Evidence-Based Clinical Guidelines

Multidisciplinary Spine Care Antithrombotic Therapies for Adults Undergoing Spine Surgery

Second Edition

Recommendations:

Comparisons & Special Considerations

Question 21. Does a specific chemoprophylaxis regimen fare better than a different one for reduction of DVT/PE following spine surgery (heparin versus lovenox)?
Question 22. What patient comorbidities (if any) create an indication for the use of a vena cava filter (temporary or permanent) for patients undergoing spine surgery (elective, trauma, or tumor)??
Question 23. If a vena cava filter is indicated, when should anticoagulation be started after spine surgery?
Question 24. Does the incidence of wound complications or neurologic decline from epidural hematoma with use of chemoprophylaxis differ for patients undergoing spinal surgery (cervical, thoracic or lumbar) for: elective, spine trauma, malignancy?
Question 25. What is the ideal measure by which to gauge the risk/benefit ratio of chemoprophylaxis in patients undergoing spinal surgery?
Question 26. If a vena cava filter is indicated, when should anticoagulation be started after spine surgery?

Question 21: Does a specific chemoprophylaxis regimen fare better than a different one for reduction of DVT/PE following spine surgery? (heparin versus lovenox)

There is insufficient evidence to make a recommendation for or against one specific chemoprophylaxis agent to prevent DVT/PE events following spine surgery. Grade of Recommendation: I

Du et al1 conducted a randomized prospective trial. The purpose was the evaluation of rivaroxaban for preventing DVT after lumbar spine surgery using parnaparin as the control group. This was a prospective randomized controlled study of 665 cases who then were randomly assigned to 1 of 2 groups, 341 to the rivaroxaban (Group A) and 324 to the parnaparin group (Group B). Group A was given 10 mg orally every day for 14 days starting 6 to 8 hours after surgery. Group B was given a subcutaneous injection 40 mg every day for 14 days starting 6 to 8 hours after surgery. The results were based on efficacy endpoint indicator (all DVT, nonfatal PE, and mortality for all caused), and the safety endpoint indicator (major bleeding events). Both the incidence of thrombotic events and bleeding events, both severe and nonsevere, were found to be not significant between the 2 groups (P>0.05). It was concluded that rivaroxaban is equally as effective as parnaparin in preventing DVT and doesn’t pose any additional postoperative bleeding events. This study provides Level I evidence that Parnaparin and Rivaroxaban have equal effectiveness for preventing VTE in lumbar spine surgery. Guo et al2 evaluated argatroban’s effectiveness and safety in preventing VTE events in patients who underwent posterior lumbar decompressive surgery. This is a retrospective comparative study in which 556 patients who underwent posterior decompressive surgery from 2013 to 2016 were included. These patients were divided into 2 groups, the ones that used argatroban and the ones that used LMWH. It compares the occurrence of VTE and hemorrhage along with allergic reactions between the 2 groups. It also looks at ODI and VAS presurgery to 6 and 12 months postsurgery. The were 274 patients in the argatroban group and 282 in the LMWH group. There was no significant difference in any of the parameters analyzed in this study, VTE (P>0.05), as well as ODI and VAS (>0.05) were not significant. It concludes that argatroban and LMWH are equally effective in preventing VTE in posterior lumbar decompression surgery without increasing postoperative bleeding events). This study provides Level III evidence that Argatroban proved to be equally effective as LWMH for anticoagulation therapy. Both drugs exhibited a similar preventive effect against postoperative VTE after posterior lumbar spine surgery. Zhang et al3 retrospectively assessed the efficacy and safety of 2 anticoagulants, apixaban and rivaroxaban, following lumbar spine surgery. Conducted at the Department of Spinal Surgery, Puai Hospital, Tongji Medical College, Huazhong University of Science and Technology in China, this retrospective study examined patients who underwent spinal procedures between May 2015 and 2017. Patients were randomly allocated to either the apixaban or rivaroxaban groups. The findings of this study, categorized as Level IV evidence, indicate that both apixaban and rivaroxaban demonstrate comparable effectiveness in preventing postoperative venous thromboembolism (VTE) after lumbar spine surgery. Additionally, apixaban exhibits an advantage of reduced bleeding compared to rivaroxaban.

References

  1. Du W, Zhao C, Wang J, Liu J, Shen B, Zheng Y. Comparison of rivaroxaban and parnaparin for preventing venous thromboembolism after lumbar spine surgery. J Orthop Surg Res. 2015;10:78. Published 2015 May 23. doi:10.1186/s13018-015-0223-7
  2. Guo Y, Zou Z, Jia L, Huang Z, Yun X, Xing G. Safety and effectiveness of argatroban versus heparin for preventing venous thromboembolism after lumbar decompressive surgery. Int J Surg. 2017;44:324-328. doi:10.1016/j.ijsu.2017.07.031
  3. Zhang K, Zhao S, Kan W, Xiao J, Pu F, Li K. Comparison of apixaban and rivaroxaban for anticoagulant effect after lumbar spine surgery: a single-center report. Future Sci OA. 2018;4(5):FSO297. Published 2018 Mar 14. doi:10.4155/fsoa-2017-0123

There is insufficient evidence supporting the use of fondaparinux as opposed to administration of aspirin at discharge following spine surgery.

Grade of Recommendation: I

Fourman et al1 evaluated the influence of fondaparinux on the occurrence of VTE subsequent to elective lumbar spine surgery in high-risk individuals. Conducted as a retrospective cohort investigation, matched patient groups, who either received or did not receive inpatient fondaparinux beginning on postoperative day 2 following elective lumbar spine surgery, were compared. All patients were prescribed acetylsalicylic acid 325 mg for one month following discharge. The primary endpoint was the occurrence of symptomatic DVT or PE within 30 days of surgery. This study provides Level III evidence indicating that patients administered fondaparinux exhibited reduced rates of symptomatic DVT and PE, along with a favorable complication profile compared to matched controls.

Reference

  1. Fourman MS, Shaw JD, Nwasike CO, et al. Use of Fondaparinux Following Elective Lumbar Spine Surgery Is Associated With a Reduction in Symptomatic Venous Thromboembolism. Global Spine J. 2020;10(7):844-850. doi:10.1177/2192568219878418

Future Directions for Research

The work group recommends more research to identify the most appropriate chemoprophylactic agents to use to prevent DVT/PE events following spine surgery.

Question 22: What patient comorbidities (if any) create an indication for the use of a vena cava filter (temporary or permanent) for patients undergoing spine surgery (elective, trauma, or tumor)?

A systematic review of the literature yielded no studies to adequately address this question.


Work Group Narrative

Although there were no studies available to directly answer this question and develop a definitive recommendation, the following risk factors were defined as criteria to indicate IVC filter placement in relevant Level IV studies:

  • Contraindication to anticoagulation therapy1,3,4
  • Past or concurrent thromboembolism or hypercoagulability1-4
  • Staged operations1-3
  • Multiple segments (≥5 levels)1,2,4
  • Multilevel procedures (≥ 3 vertebral segments)3
  • Bedridden for long periods before surgery (≥2 wk)1-4
  • Significant manipulation of abdominal vessels1,2,4
  • Expected need for significant iliocaval manipulation during exposure3
  • Active smoking1-3
  • Obesity1,3,4
  • Birth control pills/estrogen replacement therapy1,2,4
  • Single-stage anesthetic time of more than 6 hours3
  • Anesthesia duration estimated at longer than 7.5 h per surgical intervention1
  • Anesthetic time of more than 8 hours2,4
  • Combined anterior and posterior approach1-4
  • Previous spine surgery3
  • Comorbidities such as diabetes and hypertension3
  • Malignancy3,4

References:

  1. Dazley JM, Wain R, Vellinga RM, Cohen B, Agulnick MA. Prophylactic inferior vena cava filters prevent pulmonary embolisms in high-risk patients undergoing major spinal surgery. J Spinal Disord Tech. 2012;25(4):190-195. doi:10.1097/BSD.0b013e31821532bd
  2. McClendon J Jr, Oʼshaughnessy BA, Smith TR, et al. Comprehensive assessment of prophylactic preoperative inferior vena cava filters for major spinal reconstruction in adults. Spine (Phila Pa 1976). 2012;37(13):1122-1129. doi:10.1097/BRS.0b013e31824abde2
  3. Ozturk C, Ganiyusufoglu K, Alanay A, Aydogan M, Onat L, Hamzaoglu A. Efficacy of prophylactic placement of inferior vena cava filter in patients undergoing spinal surgery. Spine (Phila Pa 1976). 2010;35(20):1893-1896. doi:10.1097/BRS.0b013e3181e91dad
  4. Rosner MK, Kuklo TR, Tawk R, Moquin R, Ondra SL. Prophylactic placement of an inferior vena cava filter in high-risk patients undergoing spinal reconstruction. Neurosurg Focus. 2004;17(4):E6. Published 2004 Oct 15. doi:10.3171/foc.2004.17.4.6

Future Directions for Research

The work group recommends big data studies (eg, registries, administrative databases) to look at individual risk factors to help stratify risk factors which would indicate that vena cava filters would be useful.

Question 23: If a vena cava filter is indicated, when should anticoagulation be started after spine surgery?

A systematic review of the literature yielded no studies to adequately address this question.

Future Directions for Research

The work group recommends future research on this topic, including transition to anticoagulation, and when to remove filter.

Question 24: Does the incidence of wound complications or neurologic decline from epidural hematoma with use of chemoprophylaxis differ for patients undergoing spinal surgery (cervical, thoracic or lumbar) for: elective, spine trauma, malignancy?

A systematic review of the literature yielded no studies to adequately address this question.

Future Directions for Research

The work group recommends a large database study with the size and fidelity of the database to differentiate the differences for wound and neurological complications associated with chemoprophylaxis administration for patients receiving spine surgery for degenerative pathologies versus spine trauma versus spine malignancies.

Question 25: What is the ideal measure by which to gauge the risk/benefit ratio of chemoprophylaxis in patients undergoing spinal surgery?

A systematic review of the literature yielded no studies to adequately address this question.


Work Group Consensus Statement

In the absence of reliable evidence, the work group found that multiple measures have been found to establish different risks and benefits of DVT/PE chemoprophylaxis, including epidural hematoma, wound dehiscence, bleeding events and transfusion; however, no science has been dedicated to develop, identify, or measure the ideal risk benefit ratio of chemoprophylaxis following spine surgery.

Future Directions for Research

The work group suggests that large administrative datasets may provide relevant information that could be explored with machine learning algorithms to develop a risk stratification model.

Question 26: Does the routine postoperative assessment for DVT reduce the risk of PE in patients undergoing spinal surgery (cervical, thoracic or lumbar) for: elective, spine trauma, malignancy?

There is poor quality evidence that routine postoperative assessment for DVT does not reduce the risk of PE in patients undergoing spine surgery; however, screening for high-risk patients may be considered, as it may offer benefit. Grade of Recommendation: C

Yoshioka et al1, studied 4 distinct patient groups: Group 1 comprised patients with lumbar spinal stenosis treated with posterior decompression without fusion; Group 2 included patients with lumbar or lower thoracic degenerative disease treated with instrumentation for spine fusion; Group 3 consisted of patients with cervical degenerative disease treated with posterior decompression or instrumentation for fusion; and Group 4 comprised patients with spinal tumors treated with total spondylectomy or piecemeal excision with stabilization. Deep venous thrombosis (DVT) and pulmonary thromboembolism (PTE) screening were conducted for all 340 patients between 7 to 10 days postoperatively. All 340 patients received mechanical prophylaxis, such as compression stockings and intermittent pneumatic compression devices, from the induction of general anesthesia to postoperative ambulation. No anticoagulation medications were used for prophylaxis against VTE. Duplex ultrasonography assessments of both lower extremities and lung perfusion scintigraphy were performed 7 to 10 days postoperatively to ensure that any asymptomatic thromboembolism was not overlooked. The overall incidence of VTE was 13.5% (46/340), with a DVT rate of 11.8% (40/340) and a PTE rate of 2.9% (10/340). However, no patients experienced symptomatic DVT, and only 0.59% (2/340) experienced symptomatic PTE. Statistically significant factors that increased risk for VTE identified in the univariable analysis included advanced age, neurologic deficits, spinal tumor, intraoperative blood loss, and duration of bed rest. No significant differences were found in operative time or body mass. Multivariate analysis revealed that advanced age, neurological deficits, and spinal tumor resulted risk factors for VTE. This study provides Level IV evidence indicating the necessity for screening for PTE in high-risk patients. Kim et al2, performed a retrospective, observational study of all patients who underwent a spiral CT after spine surgery to evaluate for pulmonary embolism (PE) and deep vein thrombosis (DVT). Of the total 3331 patients undergoing spine surgery, 136 patients had spiral CT scans to evaluate for PE and proximal DVTs, and 130 were included in the final analysis. Investigators evaluated surgical procedure type, PE risk factors, CT scan indicators, prophylactic anticoagulation, and DVT/PE size, location, and treatment. The authors found that the history of PE / DVT was the only significant risk factor for a positive CT scan. Symptoms including tachycardia / arrhythmia, syncope, chest pain, and shortness of breath did not show significant associations. Risk factors including smoking, use of estrogen or oral contraceptives, and history of cancer also did not show any significant association. The surgical approach was not predictive of a positive CT scan. The study provides Level III evidence that CT scans can be positive without evidence of DVT, and patients with a history of PE / DVT may require more aggressive prophylaxis including preoperative temporary IVC filters and should be monitored more closely for signs and symptoms of thromboembolic complications. Epstein et al3 performed an analysis of 240 patients undergoing spine surgery and subsequently had negative lower extremity ultrasounds but a positive spiral computed tomography contrast angiography for PE. Two groups were included: 75 patients who underwent cervical laminectomies and multilevel fusions and 165 patients who underwent lumbar laminectomies and in situ posterolateral lumbar fusion. All patients had routine ultrasounds for DVTs, and those with signs and symptoms for a PE underwent a spiral computed tomography contrast angiography (CTA). Patients with a positive PE but a negative ultrasound were further evaluated on the severity of the PE and evaluation of hypercoagulation syndromes. The authors found that 11 patients (4.6%) experienced a PE despite negative ultrasound results, and those patients were treated with an inferior vena cava filter. Those patients with significant symptoms associated with their PE were also treated with full-dose anticoagulation. This study provides Level IV evidence that routine postoperative assessment for DVT does not reduce the risk of PE in patients undergoing elective spine surgery. Dearborn et al4 performed a prospective analysis of 116 spine surgery patients and a retrospective analysis of 318 patients to determine the incidence of symptomatic and occult DVT and PE after spinal reconstructive surgery. All prospectively studied patients had one duplex ultrasound postoperatively by the same ultrasound technologist between 3-20 days postoperatively to determine the incidence of DVTs. 73 of these patients also had a combined ventilation/perfusion (V/Q) scan to evaluate for a pulmonary embolism. Patients with symptoms of a DVT were scanned emergently. In the retrospective study, only patients with symptoms of a DVT or PE underwent doppler or perfusion scans. Only one patient in the prospective group had a positive DVT scan. The DVT was asymptomatic, and her surgery was complicated by an iliac vein laceration that required repair. However, three patients in the prospective group (2.6%) had PEs, and none of these patients had risk factors. All four of these patients underwent anterior / posterior procedures. In the retrospective group, 1 patient had an asymptomatic DVT, 7 patients had symptomatic PEs, and one patient had a fatal PE. Six of the 7 PEs occurred in patients undergoing combined anterior / posterior spinal fusions. Only 1 of the 7 PEs occurred in a patient undergoing only a posterior lumbar surgery. None of the patients with PEs had a DVT according to their clinical record. This study provides Level III evidence that routine postoperative assessment of DVT does not reduce the risk of PE in patients undergoing elective thoracolumbar surgery. Duplex ultrasound appeared insensitive for diagnosing clots before embolization in this patient group.

References

  1. Yoshioka K, Murakami H, Demura S, et al. Comparative study of the prevalence of venous thromboembolism after elective spinal surgery. Orthopedics. 2013;36(2):e223-e228. doi:10.3928/01477447-20130122-26
  2. Kim HJ, Walcott-Sapp S, Adler RS, Pavlov H, Boachie-Adjei O, Westrich GH. Thromboembolic Complications Following Spine Surgery Assessed with Spiral CT Scans: DVT/PE Following Spine Surgery. HSS J. 2011;7(1):37-40. doi:10.1007/s11420-010-9179-7
  3. Epstein NE, Staszewski H, Garrison M, Hon M. Pulmonary embolism diagnosed on computed tomography contrast angiography despite negative venous Doppler ultrasound after spinal surgery. J Spinal Disord Tech. 2011;24(6):358-362. doi:10.1097/BSD.0b013e3181fee66a
  4. Dearborn JT, Hu SS, Tribus CB, Bradford DS. Thromboembolic complications after major thoracolumbar spine surgery. Spine (Phila Pa 1976). 1999;24(14):1471-1476. doi:10.1097/00007632-199907150-00013

Future Directions for Research

The work group recommends research to identify the relationship between the occurrence of DVT and PE.