ASERalert November 2016 | Volume 1, Issue 1 ERAS for Hip and Knee (THA and TKA) Arthroplasty – A Need to Look Beyond LOS OFFICIAL PUBLICATION OF ERAS for Total Joint Arthroplasty: Past, Present and Future Enhanced Recovery for Orthopedic Surgery ERAS for Spine Surgery: A New Frontier also in this issue
ANNUAL CONGRESS OF ENHANCED RECOVERY AND PERIOPERATIVE MEDICINE APRIL 27TH -29TH , 2017 HYATT REGENCY WASHINGTON ON CAPITOL HILL 400 NEW JERSEY AVE NW, WASHINGTON, D.C. 20001 For more information please visit www.aserhq.org 2 ASER ALERT • VOLUME 1, ISSUE 1 • aserhq.org 2017
President’s Message By Tong J (TJ) Gan, MD, MHS, FRCA, President Board of Directors I t is my great pleasure to announce the inaugural issue of the ASER Newsletter. Founded in 2014, ASER is a multi-specialty nonprofit organization with an international membership and is dedicated to the practice of enhanced recovery in the perioperative patient through education and research. We are experiencing a period of tremendous expansion and growth, as is evidenced by the great interest to implement the enhanced recovery pathway in hospitals around the country. The ASER Mission is to advance the practice of perioperative enhanced recovery and to contribute to its growth and influences, by fostering and encouraging research, education, public policies, programs and scientific progress. We have achieved much over the past 2 years, including: • Annual ASER/EBPOM Congress • ASER website • ASER manual of Enhanced Recovery for Major Abdominopelvic Surgery • Enhanced Recovery Implementation Guide • Regional Leadership forums • Perioperative Medicine as the official society journal This newsletter aims to share information, best practices, sample protocols and members’ experiences in implementing enhanced recovery pathways. It serves as a forum for communication of the many activities of the society. I would like to thank Dr. Thomas Hopkins, Lyla Hance and their committee for editing the newsletter and those who generously donated their time to contribute to this edition. We want this newsletter to be valuable for you, so please share your feedback and suggestions to help us improve. Please forward it to friends and colleagues who you think will benefit from this newsletter. n Enjoy reading. Tong J (TJ) Gan, MD, MHS, FRCA President American Society for Enhanced Recovery Professor and Chairman Department of Anesthesiology Stony Brook University tong.gan@stonybrookmedicine.edu Officers President Tong J (TJ) Gan, MD, MHS, FRCA President-Elect Julie Thacker, MD Vice-President Timothy Miller MB, ChB, FRCA Treasurer Roy Soto, MD Secretary Stefan D. Holubar MD, MS, FACS, FASCRS Directors Keith A. (Tony) Jones, MD Anthony Senagore, MD Maxime Cannesson, MD, PhD Terrence Loftus, MD, MBA, FACS Andrew Shaw MB, FRCA, FFICM, FCCM Desiree Chappel, CRNA Newsletter Committee Thomas Hopkins, MD: Chair Lyla Hance, MPH: Co-Chair Jeffrey Huang, MD Uday Jain, MD, PhD Amy McCutchan, MD Asha Naik, FRCA Christina Solis, MHA Matthias Stopfkuchen-Evans, MD About ASER ASER is a nonprofit organization with an international membership, which is dedicated to thepractice of enhanced recovery in the perioperative patient through education and research. ASER’s mission is to advance the practice of perioperative enhanced recovery, to contribute to its growth and influences, by fostering and encouraging research, education, public policies, programs and scientific progress. Administrative Office American Society for Enhanced Recovery 6737 W Washington St. | Ste. 4210 Milwaukee, WI 53214 414-389-8610 | info@aserhq.org ASER ALERT • VOLUME 1, ISSUE 1 • aserhq.org 3
ERAS for Hip & Knee (THA & TKA) Arthroplasty – A Need To Look Beyond LOS By Henrik Kehlet, Prof. MD, PhD E RAS programs in total joint arthroplasty have been introduced worldwide in many centers with documented success and reduced length of stay (LOS) and morbidity. However, despite the achieved success, several challenges lie ahead. First of all “what is the optimal LOS?”, since there is a lack of documentation on the economic and safety aspects of same-day discharge vs next day in a general THA and TKA population vs the proportion of selected suitable patients. Although overall morbidity is reduced by ERAS, further studies on the relative importance of conventional risk factors needs to be clarified, since recent data question the relevance from standard risk assessment within traditional care. Still, a major problem is the need to improve pain management after discharge in relation to patient activity and optimal rehabilitation. In this context, further 4 The optimal technique of rehabilitation needs evaluation... studies are required to preoperatively predict high-pain responders in subpopulations such as pain catastrophizers, preoperative opioid users and other pain “sensitized” patients. Also, more data are required on the otherwise documented risk of postoperative delirium especially with opioid-based pain management, but where a fully implemented opioidsparing ERAS program may almost eliminate this problem. Although it is well-established that preoperative anemia should be diagnosed and treated, more focus on postdischarge anemia should be made, since it may impair rehabilitation and increase risk of organ dysfunction, but so far with sparse available data. Further data are required on thromboembolic complications and need for prophylaxis, since early mobilization with ERAS may reduce the risk. Importantly, readmissions and discharge destination must be clarified due to a huge discrepancy between individual institutions and countries and where readmission to “own institution” is insufficient because some patients may be readmitted to other institutions. Also, discharge destination, which has major economic implications, needs further evaluation, since discharge to a “nursing care facility” or “rehabilitation” institution is variable, and in some ASER ALERT • VOLUME 1, ISSUE 1 • aserhq.org feature
countries standard practice is discharge to home instead. The optimal technique of rehabilitation needs evaluation, since present data even with immediate strength training have been disappointing and where all data have documented a reduction of muscle function for several weeks postoperatively. Although patient-reported outcomes are fashionable and important, further studies to compare these with objectively measured function and activity are required, since initial data are disappointing and showing a gap between the positive patient-reported outcomes vs the rather disappointing objective recovery data. Finally, a very large number of publications on ERAS cohorts often has an insufficient interpretation compared with global literature, and a lack of balanced discussion on international experiences and consequences in different health care systems. In summary, despite an obvious success of ERAS in THA and THA to reduce LOS and morbidity, several challenges lie ahead to improve postdischarge recovery. n References Aasvang EK, Luna IE, Kehlet H. Challenges in postdischarge function and recovery: the case of fasttrack hip and knee arthroplasty. Br J Anaesth 2015; 115:861-866.Cyriac J, Garson L, Schwarzkopf R, Ahn K, Rinehart J, Vakharia S, Cannesson M, Kain Z. Total joint replacement perioperative surgical home program: 2-year follow-up. Anesth Analg 2016; 123:51-62. Artz N, Elvers KT, Lowe CM, Sackley C, Jepson P, Beswick AD. Effectiveness of physiotherapy exercise following total knee replacement: systematic review and meta-analysis. BMC Musculoskelet Disord 2015; 16:15. Cyriac J, Garson L, Schwarzkopf R, Ahn K, Rinehart J, Vakharia S, Cannesson M, Kain Z. Total joint replacement perioperative surgical home program: 2-year follow-up. Anesth Analg 2016; 123:5162. Fragiadakis GK, Gaudilliere B, Ganio EA, Aghaeepour N, Tingle M, Nolan GP, Angst MS. Patient-specific immune states before surgery are strong correlates of surgical recovery. Anesthesiology 2015; 123:12411255. Hossain FS, Konan S, Patel S, Rodriguez-Merchan EC, Haddad FS. The assessment of outcome after total knee arthroplasty: are we there yet? Bone Joint J 2015; 97-B:3-9. Jans O, Kehlet H. Postoperative orthostatic intolerance: a common perioperative problem with few available solutions. Can J Anaesth 2016 (Epub). Jorgensen CC, Petersen MA, Kehlet H. Preoperative prediction of potentially preventable morbidity after fast-track hip and knee arthroplasty: a detailed descriptive cohort study. BMJ Open 2016; 6:e009813. Kehlet H, Jorgensen CC. Rapid Recovery After Hip and Knee Arthroplasty--A Transatlantic Gap? J Arthroplasty 2015; 30:2380. Kehlet H, Jorgensen CC. Advancing surgical outcomes research and quality improvement within an enhanced recovery program framework. Ann Surg 2016; 264:237-238. Kjellberg J, Kehlet H. A nationwide analysis of socioeconomic outcomes after hip and knee replacement. Dan Med J 2016; 63:A5257.Pitter FT, Jorgensen CC, Lindberg-Larsen M, Kehlet H. Postoperative morbidity and discharge destinations after fast-track hip and knee arthroplasty in patients older than 85 years. Anesth Analg 2016; 122:18071815. Pitter FT, Jorgensen CC, Lindberg-Larsen M, Kehlet H. Postoperative morbidity and discharge destinations after fast-track hip and knee arthroplasty in patients older than 85 years. Anesth Analg 2016; 122:18071815. Thienpont E, Lavand’homme P, Kehlet H. The constraints on day-case total knee arthroplasty: the fastest fast track. Bone Joint J 2015; 97-B:40-44. FASTER RECOVERY, FEWER COMPLICATIONS, PROMOTING CHANGE Comitted to Improving Patient Care ASER Member Benefits Become an ASER member today! For further information and to apply one line visit aserhq.org/membership ASER ALERT • VOLUME 1, ISSUE 1 • aserhq.org • Implementation Consultation and Guidance • Practice Guidelines and Ongoing Research • Hospital and Patient Educational Materials • Networking • Professional Development and Education • Research Grant Opportunities • Membership Discount to Attend Annual Congress 5
ERAS for Total Joint Arthroplasty: Past, Present and Future By Ellen M. Soffin, MD, PhD; Alana E. Sigmund, MD, FHM & Chad M. Craig, MD, FACP I n the companion article in this edition, we speculate whether Enhanced Recovery After Surgery (ERAS) protocols can be usefully applied to patients undergoing spine surgery. If ERAS for spine represents an emerging concept in orthopedic surgery, ERAS for total joint arthroplasty (TJA) represents the proof of concept. In contrast to spine surgery, elective hip and knee arthroplasty are high-volume, highly standardized surgical procedures typically performed in medically optimized patients. These conditions facilitate the implementation of clinical pathways or fast-track programs which lead directly to reductions in length of stay and improved outcomes. For more than 30 years, there has been compelling evidence to support the use of packages of care to improve recovery after TJA. At Hospital for Special Surgery, Sharrock et al. transformed the care of our TJA patients by incorporating standardized perioperative interventions: universal receipt of epidural anesthesia, invasive goal-directed hemodynamic monitoring, epidural analgesia, pulse oximetry, and post-operative supplemental oxygen, with ICU-level of care for high-risk patients.1 These changes effected a reduction in mortality after total knee arthroplasty from 0.44% to 0.07% over a 10-year period. Importantly, there were no major changes in surgical technique over this interval, suggesting the bundle of interventions led to improved outcomes. More modern fast track protocols reliably demonstrate cost savings and reductions in lengthof-stay – often with discharge to home and without increased complications or readmission.2-6 . The Hospital for Special Surgery clinical pathways for total hip or knee arthroplasty feature pre-operative patient education and discharge planning, pre-emptive analgesia, post-operative nausea and vomiting prophylaxis, regional analgesia techniques, and early mobilization. Patients following these pathways achieve reduced length of stay, superior pain control, and shortened time to functional recovery.7-9 Finally, in a recent study of patients undergoing primary total hip arthroplasty, comparing patients in an enhanced recovery program to patients in the hospital’s standardcare program, the enhanced recovery group showed a decreased length of stay of 1.5 days with no increase in post-operative complications.10 program, patients underwent pre6 operative assessment by a physical therapist, and were educated about the planned day of discharge, wound care and physical therapy, They also received necessary equipment prior to admission, received spinal anesthesia, and also participated in early mobilization. A similar, although smaller, study in total knee arthroplasty showed similar results.11 In this While package of care studies in TJA show benefit for patients, they also have revealed that the two major approaches to standardized care in TJA, ERAS and clinical pathways, have basic differences in form and content. In contrast to ERAS in other surgical subspecialties, the majority of published pathways for TJA comprise intraoperative anesthesia, post-operative analgesia, and early mobilization as the basis of the care trajectory. Standardized ERAS components, including pre-operative education and nutritional optimization, goal directed fluid therapy (GDFT) and audit are often conspicuous by their absence in TJA. A recent review of ERAS for TJA suggests that despite the established success of clinical pathways, there remain major opportunities to apply ERAS principles to patients undergoing elective joint replacement.12 Although ASER ALERT • VOLUME 1, ISSUE 1 • aserhq.org
...high dose steroids reduced the amount of patient-reported pain within the first 1-2 days after both hip and knee arthroplasty. there is a large body of evidence to guide decision making in constructing pathways of care, there are equally large gaps in knowledge which suggest avenues for future work. Many ERAS interventions are resource-intensive, so understanding which patients benefit from which components is of primary importance. The literature suggests that education programs could be most effective for anxious or socially isolated patients,13 although it remains to be seen if standardizing the content and method of delivery would have a positive effect for all patients. Likewise, the optimal analgesic regimen has yet to be determined, despite an abundance of choice: epidural, peripheral nerve block or catheter, local infiltration analgesia, and oral/intravenous multimodal agents all show analgesic efficacy and are opioidsparing after TJA. Ultimately, these decisions might have to be made according to institutional practice and capability. The risk-to-benefit balance of preoperative carbohydrate loading has yet to be established in TJA and the role of goal-directed fluid therapy is unclear – and may turn out to be of lesser importance compared to colorectal surgery. The concept of auditing compliance and outcomes, and using institution-specific data to refine pathway components, is currently lacking in TJA clinical pathway care. Additionally, some have argued for a shift of clinical and research efforts from current construction of TJA ERAS pathways, to more broad peri-operative strategies to improve post-discharge function, rehabilitation potential, and global recovery, areas that may prove equally as important to patient outcomes.14 Recent arthroplasty research has focused on improving global recovery through avoiding common postASER ALERT • VOLUME 1, ISSUE 1 • aserhq.org Mallinckrodt, the “M” brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. © 2015 Mallinckrodt. June 2015 operative complications such as anemia and pain. In two separate studies, consecutive patients were enrolled in a multidisciplinary hemoglobin management program that involved pre-operative anemia work-up and management. Both studies were able to show reduced post-operative transfusion rates when compared with a historical cohort.15,16 In order to minimize post-operative pain and nausea, two randomized, placebo-controlled trials were conducted to assess the role of high-dose steroids administered during hip and knee arthroplasty. Although each study enrolled fewer than 100 patients, high dose steroids reduced the amount of patient-reported pain within the first 1-2 days after both hip and knee arthroplasty.17,18 Because of the safety and efficacy of clinical pathways in TJA, we are increasingly offering surgery to patients who probably would have been denied surgery in the past. It has become routine to perform joint replacement for the elderly, morbidly obese, high ASA Physical Status, and/or chronic opioid dependent patient. Demand for same-day or same-admission bilateral TJA is also increasing. These changing patterns require increasingly creative strategies to understand and implement best practice. It may be the right time to standardize language in order to facilitate research and practice. “Clinical pathway”, “ERAS”, “Perioperative Surgical Home” and “Fast Track” are used interchangeably in SEEING COMPLEXITY IN A NEW LIGHT. For nearly 150 years, Mallinckrodt has made complex scientific problems manageable, developing valuable diagnostic tools and treatments for patients who need them. We view challenges as opportunities. See how at Mallinckrodt.com 7
the literature, and many terms lack a definition. In addition to standard language, we advocate that a principal goal should be a standardized ERAS pathway for TJA based on the best available evidence, and including audit. We submit that this process is most effective when it occurs at the Society level with adoption of consensus guidelines, as has been the case for ERAS in other surgical subspecialties. n References 1. Sharrock NE, Cazan MG, Hargett MJ, Williams-Russo P, Wilson PD Jr: Changes in mortality after total hip and knee arthroplasty over a ten-year period. Anesth Analg 1995; 80(2):242-8. 2. Duncan CM, Hall Long K, Warner DO, Hebl JR: The economic implications of a multimodal analgesic regimen combined with minimally invasive orthopedic surgery: a comparative cost study. Reg Anesth Pain Med 2009; 34(4):301-7. 3. Duncan CM, Moeschler SM, Horlocker TT, Hanssen AD, Hebl JR: A self-paired comparison of perioperative outcomes before and after implementation of a clinical pathway in patients undergoing total knee arthroplasty. Reg Anesth Pain Med 2013; 38(6):533-8. 4. Hebl JR, Kopp SL, Ali MH, Horlocker TT, Dilger JA, Lennon RL, Williams BA, Hanssen AD, Pagnano MW: A comprehensive anesthesia protocol that emphasized peripheral nerve blockade for total knee and total hip arthroplasty. J Bone Joint Surg Am 2005; 87 Suppl 2:63-71. 5. Hebl JR, Dilger JA, Byer DE, Kopp SL, Stevens SR, Pagnano MW, Hanssen AD, Horlocker TT: A pre-emptive multimodal pathway featuring peripheral nerve block improves perioperative outcomes after major orthopedic surgery. Reg Anaesth Pain Med 2008; 33(6):510-517. 6. Sutton JC, Antoniou J, Epure LM, Huk OL, Zukor DJ, Bergeron S: Hospital Discharge within 2 Days Following Total Hip or Knee Arthroplasty Does Not Increase MajorComplication and Readmission Rates. J Bone and Joint Surg Am 2016;98;1419-28. 7. Ayalon O, Liu S, Flics S, Cahill J, Juliano K, Cornell CN: A multimodal clinical pathway can reduce length of stay after total knee arthroplasty. HSS J 2011; 7(1):9-15. Learn more about Pacira & ASER’s Partnership Campaign to Combat the Opiod Epidemic, on page 15 8. Gulotta LV, Padgett DE, Sculco TP, Urban M, Lyman S, Nestor BJ: Fast track THR: One hospital’s experience with a 2-day length of stay protocol for total hip replacement. HSS J 2011; 7(3):223-8. 9. Duggal S, Flics S, Cornell CN: Intra-articular analgesia and discharge to home enhance recovery following total knee replacement. HSS J 2015; 11(1):56-64. 10. Maempel J, Clement N, Ballantyne J, Dunstsan E: Enhanced Recovery Programmes After Total Hip Arthroplasty can Result in Reduced Length of Hospital Stay Without Compromising Functional Outcome Bone Joint J 2016; 98-B:475-482. 11. Maempel J, Walmsley P: Enhanced Recovery Programmes Can Reduce Length of Stay After Total Knee Replacement Without Sacrificing Functional Outcome at One Year. Ann R Coll Surg Engl 2015; 97:563-567. 12. Soffin EM, YaDeau JT: Enhanced recovery after surgery for primary hip and knee arthroplasty: A review of the evidence. BJA 2016; in press. 13. McDonald S, Page MJ, Beringer K, Wasiak J, Sprowson A: Preoperative education for hip or knee replacement. Cochrane Database Syst Rev 2014; 13(5). 14. Aasvang E, Luna I, Kehlet H: Challenges in postdicharge function and recovery: the case of fast-track hip and knee arthroplasty. Br J Anaesth.2015; 115(6): 861-6. 15. Holt J, Miller B, Callaghan J, Clark C, Willenborg M, Noiseux N: Minimizing Blood Transfusion in Total Hip and Knee Arthroplasty Through a Multimodal Approach. J Arthroplasty 2016; 31: 378-382. 16. Kopandis P, Hardidge A, McNicol L, Tay S, McCall P, Weinberg L: Perioperative Blood Management Programme Reduces the Use of Allogenic Blood Transfusion in Patients Undergoing Total Hip and Knee Arthroplasty. J Orthop Surg Res 2016; 11:28. 17. Lunn T, Kirstensen B, Andersen L, Husted H, Otte KS, Gaarn-Larsen L, Kehlet H: Effect of high-dose preoperative methylprednisolone on pain recovery after total knee arthroplasty: a randomized, placebo-controlled trial. Br J Anaesth 2011; 106(2):230238. 18. Lunn T, Andersen L, Kirstensen B, Husted H, Otte KS, Gaarn-Larsen L, Bandholm T, Ladelund S, Kehlet H: Effect of high-dose preoperative methylprednisone on recovery after total hip arthroplasty: a randomized, placebo-controlled trial. Br J Anaesth 2012; 110(1):66-73. Used in more than 2 MILLION PATIENTS since 2012 Pacira Pharmaceuticals, Inc. is pleased to support the American Society for Enhanced Recovery Reference: Data on fi le. Parsippany, NJ: Pacira Pharmaceuticals, Inc.; May 2016. For full Prescribing Information, please visit www.EXPAREL.com or call 1-855-RX-EXPAREL (793-9727). ©2016 Pacira Pharmaceuticals, Inc., Parsippany, NJ 07054 PP-EX-US-2048 10/16 8 ASER ALERT • VOLUME 1, ISSUE 1 • aserhq.org
YOU can reduce post-surgical complications by 32% 1 in your moderate to high-risk patients. A large body of evidence demonstrates that hemodynamic optimization through Perioperative Goal-Directed Therapy (PGDT), utilizing dynamic parameters which are informative in determining fluid responsiveness, has been shown to reduce post-surgical complications.1-4 randomized controlled trials and meta-analyses confirmed reduction of risk for AKI, anastomotic leaks, pneumonia, SSI and UTI.1-4 When evidence inspires action, Edwards Lifesciences Enhanced Surgical Recovery Program can help you implement PGDT. Your vision for reducing post-surgical complications can be realized in a single procedure, or as part of a larger quality improvement initiative. Edwards.com/ESR1 References: 1. Grocott et al. Perioperative increase in global blood flow to explicit defined goals and outcomes after surgery: a Cochrane systematic review. Br J Anaesth 2013 2. Giglio MT, Marucci M, Testini M, Brienza N. Goal-directed haemodynamic therapy and gastrointestinal complications in major surgery: a meta-analysisof randomized controlled trials. Br J Anaesth 2009; 103: 637–46 3. Dalfino L, Giglio MT, Puntillo F, Marucci M, Brienza N. Haemodynamic goal-directed therapy and postoperative infections: earlier is better. A systematic review and meta-analysis. Crit Care 2011; 15: R154 4. Corcoran T et al. Perioperative Fluid Management Strategies in Major Surgery: A Stratified Meta-Analysis. Anesthesia – Analgesia 2012 Edwards, Edwards Lifesciences, the stylized E logo and Enhanced Surgical Recovery Program are trademarks of Edwards Lifesciences Corporation or its affiliates. All other trademarks are the property of their respective owners. © 2014 Edwards Lifesciences Corporation. All rights reserved. AR11710 Edwards Lifesciences | edwards.com One Edwards Way | Irvine, California 92614 USA Switzerland | Japan | China | Brazil | Australia | India
Valuable insight to help you guide volume administration. Clarity gives you the control to make more informed decisions. ClearSight Noninvasive System CO, SV, SVV, SVR, cBP* FloTrac Minimally-Invasive System CO, SV, SVV, SVR Swan-Ganz System CCO, RVEDV, RVEF, SvO2 Edwards Lifesciences’ range of hemodynamic monitoring solutions provides key flow parameters shown to be more informative in determining fluid responsiveness than pressure-based parameters.1 Each offers continuous information which may be used in Perioperative Goal-Directed Therapy (PGDT) to hemodynamically optimize your moderate to high-risk surgery patients. The Edwards Enhanced Surgical Recovery Program can help you implement PGDT today. PGDT can help ensure your patients are consistently maintained in the optimal volume range. Know more. Know now. To see how you can individualize therapy under more conditions, visit Edwards.com/ESRsolutions 1. Michard F, Biais M. Rational fluid management: dissecting facts from fiction. Br J Anaesth 2012 * Continuous Blood Pressure For professional use. CAUTION: Federal (United States) law restricts this device to sale by or on the order of a physician. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions and adverse events. Edwards Lifesciences devices placed on the European market, meet the essential requirements referred to in Article 3 of the Medical Device Directive 93/42/EEC, and bear the CE marking of conformity. Edwards, Edwards Lifesciences, the stylized E logo, ClearSight, Enhanced Surgical Recovery Program, FloTrac and Swan-Ganz are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners. © 2014 Edwards Lifesciences Corporation. All rights reserved. AR11787 Edwards Lifesciences | edwards.com One Edwards Way | Irvine, California 92614 USA Switzerland | Japan | China | Brazil | Australia | India
Enhanced Recovery for Orthopedic Surgery By Arman Dagal MD, FRCA; Chad M. Craig, MD, FACP & Ruchir Gupta, MD T otal hip and knee replacements amount to nearly 1,000,000 surgical procedures annually in the United States and are expected to triple in volume by 2030. It is estimated that 7 million people are currently leaving with total hip or knee replacement in the United States alone. In addition to the joint replacement, spine surgery is amongst the costliest procedures in U.S. Between 1998 to 2008 the number of spinal fusion procedures increased by 137%. The spine care (direct and indirect) cost around $100 billion annually in the U.S. alone. 1 remain variable across institutions.2 Bundled Care and Health Care Delivery. The Center for Medicare and Medicaid Innovation (CMMI) was created by the Affordable Care Act to tests innovative payment and service delivery models that have the potential to reduce Medicare, Medicaid, or Children’s Health Insurance Program (CHIP) expenditures while preserving or enhancing the quality of care for the beneficiaries. The Bundled Payments for Care Improvement (BPCI) initiative is the product of the CMMI. Under this initiative hospital and physician services combined into a single payment, using episode based rather than the fee for service payment method. Bundled payments provide an incentive for the hospitals and its medical staff to improve coordination of care to improve value and eliminate unnecessary cost. Hospitals and its providers share the associated risk and financial penalties if they cannot control the cost and quality of care. In this new definition of the surgical episode also includes the post-acute care expenses up to 90 days from the surgery. Along with the mission of value-based care, this year, Joint Commission launched a new Advanced Certification program for Total Hip and Total Knee Replacement. The Advanced Total Hip and Total Knee Replacement certification program is designed to assist healthcare organizations to provide high-quality healthcare with an emphasis on patient safety. The certification program will focus on the transitions of care for patients undergoing a total joint replacement. The uniqueness of this certification begins with reviewing the procedures associated with the orthopedic consultation, pre-operative, intraoperative and post-surgical orthopedic surgeon follow up care. The Joint Commission identified standardized performance measures for this program. Currently, the joint commission is collaborating with the pilot sites to develop standards for the electronic performance measure set 1-4 in relations to Pre-admitting, Operating Rooms, PACU, and Orthopedic Units areas. https://www. jointcommission.org/total_hip__total_ knee_replacement_/ 1. Usage of Neuraxial Anesthesia 2. Postoperative Mobilization on Day of Surgery 3. Discharged to Home 4. Preoperative Functional/Health Status Assessment ERAS orthopedic care bundles. Enhanced recovery after surgery ASER ALERT • VOLUME 1, ISSUE 1 • aserhq.org (ERAS) concept emerged following the work of Henrik Kehlet, M.D., Ph.D 1992 on colorectal surgeries. ERAS is a model of coordinated care delivery of evidence-based care bundles, aimed at achieving perioperative optimization and reducing the adverse effects of the surgical stress response. A number of studies have examined the ERAS pathway care bundles for primary hip and knee replacement surgeries, with a recent review highlighting that such pathways can be applied to a wide variety of patients. Aasvang et al.3 concluded in their study that ERAS can in fact be applied routinely to all hip and knee replacement patients in order to 11 Despite the apparent success of these surgeries, quality and cost
achieve 1–3 days hospital length of stay, a reduced incidence of cardiac and venous thromboembolism complications and reduced postoperative delirium and cognitive dysfunction. The authors further showed that the mean length of stay can be decreased from 76.6 hours to 56.1 hours after implementation of the evidence-based orthopedic ERAS pathway (P < 0.001). This improvement was possible without a concomitant increase in readmission rates. Another study compared 1500 primary hip and knee replacement patients on an ERAS pathway with 3000 patients using a traditional protocol. The authors found that the median LOS decreased from 6 to 3 days, saving 5418 bed days.4 The 90-day mortality rate was also significantly reduced, as well as transfusion requirements. Other studies have found ERAS pathways feasible and safe for more complex groups of patients such as the elderly,5 with a decrease in LOS for patients aged ≥85 years, and no negative effects on morbidity and mortality rates. Additionally, the beneficial effects of ERAS are not limited to the routine primary hip and knee replacements. More complex and surgically variable procedures such as revision joint replacement, shoulder replacement, and in non-elective procedures such as fractured neck of femur patients have found outcomes to similar to those for primary total knee replacement with respect to LOS and morbidity,6 where median LOS was 2 days, no morbidity within 3 months, low readmission rates, and high levels of patient satisfaction. Major spine surgery is another specialty area that the application of ERAS principles has potential to improve patient outcomes.7 When ERAS principles are incorporated into existing or new clinical pathways, they improve the value of care delivery. Risk-adjusted 12 Conclusion Evidence exists to support the increased use of ERAS pathways. High-volume orthopedic surgeries such as total joint arthroplasty as well as spine surgery are ideal for such clinical pathways. Such high-volume procedures also allow for individual centers to track data and feedback data to help optimize the future use of pathways. Adaptation of ERAS patient outcomes, patient safety, and optimizing the use of resources are used for performance and quality indicators.8 2009 meta-analysis suggested that clinical pathways and care organization have significantly impacted the quality of care in joint replacement surgery with reduced postoperative complications, shorter length of stay and potentially lower cost of care.9 Recent, large sample analysis on perioperative fluid administration variability in the hip and knee replacement surgeries concluded that both low and high fluid volumes associate with worse outcomes.10 Suggested orthopedic ERAS care bundles Preoperative Patient education and expectation setting Preoperative nutritional assessment and optimization Carbohydrate loading Minimal preoperative fasting Anemia detection and optimization Preemptive pain management Intraoperative Minimally invasive surgery Multimodal analgesia Goal directed fluid management Nausea vomiting prophylaxis Active warming Blood loss prevention Postoperative Early return to oral diet Physiotherapy and early mobilization Early discharge principles as part of integrated care pathways appear feasible and may effectively improve patient outcomes, satisfaction and reduce cost. ERAS concepts perfectly lines up with the accountable care organizational needs to create a platform for the transformational care initiatives. We encourage institutions to identify multidisciplinary service champions to develop ERAS pathway care. A number of professional organizations including the ERAS Society (erassociety.org), and American Society of Enhance Recovery (aserhq. org) provide guidelines and resources to help with development of such pathways at the institutional level. n References 1. Davis MA, Onega T, Weeks WB, Lurie JD. Where the United States spends its spine dollars: expenditures on different ambulatory services for the management of back and neck conditions. Spine 2012;37:1693–701. 2. Maradit Kremers H, Larson DR, Crowson CS, Kremers WK, Washington RE, Steiner CA, Jiranek WA, Berry DJ. Prevalence of Total Hip and Knee Replacement in the United States. The Journal of Bone & Joint Surgery 2015;97:1386–97. 3. Aasvang EK, Luna IE, Kehlet H. Challenges in postdischarge function and recovery: the case of fast-track hip and knee arthroplasty. Hardman JG, ed. Br J Anaesth 2015:aev257–6. 4. A. Malviya, K. Martin, I. Harper, et al. Enhanced recovery program for hip and knee replacement reduces death rate. A study of 4500 consecutive primary hip and knee replacement Acta Orthop, 82 (2011), pp. 577–581 5. C.C. Jorgensen, H. Kehlet, on behalf of the Lundbeck Foundation Centre for Fast-track hip and knee replacement collaborative Group Role of patient characteristics for fast-track hip and knee arthroplasty Br J Anaesth, 110 (2013), pp. 972–980 6. H. Husted, S. Kristian Otte, B.B. Kristensen, et al. Fast-track revision knee arthroplasy Acta Orthop, 82 (2011), pp. 438–440 7. Wainwright TW, Immins T, Middleton RG. Enhanced recovery after surgery (ERAS) and its applicability for major spine surgery. Best Practice & Research Clinical Anaesthesiology 2016;30:91– 102. 8. Association EP. Clinical/care pathways. Slovenia Board Meeting, 2005. 9. Barbieri A, Vanhaecht K, Van Herck P, Sermeus W, Faggiano F, Marchisio S, Panella M. Effects of clinical pathways in the joint replacement: a metaanalysis. BMC Medicine 2009 7:1 2009;7:32. 10. Thacker JKM, Mountford WK, Ernst FR, Krukas MR, Mythen MMG. Perioperative Fluid Utilization Variability and Association With Outcomes. Annals of Surgery 2016;263:502–10. ASER ALERT • VOLUME 1, ISSUE 1 • aserhq.org
ERAS for Spine Surgery: A New Frontier By Ellen M. Soffin, MD, PhD; Alana E. Sigmund, MD, FHM & Chad M. Craig, MD, FACP I t is evident that Enhanced Recovery After Surgery (ERAS) has become an established and effective mechanism for perioperative care across surgical subspecialties. In our companion piece in the Newsletter, we propose total joint arthroplasty (TJA) as the quintessential orthopedic procedure to benefit from ERAS principles: There is already convincing evidence that clinical pathways effect cost savings and clinical benefits for TJA patients, including decreased length of stay and complications. In contrast, there is a paucity of data in the published literature and reports at the institutional level for the role of ERAS pathways in spine surgery. There is much in common between the spine surgery and colorectal surgery patient (where most ERAS evidence exists to date), including predicted systemic inflammatory response (SIR), length of stay, requirement for parenteral analgesics and complications (particularly ileus). Given the evidence and enthusiasm for ERAS, it is unexpected that spine surgery should remain so understudied with respect to ERAS protocols. This inattention occurs despite compelling biochemical, clinical and economic arguments to support ERAS for spine surgery. First, major spine surgery is associated with predicable increases in stress hormones and inflammatory cytokines1 which may be associated with a host of postoperative complications, including thromboembolism, atrial fibrillation and delirium.2,3 Preoperative steroids Specific interventions have been demonstrated to reduce biomarkers of surgical stress and improve outcomes after spine surgery. For example, intraoperative administration of the alpha-2 adrenergic agonist, dexmedetomidine, lowers interleukin-10 and cortisol and improves quality of recovery after multilevel lumbar fusion.4 lower interlukin-6 and C-reactive protein after cervical laminoplasty without increasing the risk of wound infection or compromised healing.5 Minimally invasive surgical techniques are associated with lower levels of cytokines compared to conventional techniques up to 8 days post lumbar fusion.6 The overall safety and efficacy benefits of minimally invasive approaches have yet to be fully established in lumbar spine surgery,7 but represent an intriguing possibility for future research as a component of ERAS for spine pathways. The minimally invasive approach may indeed be the ERAS-for-spine analogy to the laparoscopic approach in ERAS-for-colorectal surgery, in terms of benefits on outcomes and biomolecular markers of surgical stress.8 The second argument in favor of ERAS for spine surgery is an economic one. The demand for spine surgery and the cost of surgery are both increasing exponentially in the United States and abroad.9 Indeed, a recent economic report estimated the total annual cost for back pain in the United States (including diagnosis, treatment and rehabilitation) at over $50 billion US dollars annually, and costs are projected to increase 4.8% annually in the near term.10 According to the report, the demand for spine surgery is being driven by an aging population, an increase in the number of fusions being performed, and technical ASER ALERT • VOLUME 1, ISSUE 1 • aserhq.org advances making complex surgery more commonplace. Given these pressures, any reduction in length of stay, no matter how modest, is likely to produce significant economic gains, as has been demonstrated repeatedly for ERAS in other surgical disciplines. As an illustrative example of potential economic gains, we can consider lumbar fusion: The hospital costs associated with lumbar fusion without instrumentation was recently reported in a cohort study to be approximately $14,700.00 US dollars.11 The average length of stay was 3.5 days in a sample of 77 patients. A reduction in length of stay of just 0.5 days per patient would 13
achieve overall hospital costs savings of approximately $161,700.00 in this cohort alone. The third argument should ideally be made on the basis of evidence to indicate improved outcomes, reduced complications and rising patient satisfaction associated with ERAS for spine. However, this evidence is currently scarce and there are no published accounts of comprehensive ERAS pathways for any spine surgery subtypes at this time. However, there is an extensive literature regarding components of care that classically comprise ERAS pathways, together with encouraging results on a range of clinically important outcomes. A full review is outside the scope of this commentary, but several observations can be highlighted: multimodal analgesic regimens incorporating acetaminophen, non-steroidal antiinflammatories, anti-convulsants, and local anesthetics are opioid sparing, and associated with improved patient satisfaction, reduced length of stay, and better pain control than intravenous opioid-based therapy after spine surgery;12 a blood conservation strategy including the anti-fibrinolytic, tranexamic acid, reduces autologous blood transfusion without increasing the risk of thromboembolic events after major reconstructive spine surgery;13 identifying patients at risk of nutritional deficiency and optimizing nutritional status was associated with a faster return to nutritional baseline (or anabolic state) after major reconstruction surgery (>10 spinal levels);14 and intravenous fluid restriction is associated with less post-operative ileus after lumbar fusion irrespective of surgical approach.15 If follows that these examples could be used as the basis for ERAS for spine pathways. However, a closer examination of the state of the evidence base raises more questions than it answers and exposes significant gaps in research and knowledge: What is the role of pre-operative education and shared-decision making in the spine population? How can we standardize pathways for such heterogeneous patients, indications and surgical interventions? What is the role of epidural analgesia after spine surgery? Is early mobilization appropriate after major reconstructive procedures? These are just a very few of the questions that need to be answered urgently if ERAS for spine is to become relevant and useful. In order to most efficiently provide solutions, we advocate creating an ERAS for spine pathway that can be adopted according to institutional capability. At Hospital for Special Surgery, we have recently implemented an ERAS pathway for lumbar spine fusion. The pathway is based on current best evidence, but where evidence is lacking, we have implemented measures that have demonstrated efficacy in other ERAS protocols. We are currently enrolling patients in a prospective study to investigate the effect(s) of the pathway on patient centered outcomes. Additionally, we call for research and well-designed studies that focus on procedure-specific interventions, improving logistics, and fostering a culture of enhanced recovery across disciplines. n References 1. Watt DG, Horgan PG, McMillan DC: Routine clinical markers of the magnitude of the systemic inflammatory response after elective operation: a systematic review. Surgery 2015; 362-80. 2. Hu YF, Chen YJ, Lin YJ, Chen SA: Inflammation and the pathogenesis of atrial fibrillation. Nature Rev Cardiol 2015; 12(4):230-43. 3. Van Munster BC, Korevaar JC, Zwinderman AH, Levi M, Wiersinga WJ, De Rooij SE: Time-course of cytokines during delirium in elderly patients with hip fractures. J Am Geriatr Soc 2008; 56(9):1704-9. 4. Bekker A, Haile M, Kline R, Didehvar S, Babu R, Martiniuk F, Urban M: The effect of intraoperative infusion of dexmedetomidine on quality of recovery after major spinal surgery. J Neurosurg Anesthesiol 2013; 25(1):16-24. 5. Demura S, Takahashi K, Murakami H, Fujimaki Y, Kato S, Tsuchiya H: The influence of steroid administration on systemic response in laminoplasty for cervical myelopathy. Arch Orthop Trauma Surg 2013; 133(8):1041-5. 6. Kim KT, Lee SH, Suk, SK, Bae SC: The quantitative analysis of tissue injury markers after mini-open lumbar fusion. Spine; 31(6):712-6. 7. Payer M: “Minimally invasive” lumbar spine surgery: a critical review. Acta Neurochir (Wein) 2011; 153(7):1455-9. 8. Zhuang CL, Huang DD, Chen FF, Zhou CL, Zheng BS, Chen BC, Shen X, Yu Z: Laparoscopic versus open colorectal surgery within enhanced recovery after surgery programs: a systematic review and meta-analysis of randomized controlled trials. Surg Endosc 2015; 29(8):2091100. 9. Wainwright TW, Immins T, Middleton RG: Enhanced recovery after surgery (ERAS) and its applicability for major spine surgery. Best Pract Res Clin Anaesthesiol 2016; 30(1):91-102. 10. Ken Research. The US Spinal Surgery Market Outlook to 2017: Ageing population and technological advances to intensify the competition. 2013; Available at www.marketresearch.com/product/ sample-7535890.pdf 11. Molina CA, Zadnik PL, Gokaslan ZL, Witham TF, Bydon A, Wolinsky JP, Sciubba DM: A cohort analysis of lumbar laminectomy—current trends in surgeon and hospital fees distribution. Spine J 2013; 13(11):1434-7. 12. Devin CJ, McGirt MJ: Best evidence in multimodal pain management in spine surgery and means of assessing postoperative pain and functional outcomes. J Clin Neurosci 2015; 22:930-38. 13. Soroceanu A, Oren JH, Smith JS, Hostin R, Shaffrey CI, Mundis GM, Ames CP, Burton DC, Bess S, Gupta MC, Deviren V, Schwab FJ, Lafage V, Errico TJ: Effect of antifibrinolytic therapy on complications, thromboembolic events, blood product utilization, and fusion in adult spinal deformity surgery. Spine 2016; 41(14):E897-86. 14. Lapp MA, Bridwell KH, Lenke LG, Baldus C, Blanke K, Iffrig TM: Prospective randomization of parenteral hyperalimentation for long fusions with spinal deformity: its effect on complications and recovery from postoperative malnutrition. Spine 2001;26(7):809-17. 15. Fineberg SJ, Nandyala SV, Kurd MF, MarquezLara A, Noureldin M, Sankaranarayanan S, Patel AA, Oglesby M, Singh K: Incidence and risk factors for postoperative ileus following anterior, posterior and circumferential lumbar fusion. Spine J 2014; 1680-5. 14 ASER ALERT • VOLUME 1, ISSUE 1 • aserhq.org
Choices Matter: ASER Partners with Pacira Pharmaceuticals to Launch National Campaign to Combat Opioid Epidemic Over the past year, America’s struggle with the growing opioid epidemic has swept national headlines. New reports estimate 78 people die every day in the U.S. from overuse of opioids.1 Adding to this problem is a surreptitious factor: surgery has become an unintentional gateway to this tragic epidemic. In fact, research shows that one-in-10 patients prescribed an opioid following surgery report becoming addicted to or dependent on the drug. It’s clear that we need to improve the dialogue between patients and surgeons related to postsurgical pain management – many patients are still unaware that they have choices, including nonopioid options. That’s why ASER partnered with Pacira Pharmaceuticals to launch Choices Matter, a national, unbranded campaign designed to educate, empower and activate patients, caregivers and physicians to proactively discuss postsurgical pain management, including non-opioid options before surgery. The campaign provides an opportunity to drive consideration for non-opioid alternatives, which can potentially minimize or virtually eliminate the need for prolonged use of opioids after surgery. The Choices Matter campaign launched August 1 in New York City, featuring a top orthopedic surgeon and professional athlete and television personality Gabby Reece. Gabby recently had her own knee replacement surgery without the help of prescription opioids, which made Choices Matter an especially relevant and timely campaign for her. The campaign website – PlanAgainstPain. com – features helpful tools for patients about to undergo their own surgeries, including a customized doctor discussion guide that allows patients to facilitate conversations about non-opioid options with their surgeons. To-date, Choices Matter has generated nearly 240 media placements and more than 476.5 million media impressions. Highlights include a New York Times Letter to the Editor from ASER President, Dr. T.J. Gan, which leveraged key statistics from a national survey of patients and surgeons conducted by Pacira. Additional coverage was featured in USA Today, Good Day New York, U.S. News & World Report, CNBC-TV, Self. com, CBS New York and Parade.com. PlanAgainstPain.com has generated more than 45,000 page views and 180 discussion guide downloads to date. While our efforts have sparked a national dialogue about alternatives to opioids, there is much more work to be done to combat this growing epidemic. For more information visit PlanAgainstPain.com. n References 1. https://www.cdc.gov/drugoverdose/epidemic/ Gabby’s Story By Gabrielle Reece, Professional Volleyball Player, Sports Announcer, Fashion Model & Actress Professional Athlete and Television Personality Gabby Reece Talks About Recovery After Surgery T he intense pain in my knee was starting to affect my life, especially when I exercised or played volleyball. When it got to a place where I knew I couldn’t make it better through training, nutrition or therapy, I decided it was time to get my knee replaced. It has been a little over six months since I had my surgery, and recovery has been a long road for me. Prior to the procedure, I had made a personal decision not to take opioids. Although I was given a low-dose painkiller in the hospital, I knew I didn’t want to take a prescription home with me. I’m very respectful of the fact that opioids are addictive and, although I consider myself a strong person physically and mentally, I’m aware that addiction shows no discrimination when it comes to age, gender, ethnicity, lifestyle, etc. – it can happen to anyone. In fact, a recent survey found that one-in-10 patients prescribed an opioid following surgery report becoming addicted to or dependent on the drug. I’ve been proactive in trying to avoid that because it’s important to me to stay holistic as possible in my recovery through sleep, stress management, ASER ALERT • VOLUME 1, ISSUE 1 • aserhq.org exercise and nutrition. What I didn’t know is that there are many options available for managing pain after surgery, including non-opioids. Choices Matter is important to me because I believe we should all be advocates for our own health. This program is about giving patients the resources they need to make the most educated choice for them. That’s why I’m encouraging people to have a conversation with their doctor about alternatives to managing pain after surgery, including nonopioid options. Visit PlanAgainstPain.com to learn more and download a discussion guide that can help you or a loved one have this important conversation. n 15
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