Randomized study of temporary diaphragm pacing for enhanced recovery after surgery in cardiac surgery patients at risk of prolonged mechanical ventilation

Abstract

Objective

Prolonged mechanical ventilation after cardiac surgery significantly increases morbidity and mortality. The aim of this study is to establish the role of diaphragmatic pacing to decrease mechanical ventilation burden in high-risk patients undergoing cardiac surgery.

Methods

This is a prospective, randomized trial of temporary diaphragmatic pacing electrode use in patients undergoing cardiac surgery (NCT04899856). Prognostic enrichment strategy was used to identify patients at higher risk of prolonged mechanical ventilation by having inclusion criteria of prior open cardiac surgery, left ventricular ejection fraction less than 30%, history of stroke, intra-aortic balloon pump, or history of chronic obstructive pulmonary disease. Two electrodes were placed in each hemidiaphragm intraoperatively. On arrival to the intensive care unit, patients were randomized to immediate diaphragmatic pacing or standard of care.

Results

Forty patients received implants, with 19 in the treatment group and 21 in the standard of care group. Only 1 patient in the treatment group was on mechanical ventilation at 24 hours versus 4 patients in the standard of care group, resulting in a relative risk reduction of 71% being on mechanical ventilation at 24 hours postoperatively. Predictive enrichment strategy was used to identify patients most likely to respond to therapy of diaphragmatic pacing. In this analysis, median time on mechanical ventilation was 17.7 hours (interquartile range, 8.3-23.4) for the 15 patients in the standard of care group and 9.4 hours (interquartile range, 7.14-12.5) for the 13 patients in the treatment group, for an improvement of 8 hours with diaphragm pacing (P < .05).

Conclusions

Temporary diaphragmatic pacing improved weaning from mechanical ventilation by 8 hours with a significant reduction of prolonged mechanical ventilation. Multicenter randomized trials confirming diaphragmatic pacing as an Enhanced Recovery After Surgery tool to decrease mechanical ventilation may reduce length of stay, postoperative infections, and additive costs.