OPINIONS AND IDEAS Emerging Indications for Extracorporeal Membrane Oxygenation in Adults with Respiratory Failure Darryl Abrams1 and Daniel Brodie1 1 Division of Pulmonary, Allergy and Critical Care Medicine, Department of Medicine, Columbia University College of Physicians and Surgeons/New York–Presbyterian Hospital, New York, New York
Abstract Recent advances in technology have spurred the increasing use of extracorporeal membrane oxygenation (ECMO) in patients with severe hypoxemic respiratory failure. However, this accounts for only a small percentage of patients with respiratory failure. We envision the application of ECMO in many other forms of respiratory failure in the coming years. Patients with less severe forms of acute respiratory distress syndrome, for instance, may benefit from enhanced lung-protective ventilation with the very low tidal volumes made possible by direct carbon dioxide removal from the blood. For those in whom hypercapnia predominates, extracorporeal support will allow for the elimination of invasive
mechanical ventilation in some cases. The potential benefits of ECMO may be further enhanced by improved techniques, which facilitate active mobilization. Although ECMO for these and other expanded applications is under active investigation, it has yet to be proven beneficial in these settings in rigorous controlled trials. Ultimately, with upcoming and future technological advances, there is the promise of true destination therapy, which could lead to a major paradigm shift in the management of respiratory failure. Keywords: extracorporeal membrane oxygenation; extracorporeal carbon dioxide removal; acute respiratory distress syndrome; artificial lung
(Received in original form May 9, 2013; accepted in final form May 14, 2013 ) Correspondence and requests for reprints should be addressed to Daniel Brodie, M.D., Columbia University College of Physicians and Surgeons/New YorkPresbyterian Hospital, 622 West 168th Street, PH8E 101, New York, NY 10032. E-mail:
[email protected] Ann Am Thorac Soc Vol 10, No 4, pp 371–377, Aug 2013 Copyright © 2013 by the American Thoracic Society DOI: 10.1513/AnnalsATS.201305-113OT Internet address: www.atsjournals.org
Extracorporeal membrane oxygenation (ECMO) for adults with respiratory failure has evolved slowly over decades, crippled by early failures to demonstrate definitive success. However, recent advances in technology, accumulating evidence, and growing experience have resulted in a resurgent interest in ECMO (1, 2). Severe acute respiratory distress syndrome (ARDS) is the most commonly accepted indication for ECMO in respiratory failure. Although there are no universally accepted criteria for ECMO initiation in ARDS, severe hypoxemia (PaO2 to FIO2 ratio , 80), uncompensated hypercapnia with acidemia (pH , 7.15), or excessively high endinspiratory plateau pressures (.35–45 cm of water), despite standard of care ventilator management, have been proposed as reasonable indications for ECMO (1). An
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ongoing randomized, controlled trial of ECMO in severe ARDS may help to better define these criteria (ECMO to Rescue Lung Injury in Severe ARDS [EOLIA]; clinical trial registered with www.clinicaltrials.gov [NCT01470703]). However, very severe forms of ARDS occur infrequently (3, 4). It is our belief that wider application of extracorporeal support in respiratory failure will result from its efficiency in removing carbon dioxide at lower blood flow rates and with smaller cannulae than what is traditionally used for refractory hypoxemia. This approach could potentially benefit patients with milder forms of ARDS, exacerbations of chronic obstructive pulmonary disease (COPD), and patients awaiting lung transplantation. Future advances in technology hold the promise of a total artificial lung, which could
revolutionize the approach to both acute and chronic respiratory failure. Until evidence emerges from rigorous clinical trials, the implementation of ECMO in any of these settings should be limited to investigational studies at select centers with particular expertise.
The Reemergence of ECCO2R Extracorporeal carbon dioxide removal (ECCO2R; pronounced “ee-kor”) is a technique related to ECMO in which lower blood flow rates are used with the primary intention of carbon dioxide removal. As early as the 1970s, Gattinoni and colleagues (5–9) investigated its potential as a means of supplementing ventilation in cases of severe hypoxemic
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OPINIONS AND IDEAS respiratory failure, minimizing the need for continuous positive-pressure ventilation, a strategy referred to as “lung rest.” Early success with this technique prompted a randomized trial of ECCO2R in ARDS; however, there was no survival benefit of ECCO2R over standard-of-care ventilator management, which, in part, was attributed to complications from the device, including hemorrhage and thrombosis (10). Since that time, extracorporeal technology has undergone significant improvements. Centrifugal pumps greatly decrease the risk of tubing rupture, and may improve clinical outcomes when compared with roller pumps (11–13). Biocompatible circuit components allow for lower levels of anticoagulation, resulting in decreased bleeding risk without increases in thrombotic events, although there is no consensus on the optimal level of anticoagulation (2). Dual-lumen cannulae can support venovenous extracorporeal gas exchange with a single venous access point, minimizing the number of cannulation sites and potentially reducing the amount of recirculation of oxygenated blood (14, 15). In contrast to an arteriovenous extracorporeal configuration, this approach avoids arterial cannulation and its associated risk of limb ischemia and compartment syndrome (16). Perhaps the biggest advance has been with the gas exchange membrane itself. Modern oxygenators are considerably more efficient and more durable than older devices, and are far less prone to destruction of blood elements (17). In general, carbon dioxide removal can be achieved with lower blood flow rates—at times in the range of continuous venovenous hemodialysis—and smaller cannulae than what is typically required for oxygenation in severe hypoxemic respiratory failure, which may improve the safety profile of ECCO2R relative to ECMO (18, 19).
ECCO2R to Enhance LungProtective Ventilation in ARDS A low-volume, low-pressure ventilation strategy has been shown to improve survival in the Ventilation with Lower Tidal Volumes as Compared with Traditional Tidal Volumes for Acute Lung Injury and the Acute Respiratory Distress Syndrome (ARMA) trial conducted by the ARDS Network, and follow-up studies have corroborated the fact that lung-protective ventilation mitigates ventilator-associated 372
lung injury (20–23). The survival benefit from volume- and pressure-limited ventilation may endure well beyond the initial injury (24). However, the ability to use lung-protective ventilation is occasionally limited by severe decreases in respiratory system compliance, resulting in unacceptable, hypercapnia-induced, decreases in pH. In such cases, the clinician must sacrifice lung-protective ventilation to maintain pH, which has been a reason cited for nonadherence to low–tidal volume ventilation (25, 26). By directly removing carbon dioxide from the blood, ECCO2R could permit lung-protective ventilation in these patients by maintaining pH at low tidal volumes. More importantly, ECCO2R use in patients with ARDS could allow for even greater decreases in tidal volume and endinspiratory plateau pressures than are targeted for traditional lung-protective ventilation. If lung-protective ventilation improves mortality, then perhaps enhanced lung-protective, that is, very low–tidal volume ventilation, could provide additional benefit and might be applicable to a wide range of patients with ARDS. There are data to suggest that lower tidal volumes and end-inspiratory plateau pressures than were targeted in the ARMA trial result in an incremental reduction in ventilator-associated lung injury (27–29). In a rat model of acute lung injury, very low tidal volumes and plateau pressures (3 ml/kg and 16 cm of water) produced significantly less extravascular lung water than higher volumes and pressures (27). Secondary analysis of the ARMA trial suggests that subjects in the higher–tidal volume group would have benefited from tidal volume reduction, regardless of plateau pressure quartile, although the effect of prospectively reducing tidal volumes below 6 ml/kg could not be evaluated (28). A prospective cohort study by Needham and colleagues (24) demonstrates an independent linear relationship between tidal volume decreases and mortality reduction that extends below 6 ml/kg. In an analysis of patients who received ECMO in France during the influenza A(H1N1) pandemic, higher plateau pressures were associated with increased mortality (30). To further investigate the effect of volume and pressure on lung injury, Terragni and colleagues (29) implemented very low tidal volumes, with the assistance of ECCO2R, to reduce end-inspiratory plateau pressures from 28–30 cm of water to 25–27 cm of water in patients with ARDS. At
approximately 4 ml/kg of predicted body weight and lower end-inspiratory plateau pressures, inflammatory markers indicative of lung injury were significantly reduced as compared with higher end-inspiratory plateau pressures, suggesting that lower volumes and pressures than what was used in ARMA may further mitigate ventilatorassociated lung injury. A recent study comparing ECCO2R-facilitated very low tidal volumes to a traditional low tidal volume strategy in moderate to severe ARDS reported a trend toward more ventilator-free days in the ECCO2R arm, although the difference did not reach statistical significance, and there was no difference in mortality (31). However, post hoc analysis showed a significant difference in ventilatorfree days in the patients with greater hypoxemia. If ECCO2R can be shown to be beneficial in a broader population of patients with ARDS, the use of extracorporeal gas exchange could increase significantly. The use of ECCO2R in intensive care units could become as widespread as continuous venovenous hemodialysis—ECCO2R being the equivalent of dialysis for the lung. However, as a carbon dioxide removal device, hypercapnic respiratory failure is an even more obvious target for future applications.
Role of Extracorporeal Support in Non-ARDS Respiratory Failure An important concept to consider when evaluating the risk–benefit ratio of extracorporeal support is that it functions as lung replacement therapy. In doing so, it may obviate the need for invasive mechanical ventilation in select patients, particularly those with acute hypercapnic respiratory failure and some patients awaiting lung transplantation. The potential benefit of reducing or eliminating the need for invasive mechanical ventilation in such patients cannot be overstated. Invasive mechanical ventilation is associated with numerous problems: ventilator-associated lung injury, ventilatorassociated pneumonia, dynamic hyperinflation, suboptimal delivery of aerosolized medications, patient discomfort, and reduced oral intake (32– 35). Deconditioning may occur without aggressive physical therapy, and invasive
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Figure 1. Single-site approach to venovenous extracorporeal membrane oxygenation (ECMO) in the ambulatory patient. A dual-lumen cannula inserted in the internal jugular vein permits both the withdrawal of venous blood from the vena cavae and the reinfusion of oxygenated blood into the right atrium. Avoidance of femoral cannulation, in combination with more compact circuit components that can be easily mobilized, facilitates ambulation and physical rehabilitation in patients with respiratory failure requiring extracorporeal support. Inset: deoxygenated blood is withdrawn through ports positioned in both the superior and inferior vena cavae. The reinfusion port is oriented such that oxygenated blood is directed toward the tricuspid valve. Illustration used with permission from COACHsurgery.com and Columbia University.
mechanical ventilation is associated with high 1- and 5-year mortality rates (36). A device that reduces these risks could provide considerable benefit (Figure 1).
ECCO2R in COPD Positive-pressure ventilation is the standard of care for management of hypercapnic respiratory failure due to acute exacerbations of COPD. The use of ECCO2R has been reported in acute exacerbations of COPD, and is a strategy that could significantly alter the current management Opinions and Ideas
paradigm (18, 19, 37–39). When hypercapnia is the driving force behind the need for invasive mechanical ventilation, ECCO2R could facilitate discontinuation of positive-pressure ventilation by rapidly removing carbon dioxide, thereby reducing minute ventilation, work of breathing, and dynamic hyperinflation (18, 19). In our own pilot study of ECCO2R initiation in patients with acute exacerbations of COPD requiring invasive mechanical ventilation, we demonstrated the feasibility of using extracorporeal support to achieve early extubation and ambulation, albeit in a selected group of patients (39).
Alternatively, ECCO2R could be initiated at the point of failure of noninvasive ventilation to potentially avoid endotracheal intubation altogether (37, 38). Severe, refractory status asthmaticus and other forms of hypercapnic respiratory failure may benefit similarly (40–43).
ECMO as Bridge to Lung Transplantation Invasive mechanical ventilation is considered a relative contraindication to lung transplantation, as it often leads to poor post373
OPINIONS AND IDEAS transplant outcomes (44, 45). Patients awaiting lung transplant who require endotracheal intubation may be removed from the lung transplant wait list because of complications of invasive mechanical ventilation or deconditioning that would increase perioperative mortality. If extracorporeal support provides enough gas exchange to replace the ventilator, then transplant candidacy could be optimized by avoiding ventilator-associated complications and promoting active rehabilitation. Traditionally considered a contraindication to lung transplantation, pretransplant use of ECMO has resulted in improved rates of posttransplant survival in high-risk patients in some recent studies (46, 47). Others have reported high rates of survival when a nonintubated ECMO strategy is used as a bridge to lung transplantation, particularly when combined with an aggressive pretransplant rehabilitation program (48–51). In patients with pulmonary hypertension, two particular strategies have been employed to either preserve transplant candidacy or bridge acutely decompensated patients to recovery. In those with an atrial septal defect or a patent foramen ovale, a dual-lumen cannula may be inserted in the internal jugular vein and positioned to direct oxygenated blood across the defect, providing an oxygenated right-toleft shunt with right ventricular decompression (52–54). This configuration offers sufficient gas exchange to possibly discontinue invasive mechanical ventilation. In patients without a preexisting atrial septal defect or patent foramen ovale, atrial septostomy may enable a similar strategy (55). Alternatively, an upper body venoarterial configuration that avoids femoral cannulation may be used to provide both cardiac and pulmonary support, facilitating endotracheal extubation and physical therapy (56, 57).
centers have reported successfully starting ECMO instead of invasive mechanical ventilation, bypassing the ventilator entirely (Figure 2) (38, 48, 49, 58). The specific patient populations for whom these strategies are most appropriate have yet to be defined, including among those with hypercapnic respiratory failure or awaiting lung transplantation, and is dependent in large part on the underlying etiology of respiratory failure, the amount of oxygen support needed (i.e., whether adequate oxygenation can be achieved with the combination of ECMO and noninvasive oxygen supplementation), the degree of dyspnea, and the presence of comorbid conditions.
ECMO and Early Mobilization Patient immobilization has traditionally been a significant limitation of ECMO support. Early mobilization of critically ill patients, in general, is recognized as safe, easily protocolized, and important in reducing intensive care unit–related complications (59–61). The same benefits from early mobilization should hold true in patients requiring ECMO; however, femoral cannulation, use of heavy sedation, and concerns about circuit integrity have
been significant barriers to safe and reliable mobilization. With the development of a dual-lumen cannula that provides ECMO via the internal jugular vein, femoral access can be avoided (14, 62). An upper-body configuration significantly increases the likelihood of successful rehabilitation, including ambulation, in this patient population (48, 51, 63), though a coordinated team effort is required to reduce sedation and safely achieve mobilization. Additional configurations may optimize mobility on ECMO, including combined internal jugular venous drainage and subclavian arterial reinfusion when venoarterial support is necessary (64). More compact circuits have also facilitated mobilization within and transport between intensive care units (65).
Future Research The use of extracorporeal support inherently introduces risks that would not otherwise be present with conventional mechanical ventilation alone, including hemorrhage, thrombosis, and catheterassociated infections. Likewise, although reductions in tidal volumes to significantly less than 6 ml/kg in ARDS appears to be
Will ECMO Replace the Ventilator Entirely?
The traditional paradigm for ECMO in respiratory failure has been to initiate it as an adjunct to invasive mechanical ventilation, followed by the discontinuation of ECMO before weaning the ventilator. With the ability of ECMO to replace the gas exchange function of a ventilator, this paradigm is changing, and will continue to evolve as additional technological advancements are made. There have been several documented reports of endotracheal extubation while receiving ECMO for respiratory failure, whereas some 374
Figure 2. The evolving paradigm of extracorporeal membrane oxygenation (ECMO) in respiratory failure. (Column A) Traditional implementation of ECMO as a temporary adjunct to invasive mechanical ventilation (IMV) in severe respiratory failure. (Columns B and C) ECMO used to facilitate removal or avoidance of IMV while bridging to recovery (BTR) or bridging to transplantation (BTT). Red arrow: the more traditional paradigm of BTT or bridge to decision (BTD) from IMV and ECMO remains a consideration.
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OPINIONS AND IDEAS technically feasible when an extracorporeal circuit is implemented (29, 31), we do not yet know whether very low tidal volumes may have adverse consequences, such as excessive atelectasis or delayed alveolar recruitment during ventilator weaning. Before any recommendation for widespread adoption of extracorporeal support for indications beyond so-called “rescue therapy” in very severe cases of ARDS (66), randomized controlled trials are needed to assess the risks, benefits, and cost effectiveness of any strategy that incorporates ECCO2R (or ECMO) as either an adjunct to or replacement for invasive mechanical ventilation. Specifically, studies should compare ECCO2R-assisted very low–tidal volume ventilation to current standard-ofcare lung-protective ventilation strategies in moderate to severe ARDS. Similar use in mild ARDS is likely not yet warranted for study. However, as the technology improves and risks are reduced, this may be an option for future exploration. In patients with primarily hypercapnic respiratory failure, the use of ECCO2R, with an emphasis on early extubation and physical rehabilitation, should be evaluated against conventional ventilator management, with a focus on identifying the subset of patients that are most likely to receive the greatest, if any, benefit. To be most informative to clinicians, these studies should compare extracorporeal technology to current best practices of respiratory failure management, although some of these practices, including early mobilization and minimization of sedation, are not incompatible with extracorporeal support strategies (48, 51, 67). Given the current state of ECMO technology, its potential risks, and the lack of proven benefit, its use in most of these expanded applications should be restricted to controlled clinical trials at experienced centers. Hospitals without adequate ECMO expertise should consider referral of potential candidates to such centers. As future randomized trials are
Table 1. Emerging indications for extracorporeal membrane oxygenation or extracorporeal carbon dioxide removal in respiratory failure Nonsevere ARDS Acute hypercapnic respiratory failure, including COPD and status asthmaticus Bridge to lung transplantation Pulmonary hypertension Destination therapy device Definition of abbreviations: ARDS = acute respiratory distress syndrome; COPD = chronic obstructive pulmonary disease.
conducted, the medical community will have a better understanding of its applicability and limitations. In an era where the judicious use of medical resources is an increasingly significant consideration, careful economic analyses are also needed before further adoption of this technology. As extracorporeal use increases and technology evolves, ethical dilemmas associated with that use will arise more frequently. Addressing these issues will become increasingly important. Previous experience with ventricular assist devices, comparable to ECMO and ECCO2R in some ways, in their role as bridging therapies, may help inform clinicians about some of the potential, as well as the pitfalls, of the more widespread use of extracorporeal support.
Future Directions of Extracorporeal Technology In our opinion, extracorporeal gas exchange has the potential to significantly alter the paradigm for managing respiratory failure. In ARDS, the use of ECCO2R to enhance lung-protective ventilation by achieving very low tidal volumes may become the future standard of care. The use of extracorporeal gas exchange could extend to patients with various forms of hypercapnic respiratory failure (Table 1). Most importantly, it may eliminate the
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