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NHLBI Working Group
Image-Guided Intervention
Executive Summary

The National Heart, Lung, and Blood Institute (NHLBI) convened a Working Group (WG) of investigators on September 21, 2006, in Bethesda, Maryland, to advise the NHLBI on new research directions needed to advance the development of image-guided interventions for cardiovascular disease. Image-guided interventions offer the promise of effective therapy for cardiovascular disease while minimizing complications associated with open surgical procedures or extended cardiopulmonary bypass.

Discussion:

The WG examined several aspects of image-guided intervention, including imaging techniques, intervention planning, and instruments, in the context of cardiovascular disease. In contrast to other diseases or other organs, precise intervention in the cardiovascular system – for example, in a beating heart – requires high-resolution imaging in real time. A broad range of technologies will play a role in image-guided interventions, including magnetic resonance imaging, ultrasound, X-ray and computed tomography, and optical imaging technologies. Magnetic resonance and 3D ultrasound imaging are currently acceptable for some interventions but lack adequate spatial or temporal resolution for others. Development continues on these imaging modalities, plus others such as optical catheter imaging, but the potential improvement is constrained by the underlying physics.

No single imaging modality adequately addresses the requirements of image-guided intervention. Consequently, multimodality imaging is needed, which requires sophisticated techniques for image registration, complex displays, and human interfaces. The greatest clinical utility will come from combining images from different modalities together with images at different resolutions and images from different times in the progress of the disease. However, the image processing techniques and software needed to accomplish such image registration and fusion have not been fully developed or standardized. Libraries of both normal and pathological images would hasten development of these image processing techniques and software. Sophisticated tools for interventional and surgical planning will come from combining images together with computational models of blood flow and tissue mechanics. However, essential model validation and tissue characterization have not been completed.

The lack of compatible instruments and devices is a significant obstacle to the development of image-guided interventions for cardiovascular disease. Instruments and devices must be developed that can be seen and tracked by the corresponding imaging technique but are easier to use and more functional than existing instruments. Instruments that incorporate imaging technology, such as miniature ultrasound transducers, will improve the functionality of both the instrument and the imaging technique. Independent of imaging considerations, existing surgical instruments would benefit from miniaturization, additional degrees of rotational freedom, and sensors for fine haptic feedback. Moreover, instruments and devices must accommodate a broad variety of patient size and anatomy, particularly for pediatric applications. There are no facilities for the limited production of pre-clinical and clinical prototype instruments and devices of adequate quality for use in clinical studies.

Further development of image-guided intervention for cardiovascular disease requires collaboration between academic institutions that produce the innovation and business partners that produce the tools. This work requires the resources of large businesses and the ability to collaborate with small businesses. Funding mechanisms must encourage and enable collaborations with both large and small business partners.

Recommendations :

Establish engineering research centers to design and build compatible pre-clinical and clinical prototypes for image-guided interventions, e.g., catheters and surgical or interventional tools and devices.
Develop novel devices, instruments, materials, and manufacturing technologies for image-guided and patient-specific interventional procedures, including multi-modality images and instrumentation.
Develop image-based procedure planning tools that incorporate patient-specific mechanics and flow dynamics for interventional procedures.
Partner with an appropriate agency, such as the National Library of Medicine, to establish a repository for use by the imaging and image-guided intervention communities of cardiovascular imaging data, including pre-operative, intra-operative, and post-operative data.
Develop open-source standards and software modules for image processing, registration, segmentation, fusion, and instrument tracking for pre-operative planning and real-time cardiovascular interventions to enhance system interoperability.
Develop education and training programs for hands-on and didactic training in image-guided intervention. Large grants should include an education component as part of their dissemination plans.

Publication Plans:

The WG is planning to publish a formal report, which will include an overview of the field and review of the literature, as well as these recommendations. The report will be posted on the NHLBI public web site with a link to any peer-reviewed journal or journals where the report is published. The anticipated publication date is 2007.