Interventional procedure overview of intramuscular diaphragm stimulation for ventilator-dependent chronic respiratory failure from high spinal cord injuries

Karacam V, Sanli A, Ulugun I et al. (2018) A practical technique in laparoscopic diaphragm pacing surgery: Retrospective analyse of 43 patients. Journal of Minimal Access Surgery 14: 273–6

Case series

n=43 (5 with spinal cord injury)

The DPS implantation procedure duration may vary depending on the patient characteristics and the surgeon's experience. This study demonstrated that minimal modification in DPS implantation procedure could shorten the duration of the surgery. Shorter implantation duration can provide lower intraoperative and postoperative complications.

Study describes a modified technique for implanting the device. Only a small proportion of patients had spinal cord injury as an indication for the procedure.

Kerwin A, Yorkgitis B, Ebler D et al. (2018) Use of diaphragm pacing in the management of acute cervical spinal cord injury. Journal of Trauma and Acute Care Surgery 85: 928–31

Non-randomised comparative study

n=101

Diaphragm pacing system implantation in patients with acute cervical spinal cord injury can be 1 part of a comprehensive critical care program to improve outcomes. However, the association of DPS with the marked improved mortality seen on bivariate analysis may be due solely to improvements in critical care throughout the study period.

The study describes patients with acute spinal cord injury rather than chronic respiratory failure. The study is included in the meta-analysis by Onders et al. (2022).

Lammertse D, Charlifue S, Berliner J (2016) Longitudinal follow-up of individuals with implanted diaphragm pacing systems. American Spinal Injury Association Annual Scientific Meeting. Philadelphia, US.

Case series

n=31

24/28 (86%) patients were still using DPS (4 to 24 hours) at the time of follow-up (mean 16 hours, median 16 hours).

7/28 patients (25%) were pacing 24 hours a day.

Study reported only as conference abstract but included in the meta-analysis by Onders et al. (2022).

Onders RP, Elmo MJ, Stepien C et al. (2021) Spinal cord injury level and phrenic nerve conduction studies do not predict diaphragm pacing success or failure- all patients should undergo diagnostic laparoscopy. American Journal of Surgery 221: 585–8

Case series

n=50

Phrenic nerve conduction studies are inadequate preoperative studies. Direct laparoscopic evaluation should be offered for all spinal cord injury patients to receive the benefit of diaphragm pacing.

The study assesses the use of phrenic nerve conduction studies in patient selection.

Onders RP, Ponsky TA, Elmo MJ et al. (2011) First reported experience with intramuscular diaphragm pacing in replacing positive pressure mechanical ventilators in children. Journal of Pediatric Surgery 46: 72–6

Case series

n=6

In all patients, DPS provided tidal volumes above basal needs. Five of the patients underwent a home-based weaning program, whereas 1 patient who was implanted only 11 days after spinal cord injury never returned to the ventilator with DPS use. Another patient was weaned from the ventilator full time but died of complications of his underlying brain stem tumour. The remaining patients weaned from the ventilator for over 14 hours a day or are actively conditioning their diaphragms.

Larger or more recent studies are included.

Onders RP, Khansarinia S, Weiser T et al. (2010) Multicenter analysis of diaphragm pacing in tetraplegics with cardiac pacemakers: positive implications for ventilator weaning in intensive care units. Surgery 148:893–7

Case series

n=20

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

Study is included in systematic review by Garara et al. (2016).

Onders RP, Elmo M, Khansarinia S et al. (2009) Complete worldwide operative experience in laparoscopic diaphragm pacing: results and differences in spinal cord injured patients and amyotrophic lateral sclerosis patients. Surgical Endoscopy 23:1433-40

Case series

n=88 (50 with spinal cord injury)

In the patients with spinal cord injury, 96% were able to use DPS to provide ventilation replacing their mechanical ventilators.

Study is included in systematic review by Garara et al. (2016).

Onders RP, Elmo MJ, Ignagni AR (2007) Diaphragm pacing stimulation system for tetraplegia in individuals injured during childhood or adolescence. Journal of Spinal Cord Medicine 30: S25–9

Case series

n=10 (injured as children or adolescents)

Four patients use DPS continuously, 4 pace daytime only, and 2 patients are still actively conditioning their diaphragms. Two patients needed surgical correction of scoliosis before implantation. All patients prefer breathing with the DPS and would recommend it to others; 4 patients specifically identified that attending college or church without a ventilator eases their integration into society.

Study is included in systematic review by Garara et al. (2016).

Onders RP, DiMarco AF, Ignagni AR et al. (2005) The learning curve for investigational surgery: lessons learned from laparoscopic diaphragm pacing

for chronic ventilator dependence. Surgical Endoscopy 19: 633–7

Case series

n=6

One procedure was unsuccessful because of a nonfunctioning phrenic nerve. All 5 of the successfully implanted patients could be maintained on prolonged ventilatory support with the device.

Study is included in systematic review by Garara et al. (2016).

Same population as Onders et al. (2004) and DiMarco et al. (2005)

Onders RP, Dimarco AF, Ignagni AR et al. (2004) Mapping the phrenic nerve motor point: the key to a successful laparoscopic diaphragm pacing system in the first human series. Surgery 136: 819–26

Case series

n=6 (with spinal cord injury)

5 of 6 patients had electrodes successfully implanted at the motor point to produce adequate tidal volumes. The 1 failure caused a change in the inclusion criteria to include fluoroscopic confirmation of diaphragm movement during surface nerve stimulation. Three patients were completely free of the ventilator, and the other 2 were progressively increasing their time off the ventilator with conditioning.

Study is included in systematic review by Garara et al. (2016).

Same population as Onders et al. (2005) and DiMarco et al. (2005)

Posluszny JA, Onders R, Kerwin AJ et al. (2014) Multicenter review of diaphragm pacing in spinal cord injury: successful not only in weaning from ventilators but also in bridging to independent respiration. Journal of Trauma and Acute Care Surgery 76: 303–9

Case series

n=29

Of the stimulatable patients who had DPS, 72% (16/22) were completely free of ventilator support in an average of 10 days. For the remaining 6 patients, 2 had delayed weans of 180 days, 3 had partial weans and 1 patient went to a long-term acute care hospital and had life-prolonging measures withdrawn. Eight patients (36%) had complete recovery of respiration, and DPS wires were removed.

Study is included in systematic review by Garara et al. (2016) and in the meta-analysis included in Onders et al. (2022).

Tedde ML, Onders RP, Teixeira MJ et al. (2012) Electric ventilation: indications for and technical aspects of diaphragm pacing stimulation surgical implantation. Jornal brasileiro de pneumologia: publicacao oficial

da Sociedade Brasileira de Pneumologia e Tisilogia 38: 566–72

Case series

n=5

Follow up=6 months

Of the 5 patients, 3 could breathe using DPS alone for more than 24 hours, 1 could do so for more than 6 hours, and one could not do so at all.

Study is included in systematic review by Garara et al. (2016).

Includes the same patients as the study below.

Tedde ML, Vasconcelos Filho P, Hajjar LA et al. (2012) Diaphragmatic pacing stimulation in spinal cord injury: anesthetic and perioperative management. Clinics 67:1265–9

Case series

n=5

Follow up=6 months

The diaphragmatic pacemaker placement was successful in all patients. Two patients presented with capnothorax during the perioperative period, which resolved without consequences. After 6 months, 3 patients achieved continuous use of the diaphragm pacing system, and 1 could be removed from mechanical ventilation for more than 4 hours per day.

Study is included in systematic review by Garara et al. (2016).

Includes the same patients as the study above.

Watt J, Wiredu E, Silva P et al. (2011) Survival after short- or long-term ventilation after acute spinal cord injury: a single-centre 25-year retrospective study. Spinal Cord 49: 404–410

n=189 (19 patients used diaphragm pacing)

Mean survival in patients who used diaphragm pacing (full or part time) was 19.2 years for those aged 0 to 30 (n=13), 13.1 years for those aged 31 to 45 (n=3) and 10.3 years for those aged 46 and above (n=3). Mean survival for patients on mechanical ventilation was 17.4 years for those aged 0 to 30 (n=12), 9.9 years for those aged 31 to 45 (n=12) and 7.9 years for those aged 46 and above (n=12).

Retrospective study with a small number of patients who had diaphragm pacing. This group of patients was not described in enough detail to warrant inclusion in the main evidence summary.

Woo A La, Tchoe Ha Jin, Shin Hae Won et al. (2020) Assisted breathing with a diaphragm pacing system: a systematic review. Yonsei Medical Journal 61: 1024–33

Systematic review

n=289 (10 studies (82 patients [5 studies] with spinal cord injury)

The studies involving patients with spinal cord injury found that survival duration was not significantly different between diaphragm pacing and no diaphragm pacing. The rate of mechanical ventilation weaning in patients with spinal cord injury was reported in 1 cohort study as 33% and 1 case series as 96%. However, given that 1 study was only a case series, the results remain inconclusive. Additional well-designed studies are needed to ascertain the efficacy of DPS in patients with spinal cord injuries.

The review only included 5 relevant studies, all of which have been described in the key evidence summary or appendix of the overview. There was no meta-analysis.

Yokota K, Masuda M, Koga R et al. (2022) Diaphragm pacing implantation in Japan for a patient with cervical spinal cord injury: A case report. Medicine 101: e29719

Case report

n=1

At 1.5 years after injury, a DPS was surgically implanted to support the patient's respiratory function. The mechanical ventilator support was successfully withdrawn from the patient 14 weeks after implantation. Both the vital capacity and tidal volume of the patient were significantly promoted following implantation. The patient finally returned to daily life without any mechanical support.

Case report