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

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. 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. 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. CONCLUSION:This trial demonstrates ease of placement, removal, functionality and safety of temporary DP electrodes which therapeutically decreases diaphragm atrophy.

journal_name

Am J Surg

authors

Onders RP,Markowitz A,Ho VP,Hardacre J,Novitsky Y,Towe C,Elmo M,Kaplan C,Schilz R

doi

10.1016/j.amjsurg.2017.10.054

subject

Has Abstract

pub_date

2018-03-01 00:00:00

pages

518-521

issue

3

eissn

0002-9610

issn

1879-1883

pii

S0002-9610(17)31002-4

journal_volume

215

pub_type

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