Clinical and Industry News

LUMEDX Announces CardioImage, Digital Imaging Review Technology for Apollo Free Cardiology Imaging Kit with Demo CD Lumedx Corporation announces CardioImage, a new digital image review solution that enables physicians to access digital images from the hospital, office, or home wherever CardioImage is installed on a PC. No longer limited to dedicated diagnostic image review workstations, CardioImage saves physicians time, streamlines workflow, and helps increase productivity. In combination with Apollo, CardioImage delivers access to images, data, and reports resulting in an unparalleled view of the patient. Available to Cath Lab Digest readers is a free Cardiology Imaging Kit, complete with CardioImage Demo CD. To receive a free kit, surf www.lumedx.com/ImagingKit. Or call toll-free 1-800-966-0699, ext. 234. Unlike closed, proprietary hardware systems, the CardioImage solution is based on software that runs on industry-standard PCs and servers, including Dell, IBM, or Compaq. CardioImage consists of CardioViewer, Cardio-Echo Reporting System, and CardioImage Archival Solution. Deployment of CardioImage is as simple as installing software on your systems. Lumedx can be found on the Web at www.lumedx.com. Carolinas HealthCare System Selects Medcon for Cardiac Image Management and Archiving Carolinas HealthCare System (Charlotte, North Carolina) has selected Medcon to provide cardiac image management and archiving for its cath labs after a thorough evaluation of more than ten competing brands. The CHS engaged information system specialists, cath lab technologists, physicians, administrators, and other decision-making hospital staff in an active review of the products during all-day presentations and simultaneous weeklong on-line hookups. These live comparisons included evaluation of the systems from contending vendors in cath labs in two hospitals and their DVD archival jukebox at the central IS department. The evaluated features included the transfer time of data exchange, time to download studies from a central archival jukebox with simultaneous requests, and regarded as the sole most important deciding factor image quality. Medcon will connect its TCS Cath Acquisition and Review Workstations in nine cath labs across three distinct facilities at the CHS. The stations will be connected to central archival DVD jukeboxes at the IS Data Center. Carolinas Medical Center-Mercy will also incorporate Medcon's new ACC-NCDR compliant Cath Reporting and database module. For cardiac intranet connectivity, the CHS will use Medcon’s MDWeb, a product enabling the web publication of images, reports and data generated in the labs. For additional information, visit www.medcon.com. Heart Failure Patients Not Receiving Ideal Therapy Despite strong evidence demonstrating the benefits of adding beta-blockers to standard therapy, thousands of heart failure patients are not receiving this class of drugs as part of their treatment regimens, according to a nationwide survey of 400 cardiologists, internists, and general practitioners, known as the Heart Failure Report Card. The survey, conducted in conjunction with the Cardiovascular Institute of University of Pittsburgh Medical Center (UPMC) Health System, showed that 87 percent of physicians polled say they clearly understand the benefits of beta-blockers as seen in clinical trials. However, this understanding isn’t translating into practice physicians report that they prescribe beta-blockers to only one-third of their heart failure patients. We developed the Heart Failure Report Card to help us understand the current mindset and treatment patterns of physicians, said Dr. Arthur Feldman, director of the Cardiovascular Institute of UPMC Health System in Pennsylvania. Physicians gave letter-grade scores to various questions such as patient understanding of the disease, compliance with the necessary lifestyle changes, physician satisfaction with current medications and the availability of education about heart failure treatment options. Overall, physicians graded heart failure diagnosis and treatment in the United States with a letter-grade of C. Based on the responses of the surveyed physicians, researchers concluded that the key to optimizing heart failure treatment is education about the use of emerging therapies in clinical practice. Beta-blockers are valuable tools for managing heart failure, Feldman said. Unfortunately, the Report Card findings show that most physicians are either not prescribing them, or are waiting until symptoms have substantially worsened to prescribe them. We need to educate both physicians and patients on the most effective ways to incorporate them into treatment regimens. The Heart Failure Report Card also showed that physicians are giving their patients low grades in terms of their understanding of the disease and the lifestyle modifications necessary to manage the condition. Surgeons Might Train On Artificial Bodies Surgeons could soon be perfecting their surgery techniques on artificial bodies, produced by technology normally used to make precision tools and parts for industry. Cardiff University’s Manufacturing Engineering Centre (MEC) is developing Primacorps, a cost-effective realistic surgical trainer, for Limbs and Things Ltd. (Bristol, UK). Virtual bodies have now been created and the next step will be to make prototype physical versions, for evaluation by surgeons across Europe. Once the prototypes are approved, final parts organs and bones will be produced, using novel materials and the MEC’s rapid tooling technology. Traditionally, surgeons have acquired skills as apprentices, but many surgical trainers are uncomfortable about trainees starting to learn on real patients, and it is widely acknowledged that training has lacked uniformity and has led to an inconsistent acquisition of skills by surgeons. The project is made possible by reverse engineering. Two average individuals one male and one female were scanned from neck to upper thigh, using the Bristol Oncology Centre’s magnetic resonance imaging (MRI) tunnel scanner. Close collaboration between engineers and surgeons has been necessary to ensure that the parts could be produced by existing injection molding techniques and that they are anatomically accurate. Antibiotic Treatment May Improve Cardiovascular Function Researchers have shown that an antibiotic improved vascular function in people with angina who tested positive for Chlamydia pneumoniae in their blood. Coronary artery disease patients who tested positive for C. pneumoniae showed improved blood flow in the brachial artery and reduced blood levels of two known markers for endothelial dysfunction after five weeks of daily treatment with azithromycin. Patients given placebo did not improve. For several years, researchers have tried to identify a specific bacterium or virus that might damage the endothelium. Once a microbe was identified, researchers tried to find an antibiotic that could eradicate it, according to Dr. Juan Carlos Kaski, a study co-author and a professor of cardiovascular science at St. George’s Hospital Medical School in London. Kaski said C. pneumoniae proved to be a good candidate for this approach because it is a common infection and evidence of it has been discovered in plaque removed from arteries of people with coronary artery disease. We have found in this study that treatment with azithromycin improved the function of the endothelium, said Kaski. The antibiotic thus appears to allow the artery to increase its caliber. Forty males, average age 55, were enrolled in the study. All had documented coronary artery disease. They were randomly assigned to receive either azithromycin or placebo for five weeks. Flow-mediated dilation (FMD) of the brachial artery was measured at study entry and at the end of treatment. In addition, levels of E-selectin and von Willebrand factor (both markers of endothelial dysfunction) and levels of C-reactive protein (a marker of inflammation) were measured at entry and after treatment. After treatment, patients’ average FMD of the brachial artery improved from 2.66 percent at baseline to 4.78 percent. In the placebo group, the baseline measurement was 3.11 percent and at five weeks it was 3.09 percent, indicating no improvement. Moreover, in treated patients, the level of E-selectin declined by an average of 28.2 nanograms per milliliter (ng/mL) in treated patients and von Willebrand factor level declined by an average of 36.6 International Units per deciliter (IU/dL). The study showed improved arterial function, but it was not designed to provide evidence that the antibiotic could reverse atherosclerosis or reduce the number of heart attacks. Moreover, Kaski said the benefit of the antibiotic might not be a direct result of the drug’s ability to eradicate the pathogen, because their study showed that patients who had very high levels of C. pneumoniae antibodies had essentially the same benefit as those with low levels. A direct anti-inflammatory action of the antibiotic has been suggested because azithromycin is in a class of drugs called macrolides, which have anti-inflammatory effects. The question remains open since azithromycin did not reduce the levels of C-reactive protein in this study. The next step is to design a study that will allow the researchers to identify the mechanism responsible for the beneficial effect of antibiotics so that they arrive at a rational treatment, which might include developing even more effective antibiotics or perhaps a vaccine, or just appropriate anti-inflammatory agents. However, Kaski said it is too soon to recommend the use of antibiotics to either treat or prevent heart disease. Microbleeds May Be Risk for Stroke Complications Researchers have found a marker that may identify patients who are more likely to have bleeding complications and who may need to be treated more cautiously when being treated with clot-busting therapy drugs for ischemic stroke. Cerebral bleeding (CB) can be a devastating complication of ischemic stroke. Between 20 percent and 40 percent of stroke patients have cerebral bleeding within the first week after stroke symptoms occur, according to the study’s lead author, Dr. Norbert Nighoghossian, professor of neurology, Hospital Neurologique, Lyon, France. The purpose of the study was to detect if previous microbleeds are associated with an increased risk of cerebral bleeding after ischemic stroke. Researchers studied 100 stroke patients, ages 19 to 83, with documented ischemic damage. They analyzed the patients with various imaging technologies to assess the CB and define the presence of microbleeds. They found that patients with microbleeds were seven times more likely to develop cerebral bleeding after stroke compared to those without microbleeds. According to Nighoghossian, old microbleeds often indicate that small blood vessels are diseased. This condition is exacerbated by hypertension, diabetes and the chronic use of drugs to prevent blood clots. Therefore, he urges doctors to manage these post-stroke patients with caution if such injury is detected. The researchers also found that a new imaging technique called T2*-weighted gradient-echo MRI was best at detecting microbleeds. It offers higher sensitivity than conventional MRI imaging, which often fails to detect CB at an early stage of stroke. The authors say that this is the earliest evaluation of acute CB with T2*-weighted imaging in a large group of ischemic stroke patients. In the study, early CB was diagnosed in a total of 26 patients, 18 at the acute stage by T2*-weighted gradient-echo sequence and 8 with CT scan performed within the first week. The presence of old microbleeds was significantly related to developing CB. The baseline National Institutes of Health Stroke Scale score (a standardized assessment to determine the neurological impairment-severity of stroke) and diabetes were also significant independent predictors of CB. The cause of CB is due to many factors. The relationship between acute CB and previous vessel wall damage as revealed by the presence of microbleeds suggests an increased vascular vulnerability, Nighoghossian said. However, a larger number of patients, especially those with microbleeds, are needed to clearly establish this relationship. More research also is needed to determine if benefits outweigh the risks of using antithrombotic therapies in a subgroup at risk for both thrombotic and hemorrhagic events. I urge practitioners to carefully manage patients with diabetes and hypertension because they could be at increased risk of microbleeds and for cerebral bleeding, Nighoghossian said. Discontinuing Statins May Cause Dangerous Rebound The American Heart Association announced research showing that heart disease patients who discontinued using statins while they were hospitalized for chest pain had triple the risk of death or heart attack as people who kept taking their medicine. The message to physicians is: Don’t stop statins, said Dr. Christian W. Hamm, one of the study authors. Withdrawal of statin therapy shortly after the onset of symptoms completely eliminated the protective effect of statins in coronary heart disease patients hospitalized with severe chest pain. The researchers examined the medical records of 1,616 patients who had previously participated in an international clinical trial called PRISM Platelet Receptor Inhibition in Ischemic Syndrome Management study. The study compared the effectiveness of two blood-thinning drugs tirofiban versus heparin in coronary heart disease patients hospitalized with accelerating heart pain. When admitted to the hospital, 465 patients had been taking a statin drug for six months. Statin therapy was continued in 379 patients and discontinued in 86. After the 30-day point, researchers examined the rates of death and nonfatal heart attacks. Patients who were kept on their medication had half (.49 times) the risk of death or a nonfatal heart attack of people who had never taken a statin drug. Those who were not continued on the drugs after hospitalization had 2.93 times the risk of those who continued taking statins. The increase in deaths and acute heart attacks was only explained by the statin withdrawal, Hamm said. Moreover, one week after hospitalization, compared with patients who stayed on their medication, a significantly higher number of patients who were taken off their medication had undergone a procedure to restore blood flow through their coronary arteries. Some 165 patients treated with a statin after being hospitalized had fewer deaths or nonfatal heart attacks than patients who had never taken statins. According to Hamm, there is no specific protocol suggesting hospitalized patients discontinue statin drugs, so physicians either assumed that statins were no longer beneficial or they simply forgot to continue it. Most previous statin trials excluded patients who had suffered an acute coronary syndrome within the preceding three to six months. The drugs appear to do more than lower cholesterol. They reduce artery inflammation, and the proliferation of smooth muscle cells in the arteries. Statins also increase the release of protective nitric oxide from the cells lining the inner walls of heart arteries. Animal research indicated that suddenly withdrawing statins causes a rebound phenomenon. Rather than simply returning to normal, the level of nitric oxide released by cells drops below normal. We tried to show that the withdrawal of statins in humans results in a rebound phenomenon and has an adverse impact on patients with acute coronary syndromes, Hamm said. A placebo controlled, prospective study appears unethical to test this hypothesis. That is why we performed this retrospective analysis. There was no evidence that the discontinuation of the statins was related to the risk profile of the patients, Hamm said. Risk factors, including baseline cholesterol levels and troponin T levels at the beginning of the study were similar in patients who remained on statins and those who stopped taking statins after admission. Study Ties Homocysteine Levels to Type of Stroke Italian researchers have found strong genetic evidence linking homocysteine to the type of strokes caused by tears in the artery wall. People in the study with elevated blood levels of homocysteine were significantly more represented in the group of patients with a form of stroke called spontaneous cervical artery dissection (sCAD) than stroke-free control subjects 64 percent vs. 13.9 percent. In addition, those with sCAD were also three times more likely to have two copies of the "T" version of the C677T MTHFR gene 36 percent vs. 11 percent leading researchers to suspect homocysteine’s role may be genetic. Increased blood concentration of homocysteine seems to predispose individuals to sCAD, said Dr. Alessandro Pezzini, research assistant in the department of neurology at the University of Brescia, Italy. Our data also suggests that genetic abnormalities in homocysteine metabolism may be a factor. CAD is estimated to cause 20 percent of ischemic strokes in people under age 45. Although it can be caused by trauma, more than half the time it is spontaneous. This study focused on 25 patients with sCAD. Researchers compared fasting blood samples collected within 72 hours of symptom onset with samples from 31 non-CAD ischemic stroke patients and 36 subjects without stroke. Researchers also conducted genetic testing to determine variations in the C677T MTHFR gene of these subjects. Blood levels of homocysteine are strongly influenced by diet and genetic factors. In one study, a group found that a majority of sCAD patients showed abnormalities in their connective tissue even though they had no overt symptoms of connective tissue disease. That indicates that sCAD may be related to abnormalities in the tissue that lines the arteries, researchers said. The group is looking for a sCAD patient with a large family available in order to determine more about what causes the disease. FDA Panel Recommends Approval for InSync ICD Medtronic Inc.’s InSync implantable cardioverter defibrillator (ICD) system has received a recommendation for approval, with conditions, by the Circulatory System Devices panel of the FDA. Final FDA approval is still not guaranteed, although the agency usually follows the recommendations of its panels. The InSync ICD system combines cardiac resynchronization therapy and defibrillation therapy in a single device for the treatment of moderate to severe heart failure in patients who have left ventricular dysynchrony and who are at risk for potentially lethal ventricular arrhythmias. Clinical data presented to the FDA panel today demonstrated that, for New York Heart Association (NYHA) Class III/IV patients with ventricular dysynchrony and an indication for ICD therapy, the InSync ICD study met all of its primary safety objectives, and demonstrated: improved patient quality of life; improved exercise capacity; and improved functional capacity. The MIRACLE (Multicenter InSync Randomized Clinical Evaluation) ICD trial, evaluated the safety and therapeutic benefits of the Medtronic InSync ICD (Model 7272) device and the Attain SD (Model 4189) left-heart lead. The Attain SD lead is a 4Fr, steroid-eluting left-heart lead designed to navigate into small cardiac veins with tight pathways, adding an additional lead choice to meet clinical needs and physician preferences. MIRACLE ICD results presented to the FDA panel reflected the experience of 362 patients with moderate to severe heart failure, ventricular dysynchrony and an indication for ICD therapy who were successfully implanted with the InSync ICD. All patients received ICD therapy and were randomized to either the control group or to CRT therapy. Effectiveness endpoints were based on the randomized patients who completed a six-month follow up. Patients were required to be stabilized on heart failure medications before enrollment and maintain a stable heart failure regimen to assess the effects of cardiac resynchronization therapy on the study’s objectives. Results of the study showed that the InSync ICD system met or exceeded all safety objectives and demonstrated: improved Quality of Life assessment, as measured by the Minnesota Living With Heart Failure Questionnaire; improved exercise capacity, as measured by cardiopulmonary exercise testing; and improved functional status, as measured by the clinical composite response that considered mortality, hospitalization for heart failure and worsening NYHA heart failure classification. The InSync, InSync III and InSync ICD cardiac resynchronization systems, along with several models of Attain left-heart leads and delivery tools, are commercially available outside the United States. The InSync system, including the Attain CS Model 2188, Attain LV Model 2187 left-heart leads and the Attain LDS and Access left-heart delivery systems, were approved for use in the United States in August 2001. The InSync ICD and InSync III devices, along with the Attain SD Model 4189 and Attain Over-the-Wire Model 4193 leads, are still under clinical evaluation in the United States. Aortic Heart Valve Receives FDA Clearance St. Jude Medical has received FDA clearance for the SJM Regent heart valve. Maintaining the fundamental features found in St. Jude Medical’s mechanical heart valve products, the SJM Regent heart valve offers exceptional structural integrity, durability and low complication rates. The SJM Regent aortic heart valve features subtle design modifications to the valve's pyrolytic carbon components, resulting in unprecedented hemodynamic performance. This translates into single-digit pressure gradients even in valves as small as 19 mm. Dr. Marc Sakwa, principal investigator at William Beaumont Hospital in Royal Oak, Mich., the leading U.S. medical center for the SJM Regent heart valve clinical trials, noted, The outstanding hemodynamics resulted in a significant reduction of left ventricular (LV) mass in our patients. We believe this will contribute to better survival and improved long-term patient outcomes. MicroPlex Coil System Receives FDA Clearance, CE Mark Microvention Inc. has received 510(k) clearance from the FDA to market its MicroPlex Coil System (MCS) for the treatment of cerebral aneurysms. The company also received CE Mark for MCS allowing it to sell the product in all countries of the European Union and the European Free Trade Area. The MCS product consists of both helical coils and a unique complex coil. The coils are detached from a catheter by the physician using a proprietary HydroLink detachment system that uses micro-fluidic actuation for instantaneous release. The MCS Complex Coil has demonstrated improved ability to treat aneurysms with complicated anatomy and particularly those with wide necks. The company intends to sell the product through its own direct sales force in the U.S., France and Germany and market and sell MCS through distributors in various countries outside the U.S. Portable Ultrasound Effective In Detecting Carotid Blockages in Study Sonosite Inc. announced the results of a study examining the effectiveness of the SonoSite 180 system in detecting blockages in carotid arteries. Results of the study were presented during the American Stroke Association’s 27th International Stroke Conference (February 2002, San Antonio). The study, Screening for Carotid Artery Stenosis with Power Doppler Imaging Using a Portable Duplex Ultrasonography Device, was conducted at Wake Forest University in Winston-Salem, N.C. Researchers screened carotid arteries using the SonoSite 180 system in a prospective study of 51 patients. The degree of blockage in these patients was estimated by measuring the area ratio and the diameter ratio with 89.7 percent accuracy (area ratio) and 84.3 percent accuracy (diameter ratio) in detecting severe blockages of carotid arteries. Previously, ultrasonography has not been considered to be a convenient stroke-screening tool, because of lengthy scanning times, said Dr. Ulf Schminke, lead author of the study and research fellow at Wake Forest University. Vascular imaging with the SonoSite 180 system allows for brief and high quality evaluations at the point of examination. Hand-carried ultrasound accurately and quickly identifies severe blockage of the carotid arteries, said Dr. Charles H. Tegeler, director of the Neurosonology Lab at Wake Forest University. Technology, like the SonoSite 180 system, could potentially revolutionize vascular screening by enabling physicians to accurately identify patients having increased risk for stroke. The SonoSite 180 system can be carried by the examiner to the screening site in a backpack, rather than requiring the patient to go to an imaging center, such as a hospital’s radiology department. The results of the study suggest that with its portability and relative accuracy, the SonoSite 180 system can provide physicians with another tool for the detection of severe carotid artery blockage that could potentially increase the number of patients being screened. FDA Accepts Cholesterol Drug Application The FDA has accepted the new drug application by Merck/Schering-Plough Pharmaceuticals. Zetia is an investigational cholesterol absorption inhibitor. The application asks the FDA to approve the drug to be administered alone or with a statin to reduce elevated cholesterol levels. Zetia is the first medicine Merck/Schering-Plough Pharmaceuticals has submitted to the FDA for approval. Standard review status provides for a target of FDA action within 10 to 12 months from the date of receipt of a new drug application. The new drug application for Zetia was submitted to the FDA on Dec. 27, 2001. The new drug applications contains results from clinical trials that showed Zetia was capable of reducing LDL-C and increasing HDL-C. Zetia was also well tolerated in all of its clinical trials. If approved, the drug would become the first in a new class of lipid-lowering compounds that inhibits the intestinal absorption of cholesterol. New Medtronic ICD Wins FDA OK The FDA has granted approval to Medtronic’s Marquis DR dual- chamber implantable cardioverter-defibrillator (ICD). The new ICD, which has received the CE Mark to be marketed throughout the European Union, offers faster charge times for increased patient safety and improved longevity for less frequent replacement. The Marquis DR features Cardiac Compass to monitor cardiac disease progression, faster device telemetry and a new Leadless ECG function. A modified battery design helps give the Marquis DR a typical longevity rating of seven to eight years, depending on use. A longer battery life means less frequent device replacement for patients. The device has a charge time of just 7.5 seconds after an eight-year service life, which is comparable or better than other competitive ICDs at implant. Like all Medtronic implantable cardiac devices, Marquis DR is remote ready and compatible with the new Medtronic CareLink Network, which allows patients to remotely download information to a secure server. However, regulatory approval of the Marquis DR for use with the CareLink network is pending in the United States. Worldwide, it is estimated that less than 15 percent of patients who are indicated for the life-saving protection offered by ICDs actually receive them. In the United States alone, hundreds of thousands of people die each year from sudden cardiac arrest. GE Heart Monitors in Space GE Medical Systems Information Technologies’ heart monitoring systems are being used to monitor the cardiac health of the astronauts partaking in the fourth Hubble Space Telescope Servicing Mission. The mission was launched early Friday morning when the Space Shuttle Columbia lifted off from Kennedy Space Center, Florida. The astronauts’ cardiac information will be transmitted in real-time to Mission Control at the NASA Johnson Space Center where it will be monitored using the GE CIC Pro Clinical Information Center and the Apex Pro Telemetry System. After each space walk, the cardiac data will be further analyzed and archived using the MARS Unity Workstation. Prior to the mission, NASA developed and used its own proprietary systems. Aortic Tears Tied to Cocaine Use Cocaine can cause a lethal tearing in the heart’s main artery, a condition that should be suspected in people treated for chest pain at urban hospitals, researchers reported. The condition called aortic dissection occurs when the lining of the aorta tears, exposing the inner layer. Cocaine use is not a commonly recognized risk factor for aortic dissection, which usually occurs in older people with high blood pressure. However, researchers at San Francisco General Hospital noticed younger patients coming to the hospital with aortic dissection due to cocaine use. Most patients came to the hospital with chest pain shortly after drug use, and one developed symptoms while smoking crack, said Dr. Priscilla Y. Hsue, primary researcher from the division of cardiology at San Francisco General Hospital. Cocaine use causes an increase in stress hormones that can cause blood pressure to quickly rise. This may tear the lining of the vessel, which can allow blood to enter and rip it even further, according to Hsue. The dissection may stop blood from reaching critical organs, or even cause the aorta to rupture. In urban settings, aortic dissection should be considered when young people come to the emergency room with severe chest pain, especially if they have other risk factors like high blood pressure and smoking, Hsue said. It’s very important to get a rapid diagnosis. For untreated aortic dissection, the mortality rate can be as high as 35 percent within the first 24 hours. After 48 hours the death rate rises to about 50 percent. Researchers reviewed hospital charts from 1981-2001 looking for cases of aortic dissection. They recorded demographic information as well as information on cocaine use and coronary risk factors. Of the 38 cases found, 37 percent were related to cocaine use. Cocaine users were younger (average age of 41 vs. 59 in non-cocaine users), more likely to be African-American, and all smoked cigarettes. Twenty-nine percent of the cocaine users died in the hospital, which was almost twice the death rate of the non-cocaine users. Hypertension had been diagnosed in 79 percent of the cocaine users, 71 percent had documented left ventricular hypertrophy (thickening of the heart wall), and at least 64 percent were not taking their prescribed anti-hypertensive medication.

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