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Enhanced recovery after surgery and practical application to liver transplanation
Journal Pre-proof Enhanced recovery after surgery and practical application to liver transplanation M. Susan Mandell, Jiapeng Huang, Jing Zhao
PII:
S1521-6896(20)30006-9
DOI:
https://doi.org/10.1016/j.bpa.2020.02.001
Reference:
YBEAN 1063
To appear in:
Best Practice & Research Clinical Anaesthesiology
Received Date: 7 January 2020 Revised Date:
7 February 2020
Accepted Date: 11 February 2020
Please cite this article as: Susan Mandell M, Huang J, Zhao J, Enhanced recovery after surgery and practical application to liver transplanation, Best Practice & Research Clinical Anaesthesiology, https:// doi.org/10.1016/j.bpa.2020.02.001. This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. © 2020 Published by Elsevier Ltd.
Practical application of ERAS protocols in liver transplant care
ENHANCED RECOVERY AFTER SURGERY AND PRACTICAL APPLICATION TO LIVER TRANSPLANATION M. Susan Mandell1, Jiapeng Huang2, Jing Zhao3 Author Information: 1
Department of Anesthesiology, University of Colorado, CO, USA
2
Department of Anesthesiology, University of Louisville, Louisville, KY, USA
3
Department of Anesthesiology, Peking University, Beijing, People’s Republic of China
Corresponding Author. Jing ZHAO, MD Email: [email protected] Professor and Director Department of Anesthesiology and Operating Theater China-Japan Friendship Hospital, No. 2, Ying Hua Yuan Dong Jie Street, Beijing, 100029, China Funding: Support was provided solely from institutional and/or departmental sources. No Conflicts of Interest
Keywords: Enhanced Recovery after Surgery Practice Guidelines Peri operative Care Liver Transplant
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Practical application of ERAS protocols in liver transplant care
Abstract: There is a growing support for the use of protocols that incorporate multiple steps aimed to reduce the time patients require to regain health. A recurring limitation is the variable outcomes of these protocols with more or less success at the sites they are instituted. This review examines the essential building blocks needed to launch a successful ERAS protocol. It address why there are differences in outcome measures between centers such as length of stay and the cost of care even if the protocols and patient populations are similar. To understand what factors can affect the success of an enhanced recovery program, we explore ERAS as a process rather than a summary of detailed care steps. The influence of integrated care delivery, leadership style and choice of goals of care are explained in the context of ERAS as a process of how medical care is delivered. ERAS is presented as a solution to fragmented health care delivery which increases the cost of care and often delays recovery. The importance of Integrated Delivery System and its relationship to high quality healthcare delivery and better outcomes is explored. The role of ERAS in liver transplant is examined and how the clinical goal of early extubation resulted in a progression of evidencebased care steps to that are consistent with ERAS protocols.
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Practical application of ERAS protocols in liver transplant care There has been a rush of activity to use clinical care protocols designed to shorten recovery time in patients undergoing surgery. These programs are collectively called “enhanced recovery after surgery or ERAS” and their unifying goal is to accelerate a patient’s return to preoperative function (1). The approach uses multistep protocols to reduce surgical stress, and complications while improving postoperative outcomes by applying practices thought to optimize care in all phases of surgery (2). Goals of ERAS programs are diverse and include outcomes such as cost of care, length of stay and preventing postoperative complications (3). Some protocols focus on only specific goals such as nutritional or pain recovery (4, 5). Reductions in the cost of care make ERAS protocols attractive even though these practices lack a thorough understanding of how the individual components contribute to the whole outcome (6, 7). Even with these limitations, the benefits and safety of ERAS type protocols are relatively well established for a number of surgical procedures (3). Evaluating the, benefit and safety of an ERAS protocol may be more difficult as the complexity of the surgical procedure increases (8). This is particularly true for procedures such as liver transplantation where patient outcomes are a complex blend of donor and recipient care in addition to the clinical management of graft function and recipient severity of illness.
This review looks at ERAS as care delivered by integrated care models. We explore the complex health care systems that ERAS protocols have to fit into and how ERAS care is affected. Essential concepts needed for ERAS protocols are examined to appreciate what is required to develop a successful program.
The existing literature in liver transplant care is
reviewed to see how investigators have adapted ERAS type care plans to fit to these complex patients.
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Practical application of ERAS protocols in liver transplant care ERAS as a holistic approach to care: Enhanced recovery protocols bundle multiple steps to optimize every phase of patient care prior to discharge from hospital or outpatient surgical centers (1). They have been widely used in patients undergoing colorectal, bariatric, gynecological and neurosurgical surgeries (3). Enhanced recovery protocols have also been used in more complex procedures including cardiac surgery and liver transplantation (9, 10). Experts involved in patient care work as a team to optimize patients for surgery, decrease perioperative stress, maintain postoperative organ function, and accelerate recovery time after surgery (11). An ERAS protocols is usually delivered by an Integrated Delivery Systems (IDS) which links healthcare providers to deliver a coordinated, flow of services to a target patient population (12). All IDS care is integrated and distinct from systems where care is decentralized and the goals of treatment vary depending on aims of individual healthcare providers or the units they work in (13). Decentralized care suffers from a lack communication and coordination between providers and facilities resulting in fragmented health care that can adversely affect quality and cost (14, 15). Fragmented healthcare increases costs of care, and the risk of not receiving evidencebased or best practices, and leads to more preventable hospitalizations (15, 16). Quality was lower and costs were higher in fragmented compared to an IDS tare in patients with the same chronic conditions (17). Developing a Successful ERAS protocol: Defining Goals of Care: Similar to all types of IDS, the ERAS protocols should be supported by a structure that clarifies the goals of therapy, lines of communication and methods of problem solving (18). The working definition of integrated care by the World Health Organization sets an overall or inclusive goal for care that can be adapted to diverse practice settings. It is “the organization and management of health services so that people get the care they need, when
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Practical application of ERAS protocols in liver transplant care they need it, in ways that are user-friendly, achieve the desired results and provide value for money” (19). This guides collaboration and consequently directs downstream tasks to help team members develop specific goals and metrics that support high quality cost effective care (20, 21). The goals tend to be specific for the disease process as for orthopedic surgery compared to cancer care. The quality or effectiveness of care can be determined by measuring compliance with specific goals of the protocols in addition to adhering to the more inclusive goals used for all healthcare (22). Benchmarking is a common way of determining if the specific goals of treatment were reached (23-25). Data for benchmarking may be available from oversight agencies for aspects of care such as readmission rates (23, 24). Other methods of benchmarking include using comparative data from a group of centers or individual physician performance. The expectation is that centers should not exceed the average rate of adverse events. Quality is improved when changes are made that reduce the national, center or individual adverse events average (26). Quality Improvement as part of the ERAS protocol: Planning for continual effective change is part of the goals for each protocol and required to support quality improvement (27). This may help reduce the reluctance of care providers to adopt new evidence-based practices. Routine surveillance as opposed to isolated reviews can quickly identify areas of care where the team could do better. This has been termed continuous quality improvement. The approach works on the principle that there is always opportunity for improvement in every process (28). Standards and benchmarks are therefore dynamic and adherence to a single set of outcome goals reflects stagnation in the system. The use of continual quality improvement should cause teams to routinely redefine their goals of treatment regardless of whether they meet established
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Practical application of ERAS protocols in liver transplant care standards/benchmarks of health care. The question is “can we do better” rather than “are we doing well enough”. An important goal for the IDS is to return the patient to health and not just treat disease (18, 19). Metrics to assess quality of life have lagged behind other measures that are more easily collected and interpreted (29). Preoccupation with cost and mortality metrics to the exclusion of overall health and quality of life does not meet the inclusive goals of how well an IDS using an ERAS protocol is working. This is particularly highlighted in liver transplantation outcomes which only benchmarks patient and donor organ survival. Leadership in ERAS models of care:
The relative success of ERAS protocols depends on how
well leader(s) motivate the team to take a personal stake in the process and outcomes (30). There is a strong relationship between leadership style, patient satisfaction and the rate of adverse events regardless of the site of care (31, 32, 33). Leaders who can shift their own interests to those of the team have better health care outcomes (34). A recent systematic review showed IDS teams reduced mortality rates and had a better culture of patient safety when they had transformational leaders [30, 35]. Establishing transformational leadership in an IDS or ERAS team can be challenging since surgeons often play a leading role in ERAS protocols. However, a number of studies concluded that transactional leadership characteristics were more consistently observed in surgeons (36). This type of leadership is often supported by healthcare organizations where surgeons are viewed as primary drivers of revenues (37). This creates a conflict of interest between pursuing earnings and quality care (38). Selecting an ERAS protocol: Protocols are available from national ERAS societies or peer reviewed publications (39). These are useful care plans usually constructed from carefully reviewed evidence. However, it is not clear if these protocols work equally well if they are
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Practical application of ERAS protocols in liver transplant care introduced into an organization where they were not developed?
The material reviewed in this
paper on essential IDS/ERAS elements suggests that importing practices without using similar goals of care, supporting processes and continuous quality improvement could lead to less than expected outcomes. This does not imply that imported ERAS protocols are without value. They are excellent sources of data-driven care that can be effective under the right conditions. However, ERAS protocols can have unintended negative consequences (6). Some ERAS protocols could actually cause stagnation of care by adhering to benchmarks or standards that fail to evolve. They may also further fragment care if the IDS team hasn’t developed a collaborative culture with processes to create a smooth flow of care (40, 41). The evidence indicates the success and consequences of using ERAS protocols goes far beyond the details of care. The protocols redirect care providers to adopt a patient-centric approach that supports setting goals and use of specific metrics to measure the quality of care. This may explain why patients who receive care from IDS teams report greater satisfaction and have reduced costs of care even when they are part of different ERAS protocols (32, 42). This reinforces the message that an efficient IDS model of care is as important as the details of all ERAS protocols.
ERAS in liver transplantation: Important physician and institutional tasks for ERAS protocols and IDS function have been outlined in the preceding section. We review whether these fundamental principles have been systematically applied to enhanced recovery protocols used in liver transplant patients and examine which areas of practice that could be improved. To date there are few studies about the development, implementation and practical application of ERAS protocols in the field of liver 7
Practical application of ERAS protocols in liver transplant care transplantation. However, elements of ERAS-type care after transplantation date back to 1997 in the first published reports of immediate postoperative extubation from two centers (43, 44). Following the first reports of early extubation, there was a rapid increase in the number of centers that successfully reduced or eliminated postoperative ventilation. Investigators reported immediate or early postoperative extubation in pediatric patients and adults with greater severity of illness at centers throughout the globe (45-47). These early and notable achievements were likely facilitated by an integrated transplant team structure and function. Liver transplant specialists have always used an IDS-type of practice model to deliver comprehensive care. The rapid incorporation of early extubation protocols suggests that many transplant teams already had sufficient structure to develop and implement novel practices that enhanced recovery. However, few centers incorporated early extubation as a specific goal of their care (45-47). This has given rise to irregular extubation practices between and sometimes within an institution. Most investigators reported benefits of early extubation using well defined benchmarks of care. Liver transplant patients who were extubated early had a shorter length of intensive care stay and some centers showed earlier discharge from hospital (48). Early extubation was associated with a reduction in the number of postoperative complications and a significant decrease in the cost of care (49). Most notable were the fewer cases of pulmonary infection, and sedationdelirium associated with postoperative ventilation (45-48). Recovery of patients following early extubation was so rapid that some programs subsequently developed care protocols that allowed selected recipients to bypass the intensive care unit completely and be admitted to the surgical ward from the recovery room (49, 50, 51). The latter protocols were not associated with an increased rate of complications. Further, there were significant cost savings that accompanied a reduced use of high acuity care resources.
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Practical application of ERAS protocols in liver transplant care Anesthesiologists developed steps in the routine care of transplant recipients in order to achieve early extubation. This approach was the initial attempt to develop multiple linked steps in liver transplant care similar to an ERAS protocol that aimed at enhanced recovery. Changes in care that advanced early extubation/ fast track protocols included a reduction in the use of intraoperative sedative drugs and anesthetic agents (48-51). While this seemed like a simple step, it was a unique advance that challenged existing evidence about how much medication was needed to achieve optimal conditions for both surgery and early recovery. These advances were rapidly followed by more objective measures of fluid administration using monitors that directly and indirectly measured intra-cardiac or intravascular volume. New findings were introduced showing that intravascular volume restriction increased the number of patients who could be extubated early and was not associated with adverse outcomes (52). More centers instituted point of care coagulation tests to reduce unnecessary transfusion and prevent transfusion-related complications that could increase respiratory failure and other complications that would delay patient recovery (53). These changes in care marked the beginning of ERAS in liver transplantation as care evolved from managing individual events and conditions to care that prepared patients for a smooth transition to the next step of the recovery process. Consequently, early extubation had the potential to become both a benchmark and a driver of early recovery (48-50). The initial enthusiasm for these early ERAS-like protocols was not sustained and the development of enhanced recovery care for liver transplant patients has not significantly progressed. A potential barrier to further ERAS protocol development was the view that early extubation is a single intervention performed by the anesthesiologist rather than part of the multistep care of built by the entire IDS team (51). This is shown by the lack of clearly articulated goals to eliminate postoperative ventilation and failure to build other transplant IDS practices to support immediate extubation. Another important limitation was the lack of 9
Practical application of ERAS protocols in liver transplant care continuous quality improvement processes built into early extubation protocols to track and improve performance. After a promising start there were few new findings or development of multistep protocols that enhanced recovery. The reasons for this plateau in innovative anesthesia liver transplant care are unclear and to date only one study trialed a full ERAS protocol in liver transplant patients. A recent study from France described a protocol for adult recipients with a MELD score of less than 25 who had uncomplicated surgery and received less than 6 units of blood intraoperatively (10). Of the 26 protocol steps, the relative value of all but carbohydrate loading in increasing recovery was established and validated in the liver transplant literature. The investigators found a protocol using multiple evidence-based practices significantly reduced length of stay, postoperative complications and cost of care. While the findings again raise awareness of the benefits of ERAS type care, the investigators could not determine if this protocol was effective because of the bundled steps, underlying IDS structure or simply the fact that these patients were not as ill as many who are transplanted worldwide. Even with these limitations an important contribution of this study was showcasing a logical method to separate the confounding effects of severity of illness and graft function from the protocol design. Unlike other types of surgery, measuring outcomes is complicated by the strongly influential interactive and independent roles that graft and recipient characteristics play in the success of enhanced recovery. The study also reinforces the importance of the IDS working cooperatively to achieve specific goals of the protocol. Using protocols for enhanced recovery could lead the reader to assume that care providers have an active role in enhancing recovery. From a different perspective, ERAS steps can be seen as removing barriers that impede a patient’s inherent pace of functional recovery. Investigators came to this conclusion from their findings on early extubation studies in liver
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Practical application of ERAS protocols in liver transplant care transplant recipients (43). The observations demonstrate that medical care such as postoperative ventilation weaning can unnecessarily slow down recovery and cause iatrogenic complications. Strict adherence to a protocol prevents the patient from recovering faster than that protocol dictates. Initial studies of early extubation excluded patients with demographic and surgical characteristics thought to be associated with a higher risk of respiratory failure (43). Therefore the first early extubation study patients had a lower severity of illness, uncomplicated surgery and received less than five units of blood. However, a subsequent “Universal Intent to Treat” study design showed the majority of higher risk patients could be extubated safely and that few patient characteristics predicted successful early extubation (48). Therefore many patients excluded from early extubation in previous studies had their recovery unnecessarily delayed by physician directed choices. A reduction in the number of complications, length of hospital stay and cost of care experienced by patients who were extubated early may be interrelated. Eliminating medical interventions can reduce iatrogenic complications. A cohort of liver transplant recipients extubated early had less ventilator associated pneumonia, and required less sedation and immobilization (48). In turn, the resulting earlier mobilization may explain the reduced incidence of infection, thromboembolism and acute delirium states. It is reasonable to theorize that fewer complications contributed to some of the reduced length of stay and cost of care. The findings challenge empiric and outdated beliefs that it is “safer” to keep liver transplant recipients ventilated. The adherence to outdated practices such as routine postoperative ventilation can actually cause harm and unnecessarily increases the cost of care. The continuing increase in the severity of illness of patients presenting for liver transplant surgery raises questions if the IDS should focus on ERAS-type practices. The last national US surveys of anesthesia liver transplant practices in 2011 reported that a number of programs 11
Practical application of ERAS protocols in liver transplant care practiced early extubation in very ill patients (54). Newer survey information is needed to understand how programs have continued to adapt this practice in an increasingly sick population of patients. The evidence suggests however, that enhanced recovery is of benefit regardless of the severity of illness and ultimately serves the important purpose of returning transplant recipients to health at a more rapid pace. The importance of this care is easily missed because of the lack of benchmarks that measure the patients’ perception of the quality of life. The argument that supports enhanced recovery in liver transplant is evident. How do we then explain the large variation in perioperative liver transplant recipient care reported in the literature? Why do some centers extubate the majority of their recipients and send a significant proportion to the ward while others routinely ventilate recipients and send all to the intensive care. Centers worldwide report similar disparities and find earlier and structured introduction of enhanced recovery protocols prevents physicians in becoming “stuck” in outdated care patterns. This issue was thoroughly explored in a recent publication about early extubation asking “what is holding us back” (55, 56). Difficulty negotiating learning curves, established cultures of practice and the tendency of physicians to reject evidence were explored as contributing causes (56, 57). These issues are not simply solved by development of a protocol (58, 59). It is likely that the large variability in practice patterns between some centers is due to inherent deficits in the IDS or continuous quality improvement processes rather than a lack of resources. Only two studies to date used a continuous quality improvement paradigm to track and report early extubation in liver transplant patients (48, 59). Both investigators found that more anesthesiologists extubated transplant recipients following surgery over time. Some of this effect was attributed to negotiating a “learning curve” where anesthesiologists had to apply new skills in their practices. However, the positive outcomes of these two studies were also supported by using a continuous quality improvement program and the introduction of specific
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Practical application of ERAS protocols in liver transplant care goals of care. The latter two conditions for clinical care may have played as large a role in the successful outcomes as mastering the “learning curve”. Leadership style, differences in goals of care and use of continuous quality improvement are likely important reasons why some centers adopt advanced and innovative practices while others remain stagnant. Governing and social pressures to meet specific national benchmarks for mortality and graft survival can also dampen the enthusiasm to try something new even when IDS processes are robust. Concerns that new practices may have set backs that lead to greater patient and graft loss can also contribute to stagnation. This is an important consideration as the number of transplant candidates continues to increase far beyond the number of available organs. This is a concerning issue in countries such as the US where survival benchmarks are used to judge center performance. Failures in the IDS transplant model are still pervasive in some practices and need urgent attention. This is illustrated by the secondary role of anesthesiologists in some interprofessional transplant team. These important innovators of new technology and evidence-based practices have an essential role in high quality care of the liver transplant patient. Yet, in some countries anesthesiologists are rarely integrated into the interprofessional care team. In the US, anesthesiologists are identified as “collaborators or resources” by oversight agencies rather than members of the standard team (60). Failure to participate in routine planning by the IDS such as patient selection and quality meetings detracts from quality care and stifles the development of enhanced recovery (61). Governing agencies can also inadvertently cause IDS dysfunction by setting difficult or even conflicting goals of care. Because organs are allocated to patient with the highest waitlist mortality risk, the team may fail to optimize parameters within the Model for End Stage Liver Disease (MELD) in order to accrue more points for the patients (62). This may increase the cost of care and risk of a complication and cause transplant centers to struggle to meet national 13
Practical application of ERAS protocols in liver transplant care benchmarks for survival and graft function. These examples illustrate the complexity in decision making and the delivery of care by IDS teams for liver transplant and why it requires more than evidence to implement ERAS-type protocols for liver transplant patients. In summary, ERAS protocols are currently detail rich but require more strategic planning to be used in complex practices such as liver transplanation. The core elements necessary for effective use of bundled or single evidence based practices are processes that guide how well integrated care is delivered. There is a wealth of evidence that leadership, goals of treatment and continuous pursuit of quality influence the outcome of all care interventions. Liver transplant teams are usually organized using the IDS model and this may explain the early introduction of ERAS-type protocols. There is still considerable work needed to improve the function of liver transplant IDS teams to support continued innovation and high quality care.
Practice Points: •
Enhanced recovery after surgery (ERAS) can improve patient outcomes and reduce the cost of care.
•
ERAS uses protocols composed of a series of practice steps that have been individually tested for efficacy but the relative clinical effectiveness of each individual step is unknown as part of the protocol
•
The organization of care providers into an integrated delivery system is just as important as the clinical details of each protocol
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Practical application of ERAS protocols in liver transplant care •
Successful use of ERAS protocols requires clear goals for care and effective leadership that can encourage all team members to take responsibility for the care and outcome of patients.
•
The interprofessional liver transplant team is well organized to develop and use the enhanced recovery steps.
•
Protocols in liver transplantation for early extubation are very similar to ERAS and incorporate steps to control fluid overload and sedation.
Research Agenda •
Clinical studies are still needed to determine how individual steps in an ERAS protocol interact to affect patient outcomes and assure that individual beneficial steps retain their effectiveness when combined into the complete care plan. This will require carefully controlled studies to isolate the effects that patient and disease characteristics have on how well a protocol works
•
Additional work is needed to identify all individual and interactive factors that support effective care delivery in interdisciplinary teams.
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Practical application of ERAS protocols in liver transplant care 51. Aniskevich, S, Pai, SL. Fast track anesthesia for liver transplantation: review of the current practice. World J Hepatol. 2015; 18: 2303-8. 52. Rossaint, R, Slama, K, Jaeger, M. Fluid restriction and early extubation for successful liver transplantation. Transplant Proc. 1990;22:1533-4 53. Rana A, Petrowsky H, Hong JC, Agopian VG, Kaldas FM, Farmer D, et al. Blood Transfusion Requirement During Liver Transplantation Is an Important Risk Factor for Mortality. J Am Coll Surg. 2013; 216: 902-7 54. Walia A, Mandell MS, Mercaldo N, Michaels D, Robertson A, Banerjee A, et al. Anesthesia for liver transplantation in US academic centers: institutional structure and perioperative care. Liver Transpl. 2012; 18: 737-43. 55. Chae, MS., Kim, J., Jung, J. Choi HJ, Chung HS, Park CS, et al. Analysis of pre- and intraoperative clinical factors for successful operating room extubation after living donor liver transplantation: a retrospective observational cohort study. BMC Anesthesiol 19, 112 (2019). https://doi.org/10.1186/s12871-019-0781-z 56. Biancofiore G, Tomescu DR, Mandell MS. Rapid recovery of liver transplantation recipients by implementation of fast-track care steps: what is holding us back? Semin Cardiothorac Vasc Anesth. 2018; 22: 191-6 57. Leone, M, Ragonnet, B, Alonso, S; AzuRéa Group. Variable compliance with clinical practice guidelines identified in a 1-day audit at 66 French adult intensive care units. Crit Care Med. 2012;40:3189-95 58. Waldman, JD, Yourstone, SA, Smith, HL. Learning curves in health care. Health Care Manage Rev. 2003;28:41-54 59. Biancofiore G, Romanelli AM, Bindi ML, Consani G, Boldrini A, Battistini M, et al. Very Early Tracheal Extubation Without Predetermined Criteria in a Liver Transplant Recipient Population. Liver Transpl 2001; 7: 777-82
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Practical application of ERAS protocols in liver transplant care 60. The CMS Conditions of Participation (CoP)s for organ transplant programs: crosswalk of transplant center final rule, part 121, & OPTN policies and bylaws 15205. https://www.cms.gov/Regulations-andGuidance/Legislation/CFCsAndCoPs/Downloads/trancenterreg2007.pdf Last accessed December 5, 2019 61. Hendrickse A, Crouch C, Sakai T, Stoll WD, McNulty M, Pivalizza E, et al. Service requirements of liver transplant anesthesia teams: Society for the Advancement of Transplant Anesthesia (SATA) recommendations. Liver Transpl 2019 [Online ahead of print]; 62. Making liver distribution more fair and equitable. New national liver transplant system makes allocation more equitable and saves more lives. https://unos.org/policy/liverdistribution/ Last accessed December 5, 2019; PMID: 31883291 DOI: 10.1002/lt.25711
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PII:
S1521-6896(20)30006-9
DOI:
https://doi.org/10.1016/j.bpa.2020.02.001
Reference:
YBEAN 1063
To appear in:
Best Practice & Research Clinical Anaesthesiology
Received Date: 7 January 2020 Revised Date:
7 February 2020
Accepted Date: 11 February 2020
Please cite this article as: Susan Mandell M, Huang J, Zhao J, Enhanced recovery after surgery and practical application to liver transplanation, Best Practice & Research Clinical Anaesthesiology, https:// doi.org/10.1016/j.bpa.2020.02.001. This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. © 2020 Published by Elsevier Ltd.
Practical application of ERAS protocols in liver transplant care
ENHANCED RECOVERY AFTER SURGERY AND PRACTICAL APPLICATION TO LIVER TRANSPLANATION M. Susan Mandell1, Jiapeng Huang2, Jing Zhao3 Author Information: 1
Department of Anesthesiology, University of Colorado, CO, USA
2
Department of Anesthesiology, University of Louisville, Louisville, KY, USA
3
Department of Anesthesiology, Peking University, Beijing, People’s Republic of China
Corresponding Author. Jing ZHAO, MD Email: [email protected] Professor and Director Department of Anesthesiology and Operating Theater China-Japan Friendship Hospital, No. 2, Ying Hua Yuan Dong Jie Street, Beijing, 100029, China Funding: Support was provided solely from institutional and/or departmental sources. No Conflicts of Interest
Keywords: Enhanced Recovery after Surgery Practice Guidelines Peri operative Care Liver Transplant
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Practical application of ERAS protocols in liver transplant care
Abstract: There is a growing support for the use of protocols that incorporate multiple steps aimed to reduce the time patients require to regain health. A recurring limitation is the variable outcomes of these protocols with more or less success at the sites they are instituted. This review examines the essential building blocks needed to launch a successful ERAS protocol. It address why there are differences in outcome measures between centers such as length of stay and the cost of care even if the protocols and patient populations are similar. To understand what factors can affect the success of an enhanced recovery program, we explore ERAS as a process rather than a summary of detailed care steps. The influence of integrated care delivery, leadership style and choice of goals of care are explained in the context of ERAS as a process of how medical care is delivered. ERAS is presented as a solution to fragmented health care delivery which increases the cost of care and often delays recovery. The importance of Integrated Delivery System and its relationship to high quality healthcare delivery and better outcomes is explored. The role of ERAS in liver transplant is examined and how the clinical goal of early extubation resulted in a progression of evidencebased care steps to that are consistent with ERAS protocols.
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Practical application of ERAS protocols in liver transplant care There has been a rush of activity to use clinical care protocols designed to shorten recovery time in patients undergoing surgery. These programs are collectively called “enhanced recovery after surgery or ERAS” and their unifying goal is to accelerate a patient’s return to preoperative function (1). The approach uses multistep protocols to reduce surgical stress, and complications while improving postoperative outcomes by applying practices thought to optimize care in all phases of surgery (2). Goals of ERAS programs are diverse and include outcomes such as cost of care, length of stay and preventing postoperative complications (3). Some protocols focus on only specific goals such as nutritional or pain recovery (4, 5). Reductions in the cost of care make ERAS protocols attractive even though these practices lack a thorough understanding of how the individual components contribute to the whole outcome (6, 7). Even with these limitations, the benefits and safety of ERAS type protocols are relatively well established for a number of surgical procedures (3). Evaluating the, benefit and safety of an ERAS protocol may be more difficult as the complexity of the surgical procedure increases (8). This is particularly true for procedures such as liver transplantation where patient outcomes are a complex blend of donor and recipient care in addition to the clinical management of graft function and recipient severity of illness.
This review looks at ERAS as care delivered by integrated care models. We explore the complex health care systems that ERAS protocols have to fit into and how ERAS care is affected. Essential concepts needed for ERAS protocols are examined to appreciate what is required to develop a successful program.
The existing literature in liver transplant care is
reviewed to see how investigators have adapted ERAS type care plans to fit to these complex patients.
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Practical application of ERAS protocols in liver transplant care ERAS as a holistic approach to care: Enhanced recovery protocols bundle multiple steps to optimize every phase of patient care prior to discharge from hospital or outpatient surgical centers (1). They have been widely used in patients undergoing colorectal, bariatric, gynecological and neurosurgical surgeries (3). Enhanced recovery protocols have also been used in more complex procedures including cardiac surgery and liver transplantation (9, 10). Experts involved in patient care work as a team to optimize patients for surgery, decrease perioperative stress, maintain postoperative organ function, and accelerate recovery time after surgery (11). An ERAS protocols is usually delivered by an Integrated Delivery Systems (IDS) which links healthcare providers to deliver a coordinated, flow of services to a target patient population (12). All IDS care is integrated and distinct from systems where care is decentralized and the goals of treatment vary depending on aims of individual healthcare providers or the units they work in (13). Decentralized care suffers from a lack communication and coordination between providers and facilities resulting in fragmented health care that can adversely affect quality and cost (14, 15). Fragmented healthcare increases costs of care, and the risk of not receiving evidencebased or best practices, and leads to more preventable hospitalizations (15, 16). Quality was lower and costs were higher in fragmented compared to an IDS tare in patients with the same chronic conditions (17). Developing a Successful ERAS protocol: Defining Goals of Care: Similar to all types of IDS, the ERAS protocols should be supported by a structure that clarifies the goals of therapy, lines of communication and methods of problem solving (18). The working definition of integrated care by the World Health Organization sets an overall or inclusive goal for care that can be adapted to diverse practice settings. It is “the organization and management of health services so that people get the care they need, when
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Practical application of ERAS protocols in liver transplant care they need it, in ways that are user-friendly, achieve the desired results and provide value for money” (19). This guides collaboration and consequently directs downstream tasks to help team members develop specific goals and metrics that support high quality cost effective care (20, 21). The goals tend to be specific for the disease process as for orthopedic surgery compared to cancer care. The quality or effectiveness of care can be determined by measuring compliance with specific goals of the protocols in addition to adhering to the more inclusive goals used for all healthcare (22). Benchmarking is a common way of determining if the specific goals of treatment were reached (23-25). Data for benchmarking may be available from oversight agencies for aspects of care such as readmission rates (23, 24). Other methods of benchmarking include using comparative data from a group of centers or individual physician performance. The expectation is that centers should not exceed the average rate of adverse events. Quality is improved when changes are made that reduce the national, center or individual adverse events average (26). Quality Improvement as part of the ERAS protocol: Planning for continual effective change is part of the goals for each protocol and required to support quality improvement (27). This may help reduce the reluctance of care providers to adopt new evidence-based practices. Routine surveillance as opposed to isolated reviews can quickly identify areas of care where the team could do better. This has been termed continuous quality improvement. The approach works on the principle that there is always opportunity for improvement in every process (28). Standards and benchmarks are therefore dynamic and adherence to a single set of outcome goals reflects stagnation in the system. The use of continual quality improvement should cause teams to routinely redefine their goals of treatment regardless of whether they meet established
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Practical application of ERAS protocols in liver transplant care standards/benchmarks of health care. The question is “can we do better” rather than “are we doing well enough”. An important goal for the IDS is to return the patient to health and not just treat disease (18, 19). Metrics to assess quality of life have lagged behind other measures that are more easily collected and interpreted (29). Preoccupation with cost and mortality metrics to the exclusion of overall health and quality of life does not meet the inclusive goals of how well an IDS using an ERAS protocol is working. This is particularly highlighted in liver transplantation outcomes which only benchmarks patient and donor organ survival. Leadership in ERAS models of care:
The relative success of ERAS protocols depends on how
well leader(s) motivate the team to take a personal stake in the process and outcomes (30). There is a strong relationship between leadership style, patient satisfaction and the rate of adverse events regardless of the site of care (31, 32, 33). Leaders who can shift their own interests to those of the team have better health care outcomes (34). A recent systematic review showed IDS teams reduced mortality rates and had a better culture of patient safety when they had transformational leaders [30, 35]. Establishing transformational leadership in an IDS or ERAS team can be challenging since surgeons often play a leading role in ERAS protocols. However, a number of studies concluded that transactional leadership characteristics were more consistently observed in surgeons (36). This type of leadership is often supported by healthcare organizations where surgeons are viewed as primary drivers of revenues (37). This creates a conflict of interest between pursuing earnings and quality care (38). Selecting an ERAS protocol: Protocols are available from national ERAS societies or peer reviewed publications (39). These are useful care plans usually constructed from carefully reviewed evidence. However, it is not clear if these protocols work equally well if they are
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Practical application of ERAS protocols in liver transplant care introduced into an organization where they were not developed?
The material reviewed in this
paper on essential IDS/ERAS elements suggests that importing practices without using similar goals of care, supporting processes and continuous quality improvement could lead to less than expected outcomes. This does not imply that imported ERAS protocols are without value. They are excellent sources of data-driven care that can be effective under the right conditions. However, ERAS protocols can have unintended negative consequences (6). Some ERAS protocols could actually cause stagnation of care by adhering to benchmarks or standards that fail to evolve. They may also further fragment care if the IDS team hasn’t developed a collaborative culture with processes to create a smooth flow of care (40, 41). The evidence indicates the success and consequences of using ERAS protocols goes far beyond the details of care. The protocols redirect care providers to adopt a patient-centric approach that supports setting goals and use of specific metrics to measure the quality of care. This may explain why patients who receive care from IDS teams report greater satisfaction and have reduced costs of care even when they are part of different ERAS protocols (32, 42). This reinforces the message that an efficient IDS model of care is as important as the details of all ERAS protocols.
ERAS in liver transplantation: Important physician and institutional tasks for ERAS protocols and IDS function have been outlined in the preceding section. We review whether these fundamental principles have been systematically applied to enhanced recovery protocols used in liver transplant patients and examine which areas of practice that could be improved. To date there are few studies about the development, implementation and practical application of ERAS protocols in the field of liver 7
Practical application of ERAS protocols in liver transplant care transplantation. However, elements of ERAS-type care after transplantation date back to 1997 in the first published reports of immediate postoperative extubation from two centers (43, 44). Following the first reports of early extubation, there was a rapid increase in the number of centers that successfully reduced or eliminated postoperative ventilation. Investigators reported immediate or early postoperative extubation in pediatric patients and adults with greater severity of illness at centers throughout the globe (45-47). These early and notable achievements were likely facilitated by an integrated transplant team structure and function. Liver transplant specialists have always used an IDS-type of practice model to deliver comprehensive care. The rapid incorporation of early extubation protocols suggests that many transplant teams already had sufficient structure to develop and implement novel practices that enhanced recovery. However, few centers incorporated early extubation as a specific goal of their care (45-47). This has given rise to irregular extubation practices between and sometimes within an institution. Most investigators reported benefits of early extubation using well defined benchmarks of care. Liver transplant patients who were extubated early had a shorter length of intensive care stay and some centers showed earlier discharge from hospital (48). Early extubation was associated with a reduction in the number of postoperative complications and a significant decrease in the cost of care (49). Most notable were the fewer cases of pulmonary infection, and sedationdelirium associated with postoperative ventilation (45-48). Recovery of patients following early extubation was so rapid that some programs subsequently developed care protocols that allowed selected recipients to bypass the intensive care unit completely and be admitted to the surgical ward from the recovery room (49, 50, 51). The latter protocols were not associated with an increased rate of complications. Further, there were significant cost savings that accompanied a reduced use of high acuity care resources.
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Practical application of ERAS protocols in liver transplant care Anesthesiologists developed steps in the routine care of transplant recipients in order to achieve early extubation. This approach was the initial attempt to develop multiple linked steps in liver transplant care similar to an ERAS protocol that aimed at enhanced recovery. Changes in care that advanced early extubation/ fast track protocols included a reduction in the use of intraoperative sedative drugs and anesthetic agents (48-51). While this seemed like a simple step, it was a unique advance that challenged existing evidence about how much medication was needed to achieve optimal conditions for both surgery and early recovery. These advances were rapidly followed by more objective measures of fluid administration using monitors that directly and indirectly measured intra-cardiac or intravascular volume. New findings were introduced showing that intravascular volume restriction increased the number of patients who could be extubated early and was not associated with adverse outcomes (52). More centers instituted point of care coagulation tests to reduce unnecessary transfusion and prevent transfusion-related complications that could increase respiratory failure and other complications that would delay patient recovery (53). These changes in care marked the beginning of ERAS in liver transplantation as care evolved from managing individual events and conditions to care that prepared patients for a smooth transition to the next step of the recovery process. Consequently, early extubation had the potential to become both a benchmark and a driver of early recovery (48-50). The initial enthusiasm for these early ERAS-like protocols was not sustained and the development of enhanced recovery care for liver transplant patients has not significantly progressed. A potential barrier to further ERAS protocol development was the view that early extubation is a single intervention performed by the anesthesiologist rather than part of the multistep care of built by the entire IDS team (51). This is shown by the lack of clearly articulated goals to eliminate postoperative ventilation and failure to build other transplant IDS practices to support immediate extubation. Another important limitation was the lack of 9
Practical application of ERAS protocols in liver transplant care continuous quality improvement processes built into early extubation protocols to track and improve performance. After a promising start there were few new findings or development of multistep protocols that enhanced recovery. The reasons for this plateau in innovative anesthesia liver transplant care are unclear and to date only one study trialed a full ERAS protocol in liver transplant patients. A recent study from France described a protocol for adult recipients with a MELD score of less than 25 who had uncomplicated surgery and received less than 6 units of blood intraoperatively (10). Of the 26 protocol steps, the relative value of all but carbohydrate loading in increasing recovery was established and validated in the liver transplant literature. The investigators found a protocol using multiple evidence-based practices significantly reduced length of stay, postoperative complications and cost of care. While the findings again raise awareness of the benefits of ERAS type care, the investigators could not determine if this protocol was effective because of the bundled steps, underlying IDS structure or simply the fact that these patients were not as ill as many who are transplanted worldwide. Even with these limitations an important contribution of this study was showcasing a logical method to separate the confounding effects of severity of illness and graft function from the protocol design. Unlike other types of surgery, measuring outcomes is complicated by the strongly influential interactive and independent roles that graft and recipient characteristics play in the success of enhanced recovery. The study also reinforces the importance of the IDS working cooperatively to achieve specific goals of the protocol. Using protocols for enhanced recovery could lead the reader to assume that care providers have an active role in enhancing recovery. From a different perspective, ERAS steps can be seen as removing barriers that impede a patient’s inherent pace of functional recovery. Investigators came to this conclusion from their findings on early extubation studies in liver
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Practical application of ERAS protocols in liver transplant care transplant recipients (43). The observations demonstrate that medical care such as postoperative ventilation weaning can unnecessarily slow down recovery and cause iatrogenic complications. Strict adherence to a protocol prevents the patient from recovering faster than that protocol dictates. Initial studies of early extubation excluded patients with demographic and surgical characteristics thought to be associated with a higher risk of respiratory failure (43). Therefore the first early extubation study patients had a lower severity of illness, uncomplicated surgery and received less than five units of blood. However, a subsequent “Universal Intent to Treat” study design showed the majority of higher risk patients could be extubated safely and that few patient characteristics predicted successful early extubation (48). Therefore many patients excluded from early extubation in previous studies had their recovery unnecessarily delayed by physician directed choices. A reduction in the number of complications, length of hospital stay and cost of care experienced by patients who were extubated early may be interrelated. Eliminating medical interventions can reduce iatrogenic complications. A cohort of liver transplant recipients extubated early had less ventilator associated pneumonia, and required less sedation and immobilization (48). In turn, the resulting earlier mobilization may explain the reduced incidence of infection, thromboembolism and acute delirium states. It is reasonable to theorize that fewer complications contributed to some of the reduced length of stay and cost of care. The findings challenge empiric and outdated beliefs that it is “safer” to keep liver transplant recipients ventilated. The adherence to outdated practices such as routine postoperative ventilation can actually cause harm and unnecessarily increases the cost of care. The continuing increase in the severity of illness of patients presenting for liver transplant surgery raises questions if the IDS should focus on ERAS-type practices. The last national US surveys of anesthesia liver transplant practices in 2011 reported that a number of programs 11
Practical application of ERAS protocols in liver transplant care practiced early extubation in very ill patients (54). Newer survey information is needed to understand how programs have continued to adapt this practice in an increasingly sick population of patients. The evidence suggests however, that enhanced recovery is of benefit regardless of the severity of illness and ultimately serves the important purpose of returning transplant recipients to health at a more rapid pace. The importance of this care is easily missed because of the lack of benchmarks that measure the patients’ perception of the quality of life. The argument that supports enhanced recovery in liver transplant is evident. How do we then explain the large variation in perioperative liver transplant recipient care reported in the literature? Why do some centers extubate the majority of their recipients and send a significant proportion to the ward while others routinely ventilate recipients and send all to the intensive care. Centers worldwide report similar disparities and find earlier and structured introduction of enhanced recovery protocols prevents physicians in becoming “stuck” in outdated care patterns. This issue was thoroughly explored in a recent publication about early extubation asking “what is holding us back” (55, 56). Difficulty negotiating learning curves, established cultures of practice and the tendency of physicians to reject evidence were explored as contributing causes (56, 57). These issues are not simply solved by development of a protocol (58, 59). It is likely that the large variability in practice patterns between some centers is due to inherent deficits in the IDS or continuous quality improvement processes rather than a lack of resources. Only two studies to date used a continuous quality improvement paradigm to track and report early extubation in liver transplant patients (48, 59). Both investigators found that more anesthesiologists extubated transplant recipients following surgery over time. Some of this effect was attributed to negotiating a “learning curve” where anesthesiologists had to apply new skills in their practices. However, the positive outcomes of these two studies were also supported by using a continuous quality improvement program and the introduction of specific
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Practical application of ERAS protocols in liver transplant care goals of care. The latter two conditions for clinical care may have played as large a role in the successful outcomes as mastering the “learning curve”. Leadership style, differences in goals of care and use of continuous quality improvement are likely important reasons why some centers adopt advanced and innovative practices while others remain stagnant. Governing and social pressures to meet specific national benchmarks for mortality and graft survival can also dampen the enthusiasm to try something new even when IDS processes are robust. Concerns that new practices may have set backs that lead to greater patient and graft loss can also contribute to stagnation. This is an important consideration as the number of transplant candidates continues to increase far beyond the number of available organs. This is a concerning issue in countries such as the US where survival benchmarks are used to judge center performance. Failures in the IDS transplant model are still pervasive in some practices and need urgent attention. This is illustrated by the secondary role of anesthesiologists in some interprofessional transplant team. These important innovators of new technology and evidence-based practices have an essential role in high quality care of the liver transplant patient. Yet, in some countries anesthesiologists are rarely integrated into the interprofessional care team. In the US, anesthesiologists are identified as “collaborators or resources” by oversight agencies rather than members of the standard team (60). Failure to participate in routine planning by the IDS such as patient selection and quality meetings detracts from quality care and stifles the development of enhanced recovery (61). Governing agencies can also inadvertently cause IDS dysfunction by setting difficult or even conflicting goals of care. Because organs are allocated to patient with the highest waitlist mortality risk, the team may fail to optimize parameters within the Model for End Stage Liver Disease (MELD) in order to accrue more points for the patients (62). This may increase the cost of care and risk of a complication and cause transplant centers to struggle to meet national 13
Practical application of ERAS protocols in liver transplant care benchmarks for survival and graft function. These examples illustrate the complexity in decision making and the delivery of care by IDS teams for liver transplant and why it requires more than evidence to implement ERAS-type protocols for liver transplant patients. In summary, ERAS protocols are currently detail rich but require more strategic planning to be used in complex practices such as liver transplanation. The core elements necessary for effective use of bundled or single evidence based practices are processes that guide how well integrated care is delivered. There is a wealth of evidence that leadership, goals of treatment and continuous pursuit of quality influence the outcome of all care interventions. Liver transplant teams are usually organized using the IDS model and this may explain the early introduction of ERAS-type protocols. There is still considerable work needed to improve the function of liver transplant IDS teams to support continued innovation and high quality care.
Practice Points: •
Enhanced recovery after surgery (ERAS) can improve patient outcomes and reduce the cost of care.
•
ERAS uses protocols composed of a series of practice steps that have been individually tested for efficacy but the relative clinical effectiveness of each individual step is unknown as part of the protocol
•
The organization of care providers into an integrated delivery system is just as important as the clinical details of each protocol
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Practical application of ERAS protocols in liver transplant care •
Successful use of ERAS protocols requires clear goals for care and effective leadership that can encourage all team members to take responsibility for the care and outcome of patients.
•
The interprofessional liver transplant team is well organized to develop and use the enhanced recovery steps.
•
Protocols in liver transplantation for early extubation are very similar to ERAS and incorporate steps to control fluid overload and sedation.
Research Agenda •
Clinical studies are still needed to determine how individual steps in an ERAS protocol interact to affect patient outcomes and assure that individual beneficial steps retain their effectiveness when combined into the complete care plan. This will require carefully controlled studies to isolate the effects that patient and disease characteristics have on how well a protocol works
•
Additional work is needed to identify all individual and interactive factors that support effective care delivery in interdisciplinary teams.
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