"...Accepted into the Smithsonian Permanent Research Collection of Information Technology."

Carol S. Evans (Fannin), Tommie Morgan, Ph.D., Robert Wey, M.D.
April 6, 1998

1998 Innovation Collection
Application Nominated:	Cineless Cardiac Catheterization Laboratories
Organization Name:	Methodist Heart Center
Category:	Medicine

Long Summary

Please describe your application and the information technology used in conjunction with it. Please keep your language simple and your explanations non-technical.

The Methodist Heart Center was conceived and built to establish a dedicated cardiac care center and facility incorporating the latest clinical and technological concepts available. It was to become the first comprehensive new heart care center dedicated to digital cardiac imaging systems in Texas and in the United States. The patient population served emphasized north west and north central Texas but also attracted patients from all of Texas, surrounding states and Mexico. The clinical vision of Dr. Robert Wey, other cardiologists, and Lubbock Methodist Hospital administration required a facility that would support the delivery of the latest developments in cardiac patient care incorporating the newest computer controlled digital x-ray imaging and nuclear medicine imaging systems available. The major challenge was in identifying and quantifying the necessary clinical and technical performance necessary to fulfill the clinical challenge. This task was the responsibility of Ms. Carol Fannin, Methodist Heart Center Administrative Director of the Cardiac Catheterization Department, and a consultant, Dr. Tommie Morgan of Morgan Consulting, Inc. The task required detailed analysis of each aspect of the services to be provided by the cardiac catheterization laboratories and how the latest computer technology could be incorporated to decrease the time required to deliver the needed care while improving the quality of care delivered. This task was divided into two major components, with close coordination and collaboration required between Ms. Fannin and Dr. Morgan, to ensure that the clinical and technological concerns were consistent. The clinical requirements were analyzed and those areas which could be improved through computerization were identified. The technical requirements of each were analyzed and the necessary performance quantified. This performance quantification became the basis for all of the computerized digital imaging and support equipment acquisitions, including the computer controlled digital x-ray imaging systems.

The clinical concept was to have a facility which offered full cardiac care twenty-four hours a day with all aspects of the care computerized to the fullest extent possible. Consistent with this concept, it was necessary to identify the mechanisms required to move the massive amounts of digital information acquired in digital cardiac imaging procedures. The rapidly evolving digital imaging technology was the area where the most dramatic and beneficial advancement could be incorporated into the new cardiac cath laboratories. It was necessary to first establish what performance digital imaging technology was capable of as well as how the information could be stored/archived to meet the legal requirements of medical information. The second step was to identify the technical solutions to the clinical needs and provide this performance in a more cost effective manner.

The six (6) digital Toshiba cardiac imaging systems selected and installed in the catheterization laboratories provided improved filmless digital imaging and archiving for peripheral vascular and intracranial imaging. These digital imaging systems used a Charge Coupled Device (CCD) to acquire 1024 x 1024 digital images, which were displayed on high resolution (nominally 1024 x 1024) progressive image monitors. Each cardiac digital image is comprised of nominally 1 Mbyte of 14 bit data, and for adults is typically acquired at 30 images per second with neonatal and pediatric studies often at 60 images per second. A clinical diagnostic study is typically about 2000 images and an interventional study ranges from 3500 images to as many as 7500 images. The rate of data acquisition is daunting in terms of data handling and the amount of digital data is massive. The combination of the rate and volume of digital data presented major technological challenges, since the data had to be stored/archived essentially simultaneously with the acquisition. An inability to archive the data in a manner transparent to the clinical staff would render the digital imaging systems unworkable. (Anecdotally, it was found that a delay of even one minute was unacceptable to the cardiologists.) The modality selected for archiving the digital image data had to be fast, simple to use and relatively inexpensive since it had to be possible to archive a study individually as well as maintain a master archive of all studies. The diagnostic studies have at least 2 Gbytes of data and interventional studies have as much as 7.5 Gbytes of data. The data archive modality selected was compatible with Toshiba cardiac digital imaging systems and utilized a video broadcast quality digital tape cassette system which was modified and interfaced by Toshiba to the Sony D-2 digital tape recorder system.

In addition to the digital imaging systems in the catheterization laboratory, it was necessary to have digital image review stations as the traditional cardiac cine 35 mm film was no longer available to be viewed post procedure. The digital image review stations were developed by Toshiba based on the Sony D-2 digital tape recorder and allowed the images to be displayed with essentially the same image quality as that displayed on the digital cardiac imaging system in the cardiac catheterization laboratories.

The Toshiba digital cardiac imaging systems were at the leading edge of technology and many national core research centers did not have this digital imaging technology. Thus, it was necessary to develop a unique device to make cine film images of the digital cardiac images. This task was accomplished under the direction of Dr. Morgan thus allowing the new Methodist Heart Center clinicians to participate in core research centers providing the clinical digital imaging studies on cine film until such time as the centers were capable of receiving and viewing digital cardiac images from different types of systems. As an example of the technical performance of these systems, Dr. Robert Wey, Cardiologists of Lubbock, is the Principal Investigator on an Investigational Device Trial for carotid stenting using these digital imaging systems. The protocol requires quantifying the stenosis pre and post stent deployment which can only be satisfied using the high resolution and precision of these digital cardiac imaging systems. The computer controlled digital imaging and archive systems dramatically accelerated the diagnosis of patient cardiac disease and the related care including non-interventional as well as interventional care delivery with the associated improvement in quality of care provided. Another significant feature of the digital imaging system was that a single study or set of digital images could be conveniently recorded on standard VHS tape retrospectively as desired. This made it convenient and inexpensive to provide a copy of the study immediately available to the referring physician and to the patient to take with him for his own personal record.

The high performance of the Toshiba digital cardiac imaging systems makes them extremely susceptible to their facility environment. In fact, it was determined that the ceiling mount for the digital imaging assembly had to have additional dampening installed to nullify the new facility motion in the low frequency range (building vibrations).

Benefits

Has your project helped those it was designed to help? In your opinion, how has it affected them? What new advantage or opportunity does your project provide to people? Has your project fundamentally changed how tasks are performed? In your opinion, have you developed a technology that may lead to new ways of communicating and processing information? What change might unfold?

The Methodist Heart Center Cardiac Catheterization Department provides numerous benefits to its patients, their families, hospital administration, physicians and staff. The consistent high image quality is provided more rapidly, efficiently and cost effectively than in traditional cine film based cardiac imaging systems. The time from the onset of acute cardiac problems to initiation of therapy is so crucial to the outcome of patients with acute cardiac problems, that decreasing the time required to provide the cardiologist with the clinical images is critical to the diagnosis and treatment.

The digital cardiac imaging systems allows instantaneous viewing of each diagnostic image sequence with high image quality. This is dramatic when compared to the time necessary for a study using cine film imaging to be available for review by the cardiologist. Because the images are available instantaneously, there is no delay encountered in analyzing the study and immediately beginning the necessary clinical therapy. This is in sharp contrast to cine film based procedures, where it is not uncommon to wait 15 to 20 minutes after the study has been completed to be able to see the chemically processed cine film images.

The radiation exposure to patients and staff has been significantly reduced. This is especially important in interventional procedures and electrophysiology and pacemaker procedures which can be lengthy. The Toshiba digital system allowed the imaging sequence and techniques to be customized to provide as nearly optimal images as possible. This was accomplished by using variable width x-ray pulses, different image acquisition rates and different exposure per image techniques which resulted in reduced radiation exposures for different clinical procedures such as electrophysiology and pacemaker procedures. The staff also benefited since the image techniques were customized to the situation and thus reduced accumulative radiation exposure to the professional and support staff.

In addition, the need to repeat part or all of a procedure has essentially been eliminated due to the ability to instantaneously verify the location of the interventional device and patient anatomy at any time during the procedure.

The computer can process the digital data after acquisition to clarify or enhance a particular area of an image. Digital analysis lends accuracy to selection of angioplasty balloon or stent size.

One of the six cardiac catheterization labs is a bi-plane system used primarily when the reduction of contrast media (x-ray dye) is important. Bi- plane cardiac catheterization systems with the ability to obtain images at more complex angles are very important in the treatment of children and infants. They provide bidirectional simultaneous images of the heart, minimizing the amount of contrast media needed. Bi-plane (bidirectional) simultaneous image acquisition is also beneficial for diagnosis and treatment of cardiac arrhythmia where placement of the catheters is difficult as well as critical.

All of the single plane cardiac imaging systems use the Toshiba Model CAS-210 image system which allows peripheral vascular and intracranial studies to be performed without repositioning the patient (reversing the position of the patients head and feet on the table) which reduces the procedure time, as well as stress and discomfort to the patient.

Using the Toshiba computer controlled digital cardiac imaging systems in the catheterization laboratories has eliminated darkroom support staff, film and chemistry supply costs, film processing costs and film quality control staff costs. This resulted in a savings of over $225,000 in the first year. The utilization of technical support staff has been significantly improved since they are no longer required to be involved in handling cine film and dealing with all of the routine problems associated with cine film imaging. This has allowed the staff to enhance their focus on patient care utilizing the computer controlled digital cardiac imaging systems and archived digital image studies.

It is critical to recognize that when the Methodist Heart Center was conceived and developed, there were no digital image related standards and thus it was necessary to establish functional standards as a part of this project. In fact, there remains a lack of adequate comprehensive digital image performance standards for the acquisition, archive and transfer of clinical images in the industry.

Importance

How did information technology contribute to this project? Describe any new technologies used and/or cite innovative uses of existing technology. For example, did you find new ways to use existing technology to create new benefits for society? Or, did you define a problem and develop new technology to solve it? How quickly has your targeted audience of users embraced your innovation? Or, how rapidly do you predict they will? Does your work define new challenges for society? If so, please describe what you believe they may be.

The technology necessary to provide digital images equal or superior to cine film images was actually only being discussed in prerelease product information from Toshiba America Medical Systems, Inc. The Toshiba digital imaging system Model TDC 4000 and the image system stand Model CAS-210 were just being introduced into the market place and were selected because of the image quality, digital acquisition rates, and image storage capabilities. The combination of the image stand and the digital imaging system capable of acquiring 30 images per second at 1024 x 1024 image matrix and an adequate archiving system was so new that it was unproven, requiring extensive investigation and analysis before finalizing the acquisition. One unique capability of the system was the ability to evaluate a symptomatic patient from head to toe, facilitating vascular and intracranial image acquisition during the same procedure, thus minimizing risk to the patient while significantly expanding the information available to the cardiologist.

At the time of the selection of the system, the Toshiba medical imaging system was the only company capable of delivering a clinical imaging system incorporating the Charged Coupled Device (CCD) camera technology with the 1024 x 1024 matrix. This technology afforded high spatial resolution images which results in improved clinical image quality. The clinical images viewed both in the cath lab and on review stations are typically acquired at 30 images per second with 1024 x 1024 digital image matrix.

From the beginning of the Methodist Heart Center project, it was believed that it would be necessary to have a filmless cath lab in the near future if Methodist Heart Center was to be in the forefront of clinical care and to remain there in the future. It was also believed that digital cardiac imaging capabilities would be required to meet the needs of the evolving health care environment.

An educational program was developed to prepare the staff for the new technology when it was introduced and completed its objectives simultaneously with the opening of the Methodist Heart Center. After the Toshiba cardiac digital imaging systems were installed, Toshiba s applications specialists were very instrumental in the conversion to cine filmless operation. They provided on-site hands on clinical staff training and worked with the radiologic technologists to develop the appropriate protocols for digital cardiac image acquisition and storage which enabled the cardiologists to complete the procedure and leave the room with the archived digital image study in hand. The staff and physicians were immediately impressed with the user friendliness and ease of operation of the new Toshiba computer controlled digital cardiac imaging systems. It is essential for the medical community to transition to digital film imaging in order to be part of the more global efforts to improve clinical care while reducing the time and costs associated with the delivery of health care providing the highest possible quality patient outcomes.

Originality

What are the exceptional aspects of your project? Is it original? How? Is it the first, the only, the best or the most effective application of its kind? How did the project evolve? What is its background?

The Methodist Heart Center concept was original as well as technologically advanced since it depended on the computer controlled high performance digital cardiac imaging systems without cine film as the primary image recording media. This was the first large new dedicated heart center in the country to commit to digital cardiac imaging without cine film as an image archive backup. Reflecting this innovative and technologically advanced concept, the Heart Center has been cited nationally as a Heart Center model.

From the onset of the project, one of the primary objectives for the Heart Center was a commitment to provide the best patient care by acquiring the latest advances in cardiovascular imaging technology. The administration committed to support the Heart Center concept including digital imaging and other advanced and aggressive cardiac care concepts. The primary project team was interdisciplinary; with input from physicians, administration, radiologic technologists (including Ms. Jennie Wright, Technical Supervisor), and industry experienced consultants. This team worked for several months to assemble the necessary design definition and performance criteria for the different aspects of the project, ranging from architectural, structural and product needs. Ultimately, these needs were consolidated into a comprehensive set of performance criteria which could be used for identification and selection of technology and products. Much of the information was developed in close conjunction with the equipment vendors who were able to provide the necessary technology. The team s extensive research included site visits and consultation with users, internal review and analysis of the data acquired and compiled by the team. Information was evaluated and then consolidated into vendor and technology comparative tables and presented to the cardiologists. A comfort level had to be reached about the transition from cine film imaging to a cine filmless technology. A digital solution must provide no degradation in image quality, a decrease in procedure time, and enhanced clinical utility that would result in diagnostic excellence.

There were many claims by cardiac digital imaging system manufacturers to provide state-of-the-art digital imaging. However, the system selected was Toshiba, whose image quality, digital acquisition rates, and image storage capacity had been exhaustively evaluated quantitatively. In addition, the systems were superior with respect to the ease of use and clinical versatility.

Success

Has your project achieved or exceeded its goals? Is it fully operational? How many people benefit from it? If possible, include an example of how the project has benefited a specific individual, enterprise or organization. Please include personal quotes from individuals who have directly benefited from your work. Describe future plans for the project.

The Methodist Heart Center has consistently met and exceeded expectations and performance goals. It has been operational since 1995, with outstanding clinical acceptance and utilization. Since the Methodist Heart Center opened, there has been a 28% increase in total patients seen and treated (7,500 in 1997). There has been a 32% increase in total procedures (9,800 in 1997). The ability to diagnose quickly has aided the ability to provide primary (immediate) angioplasty for treatment of acute myocardial infarction. Primary angioplasty has always been performed at Methodist Hospital, and has only recently become the national standard.

TESTIMONIALS

The cardiologists using the digital cardiac imaging systems have seen their actual procedure times diminish with increased stability and reliability. Dr. Robert Wey and Dr. Howard Hurd, Cardiologists of Lubbock, both have repeatedly emphasized the efficiency of the catheterization laboratory design. They both have reported that, "The efficiency and utility of having all of the facilities in one place where the room layouts and imaging systems are identical, having superb image quality and precise quantitative image analysis, have tremendously improved the safety and efficiently of heart procedures. It also is important to appreciate the value of immediately having high resolution hard copy images as well as being afforded the opportunity to record dynamic imaging on VHS tape as desired."

Dr. Hurd and Dr. Morgan, Morgan Consulting, Inc., have both elected to have their own interventional cardiac procedures done in these cardiac catheterization laboratories and indicated, "The high performance of the systems was critical to determining what course of treatment to follow and the ability to see the images as they are acquired, preventing delay as well as assuring that the information needed was in the images".

The digital imaging systems continue to provide image quality without technological upgrades or subsystem replacements, which is remarkable since the digital imaging system selection was finalized approximately four years ago. Typically, computer based medical imaging systems are obsolesced within three years or less after introduction into the market place. The foresight and credibility of the three individuals involved in the concept and design implementation has been fully vindicated by the continued performance of the Toshiba digital cardiac imaging systems. The excellent performance of these systems is assured through a comprehensive image quality assurance program which includes comprehensive evaluation of the digital imaging systems on a periodic basis.

Difficulty

What were the most important obstacles that had to be overcome in order for your work to be successful? Technical problems? Resources? Expertise? Organizational problems? Often the most innovative projects encounter the greatest resistance when they are originally proposed. If you had to fight for funding, it would be useful to include a summary of the objections you faced and how you overcame them.

It was absolutely critical to discard the established perspective by previous experiences of individuals involved in order to see the project from an essentially unbiased and fresh perspective. It was also critical to establish the technological capabilities of the digital cardiac imaging systems. There had been many previously unsuccessful attempts in the industry to use digital imaging systems in busy, aggressive cardiac care programs. These tasks included the formidable obstacle of eliminating the cine film in cardiac imaging since it was a psychological security blanket for many cardiologists who had used it throughout their clinical careers.

It was necessary to develop a comprehensive data base regarding the clinical digital cardiac imaging systems and the manufacturers. It was necessary for the team to try to determine the technical and clinical limitations of the systems while observing only a brief period of clinical use, often with prototype systems since the technology was very new. The ability of the manufacturer to provide technological support as well as service support for the systems being considered was critical since, when the system degrades or fails in clinical use, it poses potentially life threatening ramifications.

Developing trained staff inhouse prior to making the transition to cardiac digital imaging in the new Methodist Heart Center was a priority. The high performance of the digital imaging systems imposed its own requirements on the new facility which went beyond those of traditional cardiac imaging systems. The high performance of the Toshiba digital cardiac imaging systems makes them extremely susceptible to their facility environment. In fact, it was determined that the ceiling mount for the digital imaging assembly had to have additional dampening installed to nullify the new facility motion in the low frequency range (building vibrations). The team aggressively addressed these many problems and systematically resolved them, thus assuring a smooth transition to computer controlled cardiac digital imaging in a very busy interventional cardiology facility.

The clinicians' involvement with core research centers continued to require cine film which presented a unique problem. The consultant directed the design and development of a cine film maker that allows the digital images to be recorded on cine film, thus insuring the continued participation in core research projects.

The ability to effectively perform whole body imaging procedures required major changes in the responsibilities of the Radiologic Technologists and the way they had to perform their duties. They were involved early in the planning stages of the filmless imaging catheterization laboratories. This enabled them to support and affect the transition to digital cardiac imaging for all staff and physicians. The Methodist Heart Center administration made a bold commitment to becoming a Cardiovascular Center of Excellence . The administration recognized that significant expenditures and changes in the clinical care protocols and procedures would be required to achieve this goal. This commitment allowed the team and staff to focus on the technical and operational challenges necessary to successfully implement state-of-the-art computer controlled digital cardiac imaging technology in routine clinical cardiac care.