Surgical skill simulation training to proficiency reduces procedural errors among novice cardiac device implanters: a randomized study.

AIMS: In cardiac device implantation, having both surgical skills and ability to manipulate catheter/lead/wire is crucial. Few cardiologists, however, receive formal surgical training prior to implanting. Skills are mostly acquired directly on-the-job and surgical technique varies across institutions; suboptimal approaches may increase complications. We investigated how novel proficiency-based progression (PBP) simulation training impacts the surgical quality of implantations, compared to traditional simulation (SIM) training. METHODS AND RESULTS: In this international prospective study, novice implanters were randomized (blinded) 1:1 to participate in a simulation-based procedure training curriculum, with proficiency demonstration requirements for advancing (PBP approach) or without (SIM). Ultimately, trainees performed the surgical tasks of an implant on a porcine tissue that was video-recorded and then scored by two independent assessors (blinded to group), using previously validated performance metrics. Primary outcomes were the number of procedural Steps Completed, Critical Errors, Errors (non-critical), and All Errors Combined. Thirty novice implanters from 10 countries participated. Baseline experiences were similar between groups. Compared to SIM-trained, the PBP-trained group completed on average 11% more procedural Steps (P < 0.001) and made 61.2% fewer Critical Errors (P < 0.001), 57.1% fewer Errors (P = 0.140), and 60.7% fewer All Errors Combined (P = 0.001); 11/15 (73%) PBP trainees demonstrated the predefined target performance level vs. 3/15 SIM trainees (20%) in the video-recorded performance. CONCLUSION: Proficiency-based progression training produces superior objectively assessed novice operators' surgical performance in device implantation compared with traditional (simulation) training. Systematic PBP incorporation into formal academic surgical skills training is recommended before in vivo device practice. Future studies will quantify PBP training's effect on surgery-related device complications.

Training and Transfer Effect of FluoroSim, an Augmented Reality Fluoroscopic Simulator for Dynamic Hip Screw Guidewire Insertion: A Single-Blinded Randomized Controlled Trial.

BACKGROUND: FluoroSim, a novel fluoroscopic simulator, can be used to practice dynamic hip screw (DHS) guidewire insertion in a high-fidelity clinical scenario. Our aim was to demonstrate a training effect in undergraduate medical students who are not familiar with this operation and its simulation. METHODS: Forty-five undergraduate medical students were recruited and randomized to either training (n = 23) or control (n = 22) cohorts. The training cohort had more exposure to FluoroSim (5 attempts each week) over a 2-week period (with a 1-week washout period in between) compared with the control cohort (a single attempt 1 week apart) over a 2-week period. Five real-time objective performance metrics were recorded: (1) tip-apex distance (TAD) (mm), (2) predicted cut-out rate (%), (3) total procedural time (sec), (4) total number of radiographs (n), and (5) total number of guidewire retries (n). RESULTS: At baseline, there was no significant difference in the performance metrics, which confirmed the absence of a selection bias. The intragroup training effect demonstrated a significant improvement in all metrics for the training cohort only. A significant difference between groups was demonstrated as the training cohort significantly outperformed the control cohort in 3 metrics (procedural time [25%], number of radiographs [57%], and number of guidewire retries [100%]; p < 0.001). A learning curve showed an inversely proportional correlation between frequency of attempts and procedural time as well as the number of digital fluoroscopic radiographs that were made, indicating the development of psychomotor skills. There was also an improved baseline of the learning curve after the 1-week washout period, suggesting skill retention. CONCLUSIONS: Skill acquisition with the FluoroSim system was demonstrated with repeat exposure in a safe, radiation-free high-fidelity clinical simulation with actual operating room equipment. The task of DHS guidewire insertion requires cognitive and psychomotor skills that take a variable number of attempts to acquire, as demonstrated on the learning curve. Additional work is required to demonstrate that the skill tested by the FluoroSim is the same skill that is required for intraoperative DHS guidewire insertion. However, use of the FluoroSim provides improvement in skills with extra-clinical training opportunities for orthopaedic trainees. CLINICAL RELEVANCE: FluoroSim has demonstrated validity and training effect. It has the potential to be approved for possible use on patients in the operating room to help surgeons with the operation. Consequently, operating time, accuracy of TAD, and surgical outcomes may all be improved.

Balancing Operative Efficiency and Surgical Education: A Functional Neurosurgery Model.

BACKGROUND: Attending surgeons have dual obligations to deliver high-quality health care and train residents. In modern healthcare, lean principles are increasingly applied to processes preceding and following surgery. However, surgeons have limited data regarding variability and waste during any given operation. OBJECTIVE: To measure variability and waste during the following key functional neurosurgery procedures: retrosigmoid craniectomy (microvascular decompression [MVD] and internal neurolysis) and deep brain stimulation (DBS). Additionally, we correlate variability with residents' self-reported readiness for the surgical steps. The aim is to guide surgeons as they balance operative safety and efficiency with training obligations. METHODS: For each operation (retrosigmoid craniectomy and DBS), a standard workflow, segmenting the operation into components, was defined. We observed a representative sample of operations, timing the components, with a focus on variability. To assess perceptions of safety and risk among surgeons of various training levels, a survey was administered. Survey results were correlated with operative variability, attempting to identify areas for increasing value without compromising trainee experience. RESULTS: A sampling of each operation (n = 36) was observed during the study period. For MVD, craniectomy had the highest mean duration and standard deviation, whereas the MVD itself had the lowest mean duration and standard deviation. For DBS, the segments with largest standard deviation in duration were registration and electrode placement. For many steps of both procedures, there was a statistically significant relationship between increasing level of training and increasing perception of safety. CONCLUSION: This proof-of-concept study introduces an educational and process-improvement tool that can be used to aid surgeons in increasing the efficiency of patient care.

Resident simulation training improves operative time of the retropubic midurethral sling procedure for stress incontinence.

INTRODUCTION AND HYPOTHESIS: Our aim was to assess whether immediate preoperative resident simulation training decreases operative time and improves resident proficiency when performing a retropubic midurethral sling (MUS) procedure. METHODS: This prospective cohort study took place over 8 months at the Icahn School of Medicine, New York, USA. During the first 4 months, all retropubic MUS procedures were performed by residents who underwent immediate preoperative simulation training. The cases completed during the following 4 months were performed by residents who had not received preoperative simulation training. During the 8-month period, residents completed self-assessment questionnaires upon completion of the surgery and attendings evaluated the residents using the Objective Structured Assessment of Technical Skills (OSATS) global rating scale. Operative time between the two periods were compared using two-sample Student's t test. Comparative analysis between groups was performed based on the OSATS scores using the Wilcoxon rank-sum nonparametric test. RESULTS: There were 22 cases in the simulation group (SG) and 20 in the no simulation group (NSG). SG mean operative time was 12.6 min and NSG mean operative time was 14.6 min (p = 0.12). The SG mean OSATS score was 30.4 versus NSG of 27.8 (p < 0.001). CONCLUSIONS: This study demonstrates that preoperative simulation significantly improves operative performance of the retropubic MUS procedure among residents and also improves their confidence in the operating room. There was a decrease in mean operative time of 2 min in the SG, but the difference was not statistically significant. This data is consistent in demonstrating improved surgical performance and resident confidence with simulation training.

Surgical Training Improves Performance in Minimally Invasive Left Ventricular Assist Device Implantation Without Cardiopulmonary Bypass.

OBJECTIVE: We introduced a live animal model for training of minimally invasive implantation of a continuous-flow left ventricular assist device (CF-LVAD) without cardiopulmonary bypass for operator's performance improvement. DESIGN: After watching a videotape of LVAD implantation on the beating heart through the cardiac apex, the surgical team performed implantation of LVADs into 5 pigs during 3 training sessions in a time series. The procedure success rate, operating time, and technical and global performances by self-evaluation and senior evaluation were compared among the sessions. SETTING: Animal Experiment Center in Peking University Third Hospital. PARTICIPANTS: Surgical team comprising a surgical operator, surgical assistant, anesthetist, and scrub nurse performed 3 training sessions in a time series. RESULTS: The urgent situations requiring proper management were myocardial laceration, massive blood loss, and ventricular arrhythmia induced by hemodynamic instability. After practice, the success rate increased to 100% in session 3. The operating times of session 2 (189.80 ± 14.34min) and session 3 (149.00 ± 22.85min) were significantly lower than that of session 1 (262.20 ± 28.26min). The technical and global performances by self-evaluation and senior evaluation were significantly better in session 3 than session 1. CONCLUSION: Simulation training with high-fidelity in vivo model for minimally invasive CF-LVAD implantation improves the surgical team's global performance, success rate, and the ability to manage emergency situations in surgery.

Are Self-study Procedural Teaching Methods Effective? A Pilot Study of a Family Medicine Residency Program.

BACKGROUND AND OBJECTIVES: A family medicine residency is a unique training environment where residents are exposed to care in multiple settings, across all ages. Procedures are an integral part of family medicine practice. Family medicine residency (FMR) programs are tasked with the job of teaching these skills at a level of intensity and frequency that allows a resident to achieve competency of such skills. In an environment that is limited by work hour restrictions, self-study teaching methods are one way to ensure all residents receive the fundamental knowledge of how to perform procedures. We developed and evaluated the efficacy of a self-study procedure teaching method and procedure evaluation checklist. METHODS: A self-study procedure teaching intervention was created, consisting of instructional articles and videos on three procedures. To assess the efficacy of the intervention, and the competency of the residents, pre- and postintervention procedure performance sessions were completed. These sessions were reviewed and scored using a standardized procedure performance checklist. RESULTS: All 24 residents participated in the study. Overall, the resident procedure knowledge increased on two of the three procedures studied, and ability to perform procedure according to expert-validated checklist improved significantly on all procedures. CONCLUSIONS: A self-study intervention is a simple but effective way to increase and improve procedure training in a way that fits the complex scheduling needs of a residency training program. In addition, this study demonstrates that the procedure performance checklists are a simple and reliable way to increase assessment of resident procedure performance skills in a residency setting.

Modifications to a 3D-printed temporal bone model for augmented stapes fixation surgery teaching.

Functional outcomes and complications in otosclerosis surgery are governed by the surgeon's experience. Thus, teaching the procedure to residents to guide them through the learning process as quickly as possible is challenging. Artificial 3D-printed temporal bones are replacing cadaver specimens in many institutions to learn mastoidectomy, but these are not suitable for middle ear surgery training. The goal of this work was to adapt such an artificial temporal bone to aid the teaching of otosclerosis surgery and to evaluate this tool. We have modified a commercially available 3D-printed temporal bone by replacing the incus and stapes of the model with in-house 3D-printed ossicles. The incus could be attached to a 6-axis force sensor. The stapes footplate was fenestrated and attached to a 1-axis force sensor. Six junior surgeons (residents) and seven senior surgeons (fellows or consultants) were enrolled to perform piston prosthesis placement and crimping as performed during otosclerosis surgery. The time required to perform the tasks and the forces applied to the incus and stapes were collected and analyzed. No statistically significant differences were observed between the junior and senior groups for time taken to perform the tasks and the forces applied to the incus during crimping and placement of the prosthesis. However, significantly lower forces were applied to the stapes by the senior surgeons in comparison with the junior surgeons during prosthesis placement (junior vs senior group, 328 ± 202.9 vs 80 ± 99.6 mN, p = 0.008) and during prosthesis crimping (junior vs senior group, 565 ± 233 vs 66 ± 48.6 mN, p = 0.02). We have described a new teaching tool for otosclerosis surgery based on the modification of a 3D-printed temporal bone to implement force sensors on the incus and stapes. This tool could be used as a training tool to help the residents to self-evaluate their progress with recording of objective measurements.

Flipped clinical training: a structured training method for undergraduates in complete denture prosthesis.

PURPOSE: To design and implement flipped clinical training for undergraduate dental students in removable complete denture treatment and predict its effectiveness by comparing the assessment results of students trained by flipped and traditional methods. METHODS: Flipped training was designed by shifting the learning from clinics to learning center (phase I) and by preserving the practice in clinics (phase II). In phase I, student-faculty interactive session was arranged to recap prior knowledge. This is followed by a display of audio synchronized video demonstration of the procedure in a repeatable way and subsequent display of possible errors that may occur in treatment with guidelines to overcome such errors. In phase II, live demonstration of the procedure was given. Students were asked to treat three patients under instructor's supervision. The summative assessment was conducted by applying the same checklist criterion and rubric scoring used for the traditional method. Assessment results of three batches of students trained by flipped method (study group) and three traditionally trained previous batches (control group) were taken for comparison by chi-square test. RESULTS: The sum of traditionally trained three batch students who prepared acceptable dentures (score: 2 and 3) and unacceptable dentures (score: 1) was compared with the same of flipped trained three batch students revealed that the number of students who demonstrated competency by preparing acceptable dentures was higher for flipped training (χ2=30.996 with p<0.001). CONCLUSION: The results reveal the supremacy of flipped training in enhancing students competency and hence recommended for training various clinical procedures.

The learning curve associated with the introduction of the subcutaneous implantable defibrillator.

AIMS: The subcutaneous implantable cardioverter defibrillator (S-ICD) was introduced to overcome complications related to transvenous leads. Adoption of the S-ICD requires implanters to learn a new implantation technique. The aim of this study was to assess the learning curve for S-ICD implanters with respect to implant-related complications, procedure time, and inappropriate shocks (IASs). METHODS AND RESULTS: In a pooled cohort from two clinical S-ICD databases, the IDE Trial and the EFFORTLESS Registry, complications, IASs at 180 days follow-up and implant procedure duration were assessed. Patients were grouped in quartiles based on experience of the implanter and Kaplan-Meier estimates of complication and IAS rates were calculated. A total of 882 patients implanted in 61 centres by 107 implanters with a median of 4 implants (IQR 1,8) were analysed. There were a total of 59 patients with complications and 48 patients with IAS. The complication rate decreased significantly from 9.8% in Quartile 1 (least experience) to 5.4% in Quartile 4 (most experience) (P = 0.02) and non-significantly for IAS from 7.9 to 4.8% (P = 0.10). Multivariable analysis demonstrated a hazard ratio of 0.78 (P = 0.045) for complications and 1.01 (P = 0.958) for IAS. Dual-zone programming increased with experience of the individual implanter (P < 0.001), which reduced IAS significantly in the multivariable model (HR 0.44, P = 0.01). Procedure time decreased from 75 to 65 min (P < 0.001). The complication rate and procedure time stabilized after Quartile 2 (>13 implants). CONCLUSION: There is a short and significant learning curve associated with physicians adopting the S-ICD. Performance stabilizes after 13 implants.

Development of a novel and simple ex vivo biologic ERCP training model.

BACKGROUND: Training and teaching of ERCP in biologic models has gained importance over the past decade. However, many existing models are expensive, are not widely available, or rely on live animals. OBJECTIVE: We describe a novel and simple ex vivo, biologic model for hands-on teaching. DESIGN: Ex vivo porcine study. SETTING: Experimental endoscopy unit. METHODS: Experimental study using a custom-made ex vivo biologic ERCP simulation model. This model contains 2 new key concepts: (1) formation of a duodenal sweep by using the porcine stomach and (2) use of multiple neo-papillae for endoscopic sphincterotomy and biliary stent placement. The papilla was re-created with chicken heart, and the bile ducts were built from chicken trachea. Endoscopic sphincterotomy was performed by using a pull-type sphincterotome. Stenting was performed with Amsterdam-type plastic stents and guidewires. MAIN OUTCOME MEASUREMENTS: The following definitions were used to evaluate the model: successful implantation of the neo-papilla, stability of the neo-papilla to the neo-duodenum, successful removal of the neo-papilla, and damage to the model. The following endoscopic endpoints were evaluated: successful cannulation, cannulation time, difficulties in positioning the papilla, quality of the biliary sphincterotomy, and prosthesis placement. Procedure-related adverse events such as perforation were also assessed. RESULTS: Ten neo-papillae were consecutively used in 1 duodenalized stomach. The implantation and removal of the neo-papillae were easily and successfully accomplished in all 10 cases without any damage to the duodenalized stomach. The stability of the neo-papilla on the duodenal sweep was excellent in all cases. Cannulation, biliary sphincterotomy, and stent placement could be successfully performed in 100% of cases. There was no damage and were no technical problems with the model. There were no adverse events during endoscopy (ie, perforations, stent misplacement). LIMITATIONS: Pilot study. CONCLUSION: Although further studies are necessary, this simple, novel ex vivo model appears useful for training in sphincterotomy and bile duct cannulation. Because the neo-papillae are interchangeable, repetitive sphincterotomies and other interventions can be performed using a single porcine model.

Image guidance shortens the learning curve for K-wire placement - an experimental study.

BACKGROUND: Computer assisted systems in orthopaedic trauma depend in most cases on fixed reference markers. This work evaluated a reference-free image-based guidance system. Outcome parameters were the number of trials needed to achieve an optimal wire position, the radiation and procedure time, and the learning curve. METHODS: Forty artificial proximal femora covered in polyurethane foam were used and randomized in two groups. Each bone was equipped with a target marker at the fovea capitis femoris. Two surgeons each inserted 20 K-wires, 10 with and 10 without assistance from the guidance system. The aim was to bring the tips of the K-wires as close as possible to the target marker. Both procedures were performed under fluoroscopic control. The new guidance system is based on 2D-C-arm images. Following the procedure the result was determined using computed tomography. RESULTS: The same accuracy (P = 0.34) was achieved with less time (P = 0.0008) and less radiation (P = 0.0002) with the guidance system. However, use of the guidance system did shorten the learning curve of both surgeons, leading to a reduced number of trials (P <0.0001). The learning curve of both surgeons was strongly correlated. From the first trial, the performance of both surgeons while using the guidance system, improved over their performance without the guidance system. CONCLUSIONS: The guidance system helped to achieve an optimal K-wire position with less radiation and less time. The major advantage is the ability of the guidance system to be integrated into the workflow and the short and flat learning curve.

The surgical learning curve of artificial urinary sphincter implantation: implications for prosthetic training and referral.

PURPOSE: We investigated the surgical learning curve of artificial urinary sphincter implantation using a large, consecutive, single surgeon series. MATERIALS AND METHODS: We retrospectively reviewed the results of the first 150 consecutive, virgin artificial urinary sphincter implantations performed by a single surgeon between 1992 and 2003 for post-prostatectomy male stress urinary incontinence. Complication and reoperation rates, and continence outcomes (daily pad use and number of patients with a functional artificial urinary sphincter at last followup) were analyzed as a function of consecutive implant cases. RESULTS: There was a significant decrease in the number of patients with complications (12 vs 3, relative risk 4.0, p = 0.012) and the number with reoperation (11 vs 3, relative risk 3.7, p = 0.026) when the first 25 patients who underwent artificial urinary sphincter implantation were compared to the second 25. No further decrease was noted beyond the first 25 cases. Despite significantly higher complication and reoperation rates in the first 25 cases, equivalent functional outcomes (same postoperative daily pad use and number of patients with a functional artificial urinary sphincter at last followup) were still achieved after artificial urinary sphincter revision. CONCLUSIONS: The surgical learning curve of placing a virgin artificial urinary sphincter was about 25 cases, as measured by complication and reoperation rates. This case number was high compared to typical exposure during residency and clinical practice. There is an urgent need to improve urological prosthetic training and emphasize the referral of artificial urinary sphincter cases to regional centers of excellence or to high volume, artificial urinary sphincter implanters to improve the surgical outcome.

Improving resident competence and knowledge regarding tension-free vaginal tape procedure: an educational module.

OBJECTIVE: The purpose of this study was to determine the effectiveness of a teaching module using simulation for the tension-free vaginal tape (TVT) procedure on procedural knowledge and skill. METHODS: Twenty-five gynecology residents participated in a teaching module about the TVT procedure and urinary incontinence, which included a simulated insertion on a training model. Questionnaires using 10-point scales for self-rated competence and knowledge and a written examination were administered before and after the module. A simulated TVT insertion was evaluated at an examination at 7 weeks and at 7 months. RESULTS: A significant median improvement of 44% on the written examination and at least one point on each of the self-rated competence and knowledge scales were observed after the teaching module. Residents performed the insertion well at both examinations (89% and 90%), regardless of surgical experience. More than 94% agreed the module was useful and improved their understanding of the procedure. CONCLUSION: A short teaching module and simulation session can effectively teach residents and improve their perceived competence with the TVT procedure.

Reducing the cost and frequency of explantations associated with single-level anterior diskectomy and fusion at a single institution through education.

STUDY DESIGN: We prospectively evaluated the costs/frequency of explanted instrumentation (devices implanted but removed prior to closure) for all single-level anterior diskectomy (1-ADF) procedures performed in 2010 at a single institution before and after surgeon education. OBJECTIVE: To determine whether surgeon education would reduce the costs/frequency of explantation for 1-ADF. SUMMARY OF BACKGROUND DATA: In 2009, we reported that the cost of explanted devices was 9.2% of the cost of implanted devices. METHODS: The costs/frequencies of explantation for 1-ADF performed in 2010 at the same institution by the same surgeons were analyzed before and after surgeon education. From January through April, surgeons were unaware of concerns regarding explantation. At the end of April 2010, spinal surgeons were educated about explantation costs/frequency at 2 meetings. Explantation costs/frequencies for the first 4 months of 2010 were compared with those for the last 8 months as well as with the results from 2009. RESULTS: Prior to surgeon education, instrumentation was explanted in 45.5% of the cases, whereas after education explantation occurred in 16% of the cases. The explantation rate (the number of explanted devices as a percentage of implanted devices) was lower after education for screws (12.5% vs. 7.7%), plates (9.4% vs. 0%), and allograft spacers (7.1% vs. 2.9%), and lower than for rates from 2009. In 2010, the overall cost of explanted devices as a percentage of implanted devices was also lower after surgeon education (5.8%) than before surgeon education in 2010 (20.0%) or 2009 (9.2%). CONCLUSION: The frequency and cost of explanted instrumentation used to perform 1-ADF were reduced through surgeon education.

How much training is required to implant and manage CRT?

PURPOSE OF REVIEW: The number of patients receiving cardiac resynchronization therapies (CRTs) is increasing at a substantial rate. The implant, however, is not always performed effectively and the complication rates are considerable. The training and accreditation to perform CRT need to be evaluated to optimize procedural and patient outcomes. RECENT FINDINGS: The relationship between higher procedural volumes and reduced procedural complications is evident and consistent across a range of surgical specialties and procedures. Present guidelines recommend that training in CRT can be achieved with five to 25 cases. The limited studies in this area suggest that this is inadequate, with complication rates of CRT reducing significantly with procedural experience well beyond 100 cases.There is increasing evidence that the development of procedural skills is dependent not only on cognitive factors, but also on a number of intrinsic visuospatial factors and fine motor dexterity. These factors can be tested objectively and the validity of adopting these techniques for the selection and training of operators is being evaluated. SUMMARY: Ongoing evaluation of the training requirements and accreditation is required to optimize the implantation of CRT.