Learning Curves and Competences of Vascular Trainees Performing Open Aortic Repair in a Simulation-Based Environment.

BACKGROUND: The aim of this study was to analyze learning curves and competency gains of novice vascular trainees when performing open aortic repair in a simulation-based environment. METHODS: This was a prospective study of 16 vascular trainees performing infrarenal open aortic repair on an inanimate abdominal aortic aneurysm simulator with pulsatile pressure and flow. Each participant performed 4 procedures as a primary surgeon while getting structured feedback by a supervising experienced vascular surgeon. All sessions were video recorded and were anonymously and independently assessed by 3 rater-trained experts on an online platform using the newly validated open abdominal aortic aneurysm repair of technical expertise assessment tool. All supervisor interferences and procedure time was noted. RESULTS: Reliability between raters was excellent (intraclass correlation coefficient = 0.92). Participants' mean scores almost doubled during the course between the first (13.4, 95% confidence interval [CI], 6.8-20) and fourth session (29.8, 95% CI, 26.3-33.3) with a mean difference of 14.6 (P < 0.001). Supervisor interference also decreased significantly from mean 3.0 (95% CI, 1.5-3.6) in the first to 0.7 (95% CI, 0.4-1.0) in the fourth session (P = 0.004). Procedure time decreased with a mean of 24 minutes: from 81 min (95% CI, 71.8-90.3) to 57 min (95% CI, 51.1-63.2, P < 0.001). There was a significant negative correlation between procedure time and the Open Abdominal Aortic Aneurysm Repair of Technical Expertise score (Pearson's r = -0.72, P < 0.01). Only half of the participants passed the pass/fail score of 27.7 points during the course. CONCLUSIONS: Novice vascular trainees achieve skills and competencies in open aortic repair in a simulated setting with dedicated supervision and feedback and can become ready for supervised surgery on real patients. Learning rates are individual, and it is important to construct training programs with emphasis on proficiency and not merely attending a course.

Ensuring Competency in Open Aortic Aneurysm Repair - Development and Validation of a New Assessment Tool.

OBJECTIVE: The aims of this study were to develop a procedure specific assessment tool for open abdominal aortic aneurysm (AAA) repair, gather validity evidence for the tool and establish a pass/fail standard. METHODS: Validity was studied based on the contemporary framework by Messick. Three vascular surgeons experienced in open AAA repair and an expert in assessment and validation within medical education developed the OPEn aortic aneurysm Repair Assessment of Technical Expertise (OPERATE) tool. Vascular surgeons with varying experiences performed open AAA repair in a standardised simulation based setting. All procedures were video recorded with the faces anonymised and scored independently by three experts in a mutual blinded setup. The Angoff standard setting method was used to establish a credible pass/fail score. RESULTS: Sixteen novices and nine experienced open vascular surgeons were enrolled. The OPERATE tool achieved high internal consistency (Cronbach's alpha .92) and inter-rater reliability (Cronbach's alpha .95) and was able to differentiate novices and experienced surgeons with mean scores (higher score is better) of 13.4 ± 12 and 25.6 ± 6, respectively (p = .01). The pass/fail score was set high (27.7). One novice passed the test while six experienced surgeons failed. CONCLUSION: Validity evidence was established for the newly developed OPERATE tool and was able to differentiate between novices and experienced surgeons providing a good argument that this tool can be used for both formative and summative assessment in a simulation based environment. The high pass/fail score emphasises the need for novices to train in a simulation based environment up to a certain level of competency before apprenticeship training in the clinical environment under the tutelage of a supervisor. Familiarisation with the simulation equipment must be ensured before performance is assessed as reflected by the low scores in the experienced group's first attempt.

Cost-Effectiveness Evaluation of Heparin Coated Versus Standard Graft for Bypass Surgery in Peripheral Artery Disease Alongside a Randomised Controlled Trial.

OBJECTIVE/BACKGROUND: Heparin coating has recently been shown to reduce the risk of graft failure in arterial revascularisation, at least transiently. The aim of this study was to assess the cost-effectiveness of heparin coated versus standard polytetrafluoroethylene grafts for bypass surgery in peripheral artery disease from a long-term healthcare system perspective. METHODS: Cost-effectiveness evaluation was conducted alongside the Danish part of the Scandinavian Propaten trial in which 431 patients planned for femoro-femoral or femoro-popliteal bypass surgery were randomised to either type of graft and followed for 5 years. Based on the intention to treat principle, the differences in healthcare costs (general practice, prescription medication, hospital admission, rehabilitation, and long-term care in 2015 Euros), life years (LYs), and quality adjusted life years (QALYs) were analysed as arithmetic means with bootstrapped 95% confidence intervals. Cost-effectiveness acceptability curves were used to illustrate the probability of cost-effectiveness for a range of threshold values of willingness to pay (WTP). RESULTS: No statistically significant differences between the randomisation groups were observed for costs or gains of LYs or QALYs. The average cost per QALY was estimated at €10,792. For a WTP threshold of €40,000 per QALY, the overall probability of cost-effectiveness was estimated at 62%, but owing to cost savings in patients with critical ischaemia (cost per QALY <€0), it increased to 89% for this subgroup. CONCLUSION: Until further evidence, heparin coated grafts appear overall, to be cost-effective over standard grafts, but important heterogeneity between claudication and critical ischaemia should be noted. While the optimal choice for claudication remains uncertain, heparin coated grafts should be used for critical ischaemia.

Midt-Term Results after Fast-Track Prophylactic Carotid Surgery Program: The Risk of Overlooking Occult Cancer.

BACKGROUND: Most guidelines recommend fast-track carotid endarterectomy (CEA) within 14 days of the last ischemic event. Long-term survival after fast-track CEA is unknown. The purpose of this study was to determine whether the fast-track CEA program in our region was associated with a reduced or increased 2-year survival and overall complication rate in our population. METHODS: Prospective 2-year follow-up in patients after the implementation of a fast-track CEA program during a period of 3½ years. Data on recurrent stroke, myocardial infarction, and death in a 2-year period after CEA were collected along with the indication for surgery and the time from ischemic event to the operation. RESULTS: Two hundred patients underwent CEA. The overall complication rate for 30 days was 3.5% (95% confidence interval [CI], 2%-5%) and 15.5% (95% CI, 13%-18%) for 2 years. During the 2-year follow-up 17 patients (8.5%; 95% CI, 7%-10%) died. Eight patients (4%; 95% CI, 2%-6%) died of advanced cancer (undiagnosed at the index event and CEA time). Of the 6 deaths occurring in patients undergoing CEA 14 days after the index event or earlier, 5 patients (83%; 95% CI, 55%-95%) died of advanced cancer. In the 11 deaths in patients who underwent CEA more than 14 days after the index event, 3 patients (27%; 95% CI, 5%-50%) died of cancer. This was a statistically significant difference (P = .049). CONCLUSION: Fast-track CEA is a safe procedure in selected patients. Our results show a potential significant risk of overlooking occult cancer, which may affect the long-term benefit from prophylactic CEA.

Clinical validation of 40-mmHg carotid stump pressure for patients undergoing carotid endarterectomy under general anesthesia.

BACKGROUND: The aim of this study was to validate a mean stump pressure (SP) of 40 mmHg as the cut off threshold for shunting during carotid endarterectomy (CEA). METHODS: A prospective analysis of recently symptomatic carotid stenosis patients undergoing fast-track CEA under general anesthesia. An arbitrary cut-off threshold of 40 mmHg (mean) was defined as the indication for shunt insertion. With an SP<40 mmHg systemic blood pressure was increased 10-20% using sympathomimetic drugs. Patients with an SP≥40 mmHg CEA were operated without a shunt. A neurological observation scheme was filled out preoperatively by the anesthesiologist and postoperatively during the first 24 hours after surgery. Endpoints for validation of SP were per new transient ischemic attack (TIA) or stroke (ipsilateral or contralateral), hypoperfusion/hypoxia syndrome or death before discharge from hospital. RESULTS: One hundred and twenty consecutive CEAs were performed in recently symptomatic patients. A significant correlation between SP and the contralateral stenosis degree of internal carotid artery (ICA) was found in our study P=0.05. Sixteen patients (14%) had SP<40 mmHg after clamping the carotid arteries. Raising blood pressure intra-operatively by 10-20% reduced the incidence of shunt insertion to only three patients (80% reduction). Of the 120 CEAs, only 2.5% (95% CI 1-6%) of patients required shunt. There was no post-operative TIA or stroke in our study. Two patients (1.65%) suffered early TIA from ipsilateral ICA after discharge from the vascular unit. CONCLUSIONS: Using a mean SP of 40 mmHg as a threshold seems to be a safe, easy and cheap method for selective shunt insertion in fast track CEA under general anesthesia with a zero false-negative rate. Raising the systemic blood pressure by 10-20% during cross clamping increased SP above the threshold value 40 mmHg, thus avoiding shunt insertion in a number of patients.