Mechanical Circulatory Support 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.

Mechanical circulatory support early after pediatric heart transplantation—an analysis from the Pediatric Heart Transplant Society

BackgroundThe use of early Mechanical Circulatory Support (MCS) following pediatric heart transplantation is not well-published. This paper attempts to uncover the incidence, predisposing factors and outcomes of MCS in a large, international cohort. MethodsThe Pediatric Heart Transplant Society Database (an international, prospective, event-driven database) was retrospectively analyzed for all cases of primary heart transplant over an 11-year period (2010-2020), dividing the cohort based on need for MCS within 30 days of transplantation. ResultsOf 4321 primary transplants, 249 (5.8%) required MCS (230 ECMO, 19 VAD). In a Cox proportional hazard model, congenital heart disease (p = 0.0002), older donor age (p < 0.0001), and longer ischemic time (p = 0.018) were each related to an increased need for MCS; increasing recipient body surface area (p < 0.0001) and increasing donor left ventricular ejection fraction (p = 0.016) were both correlated with less MCS use. 1-year survival in those requiring MCS was 54.2%, compared with 94.8% in those who did not need MCS (p < 0.0001). Later survival in patients surviving to one year was similar between the groups. ConclusionsMCS is used infrequently following pediatric heart transplant, and is related to donor, recipient and transplant factors. Although mortality is high, those surviving the first year post-transplant have excellent outcomes. Judicious use in those patients who would otherwise perish is therefore justified.

The intra-aortic balloon pump as a rescue device: Do we need to shift our strategy for cardiogenic shock rescue after cardiac surgery?

ObjectiveThe intra-aortic balloon pump (IABP) is widely used to rescue patients from complications following cardiac surgery. Given improvements in rescue strategies over the past decade, the appropriateness of IABP must be reexamined. This study assessed the risk factors, outcomes, and predictors of survival of rescue IABP placement. MethodsPatients receiving an isolated rescue IABP during or after cardiac surgery from 2012 to 2020 were studied. All adult patients undergoing cardiac surgery except transplantation and primary mechanical circulatory support (MCS) procedures were included. ResultsOf 10,591 patients, 397 (3.7%) received a perioperative IABP, including 182 (45.8%) with rescue IABP placement. The indications for rescue IABP were postcardiotomy shock (n = 66; 36.3%), failure to wean off cardiopulmonary bypass (n = 58; 31.9%), myocardial ischemia (n = 30; 16.5%), cardiac arrest (n = 25; 13.7%), and ventricular arrhythmia (n = 3; 1.6%). The in-hospital failure to rescue rate was 17.6% (n = 32 of 182) with a 90-day survival of 80.8% and 1-year survival of 76.9%. The most common etiology of mortality was ongoing cardiogenic shock (61.9%; n = 26 of 42). IABP use for >4 days and cardiac arrest as an indication for IABP were risk factors for 1-year mortality (adjusted hazard ratio, 2.68 [95% confidence interval (CI), 1.31-5.50] and 2.69 [95% CI, 1.11-6.54], respectively). ConclusionsRescue IABP following cardiac surgery is associated with increased early and 1-year mortality. Prolonged IABP use beyond 4 days or cardiac arrest as an indication portended a significantly worse prognosis. Rescue IABP may not be the optimal first-line temporary MCS for all patients, as the level of support provided might not match the severity of cardiogenic shock. Alternative MCS strategies should be considered early.

Feasibility and Effectiveness of Venoarterial Extracorporeal Membrane Oxygenation Plus Intra-Aortic Balloon Pump Assisted High-Risk Percutaneous Coronary Intervention in Complex Coronary Disease.

Mechanical circulatory support may facilitate high-risk percutaneous coronary intervention (PCI). This study aimed to assess the feasibility, safety and effectiveness of high-risk PCI under the support of venoarterial extracorporeal membrane oxygenation (VA-ECMO) combined with intra-aortic balloon pump (IABP). We enrolled patients who received VA-ECMO plus IABP-assisted PCI procedures at our center from April 2012 to June 2018. Major adverse cardiac events (MACEs) included all-cause death, myocardial infarction, and target vessel revascularization. A total of 10 patients were included, with a mean age of 71 years, EuroSCORE II of 19.9%, and SYNTAX score of 39.8. Procedural success was achieved in nine (90%) patients. The mean duration of ECMO support was 1.5 hours, and 2.6 stents were implanted per patient. Major complications included contrast-induced nephropathy needing hemodialysis in one (10%) patient, significant hemoglobin drop requiring blood transfusion in two (20%) patients, pulmonary infection in one (10%) patient, and local surgical incision infection in one (10%) patient. The accumulative mortality rates for the nine patients with procedural success were 0, 22.2%, and 44.4% at 1, 3, and 5 years follow-up, respectively. However, cardiac death occurred in only one (11.1%) patient. In addition, two patients received repeat PCI or coronary artery bypass grafting within two years following the index procedure. The overall incidence rates of MACEs were 11.1%, 44.4%, and 66.7% at 1, 3, and 5 years follow-up, respectively. VA-ECMO plus IABP-assisted high-risk PCI was feasible in patients with complex coronary disease, with a high procedural success rate and acceptable mid-term clinical outcomes.

Femoral Large Bore Sheath Management: How to Prevent Vascular Complications From Vessel Puncture to Sheath Removal.

Transfemoral access is nowadays required for an increasing number of percutaneous procedures, such as structural heart interventions, mechanical circulatory support, and interventional electrophysiology/pacing. Despite technological advancements and improved techniques, these devices necessitate large-bore (≥12 French) arterial/venous sheaths, posing a significant risk of bleeding and vascular complications, whose occurrence has been related to an increase in morbidity and mortality. Therefore, optimizing large-bore vascular access management is crucial in endovascular interventions. Technical options, including optimized preprocedural planning and proper selection and utilization of vascular closure devices, have been developed to increase safety. This review explores the comprehensive management of large-bore accesses, from optimal vascular puncture to sheath removal. It also discusses strategies for managing closure device failure, with the goal of minimizing vascular complications.

Impact of Covert Brain Infarction Following Coronary Angiography on Coronary Artery Bypass Surgery Outcomes

ObjectiveTo determine the association between preoperative covert brain infarction following coronary angiography (CAG) and major adverse cardiac and cerebrovascular events (MACCE) after CABG. DesignCohort study between January 2006 and December 2019 with the follow-up period concluding at either 5 years after surgery, the date of death, or April 27th, 2023. SettingAt a single tertiary center in Korea. ParticipantsPatients who underwent pre-operative CAG and subsequent brain magnetic resonance imaging (MRI) before elective CABG. InterventionsNone. Measurements and Main ResultsThe primary outcome was the incidence of MACCE within 30 days of CABG. MACCE included operative death (all-cause death within 30 days of surgery or before discharge), myocardial infarction, mechanical circulatory support, circulatory arrest, and stroke. The secondary outcomes included each component of MACCE and all-cause mortality at 5 years after surgery. Out of the 2,476 study patients (median [IQR] age, 65 [58 to 71] years; 24.7% were female), 212 (8.6%) had covert cerebral infarction on brain MRI after CAG but before CABG, and 353 (14.3%) patients experienced MACCE after CABG. After performing 1:4 propensity-score matching, a total of 1,057 patients were included in the final outcome analysis (212 with covert brain infarction and 845 without). The incidence of MACCE within 30 days was not significantly different between patients with a covert brain infarction and those without (15.1% [32/212] vs. 15.6% [132/845]; risk difference, -0.5, 95% confidence interval [CI]: -5.6 to 4.4; risk ratio: 0.97, 95% CI, 0.66 to 1.32; P=.85). There were also no significant differences in each component of MACCE within 30 days. There was no significant difference between the two groups in terms of all-cause mortality at 5 years (18.7% vs. 17.0%, respectively, P for stratified log-rank test=.33). ConclusionsAmong patients undergoing elective CABG, there was no significant association between covert brain infarction following CAG and the occurrence of MACCE within 30 days and long-term mortality after CABG.

Clinical Characteristics and Outcomes of Patients Suffering Acute Decompensated Heart Failure Complicated by Cardiogenic Shock.

Cardiogenic shock (CS) can stem from multiple causes and portends poor prognosis. Prior studies have focused on acute myocardial infarction-CS; however, acute decompensated heart failure (ADHF)-CS accounts for most cases. We studied patients suffering ADHF-CS to identify clinical factors, early in their trajectory, associated with a higher probability of successful outcomes. Consecutive patients with CS were evaluated (N=1162). We studied patients who developed ADHF-CS at our hospital (N=562). Primary end point was native heart survival (NHS), defined as survival to discharge without receiving advanced HF therapies. Secondary end points were adverse events, survival, major cardiac interventions, and hospital readmissions within 1 year following index hospitalization discharge. Association of clinical data with NHS was analyzed using logistic regression. Overall, 357 (63.5%) patients achieved NHS, 165 (29.2%) died, and 41 (7.3%) were discharged post advanced HF therapies. Of 398 discharged patients (70.8%), 303 (53.9%) were alive at 1 year. Patients with NHS less commonly suffered cardiac arrest, underwent intubation or pulmonary artery catheter placement, or received temporary mechanical circulatory support, had better hemodynamic and echocardiographic profiles, and had a lower vasoactive-inotropic score at shock onset. Bleeding, hemorrhagic stroke, hemolysis in patients with mechanical circulatory support, and acute kidney injury requiring renal replacement therapy were less common compared with patients who died or received advanced HF therapies. After multivariable adjustments, clinical variables associated with NHS likelihood included younger age, history of systemic hypertension, absence of cardiac arrest or acute kidney injury requiring renal replacement therapy, lower pulmonary capillary wedge pressure and vasoactive-inotropic score, and higher tricuspid annular plane systolic excursion at shock onset (all P<0.05). By studying contemporary patients with ADHF-CS, we identified clinical factors that can inform clinical management and provide future research targets. Right ventricular function, renal function, pulmonary artery catheter placement, and type and timing of temporary mechanical circulatory support warrant further investigation to improve outcomes of this devastating condition.

Clinical characteristics and short-term outcomes in patients with cardiogenic shock undergoing mechanical circulatory support escalation from intra-aortic balloon pump to impella: From the J-PVAD registry.

An escalation strategy from intra-aortic balloon pump (IABP) to Impella (AbioMed, Danvers, MA, USA) is proposed in patients with cardiogenic shock (CS) refractory to IABP therapy, but its clinical data are lacking. This study aimed to elucidate the clinical characteristics and short-term outcomes in patients undergoing IABP-Impella escalation. From the Japanese nationwide registry of Impella (J-PVAD), a total of 2578 patients with CS receiving Impella support were classified into the IABP-Impella group (n = 189) or the Primary Impella group (n = 2389). We applied 1:3 propensity score (PS) matching, selecting 185 patients and 555 patients, respectively. Before matching, the IABP-Impella group presented longer shock-to-Impella time, worse laboratory data, and more frequent inotropes and pulmonary artery catheter use than the Primary Impella group. After matching, the baseline characteristics were well-balanced. Regarding the 30-day clinical outcomes in the PS-matched cohort, there were no significant differences in the rates of mortality and major complications (a composite of bleeding, hemolysis, infection, stroke, myocardial infarction, limb ischemia, and vascular injury) between the groups. However, The IABP-Impella group showed a significantly higher rate of infection (10.3 % vs. 5.6 %, p = 0.042) and additional mechanical circulatory support use (34.1 % vs. 23.8 %, p = 0.008) than the Primary Impella group. Compared to patients with primary Impella support, those undergoing IABP-Impella escalation showed similar 30-day mortality and major complications despite poorer clinical conditions before Impella support and a more complicated clinical course after Impella insertion.

Implantable continuous-flow total artificial heart for newborns and small pediatric patients: First report of working model

ObjectiveThe need for safe and reliable mechanical circulatory support (MCS) for smaller children with severe heart failure (HF) is well defined. More specifically, in pediatric patients with advanced congenital HF, there is no implantable total artificial heart (TAH) device available for small patients. Herein, we report the development of the infant continuous-flow total artificial heart (I-CFTAH), a fully implantable in infants and newborns. MethodsAfter extensive engineering analysis, we performed an unprecedented effort: reducing the I-CFTAH's displacement volume to be 14% of the adult CFTAH pump while simultaneously decreasing pump diameter (6.2 cm to 2.6 cm) and axial length (9.8 cm to 4.8 cm). Facilitated by these proportional reductions, for the first time, a durable total artificial heart device was successfully fit in the chest of infants and newborns (height of ≥50 cm). ResultsThe functional I-CFTAH prototype demonstrated capability to support stable hemodynamics and desired device performance. The pump flow range (0.5-1.5 L/min) was confirmed in a mock circulatory testing loop. Within the tested flow range, the I-CFTAH can support small patients that could benefit from the intended cardiac output. ConclusionsThis successful effort demonstrated the feasibility of the miniature continuous-flow total artificial heart, intended for very small patient populations. I-CFTAH showed stable hemodynamics and could, therefore, become one of the few therapeutic options as a bridge to transplantation, aiming to enhance both the quality and duration of life for pediatric patients with advanced HF.

Extracorporeal membrane oxygenation as a bridge to thoracic multiorgan transplantation

BackgroundExtracorporeal membrane oxygenation (ECMO) has emerged as a crucial tool in the care of patients with multiorgan failure, and is increasingly utilized as a bridge to transplantation. While data on ECMO as a bridge to isolated heart and lung transplantation have been described, our emerging experience with ECMO as a bridge to thoracic multiorgan transplantation is not yet well understood. This study aims to investigate temporal trends, utilization, and outcomes in ECMO as a bridge to thoracic multiorgan transplantation. MethodsThe United Network for Organ Sharing database was used to identify adult patients undergoing thoracic multiorgan transplantation between 1987 and 2022. Exclusion criteria were recipient age <18 and bridging with other mechanical circulatory support including ventricular assist device (VAD) and intra-aortic balloon pump (IABP). Survival analysis was performed to compare outcomes between patients bridged to transplantation with ECMO and those who were not bridged. ResultsOf 3,927 patients undergoing thoracic multiorgan transplantation, a total of 203 (5.2%) patients received ECMO as a bridge to transplantation. Among ECMO recipients, patients were most commonly bridged to heart-lung (45.8%), followed by heart-kidney (34.5%), and lung-kidney transplantation (11.8%). At a median follow-up of 35.5 months, unadjusted survival among patients bridged with ECMO was decreased versus multiorgan transplant recipients who were not bridged (p<0.001). With adjusted multivariable Cox regression, ECMO was independently associated with an elevated risk of mortality following multiorgan transplantation (HR 1.56 [1.21-2.02], p<0.01). Among patients surviving past 30 days following transplantation, conditional long-term survival was similar between those bridged with ECMO and those not bridged (p = 0.82). ConclusionECMO is increasingly utilized as a bridge to thoracic multiorgan transplantation, and is associated with increased 30 day mortality and decreased long-term survival. In select patients surviving to 30 days following transplantation, similar long-term survival is seen between patients bridged with ECMO and those not bridged.

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

Design Issues With Pediatric Mechanical Circulatory Support Systems

Design Issues With Pediatric Mechanical Circulatory Support Systems

Mechanical circulatory support for sepsis-induced myocardial dysfunction

Mechanical circulatory support for sepsis-induced myocardial dysfunction

Prognostic Significance of Hemodynamics in Patients With Transposition of the Great Arteries and Systemic Right Ventricle.

Patients with transposition of the great arteries (TGA) and systemic right ventricle often confront significant adverse cardiac events. The prognostic significance of invasive hemodynamic parameters in this context remains uncertain. Our hypothesis is that the aortic pulsatility index and hemodynamic profiling utilizing invasive measures provide prognostic insights for patients with TGA and a systemic right ventricle. This retrospective multicenter cohort study encompasses adults with TGA and a systemic right ventricle who underwent cardiac catheterization. Data collection, spanning from 1994 to 2020, encompasses clinical and hemodynamic parameters, including measured and calculated values such as pulmonary capillary wedge pressure, aortic pulsatility index, and cardiac index. Pulmonary capillary wedge pressure and cardiac index values were used to establish 4 distinct hemodynamic profiles. A pulmonary capillary wedge pressure of ≥15 mm Hg indicated congestion, termed wet, while a cardiac index <2.2 L/min per m2 signified inadequate perfusion, labeled cold. The primary outcome comprised a composite of all-cause death, heart transplantation, or the requirement for mechanical circulatory support. Of 1721 patients with TGA, 242 individuals with available invasive hemodynamic data were included. The median follow-up duration after cardiac catheterization was 11.4 (interquartile range, 7.5-15.9) years, with a mean age of 38.5±10.8 years at the time of cardiac catheterization. Among hemodynamic parameters, an aortic pulsatility index <1.5 emerged as a robust predictor of the primary outcome, with adjusted hazard ratios of 5.90 (95% CI, 3.01-11.62; P<0.001). Among the identified 4 hemodynamic profiles, the cold/wet profile was associated with the highest risk for the primary outcome, with an adjusted hazard ratio of 3.83 (95% CI, 1.63-9.02; P<0.001). A low aortic pulsatility index (<1.5) and the cold/wet hemodynamic profile are linked with an elevated risk of adverse long-term cardiac outcomes in patients with TGA and systemic right ventricle.

Clinical Outcomes of Cardiogenic Shock Due to Spontaneous Coronary Artery Dissection Versus Cardiogenic Shock Due to Coronary Artery Disease.

Spontaneous coronary artery dissection (SCAD) can be treated conservatively. However, some SCAD patients can develop cardiogenic shock (CS). We evaluated the outcomes of SCAD-related CS using data from a national population-based cohort study from January 1, 2016, to December 30, 2019. In our study of 32,640 patients with SCAD, about 10.6% of patients presented with CS. We found that SCAD patients with CS had higher mortality and greater complications including use of mechanical circulatory devices, arrhythmias, respiratory support, and acute heart failure compared to those without CS. When comparing CS due to SCAD with that due to coronary artery disease, we found that although mortality rates were similar, those with CS due to SCAD were associated with higher risk of use of mechanical circulatory support, major bleeding, blood transfusion, and respiratory failure.

114: The Role of a Continuous Compartment Pressure Device in Managing Acute Compartment Syndrome in Patients Requiring Mechanical Circulatory Support

114: The Role of a Continuous Compartment Pressure Device in Managing Acute Compartment Syndrome in Patients Requiring Mechanical Circulatory Support

225: Pre-Transplant Short-Term Mechanical Circulatory Support Effects on Long-Term Kidney Function Outcomes Following Heart Transplant

225: Pre-Transplant Short-Term Mechanical Circulatory Support Effects on Long-Term Kidney Function Outcomes Following Heart Transplant

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.

229: Pre-Transplant Short-Term Mechanical Circulatory Support Effects on Postoperative Kidney Function Outcomes Following Simultaneous Heart-Kidney Transplant

229: Pre-Transplant Short-Term Mechanical Circulatory Support Effects on Postoperative Kidney Function Outcomes Following Simultaneous Heart-Kidney Transplant

70: To stand or not to stand: The effectiveness of early verticalization therapy in critically ill patients requiring mechanical circulatory support.

70: To stand or not to stand: The effectiveness of early verticalization therapy in critically ill patients requiring mechanical circulatory support.