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Completed FDA feasibility trial of surgically placed temporary diaphragm pacing electrodes: A promising option to prevent and treat respiratory failure.

Authors :
Onders RP
Markowitz A
Ho VP
Hardacre J
Novitsky Y
Towe C
Elmo M
Kaplan C
Schilz R
Source :
American journal of surgery [Am J Surg] 2018 Mar; Vol. 215 (3), pp. 518-521. Date of Electronic Publication: 2017 Nov 11.
Publication Year :
2018

Abstract

Background: Etiologies contributing to failure to wean from mechanical ventilation (MV) are multiple, resulting in morbid and costly outcomes. Diaphragm pacing (DP) is used in spinal cord injury to replace MV. Temporary DP could be utilized in acute respiratory failure to reduce MV.<br />Methods: A prospective FDA feasibility trial evaluated temporary DP electrodes implanted in each hemi-diaphragm during a subject's primary procedure. Objectives included: ability to provide ventilation, stability analysis with diaphragm electromyography, and adverse event monitoring.<br />Results: Twelve patients underwent successful implantation via median sternotomy, laparoscopy or laparotomy. Electrode stimulation exceeded ideal tidal volumes by an average of 37% (0%-95%) confirming ability to prevent atrophy. Daily electromyography confirmed stability of placement and was useful in evaluating hypoventilation. There were no complications and all 48 study electrodes remained intact until complete removal.<br />Conclusion: This trial demonstrates ease of placement, removal, functionality and safety of temporary DP electrodes which therapeutically decreases diaphragm atrophy.<br /> (Copyright © 2017 Elsevier Inc. All rights reserved.)

Details

Language :
English
ISSN :
1879-1883
Volume :
215
Issue :
3
Database :
MEDLINE
Journal :
American journal of surgery
Publication Type :
Academic Journal
Accession number :
29195690
Full Text :
https://doi.org/10.1016/j.amjsurg.2017.10.054