Operative and post-operative complications for patients with implanted programmable devices undergoing surgery for early-onset scoliosis: a multicenter study.

PURPOSE: Describe implanted programmable device (IPD)-related complications after spine surgery in patients with early-onset scoliosis (EOS).

METHODS

A descriptive study was conducted with patient data from a multicenter database. Eligibility criteria were: (1) diagnosis of EOS requiring spine deformity surgery, (2) presence of IPD(s), and (3) ≥ 2-year follow-up after index procedure. Each complication was categorized as related or not related to the IPD.

RESULTS

100 patients met eligibility criteria. Most either had a ventriculo-peritoneal shunt (VPS, n = 53) or an intrathecal baclofen pump (ITBP, n = 38); the remaining patients had a vagal nerve stimulator (n = 9), cochlear implant (n = 5), or a pacemaker (n = 1). A total of 55 patients experienced one or more complications of any type, but only seven experienced IPD-related complications (n = 4 IPD-related infections, n = 3 IPD-related malfunction). All complications occurred in patients with VPS or ITBP. Of the seven IPD-related complications, only two complications (one IPD-related infection and one IPD-related malfunction) occurred in the first 90 days following index spine surgery. All IPD-related complications required unplanned operations to resolve the complication.

CONCLUSION

Although post-operative complications were common for patients with IPDs who underwent spine deformity surgery, IPD-related complications were rare and most occurred later than 90 days after the index procedure. Further, the IPD-related complications did not appear to be related to potential electromagnetic fields created during surgery or magnetic lengthening. These findings suggest that, inherently, the presence of an IPD may not increase the risk of IPD-related complications (e.g., device malfunction) for patients with EOS who undergo spine deformity surgery.

CLINICAL TRIALS REGISTRATION: Not applicable.