Central Surgical AssociationMulticenter analysis of diaphragm pacing in tetraplegics with cardiac pacemakers: Positive implications for ventilator weaning in intensive care units
Section snippets
Patients and methods
Tetraplegic patients implanted with DP and who had cardiac pacemakers were identified from a database of the initial prospective study under the U.S. Food and Drug Administration (FDA)-approved Investigational Device Exemption study and then during subsequent compassionate use implantations of a humanitarian use device (HUD). This was a compilation of all patients implanted at multiple sites in a nonrandomized, controlled, interventional protocol under FDA and/or institutional review board
Results
From 2000 to 2010, >300 subjects were implanted with DP in various protocols providing >300 patient-years of DP usage. Within this group, approximately half were cervical spinal cord–injured patients with 20 having internal cardiac pacemakers in the United States; this group forms the basis for this report. Ten patients were implanted between January 2006 and July 2007; the second 10 were implanted in 2009. Subjects were 19–61 years old and had DP implantation from 6 months to 24 years
Discussion
DP has been shown to decrease a patients' dependence on positive-pressure mechanical ventilation and improve their quality of life, including some of the most basic qualities such as olfaction and taste.10 DP allows natural, negative-pressure ventilation, preferentially aerating the posterior lobes of the lungs and increasing respiratory compliance. Hirshfield et al11 reported a decrease in respiratory infections from 2 to 0 per year with phrenic pacing. The present report reinforces those
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Diaphragm stimulation elicits phrenic afferent-induced neuromuscular plasticity
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2018, Neuromodulation: Comprehensive Textbook of Principles, Technologies, and Therapies, Second Edition: Volume 1-3Complications in the Management of Patients with Spine Trauma
2017, Neurosurgery Clinics of North AmericaCitation Excerpt :It also reduces the duration of mechanical ventilation and intensive care unit stay, and decreases the rate of orotracheal intubation-associated complications such as tracheal granuloma formation and stenosis.44 Recent research has suggested that patients with diaphragm paralysis may benefit from placement of a diaphragm pacer because it can reduce dependence on positive-pressure ventilation and may even aid neuroplasticity with the development of alternative diaphragm innervation.45 Potential hematologic complications encountered in SCI most commonly include, but are not limited to, deep venous thrombosis (DVT), anemia, thrombocytopenia, and coagulopathy (Box 2).5
Enhancing neural activity to drive respiratory plasticity following cervical spinal cord injury
2017, Experimental NeurologyCitation Excerpt :These devices also range from externally controlled open-loop devices to self-regulating closed-loop interfaces. Open-loop devices, such as diaphragm pacers that can be used to treat respiratory dysfunction (Onders, 2012; Onders et al., 2007; Onders et al., 2010; Posluszny et al., 2014; Tedde et al., 2012), generate electrical stimulation based on an exogenous signal (e.g. a pre-programmed external controller). Closed-loop devices record and amplify signals from sensors (e.g. position sensor, muscle contraction sensors) implanted within the recipient, and use the recorded (endogenous) signal for stimulation.
Intramuscular diaphragmatic stimulation for patients with traumatic high cervical injuries and ventilator dependent respiratory failure: A systematic review of safety and effectiveness
2016, InjuryCitation Excerpt :Another patient presented with delayed wound infection from a suture granuloma at the superficial wire connection site, which was treated by externalising the electrodes [19]. Onders et al. reported one incidence of the DPS interacting with a pre-existing internal cardiac pacemaker [13]. One patient described intermitted aspiration of food during meals that was attributed to contraction of the diaphragm causing large negative airway pressure [21].
Case Western Reserve University, Dr Raymond Onders, and University Hospitals Case Medical Center have intellectual property rights involved with the diaphragm pacing system and equity in Synapse Biomedical who manufactures the device.