Patient Safety
Preoperative and Preprocedural Risk Assessment and Mitigation Strategies

Gene Tekmyster, DO, MBA
Chair, NASS Patient Safety Committee Keck Medicine of USC Los Angeles, CA

Akhil Chhatre, MD
Johns Hopkins School of Medicine Baltimore, MD

William Richardson, MD
Duke University Durham, NC

Obinna M. Ayogu, FMCS
Department of Neurosurgery, National Hospital Abuja, Federal Capital Territory, Nigeria

Stephen Bartol, MD, MBA, FRCSC
Windsor Regional Hospital Windsor, ON, Canada

Thomas M. Mauri, MD
Northwell Health Great Neck, NY

Ripul R. Panchal, DO
American Neurospine Institute Frisco, TX

Gazanfar Rahmathulla, MD, MBA
Mayo Clinic Health System Eau Claire, WI

Andrew F. Walker, MD
Saint Francis Medical Center Cape Girardeau, MO
Abstract
This article defines optimization as identification of modifiable risk factors for spine surgery and interventional spine procedures and suggests strategies to reduce the impact of those risks. A literature review was completed, risk factors identified, and potential mitigation strategies discussed. Developing preoperative checklists and establishing appropriate protocols can reduce perioperative complications.
Introduction
Spinal surgery and interventional spine procedures optimization involves identifying risks preoperatively that are associated with complications, and developing strategies to mitigate those risks. The Patient Safety Committee identified this as a priority.
To support this effort, a literature search was conducted by the Medical Research Librarian at the American Academy of Orthopaedic Surgeons in 2021. The literature search included the Ovid MEDLINE, Embase and Cochrane Library bibliographic databases and resulted in 1,532 unique results published between 1990 and 2021 in the English language. Additional citations were added where needed to provide a comprehensive framework of evidence and best practices.
All abstracts were reviewed by two independent reviewers within the committee work group using Rayyan1 and subsequently during the full text review stage. Disagreements that could not be resolved by discussion, we referred to a third reviewer for arbitration. At least two members from the work group extracted data from each included article using a predefined template. Modifiable preoperative risks were identified to include obesity, smoking, anemia, nutrition/frailty, diabetes, osteoporosis, anticoagulation, and narcotic usage.
The work group described these risk factors in the setting of surgical procedures as well as some larger interventional procedures and interventional spine injections.
Obesity
Obesity significantly impacts spinal health, primarily through increased biomechanical loading and systemic inflammation. Patel et al reported that patients with a BMI of 40 have a 36% probability of encountering significant perioperative complications, emphasizing the critical need for effective nonsurgical management in obese patients.2 This elevated risk is due to both direct mechanical stress on the spine and a proinflammatory state characterized by elevated adipokine levels, such as leptin, which exacerbate degenerative spinal conditions.3
Weight management strategies, including dietary modifications and physical therapy, play a pivotal role to treat obesity. Exercise programs tailored to strengthen core musculature can mitigate the mechanical load on the spine, reducing pain and disability.4 Furthermore, dietary interventions that reduce caloric intake and modulate inflammation are crucial, as they directly address the inflammatory mediators involved in degenerative spinal processes.5
Medical management often involves using anti-inflammatory medications to reduce systemic inflammation, which is particularly pronounced in obese individuals.3 Medication management also includes GLP-1 (Glucagon-like peptide-1) agonists. The current literature explores potential adverse effects associated with the use of GLP-1 agonists during the preoperative period.
These medications have a longer half-life than endogenous GLP-1, which results in a prolonged effect on delaying gastric emptying and consequently may increase the risk of aspiration. This needs to be considered when discussing the timing of discontinuing these medications prior to surgery, time for fasting and use of a clear liquid diet.6 Alongside pharmacological interventions, nonpharmacological approaches like cognitive-behavioral therapy have been reported to help manage chronic pain and improve adherence to lifestyle modifications.
Educational programs that integrate information on the relationship between obesity, spinal health, and overall wellness are essential. These programs encourage patient participation in their treatment and emphasize the importance of maintaining a healthy weight for spinal health. Regular follow-ups which include clinical evaluations and imaging studies are helpful to monitor the progression of spinal conditions and adjusting treatments as needed.2 AAOS Risk Tool suggests reasonable BMI for elective surgery is <= 40. Good strategies include a set BMI target, discussion of reasonable goals with the patient, consideration of verbal or written contrasts for weight loss goals and referral for nutritional services.7
While obesity may increase the technical difficulty and potential for certain complications associated with spinal injections and anesthesia, it should not be considered a strict contraindication to the procedure. Careful consideration of the patient's individual circumstances, including BMI and other comorbidities, and a thorough discussion of the risks and benefits are crucial for providing safe and effective care.
Smoking
There have been numerous investigations over the years regarding the risk of smoking related to spinal surgery. Recent literature on the subject strongly suggests that smoking can have negative effects on spinal surgical patients. Multiple systematic reviews8,9,10,11 linked smoking with pseudarthrosis in spinal fusion surgery, both cervical and lumbar. Li et al presented pooled results of 26 studies showing the fusion rate of smokers after spinal fusion was significantly lower than that of nonsmokers.11
Several studies reported higher infection rates in smokers8,9,12 and association with increased risk for reoperation.13 In 2021, Harrop et al likewise concluded that smoking is associated with increased risk of reoperation.14 Berman et al linked smoking with dysphagia following cervical spine surgery and increase in adjacent segment pathology.9 Mohamed et al found that smoking was associated with an increased risk of postoperative pneumonia and was a leading cause of postoperative intubation.15
Smoking cessation recommendations are controversial. Harrop et al found that there was insufficient evidence that cessation of smoking before spine surgery decreases the risk of reoperation.14 Berman et al concluded that the most important recommendation is smoking cessation for four weeks after surgery and suggested that preoperative smoking cessation should be recommended as a method to reduce comorbidities and improve overall patient health.9 The AAOS suggests stopping smoking at least 4-6 weeks prior to surgery and 6 weeks following the surgery. They suggest checking blood nicotine level prior to surgery; some insurance companies require nicotine testing prior to fusion surgery.16
Anemia
The World Health Organization broadly defines anemia as a hemoglobin concentration <13 g/dL for men and <12 g/dL for women.17 Spine surgery is commonly associated with increased perioperative blood loss, which is attributed to the long duration of surgery and rich blood supply to the spine.18
Seicean et al concluded that all levels of anemia (mild, moderate and severe) were significantly associated with prolonged length of hospitalization and poorer operative outcome in spine patients.19
Perioperative anemia reduces transfusion threshold thereby increasing the rate of blood transfusion and its potential risks which could affect overall surgical outcomes. Estimates of blood loss in spine surgery range from 100 to 4700 ml. Higher blood loss is significant in patients with presence of perioperative anemia.20 Other complications that could arise from anemia include implant failure, surgical site infections, deep vein thrombosis and pulmonary embolism.
As a result of these challenges, anemia is considered an independent risk factor for preoperative and postoperative complications in elective spine surgery.19 It is therefore clinically important to understand potential perioperative risks of anemia in spine surgery and aim at correcting anemia preoperatively.
Furthermore, surgeons should maximize the use of available minimally invasive techniques coupled with meticulous surgical dissection to minimize intra and post-operative blood loss.
Nutrition
Only one review addressed nutrition as a risk factor.21 In all 13 articles included in the review, malnutrition was assessed using albumin as a surrogate for nutritional status. On this basis, “malnutrition” was associated with an increased rate of postop complications including surgical site infections (SSI), other wound complications, non-unions, hospital readmissions, and other medical complications.
However, the authors did not find sufficient evidence to support the use of a perioperative multimodal nutrition management protocol. Albumin alone may not be adequate as a measure of nutrition; nutritional status is affected by multiple factors.22 No studies in our search have identified a single reliable measure of nutrition and its impact on surgical outcomes, as malnutrition is a multifactorial and multi-system process disorder.
The AAOS Toolkit suggests several laboratory tests to consider when evaluating for malnutrition including albumin, prealbumin, total protein, total lymphocyte count and serum transferrin levels. A suitable nutritional screening checklist should include low BMI, diabetes, anemia, inflammatory disease and obesity. If malnutrition is suspected, patients should receive nutritional counselling and supplementation, particularly with protein and vitamin D.23
However, as stated above, these labs, especially albumin and prealbumin, should be interpreted with caution to assess the underlying cause as they can reflect a sign of physiologic stress, potentially resulting from disease or trauma-related inflammation, rather than solely a reflection of nutrition status.
Vitamin D deficiency was addressed in a systematic review by Kerezoudis et al. They included five articles and found that patients presenting with vitamin D deficiency had lower fusion rates and higher rates of recurrent-persistent low back pain compared with patients with normal vitamin D levels.24 Within the Kerezoudis review, the studies examining the effect of postoperative vitamin D supplementation in deficient patients reported significant improvements in low back pain intensity, patient-reported outcomes scores and fusion rates compared with baseline and with control groups. Patients presenting for spinal fusion may benefit from correction of vitamin D deficiency to maximize the chance of a successful arthrodesis and to achieve optimal surgical outcomes.
Frailty
Four systematic reviews were identified that dealt with frailty as a risk factor in spine surgery patients. Chan et al reviewed 32 studies with a total of 127,813 patients and Baek et al included 38 articles (474,651 patients) in their systematic reviews.25,26 Multiple frailty indices were identified, but regardless of how frailty was measured, it was associated with higher mortality, an increased length of stay, increased risk of hospital readmission, nonhome discharge, and major medical complications.
Interestingly, preoperative and postoperative Oswestry Disability Index scores were not affected. Moskven et al looked at frailty and sarcopenia as predictors of outcome in a systematic review of 11 articles.27 They found that frailty, regardless of measure used, was a consistent predictor of mortality, major and minor morbidity. Sarcopenia was an inconsistent predictor, possibly a result of varying definitions and measurement techniques. Veronesi reviewed 29 retrospective studies.28 Eleven frailty indexes were identified—all of which correlated with minor and major postoperative complications, mortality and length of stay. The results of these four systematic reviews suggests that a frailty index should be incorporated in the pre-operative assessment of spine patients.
Diabetes/A1C
Uncontrolled Diabetes Mellitus is a well-established risk factor associated with diminished long-term patient-reported outcomes, increased readmission rates and an increased incidence of surgical site infections (SSI) following spine surgery.29-32
Glycated hemoglobin A1c serves as a serum biomarker to measure diabetic control with several studies establishing the relationship between preoperative HbA1c values and postoperative outcomes.
In a systematic review by Tao et al, the authors concluded that preoperative HbA1c at values > 8.0% was associated with an increased risk in all-cause postoperative complications.33 Specifically, Cancienne et al showed in patients undergoing anterior cervical discectomy that there is a significant correlation between elevated HbA1c levels (> 7.5mg/dL) and both the reoperation rate and SSI.34
In a retrospective review, Hikata et al noted that patients undergoing thoracolumbar procedures with an HbA1c > 7.0% tended to have a significantly higher incidence of SSI in comparison to patients with HbA1x < 7.0%.29 Overall, there is a strong association between elevated HbA1c and worsened postoperative outcomes following spine surgery29-34; however there is insufficient data to assess the particular risk of SSI in Spinal Cord Stimulator implantation.35
HbA1c testing, and if needed, optimization in the preoperative period of diabetic patients undergoing spine surgery should be performed to minimize complications and improve patient outcomes.
Additional Considerations for Spine Steroid Injections
Injection therapy that includes steroids as part of the injectate have a direct, short-term effect on blood sugar levels.36,37 Patients should be counseled on the risk and benefits of receiving exogeneous corticosteroids. While there is no standardized cutoff for blood glucose levels prior to performing interventional procedures, clinicians should be aware of the potential of increased blood glucose as a result of corticosteroid administration in the immediate post-procedure period.36,37
Bone Quality
Osteoporosis is defined as low bone mineral density and altered bone quality that places the patient at risk of fragility fractures and associated morbidity. Traditional methods of diagnosis are DEXA scanning and T-score calculation. The World Health Organization classifies osteoporosis as a T score <= -2.5.38 Osteopenia has a T-score -1.0 to -2.4. Osteoporosis may also be clinically diagnosed with a T-score above -2.5 if the patient has a concomitant fragility fracture or a risk of fracture based on the FRAX score. A FRAX score of >3% risk of hip fracture or >20% risk of major osteoporotic fracture (MOF) supports a clinical diagnosis of osteoporosis.
Alternative options to evaluate bone quality in the absence of a DEXA scan would be a CT scan of the spine.39 Greater than or equal to 150 Hounsfield Units (HU) at L1 is normal, less than 100 HU is considered osteoporosis and 100-150 HU is considered osteopenia.
Poor bone health has been linked to worse outcomes in spine surgery including junctional problems, screw loosening and hardware failure.40 Treatment options include optimization of calcium and vitamin D in all patients.40 For patients with osteoporosis or high FRAX scores, antiresorptive agents (bisphosphonates and denosumab) or anabolic agents are also treatment options.40
Anderson has suggested risk stratification based on assessment of bone health and complexity of surgery into normal or low risk, intermediate risk, high risk and very high risk.41 All patients should have optimization of their calcium and vitamin D. Normal or low risk patients typically have normal bone density and low FRAX scores. These patients should optimize calcium and vitamin D, without delay in surgery.38,42 Intermediate-risk patients are those with osteopenia but no fractures and a FRAX MOF of <20%; they should have calcium and vitamin D optimized, and no delay of surgery.40,43
High-risk patients are those with osteoporosis, fractures within the last two years, and a FRAX MOF of 20-30%. In addition to optimizing calcium and vitamin D, they should be treated with an antiresorptive agent or an anabolic agent. Delaying surgery should be considered in cases of multilevel or revision fusion. Very high-risk patients have osteoporosis, multiple fractures, and a FRAX MOF >30% with recent fractures. Optimization of calcium and vitamin D, prescription of an anabolic agent and delay of surgery 3-9 months are strongly recommended.44,45
Additional Considerations for Interventional Procedures
Basivertebral nerve ablation (BVNA) offers promising treatment for chronic vertebrogenic low back pain. However, its interaction with bone quality requires careful consideration particularly in the elderly and osteoporotic population, where it may temporarily increase the risk of vertebral compression fractures. Recent research suggests that while BVNA appears to have a strong long-term safety profile and may not have a long-term adverse impact on vertebral bone, a transient weakening period should be acknowledged and managed.46
A recent retrospective review by Bellow et al found no post-procedure vertebral compression fractures even in patients with osteoporosis and osteopenia.47 While the sample size was small (N=32), this is one of the few studies evaluating the safety of BVNA in patients with low bone density. Overall, the findings contribute to the growing body of literature supporting the safety and effectiveness of basivertebral nerve ablation in patients with reduced bone density.
Anticoagulation
Preoperative and preprocedural risk assessment includes evaluation of patients’ home medications, comorbidities and their associated risk for bleeding or thrombosis during or after surgery or interventional spine procedures.48,49,50,51 A thorough review of patient medical records and medication list should include evaluation of any anticoagulant or antiplatelet medications. At this time, there is a paucity of evidenced-based guidelines or literature to guide the clinician to the risks of ceasing vs maintaining anticoagulant and/or antiplatelet medications (ACAP) prior to needle based interventional procedures.48
Recent evidence does suggest a greater thrombotic risk with cessation of an ACAP agent than the bleeding risk when performing an injection or ablation procedure while maintaining ACAP medications.52-57 It appears the risk of clinically relevant bleeding complications including epidural hematoma in properly performed spine injections is low. This information is crucial in being able to quantitatively determine the risk of ceasing or maintaining anticoagulant/antiplatelet medications prior to needle based spine procedures.
For spine surgery there is evidence to support continuation of low dose aspirin (ASA) without cessation.50,51,58,59 The continuation of aspirin will not increase the risk of blood loss during spinal surgery and there is no evidence to support increased operative times or rates of blood transfusions.60 While more studies are needed to confirm this change in paradigm, the trending evidence suggests the clinically significant bleeding risk is lower than previously published while the thrombotic risk and morbidity is higher than expected and previously reported.52-57,61
Narcotic Usage
The literature search and selection process found a total of six systematic review and meta-analysis papers, or Clinical Practice Guidelines that consistently identified preoperative opioid use as a risk factor for persistent post-operative opioid use, worse surgical outcomes, increased length of stay, higher costs and utilization of resources.62-67
Lavoie-Gagne’s 2020 systematic review of 45 studies found prior use of opioids was associated with prolonged opioid use in 353,330 patients, while Kent’s 2019 systematic review of 46 articles found the incidence of persistent postoperative opioid use ranges from 0.6% to 26% for opioid-naïve patients and a range of 35% to 77% for patients with previous opioid exposure.62,63
Lo’s 2020 metanalysis of eight claims databases and five nonclaims observational studies showed that preoperative opioid users had a statistically significantly higher odds of long-term postoperative opioids.64 Wang’s 2021 systematic review of 41 articles found long-term preoperative use was associated with long-term postoperative use.65 The odds of long-term opioid use also increased with increasing preoperative dose.65 Yang’s 2019 metanalysis of 33 studies of 53,362 patients found that use of preoperative analgesia was a predictor of poor postoperative pain control.66 Yerneni’s 2020 systematic review found preoperative opioid use to be associated with increased postoperative chronic opioid use in 18 of 19 studies.67
If necessary to operate on an opioid dependent patient, Wang found insufficient level of evidence to wean off opioids preoperatively; however, one study did show that weaned patients’ return to opioid naïve patient level of risk, but the latter did include joint replacement and spine fusion surgery patients.65,68
Two studies suggest intraoperative management affects long term persistent opioid dependence likelihood. Santa Cruz Mercado (2023) found increased fentanyl administration compared to dilaudid was associated with lower frequency of uncontrolled pain; a decrease in new chronic pain diagnoses, reported at 3 months, fewer opioid prescriptions at 30, 90, and 180 days, and decreased new persistent opioid use, without significant increases in adverse effects.69
Murphy reported on analgesic benefits of a single dose of intraoperative methadone during the first 3 months after spinal surgery (but not at 6 and 12 months), and during the first month after cardiac surgery, when the intensity and frequency of pain were the greatest.70
Conclusion/Discussion
Several risk factors have been identified that are linked to an increased likelihood of complications following spinal surgery or interventional spine procedures. Protocols, risk assessment tools, or checklists can be developed and should be used to identify these factors before surgery, and mitigation strategies applied when possible to reduce the risk of adverse outcomes.71-74
Acknowledgements
The NASS Patient Safety Committee initiated this project with the goal of developing a resource outlining existing research on pre-procedure risk assessment and mitigation strategies in spine surgeries and interventions. A work group (WG) within the committee was formed under the leadership of former co-chairs TM and AW, with project co-leaders AC (interventional) and WJR (surgical). A literature search was completed in December of 2021, followed by abstract review, article retrieval, and data extraction. The final draft was reviewed by the WG, Patient Safety Committee (Waeel Hamouda, MD, PhD, FRCS; William Dillin, MD), Committee Chair (GT), and Evidence Analysis and Research Council Director (Steve Hwang, MD) prior to submission.
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Author Disclosures
G Tekmyster: Scientific Advisory Board: Boston Scientific (B)
A Chhatre: Consulting: Stryker (D); Scientific Advisory Board: Petal Surgical (1%)
W Richardson: Speaking and/or Teaching Arrangements: DePuy Spine (A, Paid directly to institution/employer)
OM Ayogu: Nothing to disclose
S Bartol: Consulting: Johnson & Johnson (B)
TM Mauri: Nothing to disclose
RP Panchal: Consulting: Evolution (D), Intelviation (B), Medtronic (C), SpineVision (C), Vivex Biologics (B); Other Office: North American Spine Society (Nonfinancial, Patient Safety Committee, CME Committee); Research Support (Staff and/or materials): Medtronic (D, Paid directly to institution/employer), Orthofix (B, Paid directly to institution/employer); Royalties: Dio Medical (B); Speaking and/or Teaching Arrangements: American Osteopathic Board of Surgery (A).
G Rahmathulla: Nothing to disclose
AF Walker: Nothing to disclose