Christopher U. Cates

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.

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.

Safety and efficacy of a novel device for treatment of thrombotic and atherosclerotic lesions in native coronary arteries and saphenous vein grafts: Results from the multicenter X-sizer for treatment of thrombus and atherosclerosis in coronary applications trial (X-TRACT) study

Intervention in thrombotic lesions and diseased saphenous vein grafts frequently results in thromboembolic complications, including no‐reflow, distal branch occlusion, periprocedural MI, and death. The utility of a novel thromboatherectomy device, the X‐Sizer, was tested in 50 consecutive patients at nine U.S. centers. A total of 61 lesions were treated in 31 vein grafts and 19 native coronary arteries; thrombus was present in 78% of lesions, and TIMI 0–1 flow in 21%. TIMI 3 flow improved from 57% at baseline to 94% postprocedure. No patient developed visible distal thromboemboli, side‐branch occlusion, or reduced antegrade flow. Thirty‐day events included one death (2.0%), Q‐ or non–Q‐wave MI in 4.0%, TVR in 6.0%, and any MACE in 6.0%. We conclude that the use of the X‐Sizer prior to percutaneous intervention is safe in high‐risk vein grafts and thrombotic lesions and results in a low rate of adverse events compared to historical controls. Cathet Cardiovasc Intervent 2003;58:419–427.

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.

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.

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 ≤ 0.30 (13.5% vs. 5.5%, P = 0.001) and contralateral carotid artery occlusion (12.7% vs. 4.6%, P = 0.001). Clinical outcomes at 30 days were similar, including death (1.24% vs. 0.76%, P = 0.184), stroke (5.32% vs. 5.34%, P = 0.954), and death, stroke, or MI (7.04% vs. 6.95%, P = 0.944). Conclusions: Most CAS procedures submitted to CARE conformed to CECD recommendations for patient selection. For reported data, clinical outcomes at 30 days were similar for procedures meeting and those not meeting recommendations, and were similar to outcomes reported by other large registries. These findings suggest that acceptable patient selection criteria for CAS are employed as it expands beyond investigators into more widespread clinical practice.

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.