BRIEF REPORT
Extracorporeal life support in patients with multiple injuries and severe respiratory failure: A single-center experience? Philippe Biderman, MD, Sharon Einav, MD, Michael Fainblut, MD, Michael Stein, MD, Pierre Singer, MD, and Benjamin Medalion, MD, Jerusalem, Israel
The use of extracorporeal life support in trauma casualties is limited by concerns regarding hemorrhage, particularly in the presence of traumatic brain injury (TBI). We report the use of extracorporeal membrane oxygenation (ECMO)/interventional lung assist (iLA) as salvage therapy in trauma patients. High-flow technique without anticoagulation was used in patients with coagulopathy or TBI. METHODS: Data were collected from all adult trauma patients referred to one center for ECMO/iLA treatment owing to severe hypoxemic respiratory failure. RESULTS: Ten casualties had a mean (SD) Injury Severity Score (ISS) of 50.3 (10.5) (mean [SD] age, 29.8 [7.7] years; 60% male) and were supported 9.5 (4.5) days on ECMO (n = 5) and 7.6 (6.5) days on iLA (n = 5). All experienced blunt injury with severe chest injuries, including one cardiac perforation. Most were coagulopathic before initiation of ECMO/iLA support. Among the seven patients with TBI, four had active intracranial hemorrhage. Complications directly related to support therapy were not lethal; these included hemorrhage from a cannulation site (n = 1), accidental removal of a cannula (n = 1), and pressure sores (n = 3). Deaths occurred owing to septic (n = 2) and cardiogenic shock (n = 1). Survival rates were 60% and 80% on ECMO and iLA, respectively. Follow-up of survivors detected no neurologic deterioration. CONCLUSION: ECMO/iLA therapy can be used as a rescue therapy in adult trauma patients with severe hypoxemic respiratory failure, even in the presence of coagulopathy and/or brain injury. The benefits of rewarming, acid-base correction, oxygenation, and circulatory support must be weighed individually against the risk of hemorrhage. Further research should determine whether ECMO therapy also confers survival benefit. (J Trauma Acute Care Surg. 2013;75: 907Y912. Copyright * 2013 by Lippincott Williams & Wilkins) LEVEL OF EVIDENCE: Therapeutic study, level V. KEY WORDS: Extracorporeal membrane oxygenation; adult respiratory distress syndrome; multiple trauma; traumatic brain injury. BACKGROUND:
A
pproximately 4.6% of adult trauma patients develop adult respiratory distress syndrome (ARDS).1 The use of extracorporeal membrane oxygenation (ECMO) in acute lung injury is controversial; only three randomized controlled trials have compared ECMO with standard therapy of patients with ARDS. The first was conducted before consensus definition of ARDS was formulated.2 The second was performed before the institution of the ARDS-net and widespread use of lung protective ventilation.3 The third, which was conducted in the era of improved ECMO technology (e.g., biocompatible tubing, which enables prolonged treatment with less hemolysis and immunologic activation) was the only one of the three which demonstrated survival benefit in the ECMO group.4 However, this trial was later criticized both for having been performed in a single high-volume center on a referral cohort and for lacking a management protocol for the patients randomized to conventional treatment.5 Submitted: July 8, 2012, Revised: July 17 2013, Accepted: July 17 2013. From the Department of Cardiothoracic Surgery (P.B., M.F., B.M.), Trauma Unit (M.S.), and Department of General Intensive Care (P.S.), Rabin Medical Center, Tel-Aviv University, Tel-Aviv; and General Intensive Care Unit (S.E.), Shaare Zedek Medical Center, Hebrew University, Jerusalem, Israel. *P.B. and S.E. contributed equally to this work. Address for reprints: Philippe Biderman, MD, Department of Cardiothoracic Surgery, Rabin Medical Center, Tel Aviv University, 39 Jabotinsky St, Petah Tikva 49100, Israel; email: [email protected]. DOI: 10.1097/TA.0b013e3182a8334f
The use of ECMO in trauma patients is further limited by concerns regarding the risk of hemorrhage during/after cannulation in the presence of consumption coagulopathy, contraindications to the anticoagulation treatment recommended during ECMO, the likelihood of decreased venous return secondary to packing of the abdomen during damage-control surgery, and the risk of secondary intracranial hemorrhage following traumatic brain injury (TBI). In this article, we present our experience with ECMO and interventional lung assist (iLA) as a rescue therapy for complex adult trauma patients with severe hypoxemic respiratory failure.
PATIENTS AND METHODS Following study approval with waiver of informed consent by the Rabin Medical Center institutional review board (#4315) was obtained, data collected at real time was retrospectively extracted from the files of all patients treated with ECMO/iLA owing to severe hypoxemic respiratory failure after severe traumatic injury during the last 5 years.
Clinical Setting The Rabin Medical Center has been the most active ECMO referral center for adults in Israel since 2004. All patients had the extracorporeal support inserted by a dedicated team. When patients were referred from a different facility, a dedicated team traveled to the referring hospital, assessed the
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patient, implanted the device, and transported the patient to Rabin Medical Center in a mobile intensive care unit modified to accommodate the necessary equipment and equipped with a backup power supply. Traditionally, the Maquet rotaflow centrifugal pump with a bioline coating PLS-I circuit was used; since 2008, an additional pumpless iLA (Novalung, Heilbronn, Germany) has been used on a regular basis. The iLA/ECMO team treats approximately 20 patients annually, with an overall survival rate of 70% for ECMO and 65% for iLA therapy (unpublished data).
exceeding 30 cm H2O and/or FIO2 of 0.8 or greater, patients with septic shock and multiple-organ failure, as well staff/ family noncommitment to full treatment were excluded. All patients with TBI underwent brain computed tomography (CT) and neurosurgical evaluation before consideration for extracorporeal life support (ECLS) treatment. If poor neurologic outcome was anticipated, ECLS was not used to prevent futile medicine.
Indications for Bypass and Bypass Method
Patients are monitored with continuous 12-lead electrocardiography, pulse oximetry, rectal temperature, invasive blood pressure measurement, and pulse contour analysis (flow trac, Edwards Lifesciences, Irvine, CA). In patients with severe shock and/or pulmonary hypertension, pulmonary pressures and SVO2 are also monitored (Viligance, Edwards Lifesciences). Echocardiography is performed at the discretion of the treating clinicians. In patients requiring venoarterial bypass, brain tissue oxygenation is monitored with near-infrared spectroscopy (INVOS, Somanetics Troy, MI). Intracranial pressure (ICP) is monitored in patients with severe brain injury (Camino fiberoptic system). All patients were in deep sedation and neuromuscular blockage before the insertion of ECLS. It is our experience that awake ECLS is seldom possible in ARDS patients. As a result and to prevent high airways and ICPs, we used short-acting sedation agents such as remifentanyl and propofol that were titrated according to the neurologic and respiratory state of the patient. Hypothermia (34-C) was induced in patients with severe TBI. Follow-up CT was performed routinely on Day 2 and at the discretion of the neurosurgeon consultant according
Bypass is instituted in accordance with Extracorporeal Life Support Organization indications.6 Most patients are initially placed on venovenous bypass (including patients where poor cardiac output or hypoxemia are assumed to be secondary to respiratory acidosis and high-minute highpressure ventilation) unless arteriovenous bypass is clearly indicated for severe hypoxemia or refractory hypotension. Our decision making flow chart is presented in Figure 1.
Inclusion Criteria All patients with an Injury Severity Score (ISS) greater than 16 in whom conventional mechanical ventilation failed to (a) control hypoxemia or (b) correct hypercapnia and respiratory acidosis and were treated with iLA/ECMO were included in the study.
Exclusion Criteria Patients older than 60 years, those receiving prolonged mechanical ventilation (97 days) with peak airway pressures
Patient Management
Figure 1. Decision making flow chart. 908
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to the physical examination and the ICP monitoring. ICP monitoring was used in all patients with severe TBI and Glasgow Coma Scale (GCS) score less than 8 on the scene and/ or at the discretion of the neurosurgeon. A full blood count and coagulation profile are drawn during initial cannulation. Coagulation is titrated with activated clotting time. In patients with substantial risk of bleeding, no anticoagulation was given until the risk of bleeding decreased. In those patients, we kept high flow on the ECMO to prevent clot formation. Alimentation includes omega-3 fatty acids, and bowel management devices are routinely used to avoid contamination of the vascular access tubing. Tracheostomy is performed within 7 days if extubation is not possible or planned by this time. Diagnosing sepsis during ECMO therapy is challenging; temperature and blood pressure are always controlled, and white blood cell count is often elevated during high-dose steroid treatment and during venoarterial ECMO. Therefore, blood cultures are performed on a daily basis, and bronchoalveolar lavage is performed routinely on alternate days using either a fiberoptic bronchoscope or a mini bronchoalveolar lavage catheter.
Ventilation Technique Conventional ventilation is continued during ECMO therapy to prevent lung collapse. Optimal positive endexpiratory pressures are determined daily by the use of the open lung tool and are usually kept at relatively low levels (2 cm H2O above the lower inflection point) to prevent the damage associated with lung recruitment-derecruitment. Peak pressures are kept at minimum through low respiratory rates (6Y8 breaths per minute) and small tidal volumes in accordance with the concept of lung protective ventilation.7 Recruitment maneuvers are performed twice daily. Additional treatment for ARDS includes intravenous methyprednisolone.8 Fluid retention is avoided through the use of loop diuretics and maintenance of a relatively negative fluid balance. In patients with severe hypoxemia, hypothermia is induced to reduce oxygen consumption (34-C for 48 hours).
Casualties were supported for 9.5 (4.5) days (median, 9; range, 5Y17 days) on ECMO and 7.6 (6.5) days (median, 6.5; range, 3Y18 days) on iLA. During this period, the following three complications directly related to bypass occurred: hemorrhage from the arterial cannulation site (n = 1), accidental removal of a venous cannula (n = 1), and pressure sores (n = 3). All were successfully controlled. Of the 10 patients, only 3 could receive heparin during the first 48 hours. The other seven patients had contraindication for anticoagulation at the time of ECMO initiation, five of them due to severe TBI with potential worsening of intracranial bleeding. In those patients who could not receive heparin, high blood flow (4Y5 L/min) was maintained to prevent clotting. In addition, all measures were taken to normalize the coagulation system (transfusion of fresh frozen plasma, platelets, and cryoprecipitate); one patient received recombinant factor VII. There were several complications that were attributed to the nature of the trauma and the resulting prolonged intensive care unit stay: acute renal failure (n = 3), pneumothorax with bronchopleural fistula (n = 2), postintubation subglottic stenoses (n = 2), moderate hypernatremia (n = 4), severe muscle weakness (n = 4), and septic shock (n = 5). The survival rate was 60% on ECMO (3 of 5) and 80% on iLA (4 of 5) (Table 1). Two deaths occurred owing to septic shock. One death was attributed to refractory cardiogenic shock with secondary multiple-organ failure.
TBI Patients Of the 10 patients, 7 had TBI. Six survived (86%). Median Glasgow Coma Scale (GCS) score on arrival was 7 (range, 5Y9) and improved in all survivors to 14 (range, 12Y15). This difference achieved statistical significance (p = 0.03, Wilcoxon signed-rank test). All patients but two regained normal neurologic status during follow-up. One patient remained with left hemiparesis, and one patient had paraplegia secondary to spine fracture. Follow-up CTs were performed in all patients during hospitalization, and no patient demonstrated worsening of cerebral bleeding.
DISCUSSION RESULTS During the study period, 10 (6 males) patients with severe traumatic injuries were supported with ECMO/iLA (5 ECMO and 5 iLA). Their mean (SD) age was 29.8 (7.7) years (range, 19Y42 years); mean (SD) ISS was 50.3 (10.5) (range, 29Y57). All patients had blunt injury, and all had severe chest injuries, including one cardiac perforation. Four had severe abdominal injuries involving solid organs, five had pelvic fractures, six had long-bone fractures, four had vascular injuries, and seven had intracranial injuries (Table 1). All casualties required aggressive ventilation before initiation of ECMO/iLA; ventilation parameters and patient arterial blood gas results before the initiation of ECMO and iLA are presented in Table 2. In addition, eight patients received inhaled nitric oxide, six were being alternated between prone and supine positions, and three were on high-frequency ventilation.
The current study presents the feasibility of salvage treatment with ECMO/iLA for casualties with multiple injuries and severe hypoxemic respiratory failure even in the presence of severe TBI. In 1992, Gentilello et al.9 attempted to overcome traumatic coagulopathy associated with hypothermia and acidosis through the use of percutaneously placed femoral arterial and venous cannulas acting as countercurrent fluid warmers. The 34 patients treated with this technique had better outcomes than did patients treated with conventional heating techniques. Perchinsky et al.10 described a 50% survival among 6 trauma patients with traumatic coagulopathy who were treated with ‘‘a simplified extracorporeal cardiopulmonary life support system.’’ In parallel, a series of groundbreaking laboratory experiments demonstrated improved survival following controlled hypothermia with extracorporeal support in animal models of exsanguinating cardiac arrest.11Y14
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909
910
21
7
37
37
6
10
32
5
42
22
4
9
27
3
19
33
2
8
28
1
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F
M
M
F
M
F
F
M
M
M
Pedestrian injury
Fall
Motor vehicle accident
Motor vehicle accident
Motor vehicle accident
Motor vehicle accident
Bombing
Motor vehicle accident
Motor vehicle accident
Fall
48
50
57
57
29
57
66
51
38
50
Injury Case Age Sex Circumstances ISS
Fractured scapula, bilateral multiple rib fractures, hemopneumothorax and severe pulmonary contusions Bilateral multiple rib fractures, bilateral hemopneumothorax, hemoptysis, laceration of pulmonary artery (left) Fracture of clavicle and thoracic vertebra. Severe bilateral lung contusion, right pneumothorax
Cardiac perforation, pulmonary perforation, esophageal perforation
Bilateral scapular fracture Thoracic vertebral fracture Multiple rib fractures, bilateral lung contusion, pneumothorax (left) Severe pulmonary contusion, laceration, hemoptysis
Abdomen/Pelvis
Liver trauma Grade IV, renal laceration. Fracture of pelvis: ischiopubic and symphysis Ruptured spleen, perforated bowel, tear of mesenteric artery with hemoperitoneum
Open book fracture of pelvis
Ruptured diaphragm and spleen, gastric perforation, liver laceration
Lacerated spleen Lacerated iliac artery and vein, retroperitoneal hemorrhage Fracture of pelvis
System Involvement
Multiple rib fractures with flail chest, severe bilateral lung contusion Fractured scapula
Thorax
GCS score, 7; severe Severe bilateral lung contusions, brain contusion with bilateral hemopneumothorax, multiple point multiple rib fractures with hemorrhages clinical flail chest Subdural hematoma Bilateral pulmonary contusion, Unstable dorsal and lumbar with underlying multiple rib fractures (left) with fracture with neurologic brain contusion underlying pneumothorax deficit, fractured pelvis Parietotemporal closed Multiple rib fractures, bilateral lung Open book pelvic fracture skull fracture, Le contusions, hemopneumothorax (left) Fort III , brain contusion
Severe brain contusionYbilateral
Epidural hematoma, brain contusion
GCS score, 7. Multiple brain hemorrhages, intraventricular hemorrhage Third-degree facial burns
Epidural hematoma, brain contusion, orbital fracture
Head and Neck
TABLE 1. Patient Demographics and Injury Characteristics
Bilateral fractured tibia (open)
Fractured femur (closed) and tibia (open)
Third-degree burns to 4 limbs (32% body surface area), fractured humerus, laceration brachial artery Fractured humerus (closed)
Fractured ankle (closed) and 2 metacarpals
Fractured femur.
None
Extremities
iLA
iLA
iLA
iLA
iLA
ECMO
ECMO
ECMO
ECMO
ECMO
Yes
Yes
No
Yes
Yes
Yes
No
Yes
No
Yes
Assistance Device Survival
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TABLE 2. Arterial Blood Gases Before Initiation of ECMO/iLA Therapy and Time to Initiation of Extracorporeal Support Arterial Blood Gases
ECMO iLA
Pao2/FIO2
Paco2, mm Hg
pH
62 (35Y82) 92 (78Y140)
62 (48Y95) 85 (65Y150)
7.21 (7.05Y7.28) 7.12 (6.9Y7.7.25)
Time From Injury to Support, d 3 (1Y7) 5 (3Y8)
These early reports all acknowledged the following main impediments to the implementation of ECMO therapy in emergency situations: the need for cannulation, the bulk of the equipment, and the expertise required. Although during the next decade, there were only sporadic descriptions of the use of ECMO for stabilization of trauma patients, often with aortic transection,15,16 important progress was occurring in the field of ECMO treatment. Portable ECMO systems were developed and tested on animal models outside conventional settings17Y19; pumpless extracorporeal lung assist devices were gaining recognition in trauma and for patient transport,20Y23 and heparin-coated tubing was introduced into clinical use.24 Madershahian et al.25 described three patients with severe thoracic injuries who were treated with ECMO owing to failure of conventional ventilation techniques to treat hypoxemia. Two patients had a GCS score of 4 upon emergency medical team arrival. The first had normal brain imaging results despite emergency department presentation with a dilated pupil. The second had severe frontal brain contusion with subarachnoid hemorrhage as per CT. Both patients survived to hospital discharge; the former never developed neurologic injury, and the latter was discharged to rehabilitation with no reference made to further intracranial hemorrhage. Arlt et al.26 described a cohort of 10 trauma patients with an age similar to our cohort but with even higher ISSs. Their patients, too, were massively transfused and mostly underwent damage-control surgery (8 of 10). They also initially used heparin-free tubing. Their survival rates were similar to those of our cohort (6 of 10), as were their rates of death from sepsis (3 of 4). The additional death was caused by retroperitoneal hemorrhage. In this series, no specific mention was made of TBI. Our cohort is as large as the largest published cohort to date and includes the largest number of TBI patients in the published literature. To the best of our knowledge, this is the second series of patients treated with a high-flow technique to avoid administration of heparin in patients with trauma-related coagulopathy.26 Our data suggest that the beneficial effects of ECMO/iLA therapy on body temperature, acid-base balance, oxygenation, and hemodynamic stability should be weighed against the risk of hemorrhage. In our experience, even patients with acute ongoing hemorrhage may gain hemodynamic benefit from this treatment modality. TBI with hemorrhage constituted a contraindication for ECMO treatment in the Cesar study. With the increasing use of surface heparinized ECMO equipment, contraindication to anticoagulation as an exclusion criterion for ECMO requires reconsideration. In our experience, heparin anticoagulation can be postponed up to 48 hours, provided that high flows are maintained.
None of the randomized controlled trials, which examined ECMO therapy head to head with conventional ventilation techniques, included patients treated with iLA. This new generation of devices has limited applicability but may encourage more frequent use of extracorporeal CO2 removal owing to its relative ease of use. This retrospective review of a small number of patients cannot serve to link treatment and outcome. It was performed in a single referral center. This may have biased our outcomes. High-volume centers are likely to have better results. However, the patients referred to our center are invariably those who are failing conventional treatment.
CONCLUSION In our experience, extracorporeal gas exchange can be used as a rescue therapy in complex adult trauma patients with severe hypoxemic respiratory failure, despite the presence of severe disseminated intravascular coagulation, active bleeding, and even TBI. ECMO is often not considered until other therapeutic options are exhausted. However, the nature of these traumatic injuries requires rapid action to make ECMO therapy possible. Further research is required to determine if ECMO/iLA therapy also confers survival benefit on critical trauma patients. AUTHORSHIP P.B. conceived and designed the study. M.F. performed the data acquisition. S.E. analyzed the data, and P.B. and S.E. performed the interpretation. S.E. drafted the manuscript with the assistance of P.B., and B.M. undertook critical revision of the manuscript.
DISCLOSURE The authors declare no conflicts of interest.
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Extracorporeal life support in patients with multiple injuries and severe respiratory failure: A single-center experience? Philippe Biderman, MD, Sharon Einav, MD, Michael Fainblut, MD, Michael Stein, MD, Pierre Singer, MD, and Benjamin Medalion, MD, Jerusalem, Israel
The use of extracorporeal life support in trauma casualties is limited by concerns regarding hemorrhage, particularly in the presence of traumatic brain injury (TBI). We report the use of extracorporeal membrane oxygenation (ECMO)/interventional lung assist (iLA) as salvage therapy in trauma patients. High-flow technique without anticoagulation was used in patients with coagulopathy or TBI. METHODS: Data were collected from all adult trauma patients referred to one center for ECMO/iLA treatment owing to severe hypoxemic respiratory failure. RESULTS: Ten casualties had a mean (SD) Injury Severity Score (ISS) of 50.3 (10.5) (mean [SD] age, 29.8 [7.7] years; 60% male) and were supported 9.5 (4.5) days on ECMO (n = 5) and 7.6 (6.5) days on iLA (n = 5). All experienced blunt injury with severe chest injuries, including one cardiac perforation. Most were coagulopathic before initiation of ECMO/iLA support. Among the seven patients with TBI, four had active intracranial hemorrhage. Complications directly related to support therapy were not lethal; these included hemorrhage from a cannulation site (n = 1), accidental removal of a cannula (n = 1), and pressure sores (n = 3). Deaths occurred owing to septic (n = 2) and cardiogenic shock (n = 1). Survival rates were 60% and 80% on ECMO and iLA, respectively. Follow-up of survivors detected no neurologic deterioration. CONCLUSION: ECMO/iLA therapy can be used as a rescue therapy in adult trauma patients with severe hypoxemic respiratory failure, even in the presence of coagulopathy and/or brain injury. The benefits of rewarming, acid-base correction, oxygenation, and circulatory support must be weighed individually against the risk of hemorrhage. Further research should determine whether ECMO therapy also confers survival benefit. (J Trauma Acute Care Surg. 2013;75: 907Y912. Copyright * 2013 by Lippincott Williams & Wilkins) LEVEL OF EVIDENCE: Therapeutic study, level V. KEY WORDS: Extracorporeal membrane oxygenation; adult respiratory distress syndrome; multiple trauma; traumatic brain injury. BACKGROUND:
A
pproximately 4.6% of adult trauma patients develop adult respiratory distress syndrome (ARDS).1 The use of extracorporeal membrane oxygenation (ECMO) in acute lung injury is controversial; only three randomized controlled trials have compared ECMO with standard therapy of patients with ARDS. The first was conducted before consensus definition of ARDS was formulated.2 The second was performed before the institution of the ARDS-net and widespread use of lung protective ventilation.3 The third, which was conducted in the era of improved ECMO technology (e.g., biocompatible tubing, which enables prolonged treatment with less hemolysis and immunologic activation) was the only one of the three which demonstrated survival benefit in the ECMO group.4 However, this trial was later criticized both for having been performed in a single high-volume center on a referral cohort and for lacking a management protocol for the patients randomized to conventional treatment.5 Submitted: July 8, 2012, Revised: July 17 2013, Accepted: July 17 2013. From the Department of Cardiothoracic Surgery (P.B., M.F., B.M.), Trauma Unit (M.S.), and Department of General Intensive Care (P.S.), Rabin Medical Center, Tel-Aviv University, Tel-Aviv; and General Intensive Care Unit (S.E.), Shaare Zedek Medical Center, Hebrew University, Jerusalem, Israel. *P.B. and S.E. contributed equally to this work. Address for reprints: Philippe Biderman, MD, Department of Cardiothoracic Surgery, Rabin Medical Center, Tel Aviv University, 39 Jabotinsky St, Petah Tikva 49100, Israel; email: [email protected]. DOI: 10.1097/TA.0b013e3182a8334f
The use of ECMO in trauma patients is further limited by concerns regarding the risk of hemorrhage during/after cannulation in the presence of consumption coagulopathy, contraindications to the anticoagulation treatment recommended during ECMO, the likelihood of decreased venous return secondary to packing of the abdomen during damage-control surgery, and the risk of secondary intracranial hemorrhage following traumatic brain injury (TBI). In this article, we present our experience with ECMO and interventional lung assist (iLA) as a rescue therapy for complex adult trauma patients with severe hypoxemic respiratory failure.
PATIENTS AND METHODS Following study approval with waiver of informed consent by the Rabin Medical Center institutional review board (#4315) was obtained, data collected at real time was retrospectively extracted from the files of all patients treated with ECMO/iLA owing to severe hypoxemic respiratory failure after severe traumatic injury during the last 5 years.
Clinical Setting The Rabin Medical Center has been the most active ECMO referral center for adults in Israel since 2004. All patients had the extracorporeal support inserted by a dedicated team. When patients were referred from a different facility, a dedicated team traveled to the referring hospital, assessed the
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patient, implanted the device, and transported the patient to Rabin Medical Center in a mobile intensive care unit modified to accommodate the necessary equipment and equipped with a backup power supply. Traditionally, the Maquet rotaflow centrifugal pump with a bioline coating PLS-I circuit was used; since 2008, an additional pumpless iLA (Novalung, Heilbronn, Germany) has been used on a regular basis. The iLA/ECMO team treats approximately 20 patients annually, with an overall survival rate of 70% for ECMO and 65% for iLA therapy (unpublished data).
exceeding 30 cm H2O and/or FIO2 of 0.8 or greater, patients with septic shock and multiple-organ failure, as well staff/ family noncommitment to full treatment were excluded. All patients with TBI underwent brain computed tomography (CT) and neurosurgical evaluation before consideration for extracorporeal life support (ECLS) treatment. If poor neurologic outcome was anticipated, ECLS was not used to prevent futile medicine.
Indications for Bypass and Bypass Method
Patients are monitored with continuous 12-lead electrocardiography, pulse oximetry, rectal temperature, invasive blood pressure measurement, and pulse contour analysis (flow trac, Edwards Lifesciences, Irvine, CA). In patients with severe shock and/or pulmonary hypertension, pulmonary pressures and SVO2 are also monitored (Viligance, Edwards Lifesciences). Echocardiography is performed at the discretion of the treating clinicians. In patients requiring venoarterial bypass, brain tissue oxygenation is monitored with near-infrared spectroscopy (INVOS, Somanetics Troy, MI). Intracranial pressure (ICP) is monitored in patients with severe brain injury (Camino fiberoptic system). All patients were in deep sedation and neuromuscular blockage before the insertion of ECLS. It is our experience that awake ECLS is seldom possible in ARDS patients. As a result and to prevent high airways and ICPs, we used short-acting sedation agents such as remifentanyl and propofol that were titrated according to the neurologic and respiratory state of the patient. Hypothermia (34-C) was induced in patients with severe TBI. Follow-up CT was performed routinely on Day 2 and at the discretion of the neurosurgeon consultant according
Bypass is instituted in accordance with Extracorporeal Life Support Organization indications.6 Most patients are initially placed on venovenous bypass (including patients where poor cardiac output or hypoxemia are assumed to be secondary to respiratory acidosis and high-minute highpressure ventilation) unless arteriovenous bypass is clearly indicated for severe hypoxemia or refractory hypotension. Our decision making flow chart is presented in Figure 1.
Inclusion Criteria All patients with an Injury Severity Score (ISS) greater than 16 in whom conventional mechanical ventilation failed to (a) control hypoxemia or (b) correct hypercapnia and respiratory acidosis and were treated with iLA/ECMO were included in the study.
Exclusion Criteria Patients older than 60 years, those receiving prolonged mechanical ventilation (97 days) with peak airway pressures
Patient Management
Figure 1. Decision making flow chart. 908
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to the physical examination and the ICP monitoring. ICP monitoring was used in all patients with severe TBI and Glasgow Coma Scale (GCS) score less than 8 on the scene and/ or at the discretion of the neurosurgeon. A full blood count and coagulation profile are drawn during initial cannulation. Coagulation is titrated with activated clotting time. In patients with substantial risk of bleeding, no anticoagulation was given until the risk of bleeding decreased. In those patients, we kept high flow on the ECMO to prevent clot formation. Alimentation includes omega-3 fatty acids, and bowel management devices are routinely used to avoid contamination of the vascular access tubing. Tracheostomy is performed within 7 days if extubation is not possible or planned by this time. Diagnosing sepsis during ECMO therapy is challenging; temperature and blood pressure are always controlled, and white blood cell count is often elevated during high-dose steroid treatment and during venoarterial ECMO. Therefore, blood cultures are performed on a daily basis, and bronchoalveolar lavage is performed routinely on alternate days using either a fiberoptic bronchoscope or a mini bronchoalveolar lavage catheter.
Ventilation Technique Conventional ventilation is continued during ECMO therapy to prevent lung collapse. Optimal positive endexpiratory pressures are determined daily by the use of the open lung tool and are usually kept at relatively low levels (2 cm H2O above the lower inflection point) to prevent the damage associated with lung recruitment-derecruitment. Peak pressures are kept at minimum through low respiratory rates (6Y8 breaths per minute) and small tidal volumes in accordance with the concept of lung protective ventilation.7 Recruitment maneuvers are performed twice daily. Additional treatment for ARDS includes intravenous methyprednisolone.8 Fluid retention is avoided through the use of loop diuretics and maintenance of a relatively negative fluid balance. In patients with severe hypoxemia, hypothermia is induced to reduce oxygen consumption (34-C for 48 hours).
Casualties were supported for 9.5 (4.5) days (median, 9; range, 5Y17 days) on ECMO and 7.6 (6.5) days (median, 6.5; range, 3Y18 days) on iLA. During this period, the following three complications directly related to bypass occurred: hemorrhage from the arterial cannulation site (n = 1), accidental removal of a venous cannula (n = 1), and pressure sores (n = 3). All were successfully controlled. Of the 10 patients, only 3 could receive heparin during the first 48 hours. The other seven patients had contraindication for anticoagulation at the time of ECMO initiation, five of them due to severe TBI with potential worsening of intracranial bleeding. In those patients who could not receive heparin, high blood flow (4Y5 L/min) was maintained to prevent clotting. In addition, all measures were taken to normalize the coagulation system (transfusion of fresh frozen plasma, platelets, and cryoprecipitate); one patient received recombinant factor VII. There were several complications that were attributed to the nature of the trauma and the resulting prolonged intensive care unit stay: acute renal failure (n = 3), pneumothorax with bronchopleural fistula (n = 2), postintubation subglottic stenoses (n = 2), moderate hypernatremia (n = 4), severe muscle weakness (n = 4), and septic shock (n = 5). The survival rate was 60% on ECMO (3 of 5) and 80% on iLA (4 of 5) (Table 1). Two deaths occurred owing to septic shock. One death was attributed to refractory cardiogenic shock with secondary multiple-organ failure.
TBI Patients Of the 10 patients, 7 had TBI. Six survived (86%). Median Glasgow Coma Scale (GCS) score on arrival was 7 (range, 5Y9) and improved in all survivors to 14 (range, 12Y15). This difference achieved statistical significance (p = 0.03, Wilcoxon signed-rank test). All patients but two regained normal neurologic status during follow-up. One patient remained with left hemiparesis, and one patient had paraplegia secondary to spine fracture. Follow-up CTs were performed in all patients during hospitalization, and no patient demonstrated worsening of cerebral bleeding.
DISCUSSION RESULTS During the study period, 10 (6 males) patients with severe traumatic injuries were supported with ECMO/iLA (5 ECMO and 5 iLA). Their mean (SD) age was 29.8 (7.7) years (range, 19Y42 years); mean (SD) ISS was 50.3 (10.5) (range, 29Y57). All patients had blunt injury, and all had severe chest injuries, including one cardiac perforation. Four had severe abdominal injuries involving solid organs, five had pelvic fractures, six had long-bone fractures, four had vascular injuries, and seven had intracranial injuries (Table 1). All casualties required aggressive ventilation before initiation of ECMO/iLA; ventilation parameters and patient arterial blood gas results before the initiation of ECMO and iLA are presented in Table 2. In addition, eight patients received inhaled nitric oxide, six were being alternated between prone and supine positions, and three were on high-frequency ventilation.
The current study presents the feasibility of salvage treatment with ECMO/iLA for casualties with multiple injuries and severe hypoxemic respiratory failure even in the presence of severe TBI. In 1992, Gentilello et al.9 attempted to overcome traumatic coagulopathy associated with hypothermia and acidosis through the use of percutaneously placed femoral arterial and venous cannulas acting as countercurrent fluid warmers. The 34 patients treated with this technique had better outcomes than did patients treated with conventional heating techniques. Perchinsky et al.10 described a 50% survival among 6 trauma patients with traumatic coagulopathy who were treated with ‘‘a simplified extracorporeal cardiopulmonary life support system.’’ In parallel, a series of groundbreaking laboratory experiments demonstrated improved survival following controlled hypothermia with extracorporeal support in animal models of exsanguinating cardiac arrest.11Y14
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910
21
7
37
37
6
10
32
5
42
22
4
9
27
3
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2
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F
M
M
F
M
F
F
M
M
M
Pedestrian injury
Fall
Motor vehicle accident
Motor vehicle accident
Motor vehicle accident
Motor vehicle accident
Bombing
Motor vehicle accident
Motor vehicle accident
Fall
48
50
57
57
29
57
66
51
38
50
Injury Case Age Sex Circumstances ISS
Fractured scapula, bilateral multiple rib fractures, hemopneumothorax and severe pulmonary contusions Bilateral multiple rib fractures, bilateral hemopneumothorax, hemoptysis, laceration of pulmonary artery (left) Fracture of clavicle and thoracic vertebra. Severe bilateral lung contusion, right pneumothorax
Cardiac perforation, pulmonary perforation, esophageal perforation
Bilateral scapular fracture Thoracic vertebral fracture Multiple rib fractures, bilateral lung contusion, pneumothorax (left) Severe pulmonary contusion, laceration, hemoptysis
Abdomen/Pelvis
Liver trauma Grade IV, renal laceration. Fracture of pelvis: ischiopubic and symphysis Ruptured spleen, perforated bowel, tear of mesenteric artery with hemoperitoneum
Open book fracture of pelvis
Ruptured diaphragm and spleen, gastric perforation, liver laceration
Lacerated spleen Lacerated iliac artery and vein, retroperitoneal hemorrhage Fracture of pelvis
System Involvement
Multiple rib fractures with flail chest, severe bilateral lung contusion Fractured scapula
Thorax
GCS score, 7; severe Severe bilateral lung contusions, brain contusion with bilateral hemopneumothorax, multiple point multiple rib fractures with hemorrhages clinical flail chest Subdural hematoma Bilateral pulmonary contusion, Unstable dorsal and lumbar with underlying multiple rib fractures (left) with fracture with neurologic brain contusion underlying pneumothorax deficit, fractured pelvis Parietotemporal closed Multiple rib fractures, bilateral lung Open book pelvic fracture skull fracture, Le contusions, hemopneumothorax (left) Fort III , brain contusion
Severe brain contusionYbilateral
Epidural hematoma, brain contusion
GCS score, 7. Multiple brain hemorrhages, intraventricular hemorrhage Third-degree facial burns
Epidural hematoma, brain contusion, orbital fracture
Head and Neck
TABLE 1. Patient Demographics and Injury Characteristics
Bilateral fractured tibia (open)
Fractured femur (closed) and tibia (open)
Third-degree burns to 4 limbs (32% body surface area), fractured humerus, laceration brachial artery Fractured humerus (closed)
Fractured ankle (closed) and 2 metacarpals
Fractured femur.
None
Extremities
iLA
iLA
iLA
iLA
iLA
ECMO
ECMO
ECMO
ECMO
ECMO
Yes
Yes
No
Yes
Yes
Yes
No
Yes
No
Yes
Assistance Device Survival
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TABLE 2. Arterial Blood Gases Before Initiation of ECMO/iLA Therapy and Time to Initiation of Extracorporeal Support Arterial Blood Gases
ECMO iLA
Pao2/FIO2
Paco2, mm Hg
pH
62 (35Y82) 92 (78Y140)
62 (48Y95) 85 (65Y150)
7.21 (7.05Y7.28) 7.12 (6.9Y7.7.25)
Time From Injury to Support, d 3 (1Y7) 5 (3Y8)
These early reports all acknowledged the following main impediments to the implementation of ECMO therapy in emergency situations: the need for cannulation, the bulk of the equipment, and the expertise required. Although during the next decade, there were only sporadic descriptions of the use of ECMO for stabilization of trauma patients, often with aortic transection,15,16 important progress was occurring in the field of ECMO treatment. Portable ECMO systems were developed and tested on animal models outside conventional settings17Y19; pumpless extracorporeal lung assist devices were gaining recognition in trauma and for patient transport,20Y23 and heparin-coated tubing was introduced into clinical use.24 Madershahian et al.25 described three patients with severe thoracic injuries who were treated with ECMO owing to failure of conventional ventilation techniques to treat hypoxemia. Two patients had a GCS score of 4 upon emergency medical team arrival. The first had normal brain imaging results despite emergency department presentation with a dilated pupil. The second had severe frontal brain contusion with subarachnoid hemorrhage as per CT. Both patients survived to hospital discharge; the former never developed neurologic injury, and the latter was discharged to rehabilitation with no reference made to further intracranial hemorrhage. Arlt et al.26 described a cohort of 10 trauma patients with an age similar to our cohort but with even higher ISSs. Their patients, too, were massively transfused and mostly underwent damage-control surgery (8 of 10). They also initially used heparin-free tubing. Their survival rates were similar to those of our cohort (6 of 10), as were their rates of death from sepsis (3 of 4). The additional death was caused by retroperitoneal hemorrhage. In this series, no specific mention was made of TBI. Our cohort is as large as the largest published cohort to date and includes the largest number of TBI patients in the published literature. To the best of our knowledge, this is the second series of patients treated with a high-flow technique to avoid administration of heparin in patients with trauma-related coagulopathy.26 Our data suggest that the beneficial effects of ECMO/iLA therapy on body temperature, acid-base balance, oxygenation, and hemodynamic stability should be weighed against the risk of hemorrhage. In our experience, even patients with acute ongoing hemorrhage may gain hemodynamic benefit from this treatment modality. TBI with hemorrhage constituted a contraindication for ECMO treatment in the Cesar study. With the increasing use of surface heparinized ECMO equipment, contraindication to anticoagulation as an exclusion criterion for ECMO requires reconsideration. In our experience, heparin anticoagulation can be postponed up to 48 hours, provided that high flows are maintained.
None of the randomized controlled trials, which examined ECMO therapy head to head with conventional ventilation techniques, included patients treated with iLA. This new generation of devices has limited applicability but may encourage more frequent use of extracorporeal CO2 removal owing to its relative ease of use. This retrospective review of a small number of patients cannot serve to link treatment and outcome. It was performed in a single referral center. This may have biased our outcomes. High-volume centers are likely to have better results. However, the patients referred to our center are invariably those who are failing conventional treatment.
CONCLUSION In our experience, extracorporeal gas exchange can be used as a rescue therapy in complex adult trauma patients with severe hypoxemic respiratory failure, despite the presence of severe disseminated intravascular coagulation, active bleeding, and even TBI. ECMO is often not considered until other therapeutic options are exhausted. However, the nature of these traumatic injuries requires rapid action to make ECMO therapy possible. Further research is required to determine if ECMO/iLA therapy also confers survival benefit on critical trauma patients. AUTHORSHIP P.B. conceived and designed the study. M.F. performed the data acquisition. S.E. analyzed the data, and P.B. and S.E. performed the interpretation. S.E. drafted the manuscript with the assistance of P.B., and B.M. undertook critical revision of the manuscript.
DISCLOSURE The authors declare no conflicts of interest.
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