Long-Term Follow-Up of Patients With Ventilator-Dependent High Tetraplegia Managed With Diaphragmatic Pacing Systems

Monden, Kimberley R.; Coker, Jennifer; Charlifue, Susan; Bennett, Stephanie; Draganich, Christina; Coons, David; Marino, Ralph J.; Berliner, Jeffrey

doi:10.1016/j.apmr.2021.03.005

Cited by 7 publications

(7 citation statements)

References 18 publications

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“…However, there have been years of data accumulated for treating patients with MV for high tetraplegic injuries. Further, there have been previous peer‐reviewed papers that have reported on the safety and effectiveness of this device in this patient population 10–18 …”

Section: Discussionmentioning

confidence: 99%

“…Further, there have been previous peer-reviewed papers that have reported on the safety and effectiveness of this device in this patient population. [10][11][12][13][14][15][16][17][18] In conclusion, diaphragm pacing represents a safe and effective alternative for SCI patients that require MV support. The firm evidence from the prospective IDE, additional published studies, as well as real-world experience have combined to establish DPS as a valid clinical tool and have thus increased application of diaphragm pacing roughly 10-fold over the previously available technologies in trauma centers and spinal cord injury rehabilitation.…”

Section: Discussionmentioning

confidence: 99%

“…13 The 53 commercial use patients were included in the supporting analyses. Other studies included a matched cohort analysis (N = 40 implanted with DPS) of acute cervical injury patients 14 ; a multicenter analysis conducted at Spinal Cord Injury Model Systems centers that was designed to evaluate the long-term outcomes of SCI patients treated with DPS (N = 31) 15,16 ; and a multicenter retrospective evaluation of long-term outcomes in 29 cervical SCI patients, 22 of whom were able to be implanted with DPS. 17 The published data from the supporting studies are summarized in Table 1.…”

Section: Study Endpointsmentioning

confidence: 99%

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Diaphragm pacing in spinal cord injury can significantly decrease mechanical ventilation in multicenter prospective evaluation

et al. 2022

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Background Cervical spinal cord injury (SCI) can lead to dependence on mechanical ventilation (MV) with significant morbidity and mortality. The diaphragm pacing system (DPS) was developed as an alternative to MV. Methods We conducted a prospective single‐arm study of DPS in MV‐dependent patients with high SCI and intact phrenic nerves. Following device acclimation, pacing effectiveness to provide ventilation was evaluated. The primary endpoint was the number who could use DPS to breathe for 4 continuous hours without MV. Secondary endpoints included the number of patients that could use DPS 24 h/day free of MV and the ability of DPS to maintain clinically acceptable tidal volume (Vt). In addition, we conducted a meta‐analysis that included the prospective study along with data from four recently published studies to evaluate DPS hourly use. Results Fifty‐three patients were implanted in the prospective study. Most were male (77.4%) with a median time from injury to treatment of 28.3 (IQR: 12.1, 83.3) months. Four‐ and 24‐h use occurred in 96.2% (95% CI: 87.0%, 99.5%) and 58.5% (95% CI: 44.1%, 74.9%), respectively. Four and 24‐h results in the meta‐analysis cohort (n = 196) exhibited similar results 92.2% (95% CI: 82.6%, 96.7%) and 52.7% (95% CI: 36.2%, 68.6%) using DPS for 4 and 24 h, respectively. DPS use significantly exceeded the calculated basal tidal volume requirements by a mean of 48.4% (95% CI: 37.0, 59.9%; p < 0.001). Conclusions This study demonstrates that in most ventilator‐dependent patients, diaphragm pacing can effectively supplement or completely replace the need for MV and support basal metabolic requirements.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Study Endpointsmentioning

confidence: 99%

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Diaphragm pacing in spinal cord injury can significantly decrease mechanical ventilation in multicenter prospective evaluation

et al. 2022

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“… 1 , 2 Approximately 1000 of these patients still require chronic MV at one year. 3 Early reports in 2020 showed that the mortality rate of SCI patients with COVID-19 was 19% which was significantly higher than non- SCI patients. 4 SCI patients are at a risk for severe COVID-19 for a number of reasons, including decreased pulmonary capacity and inability to clear secretions.…”

Section: Introductionmentioning

confidence: 99%

Observational study of early diaphragm pacing in cervical spinal cord injured patients to decrease mechanical ventilation during the COVID-19 pandemic

Onders

Elmo

Young

et al. 2023

Surgery

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“…External diaphragmatic pacing (EDP) is a passive respiratory muscle exercise methodology which stimulates the phrenic nerve to stimulate the diaphragm to passively contract regularly and effectively, and to promote the recovery of diaphragmatic dysfunction. It has been shown to effectively improve diaphragmatic dysfunction and reduce duration of MV (DMV) for patients with spinal cord injuries (SCIs) (11) and amyotrophic lateral sclerosis (ALS) (12,13).…”

Section: Introductionmentioning

confidence: 99%

The effects of external diaphragmatic pacing on diaphragm function and weaning outcomes of critically ill patients with mechanical ventilation: a prospective randomized study

Bao¹,

Chen²,

Chen³

et al. 2022

Ann Transl Med

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Background: Diaphragmatic pacing can improve diaphragm function, which is beneficial for the prognosis of patients treated with prolonged mechanical ventilation (MV). While most previous studies have focused on the role of implanted diaphragm pacing (IDP), our study is the first to examine the effects of external diaphragmatic pacing (EDP) in mechanically ventilated patients. Specifically, the effect of EDP on diaphragm function, the success rate of weaning, the duration of MV (DMV), and the intensive care unit (ICU) length of stay (ILOS) were assessed. Methods: From September 2019 to December 2020, a total of 51 mechanically ventilated patients in the ICU of the Sun Yat-sen Memorial Hospital, Sun Yat-sen University were enrolled and randomly divided into an EDP group of 27 patients and a control group of 24 patients. The control group received routine treatment, and the EDP group received EDP treatment in addition to routine treatment. The diaphragm excursion (DE), diaphragm thickening fraction (DTF), DMV, ILOS, and average survival time were recorded to evaluate efficacy. Results: Patients treated with EDP had increased DE [exp(B) =1.86, 95% CI: 1.39 to 2.50, P<0.001] and DTF [exp(B) =1.35, 95% CI: 1.05 to 1.76, P=0.022], shortened weaning time (P=0.026) and prolonged average survival time (P<0.001) compared to patients who did not receive EDP therapy. Especially in cases with difficult weaning, the improvement of DE and DTF in the EDP treatment group was more obvious than that in the control group (P=0.013 and P=0.032). Moreover, the DTF upon attempted spontaneous breathing trial (SBT) was negatively correlated with the fraction of inspired oxygen (FiO 2 ) [r=−0.54; 95% confidence interval (CI): −0.77 to −0.19; P=0.004], the arterial partial pressure of oxygen (PaO 2 ) (r=−0.58; 95% CI: −0.79 to −0.25; P=0.001), the PaO 2 /FiO 2 ratio (r=−0.52; 95% CI: −0.75 to −0.16; P=0.006), and the serum lactate concentration (Lac) (r=−0.39; 95% CI: −0.68 to 0.003; P=0.046). Conclusions: EDP treatment can effectively reduce the DMV and prolong the average survival time of mechanically ventilated patients.

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Long-Term Follow-Up of Patients With Ventilator-Dependent High Tetraplegia Managed With Diaphragmatic Pacing Systems

Cited by 7 publications

References 18 publications

Diaphragm pacing in spinal cord injury can significantly decrease mechanical ventilation in multicenter prospective evaluation

Diaphragm pacing in spinal cord injury can significantly decrease mechanical ventilation in multicenter prospective evaluation

Observational study of early diaphragm pacing in cervical spinal cord injured patients to decrease mechanical ventilation during the COVID-19 pandemic

The effects of external diaphragmatic pacing on diaphragm function and weaning outcomes of critically ill patients with mechanical ventilation: a prospective randomized study

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