Evaluation of a Magnetic Compression Anastomosis for Jejunoileal Partial Diversion in Rhesus Macaques.

PURPOSE: Metabolic surgery remains underutilized for treating type 2 diabetes, as less invasive alternative interventions with improved risk profiles are needed. We conducted a pilot study to evaluate the feasibility of a novel magnetic compression device to create a patent limited caliber side-to-side jejunoileal partial diversion in a nonhuman primate model. MATERIALS AND METHODS: Using an established nonhuman primate model of diet-induced insulin resistance, a magnetic compression device was used to create a side-to-side jejunoileal anastomosis. Primary outcomes evaluated feasibility (e.g., device mating and anastomosis patency) and safety (e.g., device-related complications). Secondary outcomes evaluated the device's ability to produce metabolic changes associated with jejunoileal partial diversion (e.g., homeostatic model assessment of insulin resistance [HOMA-IR] and body weight). RESULTS: Device mating, spontaneous detachment, and excretion occurred in all animals (n = 5). There were no device-related adverse events. Upon completion of the study, ex vivo anastomoses were widely patent with healthy mucosa and no evidence of stricture. At 6 weeks post-device placement, HOMA-IR improved to below baseline values (p < 0.05). Total weight also decreased in a linear fashion (R2 = 0.97) with total weight loss at 6 weeks post-device placement of 14.4% (p < 0.05). CONCLUSION: The use of this novel magnetic compression device to create a limited caliber side-to-side jejunoileal anastomosis is safe and likely feasible in a nonhuman primate model. The observed glucoregulatory and metabolic effects of a partial jejunoileal bypass with this device warrant further investigation to validate the long-term glucometabolic impact of this approach.

An experimental study on long term outcomes after magnetic esophageal compression anastomosis in piglets.

BACKGROUND/PURPOSE: Previous studies have shown that a patent, watertight esophageal anastomosis can be accomplished safely using specially-shaped magnets in piglets. However, it is unclear whether such a magnetic esophageal compression anastomosis (MECA) remains patent in the long-term. The purpose of this study was to evaluate the long-term outcome of MECA in an experimental pig model over an observation period of 2 months. METHODS: Ten piglets underwent creation of an MECA with custom-made 8 mm magnets and a U-shaped esophageal bypass loop to allow peroral nutrition at eight weeks of life. Two weeks later, the bypass loop was closed surgically, requiring the pigs to swallow via the newly created magnetic compression anastomosis. The pigs were fed soft chow for 2 months. They were monitored for weight gain and signs of dysphagia. At the endpoint of two months, esophagoscopy and contrast esophagography was performed. After removal of the esophagus, the tissues were macroscopiocally and histologically assessed. RESULTS: Six piglets survived until the endpoint. In two pigs, closure of the bypass loop failed, these demonstrated mean weight gain of 792 gs/day [95% Confidence interval 575 to 1009 gs/day]. Weight gain in four pigs that exclusively fed via the magnetic anastomosis averaged 577 gs/day [95% confidence interval 434 to 719 gs/day (p = 0.18)]. There were no signs of dysphagia. All magnets passed with the stool within 16 days. After 2 months, a well-formed magnetic compression anastomosis was visible and easily negotiated with a 6.5 mm endoscope. Esophogram and macroscopic findings confirmed patentency of the esophageal anastomoses. Histopathology showed a circular anastomosis lined with contiguous epithelium. CONCLUSION: MECA creates a long-term functional and patent anastomosis in pigs. This concept may facilitate minimally-invasive esophageal atresia repair by obviating a technically challenging and time-consuming hand-sewn anastomosis.

Risk Factors for Hospital-Acquired Pressure Injury in Adult Critical Care Patients.

BACKGROUND: Accurately measuring the risk of pressure injury remains the most important step for effective prevention and intervention. Relative contributions of risk factors for the incidence of pressure injury in adult critical care patients are not well understood. OBJECTIVE: To develop and validate a model to identify risk factors associated with hospital-acquired pressure injuries among adult critical care patients. METHODS: This retrospective cohort study included 23 806 adult patients (28 480 encounters) with an intensive care unit stay at an academic quaternary care center. Patient encounters were randomly split (7:3) into training and validation sets. The training set was used to develop a multivariable logistic regression model using the least absolute shrinkage and selection operator method. The model's performance was evaluated with the validation set. RESULTS: Independent risk factors identified by logistic regression were length of hospital stay, preexisting diabetes, preexisting renal failure, maximum arterial carbon dioxide pressure, minimum arterial oxygen pressure, hypotension, gastrointestinal bleeding, cellulitis, and minimum Braden Scale score of 14 or less. On validation, the model differentiated between patients with and without pressure injury, with area under the receiver operating characteristic curve of 0.85, and performed better than a model with Braden Scale score alone (P < .001). CONCLUSIONS: A model that identified risk factors for hospital-acquired pressure injury among adult critical care patients was developed and validated using a large data set of clinical variables. This model may aid in selecting high-risk patients for focused interventions to prevent formation of hospital-acquired pressure injuries.

Dynamic Risk Prediction for Hospital-Acquired Pressure Injury in Adult Critical Care Patients.

Accurately measuring the risk of pressure injury remains the most important step for effective prevention and intervention. Time-dependent risk factors for pressure injury development in the adult intensive care unit setting are not well understood. OBJECTIVES: To develop and validate a dynamic risk prediction model to estimate the risk of developing a hospital-acquired pressure injury among adult ICU patients. DESIGN: ICU admission data were split into training and validation sets. With death as a competing event, both static and dynamic Fine-Gray models were developed to predict hospital-acquired pressure injury development less than 24, 72, and 168 hours postadmission. Model performance was evaluated using Wolbers' concordance index, Brier score, net reclassification improvement, and integrated discrimination improvement. SETTING AND PARTICIPANTS: We performed a retrospective cohort study of ICU patients in a tertiary care hospital located in San Francisco, CA, from November 2013 to August 2017. MAIN OUTCOMES AND MEASURES: Data were extracted from electronic medical records of 18,019 ICU patients (age ≥ 18 yr; 21,220 encounters). Record of hospital-acquired pressure injury data was captured in our institution's incident reporting system. The information is periodically reviewed by our wound care team. Presence of hospital-acquired pressure injury during an encounter and hospital-acquired pressure injury diagnosis date were provided. RESULTS: The dynamic model predicting hospital-acquired pressure injury more than 24 hours postadmission, including predictors age, body mass index, lactate serum, Braden scale score, and use of vasopressor and antifungal medications, had adequate discrimination ability within 6 days from time of prediction (c = 0.73). All dynamic models produced more accurate risk estimates than static models within 26 days postadmission. There were no significant differences in Brier scores between dynamic and static models. CONCLUSIONS AND RELEVANCE: A dynamic risk prediction model predicting hospital-acquired pressure injury development less than 24 hours postadmission in ICU patients for up to 7 days postadmission was developed and validated using a large dataset of clinical variables readily available in the electronic medical record.

Novel Device for Endoluminal Esophageal Atresia Repair: First-in-Human Experience.

Thoracoscopic esophageal atresia (EA) repair affords many benefits to the patient; however, intracorporeal suturing of the anastomosis is technically challenging. Esophageal magnetic compression anastomosis (EMCA) is a compelling option for endoluminal EA repair, but available EMCA devices have prohibitive rates of recalcitrant stricture. Connect-EA is a new endoluminal EMCA device system that employs 2 magnetic anchors with a unique mating geometry designed to reliably create a robust anastomosis and decrease rates of leak and stricture. We describe our first-in-human experience with this novel endoluminal device for staged EA repair in 3 patients (Gross type A, B, and C) at high risk for conventional surgical repair. First, the esophageal pouches were approximated thoracoscopically. After acute tension subsided, the device anchors were endoscopically placed in the esophageal pouches and mated. Anchors were spontaneously excreted in 2 cases. Endoscopic repositioning and retrieval of the anchors were required in 1 patient because of narrowed esophageal anatomy. There were no perioperative complications. Patients were managed for 14 to 18 months. The strictures that developed in the patients were membranous and responded well to dilation alone, resolving after 4 to 5 outpatient dilations. Gastrostomies were closed between 6 and 11 months and all patients are tolerating full oral nutrition. Early experience with this new endoluminal EMCA device system is highly favorable. The device offers considerable benefit over conventional handsewn esophageal anastomosis and anastomotic outcomes are superior to available EMCA devices.

Predictors of index admission mortality and morbidity in contemporary esophageal atresia patients.

BACKGROUND/PURPOSE: The Spitz classification for esophageal atresia with/without tracheoesophageal fistula (EA/TEF) predicts mortality. This study evaluates the contemporary relevance of the Spitz classification and investigates predictors of morbidity. METHODS: EA/TEF patients born between 1995 and 2018 at two centers were retrospectively reviewed. Clinical variables including sex, prenatal diagnosis, birth weight, prematurity, major congenital heart disease (MCHD), and pre-operative mechanical ventilation (POMV) were collected. Index admission composite morbidity was considered positive if: length-of-stay >90th percentile (139 days), ventilation days >90th percentile (24 days), and/or gastrostomy was used for long-term feeding. Multivariable regression determined predictors of index admission mortality and composite morbidity. A composite morbidity predictive algorithm was created. ROC curves evaluated model discrimination. RESULTS: Of 253 patients, 13 (5.1%) experienced index admission mortality. Of the patients not suffering mortality, 74 (31.6%) experienced composite morbidity. Only MCHD predicted mortality (p = 0.001); birth weight did not (p = 0.173). There was no difference between the Spitz classification and MCHD alone in predicting mortality risk (p = 0.198); both demonstrated very good discrimination. Prenatal diagnosis, POMV, prematurity, and male sex predicted composite morbidity risk (p < 0.001; p = 0.008; p = 0.009; p = 0.05). An algorithm incorporating these predictors demonstrated good discrimination (AUC = 0.784; 95% CI: 0.724, 0.844). CONCLUSIONS: The Spitz classification maintains contemporary relevance for mortality risk, though birth weight can be de-emphasized. A new morbidity risk algorithm is proposed for early postnatal counseling. TYPE OF STUDY: Prognosis study. LEVEL OF EVIDENCE: Level IV.