Adverse Events Associated with the Vertical Expandable Prosthetic Titanium Rib (VEPTR) A Multicenter Review of 257 patients

Background: Treatment of complex congenital malformations without fusion remains controversial. Historical data for the use of growing rods is confusing, primarily due to heterogenous patient population, small numbers, the lack of controlled studies. The complication rate for growing rods in the literature ranges from 24% to more than 150%. The use of VEPTR for growth preservation and growth promotion procedures of the spine is new, with 257 patients included in the Multicenter Investigational Device Evaluation (IDE) study to date. Given the complexity of this patient population, complications are frequent. However, the incidence, type, severity, mananagement and outcome of VEPTR related complications is unknown. These data would be valuable for comparison to traditional treatment methods, and to promote prevention/avoidence of complications in future patients.

Purpose: The purpose of this study is to document the incidence, type, severity, mananagement and outcome of VEPTR related complications.

Methods: The VEPTR Registry Database was analyzed for all adverse events that occurred in 257 patients operated between 1990 and 2003. Adverse events were categorized by body systems, relationship to the VEPTR device, treatment, severity and outcome.

Results: There were 455 adverse events in 154 patients (60%). However, when analyzed by intensity, approximently 75% were moderate or minor, whereas 21% were serious. Five percent of the overall adverse events were classified as life threatening or fatal. With the exception of the fatal events, 41% resolved with surgical management, 42% with medical management, and 12% resolved without intervention. 0.7% had permanent impairment as a result of the adverse event. Classification by body system was as follows: Pulmonary/non-infective 16%, Infection/wound slough 17%, Pulmonary infection 15%, Device Migration 15%, Other 10%, Urological/GI 9%, Cardiac 8%, Device Failure 5%, and Neuro 5%.

Conclusions: It is difficult to compare the incidence of adverse events associated with VEPTR to that of historical data for growing rods. The overall incidence of adverse events associated with VEPTR compares favorably with the published literature.