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

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.

  • Raymond P. Onders, MD

      Affiliations

    • Department of Surgery, University Hospitals Case Medical Center, Cleveland, OH
    • Corresponding Author InformationReprint requests: Raymond P. Onders, MD, Department of Surgery, 11100 Euclid Avenue, Cleveland, OH 44106.
  • ,
  • Saeid Khansarinia, MD

      Affiliations

    • Department of Thoracic Surgery, Piedmont Hospital, Atlanta, GA
  • ,
  • Todd Weiser, MD

      Affiliations

    • Department of Cardiothoracic Surgery, Mount Sinai Medical Center, New York, NY
  • ,
  • Cynthia Chin, MD

      Affiliations

    • Department of Cardiothoracic Surgery, Mount Sinai Medical Center, New York, NY
  • ,
  • Eric Hungness, MD

      Affiliations

    • Department of Surgery, Northwestern University, Chicago, IL
  • ,
  • Nathaniel Soper, MD

      Affiliations

    • Department of Surgery, Northwestern University, Chicago, IL
  • ,
  • Alberto DeHoyos, MD

      Affiliations

    • Department of Surgery, Northwestern University, Chicago, IL
  • ,
  • Tim Cole, MD

      Affiliations

    • Department of Surgery, Saint Elizabeth Regional Medical Center, Lincoln, NE
  • ,
  • Christopher Ducko, MD

      Affiliations

    • Division of Thoracic Surgery, Brigham and Women's Hospital, Boston, MA

published online 27 August 2010.

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.

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 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.

PII: S0039-6060(10)00370-3

doi:10.1016/j.surg.2010.07.008

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