News

Medtronic Receives FDA Panel's Unanimous Recommendation for Approval of Revo MRI™ SureScan™ Pacing System Medtronic, Inc. announced that the U.S. FDA Circulatory System Devices Panel of the Medical Devices Advisory Committee has voted unanimously in favor of approval with conditions of the Revo MRI™ SureScan™ pacing system designed as MR Conditional, or safe for use in Magnetic Resonance Imaging (MRI) systems under specified conditions. MRI procedures are not recommended in the United States for patients who currently have implanted pacemakers; if approved, Revo MRI has the potential to be the first FDA-approved pacing system designed for use in the MRI setting. The FDA’s Circulatory System Devices Panel recommended Revo MRI for approval with conditions related to the planned post-market study, health care professional training, and labeling to reflect MRI scans are to be conducted with the full Revo MRI SureScan Pacing System. The FDA will consider the panel’s recommendation in its review of Revo MRI; however, it is not bound by its Advisory Committee’s recommendations. “MRI is critical in the diagnosis of many serious conditions; however, patients with current pacemakers most often do not have access to this vital technology,” said Pat Mackin, president of the Cardiac Rhythm Disease Management business and senior vice president at Medtronic. “We look forward to working with the FDA during the regulatory process so that we may provide certain pacemaker patients with access to MRI scans.” The number of MRI scans performed increases each year, as does the number of people with implanted cardiac devices. In 2007, there were approximately 30 million MRI scans conducted in the U.S., and that number continues to grow. It is estimated that more than 200,000 patients annually in the U.S. have to forego an MRI scan because they have a pacemaker due to the risks involved, including interference with pacemaker operation, damage to system components, lead or pacemaker dislodgement, heating of the lead tips and unintended cardiac stimulation. The FDA panel reviewed safety and effectiveness data from a prospective, randomized trial at 42 centers around the world featuring 464 implanted patients. Major inclusion criteria included standard Class I or II dual chamber pacemaker indication, which allowed for pacemaker-dependent patients. Patients were excluded if they had previously implanted medical devices or abandoned leads. Patients were randomized at implant to either receive an MRI or not to receive an MRI. The primary endpoints evaluated were safety and effectiveness of the Revo MRI pacing system in the MRI environment. For safety, the MRI group was evaluated for MRI procedure-related complications through one month post MRI. The primary effectiveness endpoint tested equivalence between MRI versus control for atrial and ventricular pacing capture thresholds and atrial and ventricular sensed amplitudes through one month post MRI. i. IMV, “Benchmark Report: MRI 2007,” IMV Medical Information Division 2008. ii. Zhan C, et al. Cardiac device implantation in the United States from 1997 through 2004: A population-based analysis. J Gen Intern Med 2008;23(Suppl 1):13–19. iii. IMV, “Benchmark Report: MRI 2007,” IMV Medical Information Division 2008. iv. Medtronic calculations cited in Rod Gimbel and Ted McKenna, “Safety of Implantable Pacemakers and Cardioverter Defibrillators in the Magnetic Resonance Imaging Environment,” Business Briefing: Long-Term Healthcare 2005 (2005) available at www.touchbriefings.com. v. Faris OP, Shein M. Food and Drug Administration perspective: Magnetic resonance imaging of pacemaker and implantable cardioverter-defibrillator patients. Circulation 2006;114:1232-1233. vi. Roguin A, et al. Magnetic resonance imaging in individuals with cardiovascular implantable electronic devices. Europace 2008;10:336-346. vii. Levine GN, et al. Safety of magnetic resonance imaging in patients with cardiovascular devices: an American Heart Association scientific statement from the Committee on Diagnostic and Interventional Cardiac Catheterization, Council on Clinical Cardiology, and the Council on Cardiovascular Radiology and Intervention: endorsed by the American College of Cardiology Foundation, the North American Society for Cardiac Imaging, and the Society for Cardiovascular Magnetic Resonance. Circulation 2007;116:2878-2891. viii. Kalin R, Stanton MS. Current clinical issues for MRI scanning of pacemaker and defibrillator patients. PACE 2005;28:326-328. ix. American College of Radiology (ACR) and the Radiological Society of North America (RSNA). MRI of the body (chest, abdomen, pelvis). June 10, 2009. Available at http://www.radiologyinfo.org/en/info.cfm?pg=bodymr. Accessed March 11, 2010. Hospices Not Deactivating Defibrillators in Patients Researchers from Mount Sinai School of Medicine have found that patients admitted to hospice care who have an implantable cardioverter defibrillator (ICD) are rarely having their ICDs deactivated and are receiving electrical shocks from these devices near the end of life. This first-of-its-kind study of hospice patients with ICDs is published in the March 2, 2010 issue of the Annals of Internal Medicine. Mount Sinai researchers surveyed 900 hospices, 414 of which responded. Ninety-seven percent of the responding hospices admitted patients with ICDs. On average, nearly 60 percent of patients did not have the shocking function of the ICD deactivated. Only 20 percent of hospices had a question on their intake forms to identify patients with ICDs, and just 10 percent reported having a policy in place to discuss deactivation with patients and their families. ICDs are effective in preventing sudden cardiac death in patients with recurrent arrhythmias, but for patients in hospice care they may cause unnecessary pain, and significant stress and anxiety for their family members who feel helpless in watching their loved one suffer. “Hospices are the foremost experts at dealing with the complex communication issues surrounding end-of-life discussions with patients and their families,” said Nathan Goldstein, MD, assistant professor, Hertzberg Palliative Care Institute, Brookdale Department of Geriatrics and Palliative Medicine, Mount Sinai School of Medicine. “The fact that so few organizations have a policy about deactivation shows how complicated these conversations are. Having a policy in place can improve communication and provide better quality of care for patients and their families.” ICD shocks may cause physical and psychological distress for patients and their caregivers. Patients report that receiving shocks from an ICD is comparable to being “kicked or punched” in the chest. Receiving ICD shocks has been associated with the development of adjustment disorders, depression, post-traumatic stress disorder, and panic disorder. Family caregivers who observe patients being shocked report feelings of fear, worry, and helplessness, and have been shown to have increased rates of depression and anxiety. For patients with advanced disease, an ICD may no longer prolong a life of acceptable quality, and cause needless discomfort. “These data indicate that developing a policy to address concerns surrounding ICDs can be highly beneficial in reducing emotional and physical discomfort for hospice patients and their families,” said Dr. Goldstein, whose team developed a model policy for ICDs in hospices based on feedback they received from several facilities. The policy includes the necessity for staff to be educated on how ICDs work, identification of patients with ICDs at the time of evaluation and admission, an informed consent discussion with the patient and family about the benefits and burdens of the device, and how to handle the device in an emergency situation. “Many patients have had these devices for years and see them as a sign of stability. It’s important to address this issue and emphasize the importance of the patient’s comfort at end of life,” Dr. Goldstein explained. The researchers received a list of 3,750 hospices from the National Hospice and Palliative Care Organization. From this list, the researchers generated a geographically weighted random sample of 100 hospices from each of the nine U.S. census regions. Survey response rate was 50 percent. “AFib Educator” Smartphone App and Desktop Widget Offers Patient Dialogue Tool AF Stat™ – a collaboration of healthcare leaders and organizations working to improve the health and well-being of people affected by atrial fibrillation (AFib) – unveiled the “AFib Educator,” a smartphone app and desktop widget to help healthcare practitioners better explain the risks and consequences of the disease to their patients. Despite the far-reaching impact of AFib, many healthcare professionals lack the tools to explain the disease and its potential consequences to patients. In fact, a 2009 Yankelovich survey found that 42 percent of physicians reported having to use their own drawings to guide patient discussions about AFib, while more than half of nurses report using their hands to describe AFib. “When you explain blood flow in a coronary artery to patients, they can visualize problems such as a blockage, but it is difficult for most patients to understand the normal electrical flow of impulses through the heart. This is magnified many times over when trying to comprehend the complexities of AFib,” said Eric Prystowsky, MD, AF Stat Medical Chair and Director of the Clinical Electrophysiology Laboratory at St. Vincent Hospital. “Until now, healthcare professionals have lacked sophisticated tools to educate their patients about AFib. The AFib Educator offers information that can help patients better understand AFib and develop a sense of urgency about managing it.” The AFib Educator provides a dynamic resource that demonstrates how the heart should look under normal rhythm, and how it performs during AFib. Featuring detailed, animated diagrams of the human heart, fluoroscopy (x-ray) animations, and EKG demos, the AFib Educator helps healthcare professionals clarify the risks associated with AFib, and shows patients specifically how it impacts the heart’s performance. The application also provides healthcare professionals with other resources to share with patients, including facts about the signs, symptoms, prevalence and risks of AFib; links to resources where patients can learn more about AFib; and an “e-mail a friend” feature, which enables healthcare professionals to e-mail background information directly to patients. Patients and caregivers can then send the information to others with or at risk for AFib. Recent research indicates that healthcare professionals as well as medical students are increasingly looking towards smartphone technology for their professional needs. Manhattan Research reports that 54 percent of all physicians own a PDA or a smartphone. Among them, 83 percent use the devices for professional purposes, and 65 percent state that they believe that the devices are essential to their practices. Furthermore, 73 percent of physicians who own a PDA or smartphone expressed a desire for more applications tailored for their specialty. Of note, cardiologists were among the group of specialties most likely to express this thought. The AFib Educator can be downloaded for free for iPhone® or iPod touch® mobile digital devices (app format) via the App StoreSM online store, or desktop (widget format) directly from www.AFStat.com. iPhone and iPod touch are trademarks of Apple Inc., registered in the U.S. and other countries. App Store is a service mark of Apple Inc., registered in the U.S. and other countries.