BB&T

GENEVA, Switzerland — Operating on the spine is not brain surgery and remains very much a physical, hands-on interventional strategy.

Which may explain, in part, the continued resistance encountered by Medtronic (Minneapolis), BrainLab (Feldkirchen, Germany) and others in this sector as they seek to expand sales of surgical guidance technologies from neurological procedures down the spinal column to include exceptional interventions for deformities and also for more routine repair.

At SpineWeek 2008, held here in May, two surgeons faced off on guidance imaging for pedicle screw placement in a session sponsored by the European Association of Neurosurgical Societies (EANS) and AO Spine, a division of Arbeitsgemeinschaft für Osteosynthesefragen (the AO Foundation).

A poll conducted ahead of what the organizers called "a duel and not a debate," showed the audience was 80% European (obviously offering some skewing of responses), made up equally of neuro and orthopedic surgeons, with 38% use navigation technology regularly.

Serge Bellon, the head of navigation products for Medtronic in Western Europe, told Biomedical Business & Technology that fewer than 15% of spine surgeons in his region use guidance assistance with pedicle screw placement. So it was encouraging to see that 29% of the group said they planned to start using it, and another 15% said they were interested in experimenting with it.

Heading the opposition was Jesus LaFuente, a surgeon at Hospital del Mar (Barcelona, Spain), who acknowledged the "impressive" nature of the technology but pointed out that it was created for the brain, where target approach planning is essential. "There is only one way to reach the target for a pedicle screw, so we have to ask if it is really necessary," he said.

Using navigational assistance for precise placement of the screws, which are vital for holding in place the heavy metal that fuses vertebrae, is time-consuming, forcing longer wound exposure, LaFuente said, adding that the reference procedure to align the real-world landmarks on an implant with the virtual points recorded for the software also causes the wound to be enlarged, creating greater exposure for the patient.

Fuentes said that even after he had passed the learning curve, the procedure took just under three hours vs. one hour for the traditional approach.

"The only clear advantage," he said, "is reducing to just two the number of X-rays required during the procedure," compared to the continual exposure to fluoroscopy in conventional surgery. And he concluded after his experience that real-time guidance "is not helpful for degenerative spine procedures" and that the medical literature shows little difference in outcomes for patients for what he called "free-hand vs. navigation."

An unabashed supporter of navigation was Frank Kandziora, MD, who in January left Charité University Hospital (Berlin) to set up the Center for Spine Surgery and Neurotraumatology at the BGU Trauma Hospital (Frankfurt, Germany).

He first asked the audience to stand and then asked any surgeon who had not misplaced a pedicle screw to remain standing. He was satisfied he had taken his best shot in the duel —- no surgeon was left standing.

Kandziora said medical literature shows the rate of misplaced screws, which can result in a range of problems from minor discomfort to major impairment if the screw pierces the spinal cord, can vary from 4% to a shocking 40%. Yet in neurological procedures where navigation is universally used, he said, when pedicle screws are placed as part of the intervention, studies show a consistent and narrow range for misplacement of between 2% and 5%.

Kandziora translated the statistics this way: Where only one screw in 1,250 is misplaced using navigation, the odds are closer to one-in-50 for spinal free-hand. "That would mean that in a hospital with a reasonable volume of procedures, five patients a year are suffering to some degree from misplaced screws."

Kandziora added that a surgeon cannot turn to navigation assistance on an occasion basis when confronted with severe deformities or some kind of special problem to be solved.

Fluorescent microscopy produces live-cell look at rRNA

Seeing small is the key to much of modern medical science, and thanks to a National Institutes of Health study, scientists now can visually track the interaction between genes and their host cells as they happen, thanks to a technique called live-cell fluorescent microscopy.

Fluorescence microscopes are not exactly new, but were limited to 2D images in previous years. Thanks to improvements in the field of visualization and the addition of image processing computer software, scientists can capture images in real time and observe how genes transmit their codes into living proteins.

In a statement, the NIH said that researchers at the National Cancer Institute have seen enough from live-cell fluorescent microscopy to establish that a version of ribosomal ribonucleic acid (rRNA) — known to scientists as RNA pol 1 — functions in a more complex manner than previously understood. The new information may shed light on the processes behind the various forms of cancer.

NIH said that RNA pol I "is not a single protein but rather a complex of subunits that assemble into the full polymerase when needed." The researchers concluded that some of the pol 1 sub-units "associate more stably with the gene and assemble active and complete RNA pol I complexes more efficiently.

To test the idea further, the scientists then interfered in the interactions between the RNA pol I subunits and another transcription factor, which was said to mimic "the conditions of a cell that was able to produce rRNA at a high rate," the NIH statement said, which the cell reacted to by drastically cutting the efficiency of rRNA output.

This outcome hints that the "efficiency with which the RNA pol I complex assembles all its subunits ... plays a significant role in determining when a given gene is turned on." If the results of this study generalize to other transcription factors "the observed may represent a general mechanism for regulating gene transcription," the statement said.

CBO analysis finds benefit of HIT, used 'by itself,' overblown

The Congressional Budget Office recently published an analysis of the impact HIT may have on the American medical economy. Its conclusion: that while HIT can make a difference, it won't be the difference that is often touted.

CBO Director Peter Orszag states in a related entry on the CBO blog that there is a widespread belief that HIT "has the potential to transform the practice of healthcare by reducing costs and improving quality," while adding that "relatively few providers —- as of 2006, about 12% of physicians and 11% of hospitals — have adopted health IT." But Orszag said that while HIT "can be an essential component of an effort to reduce cost (and improve quality)," computerization of healthcare "by itself ... typically does not produce a reduction in costs."

Orszag said that the most conspicuous examples of HIT's impact on costs and quality of care "have tended to involve relatively integrated health systems" and that such results might not generalize particularly well. Part of the slow pace, of course, involves the perception on the parts of many doctors that they "might not be able to reduce their office expenses or increase their revenue sufficiently to pay for" HIT.

He took exception to the conclusions drawn in the widely cited 2005 study of the potential impact of HIT by the Rand Corporation (Santa Monica, California), which projected annual savings of about $80 billion. Orszag said the Rand study failed to account for reimbursement systems still occasionally penalizing providers for reducing costs.

He also said the Rand study excluded data "published in peer-reviewed journals that failed to find favorable results." He said the exclusion of such data "clearly biases any estimate of the actual impact of health IT on spending."

The role of HIT on comparative effectiveness research may be significant thanks to the "large amounts of data on patients' care and health," Orszag said, but that federal subsidies for HIT are "less likely [than penalties for failure to implement HIT] to generate cost savings for the federal government because it involves up-front costs." He said that "for any given underlying financial incentive, a penalty may be more effective at triggering adoption than a subsidy if a penalty carries a negative connotation that does not apply to failing to receive a subsidy."

Concerns by Congress, but DME bidding still rolls along

A May hearing in the House of Representatives on the bidding program for durable medical equipment (DME) highlighted Congress's discomfort with the program, but the legislators may be chasing a train that already is moving quickly down the track. One of the concerns is that beneficiary access might be impeded, and Nydia Velazquez, (D-New York), chairwoman of the House Small Business Committee, also charged that the program indicates that "CMS has little regard for how its decisions are impacting small businesses."

Despite congressional concerns, a May 19 report by the Centers for Medicare & Medicaid Services said that the agency has awarded contracts to 325 bidders for durable medical equipment prosthetics, orthotics, and supplies (DMEPOS) in the 10 metropolitan areas in the first round of bidding. CMS said that the winners will "provide certain medical equipment and supplies to beneficiaries in 10 communities across the U.S. at significantly lower prices than they are paying now."

CMS planned to keep small businesses in the program by setting a target rate of participation of 30%, but actually ended up awarding roughly half the contracts to small businesses, which were defined as those grossing $3.5 million or less a year. Other provisions of the program include that beneficiaries may, "in some situations, also be able to continue to receive certain items from a grandfathered supplier," defined as "non-contract suppliers that provide certain rented equipment under the terms of the program."

Acting CMS Administrator Kerry Weems said all the winning bidders "have met our stringent standards, so beneficiaries can be assured they receive their equipment and supplies from legitimate suppliers." He added that the agency reserves the right to "terminate contracts with suppliers that don't meet these requirements."

The suppliers will begin doing business July 1.

Ad campaign underway for Hospital Compare website

The age of full transparency in healthcare took a big step forward with the Department of Health and Human Services' launch of an advertising campaign for its Hospital Compare website, placing ads in the May 21 editions of almost 60 major daily newspapers around the country. CMS reported launch of the website earlier this year year.

The ads provide the scores from hospitals located in the newspapers' readership areas, but it was not clear how nationally distributed newspapers would handle editions distributed far from the publisher's location.

Included in the ads are scores for two of the 26 quality and patient satisfaction measures, with HHS Secretary Mike Leavitt saying the the 26 measures "are intended to give consumers more information for making choices about their healthcare." Leavitt also said the move "brings us closer to meeting the goal of using new technologies to make the quality of healthcare services all across the nation more transparent to the public."

The statement says that the site at www.hospitalcompare.gov lists almost 4,000 hospitals from across the U.S. and that the ads are "aimed at reaching areas covered by about 1,000 of these hospitals." The ads report the "percentage of patients at each hospital who always received help when they requested it, as reported by the patients themselves" and the "percentage of patients at each hospital who were given antibiotics one hour prior to surgery, as reported by hospitals." They also give the averages for each state on these measures.

The data found at the Hospital Compare site is based on information "collected through a new patient survey, the Hospital Consumer Assessment of Healthcare Providers and Systems survey," which HHS described as "the first national, standardized, publicly reported survey of patients' perspectives of care."

NIH grant will support device for recovery from stroke

Stroke survivors who have lost the use of an arm because of a stroke soon will have access to an in-home exercise device to help activate new brain pathways to improve arm function. A grant from the National Institutes of Health will enable further refinement of the patented device, to be called Tailwind, which was developed at the University of Maryland (UofM) School of Medicine (Baltimore).

Clinical studies show that Tailwind improves arm movement in stroke survivors who have been paralyzed for months, even years, after a stroke. Through a licensing partnership with the medical school, Encore Path (Baltimore) will market the invention in a compact, retractable and portable design.

The FDA has designated Tailwind as an exercise device for stroke patients. The $120,000 Small Business Innovation Research grant from the National Institute of Neurological Disorders and Stroke is awarded to both the medical school and Encore Path.

Co-inventors Jill Whitall, PhD, a professor in the department of physical therapy and rehabilitation science, and Sandra McCombe Waller, PhD, an assistant professor in that department, created Tailwind through research they conducted in the late 1990s at the U of M School of Medicine. So far, the device has been tested only in patients six or more months after their first stroke.

McCombe Waller and Whitall have received funding to test the upgraded device in the sub-acute hospital setting, with patients who recently had a stroke.Tailwind will be available to stroke patients this fall, the researchers said.