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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.

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.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.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.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.

Cervical spinal cord injury (SCI) can lead to dependence on mechanical ventilation (MV) with significant morbidity and mortality. The diaphragm pacing system (DPS) was developed as an alternative to MV.We conducted a prospective single-arm study of DPS in MV-dependent patients with high SCI and intact phrenic nerves. Following device acclimation, pacing effectiveness to provide ventilation was evaluated. The primary endpoint was the number who could use DPS to breathe for 4 continuous hours without MV. Secondary endpoints included the number of patients that could use DPS 24 h/day free of MV and the ability of DPS to maintain clinically acceptable tidal volume (Vt). In addition, we conducted a meta-analysis that included the prospective study along with data from four recently published studies to evaluate DPS hourly use.Fifty-three patients were implanted in the prospective study. Most were male (77.4%) with a median time from injury to treatment of 28.3 (IQR: 12.1, 83.3) months. Four- and 24-h use occurred in 96.2% (95% CI: 87.0%, 99.5%) and 58.5% (95% CI: 44.1%, 74.9%), respectively. Four and 24-h results in the meta-analysis cohort (n = 196) exhibited similar results 92.2% (95% CI: 82.6%, 96.7%) and 52.7% (95% CI: 36.2%, 68.6%) using DPS for 4 and 24 h, respectively. DPS use significantly exceeded the calculated basal tidal volume requirements by a mean of 48.4% (95% CI: 37.0, 59.9%; p 0.001).This study demonstrates that in most ventilator-dependent patients, diaphragm pacing can effectively supplement or completely replace the need for MV and support basal metabolic requirements.

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.

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.

Pediatric spinal cord injury (SCI) at C3 level and above results in tetraplegia and profound respiratory insufficiency requiring long-term positive pressure ventilation (PPV) and is associated with significant complications and morbidity. Diaphragm pacing (DP), a form of functional electrical stimulation (FES) of the diaphragm, provides natural negative pressure breathing which can replace or decrease PPV need. There are numerous reported benefits of DP including improved speech, reduced caregiver burden, and decrease in secretions. The purposes of this paper are to review the limited literature on the safety and effectiveness of DP in pediatric SCI and describe collaboration between two unaffiliated, geographically separated institutions to facilitate implantation of DP for children with ventilator-assisted tetraplegia during inpatient rehabilitation. We further describe the process for ventilator weaning/diaphragm conditioning during inpatient rehabilitation. Two multicenter studies in adult patients with SCI demonstrate safety of the laparoscopic implantation procedure and effectiveness of the DPS system. The first pediatric patient was implanted in 2009, and since then, a total of 22 children with SCI had the system implanted. Among them, six children have now benefited from medically supervised multidisciplinary ventilator weaning/diaphragm conditioning supported by intensive activity-based restorative therapies (ABRT). For the pediatric patients reviewed, implantation of DP was a safe and effective alternative to long-term PPV. Using DP in lieu of PPV provided freedom from ventilator tubing and fear of disconnection, simplifying and facilitating ABRT. We have found that the benefits of DP far surpass the significant effort needed to facilitate implantation during inpatient rehabilitation.

Bilateral phrenic nerve paralysis leading to diaphragm paralysis causes significant pulmonary morbidity in patients. Diaphragm pacing (DP) was developed to overcome this problem and provide natural negative pressure ventilation. In spinal cord injured patients dependent on mechanical ventilation, there is strong evidence in the literature to support the use of DP to wean these patients off of mechanical ventilation. Recent evidence supports early implantation which can improve results, decrease intensive care unit time, decrease the morbidity of ventilator associated pneumonias, and decrease early mortality.

INTRODUCTION: Acute Flaccid Myelitis (AFM) is a recently recognized, polio-like illness of children that can be functionally devastating. Severe cases can lead to ventilatory failure. Incomplete phrenic nerve injuries in other populations has been shown to respond to diaphragmatic stimulation. We therefore proposed an early assessment for incomplete denervation by laparoscopic direct stimulation of the diaphragm and placement of a diaphragmatic pacing system to enhance diaphragm function. CASE PRESENTATION: A 3 year-old girl presented with AFM with clinically and electrodiagnostically severe involvement of all four limbs and muscles of respiration. Direct stimulation of the diaphragm demonstrated contraction and a diaphragmatic stimulator was placed at 3 weeks post presentation. The patient was immediately able to tolerate short bouts of reduced ventilation settings. Electromyography via the pacing wires demonstrated intact motor units consistent with partial denervation/reinnervation in the left hemidiaphragm, and no motor units in the right hemidiaphragm. At three months, she tolerated 6 h of pacing on pressure support setting. At 5 months she demonstrated larger tidal volumes with active pacing than without. DISCUSSION: In our experience, AFM patients who require chronic ventilator support are rarely able to be weaned. Despite clinical and surface electrodiagnostic evidence of complete phrenic nerve involvement, the patient’s diaphragm responded to direct stimulation. The patient preferred pacing over non-pacing times and showed improved ventilatory ability with pacing as opposed to without, though remains ventilator-dependent. These findings support augmentation of diaphragm function and possible enhanced recovery of spontaneous function.

Background and Purpose Pompe disease is an inherited disorder notable for severe, progressive ventilatory compromise. Although ventilatory failure has been attributed to myofiber dysfunction secondary to diaphragmatic glycogen accumulation, neural involvement of the phrenic motor system is also a prominent feature. Direct diaphragm pacing supplements respiratory function in other disorders of the phrenic motor system. Accordingly, it is hypothesized that augmented neuromuscular activity via diaphragm pacing would promote weaning from mechanical ventilation in patients with Pompe disease who are unresponsive to conventional, muscle-directed treatments. Case Description Three patients with Pompe disease developed diaphragm paresis that resulted in chronic mechanical ventilation dependence. After preoperative inspiratory muscle strengthening exercises failed to improve function, fine-wire pacing electrodes were laparoscopically implanted into the diaphragm. Diaphragm conditioning was initiated the first postoperative week and consisted of gradual increases in stimulation parameters, lengthening of stimulation sessions, and ventilator weaning. Ventilation and intramuscular electromyographic activity were recorded periodically during conditioning to quantify diaphragm neuromuscular function. Outcomes During paced breathing without mechanical ventilation, tidal volumes increased, and 2 patients were weaned from daytime ventilator dependence within the first 3 months of pacing, which has been sustained over the long-term. A third patient reduced reliance on daytime ventilation, but weaning was delayed by malacia of the large airways. In all patients, pacing appeared to facilitate spontaneous phrenic motor unit activity during independent breathing without ventilator or pacer support. Discussion The findings are consistent with the view that diaphragm pacing has potential rehabilitative value to reduce reliance on mechanical ventilation in people with Pompe disease, but further study is needed. Diaphragm pacing represents a paradigm shift in the management of respiratory insufficiency for Pompe disease that warrants further controlled examination.

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.

The story of the diaphragm begins over 300 million years ago when primitive vertebrates evolved to have a membrane separating the upper digestive system from the lower. Only with the evolution of warm blooded animals did the diaphragm begin to function for respiration as the lungs herniated into the chest. Some of you in the audience may be starting to look at your watch and wondering how long will this presidential speech last since we still have 100 million yearstogo?Thispresidentialaddresswillbeunlikemyusual scientific presentations about diaphragm pacing in which I typically present another analysis from one of my multiple Institutional Review Board protocols of the laparoscopic placement of electrodes into the diaphragm to help with

Mechanical ventilation (MV), although lifesaving, has significant morbidity, mortality, and health care costs. One of the primary causes of prolonged MV is diaphragm control abnormalities causing disuse atrophy. Diaphragm pacing (DP) allows diaphragm contraction leading to improved ventilation that can significantly overcome the adverse effects of positive pressure ventilation. DP has a role in replacing ventilators in spinal cord injury and delaying or decreasing ventilators in numerous other conditions.

Background: To investigate the efficacy of electrical diaphragm pacing (DP) for sleep condition in patients with amyotrophic lateral sclerosis (ALS). Method: We investigated 5 Japanese ALS patients without positive-pressure mechanical ventilation (3 men and 2 women, aged 59.6 ± 9.6 years). All of them were implanted NeuRx RA/4 Diaphragm Pacing System R (NeuRx) in the diaphragm laparoscopically. We assessed physical status and polysomnographic recordings before implantation and after 6 months of conditioning with DP turned on. Results: 4 patients completed the evaluation. Sleep condition showed the tendency to improve far from getting worse despite of deterioration of physical status and respiratory function. Conclusion: DP with NeuRx might assist the sleep condition in ALS patients at least in 6 months of follow up.

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.

Respiratory insufficiency is a critical problem in amyotrophic lateral sclerosis (ALS) patients. We herein present the case of an autopsied patient with sporadic ALS who underwent diaphragm pacing (DP). The pathology showed several localized adhesions with a markedly atrophied diaphragm. A marked loss of motor neurons with Bunina bodies and phosphorylated TDP-43 positive inclusions was found in the spinal cord and primary motor cortex. Mild hyalinization and a few multinucleated giant cells were present around the electrode tracks in the diaphragm. However, no infiltration of inflammatory cells was detected. Our findings suggest that full-time DP might not cause severe damage to adjacent diaphragm tissue.

Mechanical ventilation (MV) is a life-sustaining treatment in patients who are unable to maintain spontaneous ventilation. Failure to wean (FTW) from MV, or prolonged ventilation results in significant morbidity, mortality, and health care costs. Diaphragm pacing (DP) was initially developed to provide natural negative pressure ventilation in spinal cord injured (SCI) patients on MV. Its use has since expanded to ALS patients, as well as in critically ill patients to shorten MV time. A new technical development was that of a temporary and removable electrode. Since our group has experience with bedside NOTES with PEG rescue, we hypothesize that NOTES placement of DP electrodes is technically feasible and safe.

Mechanical ventilation (MV) has saved countless lives. Since MV was introduced, it is the primary therapy for respiratory failure and a fundamental treatment in intensive care units. Whether MV is used during a surgical procedure or to treat respiratory failure, it is generally a time-limited therapy that, when withdrawn, has no untoward sequelae. However, there are a number of patients who become dependent on MV. These patients, often referred to as “failure to wean” (FTW), present a significant physiologic and economic burden to the healthcare system.

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.

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.

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. 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. 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. 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.

The laparoscopic repair of ventral hernias can result in significant postoperative pain necessitating a prolonged hospital stay, increased narcotic use, and patient dissatisfaction. Elastomeric pain pump devices with local analgesics may significantly reduce postoperative discomfort after laparoscopic ventral hernia repair. This prospective randomized, double-blind, placebo-controlled study evaluated the effect of local anesthetic continuously infused with an elastomeric pain pump device to reduce postoperative pain. After institutional review board approval of the study, all patients undergoing laparoscopic ventral hernia repair consented to participate. Standardized technique included routine transfascial fixation sutures and titanium spiral tacks. Elastomeric pain pumps were placed percutaneously just above the mesh in the hernia sac. For 48 h postoperatively, 100 ml of continuous 0.5% Marcaine or normal saline was used at 2 ml/h. Postoperatively, the patients were evaluated every 8 h for the first 72 h, then after 2 weeks, 6 weeks, and 3 months for pain scores, narcotic usage (both oral and intravenous), return of flatus, length of hospital stay, and postoperative complications. Of the 73 patients enrolled in the study, 37 received 0.5% Marcaine, and 36 received placebo. Despite randomization, the control group had significantly more obese patients (mean body mass index [BMI], 39 vs. 33 kg/m2; p = 0.005), and more recurrent hernias (40% vs. 19%; p = 0.05), and also tended to have more prior hernia repairs (0.8 vs. 0.3; p = 0.06). There were no significant differences between the two groups in terms of operative times (p = 0.7), hernia size (p = 0.9), mesh size (p = 0.6), number of transfascial fixation sutures (p = 0.4), or number of spiral tacks (p = 0.13). Postoperative visual analog pain scores, usage of oral or intravenous narcotics, and morphine equivalents were similar between the two groups at all study points (p > 0.05). There were no significant differences between the two groups based on return of bowel function, toleration of a regular diet, or length of hospital stay. No postoperative complications directly related to the catheter were observed. This prospective randomized double-blind, placebo-controlled trial showed no advantage of an elastomeric pain pump device in terms of providing a measurable reduction in postoperative pain scores, narcotic use, time to return of bowel function, or length of hospital stay after laparoscopic ventral hernia repair. Further studies are warranted to determine other alternatives for reducing postoperative pain after laparoscopic ventral hernia repair.

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.

Paraesophageal hernia repair is often performed in an elderly population. Few studies have evaluated perioperative mortality in this group. We identified predictors of inpatient mortality using a nationally representative sample. Patients ≥80 years old undergoing transabdominal paraesophageal hernia repair were identified in the 2005 Nationwide Inpatient Sample. Congenital diaphragmatic defects and traumatic injuries were excluded. One thousand five discharges (73% female) with mean age 84.7 met inclusion criteria. Mean length of stay was 10.1 days (95% confidence interval 8.9–11.3) with a mortality of 8.2%. Non-elective repair was performed in 43%. For these patients, mortality and mean length of stay (16%; 14.3 days) were increased compared to elective repair (2.5%; 7.0 days, p

Physicians understand patient needs and are in the ideal position to identify technologies that can improve patient care. Innovation involves a long process from the initial idea to utilization in patients. This chapter outlines characteristics for the successful innovator which include personal fortitude, understanding of intellectual property rights, ability to engineer prototypes, and collaborative capabilities in business to overcome obstacles which may include time commitments, financing, and the FDA.

The Residency Review Committee for Surgery (RRC-S) re-cently mandated a 293% increase in required flexible gastroin-testinalendoscopyexperienceforgeneralsurgeryresidents.De-spite this heightened accreditation emphasis, resident exposureto flexible endoscopy remains erratic even in volume-adequatesettings. A successful endoscopy training program requiresplanning, educator and resident buy-in, and proper trainingtools. So, how does the program director in surgery change thecurriculum to prepare trainees for successful completion of theprogram?Stepstowardamoreuniformandappropriatetrainingexpe-rienceshouldincludeaddressingcurrentAccreditationCouncilforGraduateMedicalEducation(ACGME)policies,efficientlyusing available resources, including simulators, and institutinga validated, standardized endoscopy curriculum incorporatingrecommendations from surgery and gastrointestinal societies.Trainees also may benefit from structured experiences with ru-ral surgeons or other high-volume endoscopy providers. Incor-poration of multidisciplinary initiatives focused on expandingandstandardizingendoscopytrainingalsomaybehelpful.Suchinitiativesincludedevelopmentofstandardizednationalcurric-ula and proficiency-oriented skills assessment. Another bur-geoning initiative is natural orifice translumenal endoscopicsurgery (NOTES), which lends itself to novel technology de-sign, expansion and application of fundamental endoscopicskills,multidisciplinarytrainingandresearchmodels,plusout-comes assessment.Along with reviewing the aforementioned issues, this ar-ticle articulates the perspective that flexible endoscopy is anintegral part of general surgery and that alimentary tractsurgery will involve increasing utilization of endoscopictechniques in the future. If gastrointestinal surgeons are toprovide integrated and current patient care, it will be neces-sary to incorporate intralumenal and potentially translume-nal endoscopic techniques as they evolve. This article detailsthe available strategies to prepare general surgery residentsfor the scope of contemporary practice.

The NDO Plicator is a device developed for endoscopic treatment of gastroesophageal reflux disease (GERD) by approximation of tissues together with a double-pledgeted U-stitch. It was theorized that this device may facilitate transgastric natural orifice translumenal endoscopic surgery (NOTES) because closure of the transgastric defect remains a key component for advancement of this new technology.A standardized 12-mm gastrotomy was created endoscopically in four pigs using a combination of needle-knife cautery and balloon dilation. As the endoscope was removed, a Savary soft-tipped wire was introduced into the stomach, and the NDO Plicator was subsequently advanced over the wire. Each defect was identified, and the device was positioned. If necessary, the Plicator's tissue grasper was used to hold the superior aspect of the gastrotomy and bring the opposed borders of the defect within the jaws of the device. The device was fired three times, leaving three pledgeted suture bundles to close the gastric defect. After closure, each animal was explored, and the integrity of the closure was assessed. The animals underwent in vivo contrast fluoroscopy and ex vivo burst pressure testing studies for assessment of leakage at the closure site.The first animal was used to test feasibility, refine techniques, and develop a standard procedure. All of the next three animals studied showed complete sealing of the gastrotomy site without evidence of contrast extravasation on multiplanar fluoroscopic imaging. Each stomach was excised, submerged in water, and subjected to a pressurized air leak test. No leaks were noted until pressures exceeded 55 mmHg.This study supports the use of the NDO Plicator for closure of standardized gastric defects in a porcine model. In addition to closing NOTES gastrotomies, the NDO Plicator may be a particularly useful tool for obtaining complete closure of gastric perforations and anastomotic leaks, and for performing stomal reduction after gastric bypass procedures. The mechanical properties of a closure are not the only factor determining whether a leak will develop. Tissue opposition, ischemia, and tension are important factors that are not easily or reliably measured. The physiologic relevance of gastric bursting pressure is not known. Therefore, corollary animal studies with longer-term evaluation are necessary before research proceeds to clinical trials.

Natural orifice translumenal endoscopic surgery (NOTES) provides surgical access to the peritoneal cavity without skin incisions. The NOTES procedure requires pneumoperitoneum for visualization and manipulation of abdominal organs, similar to laparoscopy. Accurate measurement of the pneumoperitoneum pressure is essential to avoid potentially deleterious effects of intraabdominal compartment syndrome. A reliable method for monitoring pneumoperitoneum pressures during NOTES has not been identified. This study evaluated several methods of monitoring intraabdominal pressures with a standard gastroscope during NOTES. Four female pigs (25 kg) were sedated, and a single-channel gastroscope was passed transgastrically into the peritoneal cavity. Pneumoperitoneum was achieved via a pressure insufflator through a percutaneous, intraperitoneal 14-gauge catheter. Three other pressures were recorded via separate catheters. First, a 14-gauge percutaneous catheter passed intraperitoneally measured true intraabdominal pressure. Second, a 14-gauge tube attached to the endoscope was used to measure endoscope tip pressure. The third pressure transducer was connected directly to the accessory channel of the endoscope. The abdomen was insufflated to a range of pressures (10–30 mmHg), and simultaneous pressures were recorded from all three pressure sensors. Pressure correlation curves were developed for all animals across all intraperitoneal pressures (mean error, –4.25 to –1 mmHg). Endoscope tip pressures correlated with biopsy channel pressures (R 2 = 0.99). Biopsy channel and endoscope tip pressures fit a least-squares linear model to predict actual intraabdominal pressure (R = 0.99 for both). Both scope tip and biopsy channel port pressures were strongly correlative with true intraabdominal pressures (R 2 = 0.98 and R 2 = 0.99, respectively). This study demonstrates that monitoring pressure through an endoscope is reliable and predictive of true intraabdominal pressure. Gastroscope pressure monitoring is a useful adjunct to NOTES. Future NOTES procedures should incorporate continuous intraabdominal pressure monitoring to avoid the potentially deleterious effects of pneumoperitoneum during NOTES. This can be achieved by the integration of pressure-monitoring capabilities into gastroscopes.

Children with cervical spinal cord injury and chronic respiratory insufficiency face the risks and stigma associated with mechanical ventilators. The Diaphragm Pacing Stimulation (DPS) System for electrical activation of the diaphragm is a minimally invasive alternative to mechanical ventilation.Review of patients in a prospective Food and Drug Administration trial of the DPS System in individuals who were injured at age 18 years or younger. The procedure involved laparoscopic mapping to locate the diaphragm motor points with electrode implantation. Two weeks after surgery, stimulus/output characteristics of each electrode were determined to obtain an adequate tidal volume for ventilation. A home-based weaning protocol from the ventilator was used.Of 28 patients implanted with the DPS System, 10 had sustained cervical SCI as children or adolescents. Average age at injury was 13 years (range 1.5 to 17 y). Age at implantation ranged from 18 to 34 years. Length of time from injury to implantation averaged 9.7 years (0.8 to 19 y). All patients tolerated the implantation procedure. Four patients utilize DPS continuously (24/7), 4 patients pace daytime only, and 2 patients are still actively conditioning their diaphragms. Two patients required surgical correction of scoliosis prior to implantation. All patients prefer breathing with the DPS and would recommend it to others; 4 patients specifically identified that attending college or church without a ventilator eases their integration into society.The results show that the laparoscopic DPS system can be safely implanted in tetraplegics injured as children and used in a home-based environment to wean them off of mechanical ventilation.

Diaphragmatic dysfunction may be unilateral or bilateral, with symptoms ranging from dyspnea only on extreme exertion to ventilator dependence. The etiology, treatment, and prognosis are quite different in unilateral and bilateral paralysis. A paralyzed hemidiaphragm may occur in isolation or as part of a systemic disease, whereas bilateral diaphragmatic paralysis usually occurs as a result of a traumatic or neuromuscular degenerative process. This review covers clinical evaluation, investigative studies, and management of diaphragmatic dysfunction. Figures show diaphragmatic motion during respiration, a postoperative radiograph from a 55-year-old woman who underwent left upper lobectomy, a postoperative radiograph of a 70-year-old man who underwent left upper lobectomy for removal of a peripheral 3 cm lesion, three chest radiographs of a 25-year-old man with a residual anterior mediastinal mass after treatment for germ cell tumor, chest radiograph showing left diaphragmatic paralysis in a breast cancer patient with malignant adenopathy involving the left phrenic nerve near the left main pulmonary artery, several parallel rows of sutures placed in the muscular portion and central tendon of the diaphragm and tied with the aid of a knot pusher, a laparoscopic mapping probe held onto the left diaphragm with suction and which receives electrical stimuli from an external clinical station, an electrode implant device that houses the electrode in the needle and is placed into the diaphragm tangentially, and the diaphragm pacing system programmed for conditioning and attached via percutaneously placed diaphragm electrodes in a spinal cord-injured child for early conditioning and weaning from the ventilator. Tables list causes of isolated diaphragmatic paralysis, general causes of unilateral and bilateral diaphragmatic paralysis, and differential diagnosis of elevated hemidiaphragm on chest radiograph. A video shows current technique of laparoscopic diaphragm pacemaker insertion. This review contains 9 highly rendered figures, 3 tables, 1 video, and 22 references

A significant fraction of patients with cervical spinal cord injury suffer from respiratory muscle paralysis and dependence on chronic mechanical ventilation. In selected patients, diaphragm pacing (DP) through electrical stimulation of the phrenic nerves provides an alternative to mechanical ventilation with significant advantages in life quality.A case report of an individual who successfully underwent DP using intramuscular diaphragm electrodes. A brief review of the state of the art of DP including the clinical benefits of DP, patient selection and evaluation, description of equipment, methods of transition from mechanical ventilation to DP, potential complications and side effects, long-term outcome, and potential future developments in this field is included.Several available DP systems are available, including conventional ones in which electrodes are positioned directly on the phrenic nerves through thoracotomy and less invasive systems in which electrodes are placed within the diaphragm through laparoscopy. For patients with only unilateral phrenic nerve function, a combined intercostal and unilateral diaphragm pacing system is under development.In patients with ventilator-dependent tetraplegia, there are alternative methods of ventilatory support, which offer substantial benefits compared to mechanical ventilation.

Electrical stimulation of the phrenic nerve motor point of the diaphragm through laparoscopic implantation of a pacing system is an option for high spinal cord–injured patients with chronic respiratory insufficiency. This study assesses the operative learning curve for the initial series of patients. A series of six patients underwent laparoscopic placement of a diaphragm pacing system. The operative procedure was divided into the following four steps for analysis and rapid adjustment after each operation: exposure of the diaphragm, mapping of the phrenic nerve motor point, implantation of the pacing electrodes, and final routing of the wires to the external system. The first case required two operations, and the second case was unsuccessful because of a nonfunctioning phrenic nerve that led to a change in the preoperative screening criteria. The operative time decreased from 469 min for the first operation to 165 min for the sixth operation. The significant time decrease can be attributed to changes in the mapping and routing aspects of the operation. Key changes during this series that helped to reduce the operative time include abandonment of a software-dependent mapping technique, development of a grid algorithm for mapping, software improvement to increase the speed of stimulation and mapping, refinement of the mapping probe to maintain adequate suction on the diaphragm, shortening of the electrode lengths, and experience with the implantation of connections to the external electrodes. Presently, all five of the successfully implanted patients can be maintained on prolonged ventilatory support with the device. Analysis of every step of this investigational procedure enabled us to make rapid changes in surgical protocol, leading to decreases in operative times and expectant improvements in patient safety and efficacy. In this series, analysis was the key to developing a low-risk cost-effective outpatient diaphragm pacing system.

Diaphragm pacing from laparoscopically placed electrodes is an alternative to conventional phrenic pacers that use electrodes placed in direct contact with the nerve in the neck or chest. The challenge with the laparoscopic approach is determining where to implant the electrodes, as the phrenic nerves are not visible from the abdomen. The objective of this study was to locate the phrenic nerve “motor points” in the human diaphragm muscle from an abdominal perspective. Twenty-five cadavers were examined by excising the diaphragm muscle and assessing for the thickness of the muscle, the motor point area, and the accessibility of the motor point from the abdominal approach. The data indicate the average thickness of the muscle in the motor point region was 3.0 mm for the left and 2.9 mm for the right hemidiaphragm. The average motor point area was 73 mm2 for the left and 58.7 mm2 for the right hemidiaphragm. The motor points were accessible from an abdominal approach, but the motor point on the right hemidiaphragm was located on the central tendon in many cases (12 of 25). Thus, although the nerves branch prior to entry into the muscle on the right side, several well-placed electrodes could still activate the entire nerve. In this study, we have characterized the human diaphragm muscle in the motor point region and found that it is feasible to place laparoscopically intramuscular electrodes in the motor point region. This is the foundation for the laparoscopically placed diaphragm pacing device that has been utilized in a small series of patients.

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.

New laparoscopic techniques have revolutionized the practice of surgery. Laparoscopic cholecystectomy has become one of the most commonly performed surgeries worldwide. Although shorter hospital stays and patient comfort have offered clear advantages over open cholecystectomy, the technique has resulted in several specific complications, including bile duct injury and gallbladder perforation. Although rarely clinically significant, intraperitoneal gallstone spillage can cause abscess formation and adhesions. Although these patients can present with a confusing clinical picture, their characteristic radiologic features should be recognized. We present two cases of complicated intraperitoneal gallstone spillage radiologically diagnosed and treated with laparoscopic and interventional radiologic techniques.

Autopsy studies confirm that many intensive care unit (ICU) patients die from unrecognized sources of abdominal sepsis or ischemia. Computed tomography (CT) scans can be of limited use for these diagnoses and difficult to obtain in critically ill patients who require significant support for transport. Bedside laparoscopy has been described but still is cumbersome to perform. Bedside flexible endoscopy as a diagnostic tool or for placement of gastrostomy tubes is a standard ICU procedure. Natural orifice transluminal endoscopic surgery (NOTES) can provide access to the peritoneal cavity as a bedside procedure and may decrease the number of patients with unrecognized intra-abdominal catastrophic events.Pigs were anesthetized and peritoneal access with the flexible endoscope was obtained using a guidewire, needle knife cautery, and balloon dilatation. The transgastric endoscope was used to explore all quadrants of the abdominal cavity. The small bowel was visualized to complete the exploration. The transgastric access location was then managed with the use of a gastrostomy tube. The animals were euthanized and analyzed.Eight pigs were studied and complete abdominal exploration, including diaphragm visualization, was possible in all cases. Endoscopy-guided biopsies were performed, adhesions lysed, and the gallbladder successfully drained percutaneously. The small bowel was run successfully with percutaneous needlescopic suture graspers.These animal studies support the concept that NOTES, with management of the gastric opening with a gastrostomy tube, may be another approach for finding unrecognized sources of abdominal sepsis or mesenteric ischemia in difficult ICU patients. These encouraging results warrant a prospective human trial to assess safety and efficacy.

Laparoscopic surgical procedures are replacing traditional, more invasive surgical procedures—even in small, rural hospitals. During a period of 12 months, the authors performed laparoscopic distal pancreatectomy procedures on two patients at a 20-bed hospital in North Dakota. Although surgeons in other countries have reported performing laparoscopic distal pancreatectomy procedures, this is the first published report of a US surgical team performing this procedure. Laparoscopic dissection of the distal pancreas allows preservation of patients' spleens, decreases postoperative pain and length of hospitalization, and permits patients to return to activities of daily living more quickly than with traditional open pancreatectomy procedures. AORN J 65 (Feb 1997) 334–343.

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 (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.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.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.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.

Tetraplegia can lead to chronic respiratory failure. The need for tracheostomy mechanical ventilation significantly increases the cost of care, decreases the quality of life of the patient, and decreases life expectancy in spinal cord injury (SCI) because of pneumonias. Phrenic nerve stimulation was initially developed in the 1960s and diaphragm pacing was developed in the 1990s; both have the ability to remove a patient from positive pressure ventilation and allow them to breathe with their own diaphragm, decreasing posterior lung lobe atelectasis and pneumonia risk. This chapter summarizes the current surgical techniques, ventilator weaning options, and long-term results of functional electrical stimulation in restoring respiratory function.

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.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.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.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.

Tetraplegia can lead to chronic respiratory failure. The need for tracheostomy mechanical ventilation significantly increases the cost of care, decreases the quality of life of the patient, and decreases life expectancy in spinal cord injury (SCI) because of pneumonias. Phrenic nerve stimulation was initially developed in the 1960s and diaphragm pacing was developed in the 1990s; both have the ability to remove a patient from positive pressure ventilation and allow them to breathe with their own diaphragm, decreasing posterior lung lobe atelectasis and pneumonia risk. This chapter summarizes the current surgical techniques, ventilator weaning options, and long-term results of functional electrical stimulation in restoring respiratory function.

In patients with ventilator-dependent tetraplegia, phrenic nerve pacing (PNP) provides significant clinical advantages compared with mechanical ventilation. This technique however generally requires a thoracotomy with its associated risks and in-patient hospital stay and carries some risk of phrenic nerve injury. We have developed a method by which the phrenic nerves can be activated via intramuscular diaphragm electrodes. In one patient with ventilator-dependent tetraplegia, two intramuscular diaphragm electrodes were implanted into each hemidiaphragm near the phrenic nerve motor points via laparoscopic surgery. The motor points were identified employing a previously devised mapping technique. Because inspired volumes were suboptimal on the right, a second laparoscopic procedure was necessary to position electrodes near the anterior and posterior branches of the right phrenic nerve. During bilateral stimulation, inspired volume was 580 ml. After a reconditioning program of progressively increasing diaphragm pacing, maximum inspired volumes on the left and right hemidiaphragms increased significantly. Maximum combined bilateral stimulation was 1120 ml. Importantly, the patient has been able to comfortably tolerate full-time pacing. If confirmed in additional patients, PNP with intramuscular diaphragm electrodes via laparoscopic surgery may provide a less invasive and less costly alternative to conventional PNP.

Diaphragm pacing stimulation (DPS) for ventilator-dependent patients provides several advantages over conventional techniques such as phrenic nerve pacing or mechanical ventilator support. To date, the only existing system for DPS uses lead electrodes, percutaneously attached to an external pulse generator (PG). However, for a widespread use of this technique it would be more appropriate to eliminate the need for percutaneous wire and use a totally implantable system. The aim of this study was to determine if it were feasible to replace the external PG by an implantable system. We present here the results of a preliminary study of two different PG, currently used in other electrical stimulation (ES) clinical applications, which could be used as implantable DPS systems. One radio-frequency-powered PG, one rechargeable battery-powered PG, and the current external PG were tested. Each was attached to the externalized part of the wires, connected to the diaphragm and tidal volume (TV) was measured in one ventilator-dependent patient who has been using the current percutaneous stimulator for 3 years. Results indicated that both implantable PGs could achieve equivalent ventilatory requirements to the current external stimulator. No significant differences were observed between the three PG systems when stimulating the electrodes as used in the patient's own chronically attached PG system. We found that TV increased with increases in charge and frequency as expected when stimulating the patient's electrodes individually and in combination with each PG system. These results are a significant step toward developing a totally implantable DPS system for the ventilator-dependant patients. Further clinical tests to demonstrate the safety and efficacy of a fully implanted DPS system are warranted.

Minimally invasive techniques have become an integral part of general surgery, with recent investigation into single-incision laparoscopic cholecystectomy (SILC). This study presents a prospective, randomized, multicenter, single-blind trial of SILC compared with four-port cholecystectomy (4PLC) with the goal of assessing safety, feasibility, and factors predicting outcomes.Patients with biliary colic and documented gallstones or polyps or with biliary dyskinesia were randomized to SILC or 4PLC. Data measures included operative details, adverse events, and conversion to 4PLC or laparotomy. Pain, cosmesis, and quality-of-life scores were documented. Patients were followed for 12 months.Two hundred patients were randomized to SILC (n = 117) or 4PLC (n = 80) (3 patients chose not to participate after randomization). Patients were similar except for body mass index (BMI), which was lower in the SILC patients (28.9 vs. 31.0, p = 0.011). One SILC patient required conversion to 4PLC. Operative time was longer for SILC (57 vs. 45 min, p0.0001), but outcomes, including total adverse events, were similar (34% vs. 38%, p = 0.55). Cosmesis scores favored SILC (p0.002), but pain scores were lower for 4PLC (1 point difference in 10-point scale, p0.028) despite equal analgesia use. Wound complications were greater after SILC (10% vs. 3%, p = 0.047), but hernia recurrence was equivalent for both procedures (1.3% vs. 3.4%, p = 0.65). Univariate analysis showed female gender, SILC, and younger age to be predictors for increased pain scores, while SILC was associated with improved cosmesis scores.In this multicenter randomized controlled trial of SILC versus 4PLC, SILC appears to be safe with a similar biliary complication profile. Pain scores and wound complication rates are higher for SILC; however, cosmesis scores favored SILC. For patients preferring a better cosmetic outcome and willing to accept possible increased postoperative pain, SILC offers a safe alternative to the standard 4PLC. Further follow-up is needed to detail the long-term risk of wound morbidities, including hernia recurrence.