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Clinical Trial
. 2007;30 Suppl 1(Suppl 1):S25-9.
doi: 10.1080/10790268.2007.11753965.

Diaphragm pacing stimulation system for tetraplegia in individuals injured during childhood or adolescence

Affiliations
Clinical Trial

Diaphragm pacing stimulation system for tetraplegia in individuals injured during childhood or adolescence

Raymond P Onders et al. J Spinal Cord Med. 2007.

Abstract

Background: Children with cervical spinal cord injury and chronic respiratory insufficiency face the risks and stigma associated with mechanical ventilators. The Diaphragm Pacing Stimulation (DPS) System for electrical activation of the diaphragm is a minimally invasive alternative to mechanical ventilation.

Methods: Review of patients in a prospective Food and Drug Administration trial of the DPS System in individuals who were injured at age 18 years or younger. The procedure involved laparoscopic mapping to locate the diaphragm motor points with electrode implantation. Two weeks after surgery, stimulus/output characteristics of each electrode were determined to obtain an adequate tidal volume for ventilation. A home-based weaning protocol from the ventilator was used.

Results: Of 28 patients implanted with the DPS System, 10 had sustained cervical SCI as children or adolescents. Average age at injury was 13 years (range 1.5 to 17 y). Age at implantation ranged from 18 to 34 years. Length of time from injury to implantation averaged 9.7 years (0.8 to 19 y). All patients tolerated the implantation procedure. Four patients utilize DPS continuously (24/7), 4 patients pace daytime only, and 2 patients are still actively conditioning their diaphragms. Two patients required surgical correction of scoliosis prior to implantation. All patients prefer breathing with the DPS and would recommend it to others; 4 patients specifically identified that attending college or church without a ventilator eases their integration into society.

Conclusions: The results show that the laparoscopic DPS system can be safely implanted in tetraplegics injured as children and used in a home-based environment to wean them off of mechanical ventilation.

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Figures

Figure 1
Figure 1. Mapping instrument being used on the right diaphragm to identify the point where stimulation causes maximal contraction.
Figure 2
Figure 2. The implant instrument houses the electrode in a needle for placement in the diaphragm.
Figure 3
Figure 3. The DPS system connects to a patient by percutaneous wires with a cable.

References

    1. DeVivo MJ, Vogel LC. Epidemiology of spinal cord injury in children and adolescents. J Spinal Cord Med. 2004;27:S4–S10. - PubMed
    1. National Spinal Cord Injury Statistical Center, University of Alabama at Birmingham 2005 Annual Statistical Report, July 2005. http://www.spinalcord.uab.edu, “2005 Annual Statistical Report.”.
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    1. Aiyar H, Stellato TA, Onders RP, Mortimer JT. Laparoscopic implant instrument for the placement of intramuscular electrodes in the diaphragm. IEEE Trans Rehabil Eng. 1999;7:360–371. - PubMed

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