Results of Surgical Experience Using the VEPTR Device for the Treatment of Thoracic Insufficiency Syndrome. A Multicenter Study

Methods: We conducted an IRB approved retrospective review of 214 patients enrolled in the VEPTR IDE multicenter study. Intraoperative parameters including operative time, estimated blood loss, length of hospitalization, perioperative complications were calculated for index surgeries, expansion surgeries, and replacement surgeries.

Results: There were 1265 total surgical procedures, (Initial implantation 214; Expansion 785; Replacement 141; Removal 16; Other 109). The mean operative times were initial implantation: 213 minutes; expansion of the device: 61 minutes; replacement of the device: 111 minutes; and other surgeries: 134 minutes. Estimated blood loss for index procedure averaged 82 cc; expansion 10 cc; replacement 37 cc; and other 61 cc. There were 10 intraoperative adverse events in 9 patients associated with the index procedure, including accidental injury (3), hypotension (1), cardiovascular disease (1), anemia (3), hypokinesia (1), transient spinal cord injury (1). There were 8 adverse events associated with expansion surgeries and 20 associated with replacement surgery. The average length of hospital stay for the index surgery was 14 days for the initial implantation (range 2-266 days).

Conclusions: Thoracic Insufficiency Syndrome develops in a small number of children with severe, complex deformities of the chest wall and spine. The use of expansion Thoracoplasty with chest wall expansion stabilized using the VEPTR device offers the only current treatment for TIS that addresses both the spine and chest wall deformity. This study demonstrates that the initial implantation of the VEPTR device is safe and associated with relatively low morbidity in this challenging population of patients.