolysis. The model accounts for the effect of activation of platelets by shear stress, paracrine signaling, adhesion, and hemoglobin and ADP released during hemolysis. The effect of hemolysis with thrombosis is modelled by accounting for the hyper-adhesivity of von-Willebrand Factor on extracellular hemoglobin, and the increased rate of platelet activation induced by ADP release. Thrombosis is assessed at varying inflow rates and rotor speeds, and cases are executed where thrombosis is affected by ADP release and Hb-induced hyper-adhesivity. It is found that there is a non-negligible effect from hemolysis on thrombosis across a range of rotor speeds, and that hyperadhesivity plays a dominant role in thrombus formation in the presence of hemolysis.

Comparison of in-hospital outcomes of ST-elevation myocardial infarction patients with cardiogenic shock receiving left ventricular mechanical circulatory support devices based on transfer status.

We aimed to compare outcomes in patients who receive on-site left ventricular mechanical support versus those transferred to other facilities for mechanical support in ST-elevation myocardial infarction (STEMI) patients with cardiogenic shock. This retrospective study analyzed data from the 2016 to 2020 Nationwide Inpatient Sample (NIS) database. We identified patients with STEMIand cardiogenic shock who received Impella and LVAD placement during their hospital stay. They were divided into two groups: those with in-house (direct) placement and those transferred to higher-level medical centers. The primary goal was to compare mortality rates between these groups. During the study, 15,934 (75.2%) received in-house left ventricular support, while 5255 (24.8%) were transferred. Mean age (63 vs. 64 years) and female percentage (25 vs. 26%) were similar. The average time from admission to receiving LV support was 0.8 days for direct group versus 2.8 days for transfer group (p < 0.001). Transferred patients had a higher rate of prior heart failure (68 vs. 79%, p < 0.001) and peripheral vascular disease (10 vs. 14%, p < 0.001) but a lower rate of hypertension (23 vs. 17%, p = 0.003). There were no significant differences in other comorbidities. Primary outcome mortality did not significantly differ (44.9 vs. 44.2, p = 0.66). After multivariate analysis, transferred patients had higher rates of ECMO usage, acute kidney injury, renal replacement therapy, major bleeding, and ischemic stroke. Length of stay (8 vs. 15 days, p < 0.001) and total charges ($391,472 vs. $581,183, p < 0.001) were significantly higher in the transferred group. Among STEMI patients with cardiogenic shock, our study found no significant difference in mortality between patients transferred for and those with on-site LV support. Those transferred patients experienced more complications, longer length of stay, and increased hospital costs.

Inpatient outcomes of mechanical circulatory support devices and heart transplantation in hypertrophic cardiomyopathy

IntroductionThe pathophysiology of HCM presents unique challenges for the management of cardiogenic shock and the use of mechanical circulatory support devices (MCSD). However, outcomes investigations for MCSD and HT in HCM patients is limited to case reports. The present study investigated MCSD and HT outcomes in HCM patients in a large retrospective cohort. MethodsThe National Inpatient Sample (2016–2019) was used for the retrospective analysis of patients hospitalized for MCSD and HT using ICD-10 codes. Patients with implantation of more than one device category were excluded. These patients were divided into two cohorts, with and without HCM, and compared in terms of in-hospital mortality, trends in mortality rates, hospitalization costs and mean length of stay. ResultsAmong 267,780 patients hospitalized for MCSD and HT, 1155 patients had underlying HCM. Underlying HCM was associated with increased odds of mortality in patients receiving left ventricular assist devices (LVAD) (OR 3.4, 95% CI 1.03–11.2, p = 0.04) and temporary MCSD (OR 2.5, CI 1.8–3.6, p < 0.001). HCM was not associated with increased mortality in patients hospitalized for HT (OR 0.67, CI 0.15–2.85, p = 0.6). Patients with HCM undergoing MCSD and HT had a longer mean length of stay (22.1 vs 13.2 days, p = 0.004), and higher mean hospitalization charges ($830,103 vs $460,383, p < 0.0001) as compared to non-HCM patients. ConclusionUnderlying HCM is associated with increased in-hospital mortality in patients undergoing LVAD and temporary MCSD placement. Further prospective studies are required to expand our understanding of prognosis among HCM patients undergoing MCSD and establish management guidelines.

Combined Use of MITRACLIP and Ventricular ASSIST Devices in Cardiogenic Shock: MITRA-ASSIST Registry.

Background: Patients with cardiogenic shock (CS) and mitral regurgitation (MI) have a prohibitive risk that contraindicates surgical treatment. Although the feasibility of transcatheter edge-to-edge therapy (TEER) has been demonstrated in this setting, the benefit of the combined use of TEER with mechanical circulatory support devices (MCS) has not been studied. The aim of this study was to evaluate the clinical outcomes of TEER in patients with MCS. Methods: The MITRA-ASSIST study is a retrospective multicentre Spanish registry that included patients with MR and CS who underwent TEER in combination with MCS. The primary endpoint was death from any cause at 12 months. The secondary endpoint was a composite of death from any cause or hospitalisation for heart failure at 12 months. Results: A total of twenty-four patients in nine high-volume Spanish centres (66.2 (51-82) years, 70.8% female, EuroSCORE II 20.4 ± 17.8) were included. Acute ST-elevation myocardial infarction was the main CS aetiology (56%), and the most implanted MCS was the intra-aortic balloon pump (82.6%), followed by ECMO (8.7%), IMPELLACP® (4.3%), or a combination of both (4.3%). Procedural success was 95.8%, with 87.5% in-hospital survival. At 12-month follow-up, 25.0% of patients died, and 33.3% had a composite event of death from any cause or hospitalisation for heart failure. Conclusions: TEER in patients with concomitant CS and MR who require MCS appears to be a promising therapeutic alternative with a high device procedural success rate and acceptable mortality and heart failure readmission rates at follow-up.

Three-Year Left Ventricular Assist Device Outcomes and Strategy After Heart Transplant Allocation Score Change

BackgroundThe United Network for Organ Sharing (UNOS) adopted new criteria for the heart allocation score on 10/18/2018 to reflect changing trends of candidates’ mortality while awaiting transplant. We examined the impact of these policy changes on rates of left ventricular assist device (LVAD) implantation and outcomes posttransplant from a relatively newer UNOS database. MethodsThe UNOS registry was used to identify first-time adult heart recipients with LVAD at listing or transplant who underwent transplantation between 1/1/2016 and 3/10/2020. Survival data was collected through 3/30/2023. Those listed prior to 10/18/2018 but transplanted after were excluded. Patients were divided into before or after change groups. Demographics and clinical parameters were compared. Survival was analyzed with Kaplan-Meier curves and log-rank tests. A p<0.05 was considered significant. ResultsWe identified 4387 heart recipients with LVAD in the before (n=3606) and after (n=781) score change eras. The after group had a lower rate of LVAD implantation while listed compared to the before group (20.4% vs 34.9%, p<0.0001), and were more likely to be female (25.1% vs 20.2%, p=0.002); in both groups, most recipients (62.8%) were white. There was significantly farther distance from the donor hospital to transplant center in the after group (264.4 NM vs 144.2NM, p<0.0001) and decreased waitlist days (84.9 ± 105.1 vs 369.2 ± 459.5, p<0.0001). Recipients in the after group were more likely to utilize ECMO (3.7% vs 0.5%, p<0.0001) and IV inotropes (19.1% vs 7.5%, p<0.0001), and receive a CDC increased-risk donor organ (37.9% vs 30.5%, p<0.0001). Survival at 3-years was comparable between the two groups. ConclusionsThe allocation score change in 2018 yielded considerable changes in mechanical circulatory support device implantation strategy and outcomes. The rate of LVAD implantation decreased with increased utilization of temporary mechanical circulatory support devices.

Percutaneous mechanical support in catheter ablation of ventricular arrhythmias: hype or hope?

Catheter ablation (CA) has become an established treatment strategy for managing recurrent ventricular tachycardias (VTs) in patients with structural heart disease. In recent years, percutaneous mechanical circulatory support (PMCS) devices have been increasingly used intra-operatively to improve the ablation outcome. One indication would be rescue therapy for patients who develop haemodynamic deterioration during the ablation. However, more efforts are focused on identifying subjects who are at high risk of such deterioration and could benefit from the pre-emptive use of the PMCS. The third reason to use PMCS could be the inability to identify diffuse substrate, especially in non-ischaemic cardiomyopathy. This paper reviews available experiences using various types of PMCS in different clinical scenarios. Although PMCS allows mapping during VT, it does not significantly influence acute outcomes and not convincingly long-term outcomes. On the contrary, the complication rate appears to be higher in PMCS cohorts. Our data suggest that even in patients with severe left ventricular dysfunction, the substrate modification can be performed without the need for general anaesthesia and risk of haemodynamic decompensation. In end-stage heart failure associated with the electrical storm, implantation of a left ventricular assist device (or PMCS with a transition to the left ventricular assist device) might be the preferred strategy before CA. In high-risk patients who are not potential candidates for these treatment options, radiotherapy could be considered as a bail-out treatment of recurrent VTs. These approaches should be studied in prospective trials.

Implementation of a cardiogenic shock team in a tertiary academic center

ObjectiveObservational studies have shown that the management of patients with cardiogenic shock (CS) by dedicated multidisciplinary teams improves clinical outcomes. Nevertheless, these studies reflect a specific organizational setting with most patients being transferred from referring hospitals, hospitalized in cardiac intensive care units (ICU), or treated with mechanical circulatory support (MCS) devices. The purpose of this study was to document the organization and outcomes of a CS team offering acute care in an all-comer population. MethodsA CS team was developed in a large academic tertiary institution. The team consisted of emergency care physicians, critical care cardiologists, interventional cardiologists, cardiac surgeons, ICU physicians, and heart failure specialists and was supported by a predefined operating protocol, a dedicated communication platform, and regular team meetings. ResultsOver 12 months, 70 CS patients (69 ± 13 years old, 67% males) were included. Acute myocardial infarction (AMI-CS) was the most common cause (64%); 31% of the patients presented post-resuscitated cardiac arrest and 56% needed invasive mechanical ventilation (IMV). Coronary angiography was performed in 70% and 53% had percutaneous coronary intervention. MCS was used in 10% and 6% were referred for urgent cardiac surgery. The in-hospital mortality in our center was 40% with 39% of the patients dying within 24 h from presentation. Overall, 76% of the live patients were discharged home. ConclusionAcross an all-comer population, AMI was the most common cause of CS. A significant number of patients presented post-cardiac arrest, and the majority required IMV. Mortality was high with a significant number dying within hours of presentation.

Pragmatic approach to temporary mechanical circulatory support in acute right ventricular failure

Acute right ventricular failure (RVF) is prevalent in multiple disease states and is associated with poor clinical outcomes. Right-sided temporary mechanical circulatory support (tMCS) devices are used to unload RV congestion and increase cardiac output in cardiogenic shock (CS) with hemodynamically significant RVF. Several RV-tMCS device platforms are available; however consensus is lacking on patient selection, timing of escalation to RV-tMCS, device management, and device weaning. The purposes of this review are to 1) describe the current state of tMCS device therapies for acute RVF with CS, 2) discuss principles of escalation to RV-tMCS device therapy, 3) examine important aspects of clinical management for patients supported by RV-tMCS devices including volume management, anticoagulation, and positive pressure ventilation, and 4) provide a framework for RV-tMCS weaning.

Donor Specific Antibodies in Extracorporeal Membrane Oxygenation-Bridged Lung Transplant Recipients

BackgroundExtracorporeal membrane oxygenation (ECMO) is increasingly used as a bridge to lung transplantation. Although other mechanical circulatory support devices have been associated with anti-human leukocyte antigen antibody formation, including de novo donor-specific antibodies (dnDSA), it is unknown whether ECMO is a sensitizing exposure. MethodsThis was a single-center retrospective cohort study of lung transplant recipients. We compared dnDSA development in ECMO-bridged and non-ECMO exposed recipients. We also assessed differences in chronic lung allograft dysfunction-free survival between ECMO-bridged recipients with and without dnDSA, and between those who developed dnDSA with and without ECMO bridge. ResultsAmong 299 transplant recipients, 48 were ECMO-bridged and 251 were non-ECMO exposed. dnDSA developed in 33.3% of ECMO-bridged and 21.5% of non-ECMO exposed recipients. ECMO was associated with dnDSA development in bivariate (hazard ratio [HR], 2.08, 95% CI, 1.19-3.64, P = .01) but not multivariate analysis after adjusting for known confounders (HR, 1.10, 95% CI, 0.50-2.42, P = .82). Higher posttransplant transfusion volume was independently associated with dnDSA development (HR, 4.68, 95% CI, 2.25-9.72, P < .001). ECMO-bridged recipients with dnDSA did not have worse adjusted chronic lung allograft dysfunction-free survival than those without dnDSA (HR, 0.35, 95% CI, 0.07-1.87, P = .22) or compared to non-ECMO exposed recipients with dnDSA (HR, 0.40, 95% CI, 0.08-2.00, P = .27). ConclusionsA more restrictive posttransplant transfusion threshold among ECMO-bridged lung transplant recipients may reduce the risk of dnDSA. Surveillance for dnDSA, at least among ECMO-bridged recipients, may only be necessary in the presence of allograft dysfunction.

Volume-Outcome Relationships for Intra-Aortic Balloon Pump in Acute Myocardial Infarction.

Acute myocardial infarction (AMI) is a major scenario for the use of an intra-aortic balloon pump (IABP), particularly when complicated by cardiogenic shock, although the utilization of mechanical circulatory support devices varies widely per hospital. We evaluated the relationship, at the hospital level, between the volume of IABP use and mortality in AMI. Using a Japanese nationwide administrative database, 26,490 patients with AMI undergoing primary percutaneous coronary intervention (PCI) from 154 hospitals were included in this study. The primary endpoint was the observed-to-predicted in-hospital mortality ratio. Predicted mortality per patient was calculated using baseline variables and averaged for each hospital. The associations among PCI volume for AMI, observed and predicted in-hospital mortality, and observed and predicted IABP use were assessed per hospital. Of 26,490 patients, 2,959 (11.2%) were treated with IABP and 1,283 (4.8%) died during hospitalization. The annualized number of uses of IABP per hospital in AMI was 4.5. In lower-volume primary PCI centers, IABP was more likely to be underused than expected, and the observed-to-predicted in-hospital mortality ratio was higher than in higher-volume centers. A lower annual number of IABP use was associated with an increased mortality risk at the hospital level, suggesting that IABP use can be an institutional quality indicator in the setting of AMI.

Hemodynamics with mechanical circulatory support devices using a cardiogenic shock model

Mechanical circulatory support (MCS) devices, including veno-arterial extracorporeal membrane oxygenation (VA-ECMO) and Impella, have been widely used for patients with cardiogenic shock (CS). However, hemodynamics with each device and combination therapy is not thoroughly understood. We aimed to elucidate the hemodynamics with MCS using a pulsatile flow model. Hemodynamics with Impella CP, VA-ECMO, and a combination of Impella CP and VA-ECMO were assessed based on the pressure and flow under support with each device and the pressure–volume loop of the ventricle model. The Impella CP device with CS status resulted in an increase in aortic pressure and a decrease in end-diastolic volume and end-diastolic pressure (EDP). VA-ECMO support resulted in increased afterload, leading to a significant increase in aortic pressure with an increase in end-systolic volume and EDP and decreasing venous reservoir pressure. The combination of Impella CP and VA-ECMO led to left ventricular unloading, regardless of increase in afterload. Hemodynamic support with Impella and VA-ECMO should be a promising combination for patients with severe CS.