What Is an Echo Machine?




In this issue of JASE , Dalla Pozza et al. report a device comparison study using three “hand-carried” ultrasound devices chosen for their capability of imaging in the limited space of a neonatal intensive care unit. Performed over 2 weeks on 110 patients at a referral center in Munich, Germany, the study compared B-mode measurements and subjective assessments of image quality between a pocket-sized device, two laptop-sized devices, and a cart-based machine that served as the gold standard. The pocket-sized device performed significantly worse than the laptops in image quality, having scored excellent quality in only 65% of studies compared with a 93% to 96% rate in laptop studies. The study’s chosen end point of image quality suggests that this attribute alone defines appropriate applications for hand-carried devices.


This study, one of the first to report on the ultraportable pocket-sized ultrasound stethoscope, reignites issues central to the field of echocardiography and hand-carried devices, particularly within the United States. Hand-carried ultrasound devices could become a significant challenge to traditional cart-based echocardiography because of their relatively low price ($10,000–$50,000) and potential ease for widespread application. However, with today’s technological advancements, the term hand-carried may be no more descriptive than using the machine’s color or weight to describe its capabilities as an echocardiographic instrument. So when resolution, diagnostic modalities, and application are all considered, what exactly is an echocardiographic machine? The answer to this innocuous question may actually help define and preserve the field of echocardiography and has implications regarding the direction of future research and development, as well as accreditation and reimbursement. In this country, a discussion of what constitutes an echocardiographic machine has economic considerations that cannot be separated from those of design.


The Cost of Limited Echocardiography


At the economic center of the debate is the concept of the “limited echocardiogram,” a brief, goal-directed ultrasound application meant for specific clinical indications, such as follow-up. Although no formal device or time restrictions exist, in practice, this study is typically performed by a sonographer using an abbreviated imaging protocol on a standard echocardiograph in a visit that lasts 15 to 30 minutes. In addition to focused or follow-up indications, a limited cardiac ultrasound exam performed at the bedside has the potential to improve cost-effective referral for echocardiography. Specific patient knowledge and physician communication are necessary to recognize when a limited echocardiogram is appropriate, and a “systems approach” would be required to apply a limited echocardiographic screening strategy to a low-risk referral population to reduce costs. In the United States, sonographer-based imaging is the convention, often with minimal pretest communication with the ordering physician. As a result, limited echocardiograms are infrequently performed, accounting for <2% of the total number of Medicare outpatient echocardiographic studies. On the other hand, a physician-based limited imaging approach, using an ultrasound stethoscope, could become more prevalent in an era of accountable care by potentially reducing unnecessary echocardiographic referral costs in low-risk patients.


The concept of the limited echocardiogram was originally created to reduce the time and expense of repeated comprehensive echocardiography. Having considered costs of a standard echocardiograph, imaging time, documentation, and interpretation adjusted to the limited nature of the procedure, Medicare calculates a global payment of about $110 ($185 if limited Doppler is also performed) for this examination. The conundrum arises with the realization that cardiac ultrasound data acquired on one of the newer hand-carried ultrasound devices may actually exceed the quality of a limited echocardiographic study performed on a 10-year-old, bulky office echocardiograph. What then, if not image quality, defines an echocardiographic machine and for that matter a device that can perform a limited echocardiographic exam? Although the debate seems purely semantic, at the heart lies millions of dollars of potential payout for limited echocardiographic studies performed as quick-look exams by physicians using small, portable devices at the point-of-care. Furthermore, reimbursement at the current rate could incentivize device sales and the subtle shifting of industry research monies away from advanced echocardiographic technologies pertinent to a small expert community and toward the development of more simplified devices for use by a larger physician base. New markets in emergency medicine, critical care, and primary care could develop as brief cardiac imaging protocols are taught to clinically oriented physicians eager to improve their bedside diagnostic skills, clinical pathways, and reimbursement for patient evaluation and management. Last year, a national organization representing emergency physicians produced a white paper that advised billing limited echocardiography and abdominal and chest ultrasound charges for the performance of four quick-look views during focused abdominal sonography for trauma. Perhaps indicative of future practice, a recent increase in billing of Medicare ultrasound services prompted an investigation by the Office of Inspector General in 2009, which noted the unusual pattern of multiple ultrasound examinations being performed on a beneficiary, typically by a single new provider during the same visit. At this point, it is unknown how the widespread indiscriminate application of quick-look screening exams will affect overall echocardiographic referral volumes or reimbursement.


As the dissemination of smaller, easy-to-use equipment can potentially change the current consumer market, industry goals, and the field itself, hand-carried ultrasound has been considered a “disruptive” technology, similar to the digital camera phone in the field of photography. Soon after the release of the first hand-carried devices in 2002, the American Society of Echocardiography rapidly produced a consensus document to help payers and physicians clarify their use. Focused on the capabilities of the operator rather than device specifics, the American Society of Echocardiography’s report on appropriate training and use of this technology is only one of many ultrasound policy statements produced by national physician organizations. Emergency medicine and chest physician groups have already incorporated ultrasound training within their fellowship and postgraduate courses and whose involvement in bedside ultrasound extends to many organ systems. Initially, to stem the potential tide, a regional Medicare carrier had attempted to define echocardiography on the basis of the overall weight of the device used as being >6 lb but has now instead focused restrictions based on user qualifications. It is now clear that using the larger size or weight characteristics of current cart-based devices will not define an echocardiographic machine.




Maintaining a Gold Standard


In the simplest terms, an echocardiographic machine is the instrument used for the practice of echocardiography, whether comprehensive or limited. As a result of decades of international research and growth of professional societies, echocardiography is now recognized as a diagnostic subspecialty within cardiology and has become a gold-standard imaging modality in many aspects of cardiovascular disease. Driven by a highly specialized expert consumer market, the growth of echocardiography has been based on the near continuous development of state-of-the-art ultrasound modalities specifically for cardiac application by up-to-date echocardiographers, such as automated border detection, harmonic imaging, tissue Doppler, speckle tracking, and three-dimensional imaging. The echocardiographic study itself can be viewed as brief clips of the entire diagnostic process and does not represent the potential depth of knowledge required or extent of the ultrasound examination. Analogous to an office visit to a physician for a single symptom, it is the act of considering, discounting, and exploring only when indicated the wide range of possible diagnoses that makes the process comprehensive, not just “ruling out” a single malady. Similarly, although all modalities on an echocardiographic machine may not be used in every case, the fact that they could potentially be used may be critical in preserving the expectation that a patient referred for echocardiography will receive the optimal ultrasound evaluation to delineate all abnormalities. It is this optional expansion of the exam at the discretion of a highly trained operator that should be highly valued, requires a fully featured machine, and preserves echocardiography as being a gold-standard diagnostic test in cardiology. The necessary or basic imaging modalities that are critical to the performance of comprehensive echocardiography should likely be determined by both evidence and consensus and could include M-mode, color, spectral and tissue Doppler, multiple-transducer capability, and minimal screen resolution requirements.


Therefore, although useful to answer the simple “rule-out” referral question, pocket-sized devices are not echocardiographic machines producing limited echocardiograms, as these instruments have not been designed with the intent of providing comprehensive diagnostic services for an echocardiographer. Nonetheless, the potential of an experienced echocardiographer with a pocket-sized ultrasound device to outperform a novice with a fully featured echocardiographic machine confounds efforts of device classification. Adding to the confusion, accreditation material by the Intersocietal Commission for the Accreditation of Echocardiography Laboratories states that “machines with some, but not all of the above, equipment may be used for limited or directed echocardiographic examinations.” Regrettably, use of the ultrasound stethoscope by only accredited echocardiography labs marginalizes the technique to the smallest market that is least likely to benefit from it. Even when applied by experts for limited echocardiographic indications, small devices with simplified instrumentation will produce lesser quality serial measurements for follow-up exams and will curtail the diagnostic process for the delineation of any new findings. The designation of any ultrasound device that could be applied to the heart as an echocardiographic machine overlooks the value of decades of research and development built into the standard echocardiograph. The ability to support improvements in high-quality echocardiographs and yet promote the development and miniaturization of portable ultrasound for bedside diagnosis will require differentiating not only these two facets of ultrasound practice but also the devices used. Dalla Pozza et al. ’s study fails to differentiate the hand-carried devices used into categories with any meaning for the current debate in this country and may actually contribute to the ambiguity by concluding that these hand-carried devices, including the pocket-sized device, are all “a valuable alternative to standard echocardiographic systems.”




Maintaining a Gold Standard


In the simplest terms, an echocardiographic machine is the instrument used for the practice of echocardiography, whether comprehensive or limited. As a result of decades of international research and growth of professional societies, echocardiography is now recognized as a diagnostic subspecialty within cardiology and has become a gold-standard imaging modality in many aspects of cardiovascular disease. Driven by a highly specialized expert consumer market, the growth of echocardiography has been based on the near continuous development of state-of-the-art ultrasound modalities specifically for cardiac application by up-to-date echocardiographers, such as automated border detection, harmonic imaging, tissue Doppler, speckle tracking, and three-dimensional imaging. The echocardiographic study itself can be viewed as brief clips of the entire diagnostic process and does not represent the potential depth of knowledge required or extent of the ultrasound examination. Analogous to an office visit to a physician for a single symptom, it is the act of considering, discounting, and exploring only when indicated the wide range of possible diagnoses that makes the process comprehensive, not just “ruling out” a single malady. Similarly, although all modalities on an echocardiographic machine may not be used in every case, the fact that they could potentially be used may be critical in preserving the expectation that a patient referred for echocardiography will receive the optimal ultrasound evaluation to delineate all abnormalities. It is this optional expansion of the exam at the discretion of a highly trained operator that should be highly valued, requires a fully featured machine, and preserves echocardiography as being a gold-standard diagnostic test in cardiology. The necessary or basic imaging modalities that are critical to the performance of comprehensive echocardiography should likely be determined by both evidence and consensus and could include M-mode, color, spectral and tissue Doppler, multiple-transducer capability, and minimal screen resolution requirements.


Therefore, although useful to answer the simple “rule-out” referral question, pocket-sized devices are not echocardiographic machines producing limited echocardiograms, as these instruments have not been designed with the intent of providing comprehensive diagnostic services for an echocardiographer. Nonetheless, the potential of an experienced echocardiographer with a pocket-sized ultrasound device to outperform a novice with a fully featured echocardiographic machine confounds efforts of device classification. Adding to the confusion, accreditation material by the Intersocietal Commission for the Accreditation of Echocardiography Laboratories states that “machines with some, but not all of the above, equipment may be used for limited or directed echocardiographic examinations.” Regrettably, use of the ultrasound stethoscope by only accredited echocardiography labs marginalizes the technique to the smallest market that is least likely to benefit from it. Even when applied by experts for limited echocardiographic indications, small devices with simplified instrumentation will produce lesser quality serial measurements for follow-up exams and will curtail the diagnostic process for the delineation of any new findings. The designation of any ultrasound device that could be applied to the heart as an echocardiographic machine overlooks the value of decades of research and development built into the standard echocardiograph. The ability to support improvements in high-quality echocardiographs and yet promote the development and miniaturization of portable ultrasound for bedside diagnosis will require differentiating not only these two facets of ultrasound practice but also the devices used. Dalla Pozza et al. ’s study fails to differentiate the hand-carried devices used into categories with any meaning for the current debate in this country and may actually contribute to the ambiguity by concluding that these hand-carried devices, including the pocket-sized device, are all “a valuable alternative to standard echocardiographic systems.”

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Jun 16, 2018 | Posted by in CARDIOLOGY | Comments Off on What Is an Echo Machine?

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