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1.
Crit Care ; 28(1): 158, 2024 05 10.
Article En | MEDLINE | ID: mdl-38730424

BACKGROUND: An increasing number of patients requires extracorporeal membrane oxygenation (ECMO) for life support. This supportive modality is associated with nosocomial infections (NIs). This systematic review and meta-analysis aim to assess the incidence and risk factors of NIs in adult. METHODS: We searched PubMed, Scopus, Web of Science, and ProQuest databases up to 2022. The primary endpoint was incidence of NI. Secondary endpoints included time to infection, source of infection, ECMO duration, Intensive care and hospital length of stay (LOS), ECMO survival and overall survival. Incidence of NI was reported as pooled proportions and 95% confidence intervals (CIs), while dichotomous outcomes were presented as risk ratios (RR) as the effective index and 95% CIs using a random-effects model. RESULTS: Among the 4,733 adult patients who received ECMO support in the 30 included studies, 1,249 ECMO-related NIs per 1000 ECMO-days was observed. The pooled incidence of NIs across 18 studies involving 3424 patients was 26% (95% CI 14-38%).Ventilator-associated pneumonia (VAP) and bloodstream infections (BSI) were the most common NI sources. Infected patients had lower ECMO survival and overall survival rates compared to non-infected patients, with risk ratio values of 0.84 (95% CI 0.74-0.96, P = 0.01) and 0.80 (95% CI 0.71-0.90, P < 0.001), respectively. CONCLUSION: Results showed that 16% and 20% lower of ECMO survival and overall survival in patients with NI than patients without NI, respectively. However, NI increased the risk of in-hospital mortality by 37% in infected patients compared with non-infected patients. In addition, this study identified the significant positive correlation between ECMO duration and ECMO-related NI.


Cross Infection , Extracorporeal Membrane Oxygenation , Humans , Extracorporeal Membrane Oxygenation/adverse effects , Extracorporeal Membrane Oxygenation/statistics & numerical data , Extracorporeal Membrane Oxygenation/methods , Cross Infection/epidemiology , Cross Infection/mortality , Incidence , Risk Factors , Adult
2.
Crit Care ; 28(1): 160, 2024 05 13.
Article En | MEDLINE | ID: mdl-38741176

BACKGROUND: Limited data are available on organ donation practices and recipient outcomes, particularly when comparing donors who experienced cardiac arrest and received extracorporeal cardiopulmonary resuscitation (ECPR) followed by veno-arterial extracorporeal membrane oxygenation (ECMO) decannulation, versus those who experienced cardiac arrest without receiving ECPR. This study aims to explore organ donation practices and outcomes post-ECPR to enhance our understanding of the donation potential after cardiac arrest. METHODS: We conducted a nationwide retrospective cohort study using data from the Japan Organ Transplant Network database, covering all deceased organ donors between July 17, 2010, and August 31, 2022. We included donors who experienced at least one episode of cardiac arrest. During the study period, patients undergoing ECMO treatment were not eligible for a legal diagnosis of brain death. We compared the timeframes associated with each donor's management and the long-term graft outcomes of recipients between ECPR and non-ECPR groups. RESULTS: Among 370 brain death donors with an episode of cardiac arrest, 26 (7.0%) received ECPR and 344 (93.0%) did not; the majority were due to out-of-hospital cardiac arrests. The median duration of veno-arterial ECMO support after ECPR was 3 days. Patients in the ECPR group had significantly longer intervals from admission to organ procurement compared to those not receiving ECPR (13 vs. 9 days, P = 0.005). Lung graft survival rates were significantly lower in the ECPR group (log-rank test P = 0.009), with no significant differences in other organ graft survival rates. Of 160 circulatory death donors with an episode of cardiac arrest, 27 (16.9%) received ECPR and 133 (83.1%) did not. Time intervals from admission to organ procurement following circulatory death and graft survival showed no significant differences between ECPR and non-ECPR groups. The number of organs donated was similar between the ECPR and non-ECPR groups, regardless of brain or circulatory death. CONCLUSIONS: This nationwide study reveals that lung graft survival was lower in recipients from ECPR-treated donors, highlighting the need for targeted research and protocol adjustments in post-ECPR organ donation.


Cardiopulmonary Resuscitation , Extracorporeal Membrane Oxygenation , Tissue and Organ Procurement , Humans , Retrospective Studies , Male , Female , Middle Aged , Cardiopulmonary Resuscitation/methods , Cardiopulmonary Resuscitation/statistics & numerical data , Tissue and Organ Procurement/methods , Tissue and Organ Procurement/statistics & numerical data , Tissue and Organ Procurement/trends , Extracorporeal Membrane Oxygenation/statistics & numerical data , Extracorporeal Membrane Oxygenation/methods , Extracorporeal Membrane Oxygenation/trends , Adult , Japan/epidemiology , Cohort Studies , Tissue Donors/statistics & numerical data , Heart Arrest/therapy , Heart Arrest/mortality , Aged , Brain Death
3.
Crit Care Med ; 52(6): 869-877, 2024 06 01.
Article En | MEDLINE | ID: mdl-38752812

OBJECTIVES: To examine trends in utilization and outcomes among patients with the acute respiratory distress syndrome (ARDS) requiring prolonged venovenous extracorporeal membrane oxygenation (VV ECMO) support. DESIGN: Retrospective observational cohort study. SETTING: Adult patients in the Extracorporeal Life Support Organization registry. PATIENTS: Thirteen thousand six hundred eighty-one patients that required ECMO for the support of ARDS between January 2012 and December 2022. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Mortality while supported with VV ECMO and survival to hospital discharge based on ECMO duration were examined utilizing multivariable logistic regression. Among the 13,681 patients supported with VV ECMO, 4,040 (29.5%) were supported for greater than or equal to 21 days and 975 (7.1%) for greater than or equal to 50 days. Patients supported with prolonged VV ECMO were less likely to be discharged alive from the hospital compared with those with short duration of support (46.5% vs. 59.7%; p < 0.001). However, among patients supported with VV ECMO greater than or equal to 21 days, duration of extracorporeal life support was not significantly associated with mortality (odds ratio [OR], 0.99; 95% CI, 0.98-1.01; p = 0.87 and adjusted OR, 0.99; 95% CI, 0.97-1.02; p = 0.48). Even in those supported with VV ECMO for at least 120 days (n = 113), 52 (46.0%) of these patients were ultimately discharged alive from the hospital. CONCLUSIONS: Prolonged VV ECMO support of ARDS has increased and accounts for a substantial portion of cases. Among patients that survive for greater than or equal to 21 days while receiving VV ECMO support, duration is not predictive of survival to hospital discharge and clinical recovery may occur even after very prolonged VV ECMO support.


Extracorporeal Membrane Oxygenation , Registries , Respiratory Distress Syndrome , Humans , Extracorporeal Membrane Oxygenation/methods , Extracorporeal Membrane Oxygenation/mortality , Extracorporeal Membrane Oxygenation/statistics & numerical data , Respiratory Distress Syndrome/therapy , Respiratory Distress Syndrome/mortality , Male , Retrospective Studies , Female , Middle Aged , Adult , Time Factors , Prevalence , Aged
4.
BMJ Open Qual ; 13(2)2024 May 23.
Article En | MEDLINE | ID: mdl-38782489

INTRODUCTION: In healthcare teams, psychological safety is associated with improved performance, communication, collaboration and patient safety. Extracorporeal membrane oxygenation (ECMO) retrieval teams are multidisciplinary teams that initiate ECMO therapy for patients with severe acute respiratory failure in referring hospitals and transfer patients to regional specialised centres for ongoing care. The present study aimed to explore an ECMO team's experience of psychological safety and generate recommendations to strengthen psychological safety. METHODS: The study was conducted in the Royal Brompton Hospital (RBH), part of Guy's and St Thomas' NHS Foundation Trust in London. RBH is one of six centres commissioned to provide ECMO therapy in the UK. 10 participants were recruited: 2 consultants, 5 nurses and 3 perfusionists. Semistructured interviews were used to explore the team members' views on teamwork, their perceived ability to discuss concerns within the team and the interaction between speaking up, teamwork and hierarchy. A Reflexive Thematic Analysis approach was used to explore the interview data. RESULTS: The analysis of the interview dataset identified structural and team factors shaping psychological safety in the specific context of the ECMO team. The high-risk environment in which the team operates, the clearly defined process and functions and the structured opportunities that provide legitimate moments to reflect together influence how psychological safety is experienced. Furthermore, speaking up is shaped by the familiarity among team members, the interdependent work, which requires boundary spanning across different roles, and leadership behaviour. A hierarchy of expertise is privileged over traditional institutional ranking. CONCLUSION: This study surfaced the structural and team factors that influence speaking up in the specific context of an ECMO retrieval team. Such information is used to suggest interventions to improve and strengthen psychological safety.


Extracorporeal Membrane Oxygenation , Patient Care Team , Patient Safety , Qualitative Research , Humans , Extracorporeal Membrane Oxygenation/methods , Extracorporeal Membrane Oxygenation/standards , Extracorporeal Membrane Oxygenation/statistics & numerical data , Patient Care Team/standards , Patient Care Team/statistics & numerical data , Patient Safety/standards , Patient Safety/statistics & numerical data , London , Interviews as Topic/methods , Quality Improvement , Female , Male , Psychological Safety
5.
J Surg Res ; 298: 94-100, 2024 Jun.
Article En | MEDLINE | ID: mdl-38593603

INTRODUCTION: Extracorporeal membrane oxygenation (ECMO)-associated compartment syndrome (CS) is a rare complication seen in critically ill patients. The epidemiology and management of ECMO-associated CS in the upper extremity (UE) and lower extremity (LE) are poorly defined in the literature. We sought to determine the epidemiology and characterize treatment and outcomes of UE-CS compared to LE-CS in the setting of ECMO therapy. METHODS: Adult patients undergoing ECMO therapy were identified in the Nationwide Readmission Database (2015-2019) and followed up for 6 months. Patients were stratified based on UE-CS versus LE-CS. Primary outcomes were fasciotomy and amputation. All-cause mortality and length of stay were also collected. Risk-adjusted modeling was performed to determine patient- and hospital-level factors associated with differences in the management UE-CS versus LE-CS while controlling for confounders. RESULTS: A total of 24,047 cases of ECMO during hospitalization were identified of which 598 were complicated by CS. Of this population, 507 cases were in the LE (84.8%), while 91 (15.5%) were in the UE. After multivariate analysis, UE-CS patients were less likely to undergo fasciotomy (50.5 vs. 70.9; P = 0.013) and were less likely to undergo amputation of the extremity (3.3 vs. 23.7; P = 0.001) although there was no difference in mortality (58.4 vs. 65.4; P = 0.330). CONCLUSIONS: ECMO patients with CS experience high mortality and morbidity. UE-CS has lower rates of fasciotomy and amputations, compared to LE-CS, with similar mortality. Further studies are needed to elucidate the reasons for these differences.


Compartment Syndromes , Databases, Factual , Extracorporeal Membrane Oxygenation , Fasciotomy , Humans , Extracorporeal Membrane Oxygenation/statistics & numerical data , Extracorporeal Membrane Oxygenation/adverse effects , Male , Compartment Syndromes/etiology , Compartment Syndromes/epidemiology , Compartment Syndromes/therapy , Compartment Syndromes/mortality , Compartment Syndromes/surgery , Female , Middle Aged , Databases, Factual/statistics & numerical data , Fasciotomy/statistics & numerical data , Adult , Aged , Amputation, Surgical/statistics & numerical data , Retrospective Studies , United States/epidemiology , Lower Extremity/blood supply , Upper Extremity , Length of Stay/statistics & numerical data , Treatment Outcome
6.
ASAIO J ; 70(6): 479-484, 2024 Jun 01.
Article En | MEDLINE | ID: mdl-38237607

As the availability of extracorporeal membrane oxygenation (ECMO) expands, so has the need for interfacility transfer to ECMO centers. However, the impact of these transfers is unknown. We hypothesized that interfacility transfers would be associated with increased complications and mortality. This retrospective cohort study includes adult patients treated with venovenous (VV) ECMO at all four adult ECMO centers comprising our statewide registry. Complications, mortality, ECMO duration, length of stay, and disposition were compared based on cannulation at an ECMO center versus outside hospital and transferred by air versus ground after adjusting for baseline covariates/parameters. The study included 420 adult patients, 36% of whom were cannulated at an outside institution before transfer. Of these, 63% were transported by ground and the remainder by air. Risk adjusted logistic regression revealed similar odds of mortality between those cannulated at ECMO centers versus referring hospital and then transported (odds ratio [OR] = 0.77, confidence interval [CI] = 0.49-1.22). This study supports the practice of interfacility ECMO transfer.


Extracorporeal Membrane Oxygenation , Patient Transfer , Humans , Extracorporeal Membrane Oxygenation/methods , Extracorporeal Membrane Oxygenation/statistics & numerical data , Retrospective Studies , Male , Middle Aged , Female , Patient Transfer/statistics & numerical data , Patient Transfer/methods , Adult , Aged , Treatment Outcome , Length of Stay/statistics & numerical data
7.
Asian Cardiovasc Thorac Ann ; 31(4): 321-331, 2023 May.
Article En | MEDLINE | ID: mdl-37036252

BACKGROUND: A few prognostic scoring systems have been developed for predicting mortality in patients with cardiogenic shock requiring veno-arterial extracorporeal membrane oxygenation (VA-ECMO), albeit with variations in performance. This study aimed to assess and compare various mortality prediction models in a cohort of patients receiving VA-ECMO following cardiogenic shock or arrest. METHODS: We retrospectively analyzed 77 patients with cardiogenic shock who were placed on VA-ECMO support between March 2014 and August 2021. The APACHE II, SAPS II, SAVE, Modified SAVE, ENCOURAGE, and ECMO-ACCEPTS scores were calculated for each patient to predict the in-hospital mortality. RESULTS: Fifty-six (72.7%) patients died. All prediction model scores, except the ECMO-ACCEPTS, differed significantly between non-survivors and survivors as follows: ENCOURAGE, 23 versus 16 (p < 0.001); SAVE, -6 versus -3 (p = 0.008); Modified SAVE, -5 versus 0 (p = 0.005); APACHE II, 32 versus 22 (p = 0.009); and SAPS II, 67 versus 49 (p = 0.002). The ENCOURAGE score demonstrated the best discriminatory ability with an area under the receiver-operating characteristic curve of 0.81 (95% confidence interval: 0.7-0.81). All prognostic scoring systems possessed limited calibration ability. However, the SAPS II, SAVE, and ENCOURAGE scores had lower Akaike and Bayesian information criteria values, which were consistent with the results of the Hosmer-Lemeshow C statistic test, indicating better performance than the other scores. CONCLUSIONS: The ENCOURAGE score can help predict in-hospital mortality in all subsets of VA-ECMO patients, even though it was originally designed to predict intensive care unit mortality in the post-acute myocardial infarction setting.


Extracorporeal Membrane Oxygenation , Hospital Mortality , Shock, Cardiogenic , Humans , Male , Female , Adult , Middle Aged , Aged , Shock, Cardiogenic/mortality , Extracorporeal Membrane Oxygenation/statistics & numerical data , Retrospective Studies , Prognosis
8.
Clin Obstet Gynecol ; 66(1): 151-162, 2023 03 01.
Article En | MEDLINE | ID: mdl-36044634

In the last 2 decades, the use of venovenous (VV) and venoarterial (VA) extracorporeal membrane oxygenation (ECMO) during pregnancy and the postpartum period has increased, mirroring the increased utilization in nonpregnant individuals worldwide. VV ECMO provides respiratory support for patients with acute respiratory distress syndrome (ARDS) who fail conventional mechanical ventilation. With the COVID-19 pandemic, the use of VV ECMO has increased dramatically and data during pregnancy and the postpartum period are overall reassuring. In contrast, VA ECMO provides both respiratory and cardiovascular support. Data on the use of VA ECMO during pregnancy are extremely limited.


Extracorporeal Membrane Oxygenation , Female , Humans , Pregnancy , COVID-19/epidemiology , COVID-19/therapy , Extracorporeal Membrane Oxygenation/methods , Extracorporeal Membrane Oxygenation/statistics & numerical data , Pandemics , Respiration, Artificial , Treatment Failure , Respiratory Distress Syndrome/therapy
9.
J Heart Lung Transplant ; 42(4): 503-511, 2023 04.
Article En | MEDLINE | ID: mdl-36435686

BACKGROUND: Acute brain injury (ABI) remains common after extracorporeal cardiopulmonary resuscitation (ECPR). Using a large international multicenter cohort, we investigated the impact of peri-cannulation arterial oxygen (PaO2) and carbon dioxide (PaCO2) on ABI occurrence. METHODS: We retrospectively analyzed adult (≥18 years old) ECPR patients in the Extracorporeal Life Support Organization registry from 1/2009 through 12/2020. Composite ABI included ischemic stroke, intracranial hemorrhage (ICH), seizures, and brain death. The registry collects 2 blood gas data pre- (6 hours) and post- (24 hours) cannulation. Blood gas parameters were classified as: hypoxia (<60mm Hg), normoxia (60-119mm Hg), and mild (120-199mm Hg), moderate (200-299mm Hg), and severe hyperoxia (≥300mm Hg); hypocarbia (<35mm Hg), normocarbia (35-44mm Hg), mild (45-54mm Hg) and severe hypercarbia (≥55mm Hg). Missing values were handled using multiple imputation. Multivariable logistic regression analysis was used to assess the relationship of PaO2 and PaCO2 with ABI. RESULTS: Of 3,125 patients with ECPR intervention (median age=58, 69% male), 488 (16%) experienced ABI (7% ischemic stroke; 3% ICH). In multivariable analysis, on-ECMO moderate (aOR=1.42, 95%CI: 1.02-1.97) and severe hyperoxia (aOR=1.59, 95%CI: 1.20-2.10) were associated with composite ABI. Additionally, severe hyperoxia was associated with ischemic stroke (aOR=1.63, 95%CI: 1.11-2.40), ICH (aOR=1.92, 95%CI: 1.08-3.40), and in-hospital mortality (aOR=1.58, 95%CI: 1.21-2.06). Mild hypercarbia pre-ECMO was protective of composite ABI (aOR=0.61, 95%CI: 0.44-0.84) and ischemic stroke (aOR=0.56, 95%CI: 0.35-0.89). CONCLUSIONS: Early severe hyperoxia (≥300mm Hg) on ECMO was a significant risk factor for ABI and mortality. Careful consideration should be given in early oxygen delivery in ECPR patients who are at risk of reperfusion injury.


Brain Injuries , Carbon Dioxide , Cardiopulmonary Resuscitation , Extracorporeal Membrane Oxygenation , Hyperoxia , Oxygen , Female , Humans , Male , Middle Aged , Brain Injuries/blood , Brain Injuries/epidemiology , Brain Injuries/etiology , Carbon Dioxide/blood , Cardiopulmonary Resuscitation/adverse effects , Cardiopulmonary Resuscitation/statistics & numerical data , Extracorporeal Membrane Oxygenation/adverse effects , Extracorporeal Membrane Oxygenation/statistics & numerical data , Hyperoxia/blood , Hyperoxia/epidemiology , Hyperoxia/etiology , Intracranial Hemorrhages/blood , Intracranial Hemorrhages/epidemiology , Intracranial Hemorrhages/etiology , Ischemic Stroke/blood , Ischemic Stroke/epidemiology , Ischemic Stroke/etiology , Oxygen/blood , Registries/statistics & numerical data , Retrospective Studies , United States/epidemiology
11.
Crit Care Med ; 50(2): 224-234, 2022 02 01.
Article En | MEDLINE | ID: mdl-35100195

OBJECTIVES: In the general critical care patient population, restrictive transfusion regimen of RBCs has been shown to be safe and is yet implemented worldwide. However, in patients on venovenous extracorporeal membrane oxygenation, guidelines suggest liberal thresholds, and a clear overview of RBC transfusion practice is lacking. This study aims to create an overview of RBC transfusion in venovenous extracorporeal membrane oxygenation. DESIGN: Mixed method approach combining multicenter retrospective study and survey. SETTING: Sixteen ICUs worldwide. PATIENTS: Patients receiving venovenous extracorporeal membrane oxygenation between January 2018 and July 2019. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: The primary outcome was the proportion receiving RBC, the amount of RBC units given daily and in total. Furthermore, the course of hemoglobin over time during extracorporeal membrane oxygenation was assessed. Demographics, extracorporeal membrane oxygenation characteristics, and patient outcome were collected. Two-hundred eight patients received venovenous extracorporeal membrane oxygenation, 63% male, with an age of 55 years (45-62 yr), mainly for acute respiratory distress syndrome. Extracorporeal membrane oxygenation duration was 9 days (5-14 d). Prior to extracorporeal membrane oxygenation, hemoglobin was 10.8 g/dL (8.9-13.0 g/dL), decreasing to 8.7 g/dL (7.7-9.8 g/dL) during extracorporeal membrane oxygenation. Nadir hemoglobin was lower on days when a transfusion was administered (8.1 g/dL [7.4-9.3 g/dL]). A vast majority of 88% patients received greater than or equal to 1 RBC transfusion, consisting of 1.6 U (1.3-2.3 U) on transfusion days. This high transfusion occurrence rate was also found in nonbleeding patients (81%). Patients with a liberal transfusion threshold (hemoglobin > 9 g/dL) received more RBC in total per transfusion day and extracorporeal membrane oxygenation day. No differences in survival, hemorrhagic and thrombotic complication rates were found between different transfusion thresholds. Also, 28-day mortality was equal in transfused and nontransfused patients. CONCLUSIONS: Transfusion of RBC has a high occurrence rate in patients on venovenous extracorporeal membrane oxygenation, even in nonbleeding patients. There is a need for future studies to find optimal transfusion thresholds and triggers in patients on extracorporeal membrane oxygenation.


Erythrocyte Transfusion/standards , Extracorporeal Membrane Oxygenation/statistics & numerical data , Adult , Australia , Belgium , Cohort Studies , Croatia , Erythrocyte Transfusion/methods , Erythrocyte Transfusion/statistics & numerical data , Extracorporeal Membrane Oxygenation/methods , Female , Humans , Intensive Care Units/organization & administration , Intensive Care Units/statistics & numerical data , Italy , Male , Middle Aged , Netherlands , Retrospective Studies , Sweden , Treatment Outcome
12.
J Cardiovasc Pharmacol Ther ; 27: 10742484211069005, 2022.
Article En | MEDLINE | ID: mdl-35006031

BACKGROUND: Little data is published describing the use of medications prescribed for pulmonary arterial hypertension (PAH) in patients receiving extracorporeal membrane oxygenation (ECMO). Even though many patients with PAH may require ECMO as a bridge to transplant or recovery, little is reported regarding the use of PAH medications in this setting. METHODS: This retrospective case series summarizes the clinical experience of 8 patients with PAH receiving ECMO and reviews medication management in the setting of ECMO. RESULTS: Eight PAH patients, 5 of whom were female, ranging in age from 21 to 61 years old, were initiated on ECMO. Veno-arterial (VA) ECMO was used in 4 patients, veno-venous (VV) ECMO and hybrid ECMO configurations in 2 patients respectively. Common indications for ECMO included cardiogenic shock, bridge to transplant, and cardiac arrest. All patients were on intravenous (IV) prostacyclin therapy at baseline. Refractory hypotension was noted in 7 patients of whom 5 patients required downtitration or discontinuation of baseline PAH therapies. Three patients had continuous inhaled epoprostenol added during their time on ECMO. In patients who were decannulated from ECMO, PAH therapies were typically resumed or titrated back to baseline dosages. One patient required no adjustment in PAH therapy while on ECMO. Two patients were not able to be decannulated from ECMO. CONCLUSION: The treatment of critically ill PAH patients is challenging given a variety of factors that could affect PAH drug concentrations. In particular, PAH patients on prostacyclin analogues placed on VA ECMO appear to have pronounced systemic vasodilation requiring vasopressors which is alleviated by temporarily reducing the intravenous prostacyclin dose. Patients should be closely monitored for potential need for rapid titrations in prostacyclin therapy to maintain hemodynamic stability.


Extracorporeal Membrane Oxygenation/methods , Extracorporeal Membrane Oxygenation/statistics & numerical data , Pulmonary Arterial Hypertension/therapy , Adult , Endothelin Receptor Antagonists/therapeutic use , Female , Humans , Intensive Care Units , Male , Middle Aged , Phosphodiesterase 5 Inhibitors/therapeutic use , Retrospective Studies , Young Adult
13.
JAMA ; 327(3): 227-236, 2022 01 18.
Article En | MEDLINE | ID: mdl-35040887

Importance: Platelets represent a potential therapeutic target for improved clinical outcomes in patients with COVID-19. Objective: To evaluate the benefits and risks of adding a P2Y12 inhibitor to anticoagulant therapy among non-critically ill patients hospitalized for COVID-19. Design, Setting, and Participants: An open-label, bayesian, adaptive randomized clinical trial including 562 non-critically ill patients hospitalized for COVID-19 was conducted between February 2021 and June 2021 at 60 hospitals in Brazil, Italy, Spain, and the US. The date of final 90-day follow-up was September 15, 2021. Interventions: Patients were randomized to a therapeutic dose of heparin plus a P2Y12 inhibitor (n = 293) or a therapeutic dose of heparin only (usual care) (n = 269) in a 1:1 ratio for 14 days or until hospital discharge, whichever was sooner. Ticagrelor was the preferred P2Y12 inhibitor. Main Outcomes and Measures: The composite primary outcome was organ support-free days evaluated on an ordinal scale that combined in-hospital death (assigned a value of -1) and, for those who survived to hospital discharge, the number of days free of respiratory or cardiovascular organ support up to day 21 of the index hospitalization (range, -1 to 21 days; higher scores indicate less organ support and better outcomes). The primary safety outcome was major bleeding by 28 days as defined by the International Society on Thrombosis and Hemostasis. Results: Enrollment of non-critically ill patients was discontinued when the prespecified criterion for futility was met. All 562 patients who were randomized (mean age, 52.7 [SD, 13.5] years; 41.5% women) completed the trial and 87% received a therapeutic dose of heparin by the end of study day 1. In the P2Y12 inhibitor group, ticagrelor was used in 63% of patients and clopidogrel in 37%. The median number of organ support-free days was 21 days (IQR, 20-21 days) among patients in the P2Y12 inhibitor group and was 21 days (IQR, 21-21 days) in the usual care group (adjusted odds ratio, 0.83 [95% credible interval, 0.55-1.25]; posterior probability of futility [defined as an odds ratio <1.2], 96%). Major bleeding occurred in 6 patients (2.0%) in the P2Y12 inhibitor group and in 2 patients (0.7%) in the usual care group (adjusted odds ratio, 3.31 [95% CI, 0.64-17.2]; P = .15). Conclusions and Relevance: Among non-critically ill patients hospitalized for COVID-19, the use of a P2Y12 inhibitor in addition to a therapeutic dose of heparin, compared with a therapeutic dose of heparin only, did not result in an increased odds of improvement in organ support-free days within 21 days during hospitalization. Trial Registration: ClinicalTrials.gov Identifier: NCT04505774.


Anticoagulants/administration & dosage , COVID-19 Drug Treatment , Heparin/administration & dosage , Inpatients , Purinergic P2Y Receptor Antagonists/administration & dosage , Aged , Aged, 80 and over , Anticoagulants/adverse effects , COVID-19/blood , COVID-19/mortality , Clopidogrel/administration & dosage , Clopidogrel/adverse effects , Comorbidity , Extracorporeal Membrane Oxygenation/statistics & numerical data , Female , Hemorrhage/chemically induced , Heparin/adverse effects , Hospital Mortality , Humans , Male , Medical Futility , Middle Aged , Outcome Assessment, Health Care , Oxygen Inhalation Therapy/statistics & numerical data , Platelet Activation/drug effects , Platelet Aggregation Inhibitors/administration & dosage , Platelet Aggregation Inhibitors/adverse effects , Purinergic P2Y Receptor Antagonists/adverse effects , Receptors, Purinergic P2Y12 , Respiration, Artificial/statistics & numerical data , Thrombosis/epidemiology , Ticagrelor/administration & dosage , Ticagrelor/adverse effects , Time Factors , Treatment Outcome
14.
BMJ ; 376: e068407, 2022 01 07.
Article En | MEDLINE | ID: mdl-34996756

OBJECTIVE: To assess the effect of statin treatment versus placebo on clinical outcomes in patients with covid-19 admitted to the intensive care unit (ICU). DESIGN: INSPIRATION/INSPIRATION-S was a multicenter, randomized controlled trial with a 2×2 factorial design. Results for the anticoagulation randomization have been reported previously. Results for the double blind randomization to atorvastatin versus placebo are reported here. SETTING: 11 hospitals in Iran. PARTICIPANTS: Adults aged ≥18 years with covid-19 admitted to the ICU. INTERVENTION: Atorvastatin 20 mg orally once daily versus placebo, to be continued for 30 days from randomization irrespective of hospital discharge status. MAIN OUTCOME MEASURES: The primary efficacy outcome was a composite of venous or arterial thrombosis, treatment with extracorporeal membrane oxygenation, or all cause mortality within 30 days from randomization. Prespecified safety outcomes included increase in liver enzyme levels more than three times the upper limit of normal and clinically diagnosed myopathy. A clinical events committee blinded to treatment assignment adjudicated the efficacy and safety outcomes. RESULTS: Of 605 patients randomized between 29 July 2020 and 4 April 2021 for statin randomization in the INSPIRATION-S trial, 343 were co-randomized to intermediate dose versus standard dose prophylactic anticoagulation with heparin based regimens, whereas 262 were randomized after completion of the anticoagulation study. 587 of the 605 participants were included in the primary analysis of INSPIRATION-S, reported here: 290 were assigned to atorvastatin and 297 to placebo (median age 57 years (interquartile range 45-68 years); 256 (44%) women). The primary outcome occurred in 95 (33%) patients assigned to atorvastatin and 108 (36%) assigned to placebo (odds ratio 0.84, 95% confidence interval 0.58 to 1.21). Death occurred in 90 (31%) patients in the atorvastatin group and 103 (35%) in the placebo group (odds ratio 0.84, 95% confidence interval 0.58 to 1.22). Rates for venous thromboembolism were 2% (n=6) in the atorvastatin group and 3% (n=9) in the placebo group (odds ratio 0.71, 95% confidence interval 0.24 to 2.06). Myopathy was not clinically diagnosed in either group. Liver enzyme levels were increased in five (2%) patients assigned to atorvastatin and six (2%) assigned to placebo (odds ratio 0.85, 95% confidence interval 0.25 to 2.81). CONCLUSIONS: In adults with covid-19 admitted to the ICU, atorvastatin was not associated with a significant reduction in the composite of venous or arterial thrombosis, treatment with extracorporeal membrane oxygenation, or all cause mortality compared with placebo. Treatment was, however, found to be safe. As the overall event rates were lower than expected, a clinically important treatment effect cannot be excluded. TRIAL REGISTRATION: ClinicalTrials.gov NCT04486508.


Anticoagulants/therapeutic use , Atorvastatin/therapeutic use , COVID-19/complications , Critical Care/methods , Venous Thromboembolism/epidemiology , Adolescent , Adult , Aged , COVID-19/mortality , Critical Care/statistics & numerical data , Double-Blind Method , Extracorporeal Membrane Oxygenation/statistics & numerical data , Female , Heparin/therapeutic use , Humans , Intensive Care Units , Iran/epidemiology , Male , Middle Aged , Odds Ratio , SARS-CoV-2 , Treatment Outcome , Venous Thromboembolism/prevention & control , Venous Thromboembolism/virology , Young Adult
15.
Sci Rep ; 12(1): 1265, 2022 01 24.
Article En | MEDLINE | ID: mdl-35075252

To identify predictors of neonatal ECMO circuit health, a retrospective analysis of circuit functional pressure and flow parameters as well as infant clotting values were collected 48 h prior to and 24 h post circuit change. Circuit impairment was defined as need for partial or total circuit change. Statistical analysis used multivariate statistics and non-parametric Mann-Whitney U-test with possible non-normality of measurements. A total of 9764 ECMO circuit and clotting values in 21 circuits were analyzed. Circuit delta-P mean, and maximum values increased from 8.62 to 48.59 mmHg (p < 0.011) and 16.00 to 53.00 mmHg (p < 0.0128) respectively prior to need for circuit change. Maximum and mean Pump Flow Revolutions per minute (RPM) increased by 75% (p < 0.0043) and 81% (p < 0.0057), respectively. Mean plasma free hemoglobin (pfHb) increased from 26.45 to 76.00 mg/dl, (p < 0.0209). Sweep, venous pressure, and clotting parameters were unaffected. ECMO circuit delta-P, RPM, and pfHb were early predictors of circuit impairment.


Extracorporeal Membrane Oxygenation/instrumentation , Blood Coagulation Tests , Extracorporeal Membrane Oxygenation/statistics & numerical data , Female , Humans , Infant, Newborn , Male , Platelet Count , Retrospective Studies
16.
Am J Surg ; 223(2): 388-394, 2022 02.
Article En | MEDLINE | ID: mdl-33894980

BACKGROUND: ECMO is an established supportive adjunct for patients with severe, refractory ARDS from viral pneumonia. However, the exact role and timing of ECMO for COVID-19 patients remains unclear. METHODS: We conducted a retrospective comparison of the first 32 patients with COVID-19-associated ARDS to the last 28 patients with influenza-associated ARDS placed on V-V ECMO. We compared patient factors between the two cohorts and used survival analysis to compare the hazard of mortality over sixty days post-cannulation. RESULTS: COVID-19 patients were older (mean 47.8 vs. 41.2 years, p = 0.033), had more ventilator days before cannulation (mean 4.5 vs. 1.5 days, p < 0.001). Crude in-hospital mortality was significantly higher in the COVID-19 cohort at 65.6% (n = 21/32) versus 36.3% (n = 11/28, p = 0.041). The adjusted hazard ratio over sixty days for COVID-19 patients was 2.81 (95% CI 1.07, 7.35) after adjusting for age, race, ECMO-associated organ failure, and Charlson Comorbidity Index. CONCLUSION: ECMO has a role in severe ARDS associated with COVID-19 but providers should carefully weigh patient factors when utilizing this scarce resource in favor of influenza pneumonia.


COVID-19/complications , Extracorporeal Membrane Oxygenation/statistics & numerical data , Influenza, Human/complications , Respiratory Distress Syndrome/mortality , Adult , COVID-19/mortality , COVID-19/therapy , Extracorporeal Membrane Oxygenation/methods , Female , Hospital Mortality , Humans , Influenza, Human/mortality , Influenza, Human/therapy , Male , Middle Aged , Respiratory Distress Syndrome/diagnosis , Respiratory Distress Syndrome/etiology , Respiratory Distress Syndrome/therapy , Retrospective Studies , Severity of Illness Index , Treatment Outcome
17.
J Thorac Cardiovasc Surg ; 163(1): 140-147.e4, 2022 Jan.
Article En | MEDLINE | ID: mdl-32928549

OBJECTIVE: Venoarterial extracorporeal membrane oxygenation is a rescue therapy for patients in cardiogenic shock. We hypothesize that patients bridged to heart transplant with extracorporeal membrane oxygenation have decreased survival. METHODS: The United Network of Organ Sharing database was retrospectively reviewed from January 1, 1999, to March 31, 2018, for heart transplant recipients. Recipients bridged with any form of mechanical support and those without support were compared with recipients bridged with extracorporeal membrane oxygenation. The primary end point was restricted mean survival time through 16.7 years. RESULTS: Of 26,918 recipients, 15,076 required no pretransplant mechanical support (56.0%). Support patients included 9321 with left ventricular assist devices (34.6%), 53 with right ventricular assist devices (0.2%), 258 with total artificial hearts (1.0%), 686 with biventricular assist devices (2.6%), 1378 with intra-aortic balloon pumps (5.1%), and 146 who required extracorporeal membrane oxygenation (0.5%). In the first 16.7 years post-transplant, compared with recipients bridged with extracorporeal membrane oxygenation, estimated adjusted restricted mean survival time was higher in patients who required no mechanical support (16.6 months [14.0-19.4]) and patients with a left ventricular assist device (16.5 months [99% confidence interval, 13.9-19.2]), an intra-aortic balloon pump (11.2 months [8.3-14.7]), or a biventricular assist device (6.6 months [3.6-10.3]). Restricted mean survival time in patients with a right ventricular assist device or a total artificial heart was similar to patients with extracorporeal membrane oxygenation. CONCLUSIONS: Recipients bridged with extracorporeal membrane oxygenation were estimated to survive 16.6 months less than nonmechanical circulatory support recipients. Bridge to heart transplant with extracorporeal membrane oxygenation is a viable option, and these patients should be considered transplant candidates.


Assisted Circulation , Extracorporeal Membrane Oxygenation , Graft Rejection/mortality , Heart Transplantation , Multiple Organ Failure , Postoperative Complications/mortality , Preoperative Care , Assisted Circulation/instrumentation , Assisted Circulation/methods , Assisted Circulation/statistics & numerical data , Extracorporeal Membrane Oxygenation/methods , Extracorporeal Membrane Oxygenation/statistics & numerical data , Female , Heart Transplantation/methods , Heart Transplantation/mortality , Heart Transplantation/statistics & numerical data , Heart-Assist Devices/classification , Heart-Assist Devices/statistics & numerical data , Humans , Intra-Aortic Balloon Pumping/statistics & numerical data , Male , Middle Aged , Multiple Organ Failure/etiology , Multiple Organ Failure/mortality , Outcome and Process Assessment, Health Care , Preoperative Care/instrumentation , Preoperative Care/methods , Retrospective Studies , Survival Rate , United States , Waiting Lists
18.
Crit Care Med ; 50(2): e154-e161, 2022 02 01.
Article En | MEDLINE | ID: mdl-34637417

OBJECTIVES: To determine the safety and efficacy of a rapidly deployed intensivist-led venovenous extracorporeal membrane oxygenation cannulation program in a preexisting extracorporeal membrane oxygenation program. DESIGN: A retrospective observational before-and-after study of 40 patients undergoing percutaneous cannulation for venovenous extracorporeal membrane oxygenation in an established cannulation program by cardiothoracic surgeons versus a rapidly deployed medical intensivist cannulation program. SETTING: An adult ICU in a tertiary academic medical center in Camden, NJ. PATIENTS: Critically ill adult subjects with severe respiratory failure undergoing percutaneous cannulation for venovenous extracorporeal membrane oxygenation. INTERVENTIONS: Percutaneous cannulation for venovenous extracorporeal membrane oxygenation performed by cardiothoracic surgeons compared with cannulations performed by medical intensivists. MEASUREMENTS AND MAIN RESULTS: Venovenous extracorporeal membrane oxygenation cannulation site attempts were retrospectively reviewed. Subject demographics, specialty of physician performing cannulation, type of support, cannulation configuration, cannula size, imaging guidance, success rate, and complications were recorded and summarized. Twenty-two cannulations were performed by three cardiothoracic surgeons in 11 subjects between September 2019 and February 2020. The cannulation program rapidly transitioned to an intensivist-led and performed program in March 2020. Fifty-seven cannulations were performed by eight intensivists in 29 subjects between March 2020 and December 2020. Mean body mass index for subjects did not differ between groups (33.86 vs 35.89; p = 0.775). There was no difference in days on mechanical ventilation prior to cannulation, configuration, cannula size, or discharge condition. There was no difference in success rate of cannulation on first attempt per cannulation site (95.5 vs 96.7; p = 0.483) or major complication rate per cannulation site (4.5 vs 3.5; p = 1). CONCLUSIONS: There is no difference between success and complication rates of percutaneous venovenous extracorporeal membrane oxygenation canulation when performed by cardiothoracic surgeons versus medical intensivist in an already established extracorporeal membrane oxygenation program. A rapidly deployed cannulation program by intensivists for venovenous extracorporeal membrane oxygenation can be performed with high success and low complication rates.


Catheterization/statistics & numerical data , Extracorporeal Membrane Oxygenation/statistics & numerical data , Health Services/trends , Intensive Care Units/statistics & numerical data , Time Factors , Academic Medical Centers/organization & administration , Academic Medical Centers/statistics & numerical data , Aged , Catheterization/methods , Extracorporeal Membrane Oxygenation/methods , Female , Health Services/statistics & numerical data , Health Services/supply & distribution , Humans , Intensive Care Units/organization & administration , Internal Medicine/methods , Internal Medicine/statistics & numerical data , Male , Middle Aged , New Jersey , Retrospective Studies
19.
Crit Care Med ; 50(2): e173-e182, 2022 02 01.
Article En | MEDLINE | ID: mdl-34524154

OBJECTIVES: Electronic cigarette or vaping product use-associated lung injury is a clinical entity that can lead to respiratory failure and death. Despite the severity of electronic cigarette or vaping product use-associated lung injury, the role of extracorporeal life support in its management remains unclear. Our objective was to describe the clinical characteristics and outcomes of patients with electronic cigarette or vaping product use-associated lung injury who received extracorporeal life support. DESIGN: We performed a retrospective review of records of electronic cigarette or vaping product use-associated lung injury patients who received extracorporeal life support. Standardized data were collected via direct contact with extracorporeal life support centers. Data regarding presentation, ventilatory management, extracorporeal life support details, and outcome were analyzed. SETTING: This was a multi-institutional, international case series with patients from 10 different institutions in three different countries. PATIENTS: Patients who met criteria for confirmed electronic cigarette or vaping product use-associated lung injury (based on previously reported diagnostic criteria) and were placed on extracorporeal life support were included. Patients were identified via literature review and by direct contact with extracorporeal life support centers. MEASUREMENTS AND MAIN RESULTS: Data were collected for 14 patients ranging from 16 to 45 years old. All had confirmed vape use within 3 months of presentation. Nicotine was the most commonly used vaping product. All patients had respiratory symptoms and radiographic evidence of bilateral pulmonary opacities. IV antibiotics and corticosteroids were universally initiated. Patients were intubated for 1.9 days (range, 0-6) prior to extracorporeal life support initiation. Poor oxygenation and ventilation were the most common indications for extracorporeal life support. Five patients showed evidence of ventricular dysfunction on echocardiography. Thirteen patients (93%) were placed on venovenous extracorporeal life support, and one patient required multiple rounds of extracorporeal life support. Total extracorporeal life support duration ranged from 2 to 37 days. Thirteen patients survived to hospital discharge; one patient died of septic shock. CONCLUSIONS: Electronic cigarette or vaping product use-associated lung injury can cause refractory respiratory failure and hypoxemia. These data suggest that venovenous extracorporeal life support can be an effective treatment option for profound, refractory respiratory failure secondary to electronic cigarette or vaping product use-associated lung injury.


Electronic Nicotine Delivery Systems/statistics & numerical data , Extracorporeal Membrane Oxygenation/statistics & numerical data , Lung Injury/etiology , Respiratory Insufficiency/etiology , Vaping/adverse effects , Adolescent , Adult , Extracorporeal Membrane Oxygenation/methods , Female , Humans , Lung/abnormalities , Lung/physiopathology , Lung Injury/complications , Lung Injury/epidemiology , Male , Middle Aged , Respiratory Insufficiency/epidemiology , Retrospective Studies , Vaping/epidemiology
20.
Crit Care Med ; 50(2): 264-274, 2022 02 01.
Article En | MEDLINE | ID: mdl-34259655

OBJECTIVES: To determine the characteristics and outcomes of patients prone-positioned during extracorporeal membrane oxygenation for severe acute respiratory distress syndrome and lung CT pattern associated with improved respiratory system static compliance after that intervention. DESIGN: Retrospective, single-center study over 8 years. SETTINGS: Twenty-six bed ICU in a tertiary center. MEASUREMENTS AND MAIN RESULTS: A propensity score-matched analysis compared patients with prone-positioning during extracorporeal membrane oxygenation and those without. An increase of the static compliance greater than or equal to 3 mL/cm H2O after 16 hours of prone-positioning defined prone-positioning responders. The primary outcome was the time to successful extracorporeal membrane oxygenation weaning within 90 days of postextracorporeal membrane oxygenation start, with death as a competing risk. Among 298 venovenous extracorporeal membrane oxygenation-treated adults with severe acute respiratory distress syndrome, 64 were prone-positioning extracorporeal membrane oxygenation. Although both propensity score-matched groups had similar extracorporeal membrane oxygenation durations, prone-positioning extracorporeal membrane oxygenation patients' 90-day probability of being weaned-off extracorporeal membrane oxygenation and alive was higher (0.75 vs 0.54, p = 0.03; subdistribution hazard ratio [95% CI], 1.54 [1.05-2.58]) and 90-day mortality was lower (20% vs 42%, p < 0.01) than that for no prone-positioning extracorporeal membrane oxygenation patients. Extracorporeal membrane oxygenation-related complications were comparable for the two groups. Patients without improved static compliance had higher percentages of nonaerated or poorly aerated ventral and medial-ventral lung regions (p = 0.047). CONCLUSIONS: Prone-positioning during venovenous extracorporeal membrane oxygenation was safe and effective and was associated with a higher probability of surviving and being weaned-off extracorporeal membrane oxygenation at 90 days. Patients with greater normally aerated lung tissue in the ventral and medial-ventral regions on quantitative lung CT-scan performed before prone-positioning are more likely to improve their static compliance after that procedure during extracorporeal membrane oxygenation.


Extracorporeal Membrane Oxygenation/standards , Prone Position , Respiratory Distress Syndrome/therapy , Adult , Extracorporeal Membrane Oxygenation/methods , Extracorporeal Membrane Oxygenation/statistics & numerical data , Female , Humans , Intensive Care Units/organization & administration , Intensive Care Units/statistics & numerical data , Male , Middle Aged , Paris/epidemiology , Patient Positioning/methods , Proportional Hazards Models , Respiratory Distress Syndrome/epidemiology , Retrospective Studies
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