Elsevier

Surgery

Volume 148, Issue 4, October 2010, Pages 893-898
Surgery

Central Surgical Association
Multicenter analysis of diaphragm pacing in tetraplegics with cardiac pacemakers: Positive implications for ventilator weaning in intensive care units

Presented at Central Surgical 2010, March 10–13, 2010, Chicago, Illinois.
https://doi.org/10.1016/j.surg.2010.07.008Get rights and content

Background

Diaphragm pacing (DP) can replace mechanical ventilation in tetraplegics and in trials has assisted respiration in amyotrophic lateral sclerosis patients. This report describes results of DP in patients with cardiac pacemakers.

Methods

Prospective, single-center and multicenter, nonrandomized, controlled, interventional protocols under U.S. Food and Drug Administration and/or institutional review board approval were evaluated. Patients underwent laparoscopic diaphragm motor point mapping to identify optimal electrode site for implantation. With diaphragm conditioning, patients were weaned from their ventilator. Perioperative and long-term assessments between the cardiac pacemakers and DP were analyzed for any device-to-device interactions.

Results

Over 300 subjects were implanted from 2000 to 2010. Twenty tetraplegics with cardiac pacemakers and DP were analyzed from 6 sites. Subjects ranged from 19 to 61 years old with DP implantation 6 months to 24 years postinjury. There were no immediate or long-term device to device interactions. All patients achieved diaphragm-paced tidal volumes exceeding their basal requirements and, after conditioning, all patients could go >4 hours without mechanical ventilators; 71% could go 24 hours continuously.

Conclusion

DP can be safely implanted in tetraplegics having cardiac pacemakers. Applications for temporary use of DP to maintain diaphragm type 1 muscle fiber and improve posterior lobe ventilation may benefit complex critical care patients.

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

References (17)

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