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.

The probability of chronic success was 62.7% for the patients receiving NaviStar® ThermoCool® Catheter ablation at the nine-month effectiveness evaluation period, which is significantly superior (p

Additionally, the ThermoCool® Catheter ablation group demonstrated an excellent safety profile with no device-related serious adverse events such as death, heart attack, stroke, cerebrovascular accident, heart block or atrial perforation within seven days post ablation. Importantly, there was no clinically significant pulmonary vein stenosis in patients receiving ablation, and the incidence of serious adverse events in the ThermoCool® Catheter group in the 90 days following initiation of therapy was observed to be approximately half that in the AAD group (35.1 vs. 18.4%; p = 0.0221).

The NaviStar® ThermoCool® Catheter is currently approved in the United States for the treatment of type 1 atrial flutter and recurrent drug/device refractory sustained monomorphic ventricular tachycardia due to prior myocardial infarction.

Dronedarone (Multaq®) Reduced the Incidence and Duration of Hospitalization in Patients with Atrial Fibrillation: New Post-Hoc Analysis From ATHENA Study Showed that Multaq® on Top of Standard Therapy Significantly Decreased the Total Number of Hospital Days by 28% in Patients With Atrial Fibrillation or Flutter

New data from the landmark ATHENA trial showed that dronedarone significantly reduced the incidence and total duration of hospital stays among patients with atrial fibrillation/atrial flutter (AF/AFL). This post-hoc analysis was presented at the 2008 American Heart Association Scientific Sessions in New Orleans, Louisiana.

In this new analysis, dronedarone significantly reduced the total number of hospital days by 28 percent (p

In addition to the demonstrated reduction of AF-related hospitalization by 37 percent (p

"The incidence of AF-related hospital admissions has dramatically increased in recent years, and therapeutic solutions to reduce this burden are needed," said Dr. Christian Torp-Pedersen from the Gentofte University Hospital, Copenhagen, Denmark, and a member of the steering committee of the ATHENA study. "These new ATHENA data showed that, for the first time, an anti-arrhythmic drug significantly and consistently reduced hospitalization incidence and duration, which led to a substantial reduction of total hospitalization burden in this patient population."

A second post-hoc analysis from ATHENA also presented during the AHA confirmed the rhythm and rate controlling properties of dronedarone, previously demonstrated in lower risk populations studied in the EURIDIS, ADONIS and ERATO trials. This analysis showed that dronedarone reduced the incidence of first AF recurrence by 25 percent in patients in sinus rhythm at study initiation (p

Dronedarone also decreased mean heart rate during atrial fibrillation to 78 beats per minute, compared with 87 for placebo (p

“This study demonstrates both signify cant rhythm and rate controlling properties of dronedarone in the ATHENA population, which consisted of higher-risk patients with atrial fibrillation,” added Dr. Richard Page, professor and head of the Division of Cardiology at the University of Washington School of Medicine, Seattle, and a member of the steering committee of the ATHENA study. “It is intriguing that there was a trend toward reduction of the primary endpoint of cardiovascular hospitalization or death even in patients with permanent AF, suggesting that the benefit of dronedarone may not only be linked to arrhythmia control.”

The most frequently reported adverse events of dronedarone vs. placebo in the ATHENA trial were gastrointestinal effects (26% vs. 22%), skin disorders (10% vs. 8%, mainly rash) and mild increase in blood creatinine (4.7% vs. 1%) due to inhibition of tubular secretion of creatinine in the kidneys. The mechanism of blood creatinine increase was well defined in a separate study of healthy volunteers and is not indicative of renal toxicity. In the ATHENA trial, compared to placebo, dronedarone showed a low risk of pro-arrhythmia and no excess of hospitalizations for congestive heart failure. There was a similar rate of study drug discontinuation between the two study groups.

The landmark ATHENA study is the only double-blind, anti-arrhythmic, morbidity-mortality study in patients with AF. It was conducted in more than 550 sites in 37 countries and enrolled a total of 4,628 patients.

Dronedarone (Multaq®) is an investigational treatment and the only anti-arrhythmic drug to have shown a significant reduction in morbidity and mortality in AF/AFL patients with a favorable safety profile as evidenced by a low incidence of pro-arrhythmia (including torsades de pointes) and extra-cardiac organ toxicity. Dronedarone, discovered and developed by sanofi-aventis, has been studied in a clinical development program including more than 6,200 patients. Dronedarone (Multaq®) has been granted a priority review by the U.S. Food and Drug Administration (FDA) and a registration dossier is also under regulatory review by the European Medicines Agency (EMEA).

Clinical Data Presented at American Heart Association Meeting Show CVRx® Rheos® Therapy Improved Heart Structure and Function

Clinical data on the use of the CVRx® Rheos® System show Rheos Therapy significantly improved heart structure and function in patients with high blood pressure. Peter W. de Leeuw, professor of medicine and hypertension at the University of Maastricht in The Netherlands, presented the data (oral presentation #4426) at the American Heart Association (AHA) Scientific Sessions 2008. In addition, data from a pre-clinical study indicate that, after receiving Rheos Therapy, canines with heart failure were less likely to be induced into lethal ventricular heart rhythms, a risk factor for sudden cardiac arrest (poster session #2415).

Clinical data presented at AHA demonstrate that continuous use of Rheos Therapy in 33 Stage II hypertension patients (systolic blood pressure ≥ 160 mmHg) remodels cardiac structure and improves heart function. Specifically, the Rheos Therapy increased the left ventricular outflow tract diameter and decreased the size of the heart over a 12-month period. These changes reduce the amount of energy the heart uses to meet the needs of the body, and decreases stress on the heart.

“We are optimistic that the Rheos System will prove to be an effective means of treating hypertensive patients with left ventricular hypertrophy,” said Dr. de Leeuw. “From the current clinical trial, we are expanding our evaluation of the Rheos System and finding that not only does this unique therapy lower blood pressure, but it improves the efficiency of transferring blood from the heart to the arteries. This opens up the possibility to use of the device in patients with heart failure.”

Dr. Mengjun Wang and Dr. Hani Sabbah discussed data which show canines with heart failure are less likely to be induced into lethal ventricular heart rhythms, which can lead to sudden cardiac death, after long-term use of Rheos Therapy. At six months, the seven canines implanted with the Rheos device were much less likely to be induced into ventricular tachyarrythmias during programmed stimulation, than the four canines without a Rheos device implanted. These results demonstrate that the Rheos Therapy can prevent serious lethal heart rhythms in canines with heart failure. Studies in heart failure patients will be needed to confirm this benefit.

CVRx initially evaluated the Rheos System as a treatment for hypertension or high blood pressure. Many patients enrolled in early clinical evaluations of the Rheos System suffered from hypertension and had abnormal heart structure and function. Both conditions improved with Rheos Therapy in many of these patients. Worldwide, hypertension and heart failure are growing and leading causes of death. The Rheos System could provide a new treatment option for millions of people who cannot control these conditions with medications.

The Rheos System uses the CVRx-patented Baroreflex Activation Therapy® technology that is designed to activate the carotid baroreceptors, central components of the body’s natural cardiovascular regulation system. When the baroreceptors are activated, signals are sent through neural pathways to the brain and interpreted as a rise in blood pressure. The brain works to counteract this perceived rise in blood pressure by sending signals to other parts of the body (heart, blood vessels and kidneys) that relax the blood vessels and inhibit the production of stress-related hormones. These changes enable the heart to increase blood output, while maintaining or reducing its workload, thereby reducing blood pressure when it is elevated and alleviating the symptoms of heart failure.

The Rheos System includes the following components:

• A small device that is implanted under the collar bone;

• Two thin lead wires that are implanted at the left and right carotid arteries and connected to the pulse generator; and

• The Rheos Programmer System, an external device used by doctors to noninvasively regulate the activation energy from the generator to the lead wires.

CVRx received investigational device exemption (IDE) approval from the FDA to begin the Rheos Pivotal Trial to evaluate the safety and effectiveness of the Rheos System in treating hypertension. The trial is enrolling 300 patients at multiple clinical sites in the United States and in Europe.

Caution: CVRx Rheos System is an investigational device and is limited by Federal (or United States) law to investigational use only.

Clinical Data Launches Genetic Test for Arrhythmogenic Right Ventricular Cardiomyopathy: Company to Release its Genetic Databases for Inherited Cardiac Conditions

PGxHealth®, a division of Clinical Data, Inc., announced the launch of its new genetic test for arrhythmogenic right ventricular cardiomyopathy (ARVC), an inherited and often fatal heart condition, at the 2008 American Heart Association meeting. The addition of the FAMILION® ARVC Test expands the company’s FAMILION family of genetic tests for inherited cardiac syndromes and marks its third successful test launch in the past 12 months. Clinical Data also announced plans to make its databases of genetic mutations associated with inherited cardiac conditions, such as ARVC, available to the public.

“The launch of our FAMILION ARVC Test illustrates the company’s ongoing commitment to extend our leadership position in cardiovascular genetics by making additional tests more broadly available to clinicians, patients and their family members,” said Drew Fromkin, President and CEO of Clinical Data. “We are also reiterating our commitment to the clinical and research communities and advocacy groups by releasing our cardiac genetic databases to the public in support of efforts to more fully understand the genetic basis of these complex diseases.”

In 2006, Joint Guidelines released by the American College of Cardiology, American Heart Association and the European Society of Cardiology support the utilization of genetic testing for patients and their family members suspected of carrying mutations causative of ARVC. The FAMILION ARVC Test is a complex genetic test that sequences the five genes most commonly associated with ARVC.

“Because over 40 percent of ARVC patients suffer sudden cardiac death as their first known manifestation of disease, making an early and accurate diagnosis is critical to saving lives,” said Jeffrey Towbin, MD, Professor, Baylor College of Medicine and Texas Children’s Hospital, one of the world’s thought leaders on ARVC. “Comprehensive genetic screening that includes all five ARVC causing genes is a critical tool in the diagnosis and management of ARVC.”

In addition, PGxHealth intends to publish its FAMILION databases beginning in the spring of 2009, as part of a large-scale database project for inherited cardiac conditions. Initially, the publicly accessible data will include information related to long QT syndrome (LQTS) and Brugada syndrome (BrS), two inherited channelopathies.

“The publication of this large collection of genetic data from approximately 2,500 LQTS and 200 BrS patients, and corresponding data from a healthy reference population of almost 700 volunteers, will be an unprecedented resource for the cardiac research and clinical communities,” said Carol R. Reed, MD, Chief Medical Officer of Clinical Data. “This data release is being carefully assembled in collaboration with multiple academic thought leaders from around the world and will be made available in an anonymous, publicly accessible database, which will be regularly updated with new data from our testing.”

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