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Credits

Foreword

Table of Contents

Executive Summary

Workshop

Overview

Operational Efficiency & Workflow

Systems Integration & Technical Standards

Telecollaboration

Surgical Robotics

Intraoperative Imaging

Surgical Informatics

Appendix A

Appendix B

Appendix C




CHAPTER 6 AT A GLANCE:
INTRAOPERATIVE IMAGING

Overview

Intraoperative imaging includes the use of

  • real-time imaging modalities during the surgical procedure;
  • pre-operative images that are registered to the patient; and
  • all associated infrastructure that is necessary to enable effective application of all such technologies.

A central issue in intraoperative imaging today is the difficulty that surgeons face in obtaining information from imaging devices in the operating room (OR). Surgeons need images presented in interactive and 3D formats. They also must be able to integrate and manipulate these images during the surgical procedure.

Clinical Needs

A range of intraoperative imaging technologies is currently available; however, their integration capabilities are limited. Consequently, these imaging technologies are not used as frequently as they might. Improvements are needed in:

  • access to integrated images obtained prior to and during surgical procedures.
  • training of OR staff in pre-planning and simulation tasks that are required prior to surgery and in working effectively in a multimodality environment.

Technical Requirements

Technical priorities to address these clinical needs must focus on improving the imaging systems themselves by developing:

  1. readily accessible, real-time, 3D imaging capabilities in the OR.
  2. flexible systems that integrate current and future imaging systems and the development of standard platforms for imaging modalities.

Research Priorities

To establish the need for intraoperative imaging, research must

  1. identify specific surgical needs (per type of surgery) for intraoperative imaging.
  2. evaluate intraoperative imaging outcomes and demonstrate their value.

Priorities must focus on lobbying and otherwise encouraging imaging system developers to build products that enable intraoperative integration. In addition, purchasers must play a role in this effort by demanding products that enable integration and intraoperability of imaging systems.

The full report of this Working Group appears below.

CHAPTER 6 :
INTRAOPERATIVE IMAGING

…THE REPORT OF WORKING GROUP 5

PARTICIPANTS

Michael Brazaitis, MD, Walter Reed Army Medical Center (Clinical Leader)
Terry Peters, PhD, Robarts Research Institute (Technical Leader)
Neal Clinthorne, PhD, Xoran Technologies, Inc.
Dorian Cojocaru, PhD, University of Craiova
Matthew Freedman, MD, MBA, Georgetown University Medical Center
Warren Grundfest, MD, University of California at Los Angeles
John Haller, PhD, National Institute of Biomedical Imaging and Bioengineering
Ferenc Jolesz, MD, Brigham & Women’s Hospital
Ali Khamene, PhD, Siemens Corporate Research
Murray Loew, PhD, George Washington University
Micheal Marohn, MD, Johns Hopkins University
Calvin Maurer, PhD, Stanford University
Reuben Mezrich, MD, PhD, University of Maryland
Kensaku Mori, PhD, Nagoya University
Nassir Navab, PhD, Technical University of Munich
Sean O’Donnell, MD, Walter Reed Army Medical Center
Neil Ogden, MS, Food and Drug Administration
Frank Sauer, PhD, Siemens Corporate Research
Predrag Sukovic, PhD, Xoran Technologies, Inc.
Wolfgang Wein, Technical University of Munich
Kenneth Wong, PhD, Georgetown University Medical Center
Brad Wood, MD, NIH Clinical Center
Terry Yoo, PhD, National Library of Medicine

6.1 OVERVIEW: INTRAOPERATIVE IMAGING DEVELOPMENTS

Intraoperative imaging encompasses the use of real-time imaging modalities during the surgical procedure; the use of pre-operative images registered to the patient; and all associated infrastructure that is necessary to enable the effective use of such technologies. This Working Group addressed the use of intraoperative and preoperative imaging modalities including MRI and ultrasound, and the current status of image fusion and registration. The group also discussed visualization, image-guided surgery, tracking of instruments, and the role of new modalities such as optical imaging for diagnosis and for therapy.

The need for integrated imaging systems and improved workflow in today’s operating rooms (ORs) presents both key clinical and technical issues. Poor information availability and information flow from the imaging devices to the operating room are major obstacles to improved intraoperative diagnosis and imaging. This Working Group identified the presence of PACS (picture archiving and communications) systems as almost an impediment to the needs of surgeons. Many hospitals today have “bought into” imaging, but in fact the imaging needs of surgeons cannot be met with stationary PACS whose displays are typically in 2D formats only. For surgeons, the imaging display must be in 3D, be interactive, and also be displayed so the images can be easily consulted by surgeons during a procedure. Functional platforms for a range of equipment that can integrate real-time data from imaging devices are required to meet intraoperative needs, particularly as more complex surgeries are undertaken today.

To develop and use better intraoperative devices in the OR, experts should identify particular tools, appropriate imaging modalities for different surgical procedures, and skill sets that are required for undertaking certain procedures. They should also focus on the best ways to do a procedure using imaging technologies.


6.2 CLINICAL ISSUES: THE STATE OF INTRAOPERATIVE IMAGING

The clinical need for increased use of imaging in the OR that is acquired pre- as well as intraoperatively is driven by the increasing desire to take advantage of minimally invasive procedures for the treatment of disease throughout the human body. The goal of being able to perform “therapy” at a target site while avoiding the “surgery” necessary to gain access to that site is a clear objective that can reduce patient trauma and potentially decreases the cost of treatment delivery.

State of imaging today. Intraoperative imaging technologies that are currently available include ultrasound, endoscopes/laparoscopes, nuclear probes, and gamma pens. These modalities are being used possibly more so than magnetic resonance imaging (MRI) and computed tomography (CT) at some leading U.S. institutions. In addition, optical laparoscopic imaging is widely used and biologic spectroscopy is being used particularly for certain applications such as identifying cervical neoplasia.

However, the integration capabilities of most available imaging modalities are limited. Images acquired during a procedure are typically neither integrated nor displayed with pre-operative images. Imaging modalities are not used routinely in the OR.

Development of the field. Access to integrated images that are obtained prior to and during surgical procedures is key for improving today’s surgeries. However, this need is not shared by everyone in the medical community. In community hospitals, for instance, which have limited imaging systems on hand, integration is not only a non-issue, but the need for having and using new imaging technologies is not voiced by older surgeons, who feel that they already “know the anatomy.” More education and training about the value of advanced imaging is therefore warranted.

Furthermore, tasks and staffing approaches must be adapted to multimodality imaging environments. For instance, pre-planning and simulation prior to surgery are necessary as 3D modeling should be done prior to going into the OR. Therefore, surgical staffs must be trained and well-versed in performing these pre-surgery functions. In addition, more technical personnel need to be included on the surgical team for operating the imaging equipment. Other trained and educated OR staff, such as nurses and OR coordinators, have to “buy in” to using the equipment and scheduling its use. According to one Working Group member: “If [imaging modalities] are difficult to use, people don’t use them – the energy barrier is too great to simply have the image show up.”

Operating rooms themselves need to be reconfigured for more effective use to be made of advanced imaging. This Working Group noted that the traditional OR was not designed for today’s complex workflow and for using complicated technology such as MRI or CT. New designs are needed to obtain adequate intraoperative visualization of integrated images. There is also a pressing need to develop appropriate display systems (LCD panels, virtual screens, and so on) that suit clinical needs in terms of size and placement in the OR.


Figure 6: 3D laser ablation therapy
(courtesy of Ferenc Jolesz, MD, Brigham and Women’s Hospital)


6.3 TECHNICAL REQUIREMENTS: NEEDED IMPROVEMENTS IN IMAGING QUALITY AND EFFICACY

Making intraoperative imaging a clinically useful and welcomed option requires technical teams of developers to address the following needs.

1. Improved image quality and image guidance. Intraoperative imaging quality in its current state is deemed to be poor, overall. Its adequacy is also in question. Particularly, this Working Group noted that PACS systems (which are, in the main, tools for radiologist to view medical images – not tools for surgeons) available in the OR rarely have a 3D imaging capability available. Typical PACS in the OR tend to simply duplicate the “wall-of-film” approach used outside of the OR: that is, they mimic the way plain films are displayed in the radiology reading room. As such, they cannot meet the needs of surgeons for intraoperative, real-time imaging and display.

Not only improved quality but also improved image guidance systems are needed to meet surgical requirements. PACS systems without 3D capabilities do not allow for routine surgical planning. To illustrate this point, an example was provided indicating the different imaging needs of radiologists and neurosurgeons working with an aneurysm. Radiologists need to specifically visualize the aneurysm, while surgeons must be able to visualize the real-time surgical process. Therefore, surgeons need 3D capabilities so that they can assess the aneurysm and blood vessels from multiple dimensions and determine the surgical directions that they must take.

2. Improved reliability of image tracking. More reliable tracking of images that are taken during surgical procedures may be particularly helpful to meet the need for improved guidance during surgeries. A related need is for an automated data keeping system or book marking technique to identify and archive images taken in MR, CT, and a variety of other imaging formats during different phases of surgery.

3. Improved registration techniques. Registration needs must also be addressed by technical teams who should be tasked with developing a standardized or common methodology. Vendor-specific algorithms that are used today for some modalities are inadequate for many purposes. Standardization of a universal imaging and registration methodology is a key element on which to build navigational systems (robotic or otherwise) that are able to use registered data. Ideally, in addition, an advanced image-based system may be developed that is smart enough to manipulate images and co-register them, as needed.

4. Improved segmentation process. Segmentation is seen as an important part of intra-operative image utilization. First and foremost, it needs to be applied to the 3D source images in order to extract any sort of surface information from them, for the purpose of registering images via surface matching, or providing realistic organ visualization during the procedure. However, segmentation is not a feature typically provided by most commercial visualization packages. Segmentation also falls into the category of “tampering with the data,” in the sense that any rule applied to an image to define a surface will inevitably compromise the data to some extent. It is clear that universal segmentation algorithms are unlikely to ever become entirely automatic. Hence there is a need for intuitive interfaces to permit human intervention in the selection of the desired region, as well as to provide an evaluation of the consistency of the results.

Key technical requirements in intraoperative diagnosis and imaging are:

  • flexible imaging and registration systems to integrate both current and developing imaging systems, preferably using only one standard imaging platform for all of the imaging modalities.
  • adaptable, modular systems for increased use of multimodality imaging in the OR.
  • optimum means for visualizing fused images and images registered to the patient’s anatomy, such as those used in image-guided systems.


6.4 RESEARCH PRIORITIES

Research Needs. This working group identified six research tasks that are essential for advancing the field of intraoperative imaging:

  1. Developing targeted imaging integration systems. Integrated displays that allow multiple imaging modalities to be visualized simultaneously must be designed. There is also a need for integrated tracking and registration across modalities, and across tools and other equipment so that all data are inherently registered to a single, common coordinate system.
  2. Developing advanced registration techniques. Technique must be developed to integrate preoperative imaging with 3D real-time intraoperative imaging. There is also a need to research effective error measurement, particularly for use with non-rigid image registration.
  3. Developing as-needed clinically directed imaging systems. Instead of bringing current/traditional radiology systems into the OR, new imaging systems should be designed from the ground up, based on the requirements of the OR. Similarly, there is a need for better clinically related training of biomedical engineers, so that they can move from the “bench to the bedside” and be better able to address these clinical design issues.
  4. Developing a standardized nomenclature. There is a pressing need to develop a standardized, common language for describing how images have been formatted.
  5. Identifying specific surgical needs for intraoperative imaging. More research should be focused on identifying types of imaging that are needed today and in the Operating Room of the Future (ORF). Note: This conclusion is based on knowledge of today’s technologies, not on advances like molecular imaging which, as this Working Group recognizes, could very well change the kinds of surgeries and treatments that are practiced in the ORF. However, there is a need to study today’s imaging modalities, including functional MR and position emission tomography (PET), as the building blocks on which future developments will be based. For example, researchers need to examine potential uses of optical and molecular imaging data that can be co-registered with high-resolution anatomical imaging to improve surgical approaches to tumors.
  6. Evaluating outcomes resulting from use of intraoperative imaging. The value of intraoperative imaging still needs to be better established. Standards must also be developed by which to compare images that are integrated. These standards would allow the medical community to conclude, for example, that fusion of MR and PET is better than fusion of CT and PET.

Research Priorities. Planning for these research developments must take a two-fold approach. Activities must focus on:

  1. Lobbying industry and individual manufacturers to build imaging products that enable intraoperative integration. Developers, until now, have created for the most part stand-alone proprietary imaging systems. DICOM has been offered as a step toward standardizing imaging formats across manufacturers. Each imaging equipment manufacturer, however, still maintains proprietary fields relating to certain aspects of the images. As a result of this practice, generic software cannot deal seamlessly with multiple imaging modalities that are generated from different manufacturers’ equipment.
  2. Persuading large purchasers of imaging equipment, such as the military, to require that imaging systems meet certain standards and compatibility requirements. A market-driven approach may result in workable intraoperative imaging systems for the ORF.