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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

Objective: We performed a post hoc analysis of the Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) trial to determine the effect an on-versus off-pump strategy had on outcomes when compared with percutaneous coronary intervention. Methods: All randomized patients in EXCEL (n = 1905) were included. The outcomes of interest were the primary end point composite of death from any cause, stroke, or myocardial infarction; the composite study end point or ischemia-driven revascularization; and the rate of death from any cause at 5 years. Event rates were based on Kaplan–Meier estimates in time-to-first-event analyses. Results: Propensity matching resulted in groups of 1142 patients (571 each) for on-pump coronary artery bypass grafting versus percutaneous coronary intervention and 472 patients (236 each) for off-pump coronary artery bypass grafting versus percutaneous coronary intervention. In the on-pump coronary artery bypass grafting versus percutaneous coronary intervention matched groups, the composite end point was similar (18.0% vs 22.1%, P = .19) and the composite end point or ischemia-driven revascularization (23.3% vs 31.0%, P = .01) was lower, and mortality (7.6% vs 11.8%, P = .025) was lower in the on-pump coronary artery bypass grafting group at 5 years. In the off-pump coronary artery bypass grafting versus percutaneous coronary intervention matched groups, the composite end point (19.4% vs 22.2%, P = .47), composite end point or ischemia-driven revascularization (25.9% vs 34.2%, P = .07), and mortality (12.5% vs 14.2%, P = .59) were similar at 5 years. Conclusions: In the EXCEL trial, on-pump coronary artery bypass grafting was associated with a decreased 5-year rate of the composite outcome of death, stroke, myocardial infarction, or ischemia-driven revascularization, and decreased mortality when compared with percutaneous coronary intervention, whereas outcomes of off-pump coronary artery bypass grafting were similar to percutaneous coronary intervention.