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Background: Diaphragm Pacing(DP) demonstrates benefits over mechanical ventilation(MV) for spinal cord injured(SCI) patients. The hypothesis of this report is that phrenic nerve conduction study(PNCS) results cannot differentiate success or failure in selection of patients for DP. Direct surgical evaluation of the diaphragm should be performed., Methods: Observational report of prospective databases of patients undergoing laparoscopic evaluation of their diaphragms to assess for ability to stimulate to cause contraction for ventilation., Results: In 50 SCI patients who could not be weaned from MV, PNCS results showed latencies in stimulated patients (n = 44) and non-stimulated(n = 6) overlapped (7.8 ± 2.5 ms vs 9.4 ± 2.8 ms) and the null hypothesis cannot be rejected (p-value>0.05). Amplitudes overlapped (0.4 ± 0.2 mV vs 0.2 ± 0.2 mV) and the null hypotheses cannot be rejected (P-value >0.05). In 125 non SCI patients with diaphragm paralysis, there were 78(62.4%) with false negative PNCS., Conclusion: PNCS are inadequate pre-operative studies. Direct laparoscopic evaluation should be offered for all SCI patients to receive the benefit of DP., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: Etiologies contributing to failure to wean from mechanical ventilation (MV) are multiple, resulting in morbid and costly outcomes. Diaphragm pacing (DP) is used in spinal cord injury to replace MV. Temporary DP could be utilized in acute respiratory failure to reduce MV., Methods: A prospective FDA feasibility trial evaluated temporary DP electrodes implanted in each hemi-diaphragm during a subject's primary procedure. Objectives included: ability to provide ventilation, stability analysis with diaphragm electromyography, and adverse event monitoring., Results: Twelve patients underwent successful implantation via median sternotomy, laparoscopy or laparotomy. Electrode stimulation exceeded ideal tidal volumes by an average of 37% (0%-95%) confirming ability to prevent atrophy. Daily electromyography confirmed stability of placement and was useful in evaluating hypoventilation. There were no complications and all 48 study electrodes remained intact until complete removal., Conclusion: This trial demonstrates ease of placement, removal, functionality and safety of temporary DP electrodes which therapeutically decreases diaphragm atrophy., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: Amyotrophic lateral sclerosis patients have significant respiratory abnormalities with incomplete understanding of respiratory control. This study analyzes electromyography (EMG) of the diaphragm (dEMG) using implanted diaphragm pacing (DP) electrodes., Methods: Retrospective analysis of dEMG data were obtained during Institutional Review Board and US Food and Drug Administration approved trials. The electrodes were used to analyze epochs of dEMG during multiple respiratory cycles., Results: Fifty-three patients were implanted. Thirty-six had bilateral dEMG assessments, 18 had continuous overnight readings with pulse oximetry, and 19 had serial analysis. Several findings revealed an alteration in the central respiratory drive including central apnea, hypoventilation, and hypercarbia. The electrodes showed unilateral dysfunction and demonstrated noninvasive ventilation suppression of diaphragm activity. DP can be used for serial monitoring, to decrease hypercarbia, improve sleep, and decrease atrophy., Conclusions: Multiple abnormalities of respiratory control can be seen in amyotrophic lateral sclerosis patients using dEMG through therapeutic DP electrodes. DP is used to overcome instability of respiratory control when there are intact diaphragm motor units leading to improved survival., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Background: Respiratory insufficiency is the major cause of mortality in patients with amyotrophic lateral sclerosis or Lou Gehrig's disease. This is the final report of the diaphragm pacing (DP) pilot trial., Methods: Patients underwent laparoscopic diaphragm electrode implantations and subsequent conditioning of diaphragms. Serial respiratory function tests were performed in the initial year and followed until death., Results: Sixteen patients were implanted with no perioperative or unanticipated device-related adverse events. There were 452 implant-months of follow-up. DP allowed greater movement of the diaphragm under fluoroscopy, increased muscle thickness, and decreased the decline in forced vital capacity. Median survival from implant was 19.7 months with the cause of death respiratory in only 31%., Conclusions: Long-term analysis of DP in amyotrophic lateral sclerosis showed no safety issues and can positively influence diaphragm physiology and survival. This formed the initial basis for subsequent US Food and Drug Administration approval., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Background: There is a paucity of literature concerning general anesthesia and surgery in patients with amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease). This report summarizes the largest series of surgical cases in ALS during multicenter prospective trials of the laparoscopic diaphragm pacing system (DPS) to delay respiratory failure., Method: The overall strategy outlined includes the use of rapidly reversible short-acting analgesic and amnestic agents with no neuromuscular relaxants., Results: Fifty-one patients were implanted from March 2005 to March 2008 at 2 sites. Age at implantation ranged from 42 to 73 years and the percent predicted forced vital capacity (FVC) ranged from 20% to 87%. On preoperative blood gases, Pco(2) was as high as 60. Using this protocol, there were no failures to extubate or 30-day mortalities. The DPS system increases the respiratory system compliance by decreasing posterior lobe atelectasis and can stimulate respirations at the end of each case., Conclusions: Laparoscopic surgery with general anesthesia can be safely performed in patients with ALS undergoing DPS.