Temporary Transvenous Diaphragm Neurostimulation for Weaning from Mechanical Ventilation (RESCUE-3).

Summary

In an international RCT halted early for slow enrollment (mITT n=216), transvenous diaphragm neurostimulation increased 30-day weaning success (70% vs 61%; adjusted HR 1.34; 95% credible interval 1.01–1.78; posterior probability 97.9%) and likely reduced ventilation duration (-2.5 days; 95% CrI -5.0 to 0.1). Serious adverse events were more frequent in the treatment arm (36% vs 24%), while 30-day mortality was similar.

Key Findings

• 30-day ventilator weaning success improved: 70% (treatment) vs 61% (control); adjusted HR 1.34 (95% CrI 1.01–1.78), posterior probability 97.9%
• Ventilation duration likely reduced by 2.5 days (95% CrI -5.0 to 0.1); posterior probability 97.1%
• Serious adverse events higher with neurostimulation (36% vs 24%); 30-day mortality similar (9.8% vs 10.5%)

Clinical Implications

Diaphragm neurostimulation may be considered for difficult-to-wean patients, with careful monitoring for adverse events and patient selection. Findings justify larger confirmatory trials and inform discussions on device-enabled weaning protocols.

Limitations

• Open-label design and early termination at interim due to slow enrollment
• Increased serious adverse events signal; device and operator dependence

Future Directions

Conduct larger, blinded or pragmatic confirmatory trials to refine patient selection, quantify safety, and evaluate cost-effectiveness and long-term outcomes.