Bowel injury with AXALIF
`
`
`In a 5-year post-marketing surveillance study, Gundanna et al. (2011)
`reported complications associated with axial presacral lumbar interbody
`fusion in 9152 patients. A single-level L5-S1 fusion was performed in 8034
`patients (88%), and a two-level L4-S1 fusion was performed in 1118
`patients (12%). Complications were reported in 1.3% of patients with the
`most commonly reported complications being bowel injury (0.6%) and
`transient intraoperative hypotension (0.2%).
`
`Gundanna MI, Miller LE, Block JE. Complications with axial presacral
`lumbar interbody fusion: a 5-year postmarketing surveillance experience.
`SAS J. 2011; 5:90-94.
`
`
`Bowel and Vascular Injury Following
`13,000 Lateral Interbody Fusions
`
`Presented at SMISS 2013 Annual Conference
`By Armen R. Deukmedjian MD
`With Konrad Bach MD, Michael Park MD, Juan S. Uribe MD, FACS
`Disclosures: Armen R. Deukmedjian MD None. , Konrad Bach MD None,
`Michael Park MD None, Juan S. Uribe MD, FACS A; Orthofix, NuVasive. B;
`Orthofix, NuVasive.
`Introduction: Minimally invasive (MIS) lateral interbody fusion (LIF)
`through a retroperitoneal transpsoas approach has become increasingly
`popular as a less invasive treatment of degenerative spinal disease,
`deformity, and trauma. It offers several potential advantages over
`traditional posterior approaches to interbody fusion, including decreased
`muscle dissection, decreased post-operative muscle atrophy, and the
`ability to place a large interbody graft. It allows access to the anterior
`spinal column without the risks associated with anterior lumbar interbody
`fusion, including manipulation of the great vessels, retrograde ejaculation,
`and abdominal adhesions. Anatomic studies of the thoracolumbar
`retroperitoneal region have demonstrated that peritoneal and
`retroperitoneal structures at risk during these procedures include the aorta,
`inferior vena cava (IVC), common iliac vessels, kidneys, bowel, lumbar
`plexus, and to a much lesser extent, the spleen and liver. The object of this
`study is to evaluate the incidence of major complications following MIS
`lateral fusion performed by experienced surgeons actively engaged in an
`MIS lateral research society (SOLAS), including visceral (bowel laceration)
`
` 1
`
`NUVASIVE 1050
`NuVasive, Inc. v. Warsaw Orthopedic, Inc.
`IPR2013-00206
`IPR2013-00208
`
`

`

`and vascular complications (great vessel injury).
`
`Methods: Complication data was retrospectively collected from spine
`surgeons in both private and academic practice with active SOLAS
`(Society of Lateral Access Surgeons) membership. Only those with a
`minimum of 100 lateral interbody fusions were included to mitigate learning
`curve complication biases. Data was inclusive of all complications
`including those from early surgeon experience. Lumbar plexus injuries
`producing transient anterolateral thigh numbness, though common with
`this approach, were not included as catastrophic complications.
`
`Results: Of 77 spine surgeons contacted we achieved a 52% response
`rate (40 surgeons). 62.5% orthopedic surgeons (25), 37.5%
`Neurosurgeons (15), 20% academic (8), and 80% private (32). From 2003
`to early 2013, 13,004 patients were treated with MIS LIF. Complication
`rates were as follows: 0.08% for visceral complications (10) and 0.08% for
`vascular complication (10).
`
`Conclusion: The low incidence of catastrophic complications (< 0.1%) in a
`large series highlights the low morbidity of MIS LIF, and compares
`favorably with complication rates for alternative approaches. Although
`technically demanding, MIS LIF is a safe and reproducible alternative to
`other interbody fusion procedures with a low risk of catastrophic
`complications.
`
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` 2
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