Abstract

In October 2006, the Chief Medical Officer (CMO) of England asked Professor Sir John Tooke to chair a High Level Group on Clinical Effectiveness in response to the chapter 'Waste not, want not' in the CMOs 2005 annual report 'On the State of the Public Health'. The high level group made recommendations to the CMO to address possible ways forward to improve clinical effectiveness in the UK National Health Service (NHS) and promote clinical engagement to deliver this. The report contained a short section on research needs that emerged from the process of writing the report, but in order to more fully identify the relevant research agenda Professor Sir John Tooke asked Professor Martin Eccles to convene an expert group – the Clinical Effectiveness Research Agenda Group (CERAG) – to define the research agenda. The CERAG's terms of reference were 'to further elaborate the research agenda in relation to pursuing clinically effective practice within the (UK) National Health Service'. This editorial presents the summary of the CERAG report and recommendations.

Abstract-Object tracking is a key enabling technology in the context of computer-assisted medical interventions. Allowing the continuous localization of medical instruments and patient anatomy, it is a prerequisite for providing instrument guidance to subsurface anatomical structures. The only widely used technique that enables real-time tracking of small objects without lineof-sight restrictions is electromagnetic (EM) tracking. While EM tracking has been the subject of many research efforts, clinical applications have been slow to emerge. The aim of this review paper is therefore to provide insight into the future potential and limitations of EM tracking for medical use. We describe the basic working principles of EM tracking systems, list the main sources of error, and summarize the published studies on tracking accuracy, precision and robustness along with the corresponding validation protocols proposed. State-of-the-art approaches to error compensation are also reviewed in depth. Finally, an overview of the clinical applications addressed with EM tracking is given. Throughout the paper, we report not only on scientific progress, but also provide a review on commercial systems. Given the continuous debate on the applicability of EM tracking in medicine, this paper provides a timely overview of the state-of-the-art in the field.

Image-guided interventions are medical procedures that use computer-based systems to provide virtual image overlays to help the physician precisely visualize and target the surgical site. This field has been greatly expanded by the advances in medical imaging and computing power over the past 20 years. This review begins with a historical overview and then describes the component technologies of tracking, registration, visualization, and software. Clinical applications in neurosurgery, orthopedics, and the cardiac and thoracoabdominal areas are discussed, together with a description of an evolving technology named Natural Orifice Transluminal Endoscopic Surgery (NOTES). As the trend toward minimally invasive procedures continues, image-guided interventions will play an important role in enabling new procedures, while improving the accuracy and success of existing approaches. Despite this promise, the role of image-guided systems must be validated by clinical trials facilitated by partnerships between scientists and physicians if this field is to reach its full potential.

A proposed framework for regulatory, ethical, and legal discussions identifies six levels of autonomy for medical robotics.

PURPOSE-To assess the feasibility of the use of preprocedural imaging for guide wire, catheter, and needle navigation with electromagnetic tracking in phantom and animal models. MATERIALS AND METHODS-An image-guided intervention software system was developedbased on open-source software components. Catheters, needles, and guide wires were constructed with small position and orientation sensors in the tips. A tetrahedral-shaped weak electromagnetic field generator was placed in proximity to an abdominal vascular phantom or three pigs on the angiography table. Preprocedural computed tomographic (CT) images of the phantom or pig were loaded into custom-developed tracking, registration, navigation, and rendering software. Devices were manipulated within the phantom or pig with guidance from the previously acquired CT scan and simultaneous real-time angiography. Navigation within positron emission tomography (PET) and magnetic resonance (MR) volumetric datasets was also performed. External and endovascular fiducials were used for registration in the phantom, and registration error and tracking error were estimated. RESULTS-The CT scan position of the devices within phantoms and pigs was accurately determined during angiography and biopsy procedures, with manageable error for some applications. Preprocedural CT depicted the anatomy in the region of the devices with real-time position updating and minimal registration error and tracking error (<5 mm). PET can also be used with this system to guide percutaneous biopsies to the most metabolically active region of a tumor.CONCLUSIONS-Previously acquired CT, MR, or PET data can be accurately codisplayed during procedures with reconstructed imaging based on the position and orientation of catheters, guide wires, or needles. Multimodality interventions are feasible by allowing the real-time updated display of previously acquired functional or morphologic imaging during angiography, biopsy, and ablation.Address correspondence to B.J.W.; E-mail: bwood@nih.gov. B.J.W. and K.C. are coinventors on related US Patent Application #10/377,528, "Interstitial Magnetic Position Sensor System and Needle for Surgical and Image-guided Therapy Navigation." B.J.W. and N.G. are coinventors on US Patent Application: "Design for Guiding and Electromagnetic Tracking of Radiofrequency Ablation Needle" (US Provisional Patent Application # 60/625,186). Philips owns intellectual property and has market interest in this area. J.K., J.B., and S.K. are salaried employees of Philips Electronics. The mention of commercial devices or products, their source, or their use in connection with material reported herein is not to be construed as either an actual or implied endorsement of such products by the National Institutes of Health, the Department of Health and Human Services, or the Public Health Service. N.G. is President and a major shareholder of Traxtal, Inc. DEVICE navigation in angiography and interventional radiology has traditionally relied on real-time imaging to monitor anatomic position...