Green DJ, Watt KM, Fish DN
… +3 more, McKnite A, Kelley W, Bensimhon AR
J Extra Corpor Technol
· 2022 Sep · PMID 36742220
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Extracorporeal life support (ECLS) devices are lifesaving for critically ill patients with multi-organ dysfunction. Despite this, patients supported with ECLS are at high risk for ECLS-related complications, including no...Extracorporeal life support (ECLS) devices are lifesaving for critically ill patients with multi-organ dysfunction. Despite this, patients supported with ECLS are at high risk for ECLS-related complications, including nosocomial infections, and mortality rates are high in this patient population. The high mortality rates are suspected to be, in part, a result of significantly altered drug disposition by the ECLS circuit, resulting in suboptimal antimicrobial dosing. Cefepime is commonly used in critically ill patients with serious infections. Cefepime dosing is not routinely guided by therapeutic drug monitoring and treatment success is dependent upon the percentage of time of the dosing interval that the drug concentration remains above the minimum inhibitory concentration of the organism. This study measured the extraction of cefepime by continuous renal replacement therapy (CRRT) and extracorporeal membrane oxygenation (ECMO) circuits. Cefepime was studied in four closed-loop CRRT circuit configurations and a single closed-loop ECMO circuit configuration. Circuits were primed with a physiologic human blood-plasma mixture and the drug was dosed to achieve therapeutic concentrations. Serial blood samples were collected over time and concentrations were quantified using validated assays. In CRRT experiments, cefepime was rapidly cleared by dialysis, hemofiltration, and hemodiafiltration, with greater than 96% cefepime eliminated from the circuit by 2 hours. In the ECMO circuits, the mean recovery of cefepime was similar in both circuit and standard control. Mean (standard deviation) recovery of cefepime in the ECMO circuits ( = 6) was 39.2% (8.0) at 24 hours. Mean recovery in the standard control ( = 3) at 24 hours was 52.2% (1.5). Cefepime is rapidly cleared by dialysis, hemofiltration, and hemodiafiltration in the CRRT circuit but minimally adsorbed by either the CRRT or ECMO circuits. Dosing adjustments are needed for patients supported with CRRT.
Merritt-Genore H, Adams A, Zavala R
… +1 more, Brakke T
J Extra Corpor Technol
· 2022 Sep · PMID 36742219
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Interest in simulation has grown substantially, as has enthusiasm for team-based approaches to surgical training. In cardiothoracic surgery, the dynamic ability of the entire team is critical to emergent events. We devel...Interest in simulation has grown substantially, as has enthusiasm for team-based approaches to surgical training. In cardiothoracic surgery, the dynamic ability of the entire team is critical to emergent events. We developed innovative, interprofessional simulation events to improve team confidence. Two separate simulations event replicating critical steps and potential crises of cardiopulmonary bypass (CPB) were attended by members of the multidisciplinary cardiothoracic team. Standard CPB equipment, echocardiography, an app to control vital signs, and typical operating room tools for cannulation were all used. Participant started at their typical roles, then rotated into unfamiliar roles for subsequent simulations. Survey and Likert scale self-assessment tools were used to determine outcomes. Statistical analysis compared results. Two separate events were attended by a total of 37 team members (17 facilitators and 20 participants). Participants rotated roles through 12 routine and high-risk scenarios for instituting and separating from CPB. Participant evaluation results were highly favorable, with requests for further similar events. Objectively, the mean score for self-assessment rose significantly comparing the pre- and post-simulation assessments. Despite a small sample size, these differences did reach statistical significance in two categories: iatrogenic dissection ( 0.008), and emergent return to CPB ( 0.016). In our experience, high-fidelity interprofessional simulation promoted team communication and confidence for key scenarios related to institution of and separation from CPB.
Akkanti B, Zwischenberger J, Warner MT
… +7 more, Dinh K, Hussain R, Kazzaz F, Kingah P, Janowiak LM, Kar B, Gregoric ID
J Extra Corpor Technol
· 2022 Sep · PMID 36742217
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COVID-19 morbidity and mortality are not equivalent to other etiologies of acute respiratory distress syndrome (ARDS) as fulminant activation of coagulation can occur, thereby resulting in widespread microvascular thromb...COVID-19 morbidity and mortality are not equivalent to other etiologies of acute respiratory distress syndrome (ARDS) as fulminant activation of coagulation can occur, thereby resulting in widespread microvascular thrombosis and consumption of coagulation factors. A 53-year-old female presented to an emergency center on two occasions with progressive gastrointestinal and respiratory symptoms. She was diagnosed with COVID-19 pneumonia and admitted to a satellite intensive care unit with hypoxemic respiratory failure. She was intubated and mechanically ventilated, but her ARDS progressed over the next 48 hours. The patient was emergently cannulated for veno-venous extracorporeal membrane oxygenation (V-V ECMO) and transferred to our hospital. She was in profound shock requiring multiple vasopressors for hemodynamic support with worsening clinical status on arrival. On bedside echocardiography, she was found to have a massive pulmonary embolism with clot-in-transit visualized in the right atrium and right ventricular outflow tract. After a multidisciplinary discussion, systemic thrombolytic therapy was administered. The patient's hemodynamics improved and vasopressors were discontinued. This case illustrates the utility of bedside echocardiography in shock determination, the need for continued vigilance in the systematic evaluation of unstable patients in the intensive care unit, and the use of systemic thrombolytics during V-V ECMO in a novel disease process with evolving understanding.
Saemann L, Maier S, Rösner L
… +6 more, Kohl M, Schmucker C, Scherer C, Trummer G, Beyersdorf F, Benk C
J Extra Corpor Technol
· 2022 Sep · PMID 36742214
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Evidence regarding perfusion conditions during extracorporeal cardiopulmonary resuscitation (ECPR) is rare. Therefore, we investigated the impact of perfusion parameters on neurologic outcome and survival in patients wit...Evidence regarding perfusion conditions during extracorporeal cardiopulmonary resuscitation (ECPR) is rare. Therefore, we investigated the impact of perfusion parameters on neurologic outcome and survival in patients with in- or out-of-hospital cardiac arrest (IHCA; OHCA) treated with ECPR. We performed a systematic review with meta-analysis. The focus was set on perfusion parameters and their impact on survival and a goal neurological outcome using the cerebral performance category score of 1-2. We conducted random- and mixed-effects meta-analyses and computed pooled estimates and 95% confidence intervals (CI). We included a total of = 1,282 ECPR (100%) patients from 20 ECPR studies. The target values of flow and mean arterial pressure (MAP) were frequently available. We transferred flow and MAP target values to high, medium, and low categories. The meta-analysis could not demonstrate a single effect of flow or MAP on outcome variables. In a second mixed-effects model, the combined occurrence of targeted flow and MAP as medium and high showed a significant effect on survival (OHCA: 52%, 95% CI: 29%, 74%; IHCA: 60%, 95% CI: 35%, 85%) and on neurological outcomes (OHCA: 53%, 95% CI: 27%, 78%; IHCA: 62%, 95% CI: 38%, 86%). Random-effects analysis showed also that IHCA led to a significant 11% ( = 0.006; 95% CI: 3%, 18%) improvement in survival and 12% ( = .005; 95% CI: 4%, 21%) improvement in neurological outcomes compared to OHCA. A combination of medium flow and high MAP showed advantages in survival and for neurological outcomes. We also identified improved outcomes for IHCA.
Stammers AH, Tesdahl EA, Barletti S
… +6 more, Mongero L, Patel K, Mosca M, Sestokas A, Firstenberg MS, Jacobs JP
J Extra Corpor Technol
· 2022 Sep · PMID 36742213
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Coagulopathies develop in patients supported with the use of extracorporeal membrane oxygenation (ECMO) and can be hemorrhagic and/or thrombophilic in spite of the use of systemic anticoagulation. The purpose this study...Coagulopathies develop in patients supported with the use of extracorporeal membrane oxygenation (ECMO) and can be hemorrhagic and/or thrombophilic in spite of the use of systemic anticoagulation. The purpose this study was to examine the use of heparin and direct thrombin inhibitors (DTI) in COVID-19 patients with acute respiratory distress syndrome (ARDS) on ECMO, with a subset analysis by disease state. Following IRB approval, 570 consecutive records were reviewed of adult patients on venovenous ECMO between May 2020 and December 2021. Patients were grouped by anticoagulant use: Heparin Only (n = 373), DTI Only (bivalirudin or argatroban, n = 90), or DTI after Heparin (n = 107). The effect of anticoagulant grouping was assessed using Bayesian mixed-effects logistic regression adjusting for age, body mass index (BMI), gender, days of mechanical ventilation prior to ECMO, indication for ECMO support, hepatic and renal failure, hours on ECMO, hours off anticoagulation, coagulation monitoring target, and hospital. The primary endpoint was circuit failure requiring change-out with secondary endpoints of organ failure and mortality. Regression-adjusted probability of circuit change-outs were as follows: DTI after Heparin patients-32.7%, 95% Credible Interval [16.1-51.9%]; DTI Only patients-23.3% [7.5-40.8%]; and Heparin Only patients-19.8% [8.1-31.3%]. The posterior probability of difference between groups was strongest for DTI after Heparin vs. Heparin Only (97.0%), moderate for DTI after Heparin vs. DTI Only (88.2%), and weak for DTI Only vs. Heparin only (66.6%). The occurrence of both hepatic and renal failure for DTI Only and DTI after Heparin patients was higher than that of Heparin Only patients. Unadjusted mortality was highest for DTI after Heparin (64.5%) followed by DTI Only (56.7%), and Heparin Only (50.1%, = 0.027). DTI after Heparin was associated with an increased likelihood of circuit change-out. Unadjusted hepatic failure, renal failure, and mortality were more frequent among DTI patients than Heparin Only patients.
Simon BV, Beutner G, Swartz MF
… +4 more, Angona R, Smith K, Porter GA, Alfieris GM
J Extra Corpor Technol
· 2022 Sep · PMID 36742212
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Conservation of mitochondrial adenosine triphosphate (ATP) synthase proteins during ischemia is critical to preserve ATP supply and ventricular function. Following myocardial ischemia in adults, higher order ATP synthase...Conservation of mitochondrial adenosine triphosphate (ATP) synthase proteins during ischemia is critical to preserve ATP supply and ventricular function. Following myocardial ischemia in adults, higher order ATP synthase tetramer proteins disassemble into simpler monomer units, reducing the efficiency of ATP production. However, it is unknown if myocardial ischemia following the use of cardioplegia results in tetramer disassembly in neonates, and whether it can be mitigated by cardioplegia if it does occur. We investigated myocardial ATP synthase tetramer disassembly in both a neonatal lamb cardiac surgery model and in neonatal children requiring cardiac surgery for the repair of congenital heart disease. Neonatal lambs () were placed on cardiopulmonary bypass (CPB) and underwent cardioplegic arrest using a single dose of 30 mL/kg antegrade blood-based potassium cardioplegia ( = 4) or a single dose of 30 mL/kg antegrade del Nido cardioplegia ( = 6). Right ventricular biopsies were taken at baseline on CPB ( = 10) and after approximately 60 minutes of cardioplegic arrest before the cross clamp was released ( = 10). Human right ventricular biopsies ( = 3) were taken following 40.0 ± 23.1 minutes of ischemia after a single dose of antegrade blood-based cardioplegia. Protein complexes were separated on clear native gels and the tetramer to monomer ratio quantified. From the neonatal lamb model regardless of the cardioplegia strategy, the tetramer:monomer ratio decreased significantly during ischemia from baseline measurements (.6 ± .2 vs. .5 ± .1; = .03). The del Nido solution better preserved the tetramer:monomer ratio when compared to the blood-based cardioplegia (Blood .4 ± .1 vs. del Nido .5 ± .1; = .05). The tetramer:monomer ratio following the use of blood-based cardioplegia in humans aligned with the lamb data (tetramer:monomer .5 ± .2). These initial results suggest that despite cardioprotection, ischemia during neonatal cardiac surgery results in tetramer disassembly which may be limited when using the del Nido solution.
J Extra Corpor Technol
· 2022 Sep · PMID 36742211
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Intraoperative management for patients during orthotopic lung transplantation may be performed without mechanical circulatory support, with veno-arterial extracorporeal membrane oxygenation (VA-ECMO), or cardiopulmonary...Intraoperative management for patients during orthotopic lung transplantation may be performed without mechanical circulatory support, with veno-arterial extracorporeal membrane oxygenation (VA-ECMO), or cardiopulmonary bypass (CPB). For certain patients, an intraoperative conversion from VA-ECMO to CPB may be indicated. If a VA-ECMO patient requires CPB conversion, the previous model at our institution used two separate machines and was overall inefficient. The primary aim of this project was to develop a CPB pack modification to create a circuit that easily converts from VA-ECMO to CPB if indicated. The secondary aim was to create new supportive protocols and a comprehensive education and training curriculum for our large perfusion department to enhance patient safety. The new circuit was carefully designed and evaluated to minimize changes to the current CPB circuit while allowing for the safest configuration of VA-ECMO. A new protocol was designed with multi-disciplinary collaboration. A comprehensive education and training curriculum, as well as an objective competency assessment tool, were created. The circuit was subjectively evaluated by perfusionists and outscored our previous model in the areas of ease of setup, use, and CPB conversion. It received positive feedback from cardiothoracic surgeons and anesthesiologists as well. Lastly, it provided a financial benefit to our institution.
Wahl T, Stokes A, Varner C
… +2 more, Zeybek B, Bardia A
J Extra Corpor Technol
· 2022 Sep · PMID 36742210
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We present a 62-year-old patient with COVID-19 pneumonia on Veno-venous (VV) Extracorporeal Membrane Oxygenation (ECMO) with unique perturbations to pre and post oxygenator pressures due to fibrin deposition in despite b...We present a 62-year-old patient with COVID-19 pneumonia on Veno-venous (VV) Extracorporeal Membrane Oxygenation (ECMO) with unique perturbations to pre and post oxygenator pressures due to fibrin deposition in despite being on a Heparin/Bivalirudin infusion and activated Partial Thromboplastin Time (aPTT) within therapeutic range of 60-80 seconds. On Day 8 of ECMO support, it was noticed that flows steadily decreased despite unchanged RPMs. Unlike typical blood flow to circuit pressure relationships, the circuit pressures did not correlate with the observed decreased flow. The Delta Pressure (Δ) was not elevated. The patient's vitals were stable. On inspection post change-out, clots were noted in the oxygenator outlets. Oxygenator clots are usually associated with increased Δ. In this scenario, clots in the oxygenator blocked 1 of the 4 outlets in the oxygenator causing the flow, pressures, and Δ to drop consecutively. Due to reduced flow, the Δ was not elevated despite extensive clots. The fibrin clot location in the CardioHelp ECMO circuit may lead to unexpected pressure and flow alterations. Sole reliance on Δ as a marker for oxygenator clots may be misleading. Careful monitoring and timely diagnosis of coagulation status may lead to changes in anticoagulation goals and meaningfully impact patient outcomes.
Duffy V, Schneider B, Deitemyer M
… +2 more, Walczak A, Simsic JM
J Extra Corpor Technol
· 2022 Dec · PMID 36742028
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Hemorrhagic and thrombotic complications, including intracranial hemorrhage, embolic stroke, surgical bleeding, and circuit thrombosis, are common during extracorporeal membrane oxygenation (ECMO), occurring in up to 50%...Hemorrhagic and thrombotic complications, including intracranial hemorrhage, embolic stroke, surgical bleeding, and circuit thrombosis, are common during extracorporeal membrane oxygenation (ECMO), occurring in up to 50% of patients. These complications have a significant impact on morbidity and mortality. Our objective was to implement standardized ECMO anticoagulation guidelines for the pediatric cardiothoracic intensive care unit (CTICU) to reduce the incidence of intracranial hemorrhage while on ECMO. All CTICU patients who received ECMO from January 2016 to December 2020 were retrospectively reviewed. Standardized ECMO anticoagulation guidelines were implemented in the fourth quarter of 2017. Variables and clinical outcomes before and after guideline implementation were compared. From January 2016 to December 2017, there were 22 separate ECMO runs. Eight of 22 (36%) suffered intracranial hemorrhage while on ECMO. Seven of 8 (88%) were withdrawn from ECMO secondary to bleed and expired prior to hospital discharge. From January 2018 to December 2020, there were 22 separate ECMO runs in the CTICU. Three of 22 (14%) suffered intracranial hemorrhage while on ECMO. One of 3 (33%) expired prior to hospital discharge. Implementation of standardized ECMO anticoagulation guidelines in the CTICU was successful in improving clinical outcomes as evidenced by reduction in the incidence of intracranial hemorrhage in this high-risk patient population.
J Extra Corpor Technol
· 2022 Dec · PMID 36742025
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In this article, I discuss the potential pitfalls of interpreting values, confidence intervals, and declarations of statistical significance. To illustrate the issues, I discuss the LOVIT trial, which compared high-dose...In this article, I discuss the potential pitfalls of interpreting values, confidence intervals, and declarations of statistical significance. To illustrate the issues, I discuss the LOVIT trial, which compared high-dose vitamin C with placebo in mechanically ventilated patients with sepsis. The primary outcome - the proportion of patients who died or had persisting organ dysfunction at day 28 - was significantly higher in patients who received vitamin C ( = .01). The authors had hypothesized that vitamin C would have a beneficial effect, although the prior evidence for benefit was weak. There was no prior evidence for a harmful effect of high-dose vitamin C. Consequently, the pretest probability for harm was low. The sample size was calculated assuming a 10% absolute risk difference, which was optimistic. Overestimating the effect size when calculating the sample size leads to low power. For these reasons, we should be skeptical that vitamin C causes harm in septic patients, despite the significant result. -values and confidence intervals are probabilities concerning the chance of obtaining the observed data. However, we are more interested in the chance the intervention has a real effect on the outcome. That is to say, we are more interested in whether the hypothesis is true. A Bayesian approach allows us to estimate the false positive risk, which is the post-test probability there is no effect of the intervention. The false positive risk for the LOVIT trial (calculated from the published summary data using uniform priors for the parameter values) is 70%. Most likely, high-dose vitamin C does not cause harm in septic patients. Most likely it has no effect at all. If there is an effect, it is probably small and most likely beneficial.
J Extra Corpor Technol
· 2022 Dec · PMID 36742024
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The conduct of cardiopulmonary bypass in neonatal, infant, and pediatric patients continuously evolves as new devices and innovative techniques are introduced. Since 1989, periodic pediatric perfusion surveys have been c...The conduct of cardiopulmonary bypass in neonatal, infant, and pediatric patients continuously evolves as new devices and innovative techniques are introduced. Since 1989, periodic pediatric perfusion surveys have been conducted to ascertain practice patterns involving demographics, equipment, and perfusion techniques. The goal of this current project is to provide an updated perspective on international pediatric and congenital perfusion practice since the last survey conducted in 2016. In July 2021, a 100-question perfusion survey was distributed to 284 pediatric cardiac surgery centers using a secure web browser-based data application. Each center was given a unique survey hyperlink to ensure one response per institution and to monitor the response rate. Centers were given 1 month to complete the survey and electronic reminders were sent weekly to nonrespondents. After the survey was closed, information from completed surveys was exported to a software program for analysis. Responses were received from 153 of 284 pediatric centers for a response rate of 54%. Sixty respondents (39%) were from North American (NA) centers while 93 respondents (61%) were from non-North American (NNA) centers. The vast majority of centers use a roller head arterial pump (93%), hollow fiber oxygenators with open reservoirs (86%), and integrated arterial line filters (73%). The use of modified ultrafiltration was reported by 76% of centers. Ninety-two percent of centers reported the use of selective antegrade cerebral perfusion for aortic arch repairs. The N + 1 staffing model was most prevalent (52%), followed by two perfusionists per case (33%). Periodic surveys continue to be a useful modality in assessing regional variation in pediatric perfusion practice. This survey marked the first time the majority of responses came from non-North American institutions. Identifying these practice patterns may aid in the development of, and adherence to, regional standards and guidelines. This would foster the reduction of variation in practice and potentially improve patient safety.
J Extra Corpor Technol
· 2022 Dec · PMID 36742023
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Cardiopulmonary bypass (CPB) is routinely used for performing congenital heart operations. While most congenital heart operations can be performed with bypass times under 2 hours, complex pulmonary artery reconstructions...Cardiopulmonary bypass (CPB) is routinely used for performing congenital heart operations. While most congenital heart operations can be performed with bypass times under 2 hours, complex pulmonary artery reconstructions require longer periods of CPB to facilitate the surgical repair. This article is intended to summarize the surgical and perfusion techniques utilized in patients undergoing complex pulmonary artery reconstructions at our institution. The initial portion of this manuscript provides an in-depth description of the surgical techniques employed for pulmonary artery reconstructions. This information is important in order to understand why prolonged CPB is a necessary requirement. The manuscript then provides a detailed description of the perfusion techniques and the modifications to the CPB circuit. Finally, the manuscript provides a summary of data from a clinical study evaluating the application of these techniques in 100 consecutive children undergoing complex pulmonary artery reconstruction. The data from this study demonstrated that there was a poor correlation between duration of CPB and both the number of postoperative complications and hospital length of stay. Major adverse cardiac events occurred in 11 (11%) patients with one hospital mortality. These results suggest that prolonged CPB does not predispose to adverse outcomes in this select population of patients.
Moore AC, Sieck KN, Lojovich SJ
… +3 more, Mueller RP, Windle JE, Said SM
J Extra Corpor Technol
· 2022 Dec · PMID 36742021
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Alagille syndrome is an autosomal dominant disorder that is caused by heterozygous mutation of JAG1 or NOTCH2 gene that impacts several multisystem organs including but may not be limited to the liver, heart, musculoskel...Alagille syndrome is an autosomal dominant disorder that is caused by heterozygous mutation of JAG1 or NOTCH2 gene that impacts several multisystem organs including but may not be limited to the liver, heart, musculoskeletal, skin, and the eyes. The most common congenital heart defect associated with Alagille syndrome is multilevel right ventricular outflow tract obstruction with multiple central and peripheral branch pulmonary arterial stenoses occurring in up to two-thirds of these patients. We report two cases of Alagille syndrome who underwent extensive pulmonary arterial branch rehabilitation and experienced unusual oxygenator failure during cardiopulmonary bypass (CPB). We present lessons learned from these two cases and the changes that we implemented in our practice that facilitated smooth conduct of CPB in other cases that we performed subsequently.
J Extra Corpor Technol
· 2022 Mar · PMID 36380831
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The use of cardiopulmonary bypass (CPB) in cardiac surgery has often been associated with postoperative organ dysfunction. Roller and centrifugal pumps produce non-pulsatile flow (NPF) by default, and this still is the m...The use of cardiopulmonary bypass (CPB) in cardiac surgery has often been associated with postoperative organ dysfunction. Roller and centrifugal pumps produce non-pulsatile flow (NPF) by default, and this still is the most widely used mode of perfusion. The development of pulsatile pumps has allowed comparisons to be made with NPF. Pulsatile flow (PF) mimics the arterial pulse generated by the heart and is thought to be more physiological by some. This review aims to examine the proposed mechanisms behind the potential physiological benefits of PF during CPB and to summarize the current clinical evidence. MEDLINE and EMBASE were used to identify articles published over a 25 year period from 1995 to 2020. A literature review was conducted to determine the effects of PF on organ functions. A total of 44 articles were considered. Most of the articles published on PF were randomized controlled trials (RCTs). However, there was a wide variation in study methodology, method of pulse generation and how pulsatility was measured. Most of the evidence in favor of PF showed a marginal improvement on renal and pulmonary outcomes. In these studies, pulsatility was generated by an intra-aortic balloon pump. In conclusion, there is a lack of good quality RCTs that can inform on the short- and long-term clinical outcomes of PF. Further research is required in order to draw a conclusion with regards to the benefits of PF on organ function.