May-04

SCD-HeFT Study Yields Clues on Expanded Defibrillator Use Following a landmark study in March that showed far more patients could be saved by simple shocks from implantable defibrillators, officials must now determine who would best benefit from the cardiac devices. The SCD-HeFT study demonstrated that implantable cardioverter defibrillators lowered the risk of sudden cardiac death by 23 percent in patients with moderate heart failure. The results of the SCD-HeFT Study could double implantable cardioverter defibrillator (ICD) sales for makers of the devices that shock a dangerously irregular heartbeat back into normal rhythm. There's no doubt we are going to have to expand ICD usage after SCD-HeFt. I don't think we have any other option but to do it, said Dr. Mandeep Mehra, a heart failure specialist at the Ochsner Clinic in New Orleans. The trial's lead investigators cautioned against trying to cull meaningful data from subgroups within the study. However, doctors and Medicare officials must do just that as they seek to identify those who should be covered for the $25,000 devices, since there is no way government insurance programs can afford to pay for everyone who might benefit. While it may seem counterintuitive, Mehra said, it appears less severely ill patients may make the best ICD candidates. Severity of heart failure is ranked on a scale of 1 to 4, with class 4 being the most gravely ill patients. SCD-HeFT looked at class 2 and 3 heart failure patients and included those whose disease was caused by clogged arteries, as well as from other conditions, known as non-ischemic patients. Now we are learning that clearly in class 2 patients with heart failure, whether they have coronary disease or not, we ought to consider the placement of an ICD, Mehra said. There is not even a hint of benefit in class 3 patients from ICD. Medicare currently spends about $1 billion a year for a total of some 40,000 ICDs, according to a Medicare agency spokesman. The U.S. Centers for Medicare and Medicaid Services, known as CMS, will almost surely expand coverage based on SCD-HeFT, but by how much and for whom remain the big questions. The NASPE-Heart Rhythm Society estimates that only a quarter of those who would benefit from an ICD actually receive the devices. Medtronic has suggested an additional 600,000 patients should receive ICDs. Mehra, who has lectured the CMS on cardiac devices and has been nominated to sit on the Medicare coverage and analysis committee, said CMS will have to come up with more inclusive criteria to expand use of ICDs to the non-ischemic population and to expand it to class 2 patients. The whole thought process is going to have to be based on what is the expectation of a patient's survival, he said. These devices are not designed to make you feel better. They are designed for crisis intervention. Dr. Anne Curtis, first vice president of the Heart Rhythm Society and a professor of medicine at the University of Florida, believes SCD-HeFT data require more detailed analysis. However, she said that CMS may feel some pressure to open its wallet for ICDs for non-ischemic patients. The biggest thing to come out of SCD-HeFT is that patients with heart failure not from coronary artery disease should be eligible to receive defibrillators, Curtis said. Mehra is currently helping develop comprehensive new guidelines for the Heart Failure Society of America. We are rewriting the book on heart failure, he said. The new guidelines will address SCD-HeFT results, including the part of the study that looked at the widely used anti-arrhythmia drug amiodarone, which is sold as Cordarone by Wyeth. The routine use of amiodarone is an ill-conceived notion in heart failure, Mehra said. We now know clearly that at least in the more severe heart failure patients, that great caution has to be exercised in amiodarone use, and in fact we believe we should try to avoid amiodarone if at all possible, Mehra said. SCD-HeFT has clarified many things for us. Guidant Announces U.S. Approval of Next Generation Implantable Defibrillator Defibrillator Offers Advanced Rhythm Discrimination and Industry-Leading Longevity Guidant Corporation announced it has received market approval from the U.S. Food and Drug Administration (FDA) for its VITALITY ® 2 implantable cardioverter defibrillator system designed to treat patients at risk for sudden cardiac death due to arrhythmia. The VITALITY 2 implantable defibrillator system is a next-generation device based upon the established VITALITY line of products, and offers distinct advantages for both patients and physicians. The size and physiologic shape of the VITALITY 2, a small and thin implantable defibrillator at only 30 cc and 11 mm, is designed to facilitate ease of insertion and contribute to patient comfort. Guidant is committed to treatment options that enable physicians to provide optimal therapy for their patients at risk for sudden cardiac death, said Fred McCoy, President, Cardiac Rhythm Management, Guidant Corporation. The launch of the VITALITY 2 represents an important step forward in our ongoing efforts to help these people live longer. The VITALITY 2 system also incorporates Guidant's proprietary RHYTHM ID feature, which utilizes rhythm discrimination technology to help manage complex arrhythmias for people at risk of sudden cardiac death. This easy-to-use feature is designed to distinguish lethal from non-lethal heart rhythms and deliver the appropriate care at the appropriate time. The combination of size, longevity and advanced rhythm management options provide great benefits in terms of patient comfort and delivery of appropriate care, said Antonio Curnis, MD, consultant cardiologist, Spedali Civili, Italy. In particular, the ability of the VITALITY 2 to distinguish between lethal and non-lethal arrhythmia provides enhanced peace of mind to both the patient and physician. Full market launch of the VITALITY 2 implantable defibrillator is scheduled for May 2004. This is the fourth implantable defibrillator in the VITALITY family of products. The VITALITY with RHYTHM ID feature received CE Mark approval in Europe in 2002. Each year, sudden cardiac death claims the lives of as many as 460,000 people in the United States alone. More people die from sudden cardiac death each year than from lung cancer, breast cancer and AIDS combined. Clinical trials, such as the Guidant-sponsored Multicenter Automatic Defibrillator Implantation Trial (MADIT) II, have continually proven the lifesaving benefits of implantable defibrillator therapy in various groups of patients considered at risk for sudden cardiac death. This evidence was further studied in the National Institutes of Health-supported Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT). The preliminary results of SCD-HeFT were recently presented at the American College of Cardiology conference on March 8th, and provide additional evidence that people receiving defibrillators live longer lives. New Medtronic Devices Aid in Diagnosing and Curing Arrhythmias by Identifying and Ablating Troublesome Heart Cells Medtronic EnCirclr AL and RF Enhancr ® II Catheters Join Electrophysiology Product Line Medtronic, Inc. announced the U.S. commercial release of two electrophysiology catheters, the Medtronic EnCirclr AL Adjustable Loop Mapping Catheter and the Medtronic RF Enhancr ® II Single-Curve Ablation Catheter. The company recently received U.S. Food and Drug Administration clearance for both devices. The EnCirclr AL mapping catheter provides an innovative design to identify pathways causing atrial fibrillation. The RF Enhancr II ablation catheter with a new ergonomic handle delivers radiofrequency energy to treat various heart rhythm abnormalities. Both products represent advancements in detecting and treating cardiac rhythm problems caused by heart muscle cells that conduct errant electrical signals. More than 200,000 such procedures are performed worldwide each year. These catheters are welcome additions to the toolkit of the electrophysiologist, said Jeffrey Olgin, MD, Chief of Cardiac Electrophysiology at the University of California, San Francisco. The new technology found in these products will complement the physician's skill in delivering the curative therapies of radiofrequency ablation. The EnCirclr AL device, used prior to an ablation procedure, offers a unique distal leader with an adjustable loop diameter that can be adjusted from outside the body to help access the most difficult-to-reach atrial anatomy. Ten electrodes on the loop identify and establish the locations of problematic cells in or around the heart. The Encirclr AL catheter also can record intracardiac electrograms and provide intracardiac simulation. The RF Enhancer II catheter's new ergonomically designed handle reduces hand fatigue and facilitates one-handed operation as it provides high maneuverability and steerability to reach ablation sites. Its curve tension is adjustable for optimal stability in a wide range of cardiac ablation procedures to treat the shortness of breath, dizziness, fatigue, etc., associated with heart rhythm problems. Both new products join the Medtronic catheter product line designed for use with the Medtronic LocaLisa ® IntraCardiac Navigation System. This system provides a three-dimensional view to build a map of the heart's chambers. Physicians may use the LocaLisa system to navigate both ablation and diagnostic catheters inside the heart. EP MedSystems Receives Market Clearance from FDA for Steerable Cardiac Catheters; Expands Market Opportunity for EP MedSystems in U.S. EP MedSystems, Inc. announced that it received market clearance from the FDA for its line of deflectable diagnostic catheters. A deflectable catheter allows the physician to deflect its tip to steer the catheter into certain vessels and areas of the heart, which would be difficult with a fixed curve catheter. These catheters connect to the EP-WorkMate ® Electrophysiology Workstation, as well as other technologies that are used in the monitoring and diagnosis of arrhythmias in the heart. EP MedSystems' President and CEO Reinhard Schmidt commented: This market clearance continues to increase functionality across our three product platforms. It expands our catheter product line by giving physicians the ability to monitor difficult to reach areas of the heart. In addition, we believe this approval opens up a new market opportunity for EP MedSystems as many EP Physicians demand the increased maneuverability and ease of use offered by our new deflectable catheter line." EP MedSystems develops and markets cardiac EP products used to diagnose and treat certain cardiac rhythm disorders. Their products include the EP-WorkMate ® Electrophysiology Workstation with RPM Real-time Position Management navigation technology, the EP-4 Computerized Cardiac Stimulator, fixed and deflectable diagnostic EP catheters and related disposable supplies, the ALERT ® System and ALERT family of internal cardioversion catheters, and the ViewMate ® intracardiac ultrasound catheter imaging. GMP Companies Announces Availability of Lifesync ® Wireless ECG System U.S. Hospitals Pilot First ECG System Enabled by Bluetooth ® Wireless Technology GMP Companies, Inc. announced the availability of the LifeSync ® Wireless ECG System, following successful clinical trials at three U.S. hospitals. Cleared by the U.S. FDA, the LifeSync System is an ECG system enabled by Bluetooth ® Wireless Technology. Mercy Hospital in Miami, Florida, Piedmont Hospital in Atlanta, Georgia, and George Washington University Hospital in Washington D.C., were the first hospitals in the nation to evaluate the wireless ECG system. The LifeSync System was evaluated on about 400 patients in different departments at the three hospitals, including the cardiac care and intensive care units, cardiac stress and cath labs, and the admission and recovery units for pre- and post- cardiac cath procedures. ECG monitoring using the LifeSync System compared favorably with traditional wired ECG monitoring. Other departments may also benefit from the LifeSync System, including the emergency department. The LifeSync System is a monitoring system that eliminates lead wires and trunk cables between patients and bedside, 12-lead or transport ECG monitors. The system employs two-way radios that transmit and receive patient ECG and respiration data to existing ECG monitors, and replaces lead wires with a disposable LeadWear System. The LifeSync System can be implemented without costly changes to a hospital s infrastructure. The system is designed to save critical nurse time by eliminating the need to detach and reattach lead wires when transporting patients, and also facilitates patient mobility and ambulation. The LifeSync System provides the opportunity for enhanced patient comfort and may reduce the risk of cross contamination from reuse of lead wires. The patented LifeSync System, developed by GMP Wireless Medicine, Inc., uses standard ECG electrodes which are attached to the disposable LeadWear System worn by the patient. The Patient Transceiver and Monitor Transceiver function as two-way radios that collect and transmit ECG and respiration data to bedside or transport ECG monitors. The Patient Transceiver, worn on the patient, communicates with the Monitor Transceiver, placed on or near the ECG monitor. The transceivers are synchronized to establish a secure and robust radio link between the transceiver and monitor.The LifeSync System is now available within the U.S. Surgery may be Effective in LQTS Patients Surgery may offer hope to people with long QT syndrome (LQTS), a rare and sometimes fatal disorder. People with LQTS often do not notice any symptoms until experiencing periods of high emotional or physical stress. When the Q-T interval lengthens, the heart's ability to pump blood to the brain and other organs is compromised, which can cause fainting. LQTS can also cause ventricular fibrillation. Without treatment, fibrillation can cause cardiac arrest. Without immediate treatment, cardiac arrest usually leads to sudden cardiac death. Beta blockers are often the first line of treatment, and they are effective in 75 to 80 percent of cases. An implanted defibrillator may be used to deliver an electrical charge to correct an abnormal rhythm. However, in more severe cases, the defibrillator may be activated numerous times, which can be frightening and lower the patient's quality of life. A procedure called left cardiac sympathetic denervation (LCSD) can be performed on patients who did not respond well to other types of therapy. The surgery removes part of the nerves leading to the heart to reduce the heart's control over the sympathetic nervous system. The sympathetic nervous system controls involuntary functions such as breathing and heart rate. Italian researchers, following up on patients who had the procedure performed more than seven years ago, found that LCSD reduced fainting and cardiac arrest by 91 percent in high-risk populations. They concluded that LCSD should be considered in patients with recurrent episodes of fainting in spite of taking beta blockers and in patients who experience arrhythmia storms with an implanted defibrillator. The results of the study are published in Circulation.