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PURPOSE: Patients receiving venoarterial extracorporeal membrane oxygenation (VA-ECMO) frequently develop arterial hyperoxaemia, which may be harmful. However, lower oxygen saturation targets may also lead to harmful episodes of hypoxaemia. METHODS: In this registry-embedded, multicentre trial, we randomly assigned adult patients receiving VA-ECMO in an intensive care unit (ICU) to either a conservative (target SaO2 92-96%) or to a liberal oxygen strategy (target SaO2 97-100%) through controlled oxygen administration via the ventilator and ECMO gas blender. The primary outcome was the number of ICU-free days to day 28. Secondary outcomes included ICU-free days to day 60, mortality, ECMO and ventilation duration, ICU and hospital lengths of stay, and functional outcomes at 6 months. RESULTS: From September 2019 through June 2023, 934 patients who received VA-ECMO were reported to the EXCEL registry, of whom 300 (192 cardiogenic shock, 108 refractory cardiac arrest) were recruited. We randomised 149 to a conservative and 151 to a liberal oxygen strategy. The median number of ICU-free days to day 28 was similar in both groups (conservative: 0 days [interquartile range (IQR) 0-13.7] versus liberal: 0 days [IQR 0-13.7], median treatment effect: 0 days [95% confidence interval (CI) - 3.1 to 3.1]). Mortality at day 28 (59/159 [39.6%] vs 59/151 [39.1%]) and at day 60 (64/149 [43%] vs 62/151 [41.1%] were similar in conservative and liberal groups, as were all other secondary outcomes and adverse events. The conservative group experienced 44 (29.5%) major protocol deviations compared to 2 (1.3%) in the liberal oxygen group (P < 0.001). CONCLUSIONS: In adults receiving VA-ECMO in ICU, a conservative compared to a liberal oxygen strategy, did not affect the number of ICU-free days to day 28.
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Refractory out-of-hospital cardiac arrest (OHCA) has a very poor prognosis, with survival rates at around 10%. Extracorporeal membrane oxygenation (ECMO) for patients in refractory arrest, known as ECPR, aims to provide perfusion to the patient whilst the underlying cause of arrest can be addressed. ECPR use has increased substantially, with varying survival rates to hospital discharge. The best outcomes for ECPR occur when the time from cardiac arrest to implementation of ECPR is minimised. To reduce this time, systems must be in place to identify the correct patient, expedite transfer to hospital, facilitate rapid cannulation and ECMO circuit flows. We describe the process of activation of ECPR, patient selection, and the steps that emergency department clinicians can utilise to facilitate timely cannulation to ensure the best outcomes for patients in refractory cardiac arrest. With these processes in place our survival to hospital discharge for OHCA patients is 35%, with most patients having a good neurological function.
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[This corrects the article DOI: 10.1016/j.ccrj.2023.06.001.].
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Objective: To describe the training and accreditation process behind an intensivist-led extracorporeal membrane oxygenation (ECMO) cannulation program, and identify the rate of complications associated with the ECMO cannulation procedure. Design: A narrative review of the accreditation process, and a retrospective review of complications related to cannulation during the first four years of the intensivist program. Setting: Royal Prince Alfred Hospital, a quaternary referral hospital in Sydney. Participants: All patients initiated onto ECMO during the first four years of the intensivist cannulation program (August 2018 to August 2022).Main outcome measures: All cases were reviewed for identification of 14 pre-defined adverse events which were classified as low, medium or high clinical significance complications. Results: A total of 402 cannulations were attempted by the intensivist group in 194 separate cannulation episodes involving 179 patients. This included 93 V-V initiations, 69 V-A initiations (36 of these ECMO-CPR), 3 V-AV (veno-arteriovenous) initiations, 25 ECMO reconfigurations and four patients cannulated for peripheral cardiopulmonary bypass in cardiothoracic theatre. One of the 402 cannulations was halted as resuscitation was ceased, and one was halted and the patient transferred to theatre for central arterial cannulation. 394 out of the remaining 400 cannulations were successful (98.5%). Of 402 total cannulations, 32 complication events occurred (7.96% event rate), of which 15 (3.7% event rate) were low significance complications, 10 medium significance (2.5% event rate), and seven high clinical significance (1.7% event rate). Conclusions: Our experience of the first four years of an intensivist-led ECMO service demonstrates that our training process and cannulation technique result in the provision of a complex therapy with low levels of complications, on par with those in the published literature.
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OBJECTIVES: To determine the concordance between activated partial thromboplastin time (aPTT) and anti-factor-Xa (anti-Xa) in adults undergoing extracorporeal membrane oxygenation (ECMO) and to identify the factors associated with discordant paired aPTT/anti-Xa. DESIGN: Pre-planned secondary analysis of the Low-Dose Heparin in Critically Ill Patients Undergoing Extracorporeal Membrane Oxygenation pilot randomized unblinded, parallel-group controlled trial. SETTING: Two ICUs in two university hospitals. PATIENTS: Thirty-two critically ill patients who underwent ECMO and who had at least one paired aPTT and anti-Xa assay performed at the same time. INTERVENTIONS: We analyzed the concordance between aPTT and anti-Xa and identified factors associated with discordant paired aPTT/anti-Xa based on their respective therapeutic ranges. We also compared biological parameters between heparin resistance episode and no heparin resistance. MEASUREMENTS AND MAIN RESULTS: Of the 32 patients who were included in this study, 24 (75%) had at least one discordant paired aPTT/anti-Xa. Of the 581 paired aPTT/anti-Xa that were analyzed, 202 were discordant. The aPTT was relatively lower than anti-Xa in 66 cases (32.7%) or relatively higher than anti-Xa in 136 cases (67.3%). Thirty-three heparin resistance episodes were identified in six patients (19%). CONCLUSIONS: In these critically ill patients undergoing ECMO, one third of paired aPTT/anti-Xa measures was discordant. Coagulopathy and heparin resistance might be the reasons for discordance. Our results support the potential importance of routinely monitoring both tests in this setting.
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BACKGROUND: A multidisciplinary group of stakeholders were used to identify: (1) the core competencies of a training program required to perform in-hospital ECPR initiation (2) additional competencies required to perform pre-hospital ECPR initiation and; (3) the optimal training method and maintenance protocol for delivering an ECPR program. METHODS: A modified Delphi process was undertaken utilising two web based survey rounds and one virtual meeting. Experts rated the importance of different aspects of ECPR training, competency and governance on a 9-point Likert scale. A diverse, representative group was targeted. Consensus was achieved when greater than 70% respondents rated a domain as critical (> or = 7 on the 9 point Likert scale). RESULTS: 35 international ECPR experts from 9 countries formed the expert panel, with a median number of 14 years of ECMO practice (interquartile range 11-38). Participant response rates were 97% (survey round one), 63% (virtual meeting) and 100% (survey round two). After the second round of the survey, 47 consensus statements were formed outlining a core set of competencies required for ECPR provision. We identified key elements required to safely train and perform ECPR including skill pre-requisites, surrogate skill identification, the importance of competency-based assessment over volume of practice and competency requirements for successful ECPR practice and skill maintenance. CONCLUSIONS: We present a series of core competencies, training requirements and ongoing governance protocols to guide safe ECPR implementation. These findings can be used to develop training syllabus and guide minimum standards for competency as the growth of ECPR practitioners continues.
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Reanimación Cardiopulmonar , Oxigenación por Membrana Extracorpórea , Humanos , Técnica Delphi , Oxigenación por Membrana Extracorpórea/métodos , Reanimación Cardiopulmonar/métodos , Acreditación , Estudios RetrospectivosRESUMEN
Introduction: Critically ill patients supported with venoarterial extracorporeal membrane oxygenation (VA ECMO) are at risk of developing severe arterial hyperoxia, which has been associated with increased mortality. Lower saturation targets in this population may lead to deleterious episodes of severe hypoxia. This manuscript describes the protocol and statistical analysis plan for the Blend to Limit OxygEN in ECMO: A RanDomised ControllEd Registry (BLENDER) Trial. Design: The BLENDER trial is a pragmatic, multicentre, registry-embedded, randomised clinical trial., registered at ClinicalTrials.gov (NCT03841084) and approved by The Alfred Hospital Ethics Committee project ID HREC/50486/Alfred-2019. Participants and setting: Patients supported by VA ECMO for cardiogenic shock or cardiac arrest who are enrolled in the Australian national ECMO registry. Intervention: The study compares a conservative oxygenation strategy (target arterial saturations 92-96%) with a liberal oxygenation strategy (target 97-100%). Main Outcome Measures: The primary outcome is the number of intensive care unit (ICU)-free days for patients alive at day 60. Secondary outcomes include duration of mechanical ventilation, ICU and hospital mortality, the number of hypoxic episodes, neurocognitive outcomes, and health economic analyses. The 300-patient sample size enables us to detect a 3-day difference in ICU-free days at day 60, assuming a mean ICU-free days of 11 days, with a risk of type 1 error of 5% and power of 80%. Data will be analysed according to a predefined analysis plan. Findings will be disseminated in peer-reviewed publications. Conclusions: This paper details the protocol and statistical analysis plan for the BLENDER trial, a registry-embedded, multicentre interventional trial comparing liberal and conservative oxygenation strategies in VA ECMO.
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BACKGROUND: The use of extracorporeal membrane oxygenation (ECPR) in refractory out-of-hospital cardiac arrest (OHCA) patients is usually implemented in-hospital. As survival in ECPR patients is critically time-dependent, alternative models in ECPR delivery could improve equity of access. OBJECTIVES: To identify the best strategy of ECPR delivery to provide optimal patient access, to examine the time-sensitivity of ECPR on predicted survival and to model potential survival benefits from different delivery strategies of ECPR. METHODS: We used transport accessibility frameworks supported by comprehensive travel time data, population density data and empirical cardiac arrest time points to quantify the patient catchment areas of the existing in-hospital ECPR service and two alternative ECPR strategies: rendezvous strategy and pre-hospital ECPR in Sydney, Australia. Published survival rates at different time points to ECMO flow were applied to predict the potential survival benefit. RESULTS: With an in-hospital ECPR strategy for refractory OHCA, five hospitals in Sydney (Australia) had an effective catchment of 811,091 potential patients. This increases to 2,175,096 under a rendezvous strategy and 3,851,727 under the optimal pre-hospital strategy. Assuming earlier provision of ECMO flow, expected survival for eligible arrests will increase by nearly 6% with the rendezvous strategy and approximately 26% with pre-hospital ECPR when compared to the existing in-hospital strategy. CONCLUSION: In-hospital ECPR provides the least equitable access to ECPR. Rendezvous and pre-hospital ECPR models substantially increased the catchment of eligible OHCA patients. Traffic and spatial modelling may provide a mechanism to design appropriate ECPR service delivery strategies and should be tested through clinical trials.
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Reanimación Cardiopulmonar , Oxigenación por Membrana Extracorpórea , Paro Cardíaco Extrahospitalario , Humanos , Paro Cardíaco Extrahospitalario/terapia , Hospitales , Tasa de Supervivencia , Estudios RetrospectivosRESUMEN
OBJECTIVE: The use of extracorporeal cardiopulmonary resuscitation (ECPR) for out-of-hospital cardiac arrests (OHCA) has increased dramatically over the past decade. ECPR is resource intensive and costly, presenting challenges for policymakers. We sought to review the cost-effectiveness of ECPR compared with conventional cardiopulmonary resuscitation (CCPR) in OHCA. METHODS: We searched Medline, Embase, Tufts CEA registry and NHS EED databases from database inception to 2021 or 2015 for NHS EED. Cochrane Covidence was used to screen and assess studies. Data on costs, effects and cost-effectiveness of included studies were extracted by two independent reviewers. Costs were converted to USD using purchasing power parities (OECD, 2022).1 The Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist (Husereau et al., 2022)2 was used for reporting quality and completeness of cost-effectiveness studies; the review was registered on PROSPERO, and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. RESULTS: Four studies met the inclusion criteria; three cost-effectiveness studies reported an incremental cost-effectiveness ratio (ICER) for OHCA compared with conventional care, and one reported the mean operating cost of ECPR. ECPR was more costly, accrued more life years (LY) and quality-adjusted life years (QALYs) than CCPR and was more cost-effective when compared with CCPR and other standard therapies. Overall study quality was rated as moderate. CONCLUSION: Few studies have examined the cost-effectiveness of ECPR for OHCA. Of those, ECPR for OHCA was cost-effective. Further studies are required to validate findings and assess the cost-effectiveness of establishing a new ECPR service or alternate ECPR delivery models.
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Reanimación Cardiopulmonar , Oxigenación por Membrana Extracorpórea , Paro Cardíaco Extrahospitalario , Adulto , Análisis Costo-Beneficio , Humanos , Paro Cardíaco Extrahospitalario/terapia , Años de Vida Ajustados por Calidad de Vida , Estudios RetrospectivosRESUMEN
Veno-venous extracorporeal membrane oxygenation is increasingly used for severe but potentially reversible acute respiratory failure in adults; however, there are limited data regarding long-term morbidity. At our institution, most patients requiring veno-venous extracorporeal membrane oxygenation have been followed up by a single physician. Our primary aim was to describe the serial long-term morbidity for respiratory, musculoskeletal and psychological functioning.A retrospective audit of inpatient and outpatient medical records was conducted. A total of 125 patients treated with veno-venous extracorporeal membrane oxygenation for primary respiratory failure were included. The patients were young (mean (standard deviation) age 43.7 (4.1) years), obese (mean (standard deviation) body mass index 30.8 (10.4) kg/m2), and mostly were male (59%). Most patients (60%) had no comorbidities.The survival rate to discharge was 70%, with body mass index and the number of comorbidities being independent predictors of survival on multiple logistic regression analysis. Over half (57%) of the Australian survivors had regular outpatient follow-up. They had a median of three reviews (range 1-9) over a median of 11.8 months (range 1.5-79) months. Breathlessness and weakness resolved in most within six months, with lung function abnormalities taking longer to resolve. Over half (60%) returned to employment within six months of discharge. Over a quarter (29%) displayed symptoms of anxiety, depression or post-traumatic stress disorder.
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Oxigenación por Membrana Extracorpórea , Síndrome de Dificultad Respiratoria , Insuficiencia Respiratoria , Adulto , Australia , Humanos , Masculino , Síndrome de Dificultad Respiratoria/terapia , Insuficiencia Respiratoria/terapia , Estudios RetrospectivosRESUMEN
BACKGROUND: The use of extracorporeal membrane oxygenation (ECMO) during cardiac arrest (ECPR) has increased exponentially. However, reported outcomes vary considerably due to differing study designs and selection criteria. This review assessed the impact of pre-defined selection criteria on ECPR survival. METHODS: Systematic review applying PRISMA guidelines. We searched Medline, Embase, and Evidence-Based Medicine Reviews for RCTs and observational studies published from January 2000 to June 2021. Adult patients (> 12 years) receiving ECPR were included. Two investigators reviewed and extracted data on study design, number and type of inclusion criteria. Study quality was assessed using the Newcastle-Ottawa Scale (NOS). Outcomes included overall and neurologically favourable survival. Meta-analysis and meta-regression were performed. RESULTS: 67 studies were included: 14 prospective and 53 retrospective. No RCTs were identified at time of search. The number of inclusion criteria to select ECPR patients (p = 0.292) and study design (p = 0.962) was not associated with higher favourable neurological survival. However, amongst prospective studies, increased number of inclusion criteria was associated with improved outcomes in both OHCA and IHCA cohorts. (ß = 0.12, p = 0.026) and arrest to ECMO flow time was predictive of survival. (ß = -0.023, p < 0.001). CONCLUSIONS: Prospective studies showed number of selection criteria and, in particular, arrest to ECMO time were associated with significant improved survival. Well-designed prospective studies assessing the relative importance of criteria as well as larger efficacy studies are required to ensure appropriate application of what is a costly intervention.
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Reanimación Cardiopulmonar , Paro Cardíaco , Adulto , Paro Cardíaco/terapia , Humanos , Selección de Paciente , Estudios Prospectivos , Estudios RetrospectivosRESUMEN
Extracorporeal membrane oxygenation (ECMO) support has a high incidence of both bleeding and thrombotic complications. Despite clear differences in patient characteristics and pathologies between veno-venous (VV) and veno-arterial (VA) ECMO support, anticoagulation practices are often the same across modalities. Moreover, there is very little data on their respective coagulation profiles and comparisons of thrombin generation in these patients. This study compares the coagulation profile and thrombin generation between patients supported with either VV and VA ECMO. A prospective cohort study of patients undergoing VA and VV ECMO at an Intensive care department of a university hospital and ECMO referral centre. In addition to routine coagulation testing and heparin monitoring per unit protocol, thromboelastography (TEG), multiplate aggregometry (MEA), calibrated automated thrombinography (CAT) and von-Willebrand's activity (antigen and activity ratio) were sampled second-daily for 1 week, then weekly thereafter. VA patients had significantly lower platelets counts, fibrinogen, anti-thrombin and clot strength with higher d-dimer levels than VV patients, consistent with a more pronounced consumptive coagulopathy. Thrombin generation was higher in VA than VV patients, and the heparin dose required to suppress thrombin generation was lower in VA patients. There were no significant differences in total bleeding or thrombotic event rates between VV and VA patients when adjusted for days on extracorporeal support. VA patients received a lower median daily heparin dose 8500 IU [IQR 2500-24000] versus VV 28,800 IU [IQR 17,300-40,800.00]; < 0.001. Twenty-eight patients (72%) survived to hospital discharge; comprising 53% of VA patients and 77% of VV patients. Significant differences between the coagulation profiles of VA and VV patients exist, and anticoagulation strategies for patients of these modalities should be different. Further research into the development of tailored anticoagulation strategies that include the mode of ECMO support need to be completed.
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Arterias/fisiología , Coagulación Sanguínea/fisiología , Oxigenación por Membrana Extracorpórea , Hemostasis/fisiología , Trombina/metabolismo , Venas/fisiología , Adulto , Anticoagulantes/farmacología , Automatización , Coagulación Sanguínea/efectos de los fármacos , Oxigenación por Membrana Extracorpórea/efectos adversos , Factor Xa/metabolismo , Femenino , Hemorragia/etiología , Hemostasis/efectos de los fármacos , Heparina/farmacología , Humanos , Masculino , Persona de Mediana Edad , Tiempo de Tromboplastina Parcial , TromboelastografíaRESUMEN
Carcinosarcoma is a malignant mixed tumor composed of epithelial and mesenchymal components which arises in a variety of tissues, including, in rare cases, the orbit. A 75-year-old male with a history of basal cell carcinoma of the left medial canthus, previously treated with surgical resection and adjuvant radiation therapy, presented with a recurrent 3 cm nodule of the left medial canthus. He underwent surgical resection of the left superior and inferior eyelid with pathology revealing invasive squamous cell carcinoma of upper and lower eyelids with deep orbital tissue involvement and undifferentiated pleomorphic sarcoma involving the dermis and periosteum, consistent with carcinosarcoma. Orbital exenteration was subsequently performed. He successfully underwent adjuvant stereotactic body radiation therapy 30 Gy in 5 fractions with no significant side effects. Follow-up MRI revealed posttreatment changes without evidence of recurrent disease.
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Carcinosarcoma , Neoplasias Cutáneas , Anciano , Carcinosarcoma/radioterapia , Carcinosarcoma/cirugía , Humanos , Masculino , Órbita , Evisceración Orbitaria , Radioterapia AdyuvanteRESUMEN
The use of extracorporeal cardiopulmonary resuscitation (E-CPR) for the treatment of patients with out-of-hospital cardiac arrest who do not respond to conventional cardiopulmonary resuscitation CPR) has increased significantly in the past 10 years, in response to case reports and observational studies reporting encouraging results. However, no randomized controlled trials comparing E-CPR with conventional CPR have been published to date. The evidence from systematic reviews of the available observational studies is conflicting. The inclusion criteria for published E-CPR studies are variable, but most commonly include witnessed arrest, immediate bystander CPR, an initial shockable rhythm, and an estimated time from CPR start to establishment of E-CPR (low-flow time) of <60 minutes. A shorter low-flow time has been consistently associated with improved survival. In an effort to reduce low-flow times, commencement of E-CPR in the prehospital setting has been reported and is currently under investigation. The provision of an E-CPR service, whether hospital based or prehospital, carries considerable cost and technical challenges. Despite increased adoption, many questions remain as to which patients will derive the most benefit from E-CPR, when and where to implement E-CPR, optimal post-arrest E-CPR care, and whether this complex invasive intervention is cost-effective. Results of ongoing trials are awaited to determine whether E-CPR improves survival when compared with conventional CPR.
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Oxigenación por Membrana Extracorpórea , Paro Cardíaco Extrahospitalario/terapia , Resucitación , Oxigenación por Membrana Extracorpórea/efectos adversos , Oxigenación por Membrana Extracorpórea/mortalidad , Humanos , Paro Cardíaco Extrahospitalario/diagnóstico , Paro Cardíaco Extrahospitalario/mortalidad , Paro Cardíaco Extrahospitalario/fisiopatología , Selección de Paciente , Recuperación de la Función , Resucitación/efectos adversos , Resucitación/mortalidad , Factores de Riesgo , Resultado del TratamientoRESUMEN
BACKGROUND: Patients with prolonged cardiac arrest that is not responsive to conventional cardiopulmonary resuscitation have poor outcomes. The use of extracorporeal membrane oxygenation (ECMO) in refractory cardiac arrest has shown promising results in carefully selected cases. We sought to validate the results from an earlier extracorporeal cardiopulmonary resuscitation (ECPR) study (the CHEER trial). METHODS: Prospective, consecutive patients with refractory in-hospital (IHCA) or out-of-hospital cardiac arrest (OHCA) who met predefined inclusion criteria received protocolised care, including mechanical cardiopulmonary resuscitation, initiation of ECMO, and early coronary angiography (if an acute coronary syndrome was suspected). RESULTS: Twenty-five patients were enrolled in the study (11 OHCA, 14 IHCA); the median age was 57 years (interquartile range [IQR], 39-65 years), and 17 patients (68%) were male. ECMO was established in all patients, with a median time from arrest to ECMO support of 57 minutes (IQR, 38-73 min). Percutaneous coronary intervention was performed on 18 patients (72%). The median duration of ECMO support was 52 hours (IQR, 24-108 h). Survival to hospital discharge with favourable neurological recovery occurred in 11/25 patients (44%, of which 72% had IHCA and 27% had OHCA). When adjusting for lactate, arrest to ECMO flow time was predictive of survival (odds ratio, 0.904; P = 0.035). CONCLUSION: ECMO for refractory cardiac arrest shows promising survival rates if protocolised care is applied in conjunction with predefined selection criteria.
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Reanimación Cardiopulmonar/métodos , Oxigenación por Membrana Extracorpórea , Paro Cardíaco/terapia , Reperfusión Miocárdica , Paro Cardíaco Extrahospitalario/terapia , Adulto , Anciano , Reanimación Cardiopulmonar/mortalidad , Oxigenación por Membrana Extracorpórea/efectos adversos , Femenino , Paro Cardíaco/diagnóstico , Humanos , Masculino , Persona de Mediana Edad , Paro Cardíaco Extrahospitalario/mortalidad , Estudios Prospectivos , Estudios Retrospectivos , Tasa de Supervivencia , Resultado del TratamientoRESUMEN
In recent years, extracorporeal membrane oxygenation has become increasingly common in the treatment of in-hospital cardiac arrest in non-cardiac surgery patients. This includes cardiac arrest secondary to perioperative anaphylactic shock refractory to standard advanced life support protocols, which is a rare but catastrophic event associated with significant mortality. Neuromuscular blocking drugs are most commonly implicated in perioperative anaphylaxis, with rocuronium playing a major role. In this article, we report two cases of young and otherwise fit and well patients who experienced a perioperative arrest secondary to rocuronium anaphylaxis before elective surgery; both patients did not respond to conventional advanced life support, but survived neurologically intact after institution of urgent veno-arterial extracorporeal membrane oxygenation.
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Anafilaxia/inducido químicamente , Anafilaxia/terapia , Oxigenación por Membrana Extracorpórea/métodos , Fármacos Neuromusculares no Despolarizantes/efectos adversos , Rocuronio/efectos adversos , Adulto , Femenino , Humanos , Masculino , Periodo PerioperatorioRESUMEN
OBJECTIVES: To determine whether randomization of patients undergoing extracorporeal membrane oxygenation to either therapeutic or a low-dose anticoagulation protocol results in a difference in activated partial thromboplastin time and anti-Xa. DESIGN: Randomized, controlled, unblinded study. SETTING: Two ICUs of two university hospitals. PATIENTS: Patients admitted to the ICU, who required extracorporeal membrane oxygenation (venovenous or venoarterial) and who did not have a preexisting indication for therapeutic anticoagulation. INTERVENTIONS: Therapeutic anticoagulation with heparin (target activated partial thromboplastin time between 50 and 70 s) or lower dose heparin (up to 12,000 U/24 hr aiming for activated partial thromboplastin time < 45 s). MEASUREMENTS AND MAIN RESULTS: Thirty-two patients were randomized into two study groups that were not significantly different in demographics and extracorporeal membrane oxygenation characteristics. There was a significant difference in the daily geometric mean heparin dose (11,742 U [95% CI, 8,601-16,031 U] vs 20,710 U [95% CI, 15,343-27,954 U]; p = 0.004), daily geometric mean activated partial thromboplastin time (48.1 s [95% CI, 43.5-53.2 s] vs 55.5 s [95% CI, 50.4-61.2 s]; p = 0.04), and daily geometric mean anti-Xa (0.11 international units/mL [95% CI, 0.07-0.18] vs 0.27 [95% CI, 0.17-0.42]; p = 0.01). We found similar results when considering only venovenous extracorporeal membrane oxygenation episodes; however, no difference in daily geometric mean activated partial thromboplastin time between groups when considering only venoarterial extracorporeal membrane oxygenation episodes. CONCLUSIONS: Allocating patients on extracorporeal membrane oxygenation to two different anticoagulation protocols led to a significant difference in mean daily activated partial thromboplastin time and anti-Xa levels between groups. When considering subgroups analyses, these results were consistent in patients on venovenous extracorporeal membrane oxygenation. Our results support the feasibility of a larger trial in patients undergoing venovenous extracorporeal membrane oxygenation to compare different anticoagulation protocols; however, this study does not provide evidence on the optimal anticoagulation protocol for patients undergoing extracorporeal membrane oxygenation.
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Anticoagulantes/uso terapéutico , Enfermedad Crítica/terapia , Oxigenación por Membrana Extracorpórea/métodos , Heparina/uso terapéutico , Adulto , Anticoagulantes/administración & dosificación , Relación Dosis-Respuesta a Droga , Femenino , Heparina/administración & dosificación , Mortalidad Hospitalaria , Hospitales Universitarios , Humanos , Tiempo de Internación , Masculino , Persona de Mediana Edad , Tiempo de Tromboplastina Parcial , Proyectos PilotoRESUMEN
BACKGROUND: Despite the survival benefit of veno-arterial extracorporeal membrane oxygenation (VA-ECMO) for treatment of refractory cardiogenic shock, it can also have potentially deleterious effects of left ventricular overload and pulmonary edema. The objective of this review was to investigate the current evidence on the incidence, diagnosis, risk factors, prevention, and interventions for left ventricular overload in adult and pediatric VA-ECMO patients. METHODS: Five electronic databases, including MEDLINE, EMBASE, PubMed, Cochrane Central Register of Controlled Trials (CENTRAL), and Cochrane Database of Systematic Reviews, were searched for original published studies from their dates of inception to January 2018. All types of adult and pediatric studies that investigated LV overload in VA-ECMO and were published in the English language were reviewed. Exclusion criteria included abstracts and conference presentations. RESULTS: The reported incidence and sequelae of LV overload in VA-ECMO are highly variable, with presentations ranging from pulmonary arterial diastolic pressures of greater than 25 mmHg and LV distention on echocardiography, to severe pulmonary edema, LV thrombosis, and refractory ventricular arrhythmias. Currently, there are no standardized diagnostic criteria or guidelines for the type and timing of intervention for LV overload. Techniques for LV decompression have included direct surgical LV venting with catheter insertion via sternotomy or a minimally invasive incision; percutaneous catheterization via a transaortic, transseptal, or transpulmonary approach; ventricular assist devices; and intra-aortic balloon pumps. CONCLUSIONS: Left ventricular volume distention is a significant problem in VA-ECMO patients, with sequelae including myocardial ischemia, severe pulmonary edema, and intracardiac thrombosis. Further research is required on its incidence, diagnostic criteria, and risk factors, as well as the optimal timing and method for LV decompression, given the diversity of surgical and percutaneous techniques that are available.
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BACKGROUND: The use of extracorporeal membrane oxygenation (ECMO) in refractory cardiac arrest (ECPR) has increased exponentially. ECPR is a resource intensive service and its cost effectiveness has yet to be demonstrated. We sought to complete a cost analysis with modelling of cost effectiveness and quality of life outcomes. We sought to complete a cost analysis with modelling of cost effectiveness and quality of life outcomes of patients who have undergone ECPR. METHODS: Using data on all extracorporeal cardiopulmonary resuscitation (ECPR) patients at two ECMO centres in Sydney, Australia; we completed a costing analysis of ECPR patients. A Markov model of cost, quality of life and survival outcomes was developed to examine cost per QALY estimates and incremental cost effectiveness ratios (ICERs). Probabilistic sensitivity analysis (PSA) was completed to assess the probability of cost effectiveness for base case and variations. RESULTS: Sixty-two consecutive ECPR patients were analysed; mean age of 51.9 ± 13.6 years, 38 (61%) were in hospital cardiac arrests (IHCA). Twenty-five patients (40%) survived to hospital discharge; all with a cerebral performance category (CPC) of 1 or 2. The mean cost per ECPR patient was AUD 75,165 (50,535; ±AUD 75,737). Over 10 years ECPR was estimated to add a mean gain of 3.0 Quality Adjusted Life Years (QALYs) per patient with an incremental cost effectiveness ratio (ICER) of AUD 25,212 (16,890) per QALY, increasing to 4.0 QALYs and an ICER of AUD 18,829 (12,614) over a 15-year survival scenario. Mean cost per QALY did not differ significantly by OHCA or IHCA. CONCLUSIONS: ECMO support for refractory cardiac arrests is cost effective and compares favourably to accepted cost effectiveness thresholds.