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ICEOS 2016 Utrecht, November 2016

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1 ICEOS 2016 Utrecht, November 2016 Proximal Rib-Based Constructs in EOS: Long-Term Follow up and Survivorship Alexandra Kondratyeva, MD; Nicholas Feinberg, BA; Zachary Bloom, BA; Chun Wai Hung, MEng; Hiroko Matsumoto, MA; John Smith, MD; Josh Pahys, MD; Sumeet Garg, MD; Michael Vitale, MD, MPH; Children’s Spine Study Group

2 Background Vertical Expandable Prosthetic Titanium Rib (VEPTRTM; Synthes North America, West Chester, PA) Originally developed for thoracic insufficiency syndrome (TIS) Expanded for other indications such as early- onset scoliosis (EOS) Source: DePuy Synthes For VEPTR, the most superior or proximal attachments are rib circumferential anchors, while the distal or inferior anchors are to rib, spine, or pelvis. Source: DePuy Synthes

3 Background One of the more common cause for revisions of VEPTR devices are anchor/mechanical complications. Acute proximal anchor problems include rib fracture and rib cradle displacements. Chronic migration of the proximal rib attachments are also a common issue. Studies have reported mechanical issues, most prominently device migration and rod breakage, to comprise between 18.5% to 83.3% of all complications associated with VEPTR. (Oyoun, Spine 2014; Campbell, Spine 2007; Greggi, 2012; Hasler, Eur Spine 2010; Samdani, Clin Orth Rel Res 2010; Smith, J Neurosurg 2009; Waldhausen, J Ped Surg 2007; White, Clin Orth Rel Res 2011; Yamaguchi, Spine Deformity 2014; Williams, J Ped Ortho 2013; Waldhausen, J Ped Surg 2016).

4 Study Purpose In light of the high risk of complications, it is clear that further research is necessary to elucidate the risks related to rib- based constructs for the treatment of EOS. Goal - The purpose of this study is to examine the durability of rib-based constructs used in the treatment of EOS and to identify risk factors associated with revision or failure of the original instrumentation.

5 Methods Design Multi-center retrospective cohort study from 5 hospitals in the Children’s Spine Study Group (CSSG) Children’s Hospital of New York, New York Primary Children’s Medical Center, Utah Shriners Hospital for Children, Pennsylvania Children’s Hospital, Colorado Seattle Children’s Hospital, Washington Date range from 2002 – 2011 Analysis: Kaplan-Meir Survivorship

6 Methods Inclusion Criteria Patients with diagnosis of EOS
Treatment with proximal rib-based growing construct (VEPTR) Index surgery > 5 years Exclusion Criteria Unknown cause for implant removal

7 Patient Demographics Patient Characteristics Patients (no.) 206
Mean age at implant (year) Gender Male 103 (50%) Female EOS Etiology Congenital 46 (22.3%) Neuromuscular 88 (42.7%) Syndromic 35 (17%) Idiopathic 37 (18%) Ambulatory Status Ambulator 98 (47.6%) Non-ambulator 108 (52.4%)

8 Additional Characteristics
Preoperative Curve Characteristics VEPTR Implant Characteristics Major Cobb Classification < 20 5 (2.4%) 17 (8.3%) 140 (68%) > 90 41 (19.9%) Missing 3 (1.5%) Kyphosis Classification 13 (6.3%) 20-50 105 (51%) > 50 46 (22.3%) 42 (20.4%) Number of VEPTRs Unilateral 72 (35%) Bilateral 134 (65%) Location of Inferior Attachment Pelvis 114 (55.3%) Spine 87 (42.2%) Both 5 (2.4%)

9 Revision/Failure Risk
Number (%) Original Construct Revision/Failure 140 (68%) Original Construct – Survival to “Safe” Exit 66 (32%) Year + SD (Range) Age at revision/failure (1-8) Age at "Safe" Exit (2-13) Factors Associated with Revision/Failure Greater preoperative Major Cobb angle (p = 0.006) Preoperative hyperkyphosis (p = 0.021) Age < 6 y (p = 0.001) Inferior anchor to pelvis (p = 0.02)

10 Construct Survivorship
10% of revisions/failures occur 5+ years after index p <0.001 90% of failures occurred in the first 4 years post-index surgery Revision risk relatively consistent each year through year 7 postoperatively

11 Conclusions Majority of revisions/failures (90%) occurred within first 4 years of index surgery Risk factors for VEPTR revision/failure Inferior fixation to pelvis as opposed to spine Age < 6 years Higher preoperative major Cobb angle Preoperative hyperkyphosis Future Goal Need for elucidating risk factors to improve care for patients with EOS

12 Thank You Michael G. Vitale, MD, MPH


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