Clinical and Industry News

Boston Scientific to Acquire BridgePoint Medical, Inc.

Company to acquire minimally invasive technologies for the treatment of coronary chronic total occlusions

Boston Scientific Corporation has signed a definitive agreement to acquire BridgePoint Medical, Inc., a privately held company based in Minneapolis, Minnesota. BridgePoint Medical has developed a proprietary, catheter-based system to treat coronary chronic total occlusions (CTOs).  The transaction is expected to close in the fourth quarter of 2012 subject to customary closing conditions.

The BridgePoint Medical CTO system is comprised of the CrossBoss^™ CTO Crossing Catheter and the Stingray^® CTO Re-Entry System, and is designed to navigate highly occluded coronary arteries as a means of blood flow restoration. The system has received both U.S. Food and Drug Administration clearance and CE Mark, and is currently the only crossing and re-entry system cleared in the U.S. for use in coronary CTOs.

“Complete arterial blockages pose a major challenge in the treatment of coronary artery disease, and this CTO system gives physicians an important treatment option in these difficult cases,” said Marty Leon, MD, Director of the Center for Interventional Vascular Therapy at New York-Presbyterian Hospital/Columbia University Medical Center in New York City.  “Many of these patients would have previously been referred for bypass surgery, typically requiring weeks of recovery. Now, many of them are able to go home within 24 hours.”

Radiation Scatter Survey Results of the Radial Assist RAD BOARD Announced

Radial Assist Shares Letter from Alliance Medical Physics LLC

To: Radial Assist, LLC
Re: Radiation Scatter Survey of
Radial Assist RAD BOARD by
Alliance Medical Physics LLC

Following are the results of the radiation scatter survey conducted on the RAD BOARD on April 20, 2012. The RAD BOARD is an arm board utilized in cardiac catheterization and interventional labs for radial access. It has the added feature of being partially lined with a 15” by 9” layer of Xenolite TB for additional radiation scatter protection. Xenolite TB, which is a lead-free, super-lightweight 2-element composite equivalent to 0.35mm Pb protection, is embedded in the board under the company logo label. The survey was performed to quantify the ability of the RAD BOARD to reduce radiation scatter to the physician performing the vascular procedure.

The survey was conducted in a cardiac catheterization lab with a Philips Integris Fluoroscopic C-arm with 3 fields of view (9”, 7”, and 5”). An 8” solid water phantom was used to simulate an average size adult male chest; this phantom served as the radiation scatter medium. Measurements of radiation scatter were made with a Victoreen digital ion chamber utilizing integrate mode. These measurements were made at the typical location of the physician’s waist and neck, both with and without the RAD BOARD in place (See Figure 3).

RADIATION SCATTER SURVEY RESULTS

The results of the survey indicate that when utilizing the RAD BOARD, radiation scatter exposure levels were reduced by 33% - 40% at waist height, and 21% - 30% at neck height (See Figures 1 & 2).

Sincerely yours,

Michael S. Glaser, MS, Certified Medical Physicist Diplomat-American Board of Radiology, Alliance Medical Physics LLC 2500 Abbey Court · Alpharetta GA 30004 · 770.751.9707 · (fax) 770.753.4305

New Study Upends Assumptions About Macrophages and Cholesterol Formation

Atherosclerosis has long been presumed to be the fateful consequence of complicated interactions between overabundant cholesterol and resulting inflammation in the heart and blood vessels.
However, researchers at the University of California, San Diego School of Medicine, with colleagues at institutions across the country, say the relationship is not exactly what it appears, and that a precursor to cholesterol actually suppresses inflammatory response genes. This precursor molecule could provide a new target for drugs designed to treat atherosclerosis, which kills tens of thousands of Americans annually.

The findings are published in the September 28, 2012 issue of Cell.

Lurking within our arterial walls are immune system cells called macrophages (Greek for “big eater”) whose essential function is to consume other cells or matter identified as foreign or dangerous. “When they do that, it means they consume the other cell’s store of cholesterol,” said Christopher Glass, MD, PhD, a professor in the Departments of Medicine and Cellular and Molecular Medicine and senior author of the Cell study.  “As a result, they’ve developed very effective ways to metabolize the excess cholesterol and get rid of it.”

But some macrophages fail to properly dispose of the excess cholesterol, allowing it to instead accumulate inside them as foamy lipid (fat) droplets, which gives the cells their particular name: macrophage foam cells. 

These foam macrophages produce molecules that summon other immune cells and release molecules, signaling certain genes to launch an inflammatory response. Glass said conventional wisdom has long assumed atherosclerotic lesions – clumps of fat-laden foam cells massed within arterial walls – were the unhealthy consequence of an escalating association between unregulated cholesterol accumulation and inflammation.

Glass and colleagues wanted to know exactly how cholesterol accumulation led to inflammation, and why the macrophages failed to do their job. Using specialized mouse models that produced abundant macrophage foam cells, they made two unexpected discoveries that upend previous assumptions about how lesions form and how atherosclerosis might be more effectively treated.

“The first is that foam cell formation suppressed activation of genes that promote inflammation. That’s exactly the opposite of what we thought happened,” said Glass. “Second, we identified a molecule that helps normal macrophages manage cholesterol balance. When it’s in abundance, it turns on cellular pathways to get rid of cholesterol and turns off pathways for producing more cholesterol.”

That molecule is desmosterol – the final precursor in the production of cholesterol, which cells make and use as a structural component of their membranes. In atherosclerotic lesions, Glass said the normal function of desmosterol appears to be “crippled.”

“That’s the next thing to study; why that happens,” Glass said, hypothesizing that the cause may be linked to overwhelming, pro-inflammatory signals coming from proteins called Toll-like receptors on macrophages and other cells that, like macrophages, are critical elements of the immune system.

The identification of desmosterol’s ability to reduce macrophage cholesterol presents researchers and drug developers with a potential new target for reducing the risk of atherosclerosis.

Glass noted that a synthetic molecule similar to desmosterol already exists, offering an immediate test-case for new studies. In addition, scientists in the 1950s developed a drug called triparanol that inhibited cholesterol production, effectively boosting desmosterol levels. The drug was sold as a heart disease medication, but later discovered to cause severe side effects, including blindness from an unusual form of cataracts. It was pulled from the market and abandoned.

“We’ve learned a lot in 50 years,” said Glass. “Maybe there’s a way now to create a new drug that mimics the cholesterol inhibition without the side effects.”

Funding for this research came, in part, from National Institutes of Health grants GM U54069338 (to the LIPID MAPS Consortium), P01 HC088093 and P01 DK074868.

Abnormal Carotid Arteries Found in Children With Kidney Disease

A federally funded study led by researchers at Johns Hopkins Children’s Center has found that children with mild to moderate kidney disease have carotid atherosclerosis. The findings — published online ahead of print on Sept. 13 in the Clinical Journal of the American Society of Nephrology — are particularly striking, the researchers say, because they point to serious blood vessel damage much earlier in the disease process than previously thought. As a result, they add, even children with early-stage kidney disease should be monitored aggressively and treated promptly for both hypertension and high cholesterol to reduce the risk for serious complications down the road.

The researchers caution they are not sure whether the same fatty deposits that clog adult arteries are the reason behind the abnormally thick carotid arteries they observed in the study. But because most of the children involved in the research already had high cholesterol and hypertension, the investigators believe they are dealing with a disturbingly early onset of this condition in an already vulnerable population.

“Untreated hypertension and high cholesterol increase the risk for long-term vascular damage in any child, but in a child with kidney disease they can wreak much more serious havoc,” says study lead investigator Tammy Brady, MD, MHS, a pediatric nephrologist at Hopkins Children’s.

Chronic kidney disease by itself increases cardiovascular risk because of chronic inflammation and altered metabolism, the investigators say. But the presence of any additional risk factors — such as obesity, high cholesterol and hypertension — can further fuel that risk and put children with kidney disease on a path to early heart attack and stroke if left untreated, they add.

In the current multi-center study, which compared 101 children with kidney disease to 97 healthy children, the majority of patients with kidney disease had high blood pressure (87 percent) and elevated cholesterol (55 percent). One-quarter of them were overweight or obese.

In their study, researchers performed neck ultrasounds to measure the internal thickness of the carotid artery. On average, children with kidney disease had carotid arteries about 0.02 millimeters thicker than those of children without kidney disease, but some children had arteries up to 0.06 millimeters thicker than their healthy counterparts. High blood pressure and elevated cholesterol increased the difference. Children with hypertension had arteries 0.04 millimeters thicker on average, and children with elevated triglyceride levels had arteries that were 0.05 millimeters thicker.

“We cannot emphasize this enough: Pediatricians who take care of children with chronic kidney disease — even kids with early-stage kidney disease — should screen them early for cardiovascular damage, assess their risk factors and treat hypertension and high cholesterol promptly and aggressively,” Brady says.

An estimated 20 million Americans have chronic kidney disease, according to the CDC. Because chronic kidney disease often evolves silently over a period of years, researchers estimate that many adults with late-stage or end-stage kidney disease developed the disease as children.

SCAI Launches Appropriate Use Criteria and Guidelines Application for Smartphones, Tablets and PCs

AUC Calculator App Is Latest Addition to SCAI Quality Improvement Toolkit

Coronary revascularization appropriate use criteria (AUC) are now just a click away with the new SCAI Quality Improvement Toolkit (SCAI-QIT) AUC and Guidelines App, launched by the Society for Cardiovascular Angiography and Interventions.

“The new app is a calculator tool that makes it simple to access the AUC on heart revascularization without having to carry around printed documents,” said Kalon Ho, MD, FSCAI, architect of the new tool. “While we don’t intend for this tool to replace clinical judgment, we do hope it provides easier access to information that can guide the cath lab team’s decisions.”

Once members of the cardiac catheterization lab team input facts about a patient’s case, the app will indicate where a “typical” case with those same characteristics would fall on a spectrum of “appropriate,” “uncertain” or “inappropriate” for revascularization, as defined by the latest recommendations from leading cardiology societies, including SCAI and the American College of Cardiology Foundation, among others.

SCAI’s calculator app also recognizes that complete documentation is essential in today’s healthcare environment. The app providers users with key data, including the relevant AUC scenario number, the indication score, a summary of the patient’s case, and a link to a printer-friendly reporting sheet can be added to the patient’s chart. 

In coming months, SCAI will expand the app with new modules to help healthcare providers access interventional cardiology guidelines and additional AUC, including those for diagnostic cardiac catheterization. Plans are also underway for the app to include options for interfacing with electronic health records, further assisting providers with documentation.

The AUC and Guidelines App is part of the expanded SCAI-QIT developed by SCAI’s Quality Improvement Committee to provide tools and resources that help both facilities and providers deliver consistent quality care to cath lab patients. Currently tools focus on guidelines and AUC, national database participation, inventory management, pre-procedure activities, operator and staff requirements, procedural quality, best practices as well as facility and environmental issues. Each tool is regularly updated to incorporate the latest guidelines, regulatory requirements and feedback from the many SCAI Quality Champions who are using the tools in cath labs around the world.

“The SCAI-QIT has become an important resource for continuously improving cath lab quality. Within months of its launch, interventional cardiologists began telling us how SCAI-QIT helps them identify and address opportunities for improvement,” said SCAI Immediate Past President Christopher J. White, MD, FSCAI. “The new AUC Calculator App is an example of a tool that will help cath lab teams easily access information supportive of high-quality, evidence-based patient care.”

The new AUC Calculator app can be accessed for free at www.SCAI-QIT.org. For more information on SCAI-QIT and its numerous tools, visit www.SCAI.org/QIT.

Since it was launched in 2011, SCAI-QIT tools have been accessed more than 7,000 times, and 350 interventional cardiologists from around the world have become SCAI-QIT Quality Champions.

The SCAI-QIT was developed with founding support from Daiichi Sankyo Lilly and support from AstraZeneca.