Simulation training for invasive cardiovascular procedures: the Heart-SIMS-1 study

Preliminary data from ‘LAA-Print French registry’: A large national multi-centric prospective registry evaluating a new preoperative approach based on 3D printed simulation in LAAC procedures

Aim In patients (pts) with suspected coronary artery disease (CAD), computed tomographic angiography (CTA) may improve pt selection for invasive coronary angiography (ICA) as alternative to functional testing. However. the role of CTA in symptomatic pts after abnormal functional test (FT) is incompletely defined. Methods and results This randomized clinical trial conducted in single academic tertiary center selected 218 symptomatic pts with mild to moderately abnormal FT referred to ICA to receive either the originally intended ICA (n=103) or CTA (n=115). CTA interpretation and subsequent care decisions were made by the clinical team. Pts with high risk features on FT, previous acute coronary syndrome, previously documented CAD, chronic kidney disease (GFR<60ml/min/1.73m2) or persistent atrial fibrillation were excluded. The primary endpoint was the percentage of ICA with no significant obstructive CAD (no stenosis ≥50%) in each group. Diagnostic (DY) and revascularization (RY) yields of ICA in either group were also assessed. Pts were followed up for at least 1 year for the primary safety endpoint of all cause death/ nonfatal myocardial infarction/ stroke. Unplanned revascularization (UP) and symptomatic status (SS) were also evaluated. Pts averaged 68±9 years of age, 60% were male, 29% were diabetic. Nuclear perfusion stress test was used in 33.9% in CTA group and 31.1% in control group (p=0.655). Mean post (functional) test probability of obstructive CAD was 34%. Overall prevalence of obstructive CAD was 32.1%. In the CTA group, ICA was cancelled by referring physicians in 83 of the pts (72.2%) after receiving CTA results. For those undergoing ICA, non-obstructive CAD was found in 5 pts (15.6%) in the CTA-guided arm and 60 (58.3%) in the usual care arm (p<0.001 Mean cumulative radiation exposure related to diagnostic work up was similar in both groups (6±14 vs 5±14mSv, p=0.152). Both DY (84.4% vs 41.7, p<0.001) and RY (71.9% vs 38.8%, p=0.001) yields were significantly higher for CTA-guided ICA as compared to standard FT-guided ICA. The rate of the primary safety endpoint was similar between both groups (1.9% vs 0%, p=0.244), as well as the rates of UP (0.9% vs 0.9%, p=1.000) and SS (persistent angina: 29.6% vs 24.8%, p=0.425). Conclusions In pts with suspected CAD and mild to moderately abnormal ischemia test, a diagnostic strategy including CTA as gatekeeper is safe, effective and significantly improves diagnostic and revascularization yields of ICA. Funding Acknowledgement Type of funding source: None

Use of multidetector computed tomography after mildly abnormal myocardial perfusion stress testing in a large single-specialty cardiology practice

Simulation-based training may offer a useful approach to support skill acquisition in neurointerventional stroke treatment without exposing patients to procedural risks. As the global demand for thrombectomy rises, training strategies that ensure procedural competence while addressing workforce constraints are increasingly important. With this pilot study, we aim to generate a hypothesis as to whether additional exposure of trainees to mechanical thrombectomy could benefit from simulator training on top of the standard training carried out on flow models. This study was designed as an exploratory pilot investigation and was not able to provide inferential or confirmatory statistical conclusions. Six novice participants (advanced clinical-year medical students with completed anatomical and preclinical training, but without previous exposure to catheter-based interventions) performed two neurointerventional tasks, vascular access and mechanical thrombectomy (MTE), on flow models. After a baseline assessment, three participants received standard model-based training (control group), and three received additional simulator training using a high-fidelity angiography simulator (Mentice VIST G5). Performance was reassessed after four weeks using technical and clinical surrogate metrics, which were ranked and descriptively analyzed. No relevant differences were observed between groups for the vascular access task. In contrast, the simulator group demonstrated a trend toward improved performance in the MTE task, with greater gains in efficiency, autonomy, and procedural safety. Our findings indicate a possible benefit of even brief simulator exposure for skill acquisition for complex endovascular procedures such as MTE. While conventional training may suffice for basic skills, simulation may be particularly helpful in supporting learning in more advanced tasks.

Coronary computed tomography angiography (CCTA) offers excellent negative predictive value for coronary artery disease (CAD). In suspected single-vessel disease, invasive coronary angiography (ICA) could be simplified by deferring visualization of the normal coronary artery as identified on CCTA. This ultraselective ICA strategy might reduce procedure time, contrast use, and radiation exposure. This prospective study evaluated the potential benefits of this strategy. This was a multicentre prospective registry in three hospitals in the Netherlands. The study included patients over 18 years undergoing ICA for suspected CAD limited to a single coronary artery on CCTA. The primary endpoint was accuracy of CCTA in predicting a normal coronary artery on ICA. Secondary endpoints included potential reductions in procedure time, radiation exposure, and contrast volume with an ultraselective ICA approach. In total 102 patients were included. CCTA was correct in predicting a non-obstructive coronary artery in all patients (100 ​%). By deferring visualization of the normal coronary, a CCTA-guided ICA would have led to a reduction in procedure time (49 ​% [IQR 41-59]; 6.64 ​min [5.07-8.68] vs 3.18 ​min [2.42-4.41]), radiation exposure (35 ​% [25-44]; 5.09 ​Gy ​cm2 [3.11-7.88] vs 3.17 ​Gy ​cm2 [1.96-5.08]), and the amount of contrast agent used (33 ​% [28-41]; 71 ​ml [60-84] vs 46 ​ml [37-55]). This study demonstrated excellent performance of CCTA in predicting a normal coronary artery in patients with suspected single-vessel CAD. A CCTA-guided ultraselective ICA is feasible and offers substantial reductions in procedure time and materials, contrast agent volume and radiation exposure.

Initial Imaging-Guided Strategy Versus Routine Care in Patients With Non–ST-Segment Elevation Myocardial Infarction

BackgroundTraining in invasive procedures like pericardiocentesis is a critical component of medical education but poses significant challenges due to its complexity and infrequent clinical application. Pericardiocentesis is an invasive procedure used to remove excess pericardial fluid from the pericardial sac, typically performed to relieve cardiac tamponade. It requires precise anatomical knowledge, ultrasound guidance, and dexterous needle placement to minimize complications. Simulation-based training, particularly with innovative technologies such as 3D printing and virtual reality (VR), offers accessible and cost-effective solutions. This study compared the effectiveness of 3D-printed mannequins and VR simulations in pericardiocentesis training, focusing on learning outcomes, stress responses, and cognitive load.MethodsThirty-five final-year medical students participated in this quasi-experimental study, receiving training with both models in separate sessions under the supervision of two experienced instructors. Learning outcomes were evaluated using the objective structured clinical examination (OSCE), while stress responses were assessed via heart rate variability (HRV), a measure of fluctuations in heart rate that reflect stress levels. Perceived cognitive load was measured with the NASA Task Load Index (NASA-TLX). Wilcoxon signed-rank and Friedman tests were used for statistical analysis.ResultsThe 3D-printed mannequin outperformed VR in tasks requiring fine motor skills, such as material handling and drainage placement (Z = − 2.56, p < 0.05; Z = − 2.34, p < 0.05). VR training, however, was associated with lower mental demand and effort (Z = − 2.147, p < 0.05; Z = − 2.356, p < 0.05). Biometric analysis indicated higher stress levels during mannequin-based training (SD1/SD2, chi-square = 14.157, p < 0.01), reflecting its closer replication of real-life clinical conditions.ConclusionsBoth 3D-printed mannequins and VR simulations serve as effective tools for pericardiocentesis training, each offering unique advantages. The 3D-printed mannequin supports tactile skill acquisition, while VR enhances cognitive engagement in a low-stress environment. A hybrid approach—beginning with VR and progressing to 3D-printed models—maximizes training outcomes, particularly in resource-limited settings, where affordable simulation tools can improve access to medical education.

In patients with previous coronary artery bypass grafting, computed tomography cardiac angiography (CTCA) before invasive coronary angiography (ICA) was demonstrated in the BYPASS-CTCA trial (Randomized Controlled Trial to Assess Whether Computed Tomography Cardiac Angiography Can Improve Invasive Coronary Angiography in Bypass Surgery Patients) to reduce procedure time and incidence of contrast-associated acute kidney injury, with greater levels of patient satisfaction. Patient-related outcomes, utilization of further diagnostic imaging resources, and longer-term incidence of major adverse cardiac events were key secondary end points not yet reported. Patients with prior coronary artery bypass grafting referred for ICA were randomized 1:1 to undergo CTCA before ICA or ICA alone and followed up for a median of 3 (2.2-3.4) years. Angina status was assessed using the Seattle Angina Questionnaire and overall quality of life using the EQ-5D-5L. The incidence of noninvasive imaging use and major adverse cardiac events were compared between the 2 groups. In all, 688 patients were randomized, 344 to CTCA+ICA and 344 to ICA only. The mean age of participants was 69.8 years, with 45% undergoing ICA for acute coronary syndromes and the remainder stable angina. At 3 months follow-up, patients in the CTCA+ICA group were more likely to be angina-free (51.7% versus 43.2%; P=0.03) with greater quality of life (EQ-5D-5L index, 81.6 versus 74.4; P=0.001), although these improvements did not persist. At 3 years follow-up, imaging resource use (35.8% versus 45.1%; odds ratio, 0.68 [95% CI, 0.50-0.92]; P=0.013) and incidence of major adverse cardiac events were lower in the CTCA+ICA group (35.8% versus 43.5%; hazard ratio, 0.73 [95% CI, 0.58-0.93]; P=0.010). In patients with prior coronary artery bypass grafting undergoing ICA, CTCA before ICA leads to reductions in the use of imaging resources and the rate of major cardiac events out to 3 years, but with similar patient-related outcome measures. Together with the initial findings of BYPASS-CTCA, these data are supportive of routinely undertaking a CTCA before ICA in patients with prior coronary artery bypass grafting. URL: https://www.clinicaltrials.gov; Unique identifier: NCT03736018.

BackgroundIn the recent years, growing interest in simulation-based surgical education has led to various practical alternatives for medical training. More recently, courses based on virtual reality (VR) and three-dimensional (3D)-printed models are available. In this paper, a hybrid (virtual and physical) neurosurgical simulator has been validated, equipped with augmented reality (AR) capabilities that can be used repeatedly to increase familiarity and improve the technical skills in human brain anatomy and neurosurgical approaches.MethodsThe neurosurgical simulator used in this study (UpSurgeOn Box, UpSurgeOn Srl, Assago, Milan) combines a virtual component and a physical component with an intermediate step to provide a hybrid solution. A first reported and evaluated practical experience on the anatomical 3D-printed model has been conducted with a total of 30 residents in neurosurgery. The residents had the possibility to choose a specific approach, focus on the correct patient positioning, and go over the chosen approach step-by-step, interacting with the model through AR application. Next, each practical surgical step on the 3D model was timed and qualitatively evaluated by 3 senior neurosurgeons. Quality and usability-grade surveys were filled out by participants.ResultsMore than 89% of the residents assessed that the application and the AR simulator were very helpful in improving the orientation skills during neurosurgical approaches. Indeed, 89.3% of participants found brain and skull anatomy highly realistic during their tasks. Moreover, workshop exercises were considered useful in increasing the competency and technical skills required in the operating room by 85.8 and 84.7% of residents, respectively. Data collected confirmed that the anatomical model and its application were intuitive, well-integrated, and easy to use.ConclusionThe hybrid AR and 3D-printed neurosurgical simulator could be a valid tool for neurosurgical training, capable of enhancing personal technical skills and competence. In addition, it could be easy to imagine how patient safety would increase and healthcare costs would be reduced, even if more studies are needed to investigate these aspects. The integration of simulators for training in neurosurgery as preparatory steps for the operating room should be recommended and further investigated given their huge potential.

Coronary atherosclerotic burden in non-ischemic dilated cardiomyopathies: Prognostic implications. A sub study of 3 C registry

Cardiac Magnetic Resonance Imaging vs Coronary Angiography as Primary Strategy in Newly Diagnosed Heart Failure.

BackgroundCoronary computed tomography angiography (CCTA) allows for non-invasive assessment of obstructive coronary artery disease (CAD) beyond measures of stenosis severity alone. This assessment includes atherosclerotic plaque characteristics (APCs) and calculation of fractional flow reserve (FFR) from CCTA (FFRCT). Similarly, stress imaging by myocardial perfusion scintigraphy (MPS) provides vital information. To date, the diagnostic performance of integrated CCTA assessment versus integrated MPS assessment for diagnosis of vessel-specific ischemia remains underexplored.MethodsCREDENCE will enroll adult individuals with symptoms suspicious of CAD referred for non-emergent invasive coronary angiography (ICA), but without known CAD. All participants will undergo CCTA, MPS, ICA and FFR. FFR will be performed for lesions identified at the time of ICA to be ≥40 and <90 % stenosis, or those clinically indicated for evaluation. Study analyses will focus on diagnostic performance of CCTA versus MPS against invasive FFR reference standard. An integrated stenosis-APC-FFRCT metric by CCTA for vessel-specific ischemia will be developed from derivation cohort and tested against a validation cohort. Similarly, integrated metric by MPS for vessel-specific ischemia will be developed, validated and compared. An FFR value of ≤0.80 will be considered as ischemia causing. The primary endpoint will be the diagnostic accuracy of vessel territory-specific ischemia of integrated stenosis-APC-FFRCT measure by CCTA, compared with perfusion or perfusion–myocardial blood flow stress imaging testing, against invasive FFR.DiscussionCREDENCE will determine the performance of integrated CCTA metric compared to integrated MPS measure for diagnosis of vessel-specific ischemia. If proven successful, this study may reduce the number of missed diagnoses and help to optimally predict ischemia-causing lesions.Trial registrationClinicalTrials.gov, NCT02173275. Registered on June 23, 2014. Electronic supplementary materialThe online version of this article (doi:10.1186/s12872-016-0360-x) contains supplementary material, which is available to authorized users.

BackgroundUse of patient-specific models as a surgical planning and training tool can support novice practitioners’ surgical skill development. This study aimed to introduce a novel workflow for fabricating 3D-printed, patient-specific simulation models and evaluate their accuracy and transferability for use in periodontal and oral surgery training.MethodsPatient-specific anatomical models of the maxilla were fabricated using the CBCT and intraoral scan data. The proposed workflow outlines a novel process for creating a patient-specific model that accurately replicates both the hard and soft tissues of the patient. The accuracy of the printed models was evaluated by scanning five models and comparing them to the patient’s intraoral scan using cloud-to-cloud distance analysis. Then, in an exploratory study design, a simulated gingival flap surgery exercise was completed by 18 periodontists and 50 students. The face and content validity of the model were assessed using an 8-item online questionnaire with a VAS of 0-100 and a free comment question. The data were analyzed using descriptive statistics, Mann–Whitney U tests and independent t-test.ResultsThe printed model demonstrated high dimensional accuracy. The overall VAS score of the model was significantly higher for students than for periodontists (83.7 ± 9.7 vs. 72.1 ± 15.8, p < 0.006). The face and content validity scores reported by students were also higher (P < 0.01), with mean differences of 8.86% and 12.62%, respectively. Periodontists rated the models lower for soft-tissue tactile feedback, particularly during incision.ConclusionsThe proposed 3D-printed simulation workflow produced an accurate and educationally valuable model with the potential to enhance surgical training. Experienced surgeons suggested that refining the soft-tissue realism could further improve its overall educational value.

Transverse vaginal septum (TVS) is a rare congenital anomaly that poses significant challenges in pediatric and adolescent gynecology (PAG) training due to its low prevalence and surgical complexity. Most PAG fellows may never encounter a case during their fellowship, underscoring the need for high-fidelity simulation tools to enhance procedural readiness. Through 3D printing and silicone elastomers, a surgical task trainer replicating TVS anatomy was developed and integrated into a structured simulation curriculum using the Y-plasty technique. The curriculum was delivered during a PAG fellows' bootcamp and included a didactic session followed by hands-on simulation. Fellows completed pre- and post-session surveys assessing self-perceived confidence and curriculum acceptability, including net promoter score (NPS). Statistical analysis included Wilcoxon signed rank tests and descriptive statistics. Thirty-six fellows participated, with 66.7% reporting no prior experience with Y-plasty. Post-simulation, median confidence scores increased significantly from 2 ("slightly confident") to 3 ("moderately confident") out of 5 (p < 0.001). The curriculum received an NPS of 51.5%, indicating strong satisfaction and dissemination potential. Participants estimated that four simulation sessions would be sufficient to achieve self-perceived confidence. The study demonstrates that a single session using a 3D-printed and silicone-cast simulation model was associated with increased self-perceived confidence. The model was well-received and offers a scalable, efficient solution to address educational gaps in PAG fellowship surgical training. Future directions focus on expanding the curriculum to include other vaginal septum types and improving current model performance.

3D-printed simulation models are emerging as novel tools in various medical education fields. This study aims to investigate the evidence on the efficacy of 3D-printed jaw models compared to traditional animal models for oral surgical skill training. A comprehensive literature search was conducted up to June 2024 in Ovid Medline, Embase, Scopus, ProQuest, Epistemonikos, and ERIC databases. Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, relevant studies were identified. Data were extracted independently by two reviewers. The Medical Education Research Study Quality Instrument tool (MERSQI) was used for methodological quality assessment. A total of 1074 potentially relevant publications were initially identified. only three articles met the stringent inclusion criteria. These studies provided unique insights into the application, effectiveness, limitations, and potential of 3D-printed versus animal models in dental oral surgery education, however, their methodological design received only a moderate score based on the MERSQI evaluation. In all three studies, the participants preferred 3D-printed models over traditional cadaveric models in terms of anatomical accuracy, educational value, and surgical simulation. However, limitations were identified, particularly in replicating realistic soft tissue sensations. 3D-printed models can provide a realistic and novel alternative tool to the animal jaw, enhancing the learning experience in oral surgical skill training of dental students. Despite the limitations of the available studies, integrating 3D printing technology into dental and oral surgery education shows promise for improving educational quality. Future well-designed studies are needed to strengthen the existing evidence on this topic.