Heart Rhythm 2009: Meeting Highlights

The Heart Rhythm Society's 30th Annual Scientific Sessions took place May 13-16, 2009 in Boston, Massachusetts. Enclosed below is a compilation of highlights from the meeting. Routine EKG Screenings May Save Athletes’ Lives: New Study Reveals Abnormalities Identified by EKGs Not Detected by History and Physicals Electrocardiography-based screenings among elite collegiate athletes find potentially important pathology that is not detected by history and physical examinations alone, according to a new study released at Heart Rhythm 2009. This is the first study to evaluate the costs and yield of routine EKG screenings in a large group of high-level performing college athletes. The study was conducted as a joint venture between the Athletics Department and the Division of Cardiology and Internal Medicine at the University of Virginia in Charlottesville. The research group included Srijoy Mahapatra, MD; Jason West, MD; Dilaawar Mistry, MD; John MacKnight, MD; Ethan Saliba, PhD ATC; J. Paul Mounsey, MD; and Rohit Malhotra, MD. Participants included 1,197 competitive incoming athletes from 2005 to 2008. Each athlete had a standard 12-lead EKG performed as part of their routine pre-participation history and physical examination, conducted by the university primary care team physicians. The EKGs were first screened by the team physicians and subsequently evaluated by three cardiologists. “EKG screening remains a controversial issue and it was our intention to conduct a study that would offer further insight on the value of the EKG screening process,” stated lead author Dr. Mahapatra. “EKG screening can find potentially dangerous conditions not found on history and physical, yet EKG screening yields a large number of false positive results.” EKGs were evaluated using criteria from the European Society of Cardiology. History and physical examinations alone were insufficient to detect cardiac abnormalities. However, pre-participation EKG screening detected significant cardiac problems, including: • 1 catecholaminergic polymorphic ventricular tachycardia — this athlete was disqualified from competitive athletics at the University; • 4 accessory pathways — these athletes were successfully ablated and continued athletic participation without difficulty. Of the total 1,197 athletes, several athletes were not able to compete temporarily — pending further evaluation, due to EKG changes suggestive of potential cardiac abnormalities, including: • 18 arrhythmogenic right ventricular cardiomyopathy — all had normal MRIs; • 73 hypertrophic cardiomyopathy — all had normal echocardiograms. “EKG-based screening prior to sports participation can uncover potential indicators of cardiac risks not detected through standard pre-participation medical history and physical examinations alone,” said Dr. Malhotra. “EKG screening can help universities identify potentially life-threatening conditions before athletes take the field.” St. Jude Medical Announces Results From STAR-AF Trial St. Jude Medical, Inc. announced the results from the Substrate versus Trigger Ablation for Reduction of Atrial Fibrillation (STAR-AF) trial. The findings were presented during a late-breaking clinical trials session at Heart Rhythm 2009. The STAR-AF trial, sponsored by St. Jude Medical, was an open, randomized, prospective, multicenter clinical trial involving 108 patients, administered in several Canadian and European centers. Designed as a three-arm trial, it compared the generally accepted treatment approach of pulmonary vein isolation (PVI), with complex fractionated electrogram (CFE) guided therapy, and with a third arm that combined the two therapies. The primary endpoint of the trial was relief of atrial fibrillation (AF) episodes of 30 seconds duration or greater, up to 12 months after treatment. Study results indicate that after one ablation procedure, a combination of PVI and CFE guided therapy demonstrated significantly higher freedom from AF, at 74 percent, as compared to PVI alone at 47 percent and CFE guided therapy alone at 29 percent. Importantly, 94 percent of patients who received the combination of these treatments remained off any anti-arrhythmic medications at the end of the 12-month follow-up period. The STAR-AF trial studied patients with both symptomatic high burden paroxysmal (intermittent, but frequent and prolonged AF) and those with persistent AF. These two groups represent the largest subset of patients with AF; they experience varying degrees of intermittent AF episodes. The study participants had been unresponsive to medication that is meant to alleviate symptoms or the abnormal heart rhythm itself. “While many unanswered questions remain about the origins of and best treatment options for AF, the results of STAR-AF indicate that perhaps traditional pathways are not the optimal ones. By mapping for the areas of CFE during AF ablation, we have demonstrated an incremental benefit for patients who historically may have undergone only a PVI,” said Atul Verma, MD, an electrophysiologist in the Heart Rhythm Program at Southlake Regional Health Centre in Newmarket, Ontario, Canada, who was the principal investigator in the study. “Moreover, I feel that using an automated method for identifying the areas of CFE removes some of the subjectivity that exists in accurately targeting those regions of interest, and may be useful to physicians as they perform AF ablation.” CFEs are highly random and chaotic electrical signals in the atria that may be a source of origin or perpetuation of AF — they are extremely difficult to identify accurately by visual inspection alone. Therefore, an automatic algorithm from St. Jude Medical’s EnSite™ System was used to identify these regions in the patients randomized to receive this treatment course. The CFE guided therapy alone and hybrid PVI and CFE guided therapy strategies were being studied, because often a PVI alone will result in either recurrence of AF or another complicated atrial rhythm that requires additional patient intervention. “The results of the STAR-AF trial represent an important step toward understanding the best set of tools and therapies for treating cardiac arrhythmias, such as AF,” said Denis Gestin, president of the St. Jude Medical International Division. The Heart Rhythm Society Offers First Comprehensive Guidance on Lead Performance Millions of patients have benefitted from the life-saving technology that pacemakers and ICDs provide. However, the significant performance expectations placed on these devices and the lead wires within them present surveillance and monitoring challenges. The recognition of lead malfunction is crucial to patient safety, and to ensure physicians and patients have timely, accurate and understandable information when lead malfunctions occur, the Heart Rhythm Society has released the first comprehensive guidance document on lead performance. The document was released at Heart Rhythm 2009. Monitoring of lead performance poses unique challenges for physicians, patients, regulators and members of the industry. Pacemaker and ICD leads must deliver reliable life-sustaining therapy to the heart and convey electrical information while withstanding the hostile environment of the body. A lead may experience more than 500,000,000 repetitive cardiac cycles during its lifetime, and although substantial scientific and engineering efforts have improved their performance, leads occasionally malfunction. “The measurement and reporting of lead performance are important for clinical decision making, for setting realistic expectations for patients and physicians, for transparency, and for monitoring and improving performance,” said William H. Maisel, MD, MPH, a cardiologist at Beth Israel Deaconess Medical Center and co-chair of the Heart Rhythm Society’s Task Force on Lead Performance. “Guidance provided in this document will help set standard practices for evaluation, analysis and communication of lead performance issues moving forward.” The task force provides a wide range of recommendations on issues including communication of lead performance, pre-market evaluation of leads, post-market monitoring of lead performance, threshold for action and communication after abnormal lead performance is identified, and clinical recommendations for physicians. Emerging modalities for lead surveillance, including remote monitoring and the use of the NCDR ICD Registry™ as a post-market surveillance tool, are also addressed. In addition, the task force encourages the FDA to provide guidance that explains when and how manufacturers can legally use terms other than “recall” in their product advisory notifications. “When lead malfunctions are communicated to physicians, patients and the public, the language should be crafted to avoid unnecessary anxiety or inappropriate interventions,” said task force co-chair Robert G. Hauser, MD of the Minneapolis Heart Institute. “For example, the term ‘recall’ should not be used because it falsely implies that the lead should be removed and returned to the manufacturer.” Physicians who care for patients with cardiovascular implantable devices have several important clinical responsibilities related to lead performance. New clinician recommendations will help prevent misunderstandings, eliminate unwarranted patient anxiety and fear, and minimize inappropriate, unsafe responses to malfunctions that have low risks to patient safety. The new guidance outlines recommendations for clinicians on issues, including: • Informed consent • Monitoring of device performance • Clinical presentation of abnormal lead performance • Clinical management when abnormal lead performance is suspected • Special considerations for pediatric patients • Clinician responsibilities for reporting suspected or definite lead-related problems The complete document will be published in the June issue of the HeartRhythm Journal, the official journal of the Heart Rhythm Society. Endosense Unveils TOCCATA Trial Results Endosense has announced the release of acute clinical results from the TOCCATA (TOuCh+ for CATheter Ablation) European clinical trial at Heart Rhythm 2009. The results of the 76-patient, multicenter study confirm the feasibility, safety and value of Endosense’s TactiCath force-sensing ablation catheter during catheter ablation. TactiCath gives physicians a real-time, objective measure of contact force during the catheter ablation procedure. The TactiCath was granted the CE mark in May 2009. The TOCCATA trial was designed to evaluate the safety and value of force-sensing in the catheter ablation procedure. Conducted at eight centers in five countries, the study was led by Principal Investigator Karl-Heinz Kuck, MD, with participation from 20 additional highly experienced investigators. Enrollment in TOCCATA was completed in February 2009, with a total of 76 patients (42 right SVT and 34 paroxysmal atrial fibrillation [AF]). Safety and treatment efficacy have been proven for the SVT group, which has reached the study endpoints. Data from the AF group is anticipated by the end of May. During the study, operators were given full access to real-time force information during catheter ablation but were blinded to force information during force assessment. Key findings, extracted from 185 hours of force contact data, were the subject of two separate Heart Rhythm 2009 presentations by Dr. Kuck and TOCCATA investigator Dipen Shah, MD. These findings, based on the first comprehensive analysis of the clinical practice among several very experienced operators, confirm the results of Endosense’s extensive pre-clinical testing of the TactiCath. Of note, TOCCATA investigators discovered: • A remarkably high variability of contact force application across even very experienced operators, suggesting the critical need for an accurate and reliable tool to measure contact force during the procedure; • Twelve percent of lesions created during the AF ablation procedure with a force of less than five grams, with half of these forces being intermittent. This suggests that contact force control may help reduce the approximate 30 percent re-intervention rate for AF catheter ablation; and • A significant number of cases in which transient forces greater than 100 grams were exhibited during catheter manipulation. This is important, as pre-clinical studies have indicated that the ability to maintain more moderate levels of force may decrease the risk of complications. “The first TOCCATA results are significant for Endosense, as they validate our pre-clinical data and also clearly demonstrate the numerous important benefits of contact-force sensing during catheter ablation,” said Eric Le Royer, president and chief executive officer, Endosense. “The data also reinforces the TactiCath’s potential to be the standard-setting technology solution for contact force measurement, moving us closer to our goal of enabling the widespread adoption of catheter ablation.” The two TOCCATA abstracts highlight Endosense’s continuous commitment to developing the clinical science behind the TactiCath. Since Heart Rhythm 2006, ten abstracts have been developed on the company’s clinical research activities, based on the seminal work of Hiroshi Nakagawa, MD, PhD and Dr. Shah. This year, an additional abstract featured the importance of the concept of force-time integral in lesion characterization. African Americans Have Significantly Lower Prevalence of Atrial Fibrillation Despite Higher Prevalence of Risk Factors Despite a higher prevalence of risk factors for atrial fibrillation (AF), African Americans have a markedly lower prevalence of AF compared to Caucasians. The new study, presented at Heart Rhythm 2009, is the largest of its kind to prove that race has a direct impact on the occurrence of AF, most notably when comparing African Americans to Caucasians. More than two million people in the United States have AF, making it one of the most common cardiac arrhythmias in the country. There are several known risk factors associated with AF, including male gender, advanced age, hypertension, diabetes and cardiovascular disease. However, the understanding of how race affects an individual’s likelihood to develop AF is not well documented or explained. Led by Kan Fang, MD, the study examined adult patients with at least two clinical encounters at Henry Ford Health System during 2007. A total of 196,104 patients were identified for the study: 110,333 Caucasians and 65,657 African Americans and 20,114 patients in which race was undefined. Overall, African Americans had a lower prevalence of AF than Caucasians. African American patients within the study had a higher prevalence of risk factors associated with AF compared to the Caucasian patients, specifically hypertension (42 percent vs. 29 percent) and diabetes (17 percent vs. 12 percent). Despite the significantly higher presence of risk factors in African American patients, they have a 50 percent lower prevalence of AF compared to Caucasian patients, 1.2 percent vs. 2.5 percent, respectively. “Our results confirm what previous, smaller studies have suggested about African Americans and a lower prevalence of AF,” stated Dr. Fang. “What is truly fascinating about our findings is that African Americans can have significant risk factors for AF, even higher than those of Caucasian patients, yet have a lower occurrence.” Benefits of Catheter Ablation with the NaviStar® ThermoCool® Catheter Sustained for One Year in the Treatment of Symptomatic, Paroxysmal Atrial Fibrillation In final, one-year results of a multicenter randomized clinical study, catheter ablation demonstrated significantly better outcomes compared to anti-arrhythmic drug (AAD) therapy for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation (AF). In a presentation during the late breaking clinical trials session at Heart Rhythm 2009, patients receiving cardiac ablation with the NaviStar® ThermoCool® Catheter, manufactured by Biosense Webster, Inc., were significantly more likely to be free of recurring AF after initiation of treatment and experienced fewer serious adverse events than those receiving AAD therapy. In addition, patients receiving catheter ablation reported markedly fewer symptoms and substantially improved quality of life compared to those receiving AAD. “The final results of this trial provide electrophysiologists and their AF patients with rigorous data demonstrating the significant benefits of catheter ablation compared to ongoing treatment with medical therapy,” said David Wilber, MD, Primary Investigator of the study and the George M. Eisenberg Professor of Cardiovascular Sciences and Director, Division of Cardiology, Loyola University Medical Center in Maywood, Illinois. “In addition, this study shows that patients report an improved quality of life following ablation therapy, which is an important measure of the benefits of catheter ablation on one’s activities of daily living.” In addition to his role as Primary Investigator, Dr. Wilber is compensated for his services as a member of the company’s scientific advisory board and provides other consulting services. “We are pleased that the complete one-year post-ablation results of this trial further substantiate the safety and effectiveness of ablation with the NaviStar® ThermoCool® Catheter in patients with AF,” said Marcia Yaross, PhD, Vice President, Clinical, Regulatory and Health Policy, Biosense Webster, Inc. “Further, new analyses presented demonstrate that 63% of the ablation patients in this study remained free of any observed atrial arrhythmia during the evaluation period, not just symptomatic AF recurrence, vs. only 17% of those treated with AADs.” This clinical trial was a randomized, unblinded and controlled evaluation of symptomatic, paroxysmal AF patients who were refractory to at least one AAD and had at least three episodes of AF in the six months prior to randomization. A total of 167 patients were enrolled from 19 sites throughout the world, and the primary effectiveness endpoint was freedom from documented symptomatic AF recurrence following procedural endpoint confirmation and absent new AAD use or repeat ablation outside of protocol-defined criteria. Chronic success was achieved by 66% for patients receiving NaviStar® ThermoCool® Catheter ablation at the end of the study effectiveness evaluation period, which is significantly superior (pLate-Breaking Clinical Trial Results Announced at Heart Rhythm 2009: ALTITUDE Study A new study reports survival rates exceeding all prior data from other pivotal clinical trials for patients with either a ICD or a cardiac resynchronization therapy device (CRT-D). The results are part of the ALTITUDE study, a late-breaking clinical trial presented at Heart Rhythm 2009. Results of the ALTITUDE study, the largest study of its kind, support the use of ICDs and CRT-Ds in patients at risk of heart failure. ALTITUDE is an observational, prospective study reporting mortality outcomes in ICD and CRT-D recipients, utilizing data from 100,000 patients of a remote monitoring system. The ALTITUDE study also measured the incidence of appropriate and inappropriate shock therapies in the same, large cohort of ICD and CRT-D patients. Mortality outcomes and incidence of appropriate and inappropriate shock were measured through device information transmitted over the Internet, as well as through patient information, including symptoms, weight, and blood pressure data. “We recognized the critical need for more current data on the effectiveness of device therapies,” said lead author Leslie A. Saxon, MD, FHRS, CCDS, at USC Keck School of Medicine in Los Angeles, California. “Results reflect contemporary practice in terms of device technology, patient selection and the ability to monitor device function and symptom status over a network.” In the largest patient cohort reported to date and after a five-year period, ALTITUDE results showed ICD survival rates of 91.8% among 47,032 patients and CRT-D survival rates of 75.6% among 38,967 patients. In addition, shock is associated with decreased survival for both ICD and CRT-D patients with the five-year incidence of shock reported at 35.5% for ICD patients and 34.5% for CRT-D patients. TRUST Trial Confirms Early Detection of Cardiac Events Using ICDs with Remote Monitoring BIOTRONIK Inc. announced that data presented by Niraj Varma, MD, PhD, FRCP, at the Heart Rhythm Society’s Annual Scientific Sessions verifies that the secondary endpoints of the landmark TRUST trial have been met. Dr. Varma’s abstract, “Early Detection of ICD Events Using Remote Monitoring: The TRUST Trial,” reported that the median time from onset to evaluation for all arrhythmias, including atrial fibrillation, ventricular tachyarrhythmia, and ventricular fibrillation, was significantly lower in patients with BIOTRONIK Home Monitoring®, compared to patients followed via conventional in-office follow-ups (less than three days versus more than 30 days, respectively). The study concluded that remote monitoring with automatic daily surveillance provides rapid detection and notification of both symptomatic and asymptomatic arrhythmic events, enabling early physician evaluation. Developed by a steering committee of U.S. electrophysiologists and cardiologists, and enrolling 1,443 patients in North American sites, TRUST (Lumos-T Safely Reduces Routine Office Device Follow Up) is the first and largest study to test remote monitoring and rapid detection of symptomatic and asymptomatic cardiac events in a prospective, randomized trial. The study used BIOTRONIK Home Monitoring®, an automatic, wireless system that performs daily telemetric surveillance of the patient and the technical status of the implanted device, without requiring patient activation. “The data demonstrates yet another benefit the BIOTRONIK Home Monitoring system brings to patients, as well as physicians,“ said Dr. Varma. “Based on the results from this large-scale clinical trial, I believe that remote monitoring may improve physicians’ ability to care for patients with implanted cardiac devices and enhance patient safety.” Dr. Varma is TRUST principal investigator at the Cleveland Clinic in Cleveland, Ohio. Patients Using Psychotropic Drugs Have an Increased Risk of Dying Suddenly From an Acute Coronary Event: New Study Compares Medication Use of Sudden Cardiac Death Victims and Heart Attack Survivors Common psychotropic medications such as antipsychotics, antidepressants and benzodiazepines, may contribute to an increased risk of sudden death during an acute coronary event, according to a new study released at Heart Rhythm 2009. This case-control study is the first of its kind to compare psychotropic medication use in heart attack survivors and victims of sudden cardiac death. Led by Jussi Honkola, MD, at the University of Oulu, Finland, this prospective sub-study of Finnish Genetic Study of Arrhythmic Events (FinGesture) compared the medications of 321 sudden cardiac death victims due to an acute coronary event as confirmed by a medicolegal autopsy, with 609 patients surviving acute myocardial infarction (AMI). Medication histories were examined from autopsy records and interviews with the victims’ relatives. Findings reveal that victims of sudden cardiac death more frequently used medications compared to heart attack survivors respectively, including: • Antipsychotics (10.9 percent vs. 1.4 percent) • Antidepressants (7.4 percent vs. 3.0 percent) • Benzodiazepines (18.4 percent vs. 5.0 percent) The study also found more frequent use of beta blockers and aspirin among AMI survivors when compared to those that experienced sudden cardiac death. “Our study shows that medications may negatively impact a person’s chance of surviving an acute coronary event such as a heart attack,” said Dr. Honkola. “With more people taking medications such as painkillers and antidepressants, the public needs to understand the potential risks and serious consequences.” Medtronic-Supported Clinical Trial Shows ICD Patients Less Likely to Develop Need for Pacing When Device Uses MVP Mode MVP® (Managed Ventricular Pacing), exclusive programming on Medtronic pacemakers, which is proven to be effective in reducing unnecessary pacing in pacemaker patients, was applied in the MVP Trial of ICD patients. Data from MVP trial, sponsored by Medtronic, Inc., were presented as a late breaking clinical trial at Heart Rhythm 2009. MVP dramatically reduces unnecessary right ventricular pacing, meaning it does not deliver low-level pacing pulses to the heart when it is beating normally. The trial aimed to establish whether atrial-based, dual chamber, managed ventricular pacing set at 60 beats per minute (MVP mode) is equivalent or superior to standard ventricular pacing settings of 40 beats per minute in ICD patients. The primary endpoint combined all-cause mortality and heart failure hospitalizations. An independent Data Monitoring Committee recommended early closure of the trial when it was determined that there would not be conclusive results in evaluation of the study’s primary objective. Analysis of the trial’s secondary objectives showed that with programming the ICD to MVP mode, fewer patients developed the need for pacing than those whose devices were programmed with standard ventricular pacing. “Strong clinical evidence supporting the positive outcomes that MVP can have in pacemaker patients already exists,” said Marshall Stanton, MD, vice president of clinical research for the Cardiac Rhythm Disease Management business at Medtronic. “The analysis presented shows that MVP reduces the development of the need for pacing in some ICD patients, but there is no evidence to show atrial pacing improves outcomes among this group of ICD patients." In SAVE PACe, a previous trial of pacemaker patients published in the New England Journal of Medicine, use of Medtronic MVP or Search AV+ modes was proven to dramatically reduce unnecessary right ventricular pacing. This reduction was shown to reduce the development of persistent atrial fibrillation. It is the most common side effect of pacemakers. The Heart Rhythm Society and European Heart Rhythm Association Release Expert Consensus Statement on the Catheter Ablation of Ventricular Arrhythmias Catheter ablation is now an important therapy option to be considered when trying to control recurrent ventricular tachycardias (VT). To ensure that physicians have up-to-date knowledge of this evolving therapy, which can be life-saving for some patients, and promote the best patient care, the European Heart Rhythm Association and the Heart Rhythm Society have prepared EHRA/HRS Expert Consensus on Catheter Ablation of Ventricular Arrhythmias. The consensus statement was released at Heart Rhythm 2009. VT is characterized by a very fast heart rate and is usually seen in the setting of other serious heart disease, where it can cause cardiac arrest and sudden death. Many patients are protected from death by implanted defibrillators, but these devices do not prevent episodes of VT. Ablation can have a major impact to reduce or prevent VT episodes. VT occurs less frequently in patients without structural heart disease, in whom ablation is often effective sole therapy when treatment is required. “As the field progresses, it is important that the medical profession plays a significant role in critically evaluating therapies as they are introduced and evolve,” said Etienne Aliot, MD, from Hôpital de Brabois in Vandoeuvre-les-Nancy, France, and co-chair of the task force. “In the past, ablation was often not considered until pharmacological options had been exhausted, and often patients had suffered from recurrent episodes of VT and multiple ICD shocks. Based on available studies, experts now affirm that catheter ablation should be considered as an earlier treatment.” The European Heart Rhythm Association and the Heart Rhythm Society created a task force of international experts to conduct rigorous analysis of the available data documenting indications, techniques, benefits and risks and outcomes to produce guidance to improve the effectiveness of care, optimize patient outcomes and identify areas for improvement and future research. The statement summarizes the opinion of the task force members based on their analysis of the literature, as well as their experience in treating patients, and is directed to all health care professionals, health care institutions, manufacturers and governmental, reimbursement and regulatory bodies who are involved in the care of patients with VTs. The new consensus statement offers guidance on a range of issues, including: • Indications for catheter ablation of ventricular tachycardia • Technical aspects such as mapping systems, robotic navigation, imaging, energy sources for ablation, anticoagulation and arrhythmic drug management • Mechanisms of specific types of VTs • Ablation outcomes and considerations in specific diseases • Ablation approaches and outcomes for idiopathic VTs that are not due to structural heart disease • Training, institutional requirements and competencies for centers and physicians performing ablation • Clinical trial considerations and needs for future research “When considering catheter ablation treatment, physicians should take into account the risks and benefits that are determined by patient characteristics, as well as the availability of appropriate facilities with technical expertise,” said William Stevenson, MD, from Brigham and Women’s Hospital in Boston, and co-chair of the task force. “This consensus statement defines the indications, techniques and outcomes of catheter ablation procedure specific for the treatment of VT.” The complete guidelines will be published in the June issue of the HeartRhythm Journal, the official journal of the Heart Rhythm Society, and Europace. New MADIT II Clinical Data Analysis Shows Long-Term Survival Benefit for Implantable Defibrillator Therapy Boston Scientific Corporation announced that an analysis of long-term data from the MADIT II clinical study demonstrates that the life-saving benefits of ICD therapy remain sustainable at eight years. This is the first time long-term data have been presented regarding the life-saving benefits of ICDs in a primary prevention population. The analysis was presented during a late-breaking session at Heart Rhythm 2009. The analysis shows a sustainable mortality benefit over time, including: • At eight years, one life is saved for every six patients who receive an ICD. This represents a significant improvement over the two-year MADIT II data, which showed one life saved for every 17 patients • A 41 percent relative reduction in the risk of death for ICD patients at four years • A 37 percent relative reduction in the risk of death for ICD patients at eight years The MADIT II study, sponsored exclusively by Boston Scientific, was designed to determine whether ICDs improve survival when compared to drug therapy alone in heart attack survivors with moderate impairment of the left ventricle. Initial results published in the New England Journal of Medicine (March 21, 2002) demonstrated that ICD therapy reduced the relative risk of death by 31 percent at 20 months follow-up. "ICD therapy has proved effective in patients at risk of sudden cardiac death, and now the long-term MADIT II data show the life-saving benefits of these devices continue over time," said Arthur J. Moss, MD, Professor of Medicine at the University of Rochester Medical Center and Principal Investigator of the MADIT, MADIT II and MADIT-CRT trials. "We are proud to have been the exclusive sponsor of landmark trials like MADIT II," said Fred Colen, President, Boston Scientific Cardiac Rhythm Management. "More than 80 percent of U.S. patients who receive an ICD or CRT-D were first indicated for this life-saving therapy through Boston Scientific clinical research."* * Trials include MADIT, MADIT II, CONTAK-CD, and COMPANION.