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Long-term Follow-up of Patients with Ventilatory Dependent High Tetraplegia Managed with Diaphragmatic Pacing Systems

PI(s): Daniel Lammertse, MD, Susan Charlifue, PhD

Funded by: National Institute on Disability and Rehabilitation Research

Dates: 2011-2016

Contact: Susan Charlifue susie@craighospital.org

Diaphragmatic Pacing System (DPS) is a relatively new treatment option that has been offered to people with spinal cord injuries (SCI) who have ventilator dependent high tetraplegia. Reporting of long-term outcomes of DPS in the SCI population has been limited to a 2009 study that included 50 patients with average follow-up of 2.0 years. Therefore, the purpose of this observational longitudinal study is to collect long-term follow-up data on DPS patients implanted and/or followed at Craig Hospital since 2007, in order to identify and describe the long term outcomes for individuals with SCI using DPS. Five other participating SCI centers across the country are also participating in this study. Study methodology will consist of identifying individuals implanted with DPS since 2007 and administering the study questionnaire to individuals as they cross their 1st, 3rd, 5th or 7th anniversary with DPS. Additional information will also be abstracted from medical records for those individuals that return to Craig Hospital for routine clinical follow-up. Findings from this study will facilitate the reporting of independent long-term utilization, effectiveness, satisfaction, durability and safety outcomes of this innovative technology.