The future of simulation technologies for complex cardiovascular procedures.

Changing work practices and the evolution of more complex interventions in cardiovascular medicine are forcing a paradigm shift in the way doctors are trained. Implantable cardioverter defibrillator (ICD), transcatheter aortic valve implantation (TAVI), carotid artery stenting (CAS), and acute stroke intervention procedures are forcing these changes at a faster pace than in other disciplines. As a consequence, cardiovascular medicine has had to develop a sophisticated understanding of precisely what is meant by 'training' and 'skill'. An evolving conclusion is that procedure training on a virtual reality (VR) simulator presents a viable current solution. These simulations should characterize the important performance characteristics of procedural skill that have metrics derived and defined from, and then benchmarked to experienced operators (i.e. level of proficiency). Simulation training is optimal with metric-based feedback, particularly formative trainee error assessments, proximate to their performance. In prospective, randomized studies, learners who trained to a benchmarked proficiency level on the simulator performed significantly better than learners who were traditionally trained. In addition, cardiovascular medicine now has available the most sophisticated virtual reality simulators in medicine and these have been used for the roll-out of interventions such as CAS in the USA and globally with cardiovascular society and industry partnered training programmes. The Food and Drug Administration has advocated the use of VR simulation as part of the approval of new devices and the American Board of Internal Medicine has adopted simulation as part of its maintenance of certification. Simulation is rapidly becoming a mainstay of cardiovascular education, training, certification, and the safe adoption of new technology. If cardiovascular medicine is to continue to lead in the adoption and integration of simulation, then, it must take a proactive position in the development of metric-based simulation curriculum, adoption of proficiency benchmarking definitions, and then resolve to commit resources so as to continue to lead this revolution in physician training.

Clinical features and outcomes of carotid artery stenting by clinical expert consensus criteria: a report from the CARE registry.

BACKGROUND: In 2007, a multispecialty society task force published a clinical expert consensus document (CECD) on carotid stenting (CAS), containing recommendations for appropriate patient selection and quality of care. The CECD also inspired creation of a large, national registry of carotid revascularization, the Carotid Artery Revascularization and Endarterectomy (CARE) registry. Our goal here was to investigate whether initial CAS procedures submitted to CARE conformed to CECD recommendations, and examine their clinical outcomes. METHODS: We analyzed CAS procedures for the period January 1, 2005 through December 31, 2008. These were grouped into those that conformed to CECD recommendations [CECD(+), n = 4,636, 79.8%] and those that did not [CECD(-), n = 1,168, 20.2%]. RESULTS: The CECD(+) patients were older than CECD(-) patients (71.5 +/- 10.3 vs. 67.6 +/- 10.3 years, P = 0.001, respectively), and more frequently had chronic kidney disease (46.9% vs. 17.8%, P = 0.001), chronic lung disease (33.0% vs. 12.4%, P = 0.001), ejection fraction

The Carotid Artery Revascularization and Endarterectomy (CARE) registry: objectives, design, and implications.

This is the first comprehensive national registry that will provide data characterizing contemporary results of carotid endarterectomy (CEA) and carotid artery stenting (CAS). Carotid endarterectomy (CEA) has become the standard revascularization therapy to prevent stroke in patients with carotid artery disease, while carotid artery stenting (CAS) offers a percutaneous alternative in selected patients. Given the rapid growth in the numbers of CAS procedures being performed, there is a critical need for a national program to assess quality outcomes. The Carotid Artery Revascularization and Endarterectomy (CARE) Registry was developed through a multispecialty collaboration resulting in a comprehensive data collection tool for carotid revascularization procedures. The intent of the CARE registry is to collect and analyze clinical data to measure clinical practice, patient outcomes, and enable quality improvement for carotid revascularization. Finally, the CARE Registry satisfies the Center for Medicare and Medicaid Services (CMS) data reporting criteria for reimbursement.

Prospective, randomised and blinded comparison of proficiency-based progression full-physics virtual reality simulator training versus invasive vascular experience for learning carotid artery angiography by very experienced operators.

Introduction: We assessed the transfer of training (ToT) of virtual reality simulation training compared to invasive vascular experience training for carotid artery angiography (CA) for highly experienced interventionists but new to carotid procedures. Methods: Prospective, randomised and blinded. Setting: Catheterisation and skills laboratories in the USA. Participants: Experienced (mean volume=15 000 cases) interventional cardiologists (n=12) were randomised to train on virtual reality (VR) simulation to a quantitatively defined level of proficiency or to a traditional supervised in vivo patient case training. Outcome measures: The observed performance differences in performing a CA between two matched groups were then blindly assessed using predefined metrics of performance. Results: Experienced interventional cardiologists trained on the VR simulator performed significantly better than their equally experienced controls showing a significantly lower rate of objectively assessed intraoperative errors in CA. Performance showed 17-49% ToT from the VR to the in vivo index case. Discussion: This is the first prospective, randomised and blinded clinical study to report that VR simulation training transfers improved procedural skills to clinical performance on live patients for experienced interventionists. This study, for the first time, demonstrates that VR simulation offers a powerful, safe and effective platform for training interventional skills for highly experienced interventionists with the greatest impact on procedural error reduction.

Virtual reality training for the operating room and cardiac catheterisation laboratory.

CONTEXT: High-profile cases of medical errors in the USA and UK, and major reports from organisations such as the US Institute of Medicine and UK Senate of Surgery, have sensitised the public and medical profession. Training is a key area that must be tackled to positively affect the problem of medical errors, especially in surgery and interventional cardiology. Despite the radically novel skills required for minimally invasive surgery or interventional cardiology, current training has gone largely unchanged. At the end of the 20th century, the public and the medical profession have concluded that training on patients is no longer acceptable. STARTING POINT: Recently, Teodor Grantcharov and colleagues (Br J Surg 2004; 91: 146-50) did a randomised double-blind trial which showed that training by virtual reality (VR) significantly reduces objectively assessed intraoperative errors in laparoscopic cholecystectomy. They used a low-fidelity VR simulator. Much more sophisticated VR simulators exist for endoscopy, gynaecology, laparoscopy, orthopaedics, otolaryngology, robotics, and urology. There are few studies on the efficacy of these simulators in improving the safety of procedures on patients. WHERE NEXT: There needs to be more large and multicentre studies. Technical skills training for procedural based medicine continues to be an ad-hoc mentor-based experience for the trainee, with experience gained by practising on patients. The skills required now are so difficult to learn that this type of training is no longer acceptable. VR-simulator-based training does work, but further empirical evidence is required to convince the more conservative members of the medical community.

Stroke intervention: catheter-based therapy for acute ischemic stroke.

The majority (>80%) of the three-quarters of a million strokes that will occur in the United States this year are ischemic in nature. The treatment of acute ischemic stroke is very similar to acute myocardial infarction, which requires timely reperfusion therapy for optimal results. The majority of patients with acute ischemic stroke do not receive any form of reperfusion therapy, unlike patients with acute myocardial infarction. Improving outcomes for acute stroke will require patient education to encourage early presentation, an aggressive expansion of qualified hospitals, and willing providers and early imaging strategies to match patients with their best options for reperfusion therapy to minimize complications.

Clinical outcomes after hybrid coronary revascularization versus off-pump coronary artery bypass: a prospective evaluation.

OBJECTIVE: : Hybrid coronary revascularization is offered as an alternative strategy for patients with multivessel coronary artery disease (CAD). We present our experience and provide a comparative analysis to off-pump coronary artery bypass grafting (OPCAB). METHODS: : Ninety-one patients with multivessel CAD underwent minimally invasive left internal mammary artery to left anterior descending grafting in combination with percutaneous coronary intervention of nonleft anterior descending targets (HYBRID). The primary end point of this study was major adverse cardiac and cerebrovascular events (MACCE), defined as death, stroke, and nonfatal myocardial infarction. MACCE in the HYBRID group were compared with 4175 contemporaneously performed OPCAB operations by logistic (30-day outcomes) and Cox proportional hazards (long-term survival) regression methods. Propensity scoring was used to adjust for potential selection bias. RESULTS: : The 30-day MACCE (death/stroke/nonfatal myocardial infarction) rate was 1.1% for the HYBRID group (0%/0%/1.1%) and 3.0% for the OPCAB group (1.8%/1.1%/0.5%) (odds ratio = 0.47, P = 0.48). Angiographic left internal mammary artery evaluation was obtained in 95.6% of patients (87 of 91) revealing FitzGibbon A patency in 98.0% (96 of 98). The reintervention rate at 1 year for the HYBRID group was 5.5% (5 of 91) and was limited to repeat percutaneous coronary intervention. Three-year survival was statistically similar for the two groups (hazard ratio = 0.44, P = 0.18, see Kaplan-Meier figure). CONCLUSIONS: : Hybrid coronary revascularization may be noninferior to OPCAB with respect to early MACCE and 3-year survival in the treatment of multivessel CAD.

Interventional stroke therapy: current state of the art and needs assessment.

The primary therapeutic strategy for ischemic stroke, as for MI patients, is early reperfusion. Improvement in stroke treatment will require dedicated stroke centers to emulate MI quality indicators such as minimizing the "door-to-balloon time". A critical element in achieving this goal will be organizing the existing multidisciplinary pool of carotid interventionalists to provide the endovascular component of the acute care for ischemic stroke patients.

Learning curves and reliability measures for virtual reality simulation in the performance assessment of carotid angiography.

OBJECTIVES: Improvement in performance as measured by metric-based procedural errors must be demonstrated if virtual reality (VR) simulation is to be used as a valid means of proficiency assessment and improvement in procedural-based medical skills. BACKGROUND: The Food and Drug Administration requires completion of VR simulation training for physicians learning to perform carotid stenting. METHODS: Interventional cardiologists (n = 20) participating in the Emory NeuroAnatomy Carotid Training program underwent an instructional course on carotid angiography and then performed five serial simulated carotid angiograms on the Vascular Interventional System Trainer (VIST) VR simulator (Mentice AB, Gothenburg, Sweden). Of the subjects, 90% completed the full assessment. Procedure time (PT), fluoroscopy time (FT), contrast volume, and composite catheter handling errors (CE) were recorded by the simulator. RESULTS: An improvement was noted in PT, contrast volume, FT, and CE when comparing the subjects' first and last simulations (all p < 0.05). The internal consistency of the VIST VR simulator as assessed with standardized coefficient alpha was high (range 0.81 to 0.93), except for FT (alpha = 0.36). Test-retest reliability was high for CE (r = 0.9, p = 0.0001). CONCLUSIONS: A learning curve with improved performance was demonstrated on the VIST simulator. This study represents the largest collection of such data to date in carotid VR simulation and is the first report to establish the internal consistency of the VIST simulator and its test-retest reliability across several metrics. These metrics are fundamental benchmarks in the validation of any measurement device. Composite catheter handling errors represent measurable dynamic metrics with high test-retest reliability that are required for the high-stakes assessment of procedural skills.

Face and content validation of virtual reality simulation for carotid angiography: results from the first 100 physicians attending the Emory NeuroAnatomy Carotid Training (ENACT) program.

BACKGROUND: Increasing time and resource constraints, and the potential for patient complications, has led to an emphasis on finding innovative ways to teach catheter-based procedures outside of the laboratory. Virtual reality (VR) simulator training has been proposed as a potential training solution. We report on the initial validation of a full procedural VR simulator for carotid angiography (CA) using the Vascular Interventional System Trainer (VIST). METHODS: In all, 100 experienced physicians, currently performing endovascular procedures (71 cardiologists, 29 surgeons, and one radiologist), underwent simulator based training in CA. Each operator completed three VR simulated CAs, and assessed the VIST VR simulator for both its face and content validity. RESULTS: Assessment involved how the carotid procedure simulation looked and felt as well as how catheters behaved during the completion of the CA. Assessment was rated on a five-point Likert scale. Anatomically, physicians reported that the aortic arch and carotid vasculature were well simulated (mean = 4.4). However, the bony structures and intra-cranial vasculature correlated poorly with actual anatomic structures (means = 2.3 and 1.1, respectively). One-to-one haptic correspondence of catheters during psychomotor movements were felt to be strongly representative of live procedures. The simulated sequence of using guidewires and catheters was rated to be nearly identical to actual CA (means = 4.8). CONCLUSIONS: VIST represents one of the most sophisticated VR simulators in medicine. Physicians reported that it looked, felt, and behaved similar to working on an actual patient. Future work is required to validate whether this simulator will improve catheter performance on actual patients.

Integrated coronary revascularization with drug-eluting stents: immediate and seven-month outcome.

OBJECTIVE: We sought to demonstrate the safety and feasibility of an integrated coronary revascularization strategy that combines minimally invasive left internal thoracic artery to left anterior descending coronary artery anastomosis with drug-eluting stent implantation to non-left anterior descending coronary artery lesions. METHODS: Over 18 months, 47 consecutive patients with multivessel coronary artery disease underwent thoracoscopic harvesting of the left internal thoracic artery to graft the left anterior descending coronary artery. Anastomoses were constructed by hand, off-pump, and under direct vision through a 4-cm non-rib-spreading, muscle-sparing chest incision. Non-left anterior descending coronary artery lesions were then treated percutaneously using sirolimus- or paclitaxel-eluting stents. Angiographic follow-up was performed in all patients. RESULTS: Within the first 90 days of hospitalizations, there were no deaths, myocardial infarctions, neurologic events, or wound complications. Forty patients underwent left internal thoracic artery to left anterior descending coronary artery grafting, and 7 patients underwent left internal thoracic artery to left anterior descending coronary artery/diagonal sequential grafting for a total of 54 anastomoses. Angiographic patency scores were FitzGibbon A 96.2% (52/54) and FitzGibbon A + B 100% (54/54). A total of 65 drug-eluting stents were implanted in 61 non-left anterior descending coronary artery coronary lesions of which 49.1% (30/61) were type B2 or C lesions, including 5 left main lesions. Diabetes was present in 53.2% of patients (25/47). At a mean follow-up time of 7.0 +/- 4.8 months, the target lesion or vessel repeat revascularization rate was 6.6% (4/61) for drug-eluting stents and 1.9% (1/54) for left internal thoracic artery to left anterior descending coronary artery grafting. One anastomosis required balloon dilation, but no patients have required repeat coronary artery bypass grafting. CONCLUSIONS: Integrated coronary revascularization using drug-eluting stents is feasible and safe. There are sufficient data to justify a randomized comparison of integrated coronary revascularization with standard coronary artery bypass grafting.