Randomized Clinical Study of Temporary Transvenous Phrenic Nerve Stimulation in Difficult-to-Wean Patients

Dres, Martin

; de Abreu, Marcelo Gama ; Merdji, Hamid ; Müller-Redetzky, Holger ; Dellweg, Dominic ; Randerath, Winfried J. ; Mortaza, Satar ; Jung, Boris ; Bruells, Christian ; Moerer, Onnen ; Scharffenberg, Martin

; Jaber, Samir ; Besset, Sébastien ; Bitter, Thomas ; Geise, Arnim ; Heine, Alexander ; Malfertheiner, Maximilian V. ; Kortgen, Andreas ; Benzaquen, Jonathan ; Nelson, Teresa ; Uhrig, Alexander ; Moenig, Olaf ; Meziani, Ferhat ; Demoule, Alexandre ; Similowski, Thomas ; Beloncle, François ; Olivier, Pierre-Yves ; Lemerle, Marie ; Asfar, Pierre ; Mercat, Alain ; Böllinger, Katharina ; Giesa, Marc ; Garcia, Carmen ; Jacobi, Till ; Lambiris, Nikolas ; Machleid, Felix ; Pergantis, Panagiotis ; Grube, Bastian ; Roux, Damien ; Freita Ramos, Santiago ; Zucman, Noemie ; Dumont, Louis Marie ; Federici, Laura ; Amouretti, Marc ; Ricard, Jean-Damien ; Dreyfuss, Didier ; Wittenstein, Jakob ; Güldner, Andreas ; Ragaller, Max ; Spieth, Peter ; Uhlig, Christopher ; Harnisch, Lars-Olav ; Bloos, Frank ; Thomas-Rüddel, Daniel O. ; Chanques, Gérald ; Capdevila, Mathieu ; Aarab, Yassir ; Garnier, Fanny ; Brunot, Vincent ; Klouche, Kada ; Moulaire, Valérie ; Corne, Philippe ; Macone, Fernand ; Durand, François ; Marquette, Charles Hugo ; Delemazure, Julie ; Mayaux, Julien ; Morawiec, Elise ; Monnier, Alexandra ; Rahmani, Hassene ; Jandeaux, Louise-Marie ; Studer, Antoine ; Helms, Julie ; Clere-Jehl, Raphaël

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Rationale: Diaphragm dysfunction is frequently observed in critically ill patients with difficult weaning from mechanical ventilation. Objectives: To evaluate the effects of temporary transvenous diaphragm neurostimulation on weaning outcome and maximal inspiratory pressure. Methods: Multicenter, open-label, randomized, controlled study. Patients aged >= 18 years on invasive mechanical ventilation for >= 4 days and having failed at least two weaning attempts received temporary transvenous diaphragm neurostimulation using a multielectrode stimulating central venous catheter (bilateral phrenic stimulation) and standard of care (treatment) (n = 57) or standard of care (control) (n= 55). In seven patients, the catheter could not be inserted, and in seven others, pacing therapy could not be delivered; consequently, data were available for 43 patients. The primary outcome was the proportion of patients successfully weaned. Other endpoints were mechanical ventilation duration, 30-day survival, maximal inspiratory pressure, diaphragm-thickening fraction, adverse events, and stimulation-related pain. Measurements and Main Results: The incidences of successful weaning were 82% (treatment) and 74% (control) (absolute difference [95% confidence interval (CI)], 7% [-10 to 25]), P = 0.59. Mechanical ventilation duration (mean +/- SD) was 12.7 +/- 9.9 days and 14.1 +/- 10.8 days, respectively, P = 0.50; maximal inspiratory pressure increased by 16.6 cm H2O and 4.8 cm H2O, respectively (difference [95% CI], 11.8 [5 to 19]), P = 0.001; and right hemidiaphragm thickening fraction during unassisted spontaneous breathing was +17% and -14%, respectively, P = 0.006, without correlation with changes in maximal inspiratory pressure. Serious adverse event frequency was similar in both groups. Median stimulation-related pain in the treatment group was 0 (no pain). Conclusions: Temporary transvenous diaphragm neurostimulation did not increase the proportion of successful weaning from mechanical ventilation. It was associated with a significant increase in maximal inspiratory pressure, suggesting reversal of the course of diaphragm dysfunction.

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