Abstract
Purpose
The purpose of this study was to determine peri-operative morbidity associated with anterior vertebral body tethering (aVBT) for idiopathic scoliosis.
Method
Of 175 patients treated with aVBT, 120 patients had 2 year follow up and were included in this study. Prospectively collected clinical and radiographic data was analyzed retrospectively.
Results
Pre-operatively, the mean patient age was 12.6 year (8.2–15.7 year), Risser 0–3, with main thoracic scoliosis 51.2° (40–70°). Immediately post-operative, scoliosis improved to 26.9° (6–53°; p < 0.05), at 1-year post-operative was 23.0° (− 11 to 50°; p < 0.01 vs immediate post-op) and at 2-year post-operative was 27.5° (− 5 to 52; p = 0.64 vs immediate post-op). Pre-operative T5–T12 kyphosis was 16.0° (− 23 to 52°), post-operative was 16.9° (− 7 to 44°), at 1-year was 17.5° (− 14 to 61°) and at 2-year was 17.0° (− 10 to 50°; p = 0.72 vs pre-op). All patients underwent thoracoscopic approach, EBL 200 ml (20–900 ml), surgical time 215.3 min (111–472 min), anesthesia time 303.5 min (207–480 min), ICU stay of 0.2 day (0–2 days), and post-operative hospital stay 4.5 days (2–9 days). During the in-hospital peri-operative period, there were no unplanned return to the operating room (UPROR) and there was a 0.8% rate of complication: one pneumothorax requiring reinsertion of chest tube. By 90 days post-operative, there was no UPROR and a 5% rate of complication. Five additional patients developed complications after discharge: one CSF leak treated with blood patch injection in the clinic and resolved, two pleural effusions requiring chest tubes, one superficial wound infection and one pneumonia treated with outpatient antibiotics. By 1-year post-op, there was a 1.7% rate of UPROR and 8.3% rate of complication. Four additional patients developed complications beyond 90 days: two upper limb paresthesia required outpatient medical management, one CSF leak which initially treated blood patch injection in the clinic initially which then required UPROR, and one compensatory lumbar curve add on that was treated with extension of the tether. By 2-years post-op, there was a 6.7% rate of UPROR and 15.8% rate of complication. 9 additional complications developed after 1 year. One curve progression, one keloid scar, one right leg weakness, 4 cable failures and 2 curve overcorrections.
Conclusion
This large, multicenter series of aVBT demonstrated a 15.8% complication rate and a 6.7% UPROR rate at 2 year post-operatively. This early study during the learning curve of aVBT found higher rates of CSF leaks and overall complications than would be expected for PSFI at 1 year post-operatively and a higher rate of overall complications and of UPROR than would be expected for PSFI at 2 year post-operatively. As is common with new procedures, the complication rate may fall with further experience.
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Data availability
Registry data is available to member institutions. Measurements and analysis done at the IWK Health Centre are on a password protected server. Access may be arranged through application to the REB.
Code availability
Statistical analysis was conducted using SPSS v20 (IBM Corporation, Armonk, NY, USA).
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AA: design or the acquisition, analysis, or interpretation of data, drafted the work or revised it critically, approved, accountable. SP: design or the acquisition, analysis, or interpretation of data, drafted the work or revised it critically, approved, accountable. FM: design or the acquisition, analysis, or interpretation of data, drafted the work or revised it critically, approved, accountable. KS: design or the acquisition, analysis, or interpretation of data, drafted the work or revised it critically, approved, accountable. JM: design or the acquisition, analysis, or interpretation of datadrafted the work or revised it critically, approved, accountable. DS: design or the acquisition, analysis, or interpretation of data, drafted the work or revised it critically, approved, accountable. PG: design or the acquisition, analysis, or interpretation of datadrafted the work or revised it critically, approved, accountable. MV: design or the acquisition, analysis, or interpretation of data, drafted the work or revised it critically, approved, accountable. JO: design or the acquisition, analysis, or interpretation of datadrafted the work or revised it critically, approved, accountable. NS: design or the acquisition, analysis, or interpretation of data, drafted the work or revised it critically, approved, accountable. RHC: design or the acquisition, analysis, or interpretation of data, drafted the work or revised it critically, approved, accountable. Pediatric Spine Study Group: design or the acquisition, analysis, or interpretation of data, drafted the work or revised it critically, approved, accountable. RE-H: design or the acquisition, analysis, or interpretation of data, drafted the work or revised it critically, approved, accountable.
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Abdullah Abdullah has nothing to disclose. Stefan Parent (No PDF). Firoz Miyanji consults for Zimmer Biomet. Kevin Smit receives grant from Zimmer Biomet. Joshua Murphy consults for OrthoPediatrics, Depuy Synthes Spine and is a member of the physician advisory board. David Skaggs consults for Zimmer Biomet, orthobullets, Nuvasive, grand Rounds and Medtronic, is a board member of Growing Spine Foundation, Growing Spine Study Group, CHLA Foundation, is a member of the editorial board of Orthopedic Today, Spine Deformity, Wolter Kluwer Health, and Journal of Children's Orthopaedics, and has stocks or stock Options in Green Sun Medical, and Zipline Medical. Purnendu Gupta consults for DePuy Synthes. Michael Vitale Consults for Zimmer Biomet, Stryker, and Nuvvasive, is a board member of Pediatric Orthopedic Society of North America (POSNA), Scoliosis Research Society (SRS), Orthopedic Research and Education Foundation (OREF), and Children’s Spine Foundation (CSF). Jean Ouellet reports grants from AONA Foundation. Neil Saran has nothing to disclose. Robert H. Cho consults for DePuy Synthes, Prosidyan, NuVasive, and OrthoPediatrics. Pediatric Spine Study Group reports grants from Pediatric Orthopaedic Society of North America, grants from Food and Drug Administration, grants from NuVasive, grants from DePuy Synthes Spine, grants from Children’s Spine Foundation, and grants from Growing Spine Foundation. Ron El-Hawary consults for Depuy Synthes Spine, Medronic Spine, Globus Medical, Wishbone Medical, and Apifix Ltd, works in research and education with Depuy Synthes Spine, Joint Solutions and Medronic Spine, receives IP royalties from Wishbone Medical, and is a board member of the Pediatric Orthopaedic Society of North America, Scoliosis Research Society and the Children’s Spine Study Group.
Ethics approval
This work is a sub-study of the Pediatric Spine Study Group Registry which was approved by the Research Ethics Board at the IWK Health Centre (#1002256) in accordance with the ethical standards outlined in the Tri-Council Policy Statement and the 1964 Declaration of Helsinki and its later amendments. All sites have research ethics board approval for entry of subject data into the pediatric spine study group database (formerly the children’s spine study group database and the growing spine study group data base).
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All research participants or their legal guardians provided written consent to be a part of the registry and have the data collected be used in ongoing research on scoliosis.
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Appendix
Appendix
Grade | Definition |
---|---|
I | A complication that does not result in deviation from routine follow-up in the postoperative period and has minimal clinical relevance and requires minimal treatment (e.g., antiemetics, antipyretics, analgesics, diuretics, electrolytes, antibiotics, and physiotherapy) or no treatment |
II | A deviation from the normal postoperative course (including unplanned clinic/office visits) that requires outpatient treatment, either pharmacological or close monitoring as an outpatient |
III | A complication that is treatable but requires surgical, endoscopic, or interventional radiology procedure(s), or an unplanned hospital readmission |
IVa | A complication that is life or limb-threatening, and/or requires ICU admission, a complication with potential for permanent disability but treatable, a complication that may require organ/joint resection/replacement. No long-term disability) |
IVb | A complication that is life or limb-threatening, and/or requires ICU admission, a complication that is not treatable, a complication that requires organ/joint resection/replacement or salvage surgery. With long-term disability |
V | Death |
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Abdullah, A., Parent, S., Miyanji, F. et al. Risk of early complication following anterior vertebral body tethering for idiopathic scoliosis. Spine Deform 9, 1419–1431 (2021). https://doi.org/10.1007/s43390-021-00326-2
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DOI: https://doi.org/10.1007/s43390-021-00326-2