Martin Dres
Assistance Publique Hôpitaux de Paris
Paris, France
Disclosure information not submitted.
Marcelo Gama de Abreu
Prof. Dr.med.habil.
University Clinic Carl Gustav Caruv, United States
Disclosure information not submitted.
Title: Diaphragm Neurostimulation in Mechanically Ventilated Patients with and without Tracheostomy
Introduction: The relative effects of temporary transvenous diaphragm neurostimulation (TTDN) in difficult-to-wean patients on mechanical ventilation (MV) via endotracheal vs. tracheostomy approach have not been reported.
Methods: We conducted a multicenter, open label, randomized controlled trial of TTDN using a multi-electrode stimulating central venous catheter (Lungpacer Diaphragm Pacing Therapy System) in patients on MV for >96 hours with at least two failed spontaneous breathing trials and satisfying readiness to wean criteria. A total of 98 subjects were randomized (1:1) to TTDN (up to 120 stimulations per day; up to 30 days) or standard of care (SoC). Outcomes including change in maximal inspiratory pressure (MIP) between baseline and last available measure, the proportion of patients successfully weaned, MV duration, and 30-day mortality were assessed in patients intubated with an endotracheal tube (ET, N=46) or with a tracheostomy (Trach, N=52).
Results: Prior to enrollment in the study, ET patients were on MV for an average of 15.1 ±8 days compared to 38.4 ±22 days for Trach (p < 0.001). Change in MIP (cmH2O) improved in the ET cohort showing greater improvement with TTDN (-14.8 ±17) compared to SoC (-9.4 ±16). In the Trach cohort, the differences were more pronounced (-18.5 ±17 TTDN vs. -1.0 ±18 SoC, p< 0.05). TTDN showed marginally improved weaning success in both the ET (82% TTDN vs 76% SoC, p=NS) and Trach (80% TTDN vs 72% SoC, p=NS) cohorts and fewer days on MV in both the ET (9.9 ±9 TTDN vs 11.8 ±11 days SoC, p=NS) and Trach (15.4 +10 TTDN vs 16.2 ±11 days SoC, p=NS) cohorts. 30-day all-cause mortality was higher in the ET (14% TTDN vs 28% SoC, p=NS) than the Trach (0% TTDN vs 3% SoC, p=NS) cohort.
Conclusion: TTDN is feasible and safe in difficult to wean patients on MV with either ET or tracheostomy. Despite having a lower baseline MIP, significant diaphragm-related improvement in MIP was achieved with TTDN even in patients on prolonged MV with a tracheostomy. Mortality was higher overall in the ET cohort with a trend toward reduced mortality in the TTDN vs. SoC groups. Weaning success and days on MV showed improved (but non-significant) outcomes in the TTDN cohort for both ET and Trach subsets.