Objective Evidence of Reflux Control After Magnetic Sphincter Augmentation: One Year Results From a Post Approval Study.

OBJECTIVE: To report 1-year results from a 5-year mandated study. SUMMARY BACKGROUND DATA: In 2012, the United States Food and Drug Administration approved magnetic sphincter augmentation (MSA) with the LINX Reflux Management System (Torax Medical, Shoreview, MN), a novel device for the surgical treatment of gastroesophageal reflux disease (GERD). Continued assessment of safety and effectiveness has been monitored in a Post Approval Study. METHODS: Multicenter, prospective study of patients with pathologic acid reflux confirmed by esophageal pH testing undergoing MSA. Predefined clinical outcomes were assessed at the annual visit including a validated, disease-specific questionnaire, esophagogastricduodenoscopy and esophageal pH monitoring, and use of proton pump inhibitors. RESULTS: A total of 200 patients (102 males, 98 females) with a mean age of 48.5 years (range 19.7-71.6) were treated with MSA between March 2013 and August 2015. At 1 year, the mean total acid exposure time decreased from 10.0% at baseline to 3.6%, and 74.4% of patients had normal esophageal acid exposure time (% time pH<4 ≤5.3%). GERD Health-Related Quality of Life scores improved from a median score of 26.0 at baseline to 4.0 at 1 year, with 84% of patients meeting the predefined success criteria of at least a 50% reduction in total GERD Health-Related Quality of Life score compared with baseline. The device removal rate at 1 year was 2.5%. One erosion and no serious adverse events were reported. CONCLUSIONS: Safety and effectiveness of magnetic sphincter augmentation has been demonstrated outside of an investigational setting to further confirm MSA as treatment for GERD.

Objective evaluation of skill acquisition in novice microsurgeons.

INTRODUCTION: Medical training is increasingly focused on patient safety, limiting the ability to practice technical skills in the operative arena. Alternative methods of training residents must be designed and implemented. METHODS: Three expert microsurgeons were solicited to develop two drills to help residents acquire the basic subset of skills in microsurgery. The first drill was performance of five consecutive simple interrupted sutures on a rubber glove. Expert proficiency was considered a drill time of two standard deviations from expert mean. The drill was performed up to 10 times until completion of the task at expert proficiency. The second drill was performance of an anastomosis on silastic tubing. Residents performed the drill sequentially until performing two consecutive drills at expert proficiency. RESULTS: Eight residents with no microsurgical experience volunteered. Six of the eight residents were able to perform the rubber glove drill at expert proficiency within 10 attempts, with an average of 5.3. All of the residents were able to perform two consecutive silastic tubing drills at expert proficiency within nine attempts, with an average of 5.4. CONCLUSION: Residents were able to acquire a basic subset of microsurgical skills within a reasonable time period using these drills.

Putting the MeaT into TeaM Training: Development, Delivery, and Evaluation of a Surgical Team-Training Workshop.

BACKGROUND: Despite importance to patient care, team training is infrequently used in surgical education. To address this, a workshop was developed by the Association for Surgical Education Simulation Committee to teach team training using high-fidelity patient simulators and the American College of Surgeons-Association of Program Directors in Surgery team-training curriculum. METHODS: Workshops were conducted at 3 national meetings. Participants completed preworkshop and postworkshop questionnaires to define experience, confidence in using simulation, intention to implement, as well as workshop content quality. The course consisted of (A) a didactic review of Preparation, Implementation, and Debriefing and (B) facilitated small group simulation sessions followed by debriefings. RESULTS: Of 78 participants, 51 completed the workshops. Overall, 65% indicated that residents at their institutions used patient simulation, but only 33% used the American College of Surgeons-the Association of Program Directors in Surgery team-training modules. The workshop increased confidence to implement simulation team training (3.4 ± 1.3 vs 4.5 ± 0.9). Quality and importance were rated highly (5.4 ± 00.6, highest score = 6). CONCLUSIONS: Preparation for simulation-based team training is possible in this workshop setting, although the effect on actual implementation remains to be determined.