Introduction
The promotion of research involving cardiovascular ultrasound is part of the mission of the American Society of Echocardiography (ASE). For years, the ASE has awarded research grants to fund meritorious research by its members. The society’s journal, the Journal of the American Society of Echocardiography , and the ASE’s Annual Scientific Sessions provide venues for the publication and presentation of high-quality research. However, declining availability of federal funding for research has posed challenges for investigators, including those involved with cardiovascular ultrasound. In 2010, Dr. Sanjiv Kaul, then the ASE president, and others believed that a strategic planning session to outline goals and develop an action plan would be valuable to the ASE and its members. Thus, that year, the ASE held the first ASE Technology and Research (as in Technology and Research Summit) Summit in Chicago, preceding the Annual Scientific Sessions of the American Heart Association. To draft a roadmap for cardiovascular ultrasound research, the summit brought together academic echocardiographers, scientists, acoustic physicists, ultrasound engineers from various companies, and a staff member from the National Institutes of Health (NIH). Over the full-day meeting, several research and technology areas of topical interest with a potential for growth in the near future were discussed. These included the assessment of global and regional left ventricular (LV) function, regional myocardial perfusion, molecular imaging, therapeutic ultrasound, peripheral arterial disease, handheld ultrasound, and future technology, including sensor technology, miniaturization, and small-animal imaging systems. Additional emphasis was placed on funding training programs to attract young scientists to the field of echocardiography. A white paper 1 was published in the Journal of the American Society of Echocardiography on the basis of the proceedings of that summit. The white paper was shared with the NIH, and a meeting was held to discuss the issues in the report with leadership of the NIH at its Bethesda, Maryland, premises. It was determined at that time that a technology and research summit dedicated to echocardiography would be held every 2 years under the auspices of the ASE.
Additional accomplishments stemming from the 2010 meeting included the partnership with the European Association of Cardiovascular Imaging for the creation of a standardization task force, the Initiative to Standardize Deformation Imaging, consisting of members of the ASE, the European Association of Cardiovascular Imaging, and the Japanese Society of Echocardiography, engineers from various companies, and scientists from academia. This task force was established to respond to the need to create system-independent means for assessing regional and global cardiac function using tissue-based sampling. This task force has been meeting on a regular basis, and considerable progress has been made in its mandated task. Additionally, a guidelines and standards document concerning handheld and point-of-care ultrasound is nearing completion.
The 2012 summit was developed to build on the success of the 2010 event. With the mission of assessing the state of the art of echocardiography and projecting areas of future growth, the summit focused on a vision for the development of cardiovascular ultrasound technology and clinical research by 2020, including the necessary research infrastructure, with a particular emphasis on three-dimensional (3D) echocardiographic imaging, cardiovascular ultrasound in valvular heart disease (VHD), myocardial deformation, and therapeutic ultrasound. Participants were encouraged to describe the current issues and barriers, plan goals, and develop specific recommendations to chart the future of research and technology in cardiovascular ultrasound. The following sections summarize the summit recommendations, and key recommendations are provided in Table 1 .
| I. Administrative/infrastructure |
| a. Establish a council to bring together ultrasound engineers, scientists, the NIH, the FDA, and cardiologists |
| b. Establish a bioengineering research partnership to conduct basic and translational research supporting sonothrombolysis and ultrasound-targeted drug or gene delivery |
| c. Create an inventory of research training resources |
| d. Explore the development of imaging registries that interface with other clinical and research data sets |
| II. Guidelines and standards |
| a. Develop requirements and standards for echocardiography core labs |
| b. Develop standards for managing, storing, and assessing large 3D data sets |
| c. Standardize 3D imaging protocols, measurements, and displays |
| d. Develop a vendor-independent system to reproducibly, readily, and accurately measure myocardial deformation |
| III. Software/hardware development |
| a. Develop intelligent software to improve the quality and efficiency of echocardiographic imaging |
| b. Develop automated software quantification tools for 3D imaging |
| c. Improve 3D image quality and transducer design |
| d. Develop and validate automated methods for quantification of flow |
| e. Improve catheter and device visualization by echocardiography |
| f. Develop a vendor-independent automated system to measure myocardial deformation |
| IV. Research topics |
| a. Document the value, reproducibility, and feasibility of quantitative echocardiographic biomarkers |
| b. Conduct clinical trials demonstrating the cost-effectiveness and impact on outcomes of echocardiography |
| c. Perform clinical trials demonstrating the comparative effectiveness of Doppler echocardiography compared with other imaging modalities in TVT |
| d. Establish multicenter clinical trials in sonothrombolysis and targeted gene and drug delivery |
Selected Readings
- 1.
Kaul S, Miller JG, Grayburn PA, Hashimoto S, Hibberd M, Holland MR, et al. A suggested roadmap for cardiovascular ultrasound research for the future. J Am Soc Echocardiogr 2011;24:455-64.
Cardiovascular Ultrasound Technology Development
The panel discussed three broad goals relating to future ultrasound technology development. These were (1) to use proven technology to improve the quality of patient care, (2) to advance the diagnostic and therapeutic capabilities of ultrasound, and (3) to enhance the future development of cardiovascular ultrasound by increasing collaboration among engineers, scientists, the NIH, the Food and Drug Administration (FDA), and cardiologists.
Goal 1: Use Proven Technology to Improve the Quality of Patient Care
Doppler echocardiography is a highly useful diagnostic test in the evaluation of patients with known or suspected heart disease. The increasing numbers of at-risk cardiac patients in the United States and throughout the world may preclude them from accessing a limited number of centers of excellence for cardiovascular care, but it is reasonable to expect that they can have access to echocardiographic examinations performed with high-quality, affordable echocardiographic instrumentation. Just as advancing electronic technology has enabled handheld or hand-carried echocardiography equipment with satisfactory performance, electronic technology can soon enable the production by many companies of low-cost, highly mobile equipment with two-dimensional (2D) and Doppler echocardiographic performance approaching that of the highest performance equipment available today.
Intelligent software should be developed to improve quality and efficiency. Such software, developed jointly by the ASE and industry with encouragement by the NIH and the FDA, can provide real-time feedback during echocardiographic examinations (James B. Seward, MD, personal communication). Perhaps the easiest place to start is with a minimal set of standardized measurements and image and Doppler assessments, tailored to the indications for the examination, which are prompted by the echocardiographic machine and analyzed instantly by machine software. Depending on the initial results, the software could indicate whether the results are normal, or it could prompt additional image or Doppler views or measurements to gain further information required for adequate diagnosis or to resolve inconsistencies in the measurements taken.
The further development of intelligent software and echocardiographic machines with the optimum combination of quality, features, and affordability should be accelerated by the collaboration of engineers from the manufacturers with expert physicians from the ASE to develop products that achieve wide market acceptance. This technology will result in improved safety, accuracy, and quality of patient care.
Recommendations
- 1.
Develop cardiovascular ultrasound systems with the optimum combination of quality, features, portability, and affordability.
- 2.
Develop intelligent software to provide real-time feedback during echocardiographic examinations to improve diagnostic quality and time efficiency.
Goal 2: Advance the Diagnostic and Therapeutic Capabilities of Ultrasound
Two-dimensional transducer arrays and high-speed 3D imaging were broadly identified as the most important enabling technologies that facilitate advancement of the diagnostic and therapeutic capabilities of cardiac ultrasound. The potential directions for new diagnostic and therapeutic capabilities are far-reaching and exciting.
New 2D array transducers (for 3D images), much higher frame rates, greater data acquisition, and greater processing speeds and memory capacities, combined with radically new anatomic and physiologic functional analysis methods and image mapping, will bring about new diagnostic tests that yield far more information than is presently possible. In the future, imaging of cardiac anatomy and function will routinely be done in three dimensions, with strain mapping, electromechanical wave mapping, and synchronization tracking. This will present new challenges and barriers, because the greater amount of additional data will require new evaluation methods and standards, as well as new training and implementation among users and user groups.
New noninvasive ultrasound therapy applications, such as sonothrombolysis, histotripsy, and high-intensity focused ultrasound could make it possible to perform interventions that are currently performed invasively. For example, new noninvasive techniques that make use of high–mechanical index acoustic levels might be able to dissolve intravascular clots using 3D ultrasound transducers. In addition, histotripsy, which makes use of pulsed, high-intensity focused ultrasound, will enable the disintegration of thrombi in deep vessel thrombosis. For conduction problems such as atrial fibrillation, targeted ablation methods will make it possible to resolve these issues noninvasively. These noninvasive techniques could bring new opportunities for treatment that can begin earlier and with abbreviated time for recovery, thus positively affecting patient outcomes. Thus, the technologic development to make this feasible should become a priority.
New quantitative ultrasound tissue characterization could play a significantly greater role in the evaluation of cardiac and vascular tissues for both diagnosis and treatment. This technique uses many parameters besides backscatter to compute quantitative indices relating to tissue properties. These include the speed of sound, attenuation, strain, temperature, and higher order statistics. For example, it should be possible to noninvasively image and quantitatively identify ischemic and infarcted tissue, as well as clearly delineate coronary stenoses and characterize the size and type (hardness or softness) of plaques, as well as the presence of calcification. It should also be possible to image infarct size and volume, as well as follow the progress of intervention therapy, using of this technique. Beyond this, quantitative ultrasound tissue characterization should also make it possible to evaluate cardiac tissue texture and density, as well as calcifications and the presence of fibrosis, among many other possibilities.
Recommendations
- 1.
The development of capabilities in 3D imaging of cardiac anatomy and function with strain mapping, electromechanical wave mapping, and synchronization tracking must continue.
- 2.
The much greater amount of resulting data will require development of new evaluation methods and standards and new training and implementation among users.
- 3.
New noninvasive ultrasound therapy applications, such as sonothrombolysis, histotripsy, and high-intensity focused ultrasound, which have great potential for improving outcomes, must continue to be developed.
- 4.
New quantitative ultrasound tissue characterization methods must be further developed to evaluate cardiac and vascular tissues. These image methods offer opportunities for the early detection and treatment of disease.
Goal 3: Develop an Ongoing Forum for Promoting Interaction among Ultrasound Engineers, Scientists, the NIH, the FDA, and Cardiologists
A mechanism to facilitate the ongoing collaboration of noncardiologist scientists and engineers in ASE activities is needed. This would facilitate the two-way communication required to accelerate the development and implementation of techniques, hardware, and software to enhance the capabilities of echocardiography. The ASE was encouraged to develop a mechanism to include such individuals and create a forum for discussion on a regular, ongoing basis.
Additionally, enhancing the awareness of individuals serving in funding and regulatory governmental roles (such as the NIH and the FDA) of current capabilities and future potential of echocardiography for improved patient care is also required to speed technology development. The ASE was encouraged to develop a mechanism to increase the participation of these organizations in the ongoing dialogue regarding technology, device, and drug development.
Recommendation
- 1.
The ASE should develop a mechanism to include scientists, engineers, and those involved with research funding in forums for discussion on a regular, ongoing basis.
Selected Readings
- 1.
Lee WN, Provost J, Fujikura K, Wang J, Konofagou EE. In vivo study of myocardial elastography under graded ischemia conditions. Phys Med Biol 2011;56:1155-1172.
- 2.
Provost J, Lee WN, Fujikura K, Konofagou EE. Imaging the electromechanical activity of the heart in vivo. Proc Natl Acad Sci U S A 2011;108:8565-8570.
- 3.
Xie F, Slikkerveer J, Gao S, Lof J, Kamp O, Unger E, et al. Coronary and microvascular thrombolysis with guided diagnostic ultrasound and microbubbles in acute ST segment elevation myocardial infarction. J Am Soc Echocardiogr 2011;24:1400-1408.
- 4.
Maxwell AD, Cain CA, Duryea AP, Yuan L, Gurm HS, Xu Z. Noninvasive thrombolysis using pulsed ultrasound cavitation therapy—histotripsy. Ultrasound Med Biol 2009;35:1982-1994.
Cardiovascular Ultrasound Technology Development
The panel discussed three broad goals relating to future ultrasound technology development. These were (1) to use proven technology to improve the quality of patient care, (2) to advance the diagnostic and therapeutic capabilities of ultrasound, and (3) to enhance the future development of cardiovascular ultrasound by increasing collaboration among engineers, scientists, the NIH, the Food and Drug Administration (FDA), and cardiologists.
Goal 1: Use Proven Technology to Improve the Quality of Patient Care
Doppler echocardiography is a highly useful diagnostic test in the evaluation of patients with known or suspected heart disease. The increasing numbers of at-risk cardiac patients in the United States and throughout the world may preclude them from accessing a limited number of centers of excellence for cardiovascular care, but it is reasonable to expect that they can have access to echocardiographic examinations performed with high-quality, affordable echocardiographic instrumentation. Just as advancing electronic technology has enabled handheld or hand-carried echocardiography equipment with satisfactory performance, electronic technology can soon enable the production by many companies of low-cost, highly mobile equipment with two-dimensional (2D) and Doppler echocardiographic performance approaching that of the highest performance equipment available today.
Intelligent software should be developed to improve quality and efficiency. Such software, developed jointly by the ASE and industry with encouragement by the NIH and the FDA, can provide real-time feedback during echocardiographic examinations (James B. Seward, MD, personal communication). Perhaps the easiest place to start is with a minimal set of standardized measurements and image and Doppler assessments, tailored to the indications for the examination, which are prompted by the echocardiographic machine and analyzed instantly by machine software. Depending on the initial results, the software could indicate whether the results are normal, or it could prompt additional image or Doppler views or measurements to gain further information required for adequate diagnosis or to resolve inconsistencies in the measurements taken.
The further development of intelligent software and echocardiographic machines with the optimum combination of quality, features, and affordability should be accelerated by the collaboration of engineers from the manufacturers with expert physicians from the ASE to develop products that achieve wide market acceptance. This technology will result in improved safety, accuracy, and quality of patient care.
Recommendations
- 1.
Develop cardiovascular ultrasound systems with the optimum combination of quality, features, portability, and affordability.
- 2.
Develop intelligent software to provide real-time feedback during echocardiographic examinations to improve diagnostic quality and time efficiency.
Goal 2: Advance the Diagnostic and Therapeutic Capabilities of Ultrasound
Two-dimensional transducer arrays and high-speed 3D imaging were broadly identified as the most important enabling technologies that facilitate advancement of the diagnostic and therapeutic capabilities of cardiac ultrasound. The potential directions for new diagnostic and therapeutic capabilities are far-reaching and exciting.
New 2D array transducers (for 3D images), much higher frame rates, greater data acquisition, and greater processing speeds and memory capacities, combined with radically new anatomic and physiologic functional analysis methods and image mapping, will bring about new diagnostic tests that yield far more information than is presently possible. In the future, imaging of cardiac anatomy and function will routinely be done in three dimensions, with strain mapping, electromechanical wave mapping, and synchronization tracking. This will present new challenges and barriers, because the greater amount of additional data will require new evaluation methods and standards, as well as new training and implementation among users and user groups.
New noninvasive ultrasound therapy applications, such as sonothrombolysis, histotripsy, and high-intensity focused ultrasound could make it possible to perform interventions that are currently performed invasively. For example, new noninvasive techniques that make use of high–mechanical index acoustic levels might be able to dissolve intravascular clots using 3D ultrasound transducers. In addition, histotripsy, which makes use of pulsed, high-intensity focused ultrasound, will enable the disintegration of thrombi in deep vessel thrombosis. For conduction problems such as atrial fibrillation, targeted ablation methods will make it possible to resolve these issues noninvasively. These noninvasive techniques could bring new opportunities for treatment that can begin earlier and with abbreviated time for recovery, thus positively affecting patient outcomes. Thus, the technologic development to make this feasible should become a priority.
New quantitative ultrasound tissue characterization could play a significantly greater role in the evaluation of cardiac and vascular tissues for both diagnosis and treatment. This technique uses many parameters besides backscatter to compute quantitative indices relating to tissue properties. These include the speed of sound, attenuation, strain, temperature, and higher order statistics. For example, it should be possible to noninvasively image and quantitatively identify ischemic and infarcted tissue, as well as clearly delineate coronary stenoses and characterize the size and type (hardness or softness) of plaques, as well as the presence of calcification. It should also be possible to image infarct size and volume, as well as follow the progress of intervention therapy, using of this technique. Beyond this, quantitative ultrasound tissue characterization should also make it possible to evaluate cardiac tissue texture and density, as well as calcifications and the presence of fibrosis, among many other possibilities.
Recommendations
- 1.
The development of capabilities in 3D imaging of cardiac anatomy and function with strain mapping, electromechanical wave mapping, and synchronization tracking must continue.
- 2.
The much greater amount of resulting data will require development of new evaluation methods and standards and new training and implementation among users.
- 3.
New noninvasive ultrasound therapy applications, such as sonothrombolysis, histotripsy, and high-intensity focused ultrasound, which have great potential for improving outcomes, must continue to be developed.
- 4.
New quantitative ultrasound tissue characterization methods must be further developed to evaluate cardiac and vascular tissues. These image methods offer opportunities for the early detection and treatment of disease.
Goal 3: Develop an Ongoing Forum for Promoting Interaction among Ultrasound Engineers, Scientists, the NIH, the FDA, and Cardiologists
A mechanism to facilitate the ongoing collaboration of noncardiologist scientists and engineers in ASE activities is needed. This would facilitate the two-way communication required to accelerate the development and implementation of techniques, hardware, and software to enhance the capabilities of echocardiography. The ASE was encouraged to develop a mechanism to include such individuals and create a forum for discussion on a regular, ongoing basis.
Additionally, enhancing the awareness of individuals serving in funding and regulatory governmental roles (such as the NIH and the FDA) of current capabilities and future potential of echocardiography for improved patient care is also required to speed technology development. The ASE was encouraged to develop a mechanism to increase the participation of these organizations in the ongoing dialogue regarding technology, device, and drug development.
Recommendation
- 1.
The ASE should develop a mechanism to include scientists, engineers, and those involved with research funding in forums for discussion on a regular, ongoing basis.
Selected Readings
- 1.
Lee WN, Provost J, Fujikura K, Wang J, Konofagou EE. In vivo study of myocardial elastography under graded ischemia conditions. Phys Med Biol 2011;56:1155-1172.
- 2.
Provost J, Lee WN, Fujikura K, Konofagou EE. Imaging the electromechanical activity of the heart in vivo. Proc Natl Acad Sci U S A 2011;108:8565-8570.
- 3.
Xie F, Slikkerveer J, Gao S, Lof J, Kamp O, Unger E, et al. Coronary and microvascular thrombolysis with guided diagnostic ultrasound and microbubbles in acute ST segment elevation myocardial infarction. J Am Soc Echocardiogr 2011;24:1400-1408.
- 4.
Maxwell AD, Cain CA, Duryea AP, Yuan L, Gurm HS, Xu Z. Noninvasive thrombolysis using pulsed ultrasound cavitation therapy—histotripsy. Ultrasound Med Biol 2009;35:1982-1994.
Cardiovascular Ultrasound Clinical Research
Numerous issues must be addressed to maintain and expand the use of echocardiography in clinical research. However, among the most important issues are (1) demonstrating that echocardiographic measures can be used as surrogates for outcomes or improved outcomes; (2) the optimization of echocardiographic core lab operations, accuracy, and reproducibility; (3) the development of processes that will ensure that all enrolling sites and operators at the point of research can obtain the proper images required for clinical trials; and (4) the development of a registry of echocardiographic information (and eventually images) that can serve as a platform for quality improvement and clinical research.
Goal 1: Prove That Echocardiographic Measures Can Be Used as Surrogates for Outcome
The strengths of echocardiography remain the quantification of cardiac structure and function by a noninvasive technique that is free of ionizing radiation, relatively inexpensive, universally available, and mobile enough to be performed in almost any venue. However, for it to maintain a key position in clinical research, investigators must ensure that important clinical questions motivate the research rather than hypotheses that just tout the technical capabilities of echocardiography. For example, efforts must be made to demonstrate that echocardiographically quantified parameters correlate with or improve care decisions and outcomes. 1 In particular, the echocardiography community should pursue efforts to satisfy regulatory requirements for establishing the value and practicality of a few select, quantitatively important echocardiographic biomarkers (such as LV ejection fraction and LV mass) by enacting education and policy strategies to ensure their consistency and reproducibility regardless of equipment, patient, or time scanned. In addition, because researchers often must choose a single modality, the relative accuracy and feasibility of echocardiography in clinical research compared with other modalities must be clarified. Funding from federal agencies such as the NIH and the Patient-Centered Outcomes Research Institute is likely to be critical to accomplish these trials. It will also be important to demonstrate that the results obtained in trials comparing imaging modalities are generalizable to the community rather than just reflecting results obtained in academic medical centers.
Recommendations
- 1.
Design and perform multicenter studies that identify and link the performance of echocardiography and resulting echocardiographic findings to patient outcomes, improved care, and reduced costs.
- 2.
Formally qualify quantitative echocardiographic variables as clinical research biomarkers through a process akin to that followed for radiologic biomarker development ( ).
- 3.
Perform research that demonstrates the accuracy of echocardiographic measures such as cardiac chamber size, ventricular systolic and diastolic function, LV mass, and valve function directly compared with other competing modalities.
Goal 2: Develop Standardized Operations for Echocardiography Core Laboratories
Many clinical trials rely on echocardiographic measures confirmed by core laboratories. These uses range from patient qualification for enrollment to quantifying predefined end points in phase 2 and 3 trials of drugs and devices to monitoring of cardiac safety through postmarket surveillance studies. For echocardiography to be the imaging test of choice for these operations, the ASE must demonstrate that echocardiography core labs provide reproducible and reliable data and that these results are comparable and reproducible from core lab to core lab. To demonstrate such reproducibility and adherence to standards, it would be logical to expand on previously defined best practices with the creation of minimal standards for echocardiographic core laboratory operations. 2 Such standards could be used in the future to inform regulatory policy regarding imaging in clinical trials and, if desired, to create an accreditation process for such core labs.
In addition to ensuring high-quality data output from core labs, there are issues surrounding the logistics and regulatory compliance of transmitting, processing, and archiving thousands of images and data sets. A network of core labs working with technology developers should establish the necessary minimum standards for this aspect of core lab and clinical research operations.
Recommendations
- 1.
A task force should be formed to develop core lab minimum standards for operations and set minimum standards for reproducibility (within and between labs).
- 2.
Perform research establishing core lab best practices and reproducibility standards, including demonstrating their validity in improving the scientific goals and efficiency of trials.
Goal 3: Optimize Imaging at Points of Research
Because echocardiography is ubiquitous in clinical care, extraction of the images from the clinical care environment for use in clinical research would be an important advance. For this to succeed, standardization of image protocols, measurement conventions, and reports are necessary along with simple tools to ensure that patients’ health information is protected. These steps will enable the creation of large-scale registries or research imaging networks. In such a model, data elements from the echocardiographic report or database (rather than the actual images) could be transferred to central repositories and then used for a wide variety of investigations. However, such a model can succeed only if high-quality, standardized images are obtained and universal definitions and quality standards are used for reporting results. For example, all sites participating in such an imaging network would need to classify findings in an identical fashion. This is in contrast to the current state of affairs, whereby some laboratories report moderate mitral regurgitation and others report it as 3+ mitral regurgitation, and the criteria used to determine the severity of the regurgitation vary significantly.
Research must be performed to identify and refine those educational tools that most effectively and efficiently teach sonographers and echocardiographers proper image acquisition and measurement conventions for research applications. This may take the form of webinars, the use of social media sites for interactive training, and even instructional videos that can be viewed on smart phones and other portable communication devices.
In addition, research efforts should explore the creation of “smart” echocardiographic machines with embedded real-time decision support. Such tools could initially include “ideal image” templates for operators to mimic and searchable guidelines. More advanced tools could include automated methods that show the user when an image is adequate for the particular research application. This may take the form of on-screen schematics of properly aligned images, prompts that inform the sonographer when an image matches a model image for that required view, notification that a 3D data set is adequate for cropping and quantification, integration of wireless communication capabilities on the machine for the sonographer to communicate with core labs, and easy-to-use tools that anonymize and transfer Digital Imaging and Communications in Medicine (DICOM) image sets to research archives. Also critical will be automated measurement capabilities that reduce measurement variability and ensure uniformity of measurements across different echocardiography machines. Last, electronic health record modules are required for seamless transfer of the results to a database.
Recommendation
- 1.
Develop real-time tools that can be used by imagers in clinical echocardiography laboratories to ensure that reproducible, standard images can be obtained for research applications.
Goal 4: Create Echocardiographic Data Registries
Registries currently exist for many cardiovascular procedures, such as angioplasty, cardiac surgery, device implantation, and some aspects of care, including acute coronary syndromes and outpatient care. 3,4 These registries have been important tools to assess and improve the quality of care and are valuable platforms for clinical research. To date, imaging registries have been hampered by a lack of data standards and limited use of electronic health records. However, these barriers are being addressed, and there is increasing need for such data from both the regulatory and health care reform sectors, making such an undertaking more feasible in the future. Such registry data would be accessible to the research community, facilitating a broad range of clinical research on the effectiveness of echocardiography for the improvement of patient management and outcomes.
Recommendations
- 1.
Perform research to identify important echocardiographic variables for a cardiovascular imaging registry.
- 2.
Complete efforts to develop and disseminate a full set of echocardiographic data elements formally approved by Clinical Data Interchange Standards Consortium and Health Level 7 and published in the Cancer Data Standards Registry and Repository hosted by the National Cancer Institute.
- 3.
Develop standardized echocardiographic reports that enable seamless transfer of report data to cardiovascular imaging registries.
- 4.
The ASE should explore the operational and financial feasibility of creating a national echocardiography registry.
Selected Readings
- 1.
Douglas PS, Taylor A, Bild D, Bonow R, Greenland P, Lauer M, et al. Outcomes research in cardiovascular imaging: report of a workshop sponsored by the National Heart, Lung, and Blood Institute. JACC Cardiovasc Imaging 2009;2:897-907.
- 2.
Douglas PS, DeCara JM, Devereux RB, Duckworth S, Gardin JM, Jaber WA, et al. Echocardiographic imaging in clinical trials: American Society of Echocardiography standards for echocardiography core laboratories: endorsed by the American College of Cardiology Foundation. J Am Soc Echocardiogr 2009;22:755-766.
- 3.
Bufalino VJ, Masoudi FA, Stranne SK, Horton K, Albert NM, Beam C, et al. The American Heart Association’s recommendations for expanding the applications of existing and future clinical registries: a policy statement from the American Heart Association. Circulation 2011;17:2167-2179.
- 4.
Messenger JC, Ho KL, Young CH, Slatter LE, Draoui JC, Curtis JP, et al. The National Cardiovascular Data Registry (NCDR) data quality brief: the NCDR Data Quality Program in 2012. J Am Coll Cardiol 2012;60:1484-1488.
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