Temporary diaphragm pacing for patients at risk of prolonged mechanical ventilation after extensive aortic repair.

Objective: Prolonged mechanical ventilation (MV) after extensive aortic reconstructive surgery is common. Studies have demonstrated that diaphragm pacing (DP) improves lung function in patients with unilateral diaphragm paralysis. The goal of this study is to determine whether this technology can be applied to complex aortic repair to reduce prolonged MV and other respiratory sequelae. Methods: A retrospective review was performed of patients who underwent temporary DP after extensive aortic reconstructive surgery between 2019 and 2022. The primary end point was prolonged MV incidence. Other measured end points included diaphragm electromyography improvement, length of hospitalization, duration of intensive care unit stay, and reintubation rates. Results: Fourteen patients deemed at high risk of prolonged MV based on their smoking and respiratory history underwent DP after extensive aortic repair. The mean age was 70.2 years. The indications for aortic repair were a thoracoabdominal aortic aneurysm (n = 8, including 2 ruptured, 2 symptomatic, and 1 mycotic), a perivisceral aneurysm (n = 4), and a perivisceral coral reef aorta (n = 2). All patients had a significant smoking history (active or former) or other risk factors for ventilator-induced diaphragmatic dysfunction and prolonged MV. The mean total duration of MV postoperatively was 31.9 hours (range, 8.1-76.5 hours). The total average pacing duration was 4.4 days. Two patients required prolonged MV, with an average of 75.4 hours. Two patients required reintubation. No complications related to DP wire placement or removal occurred. Conclusions: DP is safe and feasible for patients at high risk of pulmonary insufficiency after extensive aortic reconstructive surgery.

Observational study of early diaphragm pacing in cervical spinal cord injured patients to decrease mechanical ventilation during the COVID-19 pandemic.

BACKGROUND: Decreasing the burden of mechanical ventilation for spinal cord injuries was never more relevant than during the COVID-19 pandemic. Data have shown diaphragm pacing can replace mechanical ventilation, decrease wean times, improve respiratory mechanics, and decrease hospital costs for patients with spinal cord injuries. This is the largest report of diaphragm pacing during the pandemic. METHODS: This is a retrospective analysis of prospective Institutional Review Board approved databases of nonrandomized interventional experience at a single institution. Subgroup analysis limited to traumatic cervical spinal cord injuries that were implanted laparoscopically with diaphragm electrodes within 30 days of injury. RESULTS: For the study group of early implanted traumatic cervical spinal cord injuries, 13 subjects were identified from a database of 197 diaphragm pacing implantations from January 1, 2020, to December 31, 2022, for all indications. All subjects were male with an average age of 49.3 years (range, 17-70). Injury mechanisms included falls (6), motor vehicle accident (4), gunshot wound (2), and diving (1). Time from injury to diaphragm pacing averaged 11 days (range, 3-22). Two patients are deceased and neither weaned from mechanical ventilation. Nine of the remaining 11 patients weaned from mechanical ventilation. Four patients never had a tracheostomy and 3 additional patients had tracheostomy decannulation. Three of these high-risk pulmonary compromised patients survived COVID-19 infections utilizing diaphragm pacing. CONCLUSION: Diaphragm pacing successfully weaned from mechanical ventilation 82% of patients surviving past 90 days. Forty-four percent of this group never underwent a tracheostomy. Only 22% of the weaned group required long term tracheostomies. Early diaphragm pacing for spinal cord injuries decreases mechanical ventilation usage and tracheostomy need which allows for earlier placement for rehabilitation.

Medicare reimbursement for common general surgery procedures has declined over the last decade.

BACKGROUND: The Centers for Medicare and Medicaid Services proposed reimbursement cuts for operations in 2021. Literature examining reimbursement for common operations is scarce. METHODS: Reimbursement rates were abstracted (2011-2021). Trends in reimbursement rates were analyzed using linear regression. RESULTS: From 2011 to 2021, the national inflation rate was 16.3%. Unadjusted reimbursement rates for open and laparoscopic inguinal hernia repairs increased by 6.5% and 7.2%, respectively. There was an increase in unadjusted reimbursement for open appendectomies of 5.1% and 6.1% for laparoscopic. Unadjusted reimbursement for open cholecystectomies increased by 4.4%, but decreased by 6.8% for laparoscopic. When adjusted to 2021 values, reimbursement for all six operations decreased. Laparoscopic and open cholecystectomies experienced the largest decreases (19.8%, 10.2%). CONCLUSION: Since 2011, there have been decreases in adjusted reimbursement for three common operations, independent of operative approach. Awareness of trends in reimbursement rates should be a priority to ensure sustainable general surgical care.

Treatment for bilateral diaphragmatic dysfunction using phrenic nerve reconstruction and diaphragm pacemakers.

OBJECTIVES: Bilateral diaphragmatic dysfunction results in severe dyspnoea, usually requiring oxygen therapy and nocturnal ventilatory support. Although treatment options are limited, phrenic nerve reconstruction (PR) offers the opportunity to restore functional activity. This study aims to evaluate combination treatment with PR and placement of a diaphragm pacemaker (DP) compared to DP placement alone in patients with bilateral diaphragmatic dysfunction. METHODS: Patients with bilateral diaphragmatic dysfunction were prospectively enrolled in the following treatment algorithm: Unilateral PR was performed on the more severely impacted side with bilateral DP implantation. Motor amplitudes, ultrasound measurements of diaphragm thickness, maximal inspiratory pressure, forced expiratory volume, forced vital capacity and subjective patient-reported outcomes were obtained for retrospective analysis following completion of the prospective database. RESULTS: Fourteen male patients with bilateral diaphragmatic dysfunction confirmed on chest fluoroscopy and electrodiagnostic testing were included. All 14 patients required nocturnal ventilator support, and 8/14 (57.1%) were oxygen-dependent. All patients reported subjective improvement, and all 8 oxygen-dependent patients were able to discontinue oxygen therapy following treatment. Improvements in maximal inspiratory pressure, forced vital capacity and forced expiratory volume were 68%, 47% and 53%, respectively. There was an average improvement of 180% in motor amplitude and a 50% increase in muscle thickness. Comparison of motor amplitude changes revealed significantly greater functional recovery on the PR + DP side. CONCLUSIONS: PR and simultaneous implantation of a DP may restore functional activity and alleviate symptoms in patients with bilateral diaphragmatic dysfunction. PR plus diaphragm pacing appear to result in greater functional muscle recovery than pacing alone.

Spinal cord injury level and Phrenic Nerve Conduction Studies do not predict diaphragm pacing success or failure- all patients should undergo diagnostic laparoscopy.

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.

Long-term experience with diaphragm pacing for traumatic spinal cord injury: Early implantation should be considered.

BACKGROUND: Cervical spinal cord injury can result in catastrophic respiratory failure requiring mechanical ventilation with high morbidity, mortality, and cost. Diaphragm pacing was developed to replace/decrease mechanical ventilation. We report the largest long-term results in traumatic cervical spinal cord injury. METHODS: In this retrospective review of prospective institutional review board protocols, all patients underwent laparoscopic diaphragm mapping and implantation of electrodes for diaphragm strengthening and ventilator weaning. RESULTS: From 2000 to 2017, 92 patients out of 486 diaphragm pacing implants met the criteria. The age at time of injury ranged from birth to 74 years (average: 27 years). Time on mechanical ventilation was an average of 47.5 months (range, 6 days to 25 years, median = 1.58 years). Eighty-eight percent of patients achieved the minimum of 4 hours of pacing. Fifty-six patients (60.8%) used diaphragm pacing 24 hours a day. Five patients had full recovery of breathing with subsequent diaphragm pacing removal. Median survival was 22.2 years (95% confidence interval: 14.0-not reached) with only 31 deaths. Subgroup analysis revealed that earlier diaphragm pacing implantation leads to greater 24-hour use of diaphragm pacing and no need for any mechanical ventilation. CONCLUSION: Diaphragm pacing can successfully decrease the need for mechanical ventilation in traumatic cervical spinal cord injury. Earlier implantation should be considered.

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

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.

Identification of unexpected respiratory abnormalities in patients with amyotrophic lateral sclerosis through electromyographic analysis using intramuscular electrodes implanted for therapeutic diaphragmatic pacing.

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.

Extended use of diaphragm pacing in patients with unilateral or bilateral diaphragm dysfunction: a new therapeutic option.

BACKGROUND: Diaphragm dysfunction (DD) can cause sleep abnormalities, dyspnea, atelectasis, and respiratory failure. Historical treatments, including positive pressure ventilation or diaphragm plication, may alleviate symptoms but do not restore physiologic diaphragm function. Diaphragm pacing (DP) is approved for spinal cord-injured patients and in amyotrophic lateral sclerosis. We report a series of DD patients undergoing use of DP outside of these initial indications. METHODS: This report involves a prospective, nonrandomized, interventional trial under institutional review board approval at a single institution. DP involves laparoscopic motor point mapping with implantation of intramuscular electrodes in each hemidiaphragm. Postoperatively, diaphragm conditioning ensues. RESULTS: Twenty-seven patients were evaluated; all patients had symptomatic and objective hypoventilation for an average of 36 months of symptoms. Causes included idiopathic (n = 13), chest surgery (n = 5), shoulder surgery or trauma (n = 6), and others (n = 3); 17 had bilateral involvement, 6 had nonstimulable diaphragms and were not implanted, and 21 were implanted. Thirteen (62%) had substantial clinically relevant respiratory improvements. Four ventilator patients were weaned completely. Four had partial improvement, 3 had no improvement, and 1 patient was lost to follow-up for objective analysis. CONCLUSION: This is the first report of DP being used to treat diverse causes of DD. Eighty-one percent of implanted patients experienced improvements. This success suggests a potential for a wider use of DP and areas for future research.

Final analysis of the pilot trial of diaphragm pacing in amyotrophic lateral sclerosis with long-term follow-up: diaphragm pacing positively affects diaphragm respiration.

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.

Transoral incisionless fundoplication does not significantly increase morbidity of subsequent laparoscopic Nissen fundoplication.

INTRODUCTION: Transoral incisionless fundoplication (TIF) has been used for endoscopic treatment of gastroesophageal reflux disease (GERD). Full-thickness polypropylene H-fasteners create a serosa-to-serosa gastroesophageal plication. A certain subset of TIF patients will require subsequent antireflux surgery to achieve adequate reflux control, and it is unknown whether this procedure increases the technical difficulty of laparoscopic Nissen fundoplication for recurrent GERD. PATIENTS AND METHODS: Between 2008 and 2010, patients demonstrating objective evidence of recurrent gastroesophageal reflux following TIF using the Esophyx device (Endogastric Solutions, Redmond, WA) underwent laparoscopic Nissen fundoplication. The study end points included operative time, operative blood loss, gastric or esophageal perforation, and length of hospital stay. RESULTS: In total, 7 patients underwent laparoscopic Nissen fundoplication for recurrent GERD at a median interval of 7 (range, 3-28) months after TIF. Revisional fundoplication required 97 (range, 48-122) minutes and was performed in all cases with minimal blood loss. There were no cases of esophageal or gastric perforation during the dissection of the previous fundoplication. A significant hiatal hernia was noted during 1 case, and all others revealed partially disrupted gastroesophageal fundoplications with visible dislodged polypropylene H-fasteners visible. All patients were discharged from the hospital on the first postoperative day. CONCLUSIONS: Severe recurrent gastroesophageal reflux necessitating laparoscopic Nissen fundoplication occurs in a subset of patients following TIF. In this series, previous TIF did not result in prolonged operative times, significant operative hemorrhage, or iatrogenic hollow viscus injury. These data suggest that laparoscopic Nissen fundoplication can be safely performed in this patient population without increased operative morbidity.

Ventilação elétrica: indicações e aspectos técnicos do implante cirúrgico do marca-passo de estimulação diafragmática / Electric ventilation: indications for and technical aspects of diaphragm pacing stimulation surgical implantation

OBJETIVO: Pacientes com lesão medular cervical alta em geral são dependentes de ventilação mecânica, que, embora salve vidas, está associada a complicações e redução da expectativa de vida devido a infecções respiratórias. A estimulação do diafragma por marca-passo, às vezes chamada de ventilação elétrica, induz a inspiração por estimulação dos músculos inspiratórios. Nosso objetivo foi destacar as indicações e alguns aspectos da técnica cirúrgica empregada no implante laparoscópico dos eletrodos, assim como descrever cinco casos de pacientes tetraplégicos submetidos à técnica. MÉTODOS: A seleção dos pacientes envolveu estudos de condução do nervo frênico por via transcutânea para determinar se os nervos estavam preservados. A abordagem cirúrgica foi laparoscopia clássica, com quatro trocartes. A técnica foi iniciada com o mapeamento elétrico para encontrar os "pontos motores" (pontos de contração máxima do diafragma). Se o mapeamento era bem-sucedido, dois eletrodos eram implantados na face abdominal de cada lado do diafragma para estimular ramos do nervo frênico. RESULTADOS: Dos cinco pacientes, três e um, respectivamente, eram capazes de respirar somente com o uso do marca-passo por períodos superiores a 24 e 6 h, enquanto um não era capaz. CONCLUSÕES: Embora seja necessário um acompanhamento mais longo para chegar a conclusões definitivas, os resultados iniciais são promissores, pois, no momento, a maioria dos nossos pacientes pode permanecer sem ventilação mecânica por longos períodos de tempo.

OBJECTIVE: Patients with high cervical spinal cord injury are usually dependent on mechanical ventilation support, which, albeit life saving, is associated with complications and decreased life expectancy because of respiratory infections. Diaphragm pacing stimulation (DPS), sometimes referred to as electric ventilation, induces inhalation by stimulating the inspiratory muscles. Our objective was to highlight the indications for and some aspects of the surgical technique employed in the laparoscopic insertion of the DPS electrodes, as well as to describe five cases of tetraplegic patients submitted to the technique. METHODS: Patient selection involved transcutaneous phrenic nerve studies in order to determine whether the phrenic nerves were preserved. The surgical approach was traditional laparoscopy, with four ports. The initial step was electrical mapping in order to locate the "motor points" (the points at which stimulation would cause maximal contraction of the diaphragm). If the diaphragm mapping was successful, four electrodes were implanted into the abdominal surface of the diaphragm, two on each side, to stimulate the branches of the phrenic nerve. RESULTS: Of the five patients, three could breathe using DPS alone for more than 24 h, one could do so for more than 6 h, and one could not do so at all. CONCLUSIONS: Although a longer follow-up period is needed in order to reach definitive conclusions, the initial results have been promising. At this writing, most of our patients have been able to remain ventilator-free for long periods of time.

First reported experience with intramuscular diaphragm pacing in replacing positive pressure mechanical ventilators in children.

PURPOSE: Diaphragm pacing (DP) has been shown to successfully replace mechanical ventilators for adult tetraplegic patients with chronic respiratory insufficiency. This is the first report of DP in ventilator-dependent children. METHODS: This was a prospective interventional experience under institutional review board approval. Diaphragm pacing involves outpatient laparoscopic diaphragm motor point mapping to identify the site where stimulation causes maximum diaphragm contraction with implantation of 4 percutaneous intramuscular electrodes. Diaphragm conditioning ensues to wean the child from the ventilator. RESULTS: Six children were successfully implanted ranging from 5 to 17 years old with the smallest 15 kg in weight. Length of time on mechanical ventilation ranged from 11 days to 7.6 years with an average of 3.2 years. In all patients, DP provided tidal volumes above basal needs. Five of the patients underwent a home-based weaning program, whereas one patient who was implanted only 11 days post spinal cord injury never returned to the ventilator with DP use. Another patient was weaned from the ventilator full time but died of complications of his underlying brain stem tumor. The remaining patients weaned from the ventilator for over 14 hours a day and/or are actively conditioning their diaphragms. CONCLUSION: Diaphragm pacing successfully replaced mechanical ventilators, which improves quality of life.

Multicenter analysis of diaphragm pacing in tetraplegics with cardiac pacemakers: positive implications for ventilator weaning in intensive care units.

BACKGROUND: Diaphragm pacing (DP) can replace mechanical ventilation in tetraplegics and in trials has assisted respiration in amyotrophic lateral sclerosis patients. This report describes results of DP in patients with cardiac pacemakers. METHODS: Prospective, single-center and multicenter, nonrandomized, controlled, interventional protocols under U.S. Food and Drug Administration and/or institutional review board approval were evaluated. Patients underwent laparoscopic diaphragm motor point mapping to identify optimal electrode site for implantation. With diaphragm conditioning, patients were weaned from their ventilator. Perioperative and long-term assessments between the cardiac pacemakers and DP were analyzed for any device-to-device interactions. RESULTS: Over 300 subjects were implanted from 2000 to 2010. Twenty tetraplegics with cardiac pacemakers and DP were analyzed from 6 sites. Subjects ranged from 19 to 61 years old with DP implantation 6 months to 24 years postinjury. There were no immediate or long-term device to device interactions. All patients achieved diaphragm-paced tidal volumes exceeding their basal requirements and, after conditioning, all patients could go >4 hours without mechanical ventilators; 71% could go 24 hours continuously. CONCLUSION: DP can be safely implanted in tetraplegics having cardiac pacemakers. Applications for temporary use of DP to maintain diaphragm type 1 muscle fiber and improve posterior lobe ventilation may benefit complex critical care patients.

Transgastric natural-orifice transluminal endoscopic surgery peritoneoscopy in humans: a pilot study in efficacy and gastrotomy site selection by using a hybrid technique.

BACKGROUND: Diagnostic natural-orifice transluminal endoscopic surgery (NOTES) peritoneoscopy can easily be performed with standard endoscopic equipment in animal studies. The efficacy and optimal transgastric site for NOTES access in humans, however, has not been determined. OBJECTIVE: To characterize the efficacy of various anterior gastric access locations for diagnostic transgastric NOTES peritoneoscopy in humans. DESIGN: Prospective clinical study. SETTING: Tertiary-care center with experience in NOTES peritoneoscopy. PATIENTS: Patients undergoing planned laparoscopic gastrectomy or gastrotomy involving the anterior aspect of the stomach were eligible. INTERVENTIONS: An anterior gastric site for NOTES gastrotomy was chosen and transgastric NOTES access was independently established after laparoscopic abdominal exploration. Peritoneoscopy was then performed. The site of gastrotomy was closed as part of the intended laparoscopic procedure. MAIN OUTCOME MEASURES: The ability to visualize the abdominal and pelvic organs in all four quadrants was determined. Patients were evaluated postoperatively for complications. RESULTS: Eight patients requiring 9 procedures were studied. Gastrotomy sites were classified as body (n = 3), lesser curvature (n = 3), greater curvature (n = 1), fundus (n = 1), and antrum (n = 1). Satisfactory navigation could only be performed to the right upper and both lower quadrants. The left upper quadrant, specifically the spleen, was adequately visualized in only 1 case (11%), where the gastrotomy site was at the greater curvature. One patient developed a surgical site infection requiring oral antibiotic therapy. The median postoperative stay was 2 days (range, 0-3 days). LIMITATIONS: Small number of patients. CONCLUSION: NOTES peritoneoscopy with a gastrotomy on the anterior stomach permits adequate visualization of organs in the right upper and both lower quadrants. Visualization of the left upper quadrant and spleen is, however, limited unless access is gained on the greater curvature of the stomach. The accuracy of NOTES in identifying intra-abdominal pathology compared with laparoscopy remains to be determined.

The diagnostic efficacy of natural orifice transluminal endoscopic surgery: is there a role in the intensive care unit?

BACKGROUND: Evaluation of a potential source for abdominal sepsis in a critically ill patient can be challenging. With flexible endoscopy readily available in this setting, we sought to evaluate the diagnostic efficacy of a transgastric natural orifice transluminal endoscopic surgery (NOTES) peritoneoscopy vs. laparoscopic exploration in the identification of intra-abdominal pathology in a porcine model. METHODS: In this acute study, 15 pigs were randomized to demonstrate 0 to 4 pathologic lesions: small bowel ischemia (SBI), small bowel perforation (SBP), colon perforation (CP), and gangrenous cholecystitis (GC). Two blinded surgical endoscopists were allowed 60 min to perform NOTES or laparoscopy (LAP) to correctly identify or exclude each lesion. A prototype endoscope (R-scope, Olympus, Inc), which enables independent instrument mobility, was used in the NOTES arm. RESULTS: When considering all lesions, LAP was more sensitive diagnostically than NOTES (77.4% vs. 61.3%) overall. LAP also displayed a slightly higher NPV compared with NOTES (79.4% vs. 70.7%). However, NOTES was 100% specific with 100% positive predictive value (PPV) compared with 93.1% and 92.3% with LAP, respectively. Individually, NOTES was found most sensitive with CP identification (87.5%) and least sensitive with SBP (37.5%). The sensitivity of NOTES for SBI and GC was 62.5% and 57.1%, respectively. CONCLUSIONS: The utilization of NOTES as a diagnostic tool may have an important role in the critically ill patient when operative intervention is highly morbid. Although it may be overall inferior diagnostically compared with laparoscopy, a positive identification was highly specific with a strong predictive value. Further investigation addressing an improved small bowel evaluation technique would be beneficial. A human trial of NOTES in the ICU utilizing the current technology would still initially mandate laparoscopic or open surgical confirmation and treatment.

Amyotrophic lateral sclerosis: the Midwestern surgical experience with the diaphragm pacing stimulation system shows that general anesthesia can be safely performed.

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.

Complete worldwide operative experience in laparoscopic diaphragm pacing: results and differences in spinal cord injured patients and amyotrophic lateral sclerosis patients.

BACKGROUND: Diaphragm movement is essential for adequate ventilation, and when the diaphragm is adversely affected patients face lifelong positive-pressure mechanical ventilation or death. This report summarizes the complete worldwide multicenter experience with diaphragm pacing stimulation (DPS) to maintain and provide diaphragm function in ventilator-dependent spinal cord injury (SCI) patients and respiratory-compromised patients with amyotrophic lateral sclerosis (ALS). It will highlight the surgical experiences and the differences in diaphragm function in these two groups of patients. METHODS: In prospective Food and Drug Administration (FDA) trials, patients underwent laparoscopic diaphragm motor point mapping with intramuscular electrode implantation. Stimulation of the electrodes ensued to condition and strengthen the diaphragm. RESULTS: From March of 2000 to September of 2007, a total of 88 patients (50 SCI and 38 ALS) were implanted with DPS at five sites. Patient age ranged from 18 to 74 years. Time from SCI to implantation ranged from 3 months to 27 years. In 87 patients the diaphragm motor point was mapped with successful implantation of electrodes with the only failure the second SCI patient who had a false-positive phrenic nerve study. Patients with ALS had much weaker diaphragms identified surgically, requiring trains of stimulation during mapping to identify the motor point at times. There was no perioperative mortality even in ALS patients with forced vital capacity (FVC) below 50% predicted. There was no cardiac involvement from diaphragm pacing even when analyzed in ten patients who had pre-existing cardiac pacemakers. No infections occurred even with simultaneous gastrostomy tube placements for ALS patients. In the SCI patients 96% were able to use DPS to provide ventilation replacing their mechanical ventilators and in the ALS studies patients have been able to delay the need for mechanical ventilation up to 24 months. CONCLUSION: This multicenter experience has shown that laparoscopic diaphragm motor point mapping, electrode implantation, and pacing can be safely performed both in SCI and in ALS. In SCI patients it allows freedom from ventilator and in ALS patients it delays the need for ventilators, increasing survival.

Phrenic nerve conduction studies in spinal cord injury: applications for diaphragmatic pacing.

The diaphragm pacing system (DPS) is a minimally invasive alternative to mechanical ventilation in patients with quadriplegia due to cervical myelopathy primarily caused by high cervical spinal cord injury. We evaluated 36 patients, 29 of whom had traumatic spinal cord injury, two who had a history of remote meningitis and demyelinating disease, and five who had cervical myelopathies of unknown etiology. Phrenic nerve conduction studies were performed with simultaneous fluoroscopic observation of diaphragm excursion to assess diaphragm viability. In the preoperative evaluation, diaphragm compound muscle action potentials (CMAPs) were recorded only when the diaphragm moved on fluoroscopy with ipsilateral stimulation. Twenty-six patients who were determined to have a viable diaphragm underwent DPS. Following DPS the primary outcome was the time (hours per day) that patients were able to pace and stay off the ventilator. Of 26 implanted patients, 96% (25 patients) were able to pace and tolerate being off the ventilator for more than 4 h per day. This study demonstrates that the presence of a diaphragm CMAP is associated with diaphragm movement observed by fluoroscopy in cervical myelopathy. In addition, DPS can help patients with cervical spinal cord injury to breathe unassisted by a ventilator.