Safely Introducing New Surgical Devices in Minimally Invasive Gynecologic Surgery: An Argument for Use of the IDEAL Framework.

OBJECTIVE: To review the Food and Drug Administration (FDA) premarket regulatory and postmarket surveillance processes for 2 minimally invasive gynecologic surgery case studies-the laparoscopic power morcellator and the Essure permanent birth control device-and to introduce the IDEAL (Idea, Development, Exploration, Assessment, Long-term) framework for safely introducing and monitoring minimally invasive gynecologic surgery devices. DATA SOURCES: News media publications, agency websites, legal articles, and scientific papers. METHODS OF STUDY SELECTION: Articles and papers were selected that described events leading to FDA approval of these devices and subsequent complications. TABULATION, INTEGRATION, AND RESULTS: Based on current FDA premarket regulatory processes, 67% of devices do not currently require premarket review and only 1% are subject to clinical trial requirements. The IDEAL framework delineates 5 phases for safe introduction of medical devices: idea, development, exploration, assessment, and long-term study. CONCLUSION: The laparoscopic power morcellator and Essure cases illustrate possible shortcomings in our device approval system that could be improved upon using the IDEAL framework, which limits device use until safety and efficacy data have been established and recommends postmarket surveillance.

Mesenteric Vascular Injury in Trauma: An NTDB Study.

BACKGROUND: Although abdominal trauma remains a major cause of morbidity and mortality, there has not been a large-scale multicenter study regarding outcomes in patients who incur mesenteric vascular injuries. The goal of this retrospective analysis was to investigate the factors associated with outcomes in patients with trauma diagnosed with mesenteric vascular injuries. METHODS: A retrospective database analysis was performed on patients who sustained a mesenteric vascular injury (MVI, ICD-9 902.20-902.29) identified by the 2012 National Trauma Data Bank. Data were analyzed to identify differences in hospital length of stay, emergency room (ER) and final hospital disposition, and mortality based on patient age, gender, race, Injury Severity Score (ISS), and injury type (blunt or penetrating). RESULTS: Of the 1,133 total patients included, blunt trauma accounted for 740 (65%) of the injuries, whereas penetrating trauma accounted for 364 of the injuries (32%). Patients with penetrating injuries were 1.43 times more likely to die from their injuries than those suffering from blunt trauma (95% CI 1.04-1.98, P < 0.05). Patients with a higher ISS (>16) were 5.39 times more likely to die from their injuries than those with a lower ISS (95% CI 1.89-15.4, P = 0.002); if ISS was >25, the patient was 15.1 times more likely to die (95% CI 5.5-41.7, P < 0.001). Men were more likely to suffer from penetrating injuries than women (37% vs. 13%, P < 0.001), and African Americans were nearly 4 times more likely to present with penetrating injuries (69% vs 17%, P < 0.001). Age was also associated with mortality as patients >65 years and between 21 and 44 years were more likely to die from their injuries than patients in other age categories. Of the 740 patients with blunt MVIs, 326 (44%) were taken directly from the ER to the operating room (OR) and 306 (41%) to the intensive care unit (ICU), whereas with penetrating MVIs, 311 (85%) were taken to the OR from the emergency department and 18 (5%) to the intensive care unit. Of the 740 blunt MVIs, 115 died (16%), compared with 76 (21%) of the penetrating MVIs (P < 0.001). Injuries to the hepatic and superior mesenteric arteries were associated with higher mortality, with OR 2.03 and 3.03, respectively (P < 0.001). CONCLUSIONS: The presence of mesenteric arterial injury warrants rapid identification and management as these injuries are associated with significant morbidity and mortality, with penetrating mechanism, injury to large mesenteric vessels, and increased ISS associated with increased mortality.

The Impact of Anticoagulation on Trauma Outcomes : An National Trauma Data Bank Study.

BACKGROUND: Increased prevalence of patients on anticoagulants and the advent of new therapies raise concern over how these patients fare if they sustain a traumatic injury. We investigated the role of prehospitalization anticoagulation therapy in trauma-related mortality and postacute disposition. METHODS: A retrospective analysis was performed on patients who sustained traumatic injury identified in the 2017 National Trauma Data Bank (NTDB). Patients with and without anticoagulation therapy were analyzed to identify differences in demographics, injury type, Injury Severity Score (ISS), and trauma outcomes including hospital length of stay, ER, final hospital disposition, and mortality. Logistic regression was used to correlate anticoagulation to mortality and facility discharge. RESULTS: Of the 1 000 596 patients included, 73 602 (7%) patients were on anticoagulants at the time of their trauma. Increased age was the strongest predictor for anticoagulation therapy (odds ratio 5.54, 95% CI 5.44-5.63), but being female and white were also independent predictors of anticoagulation (P < .001). Patients on anticoagulants had a significantly longer length of stay (5.11 days; 95% CI 5.06-5.15) than those who were not (4.37 days, 95% CI 4.36-4.39), were 2.20 times more likely to die (95% CI 2.12-2.28, P < .001), and were 2.77 times more likely to be discharged to a facility (95% CI 2.73-2.81, P < .001). Anticoagulation remained a significant predictor of worse trauma outcomes even when accounting for age and ISS in multivariate analysis. DISCUSSION: Anticoagulation preceding trauma-related admission is associated with higher mortality and an increased likelihood of the need for a posthospital care facility.

Surgical Education and the Longitudinal Model at the Columbia-Bassett Program.

OBJECTIVE: The aim of this study is to evaluate a longitudinal medical student surgical curriculum. DESIGN: This is a case-controlled study of students who participated in a longitudinal surgical curriculum compared to students who participated in a standard 12-week surgical clerkship. This study evaluates qualitative data including exam scores as well as qualitative data regarding student experience. SETTING: All students were from Columbia College of Physicians and Surgeons in New York City. A portion of the students completed their clerkship at the main university campus and others performed their clerkship at an affiliate site including Bassett Health Network. The longitudinal curriculum was only at the Bassett Health Network. PARTICIPANTS: All medical students who completed their surgical curriculum from 2012 to 2015 were eligible. The survey response rate was 45% for a total of 128 students. RESULTS: The students receiving the longitudinal curriculum outperformed the block students on the national shelf exam (77 vs 71, p = 0.001). The longitudinal students were also more likely to learn directly from attending surgeons and were more likely to have a greater interest in a surgical career after their surgery experience. CONCLUSIONS: The longitudinal approach to teaching surgery to medical students achieves non-inferior or superior testing outcomes when compared to the block model, and superior outcomes in terms of students' own attitudes and perceptions.

Farm Injuries: Animal Most Common, Machinery Most Lethal: An NTDB Study.

To characterize both emergency room (ER) and hospital discharge dispositions of patients presenting with farm-related injuries. The 2012 National Trauma Data Bank was queried in August 2017 for injuries occurring on a farm. Patients were stratified by gender, age group, race, Injury Severity Score (ISS), and injury type. We performed logistic regression analysis to correlate parameters with likelihood of discharge home or death. P values < 0.05 were considered significant. Five thousand six hundred thirty-one patients were identified, the majority of whom were male (72%) and white (85%). The most common mechanisms of injury included animal-related (29%), followed by falls, vehicles, and other causes. The highest ISSs were seen in vehicular injuries (11% ISS of 25+) and the greatest fatality rate was seen in machinery injuries (4%). Four thousand seven hundred fifty-three (84%) patients were admitted to the hospital, and 4056 (72%) were discharged home from the ER or after hospitalization. One hundred thirty patients (2%) died of their farm-related injury. Most patients presenting to the ER with farm-related injuries survive, are admitted to the hospital, and are ultimately discharged home. Few patients die of their injuries. Animal injury is most common and machinery injury most lethal of farm trauma patients presenting to the ER.

Abdominal and Pelvic Vascular Injury: A National Trauma Data Bank Study.

The aim of this study was to characterize the outcomes of traumatic abdominal and pelvic vascular injuries. Using the 2012 National Trauma Data Bank, we identified 5858 patients with major abdominal and/or pelvic vascular injury. Patients were stratified by age group, gender, race, Injury Severity Score (ISS), and mechanism of injury. We evaluated the percentage of patients with blunt and penetrating trauma by demographic and correlated the mechanism of injury to the ISS score, emergency room disposition, and hospital disposition. We performed a logistic regression analysis to calculate predictors of death. In the final cohort, 1458 patients (25%) with abdominal/pelvic vascular injury died of trauma. In total, 3368 patients (57%) had a blunt mechanism of injury, whereas 2353 (40%) were victims of a penetrating trauma. Patients with penetrating injuries were 1.72 times more likely to die from their injuries than those with blunt traumas. Patients with higher ISS scores (>16) were more likely to die from their injuries than patients with lower ISS scores. Men were more likely to experience a penetrating vascular injury than women (48% vs 17%). Similarly, 77 per cent of black patients had a penetrating mechanism of injury compared with 20 per cent of white patients. There were 1910 patients with penetrating injuries (81%) that went immediately from the emergency room to the OR, compared with 1287 patients with blunt injuries (38%). Of the patients with blunt injuries, 695 (21%) died, whereas 727 (31%) patients with penetrating injuries died. Abdominal and pelvic traumatic vascular injuries carry a high mortality rate. Penetrating mechanism of injury, ISS score, and race are independent predictors of mortality.

Gastrointestinal problems in 15q duplication syndrome.

Chromosome 15q duplication syndrome (Dup15q syndrome) is a neurodevelopmental disorder involving copy number gains of the maternal chromosome 15q11.2-q13 region, characterized by intellectual disability, developmental delay, autism spectrum disorder (ASD), and epilepsy. Gastrointestinal (GI) problems in Dup15q syndrome have been reported only rarely, mostly focused on neonatal feeding difficulties. A retrospective review of the medical records of 46 patients with Dup15q syndrome was conducted to assess GI issues and their treatments in this population. GI symptoms were present in 76.7% of subjects with an isodicentric duplication and 87.5% with an interstitial duplication. There was no clear association between GI issues and ASD, with symptoms occurring in 78.9% of all subjects and 78.2% of ASD subjects. The most commonly reported symptoms were gastroesophageal reflux (56.7%) and constipation (60%), with 30% of subjects reporting both. The most common treatments were polyethylene glycol for constipation and proton pump inhibitors for reflux. Behaviors such as irritability and aggressiveness improved with treatment of GI symptoms in several subjects. The results indicate that GI symptoms are common in Dup15q syndrome and may have an atypical presentation. Diagnosis may be difficult, especially in individuals who are nonverbal or minimally verbal, so increased awareness is critical for early diagnosis and treatment.

Renal Ganglioneuroma Presenting as an Apparent Renal Artery Aneurysm.

We present a case of a 30-year-old woman with a suspected contained rupture of a renal artery aneurysm which was managed with staged embolization and nephrectomy. Pathology demonstrated that the collection around the presumed aneurysmal rupture was an associated ganglioneuroma.

Uterine artery embolization: a vascular surgery procedure? One vascular surgery group's experience.

Uterine artery embolization (UAE) has been performed by interventional radiology since the 1990s for symptomatic uterine fibroids with considerable success. Endovascular-trained vascular surgeons possess the necessary skills to successfully perform this procedure after an adequate but brief training period. Fourteen successful UAE procedures were performed by two vascular surgeons over a one-year period. Indications for the procedures were bleeding (12/14 patients, 86%), pain/bloating/pressure (13/14 patients, 93%) and dyspareunia (2/14 patients, 14%). All patients were initially evaluated by a gynecologist and referred for this procedure. Complications were minor and limited. Clinical follow-up demonstrated near-complete to complete symptom resolution in all but one patient for a 93% short-term success rate. Follow-up ultrasound studies demonstrated a reduction in the uterine fibroid size in all patients three months or more postprocedure. The mean fibroid size reduction was 4.07-3.26 cm (20%), P < 0.005. UAE is a procedure of proven benefit, well-matched to many vascular surgeons' skills and practice. Up to this point, few vascular surgeons have incorporated this endovascular procedure into their practices. This initial and somewhat limited study demonstrates one vascular surgery group's early success with this procedure.