Completed FDA feasibility trial of surgically placed temporary diaphragm pacing electrodes: A promising option to prevent and treat respiratory failure

Onders, Raymond P.; Markowitz, Alan H.; Ho, Vanessa P.; Hardacre, Jeffrey M.; Novitsky, Yuri W.; Towe, Christopher W.; Elmo, Mary Jo; Kaplan, Cindy; Schilz, Robert

doi:10.1016/j.amjsurg.2017.10.054

Cited by 12 publications

(5 citation statements)

References 10 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…There are currently multiple invasive techniques for achieving stimulator‐induced diaphragm activation 5 . These can be broadly classified as transvenous methods, where the phrenic nerve is stimulated using electrodes inserted via the internal jugular or subclavian vein, 6,7 and diaphragm pacing, where electrodes are surgically implanted directly in the diaphragm 8,9 . Transvenous pacing has been shown to maintain diaphragm conditions in animals, 10 while both implanted 11 and percutaneous 12 stimulators have shown potential value in humans.…”

Section: Introductionmentioning

confidence: 99%

“…5 These can be broadly classified as transvenous methods, where the phrenic nerve is stimulated using electrodes inserted via the internal jugular or subclavian vein, 6 , 7 and diaphragm pacing, where electrodes are surgically implanted directly in the diaphragm. 8 , 9 Transvenous pacing has been shown to maintain diaphragm conditions in animals, 10 while both implanted 11 and percutaneous 12 stimulators have shown potential value in humans. However, invasive methods of phrenic nerve stimulation have a number of disadvantages that may limit their widespread application.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Non‐invasive phrenic nerve stimulation to avoid ventilator‐induced diaphragm dysfunction in critical care

et al. 2022

View full text Add to dashboard Cite

Background Diaphragm muscle atrophy during mechanical ventilation begins within 24 h and progresses rapidly with significant clinical consequences. Electrical stimulation of the phrenic nerves using invasive electrodes has shown promise in maintaining diaphragm condition by inducing intermittent diaphragm muscle contraction. However, the widespread application of these methods may be limited by their risks as well as the technical and environmental requirements of placement and care. Non‐invasive stimulation would offer a valuable alternative method to maintain diaphragm health while overcoming these limitations. Methods We applied non‐invasive electrical stimulation to the phrenic nerve in the neck in healthy volunteers. Respiratory pressure and flow, diaphragm electromyography and mechanomyography, and ultrasound visualization were used to assess the diaphragmatic response to stimulation. The electrode positions and stimulation parameters were systematically varied in order to investigate the influence of these parameters on the ability to induce diaphragm contraction with non‐invasive stimulation. Results We demonstrate that non‐invasive capture of the phrenic nerve is feasible using surface electrodes without the application of pressure, and characterize the stimulation parameters required to achieve therapeutic diaphragm contractions in healthy volunteers. We show that an optimal electrode position for phrenic nerve capture can be identified and that this position does not vary as head orientation is changed. The stimulation parameters required to produce a diaphragm response at this site are characterized and we show that burst stimulation above the activation threshold reliably produces diaphragm contractions sufficient to drive an inspired volume of over 600 ml, indicating the ability to produce significant diaphragmatic work using non‐invasive stimulation. Conclusion This opens the possibility of non‐invasive systems, requiring minimal specialist skills to set up, for maintaining diaphragm function in the intensive care setting.

show abstract

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Non‐invasive phrenic nerve stimulation to avoid ventilator‐induced diaphragm dysfunction in critical care

et al. 2022

View full text Add to dashboard Cite

show abstract

“…Ряд авторов предлагает имплантировать интраоперационно к диафрагме электроды для временной электрокардиостимуляции, традиционно используемые при кардиохирургических вмешательствах. Предложенная методика имплантации электродов и ежедневная стимуляция диафрагмы увеличивают дыхательный объем в среднем на 37 %, что уменьшает ателектазирование легочной ткани и атрофию диафрагмы, нивелирует гиповентиляцию и способствует сокращению сроков респираторной поддержки у ряда пациентов [28], однако выбор таких больных остается предметом для дискуссии. Еще один из возможных методов -шейный доступ к диафрагмальным нер вам для их электрической стимуляции, также показал свою безопасность и возможность применения [29,30].…”

Section: электрическая стимуляция нейро модуляцииunclassified

Treatment option for diaphragm dysfunction after cardiac surgery: a review and a clinical case

Paromov

Svirskii

Kirov

2022

Annals of Critical Care

View full text Add to dashboard Cite

INTRODUCTION. Dysfunction of diaphragm postoperatively is associated with worsened quality of life and increased health care costs due to prolonged respiratory support and morbidity. After cardiac operations, dysfunction of diaphragm can take place in up to 10 % of patients but often remains underdiagnosed. At the same time, histologically revealed changes, such as muscle atrophy in the diaphragm, start within 12 hours of mechanical ventilation. The therapy of diaphragm weakness is not well established and has a limited efficacy. Current analytic review describes therapeutic option for treatment ventilator-induced diaphragm dysfunction with emphasis on electric neuromodulation of phrenic nerve. OBJECTIVE. To optimize respiratory function by bilateral electrostimulation of phrenic nerves on the neck level in patient with diaphragm dysfunction after cardiac operation. MATERIALS AND METHODS. 82-year-old female patient after elective aortic valve replacement was diagnosed with dysfunction of diaphragm and respiratory failure. These changes caused the weaning failure from respirator and led to prolonged ventilator support. On the 20, 22, 24 and 26 days of postoperative period we performed invasive bilateral phrenic nerve stimulation on the neck level for 10 minutes with ultrasound navigation. RESULTS. After electrical modulation of phrenic nerves, diaphragm excursion, detected by ultrasound, was improved. After four procedures, duration of spontaneous breathing trial increased from 1 to 12 hours. On postoperative day 30, the patient was successfully weaned from respiratory support and decannulated without recurrent respiratory failure. There were no any complications during procedure, it was well-tolerated and associated with emotional improvement. CONCLUSIONS. Phrenic nerve stimulation on the neck level can be a valuable option in selected patients with respiratory failure and difficulties with ventilator weaning.

show abstract

“…4 By activating the phrenic nerve with electrical stimulation, the diaphragm is forced to contract, "exercising" it and potentially preserving its function in a manner analogous to the application of neuromuscular electrical stimulation to avoid muscle atrophy in patients in the intensive care setting. 5 Methods such as trans-venous, 6,7 percutaneous, 8 and direct surgical 9,10 implantation of stimulation electrodes have shown some success, while other approaches such as specialized esophageal electrodes are in the early stages of development. 11 These methods are, however, limited by the need for specific technical skills for application and procedural risks due to their invasive nature.…”

Section: Introductionmentioning

confidence: 99%

Closed‐loop parameter optimization for patient‐specific phrenic nerve stimulation

et al. 2023

View full text Add to dashboard Cite

BackgroundVentilator‐induced diaphragm dysfunction occurs rapidly following the onset of mechanical ventilation and has significant clinical consequences. Phrenic nerve stimulation has shown promise in maintaining diaphragm function by inducing diaphragm contractions. Non‐invasive stimulation is an attractive option as it minimizes the procedural risks associated with invasive approaches. However, this method is limited by sensitivity to electrode position and inter‐individual variability in stimulation thresholds. This makes clinical application challenging due to potentially time‐consuming calibration processes to achieve reliable stimulation.MethodsWe applied non‐invasive electrical stimulation to the phrenic nerve in the neck in healthy volunteers. A closed‐loop system recorded the respiratory flow produced by stimulation and automatically adjusted the electrode position and stimulation amplitude based on the respiratory response. By iterating over electrodes, the optimal electrode was selected. A binary search method over stimulation amplitudes was then employed to determine an individualized stimulation threshold. Pulse trains above this threshold were delivered to produce diaphragm contraction.ResultsNine healthy volunteers were recruited. Mean threshold stimulation amplitude was 36.17 ± 14.34 mA (range 19.38–59.06 mA). The threshold amplitude for reliable nerve capture was moderately correlated with BMI (Pearson's r = 0.66, p = 0.049). Repeating threshold measurements within subjects demonstrated low intra‐subject variability of 2.15 ± 1.61 mA between maximum and minimum thresholds on repeated trials. Bilateral stimulation with individually optimized parameters generated reliable diaphragm contraction, resulting in significant inhaled volumes following stimulation.ConclusionWe demonstrate the feasibility of a system for automatic optimization of electrode position and stimulation parameters using a closed‐loop system. This opens the possibility of easily deployable individualized stimulation in the intensive care setting to reduce ventilator‐induced diaphragm dysfunction.

show abstract

Completed FDA feasibility trial of surgically placed temporary diaphragm pacing electrodes: A promising option to prevent and treat respiratory failure

Cited by 12 publications

References 10 publications

Non‐invasive phrenic nerve stimulation to avoid ventilator‐induced diaphragm dysfunction in critical care

Non‐invasive phrenic nerve stimulation to avoid ventilator‐induced diaphragm dysfunction in critical care

Treatment option for diaphragm dysfunction after cardiac surgery: a review and a clinical case

Closed‐loop parameter optimization for patient‐specific phrenic nerve stimulation

Contact Info

Product

Resources

About