BB&T

VIENNA, Austria – New hardware, and increasingly new software, continues to dominate the European Congress of Radiology (ECR), covering almost 280,000 square feet of exposition space at the Austria Center Vienna, and dwarfing the conference rooms and auditoriums where thousands of scientific sessions are held.

New this year is an assertive voice raised by the organizer of the annual congress, the European Society of Radiology (ESR; Vienna), to influence issues that are redefining, and even re-engineering, how the hardware and software displayed on the exposition floor will be used in a changing landscape for healthcare delivery.

Created in December, 2005, ESR is a “success story,“ according to President Christian Herold, MD, a start-up compared to the 41 national societies it encompasses, most of which are long-established in the leading countries that make up the Old Continent.

A European-level representation of a single voice for radiologists has become particularly important recently as the European Commission (EC) seeks to exercise an influence in the emerging area of e-health by defining a framework for telemedicine and by setting onerous rules on the use of MRI.

Both topics were pushed to the top of the society's agenda for a press conference at the opening of the congress.

ECR 2010 is being held just ahead of the High Ministerial Meeting on eHealth in Barcelona where decisions will be taken and European level policy set by health ministers from 15 Member Nations of the European Union, and the society's president used the opening press conference as a bully pulpit to send a message to the ministers.

“Teleradiology was first embraced for economic reasons,“ he said, “and ESR has quite a different view seeing it as a medical act that needs to have quality and care standards associated with it.“

“We also need very clear legal definitions,“ he added.

ESR is increasingly solicited by the EC for its policy discussion in Brussels, Herold said, and the EC will participate in a joint session on e-health at ECR 2010.

Radiology is the primary driver behind e-health, the digitalization and connectivity of healthcare systems, which is enabling the possibility of telemedicine and already breaking into dozens of branches of potential applications such as telehealth, telecare, telescreening and teleradiology itself.

On a global scale, the Radiology Society of North America (Oak Brook, Illinois) created, and continues to support, the open-architecture methods of Integrating the Healthcare Enterprise (IHE) upon which an increasing number of regional and national e-health programs in Europe are based.

On the local level, the University Center Hospital (Bordeaux, France), provides a best-practice case study for e-health with a network for medical records that follows a patient along any clinical care pathway by adding layers on top of the original radiology network created for the three hospitals in the hospital group.

Radiology is both a river of critical digital data for diagnosis shared among medical groups, as well as a river of money, making up of some of the largest revenue streams for any medical center, whether for reimbursement, capital expenditures or operating budgets.

The Bordeaux group, for example, progressively paid for the construction of the underlying radiology network by recapturing savings on film realized thanks to digitizing images.

While radiology forms the backbone of e-health, the public face is at-home care and patient monitoring through telemedicine, which holds the promise of increasing access to care, improving the quality of life of chronically ill patients, reducing hospital stays, shortening waiting lists, and, most critically, cutting costs for healthcare system in Europe where the monolithic, single payer systems are banked by the governments of Member States of the European Union (EU).

Despite what it calls a tremendous potential for e-health, the EC acknowledges that “most telemedicine initiatives are no more than one-off, small-scale projects that are not integrated into healthcare systems.“

On the agenda at the upcoming High Ministerial Meeting on eHealth is an effort by the EC to remove legal barriers to the provision of healthcare at a distance, which beyond saving money for Member States, holds the potential to become a very profitable market for health system developers in Europe, thereby creating jobs and increasing a European expertise in this field.

“Teleradiology is a reality, is here to stay, and will expand,“ said Luis Donoso, MD, a member of the Executive Council of ESR at an ECR press conference presentation entitled, “eHealth: Radiology's view on telemedicine communication.“

Head of radiology services at the Hospital Clinic of Barcelona, Donoso, said ESR distinguishes carefully between telemonitoring of patients at a distance on the one hand and teleradiology on the other.

“Teleradiology is not equivalent to telereporting radiological images but it is a medical act in its own right,“ he said.

There are key differences between these two telemedical practices, he underlined, saying teleradiology is an expansion of a well-established medical practice with the secure transmission on a telematic network of acquired images and their remote interpretation.

“We would like to emphasize that the medical act is not only a report but includes evaluation of examination requests, selection of the most appropriate imaging strategy, optimization of the examination performance, customization of the imaging protocol, and integration of imaging and medical information into the report,“ Donoso said.

Published studies proposing that telemedicine activity increases efficiency and economics refer mainly to telemonitoring projects, according to the society.

“Cost savings for teleradiology cannot come at the expense of quality care and patient safety,“ he said.

Drawing a hard line in the sand on teleradiology, Donoso delivered ESR's core position that “The quality of care to the patients is improved only when teleradiology makes available a remote radiologist in cases when there is not a radiologist available at the site or a local radiologist is easily available.“

“If a doctor based in Belgium provides a report in the UK, he or she must have the proper accreditation to do so in the UK,“ explained Donoso.“There must be an agreement between the local radiologist and the teleradiologist, and the regulation of teleradiology should be the responsibility of the member state where the patient undergoes the imaging procedure.“

This core position of anchoring accountability to the site of image origin is central to ESR's insistence on a legal framework and to draw boundaries around the growing trend toward “ghosting radiology,“ or outsourcing to distant centers for second opinions and reading of routine exams.

“The problems with ghosting is not economic but ethical, as illustrated by the case of one company that signed off on hundreds of radiology exams that the contracting firm had never reviewed,“ said Donoso.

According to Herold, the society is not trying to insert a gatekeeper systems in the radiology chain but to reassert a fundamental need for proper guidelines, an appreciation for quality evaluations and a concern for patient rights.

Agfa revives product portfolio

What a difference a year makes.

At last year's European Congress of Radiology, Agfa Healthcare (Mortsel, Belgium) was on the ropes and the buzz among sales reps and executives in the corridors was that this division, which accounts for 40% of sales for the larger Agfa-Gevaert Group would be sold.

Reporting a 12% loss in sales for the division, and hammered on the Euronext-Brussels stock exchange, the holding company confirmed it would carve out the e1.2 billion ($1.5 billion) healthcare division, but with great embarrassment withdrew the proposition several months later when no one stepped forward to save the struggling business.

The stock price plummeted from e5 ($6.25) to below e1.50 ($1.90) and facing the larger global financial crisis and an uncertain future, the company's board refused to make any further previsions. It would have been a good moment to buy the stock.

“We went above six euros today,“ beamed Eric Maurincomme, head of strategy and marketing for Agfa HealthCare patrolling the exhibition space at ECR 2010 with a certain swagger.

“We are growing market share across the board with a renewed portfolio of products less than 18 months old, and we are growing our sales in consumables from contrast media to drapes and gowns,“ he said to explain the buzz among stock analysts encouraging a 'buy' position.

“Since January 2009 we have signed 50 new agreements for the IMPAX picture archiving and communication system (PACS) some of them landmark deals such as the Cleveland Clinic and the U.S. Air Force data center,“ he continued.

“Altogether we reported 100 net new site sales in 2009, he said.

Dirk Debusscher, VP of Imaging at Agfa, jumped into the conversation to add, “we also are very active on the low end of the market and a landmark here is the $500 million deal we signed with China covering four years that took us more than two years to negotiate.“

According to Maurincomme the final figures for 2009 that are due to be reported next week will show the Healthcare division lost 3% to 4% in sales, “but we doubled our profitability.“

Defending CR with next generation system

A major revenue stream for Agfa is the sale of phosphorous plates for conventional computed radiology (CR) X-ray, which is threatened by the shift to digital radiography (DR) detector plates.

An executive with Carestream Health (Rochester, New York), which is an aggressive DR vendor, estimates the worldwide market for radiology stands at $3.8 billion today and that CR continues to hold about $2.1 billion, or a 55% market share.

He added that the conversion to DR has been slower in Europe where CR holds a significantly higher market share.

The New Agfa DirectriX (DX) line is designed to defend this market share, by bridging the gap between CR and DR, and even build a preference for staying with the quality of images acquired with phosphorous-packed plates over pixels.

At ECR 2010 Agfa introduced the DX-G, for general radiology applications, and the DX-M for mammography.

Both the plates, and the digitizer that converts the image acquired by the plate to numeric format, have been re-engineered for what the company is promoting as a next-generation CR.

The DX needle-based crystalline detector plate uses a crystal phosphor that allows higher packing density and layer thickness than is offered by powder phosphor when used in a binding material.

As a result, the light spread is reduced with the crystal phosphor and sharpness of the image is increased.

The DX line also uses the ScanHead, an accelerated line-to-line scanner providing preview images faster and a high throughput of up to 130 cassettes per hour, which reduces waiting times.

A 2008 study by J. M. Fernandez, et al., compared image quality for similar exposure conditions between two flat-panel DR systems and the needle-based crystalline CR, assessing contrast quality and concluded the DX system matched one DR system and was superior to he other while providing image quality superior to a conventional CR system.

The go-to-market benefits of the new DX CR solution is enhanced image quality that the company says meets or exceeds flat-panel DR detectors, and at a significantly lower cost.

“DR has an advantage for routine examinations, but CR continues to be valued for imaging extremities and special cases,“ said Maurincomme, explaining that the needle crystal plates are even better producing resolutions at 50 microns at a lower dose, where DR, “at its best is 78 microns and most often at 100 microns.“

“High end CR is proving to be the answer,“ he said.

Both new DX systems for the new needle-crystal detector plates can also handle conventional phosphor plates, leveraging a radiography department's existing investment.

Debusscher said the Agfa strategy is to “evolve customers toward DR and not force them to make a decision that is either all-DR or all- CR.

“In 90% of the cases where we have sold digital radiology, it has been to customers integrating the new units with their existing computed radiology scanners,“ he said.

“Where a hospital may have seven radiology exam rooms, they might only have the budget, or the interest, to convert two of these rooms to DR,“ he said.

“We show them that they can keep the same familiar user interface, the same imaging platform and with little new training can upgrade to new capabilities, he said, adding, “that is proving to be a strong proposition.“.

A less straight-forward tactic on Agfa's part is promoting the new system using the “D“ label when there is nothing digital in the technology, helping to further confusion among radiologists between true digital systems and conventional CR.

Other promoted benefits for the new DX line include a user-friendly drop-and-go buffer that can handle a mix of five cassettes of different sizes, facilitating a smoother and more productive workflow.

With a smaller footprint, the DX units can be placed in any available space and used as a centralized or decentralized digitizer in the radiography department, supporting a broad range of applications.

The DX line is supported by the Agfa NX workstation and the MUSICA2 automated image processing software.

Philips challenges 'conventional' PET-CT

If doctors liked PET-CT, they are going to love PET-MRI.

And despite its high cost, doctors like PET-CT a lot, valuing the new insights into the biology of specific tumors offered by this technology that fuses metabolic processes shown by positron emission tomography (PET) images layered over the anatomical references provided by with CT.

Clinical acceptance for PET-CT in cardiac imaging and oncology is running far ahead of the published scientific support and evidence that traditionally is required ahead of widespread adoption of a novel technology.

Now Philips Healthcare (Best, the Netherlands) is pushing on a fast-track for development of an even more innovative technology that promises to combine in routine practice these dynamic images of molecular activity rendered by PET with the anatomical imaging of MRI that is, beyond a clinical doubt, far superior to CT for depicting the details of the soft tissue environment where tumors grow, and rendering sharp images of the tumor itself.

At the European Congress of Radiology here, Philips was promoting this work-in-progress announcing that this month it will bring on-line the second of two beta-site installations for PET-MRI that put the company on the leading edge of development in a race that includes both Siemens (Erlangen, Germany) and GE Healthcare (Little Chalfont, UK).

The objective for the Philips beta sites for the newly constructed Gemini True Flight PET/MR is to develop the scientific evidence ahead of engineering of the final commercial model to make the case for this novel technique and demonstrate clinical relevance.

The first site that has already imaged cardiac cases for four patients is at the Mount Sinai Medical Center (New York City) while the second site at the University Hospital of Geneva (Switzerland) certified the operations for the MRI scanner and expects to come online with the certification of the PET scanner by April, 2009.

Fast-forwarding three years when cases will be published, PET-MRI will begin a significant challenge to the leading role of PET-CT, potentially unseating this early champion of molecular imaging in short time due to the benefits of MRI.

The marginal quality of CT images is the first weakness.

More significant is that CT exposes a patient to radiation during every examination, and legal limits on exposure can limit the number of times a patient's progress with chemotherapy or cardiovascular medications can be followed up.

The issue becomes sharper when patients are participating in clinical trials where they are expected to undergo serial examinations.

MRI removes both these problems presenting superior, even the best-in-class images of soft tissue, and uses magnetic fields rather than radiation to acquire images.

There are two major problems with MRI to be solved by Philips engineers, however, before PET-MRI is ready for prime time in the clinic.

First, the powerful magnetic fields create a hostile environment for the vacuum photomultiplier tubes used in the PET gamma-ray detectors that reveal the metabolic processes of cells carrying radioactive tracer molecules.

The second issue is fusing the two images, to specifically locate the metabolic events on top of the right anatomical structure, which demands correction coding in software so complex it is worthy of its own branch of scientific papers.

In October, 2009 Philips announced a break-through at the Nuclear Science Symposium and Medical Imaging Conference in Orlando, Florida with a proof-of concept demonstration for a novel solid-state, scalable and compact digital detector technology.

This new digital silicon photomultiplier technology should enable Philips to replace the hundreds of tube-based gamma-ray detectors inside the powerful magnetic field of the MRI scanner to allow simultaneous acquisition of the two images for a near-instantaneous registration of the metabolic event and the precise location, or structure, where it took place.

Which begs the question of how Philips is able to install two beta site scanners if this technology is not yet available?

The short answer is that Philips has jury-rigged an existing Achieva 3 Tesla MRI scanner with a conventional PET scanner, creating the TF Gemini PET/MR, which is an investigational device and not available for commercial use in either the European Union or the U.S.

The longer explanation reveals a series of engineering feats that does Philips credit for innovation, and underlines the company's commitment in money and materials, for advancing the novel modality by generating evidence of clinical relevance.

The new solid state scanner is being tested on animals for simultaneous image acquisition in a Philip's-led upstream research program funded by the European Union, called HYPER Image. Meanwhile, the company has figured out how to bring the sensitive PET scanner close-enough to the pulsing magnet of the MRI to generate sequential images for fusion that are separated in time by a few minutes.

A first step is shielding the 420 gamma ray detectors of the PET scanner against the magnetic interference of the MRI, and also adding a second shield to prevent the gamma rays from affecting the performance of the MRI scanner.

The beta machine at the University of Geneva looks like two oversized doughnuts standing on end with a table between them.

The bore rings of the MRI and the PET scanner stand just three meters apart and the table is automated for positioning so that once an MRI scan of anatomy is completed, the table withdraws from the bore ring, turns the patient 180 degrees and inserts him or her into the PET scanner at a precisely programmed position to acquire the metabolic images.

The Chief of Nuclear Medicine at the University Hospital of Geneva, Osman Ratib, MD, pulled out his iPhone during an interviewto show a video of the Philips scanners arriving at 4 o'clock in the morning, saying, “And you can bet we had champagne, even at that hour.“

Philips provided a fully constructed examination room, wrapping it in a Faraday shield as well as a shield against X-rays, installing the two heavy scanners, and shipped the structure by special convoy up the Alps to Geneva.

“It was literally plug-and-play,“ exuded Ratib, a self-confessed gadget-guy, showing photos of himself on that morning holding three massive copper cables.

“It was fitted to an access door of the hospital, we plugged in these three cables, and it was ready,“ he said.

Where Cedar-Sinai is focusing on cardiac imaging applications, Ratib's group in Geneva is exploring clinical uses of the PET-MR scanning for oncology.

The two centers will meet in the field of plaque formations in coronary and carotid arteries where they expect to compare notes and publish, Ratib said.

“The neurologists are very keen to use this, too,“ he said, “but the brain is not as challenging for fusing PET and MRI because the cranium provides a fixed landscape for anatomical reference.“

“Our strength is oncology and we will be examining head-and-neck cancers, prostate and breast cancers where after a single chemotherapy session costing $10,000 we will be able to say definitively whether the treatment had any effect and should continue, or else recommend it is stopped,“ he said.

“Studies of tumors in a soft mass are critical, and today we have difficulties following patients to determine any recurrence after chemotherapy, surgery and especially radiotherapy because their anatomy has been changed,“ Ratib said.

“These tumors can be aggressive and our attention is especially sharp on the smallest structures because these are the tumors that will metastasize,“ he said.

“Putting together the PET and the MR scans the way we do it today, we cannot be sure whether the PET is showing us a muscle that moved or a lymph node of an aggressive tumor,“ he said.

“Our investigation at this point is not a formally designed study,“ he said.

“Instead, the goal is to demonstrate that reading two studies separately does not have anywhere near the diagnostic confidence as reading them fused,“ said Ratib.

According to Troy Haven, Philips senior manager for PET marketing, “We need to demonstrate clinical relevance first, because if there is not a clinical value to drive adoption, there is no point to incurring further costs and utilizing the people and resources of hospitals.“

Philips, GE face-off in HIFU-MRI

Don't say HIFU, please just say it is non-invasive treatment of uterine fibroids.

Like any industry, radiology is an alphabet soup of acronyms with major imaging modalities promoted as MRI, US and CT, with contrast enhancement adding to the mix for marketing materials touting CE-CT or CE-US, and even emerging metabolic imaging crossing over from nuclear medicine quickly creating SPECT or PET-MRI.

So why not put the short-hand reference 'HIFU-MRI' boldly into marketing materials, rather than buried in the plain text, while the headlines tout the long-winded and generic euphemism 'non-invasive treatment'?

No doubt it is the checkered past of high-intensity focused ultrasound (HIFU) that makes marketing people reluctant to broadcast the company's association with this emerging technology for treating tumors.

One of the most widespread applications for HIFU up to now, for example, has been ultrasound-assisted lipoplasty systems, or fat burning, and other office-based cosmetic surgery, which suggests something of a dodgy character to medical center clinicians.

Up to now a solid market opportunity for HIFU applications has not emerged, despite sales that had grown to $100 million worldwide by 2006, because the technology has developed unevenly and is spread across selected geographies according to regulatory approvals, reimbursement and clinical acceptance.

In Europe, for example, prostate-ablation systems are sold, while in the United States the FDA cleared devices for uterine fibroid treatment in 2004 though low reimbursement has frustrated the development of this market.

The opportunity is enormous as uterine fibroids are the most common non-cancerous tumors in women of childbearing age and up to 20% of women with uterine fibroids experience severe symptoms that require treatment.

Royal Philips Electronics (Amsterdam, the Netherlands) entered the market introducing the Sonalleve MR-HIFU that offers three-dimensional planning for the intervention and real-time monitoring of temperature and tissue effects.

Thomas Andreae, Director of MR Marketing for Philips' Emerging Systems and Therapy (Vantaa, Finland) unit said the company believes the addition of a second major competitor in the uterine fibroid market could clear the path for a robust, upward growth in sales, he said.

“And it is a newer, superior technology with significantly faster ablation to reduce the requirement for MRI time, as well as unique volumetric heating and monitoring capabilities that we expect will win greater clinical confidence,“ he added.

The obstacle for HIFU, that blocks an open-field run into the massive markets for uterine fibroid and prostate cancer therapy, is a regulatory insistence on imaging guidance to monitor the effects of the high heat generated during the treatment.

Not convinced by the merits of ultrasound for monitoring effects, which likely will change with the emergence of tissue characterization using shear wave ultrasound, both the FDA and European authorities have insisted on guidance by MRI.

The added expense of MRI exams quickly leveled the economic arguments for HIFU against other treatments, such as hysterectomy and myomectomy, which typically also require the necessary expense of hospital stays.

GE Healthcare (Little Chalfont, UK) has struggled against low outpatient reimbursement rates for the ExAblate HIFU-MRI that have stymied sales since its introduction in 2005.

In the key U.S. market, payment rates of $1,700 to $2,600 set for other minimally invasive uterine fibroid treatments, such as uterine artery embolization, hardly begin to cover the MRI-related costs that are estimated to be between $7,000 and $8,500 per treatment.

The ExAblate HIFU-MRI system is produced by InSightec (Tirat Carmel, Israel/Dallas) from GE technology transferred to the Israeli company's majority shareholder, Elbit Technology (Dallas).

GE has a 21% interest in InSightec.

The ExAblate table docks to the GE Signa HD 1.5T, as well as GE 3.0 Tesla machines since 2007.

The company says that more than 4,500 women have been treated with ExAblate since it was brought into the clinic in 2006.

In March 2009 InSightec raised $15 million from its existing investors to further develop the technology and begin clinical trails for a wider number of cancer indications

The firm expects to begin a trial in 2010 for palliative treatment of bone metastases, a treatment for which it received the CE mark in June 2007.

Uterine fibroid ablation becomes a two-hour procedure, with much of this time taken up by the MRI scanning, and is performed on an outpatient basis with the patient typically returning to normal function within two days.

As with the ExAblate system, the Philips' Sonalleve MR-HIFU is built into a gurney, charmingly referred to as a trolley in European English, so that an MRI scanner does not need to be dedicated to the procedure and can be used for other routine examinations.

Sonalleve MR-HIFU, which received CE mark for clinical use in December, 2009, can be used with either the 1.5 Tesla or 3.0 Tesla versions of the Philips Achieva MRI scanners, as well as the company's Intera low-end scanner and the Panorama open platform MRI.

The HIFU transducer is integrated into the underside of the gurney thanks to a circle cut into the middle of the table top to expose the parabolic face of the HIFU transducer against the patient's abdomen.

A shield is strapped onto the back of the patients that houses the Philips' SENSE Pelvis coil as well as the sensors for temperature monitoring.

Philips' HIFU-MR leader Andreae explains that the focal point of HIFU creates a lesion the size of a rice grain and the Sonalleve planning software can be used to design a point-by-point targeting that moves to different areas during treatment to reduce over-heating of tissue in one region.

This mobile targeting creates a challenge, he said, because the fibroids are a fairly large target and the procedure could take between three and five hours.

A second problem with HIFU is focusing a fixed energy that heats irregularly which can result in uneven ablation of the region of interest, depending on the tissue type.

Philips solution to these problems on the Sonalleve MR-HIFU is volumetric heating where the focal beam is guided in a circular pattern covering a range from 4 mm to 16 mm in a 90-second bursts, and then thermal feedback in real time.

The actual time of the applied HIFU therapy is under 10 minutes, he said, and far less with experienced operators.

Philips installed 16 first-generation Sonalleve MR-HIFU units by the end of 2009 as investigative devices to compile a clinical experience.

Clinical experience to date is based on a study with 50 patients treated at six sites in Europe, the U.S. and Asia.