BB&T European Editor

PARIS – “We wrote the Guide to Good Practice for Radiology that has been translated and adopted by radiology societies across Europe,“ said Jean-Pierre Pruvo, MD, “yet we cannot practice according to our own guidelines in France.“

The chair of the French Society of Radiology (FSR), Pruvo took to the podium at the start of the annual congress, Journées Française de Radiology (JFR), to rally colleagues behind a plan to address an alarming lack of radiology equipment that threatens to bring down what is often cited as one of the world's best healthcare systems.

“In terms of MRIs per capita, we are actually at the level of Turkey and Portugal,“ said Pruvo.

In the context of other leading industrial nations of Europe, Pruvo said France has three times fewer MRIs than Germany and half as many MRIs as countries like Spain and Italy.

Since Pruvo sounded the alarm last year at JFR calling for 250 MRI scanners for emergency departments across the country, little has changed with the average waiting time for an MRI exam at 34.6 days.

This year Pruvo added CT to the list of equipment in critically short supply with 17 scanners available for every one million inhabitants vs. 31 per million in Germany.

The decline of French radiology further deepened at the congress as radiologists heard during the session “France Sans Film“ that 50% of clinics lack any kind of PACS.

While the Ministry of Health is stepping into the PACS crisis rolling out a shared Software as a Service (SaaS) to equip 926 centers by 2016, Pruvo outlined the FSR plan for addressing the scanner crisis.

“We know we need to double the number of both CT scanners and MRI,“ he said. “When you have six MRIs and six scanners in a hospital of 800 active beds, this is insufficient. We need only look at Rotterdam that has 12 scanners and 12 MRIs for an equivalent service.“

“I want to get this message out,“ Pruvo told reporters as part of his passionate campaign to shame stakeholders into action while also negotiating with the government on a plan of action.

“I met with the Minister of Health last year in the fullness of an economic crisis, yet we are assured that both the health and education budgets will be spared in the budget negotiations,“ said Pruvo.

Since his dramatic call last year for equipping emergency departments with MRIs to enable French trauma teams to conform to practice guidelines, Pruvo has become more politic after a year spent in committee meetings and working the halls of the Health Ministry.

He said the society scored a major success in winning adoption by the Ministry of its “10 Indispensable Measures“ for addressing France's crisis in imaging modalities.

He is now building consensus among all radiologists and their respective societies for private practice, research or specialty areas around the concept of a shared technical platform for major medical centers.

By ending the turf wars and joining together in a unified call for a planned workflow, Pruvo said he can strengthen his hand for negotiations with the ministry, which holds the purse strings in this socialist, single-payer system.

The ministry sets reimbursement rules and rates, controls capital spending on equipment, and with new powers to manage regional networks created by the reforms passed last year has an authority to decide what radiology services are needed, where they are needed and which center, either private and public, will deliver the service.

Pruvo has a difficult road ahead in pushing his plan for centralizing radiology services.

“It means putting new MRIs and scanners in the same center as radiography and ultrasound modalities to enable radiologists to have the right equipment, immediately available on a 24-hour basis to propose to patients,“ he said.

“If we first organize ourselves in a platform that is multidisciplinary, diversified and highly skilled, we expect to be able to stay within established budget constraints and then demonstrate consistent savings,“ he explained.

“There are significant savings for preemptive diagnostics over hospitalization,“ he said, adding “Let's stop saying that imaging is expensive. When you have a detailed diagnosis and the possibility of treatment right away, it costs less.“

FSR will need to demonstrate these savings, and Pruvo has put forward the center he leads, Centre Hospitalier (Lille, France), as an example.

Through the group Imagerie Santé Avenir, or Future Health Imaging, a case study promoting savings one year after the installation of an MRI was put forward at the annual congress.

Less straightforward will be Pruvo's ability to hold together the diverse special interests in radiology to keep a united front before the health minister, and then to implement the plan for shared platforms at major medical centers.

During the annual congress, Pierre Schnyder, recently retired after 20 years as head of the radiology unit at the Centre Hospitalier Vaudois in Lausanne, Switzerland was awarded the French Society's highest honor, the Antoine Beclère Medal in recognition of his work.

In an interview with BB&T, Schnyder said he understood the plan by Pruvo to extend the model used in Lille, and that he uses it as well in Lausanne, but that in France centralizing services is “guaranteed to start a war.“

For starters, he said, “there will be serious conflicts among different teams fighting over the time of day for using the MRI, the conflicts with sudden and unpredictabe needs of trauma teams.“

“It will set off turf battles that do not exist today,“ he said.

Cloud computing should bring radiology online

Like other Western European countries with rapidly aging populations, France has an urgent need to implement teleradiology practices.

Yet before it can reach this advanced level of image exchange and remote consultation, France first needs to take a giant step backwards to wean its 1,845 radiology centers off film-based systems and bring them into the digital age.

The Ministry of Health chose the annual FSR meeting to roll out an ambitious initiative that offers a shortcut to the future thanks to cloud computing.

The government proposal is to externalize the archiving of radiology images by connecting every radiology clinic with a national network offering software as a service (SaaS) through a third party vendor, thereby relieving clinics of the heavy lifting required in building archive systems.

The SaaS provider would remotely manage an infrastructure and communications network that is independent of the picture archiving and communications system (PACS) used at the source clinic.

“We are going to take the 'A' out of PACS,“ explained Laurent Treluyer, who is directing the project for the health ministry in coordination with ASIP Santé, the agency building the backbone for the future French electronic medical record (EHR).

Coming down from the cloud, Treluyer's analysis of the current state of radiology systems shows that on the ground France first needs to build from A to Z a radiology information system (RIS) before it can play with PACS.

Among the 60 million exams performed each year in France, only half are available in digital formats.

Where 75% of private radiology clinics are equipped with some form of archiving or PACS, only 20% of public and non-profit hospitals are so equipped.

The head of the association for private radiologists challenged this statistic during Treluyer's presentation saying that among his member centers classed as PACS-equipped by the government, most have only basic archiving functions, and that many of these are out of date and unable to exchange images with a national storage system.

Treluyer reported that fewer than 10% of hospitals with less than 300 beds are equipped with PACS, and only 50% of those with more than 300 beds are PACS-capable.

Private clinics in France perform 55% of all exams with only 45% of the imaging equipment.

Private clinics perform more than 6,000 exams per modality vs. 3,830 exams at public and non profit site, or 57% more exams per installed modality.

“Public clinics are not necessarily less productive when you consider the severe conditions of patients being examined compared to walk-ins at the private clinics,“ explained an executive from Agfa Healthcare (Mortsel, Belgium) which is a leading provider of both PACS and radiology equipment in France.

According to Treluyer, “We can not continue with an approach of laissez-faire,“ leaving the solution to each hospital and private clinic, though he acknowledged that joining a government-run network for sharing images, “is not a natural step for radiologists.“

The impact on industry of a public plan will be to polarize the market, to organize that market, and to homogenize pricing, he said.

The offer from the industry is too overwhelming for most institutions with a complex interplay of equipment features, network performance issues, cost, and issues of maintenance and service that impact the availability or uptime, said Treluyer.

ASIP will serve as a mediator for the France Sans Film program leveraging its experience with the EHR program to supervise a bidding process to select a single provider for the national archiving systems and a communications provider to assure security and capacity of a network that today would be handling five petabytes worth of data annually.

In a tour of the exposition floor, BB&T learned that Agfa is joining with the mobile telephone provider SFR (Paris) to respond to the call for offers, that Carestream (Villers-Saint-Frambourg, France) is partnering with Santeos (Bezons, France), and GE Healthcare (Buc, France) is teaming up with Orange (Paris).

The government's plan puts a priority on sites that are not equipped with PACS, which includes 250 private clinics and 660 public or non-profit centers.

Next will be upgrades for sites that are equipped with systems that have low capabilities or out of date equipment.

By 2012 a pilot program will link 20 radiology centers in France and the full program is projected to bring all centers online by 2016.

Treluyer demonstrated the five-year timeframe is realistic offering case studies for similar programs implemented in Quebec and the UK.

“This is shrewd on his part,“ commented an executive with a leading provider of PACS.

“To convince the Ministry, he chose the example of the beloved Belle Province, which stirs sympathies and has the same population as the Paris region, and then he inspired jealousy by evoking the image of our eternal enemy,“ he said.

Meanwhile, the critical region surrounding Paris has developed an advanced program built on the cloud computing scheme that will link the first two pilots sites in 2011, according to a presentation at the congress.

The team from the Île-de-France region said they have already selected GE Healthcare as the third party vendor for the program and have assessed two dozen hospitals and clinics that are ready to participate in a demonstration of the network.

The offer to radiology centers in the regional program reflects the final cloud computing solution designed for all of France.

Radiology centers will be offered three levels of service with archiving alone for centers that already have a PACS system, the archiving plus a PACS system offered as SaaS, and then for centers without any data management system a full package of archiving plus RIS and PACS can be contracted.

Low-cost ultrasound disrupts high-priced chemo

A four-minute ultrasound exam can determine in the first 30 days of treatment whether troublesome and often brutally expensive chemotherapy should be stopped, continued or even enhanced.

Preliminary findings from a multicenter study using a novel functional imaging technique for ultrasound were presented recently at the annual congress of the French Society of Radiologists.

Dynamic contrast-enhanced ultrasonography (DCE-US) combined with a quantitative assessment of solid tumor perfusion using raw linear data was tested with 539 patients across multiple types of cancer treated with 15 different antiangiogenic drugs.

Principal investigator Nathalie Lassau, MD, from the prestigious Institute Gustave Roussy (IGR) outside Paris, said that if all goes well she will be able to present final results at the Radiological Society of North America's (Oak Brook, Illinois) annual meeting in Chicago at the end of November.

“Everything depends on the last 40 patients,“ she said, adding that the final cohort needed to meet a required statistical threshold of 579 patients in order to draw credible conclusions.

This first-ever multi-center study using ultrasound for functional imaging is already drawing interest from drug discovery teams developing chemotherapy candidates with major pharmaceutical companies, according to Lassau.

Her work establishing a standardized assessment in animal studies promises to provide phase I proof-of-concepts for a new generation of cancer treatments.

“Actually at this moment we are testing a lot of new molecules,“ she told BB&T.

Yet the study, supported by the French National Cancer Institute, also has endpoints for medical economics.

“Currently we need to wait a minimum of six months to know if a treatment is effective, and the cost of treatment is between $3,000 and $5,000 per month,“ said Anthony Sarran, MD, Institute Paoli Calmettes (Marseilles, France), who presented the results at the French radiology meeting.

“There is a tremendous opportunity for savings for the national health insurance fund, not to mention the enormous benefit to patients receiving a toxic therapy with severe side effects,“ he said.

A second economic consideration is the widespread availability of ultrasound in France, which suffers from a severe shortage of magnetic resonance imaging and computer tomography scanners.

Sarran said the cost of the exam using two bolus injections of SonoVue and performed on the Toshiba (Tokyo) Aplio ultrasound system cost 182 ($254), of which nearly half the cost is the contrast enhancement solution.

Developed by Bracco, the SonoVue contrast enhancement solution is not yet approved for use in the U.S.

Sixty-five radiologists were trained in the methodology at 19 centers across France participating in the trial, part of study criteria necessary to demonstrate results are reproducible and not operator-dependent.

Raw data were analyzed with a mathematical model to evaluate seven parameters characterizing the tumor perfusion curve and response to treatment. Data were reviewed every two months with response evaluation criteria in solid tumors (RECIST) criteria.

Results showed five parameters exhibited a significant difference in their variation between exams on Day One, Day 30 and the response at 6 months. Two parameters, area under the curve (AUC) and area under the wash-out (AUWO), proved to be statistically robust and a significant predictor at 30 days for the response rate at six months, Sarran reported.

The methodology can only be performed on the Toshiba Aplio and Aplio XG systems for the moment. Lassau said that while only Toshiba was willing to share raw linear data in 2007 when the study began, “most manufacturers have now come forward.“

“This is the next step in the program to quantify the ultrasound signals and calculate the parameters to develop a robust methodology,“ she said, adding that she has recently been named the chair of the ultrasound group for the European Organization for Research and Treatment of Cancer (EORTC) with an objective of expanding participation in the French study to other countries including Italy, Germany and the UK where centers of excellence have already expressed their interest.

She said the Dana-Farber Cancer Institute (Boston), equipped with a Toshiba Aplio scanner is working with IGR to conduct a study to validate the technique.

Christoph Simm, ultrasound business manager for Toshiba Europe said the beta version of the software module will be demonstrated at RSNA 2010 under the working name CHI-Q for Contrast Harmonic Imaging-Quantification on the Toshiba UltraExtend Workstation Platform.

Jointly developed with IGR, the software extracts quickly the data for post-processing to identify the key parameters indicating whether a patient is responding to the therapy.

“This is a customer-driven program that we are responding to to create as soon as possible a method for reliable and robust results,“ said Simm.

It is unquestionably a unique competitive advantage for Toshiba to arrive first-to-market with the module for the Aplio workstation, he acknowledged.

“But what is really going on here is putting a new technique for personalized medicine using a scanner into the hands of clinicians,“ he said.

The ultrasound signal in a first step provides rich information, localizing the tumor, measuring it and defining the extent of the disease, he explained.

“To then provide information on the response to a therapy by tracking the inflow of a contrast agent into the tumor is not an easy thing to do,“ he said, requiring high resolution and advanced signal processing.

Finally there is the big picture, he said, pooling data from individual patient exams at multiple centers across a range of organs and disease types in order to shape greater clinical confidence.

“The faster we can get through the trial-and-error to exams supported with evidence from larger populations, the more quickly we can validate diagnosis and benefit patients,“ said Simm.

“The researchers need to see similarities of a patient in Slovenia with a patient in Belgium, or else to examine all renal patients,“ he said.

“This requires managing terabytes of information and bringing other supporting agencies into the game, like the EORTC,“ he said.

New radiography products find robust market

Day-to-day radiology in France continues to turn around traditional radiography with more than 75 million exams performed each year, equivalent to 1 .2 exams for every person in the country.

FSR acknowledged during its annual Congress that with an alarming lack of MRI scanners to perform non-radiated exams, practitioners are often forced to order X-ray for diagnosis.

While research is well-advanced with the alternative modalities of MRI and ultrasound, French radiology is equally proud of its strong historic links with radiography beginning with two-time Nobel prize winner Marie Curie, and more recently with Nobel prize winner Professor Georges Charpak, who passed away in September.

Charpak's revolutionary techniques for the detection of particles led to numerous scientific breakthroughs and in the medical field, the professor himself founded the company EOS Imaging (Paris) around a whole body orthopedic scanner that reduces radiation by 90% compared to traditional X-ray and up to 1,000 times less than a scan with CT.

EOS has 25 scanners installed in Europe and after winning FDA approval in 2008, has placed five units in the United States, two with private practices.

The company is on target to double revenues in 2011, CEO Marie Meynadier told MDD during JFR.

The EOS scanner is a big-ticket sale at $500,000, an investment that Meynadier said is quickly offset at clinics by high through-put.

Patient exams take four minutes and render head-to-foot images from a front and side angle that software reconstructs as a three-dimensional image for study.

DMS rebounds with winning new product line

The Platinum from Diagnostic Medical Systems (DMS; Montpelier) could be found front-and-center at three different exhibits during JFR.

In addition to the company's own stand, the new digital radiography/fluoroscopy (DRF) system was being offered by Carestream Health France (Noisy le Grand, France) and a distributor, T2I Healthcare (Vouziers, France).

The universal diagnostic imaging system features a remote controlled table that lowers to 48 centimeters (19 inches) for easier access for patients in wheelchairs or infants, and can be accessed from any side to facilitate patient transfer from gurneys.

“Our French customers really like their remote control tables and this is state-of-the-art,“ said Carestream Marketing Manager Hugues Trousseau.

The distribution agreement with Carestream is among a string of deals DMS has put together around new products that is helping the publicly traded company rebound from losses and severe cuts to staffing.

For the first nine months of 2010 the company reported sales of €11.2 million up 24% from the same period last year.

Radiology products dominate sales and the company reports more than 80 percent of its revenues are from export.

In October the company reported Siemens Healthcare (Erlangen, Germany) had included in its catalog for international sales the new DMS Stratos digital radiography system for bone densitometry examinations.

Cone Beam CT offers exam for head-and-neck

Expanding its expertise in cone beam imaging, QR (Verona, Italy) introduced at JFR 2010 the NewTom 5G, an open gantry for supine patient positioning for orthopedic exams.

Primarily used for planning dental and maxillofacial surgery, cone beam creates a 3-D image of the head, neck and oral cavity by detecting a shaped X-ray beam focused on a scintillator material with a charge-coupled device camera.

The technique achieves shorter scan times while yielding greater spatial resolution, improved signal to noise ration and a 16 bit dynamic range of gray scale.

A unique pulse system activates the X-ray source selectively during the exam delivering less than four seconds of total exposure for a full scan and reducing radiation from 20 to 50 times compared to a conventional CT.

The smaller footprint of the CT system facilitates placement in specialized clinics.

Unlike dedicated head-and-neck modalities that scan the patient in an upright position, the CT bore design allows patients to lay flat for cranial exams while patients for lower limb exams can sit upright and place the targeted anatomy in the bore.

3D NeoVision (Saint Etienne, France) is a start-up offering dynamic reconstruction software for surgeons using the NewTom system.

Nicolas Coudert had run out of brochures by the third day of the radiology congress and is printing a new batch in English for his first showing at RSNA in November in Chicago.

Using hundreds of slices acquired by the NewTom scanner, his software “does on the computer what surgeons and radiologists have to do in their heads, which is to reconstruct the images to plan surgery,“ he said.

Spinning out of the massive Hospice Civile complex in Lyon, France, 3D NeoVision has already added two new engineers for product development and posted sales in Dubai, Belgium and the UK.

Reconstruction by the software took 30 minutes in March and today can be done in less than 3 minutes, Coudert said.