Temporary Transvenous Diaphragmatic Neurostimulation in Prolonged Mechanically Ventilated Patients: A Feasibility Trial (RESCUE 1)

Objectives: Prolonged mechanical ventilation promotes diaphragmatic atrophy and weaning difficulty. The study uses a novel device containing a transvenous phrenic nerve stimulating catheter (Lungpacer IntraVenous Electrode Catheter) to stimulate the diaphragm in ventilated patients. We set out to determine the feasibility of temporary transvenous diaphragmatic neurostimulation using this device. Design: Multicenter, prospective open-label single group feasibility study. Setting: ICUs of tertiary care hospitals. Patients: Adults on mechanical ventilation for greater than or equal to 7 days that had failed two weaning trials. Interventions: Stimulation catheter insertion and transvenous diaphragmatic neurostimulation therapy up to tid, along with standard of care. Measurements and Main Results: Primary outcomes were successful insertion and removal of the catheter and safe application of transvenous diaphragmatic neurostimulation. Change in maximal inspiratory pressure and rapid shallow breathing index were also evaluated. Eleven patients met all entry criteria with a mean mechanical ventilation duration of 19.7 days; nine underwent successful catheter insertion. All nine had successful mapping of one or both phrenic nerves, demonstrated diaphragmatic contractions during therapy, and underwent successful catheter removal. Seven of nine met successful weaning criteria. Mean maximal inspiratory pressure increased by 105% in those successfully weaned (mean change 19.7 ± 17.9 cm H2O; p = 0.03), while mean rapid shallow breathing index improved by 44% (mean change -63.5 ± 64.4; p = 0.04). Conclusions: The transvenous diaphragmatic neurostimulation system is a feasible and safe therapy to stimulate the phrenic nerves and induce diaphragmatic contractions. Randomized clinical trials are underway to compare it to standard-of-care therapy for mechanical ventilation weaning.