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Published on: February 28, 2012
Diaphragm pacing in infants and children. A life-table analysis of implanted components
D E Weese-Mayer1, A S Morrow, R T Brouillette
1Northwestern University Medical School, Children's Memorial Hospital, Department of Pediatrics, Chicago, Illinois.
Insights
Diaphragm pacing using phrenic nerve electrodes is effective for pediatric patients with hypoventilation. However, component failures, including receiver issues and wire breakage, necessitate system improvements for enhanced reliability.
Area of Science:
- Biomedical Engineering
- Pediatric Pulmonology
- Neurosurgery
Background:
- Diaphragm pacing is a vital treatment for pediatric respiratory failure.
- The Avery Laboratories (S-232-1) pacemaker system has been used since 1976.
- Long-term pediatric data on this system's implanted components is limited.
Purpose of the Study:
- To analyze the reliability and failure modes of implanted diaphragm pacing components in pediatric patients.
- To identify areas for improvement in the pacemaker system and surgical techniques.
Main Methods:
- Retrospective analysis of 33 pediatric patients (1976-present) implanted with bilateral phrenic nerve electrodes.
- Life table analysis to determine the mean time to component replacement.
- Classification of component failures.
Main Results:
- 192 system-years and 96 patient-years of pacing data were analyzed.
- Mean time to component replacement was 56.3 months.
- 26 failures occurred: 15 receiver failures, 6 electrode wire/insulation breakages, 3 infections, and 2 mechanical nerve injuries.
Conclusions:
- The diaphragm pacing system is effective but carries risks of biomedical component failure.
- Improvements needed include a hermetically sealed receiver, stronger electrode wires, and optimized surgical techniques to prevent nerve damage.
Abstract:
Since 1976, we have implanted bilateral phrenic nerve electrodes for diaphragm pacing in 33 infants and children. This population includes 23 patients with congenital central hypoventilation syndrome (CHS), two with late onset CHS and hypothalamic dysfunction, three with hypoventilation associated with Chiari II malformation and myelomeningocele, and five with quadriplegia. Our experience, totalling 192 system-years and 96 patient-years of pacing, has enabled us to document the nature and frequency of problems related to the implanted components of the Avery Laboratories (S-232-1) pacemaker system when used in a pediatric population. By life table analysis, the mean time to need for replacement of any implanted component was 56.3 months. A total of 26 failures requiring component replacement occurred and were classified into four types: (1) receiver failure (15 cases), (2) electrode wire or wire insulation breakage (six cases), (3) infection requiring diaphragm pacer system removal (three cases), and (4) mechanical nerve injury (two cases). We conclude that the present diaphragm pacing system is effective but not without risk of biomedical component failure. The present system might be substantially improved by (1) a modified receiver design with a hermetic seal to prevent fluid penetration, (2) stronger, better insulated electrode wires, and (3) modifications of surgical technique and electrode type to prevent phrenic nerve damage.
