Handheld ultrasound replacing stethoscopes in cardiology

Cardiologists are users and not direct customers for the big medical imaging companies who sell almost exclusively to radiology departments.

The large exhibitions set up at the 2008 congress of the European Society of Cardiology to demonstrate new diagnostic or guidance products are meant to influence opinions in the hope that once back at the hospital, the cardiologists will express a preference to radiology procurement and ultimately drive a big-ticket sale.

On the stand of one of the major vendors, a sales manager said he was forbidden by company policy to make a sale at the show. Yet like other boundaries and traditions in cardiology, that wall is starting to crumble as the three major players in European imaging GE Healthcare (Waukesha, Wisconsin), Philips (Andover, Massachusetts) and Siemens (Erlangen, Germany), in order of market share begin to target cardiologists’ private practices, the offices of their referring physicians, and especially mobile cardiac response teams with light-weight and increasingly powerful ultrasound units.

Handheld echocardiography is becoming the stethoscope in doctors’ everyday work, according to Professor Juhani Knuuti of the PET Centre in Turku, Finland, in comments during the ESC Congress session dedicated to “New Horizons in Imaging.” “We now see doctors in wards or during outpatient visits take out a pocket-sized echocardiography machine and check whether valves are okay or see if the patient’s heart has sufficient pumping power,” he said. GE started the trend in 2005 with the introduction of the Vivid i, a laptop-sized cardiovascular ultrasound system aimed at urgent care, emergency room, critical care, and operating rooms.

Successfully tapping an unmet need in medical practice, sales of the Vivid i tore away market share from competitors, catapulting GE by 2006 to the lead position for ultrasound worldwide. GE enjoyed the first-to-market advantages until 2007, when Siemens introduced the Acuson P-10, a pocket-sized model that pushed the portability challenge just as Blackberries took away many everyday tasks from the laptop computer. With a flip-up monitor and thumb controls, the P10 brought basic ultrasound further out of the hospital and successfully created a personal data assistant feel for cardiologists, as well as ob/gyns. Philips was the laggard in this fast-developing market, but finally arrived here at ESC 2008 with its CompactXtreme technology and the CX50.

Joris van den Huck, vice president for cardiology programs at Philips, told Medical Device Daily, “Yes, the CX-50 answers the P-10 from Siemens last year, but we have gone further.” CompactXtreme is promoted as a tool for “timely triage,” to enable the early recognition of heart disease and to reduce door-to-balloon time in an urgent-care setting. “There is also a lot that can be done in transit,” he said, “specifically [in] transmitting to the hospital echo readings of a patient en route so that the care pathway is established before he even arrives.” van den Huck said, “Triage is not something you only do for urgent care,” adding that Philips interprets the early detection of heart disease as a kind of triage of patients.

“You want to do this as close as possible to the patient in the primary care settings, such as GP offices,” he said. “This requires giving the GP the means to visualize heart disease, to measure it, and then to determine the significance of these readings.” “It is a huge market,” van den Huck said, adding that while he can not give a dollar figure, there are 1,000 hospitals in the U.S. out of a possible 1,800 which have agreed to clinical guidelines for managing patients with heart disease and that there are 5 million chest pain cases annually in the U.S. alone. “In Europe, where there is a different measure called acute coronary syndrome, there are 1 million prospective patients each year for this modality,” he told MDD.

The CX50 offers enhanced clarity and edge definition, thanks to Philips’ PureWave piezoelectric transducer and XRES adaptive image processing for reduced speckle and haze. With wireless transmission of DICOM-compatible data and a laptop-like look and feel, the CX50 is nonetheless the bulkiest unit in the portable ultrasound market, weighing in at 13 pounds. As these competitors bring new offerings to the market that move further out from the hospital, GE meanwhile is taking the Vivid i deeper into cardiology with a new offering for interventionalists. At ESC 2008, GE extended the applications of Vivid i with a bolt-on capability for intra-cardiac echocardiography (ICE) that provides ultrasound images from inside the heart to assist in percutaneous valve replacement or guiding trans-septal punctures.

“We are making a new entry into interventional echo with ICE imaging,” said Omar Ishrak, CEO of clinical systems for GE, adding that the ICE catheter is also compatible with the new Vivid q model showcased at ESC.

GE built the adapter and interface for the existing ICE catheter and probe from Biosense Webster (Waterloo, Belgium) that combines with the Vivid i portability, enabling it to join the growing suite of imaging modalities in the cath lab or the new Hybrid ORs that combine a cath lab with a traditional surgical arena.

Another trend driving growth in the ultrasound market for cardiology is the 3-D imaging capability. Adding the dimension of depth and space renders the often strange views of 2-D ultrasound into a very intuitive display of a patient’s anatomy familiar not only to physicians but any caregiver with any kind of diploma in medical studies. With real-time processing capabilities, these 3-D machines are actually four-dimensional, showing a beating heart and acquiring fresh views of blood flow, valve performance and ejection fractions with every new heartbeat. 4-D is the new buzz on the exhibition floor, with vendors boasting full-volume, single-image acquisition against stitched image processing from scattershot acquisition and real-time “in a heartbeat” acquisition of images against delayed processed images.

Heinrick Beckermann, cardiology marketing manager for Philips, told MDD, “The 3-D market is growing and is important for cardiology development because people can now see the images they understand right away, identify what is happening and can take a decision.” He said that growth in cardiology ultrasound is twice the global rate of growth for all ultrasound, which he put at “inflation plus a point,” and that 3-D sales are running far ahead of any other application in cardiology. Beckermann estimated the worldwide market for ultrasound transducers, including every application from veterinarians to hospitals, at $3 billion.

Philips may have been slow getting to market with the CX50, but it is years ahead of competitors with a unique offering for trans-esophageal echocardiography (TEE), according to van den Huck, who added that “TEE is selling like hotcakes.” Beckermann said because the TEE is unique to Philips, once a customer sees the images of the beating heart and wants that, “we win the deal every time. In this first year we have had 800 installations, counting both new units and installations within existing customers systems.” He said Philips “can be very happy with its position in ultrasound. GE is still the leader in Europe, but we used to be No. 3 and last year we moved up to second position.” He added that Siemens is still quite close to Philips, but expressed the opinion that Philips “is in trouble in imaging. They did not do some things right.”

GE enjoys a better position, he said, “but they really need to replace products that are getting old.”

Growth of minimally invasive and so-called “keyhole” surgeries is going to continue driving growth in ultrasound, Beckermann said. “When you open a patient up with a knife, you see what is happening, but when it is minimally invasive, then you must have image guidance for that surgery, and a portable ultrasound unit is the only way to see it quickly and precisely.”

Source: Medical Device Daily

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