EP Lab Digest - October 2007 - (Page 29)

OCTOBER 2007 NEWS 29 National ICD Registry’s First-Year Data Show Few Complications, Not All Physicians Formally Trained Comparative Data Expected to Improve Patient Care he registry, the nation’s first comprehensive database of detailed information about patients with the implantable medical devices, found that complications at the time of device implantation and prior to hospital discharge occurred at a 3.6 percent rate in the more than 108,000 ICD implantations at 1,117 hospitals. Adverse events included hematomas (1.2 percent), lead dislodgement (1.0 percent) and death (0.02 percent). The first-year data, which was published in the September 2007 edition of HeartRhythm, the official journal of the Heart Rhythm Society, also showed that 15 percent of the 3,249 physicians who implanted ICDs in 2006 had no formal training in device implantation. Formal training consists of the completion of an EP fellowship and CCEP boards, EP fellowship only, thoracic/cardiac surgery residency, pediatric EP fellowship, or Heart Rhythm Society clinical competency standards for ICD and CRT implantation.These physicians accounted for six percent of all implants captured by the registry last year. “The good news from this year-one data is that, in general, physicians implanting these lifesaving devices are providing heart patients with reliable, high-quality care,” said Stephen Hammill, MD, FHRS, chair of the ICD Registry™ Steering Committee and past president of the Heart Rhythm Society.“But to continue to ensure patient safety, we need to make sure that specially trained physicians are performing these procedures.” The Heart Rhythm Society established an alternate training pathway in 2004 consisting of rigorous clinical competency standards for physicians not certified in electrophysiology to help them gain the proper experience and knowledge before implanting ICD and CRT devices. The first-year data also provided an overview of who is receiving the medical devices. Continued from page 1 T The average patient is 68 years of age, white (83 percent) and male (74 percent). Medicare beneficiaries represented 70 percent of patients last year.Though the registry was established in April 2006 to be the sole repository of ICD implantation data for Medicare patients, about 88 percent of implants are being done in hospitals that are entering data for all patients. The registry is developing a longitudinal study to capture device-firing data and will subsequently be combined with Medicare claims data to record complications that may occur after discharge such as infection and lead dislodgement. “The registry has so far proven to be an ongoing, quality improvement tool that allows a hospital to compare its outcomes from ICD implantation with hospitals of a similar size,” concluded Dr. Hammill. “Access to the data helps hospitals determine if changes need to be made to ensure the best patient care possible.” The creation of the National ICD Registry™ began in September 2004 with the convening of the National ICD Registry Working Group, an interdisciplinary committee led by the Heart Rhythm Society and consisting of 17 organizations, including physician associations, health insurance providers, government officials, medical device manufacturers and registry experts.This workgroup addressed the lack of information available for determining if ICDs benefited Medicare patients, a patient population that is both older and in some cases less healthy than patients receiving ICDs in the clinical trials.The working group also determined the best approach to develop and implement the registry to collect this information without overburdening hospital participants.As a result, the ICD Registry™, a partnership of the Heart Rhythm Society and the American College of Cardiology Foundation, was created. In October 2005, CMS announced the ICD Registry™ as the official national repository of ICD information. Life Recovery Systems Receives European ® CE Mark Approval for Its ThermoSuit System Medical Device Provides Rapid In-hospital Hypothermia Therapy ife Recovery Systems, HD, LLC, of Alexandria, Louisiana and Kinnelon, New Jersey, announced that its ThermoSuit® System has been granted European CE Mark approval for temperature reduction in patients where clinically indicated (e.g., to induce hypothermia in patients to preserve cardiac and brain function in victims of cardiac arrest, stroke, heart attack, traumatic brain injury and hyperthermic patients). The ThermoSuit System uses innovative technology to rapidly cool a patient’s core temperature. It consists of a disposable body suit and a means to pump coolant within the suit over the skin of the patient. It is the first device for patient temperature management that conveniently provides a thin layer of rapidly flowing liquid coolant in direct contact with the skin. This approach gives the ThermoSuit System outstanding capabilities to rapidly and non-invasively change patient temperature. It has been designed for ease of use for clinicians who treat L patients indicated for cooling therapy, and has the potential to quickly cool these patients conveniently and rapidly. “European CE Mark approval of the ThermoSuit System is an important next step in achieving our company’s mission,” said John DiLiddo, Life Recovery Systems’Vice President of Marketing and Sales. “With the introduction in Europe of the ThermoSuit System for use in the hospital, physicians and nurses will now have a convenient, easy-to-use tool in the delivery of emergency hypothermia therapy.” Evolving international standards of care recommend that “unconscious adult patients with spontaneous circulation after out-of-hospital cardiac arrest should be cooled to 32 degrees C to 34 degrees C for 12–24 hours when the initial rhythm was ventricular fibrillation. Such cooling may also be beneficial for other rhythms or inhospital cardiac arrest.”

Table of Contents Feed for the Digital Edition of EP Lab Digest - October 2007

Finally! The New Registered Cardiac Electrophysiology Specialist (RCES) Credential: Interview with Christopher M. Nelson, RN, RCIS, FSICP ECG 101: Closing the Gap Phenomenon Contents Letter from the Editor ICD Patient Support Group: St. Peter’s Hospital Spotlight Interview: Community Healthcare System Use of Magnetic Catheter Navigation for Ablation of Focal Tachycardias Echocardiography: The Preeminent Front Line Screening and Diagnostic Tool for Cardiovascular Imaging and Physiological Assessment First Annual EP Lab Digest Salary Survey: Last Chance! Clinical Trial Update: 2007 Email Discussion Group Adopting and Implementing the AF Ablation Consensus Statement Electrophysiology in the West Summit Events Calendar The Sustained Treatment of Paroxysmal Atrial Fibrillation (STOP AF) Clinical Trial: Interview with Kevin Wheelan, MD Industry News and Products

EP Lab Digest - October 2007

For optimal viewing of this digital publication, please enable JavaScript and then refresh the page. If you would like to try to load the digital publication without using Flash Player detection, please click here.