“Patients undergoing orthopedic procedures are at higher risk of mortality from venous thromboembolism (VTE)”. Although there is little evidence for this statement in modern orthopaedic practice, it is still frequently seen in publications exploring the issue of VTE in orthopedics (Fig. 1). This has perpetuated a long-standing fear of VTE-related morbidity and mortality among both the medical community and patients alike1. Hence, numerous organizations such as the American Academy of Orthopaedic Surgeons (AAOS)2 and the American College of Chest Physicians (ACCP)3 in the U.S., and numerous other organizations across the globe, have created guidelines related to the issue of VTE in orthopedics.
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Fig. 1: Letter from Dr. Nigel Rossiter.
In view of the imperfect data available on the subject of VTE, it is no surprise that these guidelines have been criticized on some grounds. Many guidelines have limited their scope to a specific surgical procedure (e.g., total hip or knee replacement), some have failed to recognize the importance of variations in geographic and racial predisposition to VTE, and almost all have attempted to create recommendations by either preferentially or exclusively relying on high level studies only. While understandable from the methodological perspective and commendable, the latter strategy has resulted in the inclusion of studies conducted by the pharmaceutical industry, as part of regulatory requirements, to have a new chemoprophylaxis agents approved for clinical use. Such studies often have been powered to evaluate the difference in the incidence of distal deep venous thrombosis as detected with venography, but not clinically important symptomatic VTE or the rare fatal pulmonary embolus, which is the real concern for both the medical community and their patients4,5. Some guidelines have been criticized for overlooking the complications that can arise as a result of administration of some of these agents (e.g., bleeding, wound-related complications, and infection), which result in immense expense to the health-care system and can also lead to fatality6.
The International Consensus Meeting (ICM), having recognized the limitations of the current guidelines and the need for unbiased randomized trials with clinically important end points, convened a group of experts from around the globe to generate guidelines or recommendations that address the real-world issues. Delegates from 135 international societies, 68 countries, and various specialties, including anesthesia, cardiology, hematology, internal medicine, and orthopedics, were invited to comb through the literature in a systematic review format and to create practical recommendations related to all subspecialities in orthopedics that would also have global applications. This immense initiative engaged nearly 600 experts who followed the strict Delphi process7, as in prior ICM activities8,9, to generate the monumental document that stands in front of you. Over a period of 1 year, and with the critical guidance of the steering committee and engagement of the organizing committee, librarians, biostatisticians, epidemiologists, and experts from the Cochrane group, ALL published work related to VTE and orthopaedics was reviewed to generate a response/recommendation to the nearly 200 issues (questions) that had been collated from the field.
The delegates were nominated by societies or recruited on the basis of their interest in the subject matter and were selected on the basis of their published expertise (with a minimum of 3 publications related to VTE). Each question was assigned to 2 delegates who were provided the MESH terms, and at times the list of publications, by the librarians. The delegates were free to work together or independently. After 6 months of literature review and extraction of data, the delegates created the initial draft of the recommendations. The first draft of the document was then sent for review by 1 or 2 other delegates with expertise in that subject matter. The critique or suggestions arising from this initial review were sent to the authors to address. The revised document underwent a second review by an additional group of delegates. At all times, the living documents were posted on the ICM website for all to view and provide comments. All generated comments through the website were also shared with the authors of each document.
The document underwent 2 additional reviews prior to submission to The Journal of Bone and Joint Surgery. One review was done by a member of the organizing committee to ensure completeness of the document, and another review was provided by the corresponding editor for each subspeciality. The submitted work was then subjected to the usual editorial scrutiny of JBJS prior to going into “print.”
This enormous task could not have been completed in short order without the sacrifice and dedications of many. Above all, a deep gratitude goes to the delegates from around the world who selflessly dedicated hours of their scarce time to complete the task in such an expeditious and thorough manner. An initiative of this magnitude could not be completed without the critical contribution of many others (see Acknowledgements).
We are hopeful that the generated work will serve the patients and our community for years to come.
References
1. Søgaard KK, Schmidt M, Pedersen L, Horváth-Puhó E, Sørensen HT. 30-year mortality after venous thromboembolism: a population-based cohort study. Circulation. 2014 Sep 2;130(10):829-36.
2. Jacobs JJ, Mont MA, Bozic KJ, Della Valle CJ, Goodman SB, Lewis CG, Yates AC Jr, Boggio LN, Watters WC 3rd, Turkelson CM, Wies JL, Sluka P, Hitchcock K. American Academy of Orthopaedic Surgeons clinical practice guideline on: preventing venous thromboembolic disease in patients undergoing elective hip and knee arthroplasty. J Bone Joint Surg Am. 2012 Apr 18;94(8):746-7.
3. Falck-Ytter Y, Francis CW, Johanson NA, Curley C, Dahl OE, Schulman S, Ortel TL, Pauker SG, Colwell CW Jr. Prevention of VTE in orthopedic surgery patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2)(Suppl):e278S-325S.
4. Chan NC, Siegal D, Lauw MN, Ginsberg JS, Eikelboom JW, Guyatt GH, Hirsh J. A systematic review of contemporary trials of anticoagulants in orthopaedic thromboprophylaxis: suggestions for a radical reappraisal. J Thromb Thrombolysis. 2015 Aug;40(2):231-9.
5. Pellegrini VD Jr, Eikelboom J, McCollister Evarts C, Franklin PD, Goldhaber SZ, Iorio R, Lambourne CA, Magaziner JS, Magder LS; Steering Committee of The PEPPER Trial. Selection Bias, Orthopaedic Style: Knowing What We Don’t Know About Aspirin. J Bone Joint Surg Am. 2020 Apr 1;102(7):631-3.
6. Lindquist DE, Stewart DW, Brewster A, Waldroup C, Odle BL, Burchette JE, El-Bazouni H. Comparison of Postoperative Bleeding in Total Hip and Knee Arthroplasty Patients Receiving Rivaroxaban, Enoxaparin, or Aspirin for Thromboprophylaxis. Clin Appl Thromb Hemost. 2018 Nov;24(8):1315-21.
7. Dalkey N, Helmer O. An experimental application of the Delphi method to the use of experts. Manage Sci. 1963;9(3):458-67.
8. Cats-Baril W, Gehrke T, Huff K, Kendoff D, Maltenfort M, Parvizi J. International consensus on periprosthetic joint infection: description of the consensus process. Clin Orthop Relat Res. 2013 Dec;471(12):4065-75.
9. Parvizi J, Gehrke T. International consensus on periprosthetic joint infection: let cumulative wisdom be a guide. J Bone Joint Surg Am. 2014 Mar 19;96(6):441.
