Follow up Study of Diaphragm Pacing for Patients With High Tetraplegia
| Status: | Completed |
|---|---|
| Conditions: | Hospital, Neurology, Orthopedic |
| Therapuetic Areas: | Neurology, Orthopedics / Podiatry, Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/1/2017 |
| Start Date: | January 2013 |
| End Date: | April 2016 |
Long-term Follow-up of Patients With Ventilatory Dependent High Tetraplegia Managed With Diaphragmatic Pacing Systems
This is an observational longitudinal study designed to identify and describe long term
outcomes for patients with high tetraplegia who use a Diaphragmatic Pacing System (DPS). As
this is not a randomized or experimental study, no specific hypotheses are proposed. The
data collected will enable us to answer the following research questions:
1. What are the patterns of long-term DPS use (hours per day using DPS, changes in DPS
stimulus parameters, abandonment of DPS and related reasons).
2. What mechanical problems have DPS users encountered (system failure, repairs needed)?
3. What are the frequency of and reasons for rehospitalization following DPS implant?
4. What levels of care are needed at home to manage the DPS?
5. How do DPS users feel about the system (satisfaction, comfort, vocalization, taste,
swallowing)?
outcomes for patients with high tetraplegia who use a Diaphragmatic Pacing System (DPS). As
this is not a randomized or experimental study, no specific hypotheses are proposed. The
data collected will enable us to answer the following research questions:
1. What are the patterns of long-term DPS use (hours per day using DPS, changes in DPS
stimulus parameters, abandonment of DPS and related reasons).
2. What mechanical problems have DPS users encountered (system failure, repairs needed)?
3. What are the frequency of and reasons for rehospitalization following DPS implant?
4. What levels of care are needed at home to manage the DPS?
5. How do DPS users feel about the system (satisfaction, comfort, vocalization, taste,
swallowing)?
Ventilatory dependent high tetraplegia is a relatively rare but devastating condition.
Review of National Spinal Cord Injury Database statistics show that only 3.6% of patients
with tetraplegia are ventilator dependent at one year post injury.1 A subset of individuals
who are ventilatory dependent in the long term and have upper motor neuron paralysis of the
diaphragm are candidates for electrophrenic respiration (EPR) which can create inspiratory
function through electrical stimulation of the phrenic nerves, resulting in diaphragmatic
contraction. The use of this technology in ventilatory dependent tetraplegia was first
described almost 40 years ago with a pacing system using cuff electrodes surgically placed
around the phrenic nerve in the neck.2 The concept of EPR via minimally invasive
laparoscopically placed diaphragmatic electrodes was first reported in 2002.3 This new
Diaphragmatic Pacing System (DPS) had the distinct advantage of requiring less invasive
surgery for electrode implantation compared to the phrenic cuff electrode system which
required surgical exploration of the neck. In some settings, the DPS system has been
implanted as an outpatient surgery. The DPS had a potential disadvantage however in that,
unlike the traditional EPR system, the stimulating electrode leads are externalized posing
an infection risk and the electrodes are attached to a moving muscle creating a risk for
dislodgement. Once the system achieved FDA Humanitarian Use Device (HUD) exemption status in
2008, there was adoption of the Diaphragm Pacing System (DPS) among a number of SCI centers
as a treatment option for patients with ventilatory dependent high tetraplegia. Reporting of
long-term outcomes of DPS in the SCI population is limited to a 2009 report authored by the
system inventor on 50 patients with average follow-up of 2.0 ± 1.5 years (median 1.6 years,
range 0.5-8.0 years).4 The six SCIMS centers participating in this module research propose
to collect long-term follow-up data on DPS patients implanted and/or followed at their
centers since 2007. This project will enable the reporting of independent long-term
utilization, effectiveness, satisfaction, durability and safety outcomes of this innovative
technology.
Review of National Spinal Cord Injury Database statistics show that only 3.6% of patients
with tetraplegia are ventilator dependent at one year post injury.1 A subset of individuals
who are ventilatory dependent in the long term and have upper motor neuron paralysis of the
diaphragm are candidates for electrophrenic respiration (EPR) which can create inspiratory
function through electrical stimulation of the phrenic nerves, resulting in diaphragmatic
contraction. The use of this technology in ventilatory dependent tetraplegia was first
described almost 40 years ago with a pacing system using cuff electrodes surgically placed
around the phrenic nerve in the neck.2 The concept of EPR via minimally invasive
laparoscopically placed diaphragmatic electrodes was first reported in 2002.3 This new
Diaphragmatic Pacing System (DPS) had the distinct advantage of requiring less invasive
surgery for electrode implantation compared to the phrenic cuff electrode system which
required surgical exploration of the neck. In some settings, the DPS system has been
implanted as an outpatient surgery. The DPS had a potential disadvantage however in that,
unlike the traditional EPR system, the stimulating electrode leads are externalized posing
an infection risk and the electrodes are attached to a moving muscle creating a risk for
dislodgement. Once the system achieved FDA Humanitarian Use Device (HUD) exemption status in
2008, there was adoption of the Diaphragm Pacing System (DPS) among a number of SCI centers
as a treatment option for patients with ventilatory dependent high tetraplegia. Reporting of
long-term outcomes of DPS in the SCI population is limited to a 2009 report authored by the
system inventor on 50 patients with average follow-up of 2.0 ± 1.5 years (median 1.6 years,
range 0.5-8.0 years).4 The six SCIMS centers participating in this module research propose
to collect long-term follow-up data on DPS patients implanted and/or followed at their
centers since 2007. This project will enable the reporting of independent long-term
utilization, effectiveness, satisfaction, durability and safety outcomes of this innovative
technology.
Inclusion Criteria:
- Patients previously incurring a traumatic spinal cord injury resulting in high
tetraplegia
- Patients implanted with DPS
Exclusion Criteria:
- Implementation of DPS prior to 2003
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