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

Abstract

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.

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

“…18 A 2022 publication of the results of the initial FDA IDE study showed 96.2% of patients could use DP to support ventilation at least 4 hours a day. 7 They also report a meta-analysis cohort of 196 patients exhibited a similar results of 92.2% of patients successfully using DP a minimum of 4 hours.…”

“…COVID-19 leads to neurologic complications that has added strain to the rehabilitation services also used by SCI injuries. 5 Data has consistently shown diaphragm pacing (DP)(NeuRx DPS, Synapse Biomedical, Oberlin, Ohio, USA) can replace MV 7 , decrease wean times 8 , improve survival 8,9 , improve respiratory mechanics 10 and decrease hospital costs for SCI patients. 11 Our center has also reported that DP implantation within the first year of injury leads to greater odds of complete removal of MV(72.7% 24/33 subjects) than when implanted after two years (51% 22/43 subjects).…”

Diaphragm pacing and independent breathing in individuals with severe Pompe disease

“…Thus, with sufficient phrenic stimulation, normal diaphragm contractility is the goal for DP in SCI ( 37 , 44 ). When sensory loss accompanies SCI, patients can frequently tolerate high enough initial DP settings to enable a tidal volume sufficient for periods of off-ventilator, paced breathing ( 33 , 51 ). It has been suggested that the DP settings can be increased upon implant in SCI, to the lowest settings necessary to achieve a functional stimulated breath volume ( 37 , 51 ).…”

Phrenic nerve stimulation to prevent diaphragmatic dysfunction and ventilator-induced lung injury

“…The techniques for PNS can be classified as invasive electrical [ 48 , 52 – 56 ], non-invasive electrical [ 57 ] or non-invasive (electro)magnetic [ 11 ] (Fig. 2 ).…”

“…The nomenclature of the stimulation techniques was adopted from the studies in which they were first used for this particular study population. Nevertheless, the terms "EDP" [ 57 ] and "DPS" [ 48 ] have been marginally revised to improve categorisation, differentiation and comprehensibility with respect to the other existing techniques [ 11 , 52 – 56 ] …”