ERAS for Hip and Knee (THA and TKA) Arthroplasty – a Need to Look Beyond LOS

ASERalert November 2016 | Volume 1, Issue 1

ERAS for Hip and Knee (THA and TKA) Arthroplasty – A Need to Look Beyond LOS

OFFICIAL also in this issue PUBLICATION OF ERAS for Total Enhanced ERAS for Spine Joint Arthroplasty: Recovery for Surgery: A New Past, Present and Orthopedic Frontier ASER ALERT • VOLUME 1, ISSUE 1 • aserhq.org Future Surgery 1 ANNUAL CONGRESS OF ENHANCED RECOVERY AND

2017 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 Board of Directors President’s Message Officers By Tong J (TJ) Gan, MD, MHS, FRCA, President President Tong J (TJ) Gan, MD, MHS, FRCA President-Elect Julie Thacker, MD t is my great pleasure to announce Vice-President the inaugural issue of the ASER Timothy Miller MB, ChB, FRCA Newsletter. Founded in 2014, Treasurer ASER is a multi-specialty nonprofit Roy Soto, MD Iorganization with an international Secretary membership and is dedicated to the Stefan D. Holubar MD, MS, FACS, FASCRS practice of enhanced recovery in the perioperative patient through education Directors and research. We are experiencing a period of tremendous expansion and Keith A. (Tony) Jones, MD growth, as is evidenced by the great Anthony Senagore, MD interest to implement the enhanced Maxime Cannesson, MD, PhD recovery pathway in hospitals around Terrence Loftus, MD, MBA, FACS the country. Andrew Shaw MB, FRCA, FFICM, FCCM Desiree Chappel, CRNA The ASER Mission is to advance the

practice of perioperative enhanced recovery and to contribute to its pathways. It serves as a forum for Newsletter Committee growth and influences, by fostering communication of the many activities of Thomas Hopkins, MD: Chair and encouraging research, education, the society. Lyla Hance, MPH: Co-Chair public policies, programs and scientific I would like to thank Dr. Thomas Jeffrey Huang, MD progress. Hopkins, Lyla Hance and their Uday Jain, MD, PhD We have achieved much over the past committee for editing the newsletter Amy McCutchan, MD 2 years, including: and those who generously donated Asha Naik, FRCA their time to contribute to this edition. Christina Solis, MHA • Annual ASER/EBPOM Congress Matthias Stopfkuchen-Evans, MD We want this newsletter to be valuable

• ASER website for you, so please share your feedback and suggestions to help us improve. • ASER manual of Enhanced About ASER Please forward it to friends and Recovery for Major Abdominopelvic ASER is a nonprofit organization with an international colleagues who you think will benefit membership, which is dedicated to thepractice Surgery from this newsletter. n of enhanced recovery in the perioperative patient through education and research. ASER’s mission is • Enhanced Recovery Implementation to advance the practice of perioperative enhanced Enjoy reading. Guide recovery, to contribute to its growth and influences, by fostering and encouraging research, education, Tong J (TJ) Gan, MD, MHS, FRCA • Regional Leadership forums public policies, programs and scientific progress. President • Perioperative Medicine as the official American Society for Enhanced society journal Recovery Administrative Office American Society for Enhanced Recovery This newsletter aims to share Professor and Chairman 6737 W Washington St. | Ste. 4210 Milwaukee, WI 53214 information, best practices, sample Department of Anesthesiology protocols and members’ experiences Stony Brook University 414-389-8610 | [email protected] in implementing enhanced recovery [email protected]

ASER ALERT • VOLUME 1, ISSUE 1 • aserhq.org 3 ERAS for Hip & Knee (THA & TKA) Arthroplasty – A Need To Look Beyond LOS

feature By Henrik Kehlet, Prof. MD, PhD

RAS programs in total joint eliminate this problem. Although it arthroplasty have been is well-established that preoperative introduced worldwide in many The optimal anemia should be diagnosed centers with documented and treated, more focus on post- Esuccess and reduced length of technique of discharge anemia should be made, stay (LOS) and morbidity. However, since it may impair rehabilitation and despite the achieved success, increase risk of organ dysfunction, several challenges lie ahead. First of rehabilitation but so far with sparse available all “what is the optimal LOS?”, since data. Further data are required on there is a lack of documentation on needs thromboembolic complications and the economic and safety aspects of need for prophylaxis, since early same-day discharge vs next day in mobilization with ERAS may reduce a general THA and TKA population evaluation... the risk. Importantly, readmissions vs the proportion of selected suitable and discharge destination must be patients. Although overall morbidity is studies are required to preoperatively clarified due to a huge discrepancy reduced by ERAS, further studies on predict high-pain responders in between individual institutions and the relative importance of conventional subpopulations such as pain countries and where readmission to risk factors needs to be clarified, since catastrophizers, preoperative opioid “own institution” is insufficient because recent data question the relevance users and other pain “sensitized” some patients may be readmitted from standard risk assessment patients. Also, more data are required to other institutions. Also, discharge within traditional care. Still, a major on the otherwise documented risk of destination, which has major problem is the need to improve postoperative delirium especially with economic implications, needs further pain management after discharge in opioid-based pain management, but evaluation, since discharge to a relation to patient activity and optimal where a fully implemented opioid- “nursing care facility” or “rehabilitation” rehabilitation. In this context, further sparing ERAS program may almost institution is variable, and in some

4 ASER ALERT • VOLUME 1, ISSUE 1 • aserhq.org countries standard practice is In summary, despite an obvious total knee arthroplasty: are we there yet? Bone Joint J 2015; 97-B:3-9. discharge to home instead. success of ERAS in THA and THA to reduce LOS and morbidity, several Jans O, Kehlet H. Postoperative orthostatic The optimal technique of rehabilitation intolerance: a common perioperative problem with few challenges lie ahead to improve post- available solutions. Can J Anaesth 2016 (Epub). needs evaluation, since present discharge recovery. n data even with immediate strength Jorgensen CC, Petersen MA, Kehlet H. Preoperative prediction of potentially preventable morbidity after training have been disappointing and References fast-track hip and knee arthroplasty: a detailed descriptive cohort study. BMJ Open 2016; where all data have documented Aasvang EK, Luna IE, Kehlet H. Challenges in 6:e009813. a reduction of muscle function for postdischarge function and recovery: the case of fast- track hip and knee arthroplasty. Br J Anaesth 2015; Kehlet H, Jorgensen CC. Rapid Recovery After several weeks postoperatively. 115:861-866.Cyriac J, Garson L, Schwarzkopf R, Ahn Hip and Knee Arthroplasty--A Transatlantic Gap? J Although patient-reported outcomes K, Rinehart J, Vakharia S, Cannesson M, Kain Z. Total Arthroplasty 2015; 30:2380. joint replacement perioperative surgical home program: are fashionable and important, 2-year follow-up. Anesth Analg 2016; 123:51-62. Kehlet H, Jorgensen CC. Advancing surgical further studies to compare these with outcomes research and quality improvement within Artz N, Elvers KT, Lowe CM, Sackley C, Jepson P, an enhanced recovery program framework. Ann Surg objectively measured function and Beswick AD. Effectiveness of physiotherapy exercise 2016; 264:237-238. activity are required, since initial data following total knee replacement: systematic review and meta-analysis. BMC Musculoskelet Disord 2015; Kjellberg J, Kehlet H. A nationwide analysis of are disappointing and showing a gap 16:15. socioeconomic outcomes after hip and knee between the positive patient-reported replacement. Dan Med J 2016; 63:A5257.Pitter Cyriac J, Garson L, Schwarzkopf R, Ahn K, Rinehart FT, Jorgensen CC, Lindberg-Larsen M, Kehlet H. outcomes vs the rather disappointing J, Vakharia S, Cannesson M, Kain Z. Total joint Postoperative morbidity and discharge destinations objective recovery data. Finally, a replacement perioperative surgical home program: after fast-track hip and knee arthroplasty in patients 2-year follow-up. Anesth Analg 2016; 123:51- older than 85 years. Anesth Analg 2016; 122:1807- very large number of publications 62. 1815. on ERAS cohorts often has an Fragiadakis GK, Gaudilliere B, Ganio EA, Aghaeepour Pitter FT, Jorgensen CC, Lindberg-Larsen M, Kehlet insufficient interpretation compared N, Tingle M, Nolan GP, Angst MS. Patient-specific H. Postoperative morbidity and discharge destinations immune states before surgery are strong correlates of after fast-track hip and knee arthroplasty in patients with global literature, and a lack of surgical recovery. Anesthesiology 2015; 123:1241- older than 85 years. Anesth Analg 2016; 122:1807- balanced discussion on international 1255. 1815.

experiences and consequences in Hossain FS, Konan S, Patel S, Rodriguez-Merchan Thienpont E, Lavand’homme P, Kehlet H. The different health care systems. EC, Haddad FS. The assessment of outcome after 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 • Implementation Consultation and Guidance • Practice Guidelines and Ongoing Research ASER member • Hospital and Patient Educational Materials today! • Networking • Professional Development and Education For further information and • Research Grant Opportunities to apply one line visit aserhq.org/membership • Membership Discount to Attend Annual Congress

ASER ALERT • VOLUME 1, ISSUE 1 • aserhq.org 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

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 Ihip 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 length- of-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, operative assessment by a physical surgical subspecialties, the majority regional analgesia techniques, and therapist, and were educated about of published pathways for TJA early mobilization. Patients following the planned day of discharge, wound comprise intraoperative anesthesia, these pathways achieve reduced care and physical therapy, They post-operative analgesia, and early length of stay, superior pain control, also received necessary equipment mobilization as the basis of the and shortened time to functional prior to admission, received spinal care trajectory. Standardized ERAS recovery.7-9 anesthesia, and also participated in components, including pre-operative early mobilization. A similar, although education and nutritional optimization, Finally, in a recent study of patients smaller, study in total knee arthroplasty goal directed fluid therapy (GDFT) undergoing primary total hip showed similar results.11 and audit are often conspicuous arthroplasty, comparing patients in by their absence in TJA. A recent an enhanced recovery program to While package of care studies in TJA review of ERAS for TJA suggests patients in the hospital’s standard- show benefit for patients, they also that despite the established success care program, the enhanced recovery have revealed that the two major of clinical pathways, there remain group showed a decreased length of approaches to standardized care in major opportunities to apply ERAS stay of 1.5 days with no increase in TJA, ERAS and clinical pathways, principles to patients undergoing 10 post-operative complications. In this have basic differences in form and elective joint replacement.12 Although program, patients underwent pre- content. In contrast to ERAS in other

6 ASER ALERT • VOLUME 1, ISSUE 1 • aserhq.org operative complications such as anemia and pain. In two separate studies, consecutive patients were enrolled in a multidisciplinary hemoglobin management program that ...high dose involved pre-operative anemia work-up and management. Both studies were able to show reduced post-operative steroids reduced 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 the amount of 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 patient-reported pain within the first 1-2 days after both hip pain within the and knee arthroplasty.17,18 Because of the safety and efficacy of clinical pathways in TJA, we are increasingly offering surgery to patients who first 1-2 days after 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 both hip and knee chronic opioid dependent patient. Demand for same-day or same-admission bilateral TJA is also increasing. These arthroplasty. 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 there is a large body of evidence to guide decision making in and practice. “Clinical pathway”, “ERAS”, “Perioperative constructing pathways of care, there are equally large gaps in Surgical Home” and “Fast Track” are used interchangeably 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 opioid- sparing after TJA. Ultimately, these decisions might have to be made according to institutional practice and capability. The risk-to-benefit balance of preoperative carbohydrate SEEING COMPLEXITY IN A NEW LIGHT. loading has yet to be established in TJA and the role of For nearly 150 years, Mallinckrodt has made goal-directed fluid therapy is unclear – and may turn out to complex scientiﬁc problems manageable, developing valuable diagnostic tools and be of lesser importance compared to colorectal surgery. The treatments for patients who need them. concept of auditing compliance and outcomes, and using We view challenges as opportunities. See how at Mallinckrodt.com 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

Mallinckrodt, the “M” brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Recent arthroplasty research has focused on improving © 2015 Mallinckrodt. June 2015 global recovery through avoiding common post-

ASER ALERT • VOLUME 1, ISSUE 1 • aserhq.org 7 the literature, and many terms lack a definition. In addition to 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 standard language, we advocate that a principal goal should replacement. HSS J 2011; 7(3):223-8.

be a standardized ERAS pathway for TJA based on the best 9. Duggal S, Flics S, Cornell CN: Intra-articular analgesia and discharge to home available evidence, and including audit. We submit that this enhance recovery following total knee replacement. HSS J 2015; 11(1):56-64. process is most effective when it occurs at the Society level 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 with adoption of consensus guidelines, as has been the case Compromising Functional Outcome Bone Joint J 2016; 98-B:475-482. for ERAS in other surgical subspecialties. n 11. Maempel J, Walmsley P: Enhanced Recovery Programmes Can Reduce Length of Stay After Total Knee Replacement Without Sacrificing Functional Outcome at One References Year. Ann R Coll Surg Engl 2015; 97:563-567.

1. Sharrock NE, Cazan MG, Hargett MJ, Williams-Russo P, Wilson PD Jr: Changes in 12. Soffin EM, YaDeau JT: Enhanced recovery after surgery for primary hip and knee mortality after total hip and knee arthroplasty over a ten-year period. Anesth Analg arthroplasty: A review of the evidence. BJA 2016; in press. 1995; 80(2):242-8. 13. McDonald S, Page MJ, Beringer K, Wasiak J, Sprowson A: Preoperative education 2. Duncan CM, Hall Long K, Warner DO, Hebl JR: The economic implications of a for hip or knee replacement. Cochrane Database Syst Rev 2014; 13(5). multimodal analgesic regimen combined with minimally invasive orthopedic surgery: a comparative cost study. Reg Anesth Pain Med 2009; 34(4):301-7. 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. 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 15. Holt J, Miller B, Callaghan J, Clark C, Willenborg M, Noiseux N: Minimizing Blood pathway in patients undergoing total knee arthroplasty. Reg Anesth Pain Med 2013; Transfusion in Total Hip and Knee Arthroplasty Through a Multimodal Approach. J 38(6):533-8. Arthroplasty 2016; 31: 378-382.

4. Hebl JR, Kopp SL, Ali MH, Horlocker TT, Dilger JA, Lennon RL, Williams BA, Hanssen 16. Kopandis P, Hardidge A, McNicol L, Tay S, McCall P, Weinberg L: Perioperative Blood AD, Pagnano MW: A comprehensive anesthesia protocol that emphasized peripheral Management Programme Reduces the Use of Allogenic Blood Transfusion in Patients nerve blockade for total knee and total hip arthroplasty. J Bone Joint Surg Am 2005; Undergoing Total Hip and Knee Arthroplasty. J Orthop Surg Res 2016; 11:28. 87 Suppl 2:63-71. 17. Lunn T, Kirstensen B, Andersen L, Husted H, Otte KS, Gaarn-Larsen L, Kehlet H: 5. Hebl JR, Dilger JA, Byer DE, Kopp SL, Stevens SR, Pagnano MW, Hanssen AD, Effect of high-dose preoperative methylprednisolone on pain recovery after total knee Horlocker TT: A pre-emptive multimodal pathway featuring peripheral nerve block arthroplasty: a randomized, placebo-controlled trial. Br J Anaesth 2011; 106(2):230- improves perioperative outcomes after major orthopedic surgery. Reg Anaesth Pain 238. Med 2008; 33(6):510-517. 18. Lunn T, Andersen L, Kirstensen B, Husted H, Otte KS, Gaarn-Larsen L, Bandholm T, 6. Sutton JC, Antoniou J, Epure LM, Huk OL, Zukor DJ, Bergeron S: Hospital Discharge Ladelund S, Kehlet H: Effect of high-dose preoperative methylprednisone on recovery within 2 Days Following Total Hip or Knee Arthroplasty Does Not Increase Major- after total hip arthroplasty: a randomized, placebo-controlled trial. Br J Anaesth 2012; Complication and Readmission Rates. J Bone and Joint Surg Am 2016;98;1419-28. 110(1):66-73.

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

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

Maker of EXPAREL® (bupivacaine liposome injectable suspension) Pacira Pharmaceuticals is the maker of EXPAREL® PP-EX-US-2048_ASER Half Page Ad_FINAL.indd 1 10/19/16 2:25 PM

Maker of EXPAREL® (bupivacaine liposome injectable suspension) YOU can reduce

post-surgical A large body of evidence demonstrates that complications hemodynamic optimization through Perioperative Goal-Directed Therapy (PGDT), utilizing dynamic by parameters which are informative in determining fluid responsiveness, has been shown to reduce post-surgical complications.1-4 1

32% randomized controlled trials and in your moderate to high-risk meta-analyses confirmed reduction of risk for AKI, patients. 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.

Used in more than 2 MILLION PATIENTS Edwards.com/ESR1

References: since 2012 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 Pacira Pharmaceuticals, Inc. is pleased to support the American Society for Enhanced Recovery Corporation or its affiliates. All other trademarks are the property of their respective owners. © 2014 Edwards Lifesciences Corporation. All rights reserved. AR11710

Reference: Data on ﬁ le. Parsippany, NJ: Pacira Pharmaceuticals, Inc.; May 2016. Edwards Lifesciences | edwards.com One Edwards Way | Irvine, California 92614 USA For full Prescribing Information, please visit www.EXPAREL.com or call 1-855-RX-EXPAREL (793-9727). Switzerland | Japan | China | Brazil | Australia | India ©2016 Pacira Pharmaceuticals, Inc., Parsippany, NJ 07054 PP-EX-US-2048 10/16

Maker of EXPAREL® (bupivacaine liposome injectable suspension) Pacira Pharmaceuticals is the maker of EXPAREL® PP-EX-US-2048_ASER Half Page Ad_FINAL.indd 1 10/19/16 2:25 PM

Maker of EXPAREL® (bupivacaine liposome injectable suspension) Valuable insight to help you guide volume administration.

Clarity gives you the control to ClearSight Noninvasive System CO, SV, SVV, SVR, cBP* make more informed decisions. FloTrac Minimally-Invasive System CO, SV, SVV, SVR Swan-Ganz System

CCO, RVEDV, RVEF, SvO2

Edwards Lifesciences’ range of hemodynamic monitoring The Edwards Enhanced Surgical Recovery Program can solutions provides key flow parameters shown to be more help you implement PGDT today. PGDT can help ensure your informative in determining fluid responsiveness than patients are consistently maintained in the optimal volume range. pressure-based parameters.1 Know more. Know now. To see how you can Each offers continuous information which may be used in individualize therapy under more conditions, visit Perioperative Goal-Directed Therapy (PGDT) to hemodynamically Edwards.com/ESRsolutions optimize your moderate to high-risk surgery patients.

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

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 amongstT 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 Despite the apparent success of these surgeries, quality and cost 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 the electronic performance measure (ERAS) concept emerged following certification program is designed set 1-4 in relations to Pre-admitting, the work of Henrik Kehlet, M.D., Ph.D to assist healthcare organizations Operating Rooms, PACU, and 1992 on colorectal surgeries. ERAS is to provide high-quality healthcare Orthopedic Units areas. https://www. a model of coordinated care delivery of with an emphasis on patient jointcommission.org/total_hip__total_ evidence-based care bundles, aimed safety. The certification program knee_replacement_/ at achieving perioperative optimization will focus on the transitions of care and reducing the adverse effects of the for patients undergoing a total joint 1. Usage of Neuraxial Anesthesia surgical stress response. A number replacement. The uniqueness of this of studies have examined the ERAS 2. Postoperative Mobilization on Day certification begins with reviewing pathway care bundles for primary hip of Surgery the procedures associated with the and knee replacement surgeries, with orthopedic consultation, pre-operative, 3. Discharged to Home a recent review highlighting that such intraoperative and post-surgical pathways can be applied to a wide orthopedic surgeon follow up care. 4. Preoperative Functional/Health variety of patients. The Joint Commission identified Status Assessment 3 standardized performance measures Aasvang et al. concluded in their for this program. Currently, the joint ERAS orthopedic care bundles. study that ERAS can in fact be applied routinely to all hip and knee commission is collaborating with the Enhanced recovery after surgery pilot sites to develop standards for replacement patients in order to

ASER ALERT • VOLUME 1, ISSUE 1 • aserhq.org 11 achieve 1–3 days hospital length of patient outcomes, patient safety, and principles as part of integrated care stay, a reduced incidence of cardiac optimizing the use of resources are pathways appear feasible and may and venous thromboembolism used for performance and quality effectively improve patient outcomes, complications and reduced post- indicators.8 2009 meta-analysis satisfaction and reduce cost. ERAS operative delirium and cognitive suggested that clinical pathways and concepts perfectly lines up with dysfunction. The authors further care organization have significantly the accountable care organizational showed that the mean length of stay impacted the quality of care in joint needs to create a platform for the can be decreased from 76.6 hours replacement surgery with reduced transformational care initiatives. We to 56.1 hours after implementation postoperative complications, shorter encourage institutions to identify of the evidence-based orthopedic length of stay and potentially lower multidisciplinary service champions ERAS pathway (P < 0.001). This cost of care.9 Recent, large sample to develop ERAS pathway care. A improvement was possible without a analysis on perioperative fluid number of professional organizations concomitant increase in readmission administration variability in the hip and including the ERAS Society rates. knee replacement surgeries concluded (erassociety.org), and American that both low and high fluid volumes Society of Enhance Recovery (aserhq. Another study compared 1500 primary associate with worse outcomes.10 org) provide guidelines and resources hip and knee replacement patients on to help with development of such an ERAS pathway with 3000 patients Suggested orthopedic ERAS care pathways at the institutional level. n using a traditional protocol. The bundles authors found that the median LOS References decreased from 6 to 3 days, saving Preoperative 1. Davis MA, Onega T, Weeks WB, Lurie JD. Where 5418 bed days.4 The 90-day mortality Patient education and expectation setting the United States spends its spine dollars: expenditures on different ambulatory services for rate was also significantly reduced, as Preoperative nutritional assessment and the management of back and neck conditions. well as transfusion requirements. Spine 2012;37:1693–701. optimization 2. Maradit Kremers H, Larson DR, Crowson CS, Other studies have found ERAS Carbohydrate loading Kremers WK, Washington RE, Steiner CA, Jiranek pathways feasible and safe for more Minimal preoperative fasting WA, Berry DJ. Prevalence of Total Hip and Knee complex groups of patients such as Replacement in the United States. The Journal of Anemia detection and optimization Bone & Joint Surgery 2015;97:1386–97. the elderly,5 with a decrease in LOS Preemptive pain management 3. Aasvang EK, Luna IE, Kehlet H. Challenges in for patients aged ≥85 years, and no postdischarge function and recovery: the case of negative effects on morbidity and Intraoperative fast-track hip and knee arthroplasty. Hardman JG, ed. Br J Anaesth 2015:aev257–6. mortality rates. Minimally invasive surgery 4. A. Malviya, K. Martin, I. Harper, et al. Enhanced Additionally, the beneficial effects of Multimodal analgesia recovery program for hip and knee replacement reduces death rate. A study of 4500 consecutive ERAS are not limited to the routine Goal directed fluid management primary hip and knee replacement Acta Orthop, 82 primary hip and knee replacements. Nausea vomiting prophylaxis (2011), pp. 577–581 More complex and surgically variable Active warming 5. C.C. Jorgensen, H. Kehlet, on behalf of the procedures such as revision joint Lundbeck Foundation Centre for Fast-track hip Blood loss prevention and knee replacement collaborative Group Role replacement, shoulder replacement, of patient characteristics for fast-track hip and and in non-elective procedures Postoperative knee arthroplasty Br J Anaesth, 110 (2013), pp. 972–980 such as fractured neck of femur Early return to oral diet patients have found outcomes to 6. H. Husted, S. Kristian Otte, B.B. Kristensen, et al. Physiotherapy and early mobilization Fast-track revision knee arthroplasy similar to those for primary total knee Early discharge replacement with respect to LOS and Acta Orthop, 82 (2011), pp. 438–440 6 morbidity, where median LOS was 7. Wainwright TW, Immins T, Middleton RG. 2 days, no morbidity within 3 months, Conclusion Enhanced recovery after surgery (ERAS) and its applicability for major spine surgery. Best Practice low readmission rates, and high levels Evidence exists to support the & Research Clinical Anaesthesiology 2016;30:91– 102. of patient satisfaction. Major spine increased use of ERAS pathways. surgery is another specialty area that High-volume orthopedic surgeries 8. Association EP. Clinical/care pathways. Slovenia Board Meeting, 2005. the application of ERAS principles has such as total joint arthroplasty as well 7 potential to improve patient outcomes. as spine surgery are ideal for such 9. Barbieri A, Vanhaecht K, Van Herck P, Sermeus W, Faggiano F, Marchisio S, Panella M. Effects of When ERAS principles are clinical pathways. Such high-volume clinical pathways in the joint replacement: a meta- analysis. BMC Medicine 2009 7:1 2009;7:32. incorporated into existing or new procedures also allow for individual clinical pathways, they improve the centers to track data and feedback 10. Thacker JKM, Mountford WK, Ernst FR, Krukas data to help optimize the future use MR, Mythen MMG. Perioperative Fluid Utilization value of care delivery. Risk-adjusted Variability and Association With Outcomes. Annals of pathways. Adaptation of ERAS of Surgery 2016;263:502–10.

12 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

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 Iconvincing evidence that clinical pathways effect cost savings and clinical benefits forJA T 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 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 Preoperative steroids 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 The second argument in favor advances making complex surgery cytokines compared to conventional of ERAS for spine surgery is an more commonplace. Given these techniques up to 8 days post lumbar economic one. The demand for pressures, any reduction in length fusion.6 The overall safety and spine surgery and the cost of surgery of stay, no matter how modest, is efficacy benefits of minimally invasive are both increasing exponentially likely to produce significant economic approaches have yet to be fully in the United States and abroad.9 gains, as has been demonstrated established in lumbar spine surgery,7 Indeed, a recent economic report repeatedly for ERAS in other surgical but represent an intriguing possibility estimated the total annual cost disciplines. As an illustrative example for future research as a component for back pain in the United States of potential economic gains, we of ERAS for spine pathways. The (including diagnosis, treatment and can consider lumbar fusion: The minimally invasive approach may rehabilitation) at over $50 billion hospital costs associated with lumbar indeed be the ERAS-for-spine US dollars annually, and costs are fusion without instrumentation was analogy to the laparoscopic approach projected to increase 4.8% annually recently reported in a cohort study in ERAS-for-colorectal surgery, in in the near term.10 According to the to be approximately $14,700.00 terms of benefits on outcomes and report, the demand for spine surgery US dollars.11 The average length of biomolecular markers of surgical is being driven by an aging population, stay was 3.5 days in a sample of 77 stress.8 an increase in the number of fusions patients. A reduction in length of stay being performed, and technical of just 0.5 days per patient would

ASER ALERT • VOLUME 1, ISSUE 1 • aserhq.org 13 achieve overall hospital costs savings the evidence base raises more 4. Bekker A, Haile M, Kline R, Didehvar S, Babu R, Martiniuk F, Urban M: The effect of intraoperative of approximately $161,700.00 in this questions than it answers and infusion of dexmedetomidine on quality of cohort alone. exposes significant gaps in research recovery after major spinal surgery. J Neurosurg Anesthesiol 2013; 25(1):16-24. and knowledge: What is the role The third argument should ideally be of pre-operative education and 5. Demura S, Takahashi K, Murakami H, Fujimaki Y, Kato S, Tsuchiya H: The influence of made on the basis of evidence to shared-decision making in the steroid administration on systemic response indicate improved outcomes, reduced spine population? How can we in laminoplasty for cervical myelopathy. Arch Orthop Trauma Surg 2013; 133(8):1041-5. complications and rising patient standardize pathways for such satisfaction associated with ERAS heterogeneous patients, indications 6. Kim KT, Lee SH, Suk, SK, Bae SC: The for spine. However, this evidence quantitative analysis of tissue injury markers after and surgical interventions? What is mini-open lumbar fusion. Spine; 31(6):712-6. is currently scarce and there are no the role of epidural analgesia after 7. Payer M: “Minimally invasive” lumbar spine published accounts of comprehensive spine surgery? Is early mobilization surgery: a critical review. Acta Neurochir (Wein) 2011; 153(7):1455-9. ERAS pathways for any spine surgery appropriate after major reconstructive subtypes at this time. However, there procedures? These are just a very 8. Zhuang CL, Huang DD, Chen FF, Zhou CL, is an extensive literature regarding Zheng BS, Chen BC, Shen X, Yu Z: Laparoscopic few of the questions that need to versus open colorectal surgery within enhanced components of care that classically be answered urgently if ERAS for recovery after surgery programs: a systematic comprise ERAS pathways, together review and meta-analysis of randomized spine is to become relevant and controlled trials. Surg Endosc 2015; 29(8):2091- with encouraging results on a range useful. In order to most efficiently 100. of clinically important outcomes. A provide solutions, we advocate 9. Wainwright TW, Immins T, Middleton RG: full review is outside the scope of this creating an ERAS for spine pathway Enhanced recovery after surgery (ERAS) and its commentary, but several observations applicability for major spine surgery. Best Pract that can be adopted according to Res Clin Anaesthesiol 2016; 30(1):91-102. can be highlighted: multimodal institutional capability. At Hospital for analgesic regimens incorporating 10. Ken Research. The US Spinal Surgery Special Surgery, we have recently Market Outlook to 2017: Ageing population acetaminophen, non-steroidal anti- implemented an ERAS pathway for and technological advances to intensify inflammatories, anti-convulsants, and the competition. 2013; Available at lumbar spine fusion. The pathway is www.marketresearch.com/product/ local anesthetics are opioid sparing, based on current best evidence, but sample-7535890.pdf and associated with improved where evidence is lacking, we have 11. Molina CA, Zadnik PL, Gokaslan ZL, Witham TF, patient satisfaction, reduced length Bydon A, Wolinsky JP, Sciubba DM: A cohort implemented measures that have analysis of lumbar laminectomy—current trends of stay, and better pain control than demonstrated efficacy in other ERAS in surgeon and hospital fees distribution. Spine J 2013; 13(11):1434-7. intravenous opioid-based therapy after protocols. We are currently enrolling 12 spine surgery; a blood conservation patients in a prospective study to 12. Devin CJ, McGirt MJ: Best evidence in strategy including the anti-fibrinolytic, multimodal pain management in spine surgery investigate the effect(s) of the pathway and means of assessing postoperative pain and tranexamic acid, reduces autologous on patient centered outcomes. functional outcomes. J Clin Neurosci 2015; 22:930-38. blood transfusion without increasing Additionally, we call for research and the risk of thromboembolic events well-designed studies that focus on 13. Soroceanu A, Oren JH, Smith JS, Hostin R, after major reconstructive spine Shaffrey CI, Mundis GM, Ames CP, Burton DC, procedure-specific interventions, Bess S, Gupta MC, Deviren V, Schwab FJ, 13 surgery; identifying patients at risk improving logistics, and fostering a Lafage V, Errico TJ: Effect of antifibrinolytic therapy of nutritional deficiency and optimizing on complications, thromboembolic events, blood culture of enhanced recovery across product utilization, and fusion in adult spinal nutritional status was associated disciplines. n deformity surgery. Spine 2016; 41(14):E897-86. with a faster return to nutritional 14. Lapp MA, Bridwell KH, Lenke LG, Baldus C, baseline (or anabolic state) after References Blanke K, Iffrig TM: Prospective randomization of parenteral hyperalimentation for long fusions with major reconstruction surgery (>10 1. Watt DG, Horgan PG, McMillan DC: Routine spinal deformity: its effect on complications and spinal levels);14 and intravenous fluid clinical markers of the magnitude of the systemic recovery from postoperative malnutrition. Spine 2001;26(7):809-17. restriction is associated with less inflammatory response after elective operation: a systematic review. Surgery 2015; 362-80. post-operative ileus after lumbar 15. Fineberg SJ, Nandyala SV, Kurd MF, Marquez- Lara A, Noureldin M, Sankaranarayanan S, Patel fusion irrespective of surgical 2. Hu YF, Chen YJ, Lin YJ, Chen SA: Inflammation and the pathogenesis of atrial fibrillation.Nature AA, Oglesby M, Singh K: Incidence and risk approach.15 Rev Cardiol 2015; 12(4):230-43. factors for postoperative ileus following anterior, posterior and circumferential lumbar fusion. Spine 3. Van Munster BC, Korevaar JC, Zwinderman AH, J 2014; 1680-5. If follows that these examples could Levi M, Wiersinga WJ, De Rooij SE: Time-course be used as the basis for ERAS of cytokines during delirium in elderly patients with hip fractures. J Am Geriatr Soc 2008; for spine pathways. However, a 56(9):1704-9. closer examination of the state of

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 including non-opioid options before To-date, Choices Matter has generated with the growing opioid epidemic has surgery. The campaign provides an nearly 240 media placements and more swept national headlines. New reports opportunity to drive consideration for than 476.5 million media impressions. estimate 78 people die every day in the non-opioid alternatives, which can Highlights include a New York Times U.S. from overuse of opioids.1 Adding potentially minimize or virtually eliminate Letter to the Editor from ASER President, to this problem is a surreptitious factor: the need for prolonged use of opioids Dr. T.J. Gan, which leveraged key surgery has become an unintentional after surgery. statistics from a national survey of gateway to this tragic epidemic. In patients and surgeons conducted by fact, research shows that one-in-10 The Choices Matter campaign launched Pacira. Additional coverage was featured patients prescribed an opioid following August 1 in New York City, featuring a in USA Today, Good Day New York, U.S. surgery report becoming addicted to or top orthopedic surgeon and professional News & World Report, CNBC-TV, Self. dependent on the drug. athlete and television personality Gabby com, CBS New York and Parade.com. Reece. Gabby recently had her own It’s clear that we need to improve the knee replacement surgery without the PlanAgainstPain.com has generated dialogue between patients and surgeons help of prescription opioids, which more than 45,000 page views and 180 related to postsurgical pain management made Choices Matter an especially discussion guide downloads to date. – many patients are still unaware that relevant and timely campaign for her. The While our efforts have sparked a national they have choices, including non- campaign website – PlanAgainstPain. dialogue about alternatives to opioids, opioid options. That’s why ASER com – features helpful tools for patients there is much more work to be done to partnered with Pacira Pharmaceuticals about to undergo their own surgeries, combat this growing epidemic. For more to launch Choices Matter, a national, including a customized doctor discussion information visit PlanAgainstPain.com. n unbranded campaign designed to guide that allows patients to facilitate educate, empower and activate patients, conversations about non-opioid options References

caregivers and physicians to proactively with their surgeons. 1. https://www.cdc.gov/drugoverdose/epidemic/ discuss postsurgical pain management,

Gabby’s Story By Gabrielle Reece, Professional Volleyball Player, Sports Announcer, Fashion Model & Actress

I had made a personal decision not to exercise and nutrition. What I didn’t know take opioids. Although I was given a is that there are many options available Professional Athlete and Television low-dose painkiller in the hospital, I knew for managing pain after surgery, including Personality Gabby Reece Talks About I didn’t want to take a prescription home non-opioids. Recovery After Surgery with me. I’m very respectful of the fact that opioids are addictive and, although I Choices Matter is important to me he intense pain in my knee consider myself a strong person physically because I believe we should all be was starting to affect my life, and mentally, I’m aware that addiction advocates for our own health. This especially when I exercised or shows no discrimination when it comes program is about giving patients the played volleyball. When it got to to age, gender, ethnicity, lifestyle, etc. – it resources they need to make the most aT place where I knew I couldn’t make it can happen to anyone. In fact, a recent educated choice for them. That’s why I’m better through training, nutrition or therapy, survey found that one-in-10 patients encouraging people to have a conversation I decided it was time to get my knee prescribed an opioid following surgery with their doctor about alternatives to replaced. report becoming addicted to or dependent managing pain after surgery, including non- on the drug. I’ve been proactive in trying opioid options. Visit PlanAgainstPain.com It has been a little over six months since I to avoid that because it’s important to me to learn more and download a discussion had my surgery, and recovery has been a to stay holistic as possible in my recovery guide that can help you or a loved one long road for me. Prior to the procedure, through sleep, stress management, have this important conversation. n ASER ALERT • VOLUME 1, ISSUE 1 • aserhq.org 15 ASERalert Copyright© ASER 2016 unless otherwise indicated. All rights reserved. No part of this publication may be reproduced without permission from the editor.

American Society for Enhanced Recovery 6737 W Washington St. | Ste. 4210 | Milwaukee, WI 53214 414-389-8610 | [email protected]