Pulsatile Venoarterial Perfusion Using a Novel Synchronized Cardiac Assist Device Augments Coronary Artery Blood Flow During Ventricular Fibrillation

Patients with cardiogenic shock have a very high mortality. Here we report the first use of a percutaneous pulsatile cardiac assist device, based on a diagonal pump synchronized with the heart cycle by means of an electrocardiographic signal in adult pigs. Eight domestic pigs underwent mandatory ventilation. During sinus rhythm, there were no differences between pulsatile and nonpulsatile perfusion with regard to pulmonary artery pressure, pulmonary wedge pressure, central venous pressure, mean arterial pressure (MAP), mean pulse pressure, and mean coronary artery flow (CAF). After 2 min of complete cardiac arrest (ventricular fibrillation), circulatory support with the i‐cor in venoarterial nonpulsatile extracorporeal membrane oxygenation (ECMO) mode (3 L/min) restored systemic circulation, with an increase of MAP to 78.3 mm Hg and CAF to 5.27 mL/min. After changing from ECMO settings to pulsatile mode (3 L/min, 75 bpm, pulse amplitude range 3500 rpm), MAP did not change significantly (75.6 mm Hg); however, CAF increased to 8.45 mL/min. After changing back to nonpulsatile mode, MAP remained stable (83.6 mm Hg), but CAF decreased to 4.85 mL/min. Thereafter, pulsatile cardiac assist was established with a reduced blood flow of 2.5 L/min, and the pulse amplitude range was extended to 4500 rpm. Under these conditions, MAP remained stable (71.0 mm Hg), but CAF significantly increased to 15.2 mL/min (P < 0.05). Percutaneous cardiac support using a venoarterial cardiac assist device equipped with a novel diagonal pump is able to restore and increase systemic and coronary circulation during ventricular fibrillation. Electrocardiographically triggered synchronized cardiac assist provides an additional increase of coronary artery flow. These promising results are to be confirmed in humans.     

Mechanical bridge with extracorporeal membrane oxygenation and ventricular assist device to heart transplantation

The aim of this study was to evaluate the effect of double bridges with extracorporeal membrane oxygenation (ECMO) and ventricular assist devices (VADs) in clinical heart transplantation. Between May 1994 and October 2000, 134 patients underwent heart transplantation at the National Taiwan University Hospital. Ten patients received ECMO or VAD support as bridges to transplantation. The ages ranged from 3 to 63 years. The indications included cardiac arrest under cardiopulmonary resuscitation in 2 and profound cardiogenic shock refractory to conventional therapy in 8 patients. Usually ECMO was first set up as rescue therapy. If ECMO could not be weaned off after short-term (usually 1 week) support, suitable VADs (HeartMate or Thoratec VAD) were implanted for medium-term or long-term support. Five patients received ECMO support as emergency rescue for 2 to 9 days, and then moved to Thoratec VAD for 8, 49, and 55 days, respectively, or centrifugal VAD for 31 days, or HeartMate VAD for 224 days. They all survived. The survival rate of double bridges with ECMO and VAD was 100%. In postcardiotomy cardiogenic shock, circulatory collapse from acute myocardial infarction or myocarditis, ECMO is the device of choice for short-term support. If heart transplantation is indicated, VADs should replace ECMO for their superiority as a bridge to heart transplantation. Our preliminary data of double bridges with ECMO and VAD revealed good results and were reliable and effective bridges to transplantation.     

Acute Myocardial Infarction Complicated by Cardiogenic Shock: An Algorithm‐Based Extracorporeal Membrane Oxygenation Program Can Improve Clinical Outcomes

Extracorporeal membrane oxygenation (ECMO) in our institution resulted in near total mortality prior to the establishment of an algorithm‐based program in July 2010. We hypothesized that an algorithm‐based ECMO program improves the outcome of patients with acute myocardial infarction complicated with cardiogenic shock. Between March 2003 and July 2013, 29 patients underwent emergent catheterization for acute myocardial infarction due to left main or proximal left anterior descending artery occlusion complicated with cardiogenic shock (defined as systolic blood pressure <90 mm Hg despite multiple inotropes, with or without intra‐aortic balloon pump, lactic acidosis). Of 29 patients, 15 patients were treated before July 2010 (Group 1, old program), and 14 patients were treated after July 2010 (Group 2, new program). There were no significant differences in the baseline characteristics, including age, sex, coronary risk factors, and left ventricular ejection fraction between the two groups. Cardiopulmonary resuscitation prior to ECMO was performed in two cases (13%) in Group 1 and four cases (29%) in Group 2. ECMO support was performed in one case (6.7%) in Group 1 and six cases (43%) in Group 2. The 30‐day survival of Group 1 versus Group 2 was 40 versus 79% (P = 0.03), and 1‐year survival rate was 20 versus 56% (P = 0.01). The survival rate for patients who underwent ECMO was 0% in Group 1 versus 83% in Group 2 (P = 0.09). In Group 2, the mean duration on ECMO was 9.8 ± 5.9 days. Of the six patients who required ECMO in Group 2, 100% were successfully weaned off ECMO or were bridged to ventricular assist device implantation. Initiation of an algorithm‐based ECMO program improved the outcomes in patients with acute myocardial infarction complicated by cardiogenic shock.     

Feasibility of a tiny centrifugal blood pump (TinyPump) for pediatric extracorporeal circulatory support

Abstract: In this study, the performances of the TinyPump (priming volume 5 mL) system including the pediatric cannulae (Stöckert Pediatric Arterial Cannulae 2.6, 3.0, and 4.0 mm, Stöckert Instruments GmbH, Munich, Germany; Polystan 20‐Fr Venous Catheter, MAQUET GmbH, Rastatt, Germany) and an oxygenator (Terumo Capiox RX05 Baby‐RX, Terumo Cardiovascular Systems Co., Tokyo, Japan) were studied in vitro followed with preliminary ex vivo studies in 20‐kg piglets. In vitro results revealed that the TinyPump system met the requirements for pump speed, pump flow, and pressure drop as extracorporeal circulatory support during open heart surgery and extracorporeal membrane oxygenation (ECMO) in pediatric patients. In 2‐h ex vivo studies using 20‐kg piglets where the blood contacting surface of the TinyPump was coated with a biocompatible phospholipid polymer, the plasma‐free hemoglobin levels remained less than 5.0 mg/dL and no thrombus formation was observed inside the pump. The TinyPump system including the oxygenator and connecting circuits resulted in an overall priming volume of 68 mL, the smallest ever reported. The TinyPump can be a safe option for pediatric circulatory support during open heart surgery and ECMO without requiring blood transfusion.     

Comparison of Coagulation Parameters,Anticoagulation, and Need for Transfusion in Patients on Interventional Lung Assist or Veno‐Venous Extracorporeal Membrane Oxygenation

Clinical data on anticoagulation needs of modern extracorporeal membrane oxygenation (ECMO) and its impact on coagulation are scarce. Therefore, we analyzed coagulation‐related parameters, need for transfusion, and management of anticoagulation in adult patients with severe acute respiratory failure during treatment with either pumpless interventional lung assist (iLA) or veno‐venous ECMO (vv‐ECMO). Sixty‐three patients treated with iLA and 192 patients treated with vv‐ECMO at Regensburg University Hospital between January 2005 and May 2011 were analyzed. Data related to anticoagulation, transfusion, and coagulation parameters were collected prospectively by the Regensburg ECMO registry. Except for a higher, sequential organ failure assessment (SOFA) score in the ECMO group (12 [9–15] vs. 11 [7–14], P = 0.007), a better oxygenation, and a lower dosage of vasopressors in the iLA patients, both groups had similar baseline characteristics. No difference was noted in terms of outcome and overall transfusion requirements. Factors of the plasmatic coagulation system were only marginally altered over time and did not differ between groups. Platelet counts in ECMO‐treated patients, but not in those treated with iLA, dropped significantly during extracorporeal support. A more intense systemic anticoagulation with a mean activated partial thromboplastin time (aPTT) > 53 s led to a higher need for transfusions compared with the group with a mean aPTT < 53 s, whereas the average durability of membrane oxygenators was not affected. Need for red blood cell (RBC) transfusion was highest in patients with extrapulmonary sepsis (257 mL/day), and was significantly lower in primary pulmonary adult respiratory distress syndrome (ARDS) (102 mL/day). Overall, 110 (0–274) mL RBC was transfused in the ECMO group versus 146 (41–227) mL in the iLA group per day on support. The impact of modern iLA and ECMO systems on coagulation allows comparatively safe long‐term treatment of adult patients with acute respiratory failure. A moderate systemic anticoagulation seems to be sufficient. Importantly, platelets are more affected by vv‐ECMO compared with pumpless iLA.     

Extracorporeal Life Support After Cardiac Surgery in Children: Outcomes From a Single Institution

Extracorporeal life support (ECLS) is used after congenital heart surgery for several indications, including failure to separate from cardiopulmonary bypass, postoperative low cardiac output syndrome, and extracorporeal cardiopulmonary resuscitation. Here, we assessed the outcomes of ECLS in children after cardiac surgery at our institution. Medical records of all children who required postoperative ECLS at our institution were reviewed. Between 2003 and 2011, 36 (1.4%) of 2541 pediatric cardiac surgical cases required postoperative ECLS. Median age of patients was 64 days (range: 0 days–4.1 years). ECLS was in the form of either extracorporeal membrane oxygenation (ECMO; n = 24) or ventricular assist system (VAS; n = 12). Mean duration of ECLS was 4.9 ± 4.2 days. Overall, 21 patients (58%) were weaned off ECLS, and 17 patients (47%) were successfully discharged from the hospital. Patients with biventricular heart (BVH) had higher survival‐to‐hospital discharge rates compared with those with univentricular heart (UVH) (P = 0.019). Regarding ECLS type, UVH patients who received VAS showed higher rates of device discontinuation than UVH patients who received ECMO (P = 0.012). However, rates of hospital discharge were not significantly different between UVH patients who received VAS or ECMO. Surgical interventions, such as banding of Blalock–Taussig shunt to reduce pulmonary blood flow or placing bidirectional cavopulmonary shunt to minimize ventricular volume overload, were effective for weaning off ECLS in patients with UVH. ECLS is beneficial to children with low cardiac output after cardiac surgery. Rates of survival‐to‐hospital discharge were higher in BVH patients than UVH patients. Additional interventions to reduce ventricular volume load may be effective for discontinuing ECLS in patients with UVH.     

Left Ventricular Assist System Through the Left Ventricle for Acute Myocardial Infarction: Report of a Case

A 49-year-old man, who had suffered from acute myocardial infarction due to left main trunk occlusion, developed cardiogenic shock and was successfully treated with an implantation of a left ventricular assist system with left ventricular apical drainage. At present he is awaiting a heart transplant at approximately 485 days since the operation. The timely application of a left ventricular assist system before the development of multiple organ failure is thus considered to be effective for patients demonstrating acute myocardial infarction with cardiogenic shock.     

Current Status of Heart Assist and Replacement in Taiwan

Abstract: The first clinical application of intraaortic balloon pumps (IABP) in Taiwan was in 1976 to treat post-cardiotomy cardiogenic shock. It is now the most commonly used circulatory assist. From 1991 to 1995, 186 patients received IABP support with an overall mortality rate of 41.9%. The male patients had the best survival rate, 67%, after coronary artery bypass grafting. The first extracorporeal membrane oxygenation (ECMO) was in 1987 to treat intractable heart failure caused by severe acute rejection after heart transplantation. Because of poor outcome, patients only received ECMO sporadically during the past years. From November 1994 to November 1995, 30 patients received ECMO support with 50% of them eventually weaned from ECMO and 27% discharged. For short-term support or emergency rescue, ECMO was a good choice. When long-term support was required, the ventricular assist device (VAD) was a more suitable assist. One patient who received Thermedics VAD developed right heart failure and finally died of sepsis and multiple organ failure. VAD should be implanted before the secondary organ failure. The first successful clinical heart transplantation in Taiwan was performed on July 17, 1987. From 1991 to 1995, 102 patients underwent heart transplantation. The operative mortality was 3.9%, and the 1 and 5 year actuarial survival rates were 86 ± 3% and 77 ± 5%, respectively. To improve the success rate of clinical heart transplantation, organ donation should be encouraged.     

Cytokine Generation in Rabbits During Extracorporeal Lung Assist with a Mini Hollow Fiber Lung

Abstract: To examine host responses to extracorporeal lung assist (ECLA) in small animals, we developed a mini hollow fiber lung of nonmicroporous polyolefin and an extracorporeal bypass circuit with a priming volume of 25 ml. This circuit allowed ECLA of up to 72 h without blood transfusion in 20 rabbits. The ECLA procedure induced the appearance of tumor necrosis factor-a (TNF-a) and interleukin-1 (IL-1) receptor antagonist (IL-IRa) in plasma, but not IL-ip. However, these changes were observed only at the initial stage of ECLA, and the levels returned to pre-ECLA levels within 24 h. Although leukocytes adhering to the hollow fibers were immunohisto-chemically positive for IL-ip and IL-IRa, the plasma levels of these cytokines in response to ECLA were not different from those observed in rabbits given anesthesia and subjected to minor surgery but without ECLA. Thus, ECLA itself is a minor factor in the production of these cytokines.     

Assisted Circulation in Cardiac and Respiratory Insufficiency

Summary: Intra-aortic counterpulsation with a balloon pump (IABP) was used in 63 patients with cardiogenic shock, heart failure after surgery with artificial circulation, internal lacerations of the myocardium, or unstable angina. It was found that the IABP was most efficient in conditions related to myocardial ischemia. Use of arteriovenous perfusion (in 11 patients) or artificial ventricles is indicated in severe perturbations of the pumping function of the heart. As experience has shown, cardiologic and heart surgery patients usually have multiorgan insufficiency. For this reason, it is necessary to use other artificial organs in complex treatment: artificial lungs, kidneys, livers, etc.     

A Nonocclusive,Inexpensive Pediatric Pulsatile Roller Pump for Cardiopulmonary Bypass,Extracorporeal Life Support,and Left/Right Ventricular Assist Systems

A simple, inexpensive pediatric pulsatile roller blood pump has been utilized for routine cardiopulmonary bypass (CPB) procedures, extracorporeal life support (ECLS), and left/right ventricular assist systems (LVAS/RVAS) for decades in France. This particular nonocclusive pulsatile system has many advantages including several safety features for patients as well as an extremely lower cost. The objective of this study is to evaluate the performance of this particular system for CPB, ECLS, and LVAS/RVAS in pulsatile mode. This pediatric nonocclusive system was evaluated with pump flow rates of 500, 750, and 1000 mL/min under normothermic (35°C) and hypothermic (25°C) conditions in CPB, ECLS, and LVAS/RVAS circuits using clinical disposables and settings. Energy equivalent pressure (EEP), surplus homodynamic energy (SHE), and total hemodynamic energy (THE) were calculated for each experimental stage. The pump generated near physiological quality of pulsatile flow without backflow in the three simulated pediatric circuits. With increased flow rates, more hemodynamic energy was delivered to the pseudo patient. This particular nonocclusive pediatric pulsatile system performed well during all of the experimental conditions and generated adequate quality pulsatile pressure‐flow waveforms using CPB, ECLS, and LVAS/RVAS circuitry. Although this novel concept was first introduced in the 1990s, we believe that there is still need for this technology (with engineering modifications) because of significant advantages including safety and cost.     

Survival Predictors in Ventricular Assist Device Patients With Prior Extracorporeal Life Support: Selecting Appropriate Candidates

Several centers turn patients down for long‐term ventricular assist devices (VADs) once they have received extracorporeal life support (ECLS) due to the expected poor outcome in these patients. The aim of this study was to identify survival predictors in this cohort of patients. Data of patients undergoing VAD support between January 2010 and November 2013 were retrospectively reviewed. Patients on ECLS support before implantation were considered eligible for inclusion. Outcome in survivors following long‐term VAD support was compared with outcomes in nonsurvivors. Student's t‐test and χ²‐test were used as applicable. A total of 65 long‐term VADs were implanted. The inclusion criteria were met by 24 patients. Eight patients did not survive the first 30 days. All preoperative characteristics were comparable between the two groups except for statistically higher Model for End‐stage Liver Disease (MELD) score, bilirubin, white blood cell count, and blood urea nitrogen in nonsurvivors (P = 0.002, 0.01, 0.01, and 0.003, respectively). Stepwise discriminant analysis revealed MELD score as the most important survival predictor. Based on this analysis, an outcome predictor formula was generated. The 30‐day and 1‐year survival rates were 67% and 54%, respectively. In this study, we were able to determine survival predictors in VAD patients with prior ECLS support. The outcome in these patients is limited and associated with higher postoperative complications, particularly right ventricular and respiratory failure. The pre‐VAD MELD score is an important predictor of poor outcome.     

Extracorporeal Life Support Experiences of a New Congenital Heart Center in Turkey

Extracorporeal life support (ECLS) provides mechanical support following cardiac surgery when respiratory and cardiac failure occurs. We retrospectively reviewed medical records of patients who needed ECLS at a new congenital heart center in Turkey. Between December 2009 and February 2012, 616 congenital heart operations were performed. A total of 13 patients (seven female) underwent ECLS. The ages of the patients ranged between 16 days and 33 years. There were two neonatal, seven infant, three pediatric, and one adult congenital cases. Medos DPII ECLS system was used in all patients. Mean duration of ECLS was 6.2 ± 5.8 days (ranged from 29 h to 24 days). While central vascular access with aorta and right atrial cannulation was used in 11 patients, neck vessels were used in the other patients. Four patients (30.7%) weaned successfully from ECLS (two infant, two pediatric cases). Three of them had ECLS intraoperatively. In all patients, two (15.4%) were discharged from the hospital. One of them had mild neurologic deficit. Bleeding from the surgical and cannulation sites was the most common complication. Thrombus was detected in pump head and changed uneventfully in three patients. Arterial pH and lactate levels at the beginning of ECLS were significantly lower in patients who were successfully weaned from ECLS than nonsurvivors (P = 0.04 and P = 0.02, respectively). ECLS can be a lifesaving modality in the perioperative period. It may be more beneficial if ECLS is used before the development of severe acidosis and high lactate levels.     

Application of a pressure-relieving air compliance chamber in a single-pulsatile extracorporeal life support system: an experimental study

Nonpulsatile blood pumps are mainly used in extracorporeal life support systems. Although pulsating blood flow is known to be physiological, a pulsatile pump is not commonly applied in a circuit with a membrane oxygenator because of damage to the blood cells. The hypothesis that the placement of a pressure-relieving compliance chamber in a circuit might reduce blood cell trauma was tested. An extracorporeal life support circuit was constructed in an acute lung injury model of dogs by oleic acid infusion. The animals were divided into three groups. In group I (n = 6) a nonpulsatile centrifugal pump was used as a control. In group II (n = 4) a single-pulsatile pump was used, and in group III (n = 6) a single-pulsatile pump equipped with a compliance chamber was used. Pump flow was maintained at 1.8-2.0 L/min for 2 h. Hemodynamics and blood gas analyses indicated that the pulsatile groups II and III had better results than the nonpulsatile group I. The plasma-free hemoglobin level, which indicates blood cell trauma, was the lowest in group I and the highest in group II but was significantly decreased in group III. A pressure-relieving compliance chamber could significantly reduce high circuit pressures and blood cell trauma.     

Increased Plasma‐Free Hemoglobin Levels Identify Hemolysis in Patients With Cardiogenic Shock and a Trans valvular Micro‐Axial Flow Pump

Hemolysis is a potential limitation of percutaneously delivered left‐sided mechanical circulatory support pumps, including trans valvular micro‐axial flow pumps (TVP). Hemolytic biomarkers among durable left ventricular assist devices include lactate dehydrogenase (LDH) >2.5 times the upper limit of normal (ULN) and plasma‐free hemoglobin (pf‐Hb) >20 mg/dL. We examined the predictive value of these markers among patients with cardiogenic shock (CS) receiving a TVP. We retrospectively studied records of 116 consecutive patients receiving an Impella TVP at our institution between 2012 and 2017 for CS. Twenty‐three met inclusion/exclusion criteria, and had sufficient pf‐Hb data for analysis. Area under receiver‐operator characteristic (ROC) curve for diagnosing hemolysis were calculated. Mean age was 62 ± 14 years and ejection fraction was 15 ± 5%. Mean duration of support was 5.4 ± 3.5 days. Pre‐device LDH levels were >2.5x ULN in 71% (n = 5/7) of 5.0 and 29% of CP patients, while pre‐device pf‐Hb levels were >20 mg/dL in 14% (n = 1/7) of 5.0 and 25% (n = 4/16) of CP patients. Given elevated baseline LDH and pf‐Hb levels, we defined hemolysis as a pf‐Hb level >40 mg/dL within 72 h post‐implant plus clinical evidence of device‐related hemolysis. We identified that 30% (n = 7/23) had device‐related hemolysis. Using ROC curve‐derived cut‐points, an increase in delta pf‐Hb by >27mg/dL, not delta LDH, within 24 h after TVP implant (delta pf‐Hb: C‐statistic = 0.79, sensitivity: 57%, specificity: 93%, p <0.05) was highly predictive of hemolysis. In conclusion, we identified a change in pf‐Hb, not LDH, levels is highly sensitive and specific for hemolysis in patients treated with a TVP for CS.     

Postoperative Cardiac Support with a Pulsatile Assist Pump: Techniques and Results

Since 1980 this group has employed a pulsatile assist pump(s) in 23 patients. Postoperative survival was 39% (9/23). In this group, 16 patients have required left ventricular support; 9 have been weaned from the pump, and 7 have survived (44%). Three patients required right ventricular support, and two have survived (66%). Four patients required biventricular assistance, but none survived. There have been four late deaths in this group. Of the five patients alive and well, all are New York Heart Association Class I or II. Important conclusions include the following: The pulsatile pump can adequately support the pulmonary or systemic circulation for a period of days; dramatic improvement in ventricular function is frequently observed in patients with univentricular failure; adequate right ventricular function is a major determinant of survival in a patient with pulsatile left ventricular support; preoperative cardiogenic shock and/or a prolonged time on cardiopulmonary bypass (CPB) predispose the patient to diffuse intravascular coagulation and a poor result; considerable information remains to be learned regarding the selection of assist pump candidates, optimal CPB techniques, and intraoperative identification of biventricular failure, which will further improve these results.     

Mechanical circulatory support and its implications for anaesthesia and critical care

Mechanical circulatory support is an increasingly important strategy for the treatment of a subset of patients with acute heart failure. Use of extracorporeal circuits with pumps and oxygenators to augment cardiac function can be immediately lifesaving, whereas implantable therapies can allow patients, with advanced heart disease, to resume near normal lives. Options for mechanical support are expanding, with long-term prognosis improving as devices become more sophisticated and complication rates fall. The perioperative management of such patients is reliant on complex specialist pathways and effective multidisciplinary decision making. Critical care considerations for mechanical circulatory support are wide-ranging, and an understanding of the underlying physiology, device circuitry, anticoagulation, haemostasis, invasive monitoring and transoesophageal echocardiography is essential.     

Rescue extracorporeal life support for acute verapamil and propranolol toxicity in a neonate

Extracorporeal life support (ECLS) to manage acute antiarrhythmic drugs toxicity in neonates has never been reported. Here presented is a case of venoarterial extracorporeal membrane oxygenation support in a newborn with refractory low cardiac output as a result of acute Ca-channel and β-receptor antagonist toxicity for treatment of paroxysmal supraventricular tachycardia (SVT). Shortly after onset of ECLS, the baby recovered sinus rhythm and subsequent bouts of SVT were controlled by amiodarone infusion and repeated DC shocks. Weaning was possible on the 5th day after implant, once recovery of the left ventricular function and optimization of the antiarrhythmic medication were achieved. In neonates with severe but potentially reversible cardiac dysfunction caused by drug toxicity, ECLS can maintain cardiac output and vital organ perfusion while allowing time for drug redistribution, metabolism, and clearance.