A New Classification System to Report Complications in Growing Spine Surgery: A Multicenter Consensus Study   John T. Smith, MD, Charles Johnston,

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A New Classification System to Report Complications in Growing Spine Surgery: A Multicenter Consensus Study   John T. Smith, MD, Charles Johnston, MD, David Skaggs, MD, John Flynn, MD, Michael Vitale, MD A joint effort of the CWSDSG and GSSG

Disclosures Consultant: Depuy-Synthes spine Royalties: VEPTR 2 device Board Member: CWSDRF Study supported by a grant from OREF

Complications in growing spine surgery Common Variable consequences on the course of care Lack a standardized reporting system Difficult to compare results

Purpose Develop consensus for a new classification system for reporting complications in growing spine surgery Pilot study to evaluate ‘ease of use’ of the system

Methods Phase 1: Consensus meeting to develop standardized classification for reporting complications* Phase 2: Test system on 10 patients from 5 centers for ease of use OREF Grant, 2011*

Definitions Complication: An unexpected medical event in the course of treatment that may or may not affect final outcome. Severity: Severity refers to the level of care and urgency the required to treat a patient’s complication. Device related complication: A complication that occurred as a direct result of a patient’s device. To determine if the complication is device related, ask the following question: “If the patient did not have the device, would the complication occur?” Disease related complication: Complications which are not directly related to the growing spine device.

Categories of Complications Related to Growing Spine Surgery Device Related Disease Related

Severity Scores for Device Related Complications Severity Grade I: A complication that does not require an unplanned return to the operating room and can be corrected at the next planned surgery. Severity Grade II: A complication that requires an unplanned return to the operating room. IIA: Requires a single trip to the operating room. IIB: Requires multiple trips to the operating room (example, multiple I& D’s for a persistent infection.) Severity Grade III: A complication that alters the planned course of treatment.

Severity Scores for Disease Related Complications Grade I: A complication that does not require hospitalization and can be treated on an out patient basis. Grade II: A complication that requires hospitalization Grade III: A complication that alters the planned course of treatment.

Results 65 patients (5 institutions) 56 pts had at lease 1 complication; 9 with none Diagnosis: varied VEPTR:46; Growing Rods:14; Hybrids:4. Average Age: 4.7 yrs Minimum follow-up: 2 years Total surgical events: 423

Average procedures per patient Expansions: 5.3 Revisions: 1.7 Exchanges: 0.6

Complications: 181 Migration: 60 Infection: 31 Pneumonia: 21 Instrumentation failure: 23 Other: 46

What does that mean? Complication rate = 400%? Complications per procedure = 42%? Average complication per patient = 2.8?

Overall Complications when classified: Grade I: (57) Grade IIA (95) Grade IIB (10) Grade III (6)

Disease Related Complications Severity number I 4 II 15 III 1 Device Related Complications Severity number I 53 IIA 80 IIB 10 III 5

Conclusions Complications are common in growing spine surgery, but…. Only 9% of patients in this pilot study had an event significant enough to alter their plan of care. (ie: Grade III)

Conclusions Complications are expected in growing spine surgery….. Classification was easy to use Provides meaningful information regarding the impact of an adverse event on the overall plan of care Allows for comparison of different techniques

Thank you