Clinical and Industry News

Perclose A-T Simplifies Vessel Closure After Cardiac Catheterization Procedures Abbott Laboratories has launched the Perclose A-T (Auto-Tie), the latest generation in suture-mediated vessel closure systems from Abbott Vascular Devices. Many physicians had considered tying the knot the most difficult step of Abbott Vascular Devices’ suture-mediated closure procedure. By eliminating knot tying, the new Perclose A-T provides an added convenience for clinicians and helps to reduce the vessel closure procedure time. I like the security of the stitch, and because the knot is pre-tied, Perclose A-T lets me close the artery quickly and easily, leaving nothing inside the vessel, said Richard Fortuna, MD, PhD, co-director of the cardiovascular laboratory, Scripps Memorial Hospital, La Jolla, Calif. My patients have started to ask for the product by name, because they know it allows them to leave the hospital sooner and resume their normal activities. Landmark CCF Heart Study Long-Term Dual Antiplatelet Therapy Reduces Risk of Death, Heart Attack and Stroke Following Stenting Long-term dual antiplatelet therapy of at least one year following percutaneous coronary intervention (PCI) significantly decreases the risk of death, heart attack and stroke. The current standard of care following PCI is a combination of an ADP (adenosine diphosphate) receptor for 2-4 weeks post-procedure to minimize the possibility of complications, and aspirin, which is continued for life. A review of data from the multi-center CREDO trial revealed that at one year following PCI, patients on long-term antiplatelet therapy had a 26.9 percent reduction in the combined risk of death, heart attack and stroke compared with patients who stopped drug therapy after four weeks. In addition, patients who received an ADP receptor (clopidogrel) at least 6 hours before PCI experienced a relative risk reduction of 38.6 percent compared with patients who received the drug less than 6 hours prior to treatment. The findings have a substantial impact on practice, for the first time showing how long-term continuation of double therapy (aspirin and clopidogrel) decreases major events after stenting," said Eric J. Topol, MD, chairman of cardiovascular medicine at The Cleveland Clinic and chairman of the study’s steering committee. CREDO is a randomized, double-blind, placebo-controlled trial conducted among approximately 2,100 patients in the United States and Canada. Researchers reviewed data from 99 participating centers of patients who were to undergo elective PCI or who were highly likely to undergo PCI between June 1999 and April 2001. An estimated 750,000 PCI procedures are performed yearly in the U.S. Based on the results of the trial and the number of PCI procedures performed annually, nearly 50,000 patients per year would avoid death, heart attack or stroke by using clopidogrel treatment for at least one year following intervention, said Steven Steinhubl, MD, principal investigator for the CREDO trial and associate director, cardiac cath lab at the University of North Carolina. Arkansas College of Medicine Makes Microsurgery Breakthrough Using $1 Pump; International Physicians to Come for Training Using a second-hand electric pump and food coloring from a grocery store, neurosurgeons in the College of Medicine at the University of Arkansas for Medical Sciences (UAMS) have created a breakthrough teaching technique for microsurgery. The neurosurgeons, Emad Aboud, MD, Ossama Al-Mefty, MD, and M. Gazi Yasargil, MD, use the pump, which they purchased for $1, to push colored water through the vessels and arteries of an anatomical specimen the head of a cadaver so that neurosurgeons in training can experience life-like blood flow as they learn. Medical schools have always used anatomical samples as teaching tools. They rely on anatomical gifts, or donations of human remains, to supply their teaching laboratories. While the Little Rock neurosurgeons developed the technique for brain surgery, physicians can use it to instruct students and residents in angioplasty and abdominal procedures that involve the use of an endoscope, among others. The technique is an enormous improvement over using either anesthetized live laboratory animals or traditional human anatomical specimens. Many sources are available for training in neurosurgery, but none of them reliably mimic the anatomy, and particularly the characteristics of the vascular system, in the brain during live surgery, Al-Mefty explained. It’s especially important that neurosurgeons-in-training get practice dealing with hemorrhages in the brain before they perform surgery on patients. This new teaching technique should be very helpful. If a hemorrhage occurs during surgery, the student can learn how to respond without risk to a patient. The UAMS technique also promises to reduce the dependence of medical schools on laboratory animals for teaching surgical techniques. CTI Molecular Imaging Introduces REVEAL XVI PET/CT Imaging System CTI Molecular Imaging, Inc. introduced the REVEAL XVI PET/CT imaging system, offering ultra-fine, 16-slice computerized tomography (CT), which enables the system to perform high-speed cardiac procedures as well as tests for cancer detection and monitoring in only 13 minutes for most patients. The new scanner combines LSO fast PET crystal technology for superior PET imaging quality and unprecedented testing speed with ultra-fine CT for the highest resolution available for precise anatomical imaging. PET gives images of the body's function or metabolism while CT shows organ structure. David Townsend, Ph.D., professor of radiology, University of Pittsburgh Medical Center and co-inventor of the PET-CT concept, said REVEAL XVI will promote earlier and more accurate diagnosis of cancer and, potentially, coronary heart disease. Our expectations are that the LSO PET scan merged with a 16-slice CT image will foster more accurate tumor detection and precise localization, improved biopsy sampling, and better assessment of patient response to therapy, said Townsend. Further, the addition of the 16-slice CT capability is a major breakthrough because it allows the PET-CT scanner to perform high-speed cardiac tests, such as CT angiographies and real-time interventional studies. This was a limitation with the earlier dual-slice version. In cardiac imaging with REVEAL XVI, we can detect emerging coronary- artery blockages earlier and spot local plaques on the artery wall thanks to the ultra-fine CT. It's conceivable that the PET component could help physicians determine which plaques are inflammatory and at risk for plaque rupture, said Todd Blodgett, MD, University of Pittsburgh Medical Center. Blodgett added that the superior resolution from 16-slice CT images enables radiologists to see coronary arteries in exquisite detail. Combining faster scan times with better resolution allows visualization of coronary activity within one cardiac cycle for evaluation of coronary-artery problems, wall-motion abnormalities and heart-tissue viability, said Blodgett. The REVEAL XVI will be available for customer installations by mid-2003. OmniSonics Medical Technologies Receives CE Mark for Resolution 360 Therapeutic Wire OmniSonics Medical Technologies, Inc., developing products to treat vascular occlusive disease based on its OmniWave technology platform, has received CE Mark in the European Union for its Resolution 360 Therapeutic Wire. The Company received its first CE Mark in June 2002 for its Resolution® System, which delivers low power, acoustic energy 360 degrees around the active length of the wire to rapidly resolve thrombus into micro-particles smaller than red blood cells. With this second CE Mark, OmniSonics can now market the Resolution System and 360 Therapeutic Wire in the European Union, initially for the treatment of lower extremity thrombotic occlusions and thrombosed hemodialysis fistulae. OmniSonics recently announced that the Company has received IDE approval from the FDA and has commenced a U.S. study to demonstrate the safety and effectiveness of the Resolution System in treating thrombosed hemodialysis access grafts. This followed news of a series of successful peripheral vascular procedures performed in Europe and Australia with the Resolution System. The Resolution System consists of three main components: a generator, handpiece and the Resolution 360 Therapeutic Wire. The single patient contact therapeutic wire is designed to target thrombotic material using low-power acoustic energy 360 degrees around its active 20 cm length. For more information on OmniSonics Medical Technologies, Inc., visit www.omnisonics.com. GE Medical Systems Receives FDA Clearance for Software That Fuses 3D X-ray and MR Images of the Brain GE Medical Systems announced that it has received clearance from the U.S. Food & Drug Administration (FDA) to market a software to fuse 3D X-ray and magnetic resonance (MR) images. This software is designed to help neuroradiologists and neurosurgeons in planning the treatment of blood vessel disorders in the brain. By fusing the 3D X-ray and MR images, physicians can visualize the precise location of both brain tissue and blood vessels, and their exact relationship to one another. The fusion software combines two critical types of image data that clinicians need when treating brain disorders. MR images show normal brain tissue as well as abnormal growths, such as tumors, in fine detail. Meanwhile, 3D X-ray images show arteries with extreme clarity, including vessels too small to be seen with MR imaging. The fusion of MRI and 3D X-ray has proven to be a unique technology that allows us to precisely locate and more safely treat vascular malformations in the brain that are very small in size but critically important as they are associated with brain hemorrhage, said Karel G. TerBrugge, MD, Head of the Division of Neuroradiology and Professor of Radiology and Surgery at the University of Toronto. Without this technique, we would not be able to determine the precise location of these lesions, which are too small to be seen and recognized using conventional imaging techniques. The GE software, which operates on GE's Advantage Workstation, can fuse images acquired with commonly-used X-ray and MR equipment, accommodating 3D MR images created with any DICOM MR scanner. The 3D X-ray images must be acquired on a GE Advantx vascular system (LCV+ or LCA+ single-plane systems, and LCN+ or LCA/LP+ bi-plane systems). Image fusion is performed on the multi-modality GE Advantage Workstation after loading the X-ray and MR images. Initially, the user identifies pairs of registration points so that the software can link the data to perform the fusion. The fused images can then be viewed as a single volumetric 3D image in color, or alternatively the X-ray and MR images can be viewed side-by-side. Fused images are DICOM-compatible, thus able to be stored, exported to a radiotherapy planning station, or transmitted to a remote site for further analysis. Scion Cardio-Vascular Sues Abbott Laboratories Over CLO-SUR P.A.D. On November 22, 2002, Scion Cardio-Vascular, Inc., a Miami-based medical device design and manufacturing company, filed a six-count complaint in Federal court against Illinois-based Abbott Laboratories. The complaint alleges that in January 2002, Abbott Laboratories and Scion entered into a confidentiality agreement under which Scion provided information to Abbott about a Scion product called the Clo-Sur P.A.D. Scion developed the Clo-Sur P.A.D. to close puncture sites resulting from minimally invasive cardiovascular and radiologic procedures, including cardiac catheterization. The Clo-Sur P.A.D. accelerates coagulation and reduces the time and effort required to close the puncture site to under ten minutes. According to the complaint, Abbott was considering making an equity investment in Scion and contracting to distribute the P.A.D. (an acronym created by Scion for pressure applied dressing). Instead, the complaint alleges that Abbott, after being provided with information about the product and its marketing, abandoned a proposed arrangement with Scion and, using information obtained from Scion, is bringing to market a competing pad. The complaint states claims for fraud, breach of the confidentiality agreement, and trademark and copyright violations. These claims are without merit, and we will vigorously defend our intellectual property, said Abbott spokeswoman Melissa Brotz. Abbott's Brotz said the product referred to is called Chito-seal, and the company launched a limited introduction of the product in the United States in November. Bypass Bests Angioplasty for Some With Blocked Artery Bypass surgery to restore blood flow for certain people with a single blockage in a coronary artery may produce better long-term results than angioplasty using a stent. The study found that bypass surgery offered better results for people with high-grade artery lesions. However, the study didn't compare bypass surgery to newer stents. Dutch and Italian researchers studied 102 people with a single B2 or C lesion in a coronary artery. The patients were randomly assigned to receive either angioplasty or bypass surgery. The bypass surgery patients had a keyhole type of operation. The surgeon worked through a small incision in the chest and grafted a bypass vessel around the blocked artery. Three years after the procedures, the researchers counted the number of patients who had died, suffered a heart attack or stroke, and those who needed a second procedure because of a clog in the same artery. The study found that 23.5 percent of the people who received angioplasty had a heart attack, stroke or needed a second procedure, compared to 9.8 percent of the people who had bypass surgery. However, there were no deaths in the angioplasty group, compared to two deaths in the bypass surgery group. The study also found that people in the bypass surgery group were less likely to have a return of angina, needed much less medication, and were in better condition than the angioplasty/stent group. Mammograms May Detect Heart Disease Mammogram images can detect calcifications in breast arteries that may indicate an increased chance of developing heart disease, according to the Mayo Clinic study of 1,803 women. Women with breast-artery calcifications were 20 percent more likely to have heart disease than those without calcifications, the researchers found. The abnormalities show up as distinct white lines on mammogram images and should not be confused with other types of breast calcifications that may be insignificant or, in some cases, malignant, the researchers said. Pretty much every radiologist can tell the difference; it's not a difficult distinction, said lead author Dr. Kirk Doerger, a Mayo Clinic radiology resident. Still, radiologists generally are thinking cancer not heart disease when they analyze mammograms. The reason why mammograms are done is for cancer detection. This is just an extra piece of information that could help discover women who are at increased risk of having narrowing in the arteries supplying their heart, Doerger said. His research was to be presented Wednesday in Chicago at the Radiological Society of North America's annual meeting. More than 350,000 U.S. women die of heart disease each year, compared with about 40,000 who die from breast cancer. Yet many women believe breast cancer is a greater risk and may not know they have heart disease, underscoring the need for better detection methods, the researchers said. They reviewed mammograms for patients who'd also undergone angiograms imaging tests to detect heart disease at the Mayo Clinic from 1991 to 2001. Participants were aged 65 on average and already at increased risk for heart disease based on their age. The risk from calcifications is not as strong as conventional factors linked to heart disease, such as high blood pressure and elevated cholesterol, but it should not be ignored, Doerger said. He said such calcifications should be noted in radiologists' mammogram reports and that afflicted women should be referred to their regular doctors for further assessment. This is quite a dramatic observation, said Dr. Linda Warren Burhenne, a mammography specialist in Vancouver, Canada. The literature is quite sparse in this field. Burhenne said radiologists frequently see such calcifications, which often show up as skinny parallel lines where calcifications have formed inside artery walls. Unless it's really dramatic, we just don't pay attention to it ... because it has not been determined to be of any importance until now, she said. Dr. Robert Bonow, president of the American Heart Association, called the results intriguing but preliminary. The women studied were already at high risk for heart disease. Whether breast-artery calcifications in lower-risk women would be meaningful remains to be seen, Bonow said. Still, he said the findings could potentially be significant because so many women die of heart disease, and because mammograms are so routine.

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