Guidelines on the Evaluation and Treatment of Patients with Thoracolumbar Spine Trauma

6. Hemodynamic Management

download pdf Neurosurgery, 2018

Sponsored by: Congress of Neurological Surgeons and the Section on Disorders of the Spine and Peripheral Nerves in collaboration with the Section on Neurotrauma and Critical Care

Endorsed by: The Congress of Neurological Surgeons (CNS) and the American Association of Neurological Surgeons (AANS)

Sanjay S. Dhall, MD,¹ Andrew T. Dailey, MD,² Paul A. Anderson, MD,³ Paul M. Arnold, MD,⁴ John H. Chi, MD, MPH,⁵ Kurt M. Eichholz, MD,⁶ James S. Harrop, MD,⁷ Daniel J. Hoh, MD,⁸ Sheeraz Qureshi, MD, MBA,⁹ Craig H. Rabb, MD,¹⁰ P. B. Raksin, MD,¹¹ Michael G. Kaiser, MD,¹² and John E. O’Toole, MD, MS¹³

1. Department of Neurological Surgery, University of California, San Francisco, San Francisco, California

2. Department of Neurosurgery, University of Utah, Salt Lake City, Utah

3. Department of Orthopedics and Rehabilitation, University of Wisconsin, Madison, Wisconsin

4. Department of Neurosurgery, University of Kansas School of Medicine, Kansas City, Kansas

5. Department of Neurosurgery, Harvard Medical School, Brigham and Women’s Hospital, Boston, Massachusetts

6. St. Louis Minimally Invasive Spine Center, St. Louis, Missouri

7. Departments of Neurological Surgery and Orthopedic Surgery, Thomas Jefferson University, Philadelphia, Pennsylvania

8. Lillian S. Wells Department of Neurological Surgery, University of Florida, Gainesville, Florida

9. Department of Orthopaedic Surgery, Weill Cornell Medical College, New York, New York

10. Department of Neurosurgery, University of Utah, Salt Lake City, Utah

11. Division of Neurosurgery, John H. Stroger, Jr. Hospital of Cook County and Department of Neurological Surgery, Rush University Medical Center, Chicago, Illinois

12. Department of Neurosurgery, Columbia University, New York, New York

13. Department of Neurological Surgery, Rush University Medical Center, Chicago, Illinois

Correspondence:

Sanjay S. Dhall, MD

Associate Professor, Department of Neurological Surgery

University of California, San Francisco

Director of Spinal Neurotrauma, San Francisco General Hospital

505 Parnassus Avenue

San Francisco, CA 94143-0112

Email: sanjaydhall@gmail.com

Keywords: Hemodynamic management, mean arterial pressure, thoracolumbar spinal cord injury

Abbreviations

AISA – American Spinal Injury Association Spinal Injury grade

BP – blood pressure

MAP - mean arterial blood pressure

SCI - spinal cord injury

TLSCI - thoracolumbar spinal cord injury

No part of this article has been published or submitted for publication elsewhere.

ABSTRACT 

Background: Thoracolumbar spinal cord injuries (TLSCIs) have been studied less than cervical spinal cord injuries. Much of the management of TLSCI has been extrapolated from cervical spinal cord injuries studies, including the management of blood pressure.

Objective: The task force attempted to answer the question: Does the active maintenance of arterial blood pressure after injury affect clinical outcomes in patients with thoracic and lumbar fractures?

Methods: The task force members identified search terms/parameters and a medical librarian implemented the literature search, consistent with the literature search protocol (see Appendix I), using the National Library of Medicine PubMed database and the Cochrane Library for the period from January 1, 1946 to March 31, 2015.

Results: The task force selected 19 articles for full-text review. Of these, 18 were rejected for not meeting inclusion criteria or for being off topic. The majority of rejected articles did not include TLSCI or did not provide separate analysis of thoracolumbar injuries. One manuscript was selected for inclusion in this systematic review.

Conclusion: There is insufficient evidence to recommend for or against the use of active maintenance of arterial blood pressure after thoracolumbar spinal cord injury. However, considering published data from pooled (cervical and thoracolumbar) spinal cord injury patient populations, clinicians may choose to maintain mean arterial blood pressures >85 mm Hg in an attempt to improve neurological outcomes.

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INTRODUCTION

Goals and Rationale

This clinical guideline was created to improve patient care by outlining the appropriate information-gathering and decision-making processes involved in the evaluation and treatment of patients with thoracolumbar spine trauma. The surgical management of these patients often takes place under a variety of circumstances and by various clinicians. This guideline was created as an educational tool to guide qualified physicians through a series of diagnostic and treatment decisions to improve the quality and efficiency of care.

Thoracolumbar spinal cord injuries (TLSCIs) have historically had a relatively lower incidence and thus have been studied less often than other spinal cord injuries (SCIs). Much of the management of TLSCI has been extrapolated from cervical SCI studies, including the management of blood pressure (BP).^1,2 The task force attempted to answer the question: Does the active maintenance of arterial BP after injury affect clinical outcomes in patients with thoracic and lumbar fractures? While the application of mean arterial BP (MAP) goals to TLSCI is becoming more frequent in trauma centers, it is worthy of study as there is some risk of complication, particularly in older and more frail populations.

Methods

The guidelines task force initiated a systematic review of the literature and evidence-based guideline relevant to the diagnosis and treatment of patients with thoracolumbar trauma. Through objective evaluation of the evidence and transparency in the process of making recommendations, this evidence-based clinical practice guideline was developed for the diagnosis and treatment of adult patients with thoracolumbar injury. These guidelines are developed for educational purposes to assist practitioners in their clinical decision-making processes. Additional information about the methods used in this systematic review can be found in the introduction and methodology chapter.

Literature Search

The task force members identified search terms/parameters, and a medical librarian implemented the literature search, consistent with the literature search protocol (see Appendix I), using the National Library of Medicine PubMed database and the Cochrane Library (which included the Cochrane Database of Systematic Reviews, the Database of Abstracts of Reviews of Effect, the Cochrane Central Register of Controlled Trials, the Health Technology Assessment Database, and the National Health Service Economic Evaluation Database) for the period from January 1, 1946 to March 31, 2015, using the  search strategies provided in Appendix I.

RESULTS

The literature search yielded 1100 abstracts. Task force members reviewed all abstracts yielded from the literature search and identified the literature for full-text review and extraction, addressing the clinical questions, in accordance with the literature search protocol (Appendix I). Task force members identified the best research evidence available to answer the targeted clinical questions. When level I, II, and/or III literature was available to answer specific questions, the task force did not review level IV studies.

The task force selected 19 articles for full-text review. Of these, 18 were rejected for not meeting inclusion criteria or for being off topic. The majority of rejected articles did not include TLSCI or did not provide separate analysis of these injuries. One manuscript was selected for inclusion in this systematic review (Appendix II).

Inclusion/Exclusion Criteria

Articles were retrieved and included only if they met specific inclusion/exclusion criteria. These criteria were also applied to articles provided by guideline task force members who supplemented the electronic database searches with articles from their own files. To reduce bias, these criteria were specified before conducting the literature searches.

Articles that do not meet the following criteria were, for the purposes of this evidence-based clinical practice guideline, excluded. To be included as evidence in the guideline, an article had to be a report of a study that:

• Investigated patients with thoracolumbar injuries;
• Included patients ≥18 years of age;
• Enrolled ≥80% of thoracolumbar injuries (studies with mixed patient populations were included if they reported results separately for each group/patient population);
• Was a full article report of a clinical study;
• Was not an internal medical records review, meeting abstract, historical article, editorial, letter, or commentary;
• Appeared in a peer-reviewed publication or a registry report;
• Enrolled ≥10 patients per arm per intervention (20 total) for each outcome;
• Included only human subjects;
• Was published in or after 1946;
• Quantitatively presented results;
• Was not an in vitro study;
• Was not a biomechanical study;
• Was not performed on cadavers;
• Was published in English;
• Was not a systematic review, meta-analysis, or guideline developed by others*;
• Was a case series (therapeutic study) where higher level evidence exists.

RCT, Randomized controlled trial.

^aA complete assessment of quality of individual studies requires critical appraisal of all aspects of the study design.

^bA combination of results from ≥2 previous studies.

^cStudies provided consistent results.

^dStudy was started before the first patient enrolled.

^ePatients treated one way (e.g., instrumented arthrodesis) compared with a group of patients treated in another way (e.g., unsintrumented arthrodesis) at the same institution.

^fThe study was started after the first patient enrolled.

^gPatients identified for the study based on their outcome, called “cases” (e.g., pseudoarthrosis) are compared to those who did not have outcome, called “controls” (e.g., successful fusion).

^hPatients treated one way with no comparison group of patients treated in another way.

Appendix IV. Linking Levels of Evidence to Grades of Recommendation

^aNote that in the presence of multiple consistent studies, and a single outlying, inconsistent study, the Grade of Recommendation will be based on the level of the consistent studies.

Appendix V. Criteria Grading the Evidence

The task force used the criteria provided below to identify the strengths and weaknesses of the studies included in this guideline. Studies containing deficiencies were downgraded one level (no further downgrading allowed, unless so severe that study had to be excluded). Studies with no deficiencies based on study design and contained clinical information that dramatically altered current medical perceptions of topic were upgraded.

1. Baseline study design (i.e., therapeutic, diagnostic, prognostic) determined to assign initial level of evidence.
2. Therapeutic studies reviewed for following deficiencies:
   • Failure to provide a power calculation for an RCT;
   • High degree of variance or heterogeneity in patient populations with respect to presenting diagnosis/demographics or treatments applied;
   • <80% of patient follow-up;
   • Failure to utilize validated outcomes instrument;
   • No statistical analysis of results;
   • Cross over rate between treatment groups of >20%;
   • Inadequate reporting of baseline demographic data;
   • Small patient cohorts (relative to observed effects);
   • Failure to describe method of randomization;
   • Failure to provide flowchart following patients through course of study (RCT);
   • Failure to account for patients lost to follow-up;
   • Lack of independent post-treatment assessment (e.g., clinical, fusion status, etc.);
   • Utilization of inferior control group:
     • Historical controls;
     • Simultaneous application of intervention and control within same patient.
   • Failure to standardize surgical/intervention technique;
   • Inadequate radiographic technique to determine fusion status (e.g., static radiographs for instrumented fusion).
3.  Methodology of diagnostic studies reviewed for following deficiencies:
   • Failure to determine specificity and sensitivity;
   • Failure to determine inter- and intraobserver reliability;
   • Failure to provide correlation coefficient in the form of kappa values.
4.  Methodology of prognostic studies reviewed for following deficiencies:
   • High degree of variance or heterogeneity in patient populations with respect to presenting diagnosis/demographics or treatments applied;
   • Failure to appropriately define and assess independent and dependent variables (e.g., failure to use validated outcome measures when available).

Appendix VI. Evidence Tables

© Congress of Neurological Surgeons

Source: Neurosurgery, September 6, 2018