Endoscopic anterior fundoplication with the Medigus Ultrasonic Surgical Endostapler (MUSE™) for gastroesophageal reflux disease: 6-month results from a multi-center prospective trial

BACKGROUND: Both long-term proton pump inhibitor (PPI) use and surgical fundoplication have potential drawbacks as treatments for chronic gastroesophageal reflux disease (GERD). This multi-center, prospective study evaluated the clinical experiences of 69 patients who received an alternative treatment: endoscopic anterior fundoplication with a video- and ultrasound-guided transoral surgical stapler. METHODS: Patients with well-categorized GERD were enrolled at six international sites. Efficacy data was compared at baseline and at 6 months post-procedure. The primary endpoint was a ≥ 50 % improvement in GERD health-related quality of life (HRQL) score. Secondary endpoints were elimination or ≥ 50 % reduction in dose of PPI medication and reduction of total acid exposure on esophageal pH probe monitoring. A safety evaluation was performed at time 0 and weeks 1, 4, 12, and 6 months. RESULTS: 66 patients completed follow-up. Six months after the procedure, the GERD-HRQL score improved by >50 % off PPI in 73 % (48/66) of patients (95 % CI 60-83 %). Forty-two patients (64.6 %) were no longer using daily PPI medication. Of the 23 patients who continued to take PPI following the procedure, 13 (56.5 %) reported a ≥ 50 % reduction in dose. The mean percent of total time with esophageal pH <4.0 decreased from baseline to 6 months (P < 0.001). Common adverse events were peri-operative chest discomfort and sore throat. Two severe adverse events requiring intervention occurred in the first 24 subjects, no further esophageal injury or leaks were reported in the remaining 48 enrolled subjects. CONCLUSIONS: The initial 6-month data reported in this study demonstrate safety and efficacy of this endoscopic plication device. Early experience with the device necessitated procedure and device changes to improve safety, with improved results in the later portion of the study. Continued assessment of durability and safety are ongoing in a three-year follow-up study of this patient group

Nonoperative management of blunt splenic and liver injuries in adult polytrauma

Background: Isolated splenic or hepatic injuries are present in approximately 30% of all cases of adult abdominal trauma. Most authors quoted above have limited nonoperative management (NOM) to patients with isolated organ injury. Results of NOM following blunt hepatic and splenic trauma in patients with multiple injuries were evaluated in this study. Materials and Methods: Retrospective chart review was performed on multiple injured adults with splenic and liver injures resulting from blunt trauma. Associated injuries, clinical signs at presentation, used diagnostic tools, injury grading, transfusion requirements, morbidity and mortality were documented. Results: Medical records of 275 patients aged from 17 to 81 years with blunt splenic and liver trauma and associated injuries were analyzed. Patients with hemodynamic instability or obvious peritoneal signs were excluded from further study. Surgery was indicated in 106 patients without response or transient response for fluid challenge. 131 of 237(55%) patients were selected for NOM: 78 with splenic, 46 with liver and 7 with injuries to both. 25(19%) patients were older 55 years. The mean injury severity score was 25.2. Injury grade ranged from I-IV and the degree of hemoperitoneum was from mild to severe. 8 patients failed NOM (6%). Mean blood transfusion requirement during first 24 hours at admission was 0.3 units. Morbidity rate was 1.2%. Two patients (1.5%) died following severe head trauma. Conclusion: Nonoperative strategy is the preferred modality for the care of blunt splenic and liver injuries in the hemodynamically stable patients, irrespective of age, grade of injury, associated injuries or degree of hemoperitoneum

Trans-oral anterior fundoplication: 5-year follow-up of pilot study

Abstract Background This is a report of an IRB-approved pilot study of 13 patients who received a trans-oral anterior partial fundoplication for the treatment of GERD using an ultrasound-guided, flexible surgical stapler. All patients had a history of PPI use, objective evidence of GERD, and no significant comorbidity. Under general anesthesia, a flexible stapler was passed trans-orally into the stomach and placed two or three quintuplets of titanium staples approximately 3 cm above the gastroesophageal junction. The stapler contains an ultrasonic range finder, video camera, and illuminator. Methods Primary follow-up at 6 weeks included pH metrics, GERD-HRQL scores, and PPI use. The protocol allowed annual telephone interviews for the following 5 years to collect GERD-HRQL scores, PPI use, satisfaction with the procedure, and willingness to have the procedure again. Results At 6 weeks, mean total acid exposure was significantly reduced, and 12/13 patients reduced GERD-HRQL scores by C50 %. Twelve of 13 patients had stopped daily GERD medications, and nine of 13 had stopped all GERD medications. Each year, 11 of the 13 patients could be reached with all 13 patients having at least 4-year followup. Throughout the follow-up period, GERD-HRQL scores were normal (\10) in all but one patient. All patients would agree to do the procedure again. The median satisfaction score is 8 (range 6-10) on a scale of 1-10. None reported dysphagia. At 1 year, 54 % of respondents (6/11) had eliminated PPI use, with another 27 % (3/11) taking a reduced dose. Combining respondents at 4 and 5 years to account for all patients, 54 % (7/13) had eliminated and another 23 % (3/13) reduced PPI use C50 %. Conclusion At 5 years, the procedure remained effective as demonstrated by the improved quality of life and changes in PPI use. The results remained stable after the second year

Life Threatening Idiopathic Recurrent Angioedema Responding to Cannabis

We present a case of a 27-year-old man with recurrent episodes of angioedema since he was 19, who responded well to treatment with medical grade cannabis. Initially, he responded to steroids and antihistamines, but several attempts to withdraw treatment resulted in recurrence. In the last few months before prescribing cannabis, the frequency and severity of the attacks worsened and included several presyncope events, associated with scrotal and neck swelling. No predisposing factors were identified, and extensive workup was negative. The patient reported that he was periodically using cannabis socially and that during these periods he was free of attacks. Recent data suggest that cannabis derivatives are involved in the control of mast cell activation. Consequently, we decided to try a course of inhaled cannabis as modulators of immune cell functions. The use of inhaled cannabis resulted in a complete response, and he has been free of symptoms for 2 years. An attempt to withhold the inhaled cannabis led to a recurrent attack within a week, and resuming cannabis maintained the remission, suggesting a cause and effect relationship

Nonoperative management of blunt splenic and liver injuries in adult polytrauma

Background: Isolated splenic or hepatic injuries are present in approximately 30% of all cases of adult abdominal trauma. Most authors quoted above have limited nonoperative management (NOM) to patients with isolated organ injury. Results of NOM following blunt hepatic and splenic trauma in patients with multiple injuries were evaluated in this study. Materials and Methods: Retrospective chart review was performed on multiple injured adults with splenic and liver injures resulting from blunt trauma. Associated injuries, clinical signs at presentation, used diagnostic tools, injury grading, transfusion requirements, morbidity and mortality were documented. Results: Medical records of 275 patients aged from 17 to 81 years with blunt splenic and liver trauma and associated injuries were analyzed. Patients with hemodynamic instability or obvious peritoneal signs were excluded from further study. Surgery was indicated in 106 patients without response or transient response for fluid challenge. 131 of 237(55%) patients were selected for NOM: 78 with splenic, 46 with liver and 7 with injuries to both. 25(19%) patients were older 55 years. The mean injury severity score was 25.2. Injury grade ranged from I-IV and the degree of hemoperitoneum was from mild to severe. 8 patients failed NOM (6%). Mean blood transfusion requirement during first 24 hours at admission was 0.3 units. Morbidity rate was 1.2%. Two patients (1.5%) died following severe head trauma. Conclusion: Nonoperative strategy is the preferred modality for the care of blunt splenic and liver injuries in the hemodynamically stable patients, irrespective of age, grade of injury, associated injuries or degree of hemoperitoneum

A Nearly Lethal Screw: An Unusual Cause of Recurrent Bradycardia and Asystole Episodes after Fixation of the Cervical Spine

We present a case of a 51-year-old man who was injured in a bicycle accident. His main injury was an unstable fracture of the cervical and thoracic vertebral column. Several hours after his arrival to the hospital the patient underwent open reduction and internal fixation (ORIF) of the cervical and thoracic spine. The patient was hospitalized in our critical care unit for 99 days. During this time patient had several episodes of severe bradycardia and asystole; some were short with spontaneous return to sinus and some required pharmacological treatment and even Cardiopulmonary Resuscitation (CPR). Initially, these episodes were attributed to the high cervical spine injury, but, later on, CT scan suggested that a fixation screw abutted on the esophagus and activated the vagus nerve by direct pressure. After repositioning of the cervical fixation, the bradycardia and asystole episodes were no longer observed and the patient was released to a rehabilitation ward. This case is presented in order to alert practitioners to the possibility that, after operative fixation of cervical spine injuries, recurrent episodes of bradyarrhythmia can be caused by incorrect placement of the fixation screws and might be confused with the natural history of the high cervical cord injury

Inguinal Herniation of the Urinary Bladder Presenting as Recurrent Urinary Retention

Herniation of the urinary bladder into the inguinal canal is an uncommon finding, observed in 0.5–4% of inguinal hernias (Curry (2000)). It is usually associated with other conditions that increase intra-abdominal pressure such as bladder neck obstruction due to prostatic hypertrophy. Consequently, in men, it is usually associated with some degree of urinary retention. We present a 42-year-old man in whom herniation of the urinary bladder was the cause of urinary retention, and not vice versa. The patient was on tumor necrosis factor alpha antagonist (TNFA) (Etanercept) for severe Ankylosing spondylitis. Initially, the urinary retention was thought to be a side effect of the medication, but after the drug was discontinued, urinary retention persisted. CT and MRI demonstrated huge herniation of the urinary bladder into the inguinal canal. Immediately after the hernia was repaired, bladder function was restored. TNF treatment was restarted, and no further urinary symptoms were observed in the next two years of follow-up. In this case, the primary illness and its treatment were distracting barriers to early diagnosis and treatment. In younger patients with a large hernia who develop unexpected urinary retention, herniation of the urinary bladder should be highly considered in the differential diagnosis