Study: AxiaLIF – Low Complications (written by Walter Eisner @ OTW)
A study published in the September issue of the SAS Journal says Trans1’s AxialLIF’s complication rate compares favorably to open fusion approaches.
Coverage
Is TranS1 finally going to get some love from insurance carriers that have balked at covering the procedure due to a lack of clinical evidence in peer reviewed journals? The company tells OTW that five papers have been accepted in peer review this year. This is the first to be published while more are coming related to efficacy.
Last January Humana Inc. changed its reimbursement policy to include coverage for the presacral approach at the same level as other interbody fusion surgeries.
Complication Rate Findings
The study, “Complications with axial presacral lumbar interbody fusion: A 5-year postmarketing surveillance experience,” was conducted by Mukund I. Gundanna, M.D., Larry E. Miller, Ph.D. and Jon E. Block, Ph.D.
The researchers found a 1.3% overall complication rate in a retrospective analysis of 9,152 AxiaLIF patients. No deaths were reported.
AxiaLIF’s complication rate compares well to the complication rates found in open fusion approaches, which range from 1.5% to more than 8%, according to the study. If carriers accept this evidence, AxiaLIF simply becomes another fusion procedure.
The procedure utilizes an axial presacral approach. According to the study, a single-level L5-S1 fusion was performed in 8,034 patients (88%), and a 2-level (L4-S1) fusion was used in 1,118 (12%). A predefined database was designed to record device- or procedure-related complaints via spontaneous reporting. The complications that were recorded included bowel injury, superficial wound and systemic infections, transient intraoperative hypotension, migration, subsidence, presacral hematoma, sacral fracture, vascular injury, nerve injury, and ureter injury.
Complications were reported in 120 of 9,152 patients (1.3%). The most commonly reported complications were bowel injury (n = 59, 0.6%) and transient intraoperative hypotension (n = 20, 0.2%). The overall complication rate was similar between single-level (n = 102, 1.3%) and 2-level (n = 18, 1.6%) fusion procedures, with no significant differences noted for any single complication.
The authors concluded that axial interbody lumbar fusion through the presacral approach “is associated with a low incidence of complications.”
From their lips to insurers’ ears.
This study was supported, in part, by TranS1. The company provided the authors with access to their complaint-reporting database.