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Development of consensus-based best practice guidelines for response to intraoperative neuromonitoring events in high-risk spinal deformity surgery

Abstract

Purpose

To expand on previously described intraoperative aids by developing consensus-based best practice guidelines to optimize the approach to intraoperative neuromonitoring (IONM) events associated with “high-risk” spinal deformity surgery.

Methods

Consensus was established among a group of experienced spinal deformity surgeons by way of the Delphi method. Through a series of iterative surveys and a final virtual consensus meeting, participants expressed their agreement (strongly agree, agree, disagree, and strongly disagree) with various items. Consensus was defined as ≥ 80% agreement (“strongly agree” or “agree”). Near-consensus was defined as ≥ 60% but < 80%. Equipoise was ≥ 20% but < 60%, and consensus to exclude was < 20%.

Results

15 out of 15 (100%) invited surgeons agreed to participate. Final consensus supported inclusion of 105 items (53 in Response Algorithm, 13 in Ongoing Consideration of Etiology, 31 in Real-Time Data Scenarios, 8 in Patterns of IONM Loss), which were organized into a final set of best practice guidelines.

Conclusion

Detailed consensus-based best practice guidelines and aids were successfully created with the intention to help organize and direct the surgical team in exploring and responding to neurological complications during high-risk spinal deformity surgery.

Level of evidence

Level V.

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Funding

No funding was received to conduct this study.

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LGL: Made substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data; or the creation of new software used in the work. Drafted the work or revised it critically for important intellectual content. Approved the version to be published. Agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. ANF: Made substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data; or the creation of new software used in the work. Drafted the work or revised it critically for important intellectual content. Approved the version to be published. Agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. RRI: Made substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data; or the creation of new software used in the work. Drafted the work or revised it critically for important intellectual content. Approved the version to be published. Agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. HM: Made substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data; or the creation of new software used in the work. Drafted the work or revised it critically for important intellectual content. Approved the version to be published. Agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. 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MPK: Made substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data; or the creation of new software used in the work. Drafted the work or revised it critically for important intellectual content. Approved the version to be published. Agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. HJK: Made substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data; or the creation of new software used in the work. Drafted the work or revised it critically for important intellectual content. Approved the version to be published. Agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. 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Corresponding author

Correspondence to Hiroko Matsumoto.

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Conflict of interest

Dr. Lenke reports personal fees from Medtronic, non-financial support from Broadwater, grants and non-financial support from Scoliosis Research Society, grants from EOS, grants from Setting Scoliosis Straight Foundation, other from Evans Family Donation, other from Fox Family Foundation, grants and non-financial support from AOSpine, personal fees from Abryx, personal fees from EOS Technologies, personal fees from Acuity Surgical. Dr. Matsumoto reports personal fees from Pediatric Spine Study Group, grants from POSNA, grants from SRS, outside the submitted work. Dr. Samdani reports personal fees from DePuy Synthes Spine, personal fees from Ethicon, personal fees from Globus Medical, personal fees from Medical Device Business Services, personal fees from Mirus, personal fees from NuVasive, personal fees from Orthofix, personal fees from Stryker, personal fees from Zimmer Biomet, outside the submitted work. Dr. Smith reports personal fees from Stryker, personal fees from Cerapedics, personal fees from Carlsmed, personal fees from Zimmer Biomet, grants and personal fees from NuVasive, personal fees from Thieme, grants from DePuy Synthes/ISSGF, personal fees from DePuy Synthes, grants from AOSpine, outside the submitted work. Dr. Smith reports stock ownership in Alphatec and NuVasive. Dr. Gupta reports personal fees, non-financial support and other from DePuy, personal fees from Innomed, personal fees and non-financial support from Medtronic, personal fees and non-financial support from Globus, non-financial support from Scoliosis Research Society, personal fees and non-financial support from AO Spine, non-financial support from National Health Spine Foundation, other from J&J, other from P&G, personal fees from Malaysia Spine Society, personal fees from Louisiana State Univ, personal fees and non-financial support from Alphatec, non-financial support from Mizuho, non-financial support from Medicrea, outside the submitted work. Dr. Kelly reports personal fees from Deputy Editor at Spine, grants from Setting Scoliosis Straight Foundation, outside the submitted work. Dr. Kim reports grants or contracts from ISSGF (paid to institution) and SI Bone (paid to institution), royalties or licenses from Zimmer Biomet (personal fees), Stryker (personal fees), and Acuity-Surgical (personal fees). Dr. Kim reports participation as a Nuvasive advisory board member, Aspen Medical advisory board member, and Vivex Biologics advisory board member. Dr. Sciubba reports consulting fees from Depuy-Synthes (personal fees). Medtronic (personal fees), Stryker (personal fees), and Baxter (personal fees). Dr. Sciubba reports a leadership or fiduciary role in AO Spine North America. Dr. Cho reports royalties or licenses from Globus Medical (IP royalties). Dr. Cho reports consulting fees from Stryker. Dr. Cho reports a leadership or fiduciary role in AAOS, American Orthopedic Association, AO Spine North America, Cervical Spine Research Society, North American Spine Society, and Scoliosis Research Society. Dr. Cho reports stock ownership in Aldentify. Dr. Polly reports grants or contracts Medtronic (to institution), MizuhoOSI (to institution). Dr. Polly reports royalties or licenses from SI Bone (personal) and Springer (personal). Dr. Polly reports consulting fees from SI Bone (personal) and Globus (personal). Dr. Polly reports patents (planned, issued, or pending) from SI bone (personal) and Globus (personal). Dr. Polly reports participation on a Data Safety Monitoring Board or Advisory Board with SI Bone. Dr. Polly reports a leadership or fiduciary role in American Spine Registry (executive committee), Scoliosis Research Society (committees), and North American Spine Society (committees). Dr. Lewis reports consulting fees from Stryker Spine (personal), L&K Biomed (personal). Dr. Lewis reports payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Medtronic (personal), AO Spine (personal), Scoliosis Research Society (personal). Dr. Lewis reports support for attending meetings and/or travel from AO Spine (personal), Scoliosis Research Society (personal). Dr. Lewis reports participation on a Data Safety Monitoring Board or Advisory Board with AO Spine. Dr. Lewis reports a leadership or fiduciary role in AO Spine (Research Commission, Chair Knowledge Forum Deformity). Dr. Lewis reports stock ownership in Covr Medical and Augmedics. Dr. Lewis reports Medtronic fellowship support to institution, Depuy Synthes fellowship support to institution, and Stryker Spine fellowship support to institution. Dr. Angevine reports participation on a Data Safety Monitoring Board or Advisory Board with National Institutes of Health. Dr. Vitale reports grants and personal fees from Biomet, grants and non-financial support from Children's Spine Foundation, personal fees from East Coast Orthotics and Prosthetics, other from FOX, non-financial support from IPOS, grants from OREF, grants and non-financial support from POSNA, non-financial support from Project for Safety in Spine Surgery, grants from OSRF, grants from SRS, personal fees from Stryker, non-financial support from Wellinks, outside the submitted work.

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This study was approved by the Columbia University Institutional Review Board (Protocol AAAT4317) and was performed in accordance with the ethical standards of the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards.

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Lenke, L.G., Fano, A.N., Iyer, R.R. et al. Development of consensus-based best practice guidelines for response to intraoperative neuromonitoring events in high-risk spinal deformity surgery. Spine Deform 10, 745–761 (2022). https://doi.org/10.1007/s43390-022-00485-w

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  • DOI: https://doi.org/10.1007/s43390-022-00485-w

Keywords

  • Spinal deformity
  • Intraoperative neuromonitoring
  • Neurological deficit
  • High-risk
  • Expert consensus
  • Best practice guideline