Invasive Cardiology News

CPR Pioneer Dr. Peter Safar Dies at 79 Dr. Peter Safar, a pioneer in emergency medicine who also was regarded as the father of cardiopulmonary resuscitation, died August 3rd, of cancer. He was 79. Safar, who died at his home in suburban Pittsburgh, was credited with establishing the country's first physician-staffed, multidisciplinary intensive care unit. He also developed the ABCs of CPR, a lifesaving technique taught to everyone from surgeons to Boy Scouts. "This was really a loss for mankind," said Dr. Patrick Kochanek, the director of Safar Center for Resuscitation Research at the University of Pittsburgh. Safar established the first intensive care unit in 1958 at the Baltimore City Hospital, Kochanek said. There already were such units for specific ailments, but Safar established the modern ICU that most people are familiar with today, he said. Also in the 1950s, Safar developed a method of mouth-to-mouth resuscitation that he combined with chest compression, a rescue technique that had already been researched and documented by others. The result was a first-aid method that many people learn using a lifelike mannequin known as a Resusci-Anne doll. "He was a firm believer that it was something that the masses needed to learn," Kochanek said. Safar's work with CPR was just one aspect of his goal of creating a system of care from accident scene to operating room. "He wanted prepare the people who show up at an accident scene first the passer-by so they can sustain a victim until a paramedic arrives. And then, the paramedic cares for the patient until they reach the emergency room and so on," said Frank Poliafico, the executive director of the AED Instructor Foundation, a group that helps those who teach CPR and automatic external defibrillator use. Born in 1924 in Vienna, Austria, Safar studied at the University of Vienna and Yale University before studying anesthesiology at the University of Pennsylvania. In the 1950s, Safar established anesthesiology departments in Peru and Baltimore, briefly joining the staff of Johns Hopkins Hospital. In the 1960s, he was a founding members of the U.S. National Research Councils Committee on EMS. He also established guidelines for ambulance design and emergency medical technician and paramedic training. Safar stepped down as chairman of the University of Pittsburgh Medical Center's anesthesiology department in 1979 and went on to establish the International Resuscitation Research Center, which he ran until 1994. It later became the Safar Center for Resuscitation Research. Most recently, Safar was studying if cooling the body just a few degrees can prevent brain damage in people who survive cardiac arrest but are left unconscious. This is a huge loss. Can you imagine what he would have come up with in the future?" said James E. Cottrell, president of the American Society of Anesthesiologists. Safar is survived by his wife and two sons. Boston Scientific and Corautus Genetics Enter Alliance to Develop and Commercialize Gene Therapy Technology to Treat Cardiovascular Disease Boston Scientific Corporation and Corautus Genetics Inc. have entered into a strategic alliance to develop and commercialize a gene therapy technology to treat cardiovascular disease, focusing initially on patients with severe ischemic heart disease who have been unresponsive to conventional therapies. Boston Scientific has obtained exclusive rights to distribute Corautus' vascular endothelial growth factor 2 (VEGF-2) gene products once regulatory approval is obtained. Corautus plans to begin clinical trials in the fourth quarter to test the efficacy of its (VEGF-2) gene. The gene will be delivered with a Boston Scientific cardiac delivery catheter. This catheter is designed specifically to deliver genes to the heart without deactivating the gene, which may be a problem with non-gene specific catheters. Earlier trials using Corautus’ VEGF-2 gene therapy showed promising clinical improvements in patients with severe coronary disease when compared to patients receiving a placebo. The introduction of VEGF-2 gene therapy may produce new blood vessels in heart tissue, thus increasing blood supply and helping relieve angina symptoms and improve heart function. The American Heart Association estimates that there are six to seven million patients who suffer from angina in the United States. It is estimated that up to 300,000 patients have angina that is unresponsive to conventional therapy. Treatment of ischemic heart disease with VEGF-2 gene therapy shows great promise, based on the earlier clinical trials we have conducted, said Douglas Losordo, MD, Chief of Cardiovascular Research at Caritas St. Elizabeth’s Medical Center of Boston. In these earlier trials, the incidents of angina attacks were reduced with no evidence of significant negative side effects. I’m looking forward to beginning the next trial to evaluate the efficacy of this therapy in a larger patient population. DeRoyal Develops Suction Liner System with 28% More Flow Power DeRoyal has developed and brought to market a surgical suction liner system called ReliaFlex that provides 28% more suction flow power than other liners while eliminating regurgitation and splashing. The increased suction flow delivered by ReliaFlex better evacuates the surgical site of blood and other fluids, with more clarity leading to safer patient care and more satisfied surgeons. Intense research and design went into in engineering ReliaFlex liners to give them 20% larger diameter vacuum ports and hoses. In addition, the filter/valve combination has over 1,000% more surface area for air to pass through. The combination of these two factors results in ReliaFlex providing 200 standard cubic feet per hour (SCFH) of airflow at 16 inches of Mercury (in Hg). This yields 28% more flow power than the market leader at the same vacuum. ReliaFlex has larger liner sizes than most systems for increased capacity, which also reduces the problem of splashes and regurgitation from patient and vacuum ports when the liner is removed from its outer canister shell. When this sort of splashing occurs in regular liners, it puts clinicians at risk for exposure to bloodborne pathogens like Hepatitis C and HIV. According to Watermeier, the latex safe ReliaFlex Liner system offers everything needed for optimal infection control and can be flexibly used with the regulator, wall outlet, or central vacuum system. ReliaFlex comes in three canister sizes (1300cc, 1800cc or 3200cc), larger than most on the market, to collect more waste and reduce the need for multiple liners for a given procedure. Orthopedic sized ports are part of each liner, with built-in pour spouts and attached press-on caps for each port and pour spout. ReliaFlex’s unique lid design catches excess fluid when tubing is removed from the ports. The built-in, hydrophobic filter/valve combination prevents overflow into the wall suction system, while providing filtration of Staphylococcus aureus at 99.5% efficiency. DeRoyal ReliaFlex comes in a variety of standard kits, with seven component configurations to choose from in each size category, for a total of 21 different kit combinations from which to select. Kits can include elbows, tubing (both funnel and connector styles) and solidifier (packaged in a convenient burstable pouch). The durable outer canister shells come in either a bracket style with pre-attached reinforced tubing ready to connect easily to the ReliaFlex liner or in a DISS mount option. Each polycarbonate bracket has internal on/off valve and the alternative DISS Mount option prevents adapter breakage and enhances safety once a liner is full. Initial hardware is provided by DeRoyal to its customers on a consignment basis. LuMend’s New Frontrunner Micro Guide Catheter Provides Added Support, Enhanced Deliverability and Rapid Guide Wire Exchange for Crossing CTOs MGC & X39 Catheters Work as System in Coronary & Peripheral Arteries LuMend Corporation announced that it has launched the Frontrunner® Micro Guide Catheter (MGC). The MGC is used in conjunction with the recently launched .039 Frontrunner X39 CTO Catheter. Both devices are FDA-cleared to treat CTOs in the coronary and peripheral arteries. The system combines the controlled blunt micro-dissection of the X39 with the added support, enhanced deliverability and access provided by the MGC. The cornerstone of the Frontrunner X39 technology is controlled, blunt micro-dissection, which gently separates atherosclerotic plaque, creating a passage through the CTO. The MGC provides additional support for the X39 during crossing, as well as easily directs the Frontrunner to the CTO and away from side branches. It can be delivered via a .014 wire or with the Frontrunner X39 inserted. After a passage is created and the Frontrunner X39 is removed, the MGC acts as a conduit by staying in place in the artery. This enables rapid guide wire exchange and provides physicians with the opportunity to treat patients using less-invasive coronary procedures such as balloon angioplasty and drug-eluting stents. The technique is similar to the instrument exchanges currently used during percutaneous intervention. It is estimated that CTOs are present in approximately one third of all diagnostic angiograms completed on patients with coronary artery disease. Studies show a distinct ten-year patient survival advantage for a successfully revascularized coronary CTO compared to a failed revascularization. FDA Approves Labeling Change for Spectranetics’ Coronary Laser Catheters New Labeling to Treat Heart Attack Patients Reflects Individualization of Use at Physician’s Discretion The Food and Drug Administration (FDA) approved a labeling change for Spectranetics' excimer laser coronary atherectomy (ELCA) catheters that allows individualization of use for treatment of patients with acute myocardial infarction (AMI), acute thrombosis, or ejection fraction less than 30%. Under the new labeling, patients with these clinical conditions can be treated with the laser after individual consideration by their doctor. The FDA approved the new labeling in response to a Pre-Market Approval (PMA) Supplement submitted on February 10, 2003. The approved labeling changes relied on both research and clinical studies data. Among the clinical studies was the CARMEL registry, a cohort of 151 heart attack patients treated at eight international sites. This study analyzed the application of the excimer laser as a revascularization tool for patients with AMI. The laser was applied to the infarct related artery for purposes of clearing the obstructive atherosclerotic plaque and associated thrombus. The investigators noted a high procedural success rate combined with a low rate of complications. Dr. On Topaz, Professor of Medicine (Cardiology) and Pathology at the Medical College of Virginia, Virginia Commonwealth University, Richmond, Virginia, and CARMEL Principal Investigator, commented, There is considerable evidence stemming from clinical studies and basic research clearly pointing to the ability of the excimer laser light to successfully remove thrombus from target lesions in the settings of acute myocardial infarction and unstable angina. Similar observations are made in the treatment of patients with peripheral atherosclerotic vascular disease. The cumulative data and experience in thrombus-laden lesions supports further investigation of the utilization of the excimer laser for other areas within the vascular system, including saphenous vein grafts and selective patients with acute stroke. AVI Begins Phase II Study of Systemic Delivery Of Resten-NG in Restenosis Trial to Incorporate Proprietary Antisense and Microbubble Delivery Technologies AVI BioPharma, Inc. has initiated a Phase II clinical study of its antisense drug, Resten-NG®, in patients undergoing angioplasty and stent placement. Resten-NG, the company’s flagship cardiovascular NEUGENE® antisense agent, works by inhibiting the expression of the c-myc gene, which plays a key role in the development of restenosis. In the study, Resten-NG will be delivered using AVI's proprietary microbubble delivery system. Delivering Resten-NG systemically using microbubbles has been as effective as local delivery with stents and catheters in our preclinical tests, said David H. Mason, Jr., MD, senior vice president of Clinical Development and Regulator Affairs at AVI. Our microbubble technology may offer a potential cost-effective supplement, or alternative, to using drug-coated stents. This alternative method may be used even in patients who require placement of multiple stents. The placebo-controlled study will be conducted at the University of Nebraska Medical Center under the direction of Thomas Porter, MD, and Edward O'Leary, MD. Patients undergoing angioplasty and stent placement will be given Resten-NG via intravenous injection of drug-coated microbubbles. In preclinical experiments, the microbubbles have been shown to concentrate at the sites of vascular injury. Subtle Signs Point to Early Diabetic Heart Disease Researchers have found that an ultrasound test can detect the beginnings of a heart problem in diabetics, before it becomes obvious. At that point, treatment could stop the condition getting worse. Dr. Thomas H. Marwick and colleagues, from the University of Queensland in Brisbane, Australia, used a special ultrasound, called tissue Doppler imaging (TDI), to look at the hearts of 41 diabetic patients and 41 healthy subjects. None of the diabetics had any signs or symptoms of heart disease. TDI showed that the diabetics’ hearts didn’t beat as strongly, or relax as well between beats, as the healthy subjects’. Still, the difference was subtle and would have been missed with a standard ultrasound of the heart, they add. Interestingly, however, the diabetics' hearts responded to a stress-inducing chemical just like healthy people's hearts, suggesting that blockage of the arteries feeding the heart is not yet a problem for these patients. Evaluating the heart with TDI may allow the early detection of diabetic heart disease, Marwick's team notes. Dr. Eugenio Picano, from the Institute of Clinical Physiology in Pisa, Italy, commented that detecting diabetic heart disease at an early stage is important because this is when therapeutic interventions are likely to have the strongest impact. Medtronic Announces U.S. Availability of the NC Stormer Balloon Catheter Medtronic, Inc. announced full U.S. availability of the company's NC Stormer® high pressure, non-compliant balloon dilatation catheter. The NC Stormer balloon is now available on both Medtronic's Zipper Multi-Exchange (MX) and Over-the-Wire delivery platforms. The company recently launched the Stormer, its semi-compliant balloon catheter, on the Zipper MX platform, which facilitates fast and easy exchange of guidewires and catheters during a coronary angioplasty or stenting procedure. Unique features include: Fulcrum Plus Balloon Material, which yields low crossing profiles and excellent re-wrap, thus allowing physicians to reach and cross challenging lesions, as well as reposition and re-expand the balloon during the procedure. Precise balloon placement and expansion, with lengths that support the variety of drug-eluting stent sizes currently offered in the United States, controlled compliance for optimal sizing within the stent, and minimization of edge effect and longitudinal growth to protect healthy tissue in the era of drug-eluting stents. A highly flexible tip, which maximizes guidewire conformability for crossing lesions and previously deployed stents. Other advantages of the Stormer balloon catheter family include: Intelligent Balloon Folding, which varies the number of folds depending on balloon diameter, yields lower crossing profiles and improves refolding for repeated dilatations. Selective Dura-Trac Coating, which provides durable lubricity and helps physicians maintain balloon positioning during a procedure. The Stormer Balloon catheter, now available in the United States on the Zipper MX platform, has been available on an over-the-wire platform in the United States since May 2002, in Europe since August 2002, and Japan since March 2003. The NC Stormer Balloon catheter is available in the United States on Zipper MX and over-the-wire platforms. Study: Driving a Bus or Taxi Ups Heart Attack Risk Driving a bus or taxi may be hazardous to a person’s health, a team of Stockholm researchers reports. They found that heart attacks were more common among men who had worked as bus or taxi drivers for at least one year than among non-professional drivers. These professional drivers were also more likely to smoke and be overweight, but their increased heart attack risk could not be explained by major (heart-related) risk factors or social factors, said lead study author Dr. Carolina Bigert, of Karolinska Hospital in Sweden. However, she said, certain work-related factors may be partly to blame. It is possible that psychological demands in their jobs, such as stress, might contribute to the increased risk, but we cannot draw any conclusions about this from the present study, Bigert said. Other researchers have also reported that professional drivers bus drivers, in particular may be at increased risk of heart disease. The exact reason is unknown, but unhealthy lifestyle habits, job stress, motor exhaust exposure and other factors are all thought to play a part. In the current study, Bigert and her team investigated other potential causes of increased heart attack risk among professional drivers. They identified more than 1,000 men ages 45 to 70 who had experienced a fatal or non-fatal first heart attack in 1992 or 1993. Of this group, 147 men had worked as a professional bus, taxi or truck driver for at least one year. For comparison, the study also included nearly 1,500 men 129 of whom were professional drivers who had never had a heart attack. Overall, bus drivers were more than twice as likely to have a heart attack as men who had never worked as professional drivers. And the risk among taxi drivers was only slightly lower than that for their bus-driving peers, Bigert and her team report. Though the drivers’ heart attack risk declined when the researchers accounted for other factors such as their smoking and drinking habits, and rates of diabetes and high blood pressure their risk still remained higher than that of the comparison group. It seems possible that factors in the work environment for urban bus and taxi drivers contribute to their increased risk of (heart attack), Bigert said. Truck drivers were also initially 66 percent more likely than other men to have a heart attack, but their increased risk was largely explained by their smoking habits, physical inactivity, diabetes and other factors, the report indicates. Depression Makes Heart Patients Feel Worse Cardiac patients who suffer from depression are more likely to feel sick, even when their heart is in better shape than their non-depressed peers. Depression nearly doubled the chance of having a worse quality of life, says Dr. Mary A. Whooley. In the ongoing study, called the Heart and Soul Study, Whooley and her co-researchers evaluated 1,024 participants with heart disease, 20 percent of whom had symptoms of depression. They used two traditional measures to evaluate heart function, including left ventricular ejection fraction and exercise-induced ischemia. They also asked the participants to rate their overall health, physical limitations, quality of life and symptoms. Depressed patients were more likely to report lower health status, including more frequent episodes of chest pain, more physical limitations and worse quality of life and overall health, than non-depressed patients. Even when the severity of the disease was taken into account, based on the physical tests, the depressed patients were more likely to have lower quality of life than others. I wasn't surprised that depression was associated with a poor quality of life, Whooley says. What did surprise her, she says, is that the two traditional measures of heart functioning weren't associated with how well patients felt or how well they rated their quality of life. In clinical practice, I focus on trying to improve the ejection fraction and ischemia, Whooley says. The rationale is that if you fix the physical problems, they will feel better. In this case, it didn't pan out, she adds. While 20 percent of the patients in her study were depressed, Whooley says up to 40 percent of heart patients overall may be. In her sample, followed from September 2000 to December 2002, all subjects had a history of heart disease, including attacks, bypass surgery or balloon angioplasty to open up vessels. Doctors need to be more aware of depression, she says, and patients also need to be more comfortable accepting treatment for depression. Other experts agree more awareness of depression is needed. Physicians as a whole are not doing a good job of identifying or treating [depression], says Robert Maurer, a clinical psychologist at Santa Monica-UCLA Medical Center. It confirms what we already believed. Even cardiologists acknowledge doctors need to be more aware of the possibility of depression in their heart patients. Based on this study, doctors need to learn more about depression and identify these patients early on and then identify safe agents we can used to treat it, says Dr. Ravi Dave, a cardiologist at Santa Monica-UCLA Medical Center. I think this study is unique because it shows that depression had more of an effect on the patient's reported overall health status than did the objective findings of the doctors, Dave adds. The medical tests to evaluate the heart's physical functioning are important, Dave says. But so is paying attention to the patient’s psychological status. In his own practice, Dave says, he sees the impact of depression. I have patients with very terrible heart muscle function who go out and climb Mt. Whitney, he says. Yet, he also has some patients with less damage to their hearts who are very depressed and don’t get out of their chairs to do any exercise. The best advice for a heart disease patient who thinks he or she is depressed, Maurer says, is to seek a formal evaluation for depression. If your doctor says it's needed, use [antidepressant] medication for six months to a year. Depression is a very important aspect [of heart disease] that needs to be recognized and treated, Dave says. The good news? Depression is a modifiable risk factor, which is great, he says.

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