Prospective FDA Feasibility Trial of Laparoscopically Placed Temporary Diaphragm Pacing Electrodes: A New Reversible Therapy to Treat Respiratory Failure

Raymond Onders, MD, MaryJo Elmo, Cindy Kaplan, Ajita S Prabhu, MD, Jeffrey M Hardacre, MD. University Hospitals Case Medical Center

Introduction: Acute respiratory failure requiring mechanical ventilation (MV) is a common life-threatening result of varied diseases. MV comprises 30% of all Intensive Care Unit (ICU) admissions and 40% of MV time is spent weaning. MV patients consume more resources, have longer ICU and hospital stays, and experience more complications. Reducing MV is a priority for health care providers, administrators, systems and payers. Diaphragm Pacing(DP) is FDA approved and is used in Spinal Cord Injury and Amyotrophic Lateral Sclerosis to either replace, decrease or delay invasive mechanical ventilation. This reports use of a new temporary DP electrode that will identify and treat respiratory compromise.

Methods: This was a prospective FDA (IDE #G150040); IRB approved (#4-15-03) and listed on (NCT 02410798) trial to evaluate the feasibility of temporary DP electrodes. This is a subgroup analysis of the 4 abdominal laparoscopic procedures with subsequent implantation of DP electrodes. 

Results: Four patients, 2 males and 2 females, successfully underwent placement of two temporary electrodes into each diaphragm during a laparoscopic abdominal procedure.  Ages ranged from 61 to 80, with an average age of 67.8 years.  Primary surgical procedures included adrenalectomy (1) and benign foregut procedures (3). The subjects had multiple co-morbidities with an ASA of 2 to 3.  Average BMI was 31.3 with a range of 24.3 to 37.0.  At the end of the primary procedure, DP electrodes were easily implanted and stimulated.  Stimulation settings, including amplitude, pulse width, frequency and inspiratory time, were adjusted to achieve ideal tidal volumes.   In three patients, stimulated tidal volumes exceeded the ideal tidal volume by an average of 26.3% and in one patient ideal tidal volume was met.  There was no cardiac interference while stimulating the diaphragm at maximum settings.   Postoperatively, respiratory function was monitored by recording diaphragm EMG activity daily throughout their hospital stay utilizing the temporary pacing electrodes.  There were no complications associated with the placement of the temporary diaphragm pacing electrodes and all 16 study electrodes remained in place until removal prior to discharge.  There was minimal pain reported with complete intact removal of all 16 electrodes at the bedside. 

Conclusions: This trial demonstrates the ease of placement, removal and functionality of temporary DP electrodes. For patients that develop respiratory failure, laparoscopically placed DP wires can provide a novel adjunctive therapy stimulating the diaphragm and potentially reducing MV.

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