Three-dimensionally printed surface features to anchor endoluminal spring for distraction enterogenesis.

Spring-mediated distraction enterogenesis has been studied as a novel treatment for short bowel syndrome (SBS). Previous approaches are limited by multiple surgeries to restore intestinal continuity. Purely endoluminal devices require a period of intestinal attachment for enterogenesis. The purpose of this study is to modify the device to prevent premature spring migration in a porcine model. Two models were created in juvenile mini-Yucatan pigs for the placement of three-dimensionally printed springs. (1) Two Roux-en-y jejunojenostomies with two Roux limbs were made. A spring with bidirectional hooked surface features was placed in one Roux limb and a spring with smooth surface was placed in the other Roux limb. (2) The in-continuity model had both hooked and smooth surface springs placed directly in intestinal continuity. Spring location was evaluated by weekly radiographs, and the intestine was retrieved after 2 to 4 weeks. Springs with smooth surfaces migrated between 1 to 3 weeks after placement in both porcine models. Springs with bidirectional hooked surface features were anchored to the intestine for up to 4 weeks without migration. Histologically, the jejunal architecture showed significantly increased crypt depth and muscularis thickness compared to normal jejunum. Bidirectional features printed on springs prevented the premature migration of endoluminal springs. These novel spring anchors allowed for their endoluminal placement without any sutures. This approach may lead to the endoscopic placement of the device for patients with SBS.

Innovation within a university setting.

Elisabeth K. Wynne, MD, completed her undergraduate degree in bioengineering and is currently a surgical resident in training at the University of Washington. From 2014-2016, she served as a Biodesign Fellow at Stanford University. She plans to pursue a career of innovation as an academic surgeon. Thomas M. Krummel, MD, is the Emile Holman Professor and Chair Emeritus of the Department of Surgery at Stanford University School of Medicine. Throughout his career, Dr Krummel has been a pioneer and an innovator. For >12 years, he has partnered with Dr Paul Yock to co-direct the Stanford Biodesign program, which is designed to teach innovation at the emerging frontiers of engineering and biomedical sciences. Dr Krummel is Chairman of the Fogarty Institute for Innovation Board of Directors, and President of the International Scientific Committee at Institut de Recherche contre les Cancers de l'Appareil Digestif - IRCAD at the University of Strasbourg and is a frequent consultant to the medical device industry.

Outcomes from a postgraduate biomedical technology innovation training program: the first 12 years of Stanford Biodesign.

The Stanford Biodesign Program began in 2001 with a mission of helping to train leaders in biomedical technology innovation. A key feature of the program is a full-time postgraduate fellowship where multidisciplinary teams undergo a process of sourcing clinical needs, inventing solutions and planning for implementation of a business strategy. The program places a priority on needs identification, a formal process of selecting, researching and characterizing needs before beginning the process of inventing. Fellows and students from the program have gone on to careers that emphasize technology innovation across industry and academia. Biodesign trainees have started 26 companies within the program that have raised over $200 million and led to the creation of over 500 new jobs. More importantly, although most of these technologies are still at a very early stage, several projects have received regulatory approval and so far more than 150,000 patients have been treated by technologies invented by our trainees. This paper reviews the initial outcomes of the program and discusses lessons learned and future directions in terms of training priorities.

Symbiotic or parasitic? A review of the literature on the impact of fellowships on surgical residents.

OBJECTIVE: We conducted a systematic review of published literature to gain a better understanding of the impact of advanced fellowships on surgical resident training and education. BACKGROUND: As fellowship opportunities rise, resident training may be adversely impacted. METHODS: PubMed, MEDLINE, Scopus, BIOSIS, Web of Science, and a manual search of article bibliographies. Of the 139 citations identified through the initial electronic search and screened for possible inclusion, 23 articles were retained and accepted for this review. Data were extracted regarding surgical specialty, methodology, sample population, outcomes measured, and results. RESULTS: Eight studies retrospectively compared the eras before and after the introduction of a fellowship or trended data over time. Approximately half used data from a single institution, whereas the other half used some form of national data or survey. Only 3 studies used national case data. Fourteen studies looked at general surgery, 6 at obstetrics-gynecology, 2 at urology, and 1 at otolaryngology. Only one study concluded that fellowships have a generally positive impact on resident education, whereas 9 others found a negative impact. The remaining 13 studies found mixed results (n = 6) or minimal to no impact (n = 7). CONCLUSIONS: The overall impact of advanced surgical fellowships on surgical resident education and training remains unclear, as most studies rely on limited data of questionable generalizability. A careful study of the national database of surgery resident case logs is essential to better understand how early surgical specialization and fellowships will impact the future of general surgery education.

Applying a structured innovation process to interventional radiology: a single-center experience.

PURPOSE: To determine the feasibility and efficacy of applying an established innovation process to an active academic interventional radiology (IR) practice. MATERIALS AND METHODS: The Stanford Biodesign Medical Technology Innovation Process was used as the innovation template. Over a 4-month period, seven IR faculty and four IR fellow physicians recorded observations. These observations were converted into need statements. One particular need relating to gastrostomy tubes was diligently screened and was the subject of a single formal brainstorming session. RESULTS: Investigators collected 82 observations, 34 by faculty and 48 by fellows. The categories that generated the most observations were enteral feeding (n = 9, 11%), biopsy (n = 8, 10%), chest tubes (n = 6, 7%), chemoembolization and radioembolization (n = 6, 7%), and biliary interventions (n = 5, 6%). The output from the screening on the gastrostomy tube need was a specification sheet that served as a guidance document for the subsequent brainstorming session. The brainstorming session produced 10 concepts under three separate categories. CONCLUSIONS: This formalized innovation process generated numerous observations and ultimately 10 concepts to potentially to solve a significant clinical need, suggesting that a structured process can help guide an IR practice interested in medical innovation.

NOTES and other emerging trends in gastrointestinal endoscopy and surgery: the change that we need and the change that is real.

In this inaugural year of a historic presidency, gastroenterologists and gastrointestinal surgeons may well want to turn their attention to more immediate transformative events that have the potential to revolutionize their own practice in the near future. The most visible and, perhaps, controversial of these is natural orifice transluminal endoscopic surgery (NOTES), but other equally important changes are emerging as investigators around the globe vie with one another in the demonstration of increasingly audacious procedures. As is to be expected, we are also already seeing a backlash from more conservative scholars attempting to temper what they believe to be the surgical equivalent of irrational exuberance. However, by far the most common attitude among gastroenterologists toward these changes is one of indifference. In this piece, we discuss the circumstances that led to the development of NOTES and other innovative procedures, the peril that lies in ignoring them, and the true promise that they hold for our specialties.

Simulation-based endovascular skills assessment: the future of credentialing?

OBJECTIVES: Simulator-based endovascular skills training measurably improves performance in catheter-based image-guided interventions. The purpose of this study was to determine whether structured global performance assessment during endovascular simulation correlated well with trainee-reported procedural skill and prior experience level. METHODS: Fourth-year and fifth-year general surgery residents interviewing for vascular fellowship training provided detailed information regarding prior open vascular and endovascular operative experience. The pretest questionnaire responses were used to separate subjects into low (<20 cases) and moderate (20 to 100) endovascular experience groups. Subjects were then asked to perform a renal angioplasty/stent procedure on the Procedicus Vascular Intervention System Trainer (VIST) endovascular simulator (Mentice Corporation, Gothenburg, Sweden). The subjects' performance was supervised and evaluated by a blinded expert interventionalist using a structured global assessment scale based on angiography setup, target vessel catheterization, and the interventional procedure. Objective measures determined by the simulator were also collected for each subject. A postsimulation questionnaire was administered to determine the subjects' self-assessment of their performance. RESULTS: Seventeen surgical residents from 15 training programs completed questionnaires before and after the exercise and performed a renal angioplasty/stent procedure on the endovascular simulator. The beginner group (n = 8) reported prior experience of a median of eight endovascular cases (interquartile range [IQR], 6.5-17.8; range, 4-20), and intermediate group (n = 9) had previously completed a median of 42 cases (IQR, 31-44; range, 25-89, P = .01). The two groups had similar prior open vascular experience (79 cases vs 75, P = .60). The mean score on the structured global assessment scale for the low experience group was 2.68 of 5.0 possible compared with 3.60 for the intermediate group (P = .03). Scores for subcategories of the global assessment score for target vessel catheterization (P = .02) and the interventional procedure (P = .05) contributed more to the differentiation between the two experience groups. Total procedure time, fluoroscopy time, average contrast used, percentage of lesion covered by the stent, placement accuracy, residual stenosis rates, and number of cine loops utilized were similar between the two groups (P > .05). CONCLUSION: Structured endovascular skills assessment correlates well with prior procedural experience within a high-fidelity simulation environment. In addition to improving endovascular training, simulators may prove useful in determining procedural competency and credentialing standards for endovascular surgeons.