American Heart Association 2008 Scientific Sessions: Highlights

Medtronic Data Presented at American Heart Association Scientific Sessions 2008 Supports Utility of Painless Pacing Therapies in ICD Patients

New data presented at Scientific Sessions 2008 from Medtronic shows that survival among patients with implantable cardioverter defibrillators (ICDs) treated only with anti-tachycardia pacing (ATP) was superior to patients who experienced at least one shock-treated episode, further demonstrating the clinical benefit of ATP. Additionally, the analysis evaluating more than 2,000 patients found no link between inappropriate therapy and mortality, nor a causal relationship between ICD therapy (ATP or shock) and mortality.

ATP allows most patients with ICDs to receive painless pacing pulses to safely and effectively terminate dangerous ventricular tachyarrhythmias.

In the analysis, there were 3,630 treated tachyarrhythmia episodes, of which 97 percent were classified as either ventricular tachycardia (VT) or fast VT (FVT), irregular heart rhythms ranging from 100-300 beats per minute, which are treatable by an ICD. Of these episodes for which therapy was delivered, 80.2 percent were successfully treated with ATP. In fact, 91.9 percent of 2,176 treated VT episodes were successfully terminated by ATP, without the need for a shock. In addition, 68.2 percent of 1,339 treated FVT episodes were terminated by ATP, without the need for a shock.

“Today’s highly advanced ICDs can deliver both painless ATP therapy as well as a high-energy shock, if needed, to terminate dangerous heart rhythms and save lives,” said Michael O. Sweeney, MD, director, Cardiac Pacing and Implantable Device Therapies, Brigham and Women’s Hospital, and who led the analysis. “Previous studies of ATP technology have proven its ability to improve patients’ quality of life by reducing discomfort sometimes associated with life-saving shocks.”

He continued, “This new data suggests that aggressive use of ATP as part of a broad strategy to reduce shocks may not only improve patient tolerance of the therapy, but also may further enhance the life-saving benefit of ICDs beyond what has been shown in previous studies. This analysis provides further evidence that ATP should be routinely programmed in all ICD patients.”

David Steinhaus, MD, medical director for the Cardiac Rhythm Disease Management business at Medtronic, said, “These findings further demonstrate the clinical benefit to advancing pain-free therapies for patients.”

GE Launches Products, Collabora-tions, Innovation at AHA Meeting: GE Healthcare Showcases New Products in Diagnostic, Ultrasound, Invasive Cardiology Lines

At the 2008 Scientific Sessions of the American Heart Association, the company showcased new products, new relationships and, above all, a new way to look at clinical practice.

Cardiovascular Ultrasound: Three new ultrasound devices made a U.S. debut. The Vivid E9 is making the promise of true 4D heart imaging and opening the door to full cardiac studies in a completely 4D environment. Vivid q adds quantitative analysis to portable excellence, bringing even more diagnostic confidence into the equation while its intravascular ultrasound (ICE) imaging probe opens up an entirely new care area.

Diagnostic Cardiology: Among the new releases from GE’s Diagnostic Cardiology business at AHA was EMR Gateway, an innovation that delivers electrocardiogram (ECG) results and patient demographic data to virtually any Electronic Medical Records (EMR) system. In addition, the company announced a new electrocardiograph system in MAC 1600, Event Recording for advanced arrhythmia assessment and a new version of its ECG management system. These advancements are all designed to aid healthcare providers in efficient selection of appropriate treatment.

Cardiovascular Services: GE Healthcare’s Ultrasound Service team announced the availability of AcoustiCare, a package including as many as four, fully covered, transesophageal ultrasound probe repairs per year. Each repair consists of genuine, upgraded OEM parts and results in a like-new, remanufactured transducer probe. GE’s Interventional Service team for Hemodynamic & EP Recording Equipment, including Mac-Lab IT®, CardioLab IT® and ComboLab IT, will unveil Proactive System Check-up & Patch Management coverage for facilities needing optimal efficiency and security. This proactive system check-up can improve network performance, prevent workflow interruption and keep the system performing at optimal levels.

BIOTRONIK Announces Positive Clinical Trial Results at American Heart Association Scientific Sessions: TRUST Study Shows Remote Monitoring of ICD Enables Earlier Detection of Arrhythmic Events with Fewer In-Office Visits

BIOTRONIK announced that data presented at the New Trials in Electrophysiology and Pacing Session of the American Heart Association (AHA) 2008 Scientific Sessions shows remote monitoring of its implantable cardioverter defibrillators (ICDs) is a safe and effective alternative to conventional in-office follow-up care, which helps reduce the burden on capacity-constrained cardiac centers.

Developed by a steering committee of U.S. electrophysiologists and enrolling 1,443 patients in 105 North American sites three months ahead of schedule, TRUST (Lumos-T Safely Reduces Routine Office Device Follow Up) is the first and largest study to test remote monitoring and fewer scheduled office visits in a prospective, randomized trial. The study used BIOTRONIK Home Monitoring®, an automatic, wireless system (i.e., does not require patient activation) that performs daily telemetric surveillance of the patient and the technical status of the implanted device.

"The data demonstrates that the BIOTRONIK Home Monitoring system safely reduces the need for conventional in-office visits, while improving follow-up adherence, and enables earlier evaluation of clinically relevant cardiovascular events," said Dr. Niraj Varma, TRUST principal investigator, Cleveland Clinic. "Based on the results from this large-scale clinical trial, I believe remote monitoring may improve the way physicians care for patients with implanted cardiac devices."

In comparison with the control group of patients enrolled in conventional in-office follow up, clinical trial data from TRUST show that remote monitoring:

• Reduces the number of in-office follow-up visits, while maintaining patient safety. The remote monitoring group had approximately half the total number of office visits as compared to the conventional follow-up group while achieving the same patient outcomes.

• Leads to earlier detection of arrhythmic events. In the remote monitoring group, the time from onset of the arrhythmic event to evaluation was reduced by 21-35 days compared to the control group, depending on the type of arrhythmia detected.

• Drives efficient use of clinic time. Eighty-nine percent of remote monitoring alerts were managed remotely and required no follow-up office visit. About 30 percent of unscheduled office visits among patients in both the control and study groups required physician interaction and were considered "actionable." However, unscheduled office visits that were triggered by the remote monitoring system nearly doubled the rate of treatment; more than 51 percent led to some action by the clinician, making better use of clinic time.

"The study results show that remote monitoring facilitates follow-up care and, very importantly, enhances patient safety, which can provide patients with additional security," said Dr. Andrew Epstein, TRUST principal investigator and professor of medicine in the division of cardiovascular disease at the University of Alabama at Birmingham.

"Decreasing the number of non-actionable, scheduled and unscheduled office visits through remote monitoring will ease the pressure of overloaded cardiac clinics. This will permit physicians to focus on patients who actually require intervention," said Dr. Charles Love, TRUST principal investigator and director of arrhythmia device services and associate investigator, Dorothy M. Davis Heart & Lung Research Institute at The Ohio State University Medical Center.

The TRUST clinical study tested the hypothesis that remote monitoring was safe and effective for ICD follow up for more than one year in a prospective, randomized controlled clinical trial. The multi-center trial involved 1,443 enrolled patients at 105 sites in the United States and Canada who were randomized 2:1 to remote monitoring or conventional groups. Patients participating in the TRUST trial had either a single chamber or dual chamber ICD.

Study Finds Catheter Ablation With the NaviStar® ThermoCool® Catheter Superior to Anti-Arrhythmic Drug Therapy for the Treatment of Symptomatic, Paroxysmal Atrial Fibrillation

Catheter ablation has been shown in a randomized, multi-center clinical trial to significantly outperform anti-arrhythmic drug (AAD) therapy for the treatment of symptomatic paroxysmal atrial fibrillation (AF). Atrial fibrillation is the most prevalent cardiac arrhythmia and one of the most common causes of stroke.

In data presented at the American Heart Association’s Annual Scientific Sessions, patients receiving cardiac ablation with the NaviStar® ThermoCool® Catheter, manufactured by Biosense Webster, Inc., were significantly more likely to be free of recurring AF at nine months after initiation of treatment and experienced fewer serious adverse events after 90 days than those receiving AAD therapy.

“This is the first time in an FDA-monitored, controlled clinical study that catheter ablation has been shown to outperform traditional medical therapy,” said David Wilber, MD, principal 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. “These data are extremely important to the electrophysiology community widely adopting alternative treatments to traditional medical therapy, which can often cause significant side effects for patients suffering from this debilitating condition.”

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.

Currently, there are no ablation catheters approved for marketing by the Food and Drug Administration (FDA) for the treatment of AF in the United States. Biosense Webster submitted a Pre-Market Approval (PMA) Supplement for an AF indication for its ThermoCool® Catheter, based on this study data. The PMA Supplement was granted priority review by FDA, which will convene the Circulatory System Devices Advisory Panel to review the application.

“We are pleased that our application was granted priority review, and we look forward to discussing this potential treatment advance with members of the advisory panel,” said Shlomi Nachman, Worldwide President of Biosense Webster.

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.

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