Clinical and Industry News

Heart Rhythm Society Statement on ICD Safety and Effectiveness In light of the study that was released in the New England Journal of Medicine on September 3, 2008 titled “Prognostic Importance of Defibrillator Shocks in Patients with Heart Failure,” the Heart Rhythm Society would like to reiterate its stance on the importance of implantable cardiac defibrillators (ICDs) in patients with life-threatening arrhythmias. ICDs are 99 percent effective in stopping life-threatening arrhythmias and are the most successful therapy to treat ventricular fibrillation, the major cause of sudden cardiac arrest. However, only 35 percent of patients who could be helped by an ICD have one. ICDs continuously monitor the heart rhythm, automatically function as pacemakers for heart rates that are too slow, and deliver life-saving shocks if a dangerously fast heart rhythm is detected. It is important to note that while the study shows a link between ICD shocks and patient mortality, patients who received shocks were in worse health prior to the shock than those who were not shocked. The increased mortality rate is related to their overall health condition rather than ICD activity. Patients receive shocks to stop potentially life-threatening heart rhythms, and many recent studies have shown a drastic decrease in the number of inappropriate shocks. “Like many other studies, the SCD-HeFT trial clearly demonstrates that ICD devices save lives,” said Dr. N.A. Mark Estes, President of the Heart Rhythm Society. “While there is an association between patients who are shocked and an increased mortality, receiving a life-saving shock does not independently predict a patient’s survival rate.” The Heart Rhythm Society is dedicated to improving the care of patients by promoting research, education and optimal health care policies and standards. The Society strongly supports measures that would improve the health and safety of patients living with these devices. Stopping a Killer: LUMEN 2009 Looks to Establish National Protocol for Treating Heart Attack Patients: Number One Killer of Men and Women Can Exist Unchecked by Local Municipalities It is the very early hours of the morning and you awake with a tightness in your chest. This uncomfortable pressure is making it difficult to breathe, and you feel lightheaded and nauseous. Your first instinct is to shrug off the fear that you might be having a heart attack and attribute your pain to heartburn from overindulging the night before or even food poisoning. Yet if you continue to avoid taking your pain and symptoms seriously, your life is at risk — and the clock is ticking. According to the American College of Cardiology (ACC), the majority of deaths from ST elevation myocardial infarction (STEMI), a heart attack caused by complete obstruction of a coronary artery, occurs within the first 1 to 2 hours after symptom onset. Yet although heart disease is the leading cause of death in the United States, there is still no protocol in place for an integrated STEMI system and national STEMI policy. LUMEN 2009: The Symposium on Optimal Treatments for Acute MI launches February 26-28, 2009 in Miami Beach to address the need for establishing protocols nationwide for the appropriate care of acute heart attack patients. In the scenario above, time is of the essence. Call 9-1-1. Do not drive or have someone drive you. Transportation by EMS is a better option than self-transport because you can be immediately evaluated and have treatment initiated by paramedics prior to arriving at the hospital. The appropriate staff can be called in while you are still in transport. But even as skilled staff is en route to the hospital and EMS is working to save your life, in most American communities, you are not going to receive the critical care you need. For patients experiencing a heart attack, where time is absolutely critical, there is no established national protocol to treat STEMI patients, one that would ensure patients are routed to a STEMI-certified hospital equipped to not only save the life of the patient, but to make sure minimal damage is done to the heart muscle. Instead, EMS has only one guideline set out by local municipalities — transport the critical care heart attack patient to the closest hospital, often a facility that lacks the equipment and expertise to save the heart attack victim. STEMI expert Dr. Sameer Mehta and many of his colleagues argue that the U.S. is well behind some of its international counterparts in establishing STEMI protocols to effectively treat these patients in ways that parallel our current national trauma system. “Level one trauma centers are set up for catastrophic events like car accidents with emergency medical personnel assessing the immediate need of a patient at the scene and then transporting that patient to the closest trauma center equipped to handle that patient’s needs, not the closest hospital. Such patients are also often transported by helicopter to ensure quick, immediate access to quality care,” says Dr. Mehta, Lumen 2009 Program Director and author of the Textbook of STEMI Interventions. A national initiative to establish STEMI Receiving Centers within hospitals is the backbone of LUMEN 2009: The Symposium on Optimal Treatments for Acute MI. In various European countries, such as Denmark, integrated centers for STEMI care have been operational for several years. In Ottawa, Canada, a program exists under which 800,000 residents of the city have been triaged to receive angioplasty for the occluded artery. In limited areas of the United States, some integrated systems of triage and transfer for STEMI patients have been created by local emergency service operations. These include the Mayo Clinic, Minneapolis Heart Institute, SOCAL system in Southern California and RACE system in North Carolina. Yet the majority of Americans, even those in large, metropolitan cities, will not be treated successfully for their STEMI. LUMEN 2009 brings together international leaders to discuss needed protocols vital to establishing a national system to combat the number one killer of men and women in the U.S. “Time = heart muscle,” adds Dr. Mehta, who advocates angioplasty for STEMI patients instead of thrombolytic therapy (drugs), whenever possible. “The longer the time to treatment, the greater the amount of heart muscle affected by deprivation of oxygenated blood and the likelihood that the patient will die or be unable to fully recover.” The time from the patient’s arrival at the hospital to the opening of their blocked artery, often referred to as door-to-balloon (D2B) time, should be no more than 90 minutes, as recommended by the American College of Cardiology/American Heart Associations (ACC/AHA) Clinical Guidelines for STEMI care; any longer than 90 minutes can mean irreversible damage to the heart muscle. Of the 500,000 reported STEMI patients in the U.S. annually, only half find themselves in hospitals capable of performing immediate angioplasty. Although thrombolytics offer relief of symptoms and have the advantage of being administered early and even in the ambulance, a very high proportion of patients do not achieve complete clearing of the blockage and a majority end up also needing angioplasty. The long-term recovery of the heart muscle is better with angioplasty and the risk of stroke is less. “Establishing a national protocol is vital, and possible. STEMI treatment is not just the domain of the interventional cardiologist; it is a matter of public health policy,” says Dr. Mehta. LUMEN 2009, the world’s premier STEMI meeting, is expected to draw international experts discussing issues related to STEMI interventions, and key areas of interventional cardiology and vascular interventions. Dr. Sameer Mehta serves as the Director of LUMEN 2009. The four Co-Directors for the CME program include world experts Dr. Samin Sharma (Complex Coronary Interventions), Dr. Brahmajee Nallamothu (D2B Processes), Dr. William Hoekstra (Emergency Medicine Pathways for STEMI) and Barbara Unger, RN (STEMI Systems & Cardiovascular Nursing). The innovative CME agenda will include lectures, debates, workshops, certification courses and industry satellite programs. The meeting will be held February 26-28, 2009 at the Loews Miami Beach Hotel in Miami Beach, Florida. According to a Centers for Disease Control (CDC) study, “Prevalence of Heart Disease – United States,” Florida residents rank in the top 10 for high prevalence of heart disease. LUMEN 2009 will become the one-stop, STEMI educational rendezvous for Clinical and Interventional Cardiologists, Cardiac and Vascular Surgeons, Emergency Department staff, Critical Care Nurses, Cardiovascular Laboratory Technicians and Nurses, Paramedics, and Hospital Administrators who are all invested in optimal outcomes for heart attack patients. To learn more, visit www.LUMENami.com. LUMEN 2009 is sponsored by the North American Center for Continuing Medical Education (NACCME), a wholly-owned subsidiary of HMP Communications Holdings, LLC. NACCME provides a wide array of accredited CME offerings, with industry thought leaders participating in round table meetings, webcasts, symposia, conferences, seminars, podcasts, and satellite programs. New Data on the Benefit of Cardiac Devices in Heart Failure Patients Presented New analyses presented during the annual congress of the European Society of Cardiology (ESC) on the effects of cardiac resynchronization therapy (CRT) in patients with mild heart failure from the REVERSE (Resynchronization Reverses Remodeling in Systolic Left Ventricular Dysfunction) trial show improvement in several areas, including left ventricular ejection fraction (LVEF), a standard measure of the heart’s pumping effectiveness and a key indicator of heart health. Patients with CRT experienced improvement in LVEF from 28 percent at baseline to 35 percent at 18 months; a healthy heart’s pumping effectiveness ranges from 50 to 75 percent. The new analyses also demonstrate the ability of CRT to prevent or slow the progression of the disease in patients with mild heart failure. Led by Prof. Cecilia Linde, MD, PhD, of Karolinska University Hospital, Stockholm, Sweden, and supported by Medtronic, Inc., REVERSE is the first large-scale, global, randomized, double-blind trial to evaluate CRT in mildly symptomatic heart failure patients or asymptomatic patients who previously had heart failure symptoms. “The positive results we are seeing from CRT in patients with mild heart failure are similar to those reported in patients with more advanced disease studied in earlier trials,” said Prof. Linde. “When we started the REVERSE trial, we found that although the patients had mild symptoms and were well treated with recommended drug therapies, their hearts didn’t function very well in the left ventricle. These patients need treatment options beyond medication, such as CRT.” The new analyses presented at the ESC Congress included detailed data on the heart’s left ventricular function obtained via cardiac ultrasound. In addition to LVEF improvements seen at 18 months, a measure of the heart’s volume and size (left ventricular end-systolic volume index, or LVESVi) improved with CRT from 95 ml/m2 at the start of the trial to 68 ml/m2 after 18 months. No similar improvements were seen in patients who did not receive CRT. These improvements are significant because cardiac structure and remodeling can correlate with improvements in patients’ health in terms of delayed time to heart failure hospitalizations, which also was observed in the REVERSE study at 18 months. Twelve-month REVERSE data has been presented at a number of scientific congresses in Europe and the United States. Despite the trial not meeting statistical significance for its primary endpoint (percent of patients worsened at 12 months using a heart failure Clinical Composite Score), the data showed that more patients in the trial improved with CRT. The findings of the 12-month data were maintained at 18 months. The European, blinded cohort in the REVERSE trial continues to be followed for a total of 24 months; additional data on the effects of CRT over that time period will be released in the future. CRT has been established as a proven life-saving therapy for patients with advanced stages of heart failure. However, REVERSE is the first large-scale trial to show that heart failure patients with milder symptoms, or no symptoms at all, might benefit from the therapy. Caution: The CRT devices used in the REVERSE trial are investigational for the patient population studied; their use is limited by federal (or United States) law. Cardima Completes First Successful Cases in Thailand and Commences Training Program with Dr. Li Poa Cardima, Inc., a medical device company focused on the treatment of atrial fibrillation (AF) and manufacturer of the Cardima Surgical Ablation System and the REVELATION® line of therapeutic electrophysiology catheters, has commenced training physicians in Thailand on the use of the Cardima Surgical Ablation System. The training on August 22-25, 2008 was performed under the direction of Dr. Li Poa. He worked closely with Dr. Suchart Chaiyaroj, Chief of Cardiothoracic Surgery, and his associate Dr. Khanat Kruthkul, at Ramathibodi Hospital. A total of four patients to date have been successfully ablated using the Cardima Surgical Ablation System. “The training session here in Thailand went extremely well. The Thai surgeons at Ramathibodi Hospital were extremely supportive of this effort and very impressed with the performance of the Cardima product and its ability to create deep lesions,” stated Dr. Poa. “Surgeons from leading Thai medical institutions attended and we are now on our way to establishing a core team of highly proficient surgeons capable of treating atrial fibrillation using the Cardima products.” Dr. Suchart Chaiyaroj commented on behalf of Ramathibodi Hospital and the Thai physicians participating in the program, “This training program and the development of an AF Center of Excellence in Thai medical facilities is a tremendous development for both our domestic health system and our medical tourism program. We very much appreciate the support of Dr. Li Poa, MEDS Global Healthcare, and Cardima in establishing this program. Dr. Khanat Kruthkul, the other physicians who attended and I were very impressed with the Cardima Surgical Ablation System. We look forward to improving the health of many patients once this surgical ablation program is fully launched and we start treating AF patients effectively here in Thailand in large numbers. With the Cardima Surgical System we can now work effectively together with our EP colleagues and offer treatment for standalone AF.” Several institutions and individuals have provided significant levels of support to this new program to develop Thailand as a Center of Excellence for the treatment of atrial fibrillation; in particular, the cardiology faculty at Ramathibodi Hospital, which is associated with Mahidol University, Dr. Li Poa, Dr. Suchart Chaiyaroj, Chief of Cardiothoracic Surgery at Ramathibodi Hospital, Dr. Khanat Kruthkul, the Thai Ministry of Health, MEDS Global Healthcare USA, the Thai Finance Ministry, DKSH Diethelm Ltd., as well as Cardima. “We need to give a lot of credit to Dr. Li Poa and to the Thai physicians who worked closely to get this training session under way so quickly and to all the companies and institutions that provided support. Cardima has only recently received market approval in Thailand, and to be treating patients and training leading Thai physicians this soon is extremely exciting for everyone at Cardima,” said Robert Cheney, CEO of Cardima. Dr. Poa is the Chief of Cardiothoracic Surgery and Cardiac Surgery Program Director at Stamford Hospital, Connecticut, a major teaching affiliate of the Columbia University College of Physicians and Surgeons where he is a faculty member. Dr. Poa specializes in endoscopic cardiac access and the surgical treatment of AF and other minimally invasive techniques. Dr. Suchart Chaiyaroj is the Chief of Cardiothoracic Surgery at Ramathibodi Hospital, which is the teaching hospital for the Faculty of Medicine of Mahidol University, the longest established medical teaching institution in Thailand. Mahidol University and its Faculty of Medicine, where Dr. Suchart Chaiyaroj serves as an Associate Professor of Cardiothoracic Surgery, has been ranked as the leading university and research institution in Thailand.