Engineering › Biomedical Engineering

Mechanical Circulatory Support Devices

Description

This cluster of papers focuses on advancements in mechanical circulatory support systems, including the use of left ventricular assist devices, extracorporeal membrane oxygenation, and ventricular assist devices for patients with cardiogenic shock and heart failure. It also covers topics such as cardiac resuscitation, percutaneous coronary intervention, thrombosis, and hemodynamic support.

Keywords

Left Ventricular Assist Device; Extracorporeal Membrane Oxygenation; Cardiogenic Shock; Heart Failure; ECMO; Ventricular Assist Device; Cardiac Resuscitation; Percutaneous Coronary Intervention; Thrombosis; Hemodynamic Support

In patients with severe heart failure, prolonged unloading of the myocardium with the use of a left ventricular assist device has been reported to lead to myocardial recovery in small … In patients with severe heart failure, prolonged unloading of the myocardium with the use of a left ventricular assist device has been reported to lead to myocardial recovery in small numbers of patients for varying periods of time. Increasing the frequency and durability of myocardial recovery could reduce or postpone the need for subsequent heart transplantation.
The novel influenza A(H1N1) pandemic affected Australia and New Zealand during the 2009 southern hemisphere winter. It caused an epidemic of critical illness and some patients developed severe acute respiratory … The novel influenza A(H1N1) pandemic affected Australia and New Zealand during the 2009 southern hemisphere winter. It caused an epidemic of critical illness and some patients developed severe acute respiratory distress syndrome (ARDS) and were treated with extracorporeal membrane oxygenation (ECMO).To describe the characteristics of all patients with 2009 influenza A(H1N1)-associated ARDS treated with ECMO and to report incidence, resource utilization, and patient outcomes.An observational study of all patients (n = 68) with 2009 influenza A(H1N1)-associated ARDS treated with ECMO in 15 intensive care units (ICUs) in Australia and New Zealand between June 1 and August 31, 2009.Incidence, clinical features, degree of pulmonary dysfunction, technical characteristics, duration of ECMO, complications, and survival.Sixty-eight patients with severe influenza-associated ARDS were treated with ECMO, of whom 61 had either confirmed 2009 influenza A(H1N1) (n = 53) or influenza A not subtyped (n = 8), representing an incidence rate of 2.6 ECMO cases per million population. An additional 133 patients with influenza A received mechanical ventilation but no ECMO in the same ICUs. The 68 patients who received ECMO had a median (interquartile range [IQR]) age of 34.4 (26.6-43.1) years and 34 patients (50%) were men. Before ECMO, patients had severe respiratory failure despite advanced mechanical ventilatory support with a median (IQR) Pao(2)/fraction of inspired oxygen (Fio(2)) ratio of 56 (48-63), positive end-expiratory pressure of 18 (15-20) cm H(2)O, and an acute lung injury score of 3.8 (3.5-4.0). The median (IQR) duration of ECMO support was 10 (7-15) days. At the time of reporting, 48 of the 68 patients (71%; 95% confidence interval [CI], 60%-82%) had survived to ICU discharge, of whom 32 had survived to hospital discharge and 16 remained as hospital inpatients. Fourteen patients (21%; 95% CI, 11%-30%) had died and 6 remained in the ICU, 2 of whom were still receiving ECMO.During June to August 2009 in Australia and New Zealand, the ICUs at regional referral centers provided mechanical ventilation for many patients with 2009 influenza A(H1N1)-associated respiratory failure, one-third of whom received ECMO. These ECMO-treated patients were often young adults with severe hypoxemia and had a 21% mortality rate at the end of the study period.
Background— The landmark Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) trial first demonstrated that implantation of left ventricular assist devices (LVADs) as destination therapy … Background— The landmark Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) trial first demonstrated that implantation of left ventricular assist devices (LVADs) as destination therapy (DT) can provide survival superior to any known medical treatment in patients with end-stage heart failure who are ineligible for transplantation. In the present study, we describe outcomes of DT in the post-REMATCH era in the United States. Methods and Results— The present study included 280 patients who underwent HeartMate XVE LVAD implantation between November 2001 and December 2005. A preoperative risk score for in-hospital mortality after LVAD implantation was established in 222 patients with complete data. All patients were followed up until death or December 2006. The 1-year survival after LVAD implantation was 56%. The in-hospital mortality after LVAD surgery was 27%. The main causes of death included sepsis, right heart failure, and multiorgan failure. The most important determinants of in-hospital mortality were poor nutrition, hematological abnormalities, markers of end-organ or right ventricular dysfunction, and lack of inotropic support. Stratification of DT candidates into low (n=65), medium (n=111), high (n=28), and very high (n=18) risk on the basis of the risk score calculated from these predictors corresponded with 1-year survival rates of 81%, 62%, 28%, and 11%, respectively. Conclusions— Appropriate selection of candidates and timing of LVAD implantation are critical for improved outcomes of DT. Patients with advanced heart failure who are referred for DT before major complications of heart failure develop have the best chance of achieving an excellent 1-year survival with LVAD therapy.
Early mechanical revascularization in patients with acute myocardial infarction (AMI) complicated by cardiogenic shock is a therapeutic strategy that reduces mortality. It has been a class I recommendation in guidelines … Early mechanical revascularization in patients with acute myocardial infarction (AMI) complicated by cardiogenic shock is a therapeutic strategy that reduces mortality. It has been a class I recommendation in guidelines from the American College of Cardiology and the American Heart Association since 1999 for patients younger than 75 years. However, little is known about implementation of these guidelines in practice.To assess trends in early revascularization and mortality for patients with cardiogenic shock complicating AMI and to determine whether the national guidelines affect revascularization rates.Prospective, observational study of 293,633 patients with ST-elevation myocardial infarction (25,311 [8.6%] had cardiogenic shock; 7356 [29%] had cardiogenic shock at hospital presentation) enrolled in the National Registry of Myocardial Infarction (NRMI) from January 1995 to May 2004 at 775 US hospitals with revascularization capability (defined as the capability to perform cardiac catheterization, percutaneous coronary intervention [PCI], and open-heart surgery).Management patterns and in-hospital mortality rates.There was an increase in primary PCI rates from 27.4% to 54.4% (P<.001) in hospitals with revascularization capability that paralleled the change in PCI for ST-elevation myocardial infarction. There was no significant change in rates of immediate coronary artery bypass graft surgery (from 2.1% to 3.2%). Propensity-adjusted multivariable analyses demonstrated that primary PCI was associated with a decreased odds of death during hospitalization (odds ratio, 0.46; 95% confidence interval, 0.40-0.53). There were no differences in the rates of change in revascularization rates based on the date when the guidelines were released regardless of patient age. Overall in-hospital cardiogenic shock mortality decreased from 60.3% in 1995 to 47.9% in 2004 (P<.001).The use of PCI for patients with cardiogenic shock was associated with improved survival in a large group of hospitals with revascularization capability. The American College of Cardiology and American Heart Association guidelines had no detectable temporal impact on revascularization rates. These findings support the need for increased adherence to these guidelines.
We observed an apparent increase in the rate of device thrombosis among patients who received the HeartMate II left ventricular assist device, as compared with preapproval clinical-trial results and initial … We observed an apparent increase in the rate of device thrombosis among patients who received the HeartMate II left ventricular assist device, as compared with preapproval clinical-trial results and initial experience. We investigated the occurrence of pump thrombosis and elevated lactate dehydrogenase (LDH) levels, LDH levels presaging thrombosis (and associated hemolysis), and outcomes of different management strategies in a multi-institutional study.
A 41-year-old woman presents with severe pneumonia, and the acute respiratory distress syndrome (ARDS) develops. Despite mechanical ventilation, her oxygenation deteriorates. The use of extracorporeal membrane oxygenation (ECMO) is recommended. A 41-year-old woman presents with severe pneumonia, and the acute respiratory distress syndrome (ARDS) develops. Despite mechanical ventilation, her oxygenation deteriorates. The use of extracorporeal membrane oxygenation (ECMO) is recommended.
Background— Although coronary artery bypass grafting is generally preferred in symptomatic patients with severe, complex multivessel, or left main disease, some patients present with clinical features that make coronary artery … Background— Although coronary artery bypass grafting is generally preferred in symptomatic patients with severe, complex multivessel, or left main disease, some patients present with clinical features that make coronary artery bypass grafting clinically unattractive. Percutaneous coronary intervention with hemodynamic support may be feasible for these patients. Currently, there is no systematic comparative evaluation of hemodynamic support devices for this indication. Methods and Results— We randomly assigned 452 symptomatic patients with complex 3-vessel disease or unprotected left main coronary artery disease and severely depressed left ventricular function to intra-aortic balloon pump (IABP) (n=226) or Impella 2.5 (n=226) support during nonemergent high-risk percutaneous coronary intervention. The primary end point was the 30-day incidence of major adverse events. A 90-day follow-up was required, as well, by protocol. Impella 2.5 provided superior hemodynamic support in comparison with IABP, with maximal decrease in cardiac power output from baseline of āˆ’0.04±0.24 W in comparison with āˆ’0.14±0.27 W for IABP ( P =0.001). The primary end point (30-day major adverse events) was not statistically different between groups: 35.1% for Impella 2.5 versus 40.1% for IABP, P =0.227 in the intent-to-treat population and 34.3% versus 42.2%, P =0.092 in the per protocol population. At 90 days, a strong trend toward decreased major adverse events was observed in Impella 2.5–supported patients in comparison with IABP: 40.6% versus 49.3%, P =0.066 in the intent-to-treat population and 40.0% versus 51.0%, P =0.023 in the per protocol population, respectively. Conclusions— The 30-day incidence of major adverse events was not different for patients with IABP or Impella 2.5 hemodynamic support. However, trends for improved outcomes were observed for Impella 2.5–supported patients at 90 days. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00562016.
Rationale: Increasing use of extracorporeal membrane oxygenation (ECMO) for acute respiratory failure may increase resource requirements and hospital costs. Better prediction of survival in these patients may improve resource use, … Rationale: Increasing use of extracorporeal membrane oxygenation (ECMO) for acute respiratory failure may increase resource requirements and hospital costs. Better prediction of survival in these patients may improve resource use, allow risk-adjusted comparison of center-specific outcomes, and help clinicians to target patients most likely to benefit from ECMO.Objectives: To create a model for predicting hospital survival at initiation of ECMO for respiratory failure.Methods: Adult patients with severe acute respiratory failure treated by ECMO from 2000 to 2012 were extracted from the Extracorporeal Life Support Organization (ELSO) international registry. Multivariable logistic regression was used to create the Respiratory ECMO Survival Prediction (RESP) score using bootstrapping methodology with internal and external validation.Measurements and Main Results: Of the 2,355 patients included in the study, 1,338 patients (57%) were discharged alive from hospital. The RESP score was developed using pre-ECMO variables independently associated with hospital survival on logistic regression, which included age, immunocompromised status, duration of mechanical ventilation before ECMO, diagnosis, central nervous system dysfunction, acute associated nonpulmonary infection, neuromuscular blockade agents or nitric oxide use, bicarbonate infusion, cardiac arrest, PaCO2, and peak inspiratory pressure. The receiver operating characteristics curve analysis of the RESP score was c = 0.74 (95% confidence interval, 0.72–0.76). External validation, performed on 140 patients, exhibited excellent discrimination (c = 0.92; 95% confidence interval, 0.89–0.97).Conclusions: The RESP score is a relevant and validated tool to predict survival for patients receiving ECMO for respiratory failure.
Background— This study evaluated the hypothesis that transendocardial injections of autologous mononuclear bone marrow cells in patients with end-stage ischemic heart disease could safely promote neovascularization and improve perfusion and … Background— This study evaluated the hypothesis that transendocardial injections of autologous mononuclear bone marrow cells in patients with end-stage ischemic heart disease could safely promote neovascularization and improve perfusion and myocardial contractility. Methods and Results— Twenty-one patients were enrolled in this prospective, nonrandomized, open-label study (first 14 patients, treatment; last 7 patients, control). Baseline evaluations included complete clinical and laboratory evaluations, exercise stress (ramp treadmill), 2D Doppler echocardiogram, single-photon emission computed tomography perfusion scan, and 24-hour Holter monitoring. Bone marrow mononuclear cells were harvested, isolated, washed, and resuspended in saline for injection by NOGA catheter (15 injections of 0.2 cc). Electromechanical mapping was used to identify viable myocardium (unipolar voltage ≄6.9 mV) for treatment. Treated and control patients underwent 2-month noninvasive follow-up, and treated patients alone underwent a 4-month invasive follow-up according to standard protocols and with the same procedures used as at baseline. Patient population demographics and exercise test variables did not differ significantly between the treatment and control groups; only serum creatinine and brain natriuretic peptide levels varied in laboratory evaluations at follow-up, being relatively higher in control patients. At 2 months, there was a significant reduction in total reversible defect and improvement in global left ventricular function within the treatment group and between the treatment and control groups ( P =0.02) on quantitative single-photon emission computed tomography analysis. At 4 months, there was improvement in ejection fraction from a baseline of 20% to 29% ( P =0.003) and a reduction in end-systolic volume ( P =0.03) in the treated patients. Electromechanical mapping revealed significant mechanical improvement of the injected segments ( P &lt;0.0005) at 4 months after treatment. Conclusions— Thus, the present study demonstrates the relative safety of intramyocardial injections of bone marrow–derived stem cells in humans with severe heart failure and the potential for improving myocardial blood flow with associated enhancement of regional and global left ventricular function.
XTRACORPOREAL MEMBRANE OXYgenation (ECMO) can support gas exchange independently of mechanical ventilation in patients with severe acute respiratory failure.ECMO may be used either as a rescue intervention or to minimize … XTRACORPOREAL MEMBRANE OXYgenation (ECMO) can support gas exchange independently of mechanical ventilation in patients with severe acute respiratory failure.ECMO may be used either as a rescue intervention or to minimize ventilator-associated lung injury 1 and its associated multiple organ dysfunction, 2 both crucial determinants of survival for patients with acute respiratory distress syndrome (ARDS).
In current international guidelines, intraaortic balloon counterpulsation is considered to be a class I treatment for cardiogenic shock complicating acute myocardial infarction. However, evidence is based mainly on registry data, … In current international guidelines, intraaortic balloon counterpulsation is considered to be a class I treatment for cardiogenic shock complicating acute myocardial infarction. However, evidence is based mainly on registry data, and there is a paucity of randomized clinical trials.
Forty-three patients were entered in an uncontrolled study designed to evaluate extracorporeal membrane lung support in severe acute respiratory failure of parenchymal origin. Most of the metabolic carbon dioxide production … Forty-three patients were entered in an uncontrolled study designed to evaluate extracorporeal membrane lung support in severe acute respiratory failure of parenchymal origin. Most of the metabolic carbon dioxide production was cleared through a low-flow venovenous bypass. To avoid lung injury from conventional mechanical ventilation, the lungs were kept "at rest" (three to five breaths per minute) at a low peak airway pressure of 35 to 45 cm H2O (3.4 to 4.4 kPa). The entry criteria were based on gas exchange under standard ventilatory conditions (expected mortality rate, greater than 90%). Lung function improved in thirty-one patients (72.8%), and 21 patients (48.8%) eventually survived. The mean time on bypass for the survivors was 5.4 +/- 3.5 days. Improvement in lung function, when present, always occurred within 48 hours. Blood loss averaged 1800 +/- 850 mL/d. No major technical accidents occurred in more than 8000 hours of perfusion. Extracorporeal carbon dioxide removal with low-frequency ventilation proved a safe technique, and we suggest it as a valuable tool and an alternative to treating severe acute respiratory failure by conventional means.
Techniques are described for insertion of vinyl catheters into the umbilical and limb vessels of the fetus of the sheep or the goat through small uterine incisions, with the ewes … Techniques are described for insertion of vinyl catheters into the umbilical and limb vessels of the fetus of the sheep or the goat through small uterine incisions, with the ewes under spinal analgesia. The catheters are exteriorized and the fetus can be studied in its normal intrauterine environment. During constant infusion of antipyrine into a fetal limb vein, placental arteriovenous difference of antipyrine was measured, and fetal umbilical blood flow was calculated by the Fick method. "Carbonized" microspheres (50-µ diameter) labeled with various nuclides were injected into different venous sites in the fetus. The distribution pattern of the microspheres was used to determine the relative distribution of blood flow. Experimental evidence is provided that (1) there is no significant recirculation of microspheres, (2) the distribution of spheres is proportional to flow, and (3) circulatory physiology is not altered by injection of spheres. Quantitative data on the distribution of umbilical venous and superior and inferior vena caval return were obtained. It was possible to determine the actual blood flow to each of the fetal organs by relating the proportions of nuclide in each organ to that in the placenta. Total cardiac output was then calculable, taking into consideration the hemodynamic arrangement of the fetal circulation.
Background The neurological morbidity associated with prolonged periods of circulatory arrest has led some cardiac surgical teams to promote continuous low-flow cardiopulmonary bypass as an alternative strategy. The nonneurological postoperative … Background The neurological morbidity associated with prolonged periods of circulatory arrest has led some cardiac surgical teams to promote continuous low-flow cardiopulmonary bypass as an alternative strategy. The nonneurological postoperative effects of both techniques have been previously studied only in a limited fashion. Methods and Results We compared the hemodynamic profile (cardiac index and systemic and pulmonary vascular resistances), intraoperative and postoperative fluid balance, and perioperative course after deep hypothermia and support consisting predominantly of total circulatory arrest or low-flow cardiopulmonary bypass in a randomized, single-center trial. Eligibility criteria included a diagnosis of transposition of the great arteries and a planned arterial switch operation before the age of 3 months. Of the 171 patients, 129 (66 assigned to circulatory arrest and 63 to low-flow bypass) had an intact ventricular septum and 42 (21 assigned to circulatory arrest and 21 to low-flow bypass) had an associated ventricular septal defect. There were 3 (1.8%) hospital deaths. Patients assigned to low-flow bypass had significantly greater weight gain and positive fluid balance compared with patients assigned to circulatory arrest. Despite the increased weight gain in the infants assigned to low-flow bypass, the duration of mechanical ventilation, stay in the intensive care unit, and hospital stay were similar in both groups. Hemodynamic measurements were made in 122 patients. During the first postoperative night, the cardiac index decreased (32.1±15.4%, mean±SD), while pulmonary and systemic vascular resistance increased. The measured cardiac index was &lt;2.0 L Ā· min āˆ’1 Ā· m āˆ’2 in 23.8% of the patients, with the lowest measurement typically occurring 9 to 12 hours after surgery. Perfusion strategy assignment was not associated with postoperative hemodynamics or other nonneurological postoperative events. Conclusions After heart surgery in neonates and infants, both low-flow bypass and circulatory arrest perfusion strategies have comparable effects on the nonneurological postoperative course and hemodynamic profile.
Nine medical centers collaborated in a prospective randomized study to evaluate prolonged extracorporeal membrane oxygenation (ECMO) as a therapy for severe acute respiratory failure (ARF). Ninety adult patients were selected … Nine medical centers collaborated in a prospective randomized study to evaluate prolonged extracorporeal membrane oxygenation (ECMO) as a therapy for severe acute respiratory failure (ARF). Ninety adult patients were selected by common criteria of arterial hypoxemia and treated with either conventional mechanical ventilation (48 patients) or mechanical ventilation supplemented with partial venoarterial bypass (42 patients). Four patients in each group survived. The majority of patients suffered acute bacterial or viral pneumonia (57%). All nine patients with pulmonary embolism and six patients with posttraumatic acute respiratory failure died. The majority of patients died of progressive reduction of transpulmonary gas exchange and decreased compliance due to diffuse pulmonary inflammation, necrosis, and fibrosis. We conclude that ECMO can support respiratory gas exchange but did not increase the probability of long-term survival in patients with severe ARF. (<i>JAMA</i>242:2193-2196, 1979)
Extracorporeal membrane oxygenation (ECMO) may provide mechanical pulmonary and circulatory support for patients with cardiogenic shock refractory to conventional medical therapy. Prediction of survival in these patients may assist in … Extracorporeal membrane oxygenation (ECMO) may provide mechanical pulmonary and circulatory support for patients with cardiogenic shock refractory to conventional medical therapy. Prediction of survival in these patients may assist in management of these patients and comparison of results from different centers. To identify pre-ECMO factors which predict survival from refractory cardiogenic shock requiring ECMO and create the survival after veno-arterial-ECMO (SAVE)-score. Patients with refractory cardiogenic shock treated with veno-arterial ECMO between January 2003 and December 2013 were extracted from the international Extracorporeal Life Support Organization registry. Multivariable logistic regression was performed using bootstrapping methodology with internal and external validation to identify factors independently associated with in-hospital survival. Of 3846 patients with cardiogenic shock treated with ECMO, 1601 (42%) patients were alive at hospital discharge. Chronic renal failure, longer duration of ventilation prior to ECMO initiation, pre-ECMO organ failures, pre-ECMO cardiac arrest, congenital heart disease, lower pulse pressure, and lower serum bicarbonate (HCO3) were risk factors associated with mortality. Younger age, lower weight, acute myocarditis, heart transplant, refractory ventricular tachycardia or fibrillation, higher diastolic blood pressure, and lower peak inspiratory pressure were protective. The SAVE-score (area under the receiver operating characteristics [ROC] curve [AUROC] 0.68 [95%CI 0.64–0.71]) was created. External validation of the SAVE-score in an Australian population of 161 patients showed excellent discrimination with AUROC = 0.90 (95%CI 0.85–0.95). The SAVE-score may be a tool to predict survival for patients receiving ECMO for refractory cardiogenic shock (www.save-score.com).
Patients with advanced heart failure have improved survival rates and quality of life when treated with implanted pulsatile-flow left ventricular assist devices as compared with medical therapy. New continuous-flow devices … Patients with advanced heart failure have improved survival rates and quality of life when treated with implanted pulsatile-flow left ventricular assist devices as compared with medical therapy. New continuous-flow devices are smaller and may be more durable than the pulsatile-flow devices.In this randomized trial, we enrolled patients with advanced heart failure who were ineligible for transplantation, in a 2:1 ratio, to undergo implantation of a continuous-flow device (134 patients) or the currently approved pulsatile-flow device (66 patients). The primary composite end point was, at 2 years, survival free from disabling stroke and reoperation to repair or replace the device. Secondary end points included survival, frequency of adverse events, the quality of life, and functional capacity.Preoperative characteristics were similar in the two treatment groups, with a median age of 64 years (range, 26 to 81), a mean left ventricular ejection fraction of 17%, and nearly 80% of patients receiving intravenous inotropic agents. The primary composite end point was achieved in more patients with continuous-flow devices than with pulsatile-flow devices (62 of 134 [46%] vs. 7 of 66 [11%]; P<0.001; hazard ratio, 0.38; 95% confidence interval, 0.27 to 0.54; P<0.001), and patients with continuous-flow devices had superior actuarial survival rates at 2 years (58% vs. 24%, P=0.008). Adverse events and device replacements were less frequent in patients with the continuous-flow device. The quality of life and functional capacity improved significantly in both groups.Treatment with a continuous-flow left ventricular assist device in patients with advanced heart failure significantly improved the probability of survival free from stroke and device failure at 2 years as compared with a pulsatile device. Both devices significantly improved the quality of life and functional capacity. (ClinicalTrials.gov number, NCT00121485.)
The use of left ventricular assist devices is an accepted therapy for patients with refractory heart failure, but current pulsatile volume-displacement devices have limitations (including large pump size and limited … The use of left ventricular assist devices is an accepted therapy for patients with refractory heart failure, but current pulsatile volume-displacement devices have limitations (including large pump size and limited long-term mechanical durability) that have reduced widespread adoption of this technology. Continuous-flow pumps are newer types of left ventricular assist devices developed to overcome some of these limitations.In a prospective, multicenter study without a concurrent control group, 133 patients with end-stage heart failure who were on a waiting list for heart transplantation underwent implantation of a continuous-flow pump. The principal outcomes were the proportions of patients who, at 180 days, had undergone transplantation, had cardiac recovery, or had ongoing mechanical support while remaining eligible for transplantation. We also assessed functional status and quality of life.The principal outcomes occurred in 100 patients (75%). The median duration of support was 126 days (range, 1 to 600). The survival rate during support was 75% at 6 months and 68% at 12 months. At 3 months, therapy was associated with significant improvement in functional status (according to the New York Heart Association class and results of a 6-minute walk test) and in quality of life (according to the Minnesota Living with Heart Failure and Kansas City Cardiomyopathy questionnaires). Major adverse events included postoperative bleeding, stroke, right heart failure, and percutaneous lead infection. Pump thrombosis occurred in two patients.A continuous-flow left ventricular assist device can provide effective hemodynamic support for a period of at least 6 months in patients awaiting heart transplantation, with improved functional status and quality of life. (ClinicalTrials.gov number, NCT00121472 [ClinicalTrials.gov].).
We observed complement activation in 15 adults undergoing total cardiopulmonary bypass. Plasma levels of C3a were significantly elevated (P < 0.0001) at the beginning of the procedure, and they continued … We observed complement activation in 15 adults undergoing total cardiopulmonary bypass. Plasma levels of C3a were significantly elevated (P < 0.0001) at the beginning of the procedure, and they continued to increase steadily thereafter. At the end of the procedure, C3a levels were more than five times higher than preoperative levels. Plasma levels of C5a (a factor that binds avidly to neutrophils) did not change significantly during cardiopulmonary bypass. Instead, there was significant neutrophilia (P = 0.03) during bypass, and significant transpulmonary neutropenia (P = 0.0002) occurred when cardiopulmonary circulation was reestablished at partial bypass. The neutropenia is consistent with pulmonary-vascular sequestration of C5a-activated granulocytes. We also found that incubation of blood with the nylon-mesh liner of bubble oxygenators, as well as vigorous oxygenation of whole blood, promotes conversion of complement. We conclude that the complement-derived inflammatory mediators C3a and C5a produced during extracorporeal circulation may contribute to the pathogenesis of "post-pump syndromes."
Although left ventricular dysfunction is common during ventilatory support with positive end-expiratory pressure (PEEP), the mechanism of this disorder remains unclear. In 10 patients with the adult respiratory-distress syndrome we … Although left ventricular dysfunction is common during ventilatory support with positive end-expiratory pressure (PEEP), the mechanism of this disorder remains unclear. In 10 patients with the adult respiratory-distress syndrome we studied the effects of a stepwise increase in PEEP from 0 to 30 cm H2O on left ventricular output, intracardiac transmural pressures, and two-dimensional echocardiographic measurements of left ventricular cross-sectional area at end-systole and at end-diastole. Increasing PEEP was associated with progressive declines in cardiac output, mean blood pressure, and left ventricular dimensions and with equalization of right and left ventricular filling pressures. The radius of septal curvature decreased at both end-diastole and end-systole, implying a leftward shift of the interventricular septum. At the highest PEEP, blood-volume expansion did not restore cardiac output, although left ventricular transmural filling pressures had returned to base-line values. We conclude that decreased cardiac output during PEEP is mediated by a leftward displacement of the interventricular septum, which restricts left ventricular filling. (N Engl J Med. 1981; 304:387–92.)
Continuous-flow left ventricular assist systems increase the rate of survival among patients with advanced heart failure but are associated with the development of pump thrombosis. We investigated the effects of … Continuous-flow left ventricular assist systems increase the rate of survival among patients with advanced heart failure but are associated with the development of pump thrombosis. We investigated the effects of a new magnetically levitated centrifugal continuous-flow pump that was engineered to avert thrombosis.
Data on extracorporeal life support (ECLS) use and survival submitted to the Extracorporeal Life Support Organization's data registry from the inception of the registry in 1989 through July 1, 2016, … Data on extracorporeal life support (ECLS) use and survival submitted to the Extracorporeal Life Support Organization's data registry from the inception of the registry in 1989 through July 1, 2016, are summarized in this report. The registry contained information on 78,397 ECLS patients with 58% survival to hospital discharge. Extracorporeal life support use and centers providing ECLS have increased worldwide. Extracorporeal life support use in the support of adults with respiratory and cardiac failure represented the largest growth in the recent time period. Extracorporeal life support indications are expanding, and it is increasingly being used to support cardiopulmonary resuscitation in children and adults. Adverse events during the course of ECLS are common and underscore the need for skilled ECLS management and appropriately trained ECLS personnel and teams.
Mechanical circulatory support with a left ventricular assist device (LVAD) is an established treatment for patients with advanced heart failure. We compared a newer LVAD design (a small intrapericardial centrifugal-flow … Mechanical circulatory support with a left ventricular assist device (LVAD) is an established treatment for patients with advanced heart failure. We compared a newer LVAD design (a small intrapericardial centrifugal-flow device) against existing technology (a commercially available axial-flow device) in patients with advanced heart failure who were ineligible for heart transplantation.
Cardiogenic shock is a high-acuity, potentially complex, and hemodynamically diverse state of end-organ hypoperfusion that is frequently associated with multisystem organ failure. Despite improving survival in recent years, patient morbidity … Cardiogenic shock is a high-acuity, potentially complex, and hemodynamically diverse state of end-organ hypoperfusion that is frequently associated with multisystem organ failure. Despite improving survival in recent years, patient morbidity and mortality remain high, and there are few evidence-based therapeutic interventions known to clearly improve patient outcomes. This scientific statement on cardiogenic shock summarizes the epidemiology, pathophysiology, causes, and outcomes of cardiogenic shock; reviews contemporary best medical, surgical, mechanical circulatory support, and palliative care practices; advocates for the development of regionalized systems of care; and outlines future research priorities.
In patients who have acute myocardial infarction with cardiogenic shock, early revascularization of the culprit artery by means of percutaneous coronary intervention (PCI) improves outcomes. However, the majority of patients … In patients who have acute myocardial infarction with cardiogenic shock, early revascularization of the culprit artery by means of percutaneous coronary intervention (PCI) improves outcomes. However, the majority of patients with cardiogenic shock have multivessel disease, and whether PCI should be performed immediately for stenoses in nonculprit arteries is controversial.In this multicenter trial, we randomly assigned 706 patients who had multivessel disease, acute myocardial infarction, and cardiogenic shock to one of two initial revascularization strategies: either PCI of the culprit lesion only, with the option of staged revascularization of nonculprit lesions, or immediate multivessel PCI. The primary end point was a composite of death or severe renal failure leading to renal-replacement therapy within 30 days after randomization. Safety end points included bleeding and stroke.At 30 days, the composite primary end point of death or renal-replacement therapy had occurred in 158 of the 344 patients (45.9%) in the culprit-lesion-only PCI group and in 189 of the 341 patients (55.4%) in the multivessel PCI group (relative risk, 0.83; 95% confidence interval [CI], 0.71 to 0.96; P=0.01). The relative risk of death in the culprit-lesion-only PCI group as compared with the multivessel PCI group was 0.84 (95% CI, 0.72 to 0.98; P=0.03), and the relative risk of renal-replacement therapy was 0.71 (95% CI, 0.49 to 1.03; P=0.07). The time to hemodynamic stabilization, the risk of catecholamine therapy and the duration of such therapy, the levels of troponin T and creatine kinase, and the rates of bleeding and stroke did not differ significantly between the two groups.Among patients who had multivessel coronary artery disease and acute myocardial infarction with cardiogenic shock, the 30-day risk of a composite of death or severe renal failure leading to renal-replacement therapy was lower among those who initially underwent PCI of the culprit lesion only than among those who underwent immediate multivessel PCI. (Funded by the European Union 7th Framework Program and others; CULPRIT-SHOCK ClinicalTrials.gov number, NCT01927549 .).
In an early analysis of this trial, use of a magnetically levitated centrifugal continuous-flow circulatory pump was found to improve clinical outcomes, as compared with a mechanical-bearing axial continuous-flow pump, … In an early analysis of this trial, use of a magnetically levitated centrifugal continuous-flow circulatory pump was found to improve clinical outcomes, as compared with a mechanical-bearing axial continuous-flow pump, at 6 months in patients with advanced heart failure.
The efficacy of venovenous extracorporeal membrane oxygenation (ECMO) in patients with severe acute respiratory distress syndrome (ARDS) remains controversial. The efficacy of venovenous extracorporeal membrane oxygenation (ECMO) in patients with severe acute respiratory distress syndrome (ARDS) remains controversial.
In two interim analyses of this trial, patients with advanced heart failure who were treated with a fully magnetically levitated centrifugal-flow left ventricular assist device were less likely to have … In two interim analyses of this trial, patients with advanced heart failure who were treated with a fully magnetically levitated centrifugal-flow left ventricular assist device were less likely to have pump thrombosis or nondisabling stroke than were patients treated with a mechanical-bearing axial-flow left ventricular assist device.We randomly assigned patients with advanced heart failure to receive either the centrifugal-flow pump or the axial-flow pump irrespective of the intended goal of use (bridge to transplantation or destination therapy). The composite primary end point was survival at 2 years free of disabling stroke or reoperation to replace or remove a malfunctioning device. The principal secondary end point was pump replacement at 2 years.This final analysis included 1028 enrolled patients: 516 in the centrifugal-flow pump group and 512 in the axial-flow pump group. In the analysis of the primary end point, 397 patients (76.9%) in the centrifugal-flow pump group, as compared with 332 (64.8%) in the axial-flow pump group, remained alive and free of disabling stroke or reoperation to replace or remove a malfunctioning device at 2 years (relative risk, 0.84; 95% confidence interval [CI], 0.78 to 0.91; P<0.001 for superiority). Pump replacement was less common in the centrifugal-flow pump group than in the axial-flow pump group (12 patients [2.3%] vs. 57 patients [11.3%]; relative risk, 0.21; 95% CI, 0.11 to 0.38; P<0.001). The numbers of events per patient-year for stroke of any severity, major bleeding, and gastrointestinal hemorrhage were lower in the centrifugal-flow pump group than in the axial-flow pump group.Among patients with advanced heart failure, a fully magnetically levitated centrifugal-flow left ventricular assist device was associated with less frequent need for pump replacement than an axial-flow device and was superior with respect to survival free of disabling stroke or reoperation to replace or remove a malfunctioning device. (Funded by Abbott; MOMENTUM 3 ClinicalTrials.gov number, NCT02224755.).
Abstract Background The outcome of cardiogenic shock complicating myocardial infarction has not appreciably changed in the last 30 years despite the development of various percutaneous mechanical circulatory support options. It … Abstract Background The outcome of cardiogenic shock complicating myocardial infarction has not appreciably changed in the last 30 years despite the development of various percutaneous mechanical circulatory support options. It is clear that there are varying degrees of cardiogenic shock but there is no robust classification scheme to categorize this disease state. Methods A multidisciplinary group of experts convened by the Society for Cardiovascular Angiography and Interventions was assembled to derive a proposed classification schema for cardiogenic shock. Representatives from cardiology (interventional, advanced heart failure, noninvasive), emergency medicine, critical care, and cardiac nursing all collaborated to develop the proposed schema. Results A system describing stages of cardiogenic shock from A to E was developed. Stage A is ā€œat riskā€ for cardiogenic shock, stage B is ā€œbeginningā€ shock, stage C is ā€œclassicā€ cardiogenic shock, stage D is ā€œdeterioratingā€, and E is ā€œextremisā€. The difference between stages B and C is the presence of hypoperfusion which is present in stages C and higher. Stage D implies that the initial set of interventions chosen have not restored stability and adequate perfusion despite at least 30 minutes of observation and stage E is the patient in extremis, highly unstable, often with cardiovascular collapse. Conclusion This proposed classification system is simple, clinically applicable across the care spectrum from pre‐hospital providers to intensive care staff but will require future validation studies to assess its utility and potential prognostic implications.
Nine medical centers collaborated in a prospective randomized study to evaluate prolonged extracorporeal membrane oxygenation (ECMO) as a therapy for severe acute respiratory failure (ARF). Ninety adult patients were selected … Nine medical centers collaborated in a prospective randomized study to evaluate prolonged extracorporeal membrane oxygenation (ECMO) as a therapy for severe acute respiratory failure (ARF). Ninety adult patients were selected by common criteria of arterial hypoxemia and treated with either conventional mechanical ventilation (48 patients) or mechanical ventilation supplemented with partial venoarterial bypass (42 patients). Four patients in each group survived. The majority of patients suffered acute bacterial or viral pneumonia (57%). All nine patients with pulmonary embolism and six patients with posttraumatic acute respiratory failure died. The majority of patients died of progressive reduction of transpulmonary gas exchange and decreased compliance due to diffuse pulmonary inflammation, necrosis, and fibrosis. We conclude that ECMO can support respiratory gas exchange but did not increase the probability of long-term survival in patients with severe ARF. (<i>JAMA</i>242:2193-2196, 1979)
High shear stress and turbulence in a miniature axial blood pump are affected by the pump’s blade structure. which impacts the pump’s hemodynamics and hemocompatibility performance. This study designed blades … High shear stress and turbulence in a miniature axial blood pump are affected by the pump’s blade structure. which impacts the pump’s hemodynamics and hemocompatibility performance. This study designed blades for a miniature axial blood pump via computational fluid dynamics (CFD). The optimal blade angle distribution must improve hemodynamic and hemocompatibility performance under the designed operating conditions (45,000 rpm rotational speed and 3 L/min flow rate). First, the blade inlet angles β 1 were varied from āˆ’100° to āˆ’220°. Second, using the optimal β 1, the blade angle distribution was changed by setting different curvatures at different curvature positions. Finally, the relationships among blade angle distribution parameters and hemodynamic, hemolysis, and thrombosis risk were analyzed. The results indicated that angle distribution should avoid positive curvature, and that ā€œthe absolute value of negative curvature percentage should increase progressively with the increasing of curvature position.ā€ Compared with the original impeller, the CFD and experimental results revealed an optimized impeller with a 17.4% increase in pressure head, a 2.1% increase in hydraulic efficiency, an 8.4% decrease in hemolysis index, and a 5.3% decrease in volume-averaged scaled activated platelet concentration. CFD-guided blade angle optimization can improve the hemodynamic and hemocompatibility performance of miniature axial blood pumps.
Cardiogenic shock continues to portend a poor prognosis. Despite ongoing efforts over the past few decades to help improve mortality, little progress has been made in improving the short-term and … Cardiogenic shock continues to portend a poor prognosis. Despite ongoing efforts over the past few decades to help improve mortality, little progress has been made in improving the short-term and long-term outcomes of patients presenting with cardiogenic shock. This is especially true of those presenting with acute myocardial infarct related cardiogenic shock. Cardiogenic shock should be understood as a continuum. Patients can move from one stage of shock to another and hence should be assessed on an ongoing basis. Cardiogenic shock should be assessed based on the severity, the phenotypic presentation and the concomitant processes that influence prognosis. Right ventricular cardiogenic shock and mixed cardiogenic shock have been recognized as predictors of worse overall prognosis. Incorporating detailed classification of cause of cardiogenic shock into routine clinical practice and will help with standardizing nomenclature and aid in understanding of the disease process and assist in refining interventions. Early identification, risk stratification and understanding the nuances of presentation may help with selecting appropriate treatment strategies. Aggressive management should include multidisciplinary team-based approaches to help escalate care as needed.
Introduction Neonatal hypoxic respiratory failure is commonly assessed with the oxygenation index (OI) to determine severity and guide ECMO initiation. Calculation of the OI requires arterial blood sampling which can … Introduction Neonatal hypoxic respiratory failure is commonly assessed with the oxygenation index (OI) to determine severity and guide ECMO initiation. Calculation of the OI requires arterial blood sampling which can be difficult to obtain. A non-invasive alternative, the oxygen saturation index (OSI), has shown promise, but its utility in ECMO determination is not well-described. We aimed to evaluate the correlation between the OI and OSI in neonates requiring ECMO. Methods We pursued a retrospective chart review of 64 neonatal ECMO patients at Kentucky Children's Hospital (2012–2022) and analyzed OI and OSI values in the 12 h preceding ECMO initiation. Results A moderate correlation was observed between the OI and OSI. An OSI &amp;gt;17.41 predicted ECMO initiation, and OI can be estimated with the equation: OI = 1.978(OSI)—6.743. Conclusion These findings suggest OSI may be a useful adjunct to OI for assessing neonatal respiratory failure and could be beneficial when arterial sampling is impractical.
Objective: To investigate the prognostic factors in patients with acute myocardial infarction (AMI) who underwent interventional therapy assisted by venous-arterial extracorporeal membrane oxygenation (VA-ECMO). Methods: This single-center retrospective cohort study … Objective: To investigate the prognostic factors in patients with acute myocardial infarction (AMI) who underwent interventional therapy assisted by venous-arterial extracorporeal membrane oxygenation (VA-ECMO). Methods: This single-center retrospective cohort study enrolled AMI patients who received VA-ECMO-assisted interventional therapy in the Department of Cardiology at the Second Hospital of Jilin University from June 2018 to November 2022. Patients were divided into the in-hospital survival group and in-hospital death group based on the in-hospital survival. Data on patient demographics, laboratory tests, imaging examinations, coronary angiography results, VA-ECMO-related parameters, complications, and prognosis were collected through the electronic medical record system. Results: A total of 71 AMI patients were enrolled, with an age of (62.4±11.1) years, of whom 54 (76%) were male. There were 46 patients in the in-hospital survival group and 25 patients in the in-hospital death group. Compared to the in-hospital survival group, the in-hospital death group exhibited significantly higher levels of cardiac troponin I (36.08 (2.86, 100.00) μg/L vs. 2.75 (0.18, 13.86) μg/L, P=0.01) and B-type natriuretic peptide (1 724.50 (50.00, 4 200.50) vs. 460.85 (163.80, 1 862.33), P=0.01), and the left ventricular ejection fraction was lower ((35.0±12.9)% vs. (43.0±12.8)%, P=0.01), moreover the incidence of patients with left main coronary artery disease (80% (20/25) vs. 39% (18/46), P<0.01), cardiac arrest (56% (14/25) vs. 20% (9/46), P<0.01), cardiopulmonary resuscitation (52%(13/25) vs. 26%(12/46), P=0.03), and the time from cardiac arrest to ECMO initiation >24 hours (84% (21/25) vs. 9% (4/46), P<0.01) were higher. Conclusions: The prognosis of AMI patients undergoing VA-ECMO-assisted interventional therapy may be influenced by a number of related factors, including cardiac troponin I, B-type natriuretic peptide levels, left ventricular ejection fraction, combined with left main coronary artery disease, cardiac arrest and cardiopulmonary resuscitation, and the interval between cardiac arrest and the initiation of ECMO.
Extracorporeal membrane oxygenation (ECMO) has a history that is a testament to the pioneering spirit of medical innovators. It is intricately linked with the development of cardiopulmonary bypass (CPB) technology. … Extracorporeal membrane oxygenation (ECMO) has a history that is a testament to the pioneering spirit of medical innovators. It is intricately linked with the development of cardiopulmonary bypass (CPB) technology. The journey of ECMO can be traced back to the mid-20th century when experiments started with CPB to support patients undergoing cardiac surgery. However, it was not until the 1970s that ECMO emerged as a standalone therapy. Throughout the following decades, ECMO technology advanced rapidly, with improvements in circuit design, oxygenators, and pump technology enhancing its safety and efficacy. ECMO's versatility soon became apparent as it was employed in various clinical scenarios, including acute respiratory distress syndrome (ARDS), cardiac failure, and even as a bridge to lung or heart transplantation. In recent years, efforts have focused on miniaturisation, cost reduction, and developing portable systems, enabling their use outside traditional intensive care settings. Today, ECMO remains not just a tool but a lifeline in the management of life-threatening cardiorespiratory failure. It offers hope and a second chance to patients when conventional therapies fall short, underscoring its critical importance in critical care medicine, cardiology, transplant and cardiothoracic surgery. This article provides a concise yet comprehensive overview of the history and recent advancements in ECMO.
Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) is used in cardiogenic shock, but sex-specific outcomes remain unclear. This study investigated in-hospital mortality differences by sex among patients receiving extracorporeal cardiopulmonary resuscitation (ECPR). … Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) is used in cardiogenic shock, but sex-specific outcomes remain unclear. This study investigated in-hospital mortality differences by sex among patients receiving extracorporeal cardiopulmonary resuscitation (ECPR). We retrospectively reviewed adults with cardiogenic shock treated with VA-ECMO at National Taiwan University Hospital between 2010 and 2021. After propensity score matching to improve comparability between groups, survival outcomes were assessed using Kaplan-Meier estimates, and Cox proportional hazards models were used to evaluate the effect of sex on in-hospital mortality. Of the 1329 patients (average age: 57.1±15.0 years; 953 men), 670 underwent VA-ECMO for ECPR. Women in the VA-ECMO group exhibited a lower prevalence of out-of-hospital cardiac arrest (6.7% versus 10.7%, P=0.031), a lower body mass index (24.0±4.4 versus 25.0±4.3, P<0.001), and lower rates of diabetes (26.2% versus 33.2%, P=0.017) and coronary artery disease (20.9% versus 28.6%, P=0.005) after propensity score matching. No discernible sex differences were observed in the baseline characteristics of the ECPR subgroup. Kaplan-Meier analyses showed no significant sex differences in mortality for VA-ECMO (log-rank P=0.1), but significant disparities were noted for ECPR (log-rank P=0.006). In the ECPR group, female patients exhibited higher mortality rates compared with men (hazard ratio, 1.37 [95% CI, 1.09-1.72]; P=0.007), independent of Survival After Veno-Arterial ECMO score severity. Women who underwent ECPR had higher in-hospital mortality rates regardless of the severity of their Survival After Veno-Arterial ECMO scores, despite the absence of significant sex differences in VA-ECMO mortality. This emphasizes the necessity for sex-based strategies in ECPR administration.
Although durable mechanical circulatory support (MCS) has been promising in supporting advanced heart failure patients, device hemocompatibility-related complications remain a major concern compared with heart transplantation. We investigated the blood … Although durable mechanical circulatory support (MCS) has been promising in supporting advanced heart failure patients, device hemocompatibility-related complications remain a major concern compared with heart transplantation. We investigated the blood damage potential of the three most recent clinically available, implantable MCS devices and compared their biocompatibility performance. One axial pump (HeartMate II) and two centrifugal pumps (HeartMate 3 and BrioVAD) were chosen for this study. In vitro experiments with healthy human blood and computational fluid dynamics simulations were performed to compare high-mechanical shear-induced blood trauma in these devices. Regions of higher shear stresses were identified. Power-law relations between shear stress and blood damage were implemented to assess hemolysis, platelet activation, and platelet receptor shedding of key functional receptors (glycoprotein [GP] Ibα, and GPVI) caused by these devices. HeartMate II caused the most severe blood trauma among these three devices, producing an order of magnitude larger values for hemolysis and platelet activation compared with HeartMate 3 and BrioVAD. Also, HeartMate II consistently exhibited the highest levels of receptor shedding, approximately double those caused by the HeartMate 3 and BrioVAD. The HeartMate 3 and BrioVAD centrifugal pumps showed similar performance in terms of blood damage.
ABSTRACT Cardiogenic shock (CS) remains a high morbidity and mortality condition worldwide frequently complicating acute myocardial infarction (AMI) and decompensated heart failure (HF). Within the management of CS, mechanical circulatory … ABSTRACT Cardiogenic shock (CS) remains a high morbidity and mortality condition worldwide frequently complicating acute myocardial infarction (AMI) and decompensated heart failure (HF). Within the management of CS, mechanical circulatory support (MCS) devices play a critical role in maintaining hemodynamic stability, preserving end‐organ perfusion and bridging patients through to recovery, implantation of durable support or transplantation. Despite their use, optimal timing of initiation, as well as patient and device selection remain unclear. This review explores the current landscape of MCS devices, surrounding evidence and key distinctions between devices. With increasing acknowledgment for the heterogeneity of CS, understanding the strengths and limitations of each device remains crucial to improving outcomes in this high‐risk population.

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A systemic inflammatory response can contribute to poor outcomes in an advanced stage of cardiogenic shock (CS). We investigated the efficacy of extracorporeal endotoxin and cytokine adsorption using oXiris in … A systemic inflammatory response can contribute to poor outcomes in an advanced stage of cardiogenic shock (CS). We investigated the efficacy of extracorporeal endotoxin and cytokine adsorption using oXiris in patients with CS undergoing venoarterial extracorporeal membrane oxygenation (VA-ECMO). In this prospective, single-center, randomized, open-label pilot trial, 40 patients with CS who were undergoing VA-ECMO were randomly assigned to receive either oXiris for 24 h (n = 20) or usual care (n = 20). The primary endpoint was endotoxin levels at 48 h. Secondary endpoints included changes in inflammatory cytokines, vasoactive-inotropic score (VIS), ECMO weaning success, and in-hospital and 30-day mortality. The median endotoxin levels at 48 h were 0.5 (IQR 0.4-1.0) in the oXiris group and 0.4 (IQR 0.2-0.5) in the control group, with no significant difference between them (P = 0.097). The oXiris group showed significant temporal reductions in GDF-15 and IL-6 levels, with IL-6 revealing significant reductions from baseline to 24 h (P = 0.020) and from baseline to 7 days (P = 0.003). VIS decreased significantly from baseline to 48 h (-13.63, 95% CI: -20.90 - -6.34, P < 0.001) and 7 days (-12.19, 95% CI: -21.0 - -3.31, P = 0.007) in the oXiris group, but intergroup differences were insignificant. ECMO weaning success, duration of ECMO support, and mortality rates were similar between the groups. In this pilot study conducted on CS patients requiring VA-ECMO, oXiris treatment did not significantly reduce endotoxin levels or improve patient centered clinical outcomes. NCT05642273, registered 8 December 2022.
Abstract Heart failure (HF) is a significant health threat, and the short-term percutaneous interventional left ventricular assist devices (PLVADs) play an important role in the management of it. However, studies … Abstract Heart failure (HF) is a significant health threat, and the short-term percutaneous interventional left ventricular assist devices (PLVADs) play an important role in the management of it. However, studies on PLVAD blood flow patterns at varying rotational speeds are limited. Therefore, it is essential to explore the hemodynamic profiles of PLVADs under varying modes. A patient-specific model was developed, and the lumped-parameter model (LPM) was used as boundary conditions. The hemodynamic changes of PLVAD under pulsating flow (PF) and counterpulsating flow (CPF) were analyzed using computational fluid dynamics (CFD). Key parameters, including pressure, wall shear stress (WSS), oscillatory shear index (OSI), time-averaged wall shear stress (TAWSS), endothelial cell activation potential (ECAP), relative residence time (RRT), and velocity, were calculated and compared under continuous-flow (CF) condition. PLVAD support reduced afterload, and both pulsatile modes exhibited better pulsatility than CF, particularly the PF mode. In CPF mode, the native heart performed the least work, which may be more conducive to recovery. The trends for WSS, pressure, and velocity were similar across conditions, but their magnitudes varied. Overall, PLVAD support can increase TAWSS and decrease OSI, RRT, and ECAP. Although there was no significant difference in TAWSS and OSI among CF, PF, and CPF, we observed the smallest RRT for PF and the smallest ECAP for CPF. Hemodynamic data suggest that pulsatile patterns appear to reduce the risk of thrombosis and other complications compared to CF.
Extracorporeal membrane oxygenation (ECMO) is a crucial life support therapy for patients with severe cardiac and respiratory failure. However, the complications associated with venoarterial ECMO (VA-ECMO), including thrombus formation, bleeding, … Extracorporeal membrane oxygenation (ECMO) is a crucial life support therapy for patients with severe cardiac and respiratory failure. However, the complications associated with venoarterial ECMO (VA-ECMO), including thrombus formation, bleeding, and hemolysis, remain significant challenges that impact patient outcomes and healthcare costs. These complications primarily arise from blood-material interactions within the ECMO circuit, necessitating the development of biocompatible materials to optimize hemocompatibility. This review provides an updated overview of the latest advancements in VA-ECMO materials, focusing on cannula, oxygenators, and centrifugal pumps. Various surface modifications, such as heparin coatings, nitric oxide-releasing polymers, phosphorylcholine (PC)-based coatings, and emerging omniphobic surfaces, have been explored to mitigate thrombosis and bleeding risks. Additionally, novel oxygenator membrane technologies, including zwitterionic polymers and endothelial-mimicking coatings, offer promising strategies to enhance biocompatibility and reduce inflammatory responses. In centrifugal pumps, magnetic levitation systems and hybrid polymer-composite impellers have been introduced to minimize shear stress and thrombogenicity. Despite these advancements, no single material has fully addressed all complications, and further research is needed to refine surface engineering strategies. This review highlights the current progress in ECMO biomaterials and discusses future directions in developing more effective and durable solutions to improve patient safety and clinical outcomes.
Background Standardized protocols with optimal hemodynamic targets for percutaneous ventricular assist device (PVAD) management remain undefined. We aimed to evaluate the proportion of phase‐specific hemodynamic criteria achieved during PVAD support … Background Standardized protocols with optimal hemodynamic targets for percutaneous ventricular assist device (PVAD) management remain undefined. We aimed to evaluate the proportion of phase‐specific hemodynamic criteria achieved during PVAD support and their association with outcomes in patients with cardiogenic shock. Methods This multicenter retrospective study enrolled patients with cardiogenic shock requiring PVAD (Impella). Patients were evaluated at 24 hours post‐PVAD, venoarterial extracorporeal membrane oxygenation weaning, and PVAD weaning. Hemodynamic criteria consisted of key targets, including mean arterial pressure ≄60 mm Hg, lactate &lt;2.0 mmol/L, right atrial pressure &lt;15 mm Hg, pulmonary artery wedge pressure &lt;20 mm Hg, pulmonary artery pulsatility index ≄1.0, and cardiac power output ≄0.6 W. The primary outcome was a composite of 30‐day all‐cause mortality and unplanned mechanical circulatory support reintroduction. Results A total of 501 patients were enrolled: 206 (41%) with PVAD alone and 295 (59%) with PVAD and venoarterial extracorporeal membrane oxygenation. The majority of patients were supported with Impella CP (406, 81%). Fulfillment of criteria was observed in 37%, 52%, and 45% at 24 hours post‐PVAD, venoarterial extracorporeal membrane oxygenation weaning, and PVAD weaning, respectively. Patients with unfulfilled criteria at each evaluation point were at high risk for the primary outcome (hazard ratio, 3.2 [95% CI, 2.1–4.8]; hazard ratio, 2.1 [1.2–3.7]; and hazard ratio, 2.0 [95% CI, 1.1–3.6]). Hemodynamic criteria achievement consistently stratified the risk of the primary outcome across different subgroups, including shock cause, shock stage, and concomitant use of venoarterial extracorporeal membrane oxygenation. Conclusions Phase‐specific hemodynamic criteria are often unmet and are associated with significantly higher risks of short‐term fatal events.
Background: The use of temporary left ventricular assist devices (T-LVADs) for circulatory support in cardiogenic shock is increasing along with complications like acute kidney injury requiring kidney replacement therapy (KRT). … Background: The use of temporary left ventricular assist devices (T-LVADs) for circulatory support in cardiogenic shock is increasing along with complications like acute kidney injury requiring kidney replacement therapy (KRT). While KRT is linked to mortality in cardiogenic shock, data on mortality in patients receiving both T-LVAD and KRT is limited. Methods: We conducted a systematic review and meta-analysis, searching three databases from inception through 30 December 2023 for studies reporting on patients with concurrent T-LVAD and KRT support during cardiogenic shock. We performed random effects meta-analyses, looking at in-hospital mortality as our primary outcome. Subgroup analysis was performed based on the continent, timing of KRT, and type of T-LVAD. Risk of bias was assessed with the Joanna Briggs Institute checklists and certainty of evidence with the GRADE approach. Results: We included 35 studies after screening through 89 full-text articles, consisting of 2277 individuals receiving T-LVAD and 722 (30.9%, 95% CI: 25.8-36.6) receiving concurrent KRT. In-hospital mortality was pooled across six studies, with 91 non-survivors (65.5%) amongst 139 individuals (95% CI: 57.2-72.9). Concurrent KRT and T-LVAD was associated with higher in-hospital (OR 3.48, 95% CI: 2.20-5.49) and overall mortality (OR 2.19, 95% CI 1.01-4.76) compared to patients not on KRT. The proportion of patients on KRT were significantly (pinteraction=0.0004) larger in Europe (37.2%, 95% CI: 32.2-42.4) than North America (18.2%, 95% CI: 12.0-26.7). Region, type of T-LVAD and publication year did not significantly impact any of the mortality outcomes. Conclusion: Patients on concurrent KRT and T-LVAD suffer significantly greater odds of mortality compared to patients not receiving KRT during their hospital admission. A substantial proportion of patients receiving T-LVADs require KRT. Further studies with head-to-head comparisons between KRT and non-KRT treatment arms are warranted to confirm our findings, in addition to identifying at-risk populations that require KRT and potential interventions to improve survival in this subset of patients.
The rising number of people with heart failure is leading to a corresponding increase in heart failure-related deaths. End-of-life care for these patients involves supplementing standard treatments with therapies aimed … The rising number of people with heart failure is leading to a corresponding increase in heart failure-related deaths. End-of-life care for these patients involves supplementing standard treatments with therapies aimed at managing symptoms that don’t respond to guideline-directed medical care. The INCOR, a lightweight (200 g), implantable, magnetically levitated axial flow pump (providing non-pulsatile flow), is designed for long-term left ventricular support. This video tutorial details the initial single-centre clinical experience with this device.
Cardiac transplantation is the gold standard treatment for end-stage heart failure, offering definitive therapy for patients unresponsive to advanced medical management. Extracorporeal membrane oxygenation (ECMO) plays a pivotal role in … Cardiac transplantation is the gold standard treatment for end-stage heart failure, offering definitive therapy for patients unresponsive to advanced medical management. Extracorporeal membrane oxygenation (ECMO) plays a pivotal role in critically supporting ill patients as a bridge to transplant, providing temporary hemodynamic and respiratory stabilization. ECMO is particularly effective in patients with cardiogenic shock or multi-organ dysfunction, improving tissue oxygenation and perfusion while awaiting a suitable donor organ. Despite its life-saving potential, ECMO is associated with significant risks, including hemorrhage, thromboembolism, infection, and prolonged organ dysfunction. Careful candidate selection, meticulous anticoagulation management, and a multidisciplinary team approach are essential to mitigate these complications and optimize outcomes. Emerging evidence highlights the potential of ECMO to expand the transplant candidate pool and improve survival rates. As an integral part of advanced heart failure treatment, ECMO continues to evolve, offering hope to patients in critical need of a heart transplant. Refractory cardiogenic shock has a high mortality rate despite optimal medical management. Cardiogenic shock is one of the main causes of in-hospital mortality, with significant variations in incidence depending on access to advanced therapies such as the use of venoarterial extracorporeal membrane oxygenation (VA-ECMO), which is a vitally important therapy. Its implementation as part of the treatment of patients with refractory cardiogenic shock is necessary.
Abstract Introduction Bleeding events are common during the provision of Venoarterial ECMO (VA ECMO). Previous observational has suggested that these bleeding events are associated with an increased risk of in-hospital … Abstract Introduction Bleeding events are common during the provision of Venoarterial ECMO (VA ECMO). Previous observational has suggested that these bleeding events are associated with an increased risk of in-hospital mortality however data on long term mortality and functional outcomes are lacking. Methods This multi-centre prospective observational study included patients enrolled in the EXCEL registry from February 2019 until June 2023. We collected baseline demographics, and details of ECMO support. The primary outcome was a composite of death or new disability (defined as an increase of ≄ 10%. in the world health organisation disability assessment schedule score) at 180 days after ECMO initiation. We used multivariable logistic and quantile regression adjusted for illness severity and patient characteristics and diagnosis to assess the association of bleeding with death and new disability and other functional and clinical outcomes. Results The final study cohort included 704 participants, median [interquartile range IQR] age 54.5 [42 to 64] years and 259 (36.8%) were female. Bleeding complications occurred in 312 (44.3%) participants and 154 (22.3%) had major bleeding. Patients with bleeding complications were more often receiving VA ECMO for peri-operative support [112 (36.4%) vs (73 (19.3%), p &lt; 0.001). Patients who experienced bleeding complications were at significantly increased risk of the primary outcome at 6 months risk difference (RD) 8.95% (95% CI: 1.62 to 16.14). However, this finding was due to a significantly increased risk of new disability- adjusted RD 18.04% (95% CI: 6.22 to 29.55) rather than an increased risk of mortality in patients with bleeding compared to no bleeding [adjusted RD 5.71% (95% CI: -1.55 to 13.01)]. Patients with bleeding complications were also associated with an increased use of healthcare resources such as ICU length of stay and renal replacement therapy. Conclusion Bleeding increased the rate of death and disability at 6-months, but this was driven by increased disability rather mortality. Bleeding complications were associated with an increased use of healthcare resources. Prospective studies to address modifiable risk factors for bleeding complications are warranted.
ABSTRACT Background Heart failure (HF) affects approximately 64 million patients worldwide, where the heart's impaired ability to pump blood leads to reduced quality of life and a high 5‐year mortality … ABSTRACT Background Heart failure (HF) affects approximately 64 million patients worldwide, where the heart's impaired ability to pump blood leads to reduced quality of life and a high 5‐year mortality rate. Total artificial hearts (TAHs) offer a promising solution, but to ensure a good quality of life and prolong life expectancy for end‐stage HF patients, TAHs must adapt to the body's varying metabolic demands. Methods This study evaluates the physiological control performance of the Realheart TAH using a hybrid mock circulation loop that simulates dynamic physiological states, such as sleep, rest, and exercise. The Realheart TAH features a preload‐based control mechanism that adjusts heart rate (HR) and stroke volume (SV) in response to changes in atrial pressure, closely mimicking the native heart's ability to meet varying blood flow demands. The controller's adaptability and robustness were further tested under different levels of pulmonary vascular resistance (PVR), simulating conditions that challenge flow balance. Results The results demonstrate that the Realheart TAH maintains flow balance between the right and left ventricles and stabilizes atrial pressures across all tested conditions. During simulated exercise, the controller increased cardiac output (CO) by up to 2.1 times from rest while maintaining stable atrial pressures, compared to a maximum increase of 1.2 times without the controller. During sleep, CO decreased by 25%, whereas a decrease of only 5% was observed without the controller. Under increased PVR, the controller adjusted SV and HR to preserve consistent CO and prevent blood volume build‐up in the atria, which could otherwise lead to dangerously high atrial pressures. Conclusion The physiological control system demonstrated its ability to adapt to rapid transitions between physiological states, although occasional undershoots in pressure were observed during transitions from exercise to rest conditions. This study highlights the Realheart TAH's ability to autonomously adjust to varying physiological conditions and patient needs, showing promise for treating patients with advanced HF. Future work will focus on optimizing the control system to further enhance the device's responsiveness and stability during rapid physiological transitions.
Abstract Right heart catheterization (RHC) plays a pivotal role across the spectrum of heart failure, from ambulatory patients to those in cardiogenic shock or under consideration for left ventricular assist … Abstract Right heart catheterization (RHC) plays a pivotal role across the spectrum of heart failure, from ambulatory patients to those in cardiogenic shock or under consideration for left ventricular assist device (LVAD) therapy and heart transplantation. Hemodynamic data are critical for early recognition of clinical deterioration, prognostication, and guiding treatment decisions. This state-of-the-art review provides a practical guide to hemodynamic assessment, troubleshooting, and interpretation of hemodynamic variables assessed with RHC for clinicians treating patients with heart failure in the acute setting, including acute heart failure and cardiogenic shock as well as chronic heart failure and advanced disease states that may warrant LVAD or heart transplantation. A special focus is set on contextualizing hemodynamic variables within the clinical presentation to avoid diagnostic misclassification. In addition, opportunities for future research, including novel parameters as well as forward-thinking non-invasive technologies to inform hemodynamics, are discussed.
Background: While the role of sex-based differences in acute myocardial infarction-related cardiogenic shock (AMI-CS) is well described, their relevance among patients with non-acute myocardial infarction-related CS (nonAMI-CS) is less well … Background: While the role of sex-based differences in acute myocardial infarction-related cardiogenic shock (AMI-CS) is well described, their relevance among patients with non-acute myocardial infarction-related CS (nonAMI-CS) is less well known. Methods: Adult patients treated for cardiogenic shock (CS) between 2016 and 2022 across eleven hospitals within our health system were included. NonAMI-CS etiologies were classified as heart failure or secondary CS (valvular and arrhythmia-triggered). Stratification by sex was used to compare characteristics, management strategies, and outcomes between men and women. Logistic regression models were used to examine the effect of clinical characteristics and management strategies on hospital mortality by sex, along with the effect of sex on different management strategies. Results: Of 2256 patients, women comprised the minority (36%) and also exhibited older age and more comorbidities. Both sexes displayed similar presenting shock stages, according to those established by the Society for Cardiovascular Angiography and Interventions (SCAI). Valvular shock was the only etiology which was more prevalent in women. Women received fewer invasive interventions, including treatment with pulmonary artery catheters (44% vs. 53%; p < 0.01) and mechanical circulatory support devices (15% vs. 22%; p < 0.01). While sex was not independently associated with increased mortality (OR = 1.16, 95% CI = 0.68-1.96), women were more likely to be discharged to skilled nursing facilities (SNF). Conclusions: Although women with nonAMI-CS exhibit a higher risk profile and undergo fewer invasive procedures, their survival rate is comparable to that of men. However, women are more likely to require SNF care upon discharge.
Objectives: Previous studies have shown that inaccurate peripheral oxygen saturation (SpO2) readings compared with arterial oxygen saturation (SaO2) may occur in extracorporeal membrane oxygenation (ECMO) patients. We hypothesized that a … Objectives: Previous studies have shown that inaccurate peripheral oxygen saturation (SpO2) readings compared with arterial oxygen saturation (SaO2) may occur in extracorporeal membrane oxygenation (ECMO) patients. We hypothesized that a greater Sp o 2 –Sa o 2 discrepancy in extracorporeal cardiopulmonary resuscitation (ECPR) patients is associated with higher mortality due to unrecognized hypoxemia. Design: Retrospective analysis. Setting: Data within the Extracorporeal Life Support Organization Registry from 496 ECMO centers (2018–2024). Patients: Patients 18 years old or older receiving ECPR (first-run only). Interventions: None. Measurements and Main Results: Laboratory measurements including Sp o 2 –Sa o 2 were measured at 24 hours of ECMO support. Acute brain injury (ABI) included hypoxic-ischemic brain injury, ischemic stroke, intracranial hemorrhage, and seizures. Based on an inflection point in cubic spline analysis, a Sp o 2 –Sa o 2 threshold greater than or equal to 4% was used as a binary variable to assess its association with in-hospital mortality. Three thousand nine hundred seventy ECPR patients (median age, 57 yr; 71% male) were included. The median ECMO duration was 4 days (interquartile range, 2–7 d). There were 634 patients (16%) with Sp o 2 –Sa o 2 greater than or equal to 4% and 3336 (84%) with Sp o 2 –Sa o 2 less than 4%. Overall mortality was 60% ( n = 2391). Patients with Sp o 2 –Sa o 2 greater than or equal to 4% had higher mortality compared with patients with Sp o 2 –Sa o 2 less than 4% (67%, n = 425 vs. 59%, n = 1966; p &lt; 0.001). Patients with Sp o 2 –Sa o 2 greater than or equal to 4% had higher serum lactate values than those with Sp o 2 –Sa o 2 less than 4% (3.1 vs. 2.8 mmol/L; p = 0.0017). In multivariable logistic regression adjusted for preselected covariates, Sp o 2 –Sa o 2 greater than or equal to 4% was associated with increased risk of mortality (adjusted odds ratio [aOR], 1.39; 95% CI, 1.13–1.71). Additional risk factors associated with higher mortality included ABI (aOR, 5.81; 95% CI, 4.70–7.20), hyperoxemia greater than or equal to 300 mm Hg (aOR, 1.93; 95% CI, 1.53–2.43), hyperoxemia 200–299 mm Hg (aOR, 1.76; 95% CI, 1.37–2.25), gastrointestinal hemorrhage (aOR, 1.69; 95% CI, 1.42–2.00), renal replacement therapy (aOR, 1.48; 95% CI, 1.03–2.11), hypoxemia less than 60 mm Hg (aOR, 1.45; 95% CI, 1.00–2.10), older age (aOR, 1.19; 95% CI, 1.13–1.26), and higher lactate (aOR, 1.17; 95% CI, 1.13–1.20). Race/ethnicity was not associated with higher mortality. Conclusions: Sp o 2 –Sa o 2 greater than or equal to 4% in the first 24 hours after ECPR is associated with increased risk of mortality, potentially due to unrecognized hypoxemia, irrespective of race/ethnicity.
Background: Myocardial infarction complicated by cardiogenic shock (MI-CS) remains a critical condition with high mortality rates, despite advances in treatment. Systemic inflammation plays a significant role in MI-CS progression; however, … Background: Myocardial infarction complicated by cardiogenic shock (MI-CS) remains a critical condition with high mortality rates, despite advances in treatment. Systemic inflammation plays a significant role in MI-CS progression; however, its dynamics across different stages of the Society for Cardiovascular Angiography and Interventions (SCAI) classification remain poorly understood. This study aimed to evaluate indices of systemic inflammation-neutrophil-lymphocyte ratio (NLR), platelet-lymphocyte ratio (PLR), systemic immune-inflammation index (SII), systemic inflammation response index (SIRI), and aggregate index of systemic inflammation (AISI)-in MI-CS patients, correlating them with SCAI stages and survival outcomes. Methods: A single-center retrospective study included 132 patients with MI-CS, categorized into SCAI stages A-E. All patients were assessed for demographic, clinical, and laboratory data, procedural and treatment characteristics, MI timing, and outcomes. Complete blood count test data were used to calculate inflammatory indices and evaluate types of immune reactions. Results: PLR, SII, and AISI peaked at SCAI stage C and declined significantly at stage E, suggesting suppressed inflammation in advanced shock. SIRI emerged as a key prognostic marker for stage C patients, with elevated levels associated with larger infarct size, higher heart rate, and predominant innate immune activation. Patients with SIRI ≄ 3.34 had significantly lower two-year survival (log-rank test, p = 0.006). Conclusions: Inflammation indices, particularly SIRI, provide valuable prognostic insights in MI-CS, reflecting disease severity and heterogeneity of immune response. The decline in inflammatory indices at SCAI stage E may indicate immune suppression in extreme MI-CS, underscoring the need for personalized therapeutic strategies.
Computational fluid dynamics (CFD) models have been widely used to evaluate the hydrodynamic and gas exchange performances of oxygenators, which are crucial in supporting patients with lung diseases or failure. … Computational fluid dynamics (CFD) models have been widely used to evaluate the hydrodynamic and gas exchange performances of oxygenators, which are crucial in supporting patients with lung diseases or failure. However, while CFD models have been effective in analyzing oxygen transfer, they have not adequately addressed the experimentally demonstrated effects of varying sweep gas flow rates on CO2 removal. This is a critical gap, as sweep gas flow directly influences the CO2 transfer efficiency in oxygenators. To fill this gap, we extend our previously developed 1D mathematical model into a 3D computational framework to predict both blood pressure drops and the rates of oxygen and CO2 transfers in oxygenators. The comparison between our model predictions and experimental data validates the model’s capability in capturing the overall trends in CO2 transfer/removal rates under different sweep gas flow rates. The results also demonstrated that our model can predict CO2 removal more accurately, particularly in scenarios where adjusting the sweep gas flow rate is essential for optimizing the oxygenator performance.
Background Post-cardiotomy cardiogenic shock (PCCS) is a serious condition that necessitates veno-arterial extracorporeal membrane oxygenation (VA-ECMO). Although acute kidney injury (AKI) often complicates PCCS, its specific effects on patient outcomes … Background Post-cardiotomy cardiogenic shock (PCCS) is a serious condition that necessitates veno-arterial extracorporeal membrane oxygenation (VA-ECMO). Although acute kidney injury (AKI) often complicates PCCS, its specific effects on patient outcomes remain unclear. This study seeks to evaluate the impact of AKI on 90-day mortality. Methods This retrospective study included 91 patients with postoperative cardiogenic shock requiring venoarterial extracorporeal membrane oxygenation following cardiac surgery between 2013 and 2023. Rapid-onset AKI was defined as KDIGO Stage 2 or higher within 24 h of ICU admission. Survival was analyzed using Kaplan–Meier and Cox regression methods to assess its association with 90-day mortality. Results Twenty-four patients (26.4%) were classified as rapid-onset AKI. The median age, primary diagnosis, and preoperative serum creatinine levels were similar between groups. However, the rapid-onset AKI group had a preoperative lower left ventricular ejection fraction (42.5% vs. 60.0%, p = 0.006), longer cardiopulmonary bypass time (332 vs. 245 min, p = 0.009), and a longer duration of mechanical circulatory support (6.0 vs. 2.0 days, p = 0.001). The success rate of weaning from mechanical circulatory support was lower (61.1% vs. 93.3%, p = 0.002), and the 90-day cumulative survival probability was lower in the rapid-onset AKI group (29.1% [95% confidence interval (CI): 15.6–54.4 vs. 79.1% [95% CI: 69.9–89.4], p &amp;lt; 0.001). Cox regression analysis confirmed an independent association between rapid-onset AKI and 90-day mortality (adjusted hazard ratio: 3.15, 95% CI: 1.38–7.19, p = 0.006). Conclusion Rapid-onset AKI was significantly associated with increased 90-day mortality in patients with PCCS who required V-A ECMO.
Purpose of review Despite improvements in reperfusion and adjunctive therapies cardiogenic shock associated with acute myocardial infarction is still associated with a mortality of 40–50%. Therefore, mechanical circulatory support devices … Purpose of review Despite improvements in reperfusion and adjunctive therapies cardiogenic shock associated with acute myocardial infarction is still associated with a mortality of 40–50%. Therefore, mechanical circulatory support devices are increasingly used. One option is veno-arterial extracorporal membrane oxygenation (VA-ECMO). VA-ECMO can be implanted percutaneously and blood is actively pumped into a tubing system outside the body which also incorporates an artificial lung for oxygenation and removal of carbon dioxide and then sent back retrograde in the aorta. This review summarizes the current evidence for the use of VA-ECMO in cardiogenic shock. Recent findings Four randomized clinical trials including the large ECLS-SHOCK trial with 417 patients and two individual patient data meta-analyses did not show any mortality benefit with the routine use of VA-ECMO, but a consistent increase in bleeding and peripheral vascular ischemic complications. So far, patients with STEMI and a low likelihood of brain injury might be an attractive group for the use of VA-ECMO. In addition patients in need for oxygenation might benefit from VA-ECMO. Summary The results of the ECLS-SHOCK trial and the meta-analyses call for a conservative approach regarding a routine unselected use of early VA-ECMO in patients with infarct-related cardiogenic shock.
Background and Objectives: Coronavirus disease 2019 (COVID-19) triggers a dysregulated host response that may culminate in refractory hypoxaemic shock. Whether veno-venous ECMO modifies the inflammatory cascade more effectively in COVID-19 … Background and Objectives: Coronavirus disease 2019 (COVID-19) triggers a dysregulated host response that may culminate in refractory hypoxaemic shock. Whether veno-venous ECMO modifies the inflammatory cascade more effectively in COVID-19 than in other septic states, and how it compares with conventional ventilatory support for COVID-19, remains uncertain. We compared three groups: COVID-19 patients supported with ECMO (COVID-ECMO, n = 25), non-COVID-19 septic shock patients on ECMO (SEPSIS-ECMO, n = 19) and critically ill COVID-19 patients managed without ECMO (COVID-CONV, n = 74). Methods: This retrospective study (January 2018-January 2025) extracted demographic, laboratory and clinical data at baseline, 48 h and 72 h. The primary end-point was the 72 h change in SOFA score (Ī”SOFA). The secondary end-points included the evolution of interleukin-6 (IL-6), C-reactive protein (CRP), D-dimer and ferritin; haemodynamic variables; and 28 day mortality. A post hoc inverse-probability-of-treatment weighting (IPTW) sensitivity analysis adjusted for between-group severity imbalances. Results: Baseline APACHE II differed significantly (29.5 ± 5.8 COVID-ECMO, 27.4 ± 6.1 SEPSIS-ECMO, 18.2 ± 4.9 COVID-CONV; p < 0.001). At 48 h, IL-6 fell by 51.8% in COVID-ECMO (-1 116 ± 473 pg mL-1) versus 32.4% in SEPSIS-ECMO and 18.7% in COVID-CONV (p < 0.001). The Ī”SOFA values at 72 h were -4.6 ± 2.2, -3.1 ± 2.5 and -1.4 ± 1.9, respectively (p < 0.001). ECMO groups achieved larger mean arterial pressure rises (+16.8 and +14.2 mmHg) and greater norepinephrine reduction than COVID-CONV. The twenty-eight-day mortality was 36.0% (COVID-ECMO), 42.1% (SEPSIS-ECMO) and 39.2% (COVID-CONV) (p = 0.88). Across all patients, IL-6 clearance correlated with Ī”SOFA (ρ = 0.48, p < 0.001) and with vasopressor-free days (ρ = 0.37, p = 0.002). Conclusions: ECMO, regardless of aetiology, accelerates inflammatory-marker decline and organ failure recovery compared with conventional COVID-19 management, but survival advantage remains elusive. COVID-19 appears to display a steeper cytokine-response curve to ECMO than bacterial sepsis, suggesting phenotype-specific benefits that merit confirmation in prospective trials.
Lymphocele is a known complication of veno-arterial extracorporeal membrane oxygenation (VA-ECMO). We present a novel application of fluorescent lymphatic imaging for the highly selective treatment of lymphatic leaks after VA-ECMO … Lymphocele is a known complication of veno-arterial extracorporeal membrane oxygenation (VA-ECMO). We present a novel application of fluorescent lymphatic imaging for the highly selective treatment of lymphatic leaks after VA-ECMO and describe patient outcomes at our institution. A retrospective review of patients who underwent lymphatic ligation following VA-ECMO from 2022 to 2024 was performed. Fluorescent imaging and intradermal indocyanine green injection were used to identify and ligate lymphatic leaks within the debrided wound bed. Ten patients with a mean age of 48.3 years were included. The mean number of lymphatics ligated was 5. Mean days from decannulation to ligation and from ligation to drain removal were 18.4 and 22.2, respectively. There was a significant decrease in drain output immediately following ligation (197.4 ml/day vs. 64.2 ml/day; p = 0.016). A shorter time from decannulation to ligation was significantly correlated with a decrease in drain output. A higher drain fluid lymphocyte percentage was significantly correlated with a shorter time to drain removal. Fluorescent imaging-guided lymphatic ligation is an effective method for treating lymphatic leak after decannulation from VA-ECMO. Drain fluid analysis and early consultation with plastic surgery should be encouraged in the event of high-output lymphocele.
Extracorporeal membrane oxygenation (ECMO) is an important rescue strategy for neonates with severe cardiorespiratory failure, yet its role in the management of hypoxic-ischemic encephalopathy (HIE) remains subject to debate. Historically, … Extracorporeal membrane oxygenation (ECMO) is an important rescue strategy for neonates with severe cardiorespiratory failure, yet its role in the management of hypoxic-ischemic encephalopathy (HIE) remains subject to debate. Historically, clinicians have been reluctant to offer ECMO to infants with significant neurological injury because of concerns related to poor neurodevelopmental outcomes and elevated risk of complications such as hemorrhage and stroke. Over the past two decades, however, accumulating evidence has suggested that many neonates with HIE not only tolerate ECMO well but may also achieve meaningful survival and functional recovery. In this state-of-the-art narrative review, we surveyed and synthesized observational studies, retrospective cohorts, and case series published since 2000 that evaluated ECMO in neonates with HIE. While randomized controlled trials dedicated exclusively to this population remain scarce, the available data indicate that ECMO can be safely implemented alongside standard therapies—including therapeutic hypothermia—without uniformly prohibitive rates of bleeding or adverse neurodevelopment. Although small sample sizes and single-center experiences limit the strength of these conclusions, survival rates in combined TH–ECMO cohorts are often reported above 80–90%, with a substantial proportion of survivors demonstrating acceptable early neurodevelopmental outcomes. Overall, growing clinical acceptance of ECMO in HIE highlights the need for careful, individualized assessment of benefits and risks, as well as transparent discussions with families. Future multicenter collaborations focusing on robust longitudinal follow-up and evidence-based protocols will be essential to guide best practices and optimize outcomes for this high-risk neonatal population.
Introduction: Pulmonary embolism (PE) associated with hemodynamic compromise, termed high-risk or massive acute PE (MAPE), is associated with increased morbidity and mortality. Despite advancements in procedural techniques and an increase … Introduction: Pulmonary embolism (PE) associated with hemodynamic compromise, termed high-risk or massive acute PE (MAPE), is associated with increased morbidity and mortality. Despite advancements in procedural techniques and an increase in the availability of advanced therapies, the outcomes associated with high-risk PE remain poor. Here, we review the literature surrounding the use of Veno-arterial Extracorporeal Membrane Oxygenation (VAECMO), primarily as a bridging therapy, in patients presenting with high-risk pulmonary embolism. Methods: We conducted a systematic review and meta-analysis utilizing PubMed/MEDLINE from database inception until March 2024. The terms ā€œhigh-risk PEā€, ā€œmassive PEā€ and ā€œMAPEā€ were paired with ā€œVA-ECMOā€, ā€œbridge therapyā€ and ā€œsolo therapyā€ along with related terms to find and analyze relevant studies. The primary outcome assessed was in-hospital mortality. Results: Most comparative studies involved assessing VA-ECMO's utility as solo therapy vs as a bridge to advanced therapy. Out of the data involving VA-ECMO as solo therapy, most showed definite survival benefit in subset of populations with VA-ECMO's role being varied by age and cardiac arrest presence. A portion of studies were notable for finding no difference in outcomes; however no major retrospective determined negative effect of VA-ECMO. In headto- head studies as a bridge, studies from multiple centers highlighted VA-ECMO's role in stabilizing and improving survival in massive PE prior to systemic or catheter directed thrombolysis. Follow-up studies were limited, however one retrospective showed 30-day mortality of 31% and the 1-year mortality of 54% post PERT call. Follow-up echocardiograms performed on survivors between 30-365 days from Pulmonary Embolism Response Team (PERT) activation interestingly all had normal Right Ventricular (RV) size and function with mild to no tricuspid regurgitation. Conclusion: Most major literature supports the use of VA-ECMO as either solo therapy or a bridge to advanced therapy in MAPE with additional shock or cardiac arrest. However, further studies are needed to develop society guidelines for regular initiation in cases of MAPE.
ABSTRACT Introduction Prolonged extracorporeal circulation time is known to cause intraoperative and postoperative bleeding, but the underlying mechanism is not fully understood. In this study, we analyzed the effects of … ABSTRACT Introduction Prolonged extracorporeal circulation time is known to cause intraoperative and postoperative bleeding, but the underlying mechanism is not fully understood. In this study, we analyzed the effects of artificial lung and roller pump on platelet morphology and activation using a simulated extracorporeal circulatory circuit. Methods Blood was drawn from healthy volunteers in the presence of unfractionated heparin as an anticoagulant and recirculated for 180 min at 0.75 L/min with the circuit under a room temperature. After the samples were collected, platelet counts, platelet surface markers, and platelet activation markers were measured. Results When whole blood was circulated for 180 min, platelet counts, platelet sizes, and expressions of glycoprotein Ibα (CD42b) and glycoprotein IIb (CD41) significantly decreased after recirculation. In addition, dense bodies and α‐granules within platelets were also reduced after recirculation. Adhesion to collagen and platelet aggregation were significantly reduced after recirculation compared to pro‐circulation. When platelets were stimulated with A23187 pro‐ and post‐extracorporeal circulation, the expression of P‐selectin was significantly lower in CD42b āˆ’ platelets than in CD42b + platelets. On the other hand, phosphatidylserine (PS) exposure in CD42b āˆ’ platelets was higher than in CD42b + platelets with or without stimulation. Conclusion It was suggested that artificial lungs and roller pumps may reduce platelet activity by causing cleavage of platelet membrane glycoproteins and release of granules within platelets.
DIC was suspected of being the cause of fatal rewarming deaths in neonatal cold injury (NCI) in the absence of any other known explanation for this complication. It was associated … DIC was suspected of being the cause of fatal rewarming deaths in neonatal cold injury (NCI) in the absence of any other known explanation for this complication. It was associated with thrombocytopenia, bleeding, and abnormal clotting studies. Subsequently, this suspicion was questioned because of the reversibility of thrombocytopenia and more recently because of the delineation of a new entity DRT (delayed rewarming thrombocytopenia) that better explained the clinical and laboratory features of this condition. The sudden bleeding that occurs after 24 hours of hypothermia is explained by the reappearance, on rewarming, of the second stage of (irreversible) platelet aggregation that does not occur below 32°C, and the presence of high levels of ADP that leak from erythrocytes. It is recommended that DRT should be treated by rapid rewarming, blocking of the second phase of platelet aggregation or platelet transfusions rather than replacement therapy with several clotting factors that would be appropriate in DIC.
ABSTRACT Objective To describe the utilization patterns and outcomes of pediatric patients supported with oxygenators during their ventricular assist device (VAD) course. Design Multi-center, retrospective cohort study using data from … ABSTRACT Objective To describe the utilization patterns and outcomes of pediatric patients supported with oxygenators during their ventricular assist device (VAD) course. Design Multi-center, retrospective cohort study using data from the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) registry. Setting Data query from the ACTION registry, which collects clinical data on pediatric patients with end-stage heart disease, reported cases of combined oxygenator-VAD use. Patients Sixty-one pediatric patients (27 female) from 21 contributing ACTION centers were supported on oxygenators during their VAD course between 2013-2024. The median age was 272 days (IQR 68-1334), and the median weight was 7.9kg (IQR 4.4-12). The majority had congenital heart disease (CHD), with 66% having single-ventricle pathology. Interventions None. Measurement and Main Results The study population demonstrated high illness severity at the time of VAD implant, with 97% requiring inotropic support, 79% requiring mechanical ventilation, and 46% on ECMO. The total median duration of VAD support was 45 days (IQR 16-163). Of the 61 patients, 44% achieved transplant or recovery. The mortality rate was high at 52%, and was associated with younger age, smaller size, CHD and pre-implant use of neuromuscular blocking agents. Adverse events included infection (36%), major bleeding (36%), central nervous system injuries (21%), and dialysis (20%). None demonstrated clinically significant association with oxygenator support timing, but mortality was associated with higher adverse events rates, particularly pulmonary hemorrhage, dialysis, and infections (especially mediastinitis). Conclusion Pediatric patients requiring oxygenators during VAD therapy exhibit high illness severity and frequent adverse events. Mortality is high and associated with younger age, smaller size, CHD, pre-implant use of neuromuscular blocking agents as well frequency of on-device adverse events, particularly pulmonary hemorrhage, dialysis, and infections. Oxygenator support likely reflects disease severity rather than directly contributing to mortality. Further investigation is needed to optimize patient selection and management strategies. Research In Context Over the past two decades, pediatric VAD utilization has increased. Support from collaborative networks like ACTION has enabled investigation of nuanced strategies, such as temporary oxygenator use, providing a platform to evaluate feasibility, safety, and patient-specific considerations across diverse populations. In adult populations, oxygenator use alongside VADs has been employed for respiratory failure, ARDS, RV support, and as a bridge to lung transplant or transition from ECMO. However, these strategies have not been systematically studied in pediatric cohorts until now. This study presents the most comprehensive review of pediatric (or adult) oxygenator-VAD support to date, characterizing patient populations, utilization patterns, and associated outcomes. It provides foundational data for guiding future research into management strategies in this high-risk group. At the Bedside Pediatric patients requiring oxygenator support during VAD therapy were typically younger, smaller, and had complex congenital heart disease, particularly single-ventricle physiology. These characteristics were associated with higher mortality and reflect a population with profound critical illness at baseline. This cohort experienced high rates of adverse events, including major bleeding, infections, dialysis, and neurologic injury. While oxygenator timing was not independently associated with outcomes, mortality exceeded 50% and was linked to complications such as dialysis, pulmonary hemorrhage, and infections. Clinicians should view oxygenator-VAD support as a surrogate marker for extreme illness severity rather than a direct contributor to poor outcome. This study highlights the need for tailored management strategies and informs clinician and family decision-making in this high-risk population.
Heart failure (HF) is a major clinical and public health problem. Cardiac assist devices are crucial treatment modalities for end‐stage HF, but they still face limitations, such as direct blood … Heart failure (HF) is a major clinical and public health problem. Cardiac assist devices are crucial treatment modalities for end‐stage HF, but they still face limitations, such as direct blood contact and high power consumption. We present a lightweight (&lt;60 g), compact, electroactive polymer (EAP)‐based cardiac assist device (E‐CAD) as a nonblood‐contacting, low‐power alternative to address these limitations. E‐CAD consists of EAP units paired with negative bias springs (NBSs), mounted on a flexible sleeve that wraps around the heart to assist in cardiac compression. The device is designed to be biomimetic to match the regionally varying mechanical stiffness of the heart. Benchtop silicone phantom and ex vivo porcine tests demonstrated E‐CAD's ability to increase volume displacement by 1.21‐fold in benchtop tests with a silicone phantom and 1.17‐fold in ex vivo settings, along with an associated increase in ejection fraction, compared to cases without the device. Furthermore, it operates on low power (&lt;0.3 W), enabling a compact design with a thin driveline (outer diameter = 0.3 mm), which reduces infection risk. In summary, we showed that EAP‐based direct cardiac compression was feasible with low power demand. The improvement in cardiac output may translate into clinical benefits for advanced HF patients.
Background and purpose: Unfractionated heparin (UFH) is the most commonly utilized rapid-onset anticoagulant, valued for its potency and reversibility with protamine. However, UFH and protamine are associated with significant side … Background and purpose: Unfractionated heparin (UFH) is the most commonly utilized rapid-onset anticoagulant, valued for its potency and reversibility with protamine. However, UFH and protamine are associated with significant side effects, including increased morbidity and mortality, and concerns about sustainability due to the environmental impact of large-scale pig farming for heparin production. This study evaluates an alternative anticoagulant strategy using a factor IXa (FIXa) aptamer paired with a matched oligonucleotide antidote, comparing its efficacy and safety to heparin-protamine in a rat extracorporeal membrane oxygenation (ECMO) model. Methods: Twenty-four Sprague-Dawley rats were randomized into two groups: one receiving heparin (600 IU/kg) and protamine (1 mg/100 IU heparin), and the other receiving a cholesterol-modified FIXa aptamer (10 mg/kg) and its antidote (50 mg/kg). Coagulation parameters, platelet counts, inflammatory markers, cardiac function, and histopathology were assessed during and after 60 minutes of ECMO. Results: The FIXa aptamer effectively maintained circuit patency without clot formation, comparable to heparin. The antidote rapidly reversed the aptamer’s anticoagulant activity, similar to protamine’s reversal of heparin. Notably, the aptamer-antidote group demonstrated superior outcomes, including improved mean arterial pressure (58 ± 6 mmHg vs. 54 ± 3 mmHg at 30 minutes; 59 ± 8 mmHg vs. 51 ± 5 mmHg at 3 hours post-ECMO) and cardiac function (shortening fraction: 60 ± 16% vs. 42 ± 8%; P = 0.01). Additionally, the aptamer group exhibited better platelet preservation (platelet count decrease: āˆ’288,000 ± 121,000/μL vs. āˆ’404,000 ± 89,000/μL; P = 0.03). Inflammatory profiles were similar between groups, except for a transient increase in interleukins 10 (IL-10) in the aptamer group. Histopathological analysis revealed no significant differences in myocardial lesions. Conclusions: The antidote-controlled anti-FIXa aptamer represents an alternative anticoagulant strategy that may prove useful for managing patients with a history of heparin-induced thrombocytopenia (HIT) and myocardial dysfunction associated with protamine administration.