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    Interventional procedure overview of vertebral body tethering for idiopathic scoliosis in children and young people

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    Safety summary

    Overall complications

    Overall complications were reported in 27% (10/37) of patients in the VBT group, 61% (31/51) in the MCGR group and 14% (6/42) in the PSF group in the non-randomised comparative study of 130 patients (p<0.0005; Mackey 2021).

    The pooled complication rate was 26% (95% CI 12% to 40%, I2=86.14%; 10 studies) in patients who had anterior VBT and 2% (95% CI 0% to 4%, I2=19.21%; 9 studies) in patients who had PSF in the meta-analysis of 24 studies (n=1,280; Shin 2021). Of the studies with a follow up of less than 36 months (number of studies not reported), the pooled complication rate was 12% (95% CI 4.4% to 18.6%) for anterior VBT and 1% (95% CI 0.0% to 2.4%) for PSF. Of the studies with a follow up of 36 months or more (number of studies not reported), the pooled complication rate was 25% (95% CI 19.1% to 31.7%) and 3% (0.5% to 5.3%) respectively.

    Pulmonary complications

    Pneumothorax was reported in 1 patient at postoperative day 3 in the case series of 120 patients and this event resolved with reinsertion of chest tube (Abdullah 2021). Small pneumothorax was reported in 1 patient after chest drain removed in the case series of 112 patients and this event resolved spontaneously (Rushton 2021).

    Pleural effusion was reported in 2 patients by 90 days postoperation in the case series of 120 patients (Abdullah 2021). Both patients needed chest tubes and antibiotics. Recurrent, right-side pleural effusion was reported in 3 patients at 2 to 6 weeks after surgery in the case series of 90 patients (Baroncini 2021). Of the 3 patients, 2 patients had chest-tube reinsertion and 1 had exploratory thoracotomy because of bleeding from the right pulmonary ligament, but this lesion could not be repaired, and a chest-tube was reinserted. All these 3 patients recovered well and without sequelae. Pleural effusion was reported in 1 patient in the case series of 31 patients and the patient needed readmission within 3 days, but a chest tube was not reinserted (Alanay 2020).

    Pneumonia was described in 1 patient at 2 weeks after surgery in the case series of 120 patients (Abdullah 2021). The patient had oral antibiotics, and this even resolved by 6 weeks postoperation. Pneumonia was reported in 2 patients after discharge in the case series of 112 patients and they were managed by family doctors (Rushton 2021).

    Minor pulmonary embolism was reported in 1 patient in the case series of 90 patients (Baroncini 2021). This event happened after a 24-hour flight. The patient had intramuscular low-molecular-weight heparin therapy for 1 month and then recovered well.

    Persistent atelectasis of the lower left lobe was reported in 1 patient on the second postoperative day after thoracic VBT from the right side in the case series of 90 patients (Baroncini 2021). Since the patient did not tolerate non-invasive ventilation, intubation was needed for 3 days. The symptoms resolved after bronchoscopic removal of a large mucus accumulation. The patient recovered well and without sequelae. Atelectasis needed admission to intensive care for respiratory support was reported in 4 patients in the case series of 112 patients (Rushton 2021). Atelectasis was reported in 2 patients in the case series of 31 patients and these events resolved with intensive physical therapy (Alanay 2020). Atelectasis with pulmonary oedema was reported in the anterior VBT group (exact number of patients with this complication was not reported) but not in the PSF group in the non-randomised comparative study of 49 patients (Newton 2020). This event was treated with positive airway pressure and resolved by postoperative day 6.

    Haemothoraces was described in 2 patients in the case series of 112 patients (Rushton 2021). One patient needed drainage and the other returned to theatre for bleeding control.

    Chylothorax was reported in 1 patient in the case series of 31 patients and this event resolved with dietary precautions (Alanay 2020).

    Pulmonary complications were reported in 11 patients who had anterior VBT and 1 patient who had PSF in the meta-analysis of 24 studies (n=1,280; Shin 2021).

    CSF leak

    CSF leak was reported in 2 patients who also presented with headaches (1 patient at 3 weeks postoperation and 1 patient at 4 months after surgery) in the case series of 120 patients (Abdullah 2021).

    CSF leak was described in 2 patients who also presented with orthostatic headaches and vomiting at 1 or 2 weeks after operation in the case series of 112 patients (Rushton 2021). One related to a T12 screw narrowly breaching the posterior wall needing revision and the other without obvious cause was treated conservatively.

    Mechanical complications

    Cable failure was described in 4 patients by 2 years after surgery in the case series of 120 patients (Abdullah 2021). Of the 4 patients, 2 patients had surgery management (UPROR: 1 patient for tether replacement and 1 patient for PSF).

    Tether rupture was reported in 28 patients in the case series of 90 patients with adolescent idiopathic scoliosis (Baroncini 2021). Tether breakage was reported in 12 patients who had anterior VBT and 2 of the 12 patients had revision because of progression associated with cord failure in the non-randomised comparative study of 49 patients (Newton 2020). Of the identified broken tethers, most broke at 1 level, but ranged from 1 to 3 levels. Tether breakage was reported in 36 patients (3 patients had confirmed tether breakage and 33 had radiographs suggestive of tether breakage) at a mean follow up of 31 months in the case series of 112 patients (Rushton 2021). The most common sites for breakage were T9/10, T10/11 and T11/12 happening in 11, 13 and 7 patients, respectively. Tether breakage was reported in 17 patients who had anterior VBT and no patients who had PSF in the meta-analysis of 24 studies (n=1,280; Shin 2021).

    Adding-on was described in 7 patients who had anterior VBT and 2 patients who had PSF in the meta-analysis of 24 studies (n=1,280; Shin 2021). In the same meta-analysis, screw pull-out/loosening was reported in 1 patient who had anterior VBT and 6 patients who had PSF.

    Mechanical complications were reported in 6 patients (1 UIV loosening, 1 pull-out, 1 migration, 1 LIV pull-out, loss of previously achieved correction, and 1 tether breakage) in the case series of 31 patients (Alanay 2020).

    Curve progression or overcorrection

    Compensatory curve progression was reported in 1 patient between 3 months and 1 year after surgery in the case series of 120 patients (Abdullah 2021). The patient had surgery (UPROR) for extension of the tether to the lumbar region. In the same study, curve progression was reported in 1 patient around 1 year after the initial surgery and the patient had UPROR for PSF.

    Curve overcorrection was observed in 2 patients at 2-year follow up in the case series of 120 patients (Abdullah 2021). Both patients had surgical management (UPROR) for removal of the tether. Overcorrection was reported in 6 patients in the case series of 31 patients (Alanay 2020). Two overcorrections were greater than or equal to ‑10o, 1 was ‑3o, and 3 were less than ‑10o. Overcorrection was reported in 17 patients who had anterior VBT and 2 patients who had PSF in the meta-analysis of 24 studies (n=1,280; Shin 2021).

    Revisions or reoperations

    Revision was reported in 7 patients (9 revision procedures: 7 first revision and 2 second revision) in the anterior VBT group and no patients in the PSF group in the non-randomised comparative study of 49 patients (Newton 2020). The reasons for first revision which happened at a mean follow up of 2.3 years included overcorrection (n=3), broken tether with progression (n=2) and progression of lumbar curve (n=2). The reasons for second revision were broken tether with progression (n=1, at 2.8 years after the initial operation) and progression (n=1, at 3.1 years after the initial operation).

    Planned revision was described in 3 patients who had VBT, 16 patients who had MCGR and no patients who had PSF (p<0.0005) in the non-randomised comparative study of 130 patients (Mackey 2021). Unplanned revision was reported in 6, 11 and 3 patients respectively (p=0.154). At the final follow up, 2 patients in the VBT group and 17 patients in the MCGR group had definitive fusions.

    Revision surgery was needed in 3 patients in the case series of 90 patients (Baroncini 2021). Revision was for loss of correction caused by tether rupture.

    Revision was reported in 15 patients who needed 18 revision procedures in the case series of 112 patients (Rushton 2021). Of these 15 patients, 8 needed tether revisions for replacement, extension or loosing of tethers and 7 needed fusion operations.

    Revision surgerywas needed in 7 patients in the case series of 57 patients (Samdani 2021). Of these 7 patients, 5 had a tether release for overcorrection and 2 had the tether extended for adding-on. In 1 patient whose curve had overcorrected, the tether release did not stop the curve overcorrection. Subsequently, this patient had PSF approximately 4.6 years after the original tether surgery.

    The pooled reoperation rate was 14% (95% CI 5.6% to 22.6%) in patients who had anterior VBT (10 studies) and less than 1% (95% CI 0.0% to 2.3%) in patients who had PSF (4 studies) in the meta-analysis of 24 studies (n=1,280; Shin 2021). Of the studies with a follow up of less than 36 months (number of studies not reported), the pooled reoperation rate was 3% (95% CI 0.0% to 8.4%) for anterior VBT and 1% (95% CI 0.0% to 1.7%) for PSF. Of the studies with a follow up of 36 months or more (number of studies not reported), the pooled reoperation rate was 25% (95% CI 10.7% to 38.7%) and 2% (0.0% to 5.4%) respectively. In the same meta-analysis, the pooled conversion rate of anterior VBT-to-PSF was 1.4% (CI: 0% to 4.5%) in patients who had anterior VBT. All conversions were because of deformity progression despite tethering.

    Infection

    Chest infection was reported in 1 patient in the case series of 90 patients (Baroncini 2021). This patient was admitted to the local hospital 2 weeks after surgery because of fever and dyspnoea and had antibiotics for 2 weeks to treat chest infection. This patient recovered well and without sequelae.

    Clostridium difficile infection was described in 1 patient in the case series of 112 patients (Rushton 2021).

    Superficial wound infection was found in 1 patient after 1-week postoperation in the case series of 120 patients (Abdullah 2021). The patient had local wound care and oral antibiotics, and the event resolved by 2 weeks postoperation. Superficial wound infection was reported in 1 patient in the case series of 112 patients (Rushton 2021).

    Infection (grouped category) was reported in 1 patient who had anterior VBT and 4 patients who had PSF in the meta-analysis of 24 studies (n=1,280; Shin 2021).

    Others

    Ureteral injury following VBT with subsequent erosion and stricture formation was reported in the single case report and the patient had definitive ureteral reconstruction (Rathbun 2019).

    Neurological complications were reported in 2 patients who had anterior VBT and 6 patients who had PSF in the meta-analysis of 24 studies (n=1,280; Shin 2021).

    Right arm and shoulder paraesthesia was reported in 2 patients after 3 months postoperation in the case series of 120 patients (Abdullah 2021). Both patients had outpatient medical management and the events did not resolve by 1-year follow up.

    Right leg weakness was reported in 1 patient at 2-year follow up in the case series of 120 patients and the event was being observed (Abdullah 2021).

    Pain radiating down the leg was reported in the anterior VBT group (exact number of patients with this complication was not reported) at 3 years postoperation but not in the PSF group in the non-randomised comparative study of 49 patients (Newton 2020). This event resolved with physical therapy and its relationship to procedure was unclear.

    Horner syndrome with asymmetric pupils was reported in the anterior VBT group (exact number of patients with this complication was not reported) but not in the PSF group in the non-randomised comparative study of 49 patients (Newton 2020).

    Anecdotal and theoretical adverse events

    In addition to safety outcomes reported in the literature, professional experts are asked about anecdotal adverse events (events which they have heard about) and about theoretical adverse events (events which they think might possibly occur, even if they have never happened).

    For this procedure, professional experts listed the following anecdotal and theoretical adverse events: aorta, lung and nerve injuries.