Late-breaking clinical trials

The following late-breaking clinical trials are being presented during HEART RHYTHM 2006, the Heart Rhythm Society's 27th Annual Scientific Sessions May 17-20 in Boston

Statins Have Significant Benefits For ICD Patients
Statins reduced the mortality by 78 percent in patients with nonischemic dilated cardiomyopathy (DCM) enrolled in the DEFINITE trail. Researchers at Chicago's Northwestern University believe the dramatic findings show the cholesterol-lowering drug may have other beneficial qualities that significantly improve heart function. "Statins may have other effects on the heart that could result in improved survival for patients with DCM, whether they have high cholesterol or not," said Jeffrey Goldberger, MD, lead author and director of clinical cardiac electrophysiology at Northwestern. Dr. Goldberger said further study is needed to test this and to learn more about the other ways that statins may benefit the heart. The retrospective study examined data from 458 patients enrolled in the DEFINITE trial. Effects of Statin Therapy on Arrhythmic Events and Survival in Patients with Nonischemic Dilated Cardiomyopathy: a DEFINITE Substudy

Ablation Achieves Higher Success Rates Than Drug Therapy For Atrial Fibrillation
Ablation was found to be far more effective than anti-arrhythmic drugs (AAD) to treat atrial fibrillation in patients who had already failed at least one drug regimen. Ablation, a relatively non-invasive procedure to deaden tissue in the heart that disturbs its normal rhythms, had a 75 percent success rate in preventing arrhythmias; AAD alone had a six percent success rate. The randomized trial, the first to compare ablation and AAD, followed 112 patients at four centers worldwide for 12 months. Initially, approximately half the patients received ablation and half were treated with AAD. Thirty-seven patients in the AAD group joined the ablation group because of unacceptable control of their arrhythmia with drugs. "Patients for whom initial drug therapy is not effective should discuss with their doctors if ablation is a valid option," said Pierre Jais, MD, lead author and cardiologist, Haut-Leveque Hospital in Bordeaux-Pesssac, France.

Atrial Fibrillation Ablation vs. Antiarrhythmic Drugs: A Multicenter Randomized Trial
Cryoablation For Pulmonary Vein Isolation More Effective Than Mitral Valve Surgery Swedish researchers have found that pulmonary vein isolation (PVI) using epicardial cryoablation was more effective than mitral valve surgery (MVS) alone. Twenty-one out of 30 patients (70 percent) with permanent atrial fibrillation and who received MVS combined with epicardial cryoablation were able to restore and maintain normal heart rhythms for six months. Only 15 out of 35 patients treated with MVS alone maintained normal rhythms. Cryoablation uses freezing to destroy harmful heart tissues. Both patients and cardiologists were blinded to the randomized therapy. "Our study shows that using epicardial cryoablation for pulmonary vein isolation can be recommended as an adjunctive therapy for patients with permanent atrial fibrillation undergoing mitral valve surgery," said lead author and cardiologist Carina Blomstrom-Lundqvist, MD, PhD., University Hospital in Uppsala, Sweden.

Epicardial Pulmonary Vein Isolation for Permanent Atrial Fibrillation in Patients Undergoing Mitral Valve Surgery-A Randomized Double Blind Multicenter Study-the SWEDMAF Study
Dual-Chamber ICD Programming Found To Be As Safe As Single-Chamber Programming When using a programming feature to reduce the amount of right ventricular pacing, ICDs that paced both the upper and lower chambers of the heart did not pose safety risks for patients when compared to ICDs pacing only in the heart's lower chamber. This large prospective trial held at 108 sites worldwide randomized 988 ICD recipients to receive either single-chamber programming or dual-chamber programming. Only 32 out of 502 patients (6.4%) randomized to dual-chamber programming died or were hospitalized for heart failure during study follow-up, versus 46 of 488 (9.5%) patients randomized to single-chamber programming. "Our trial shows that dual-chamber programming can be as good as, if not better than, single-chamber programming for appropriate patients," said Brian Olshansky, MD, co-principal investigator and Director of Cardiac Electrophysiology, University of Iowa Hospitals. Dr. Olshansky said this trial refutes the notion that dual-chamber programming poses inherent safety risks and shows that the benefits of dual-chamber pacing could be provided in a majority of patients. Is Dual Chamber Programming Inferior to Single Chamber Programming in an Implantable Cardioverter Defibrillator? Results of the INTRINSIC RV Study

Lipid-Lowering Therapy Benefits ICD Patients With Coronary Artery Disease
Intensive lipid-lowering therapy significantly reduced recurrences of ventricular arrhythmias in ICD patients with coronary artery disease. Treatment with the drug atorvastatin (80 mg daily) resulted in a 59 percent reduction in the number of days that patients experienced an ICD intervention. Overall, 11 of 53 patients (21 percent) on atorvastatin had an ICD intervention over 12 months while 20 of 53 (38 percent) in the placebo group had an ICD shock. "This trial finds that a lipid-lowering therapy can be an effective treatment for patients with ICDs and who have coronary artery disease," said Johan De Sutter, MD, PhD, lead author and cardiologist, University Hospital Ghent in Ghent, Belgium. Intensive Lipid-Lowering Therapy and Ventricular Arrhythmias in Patients with Coronary Artery Disease and Internal Cardioverter Defibrillator Implants: the CLARIDI Trial

Ablation Reduces Therapy In Patients With ICDs for Prevention of Sudden Cardiac Arrest
Catheter ablation decreased appropriate ICD therapies by more than 50 percent in post-heart attack patients who received an ICD for the secondary prevention of sudden cardiac arrest. The study examined data from 64 control patients that received only ICDs and 62 patients who received ICDs and ablation. During two years of follow up, ICD therapy occurred in 20 control patients (31 percent) and 9 ablation patients (15 percent). ICD shocks were recorded in 16 control patients (24 percent) and five ablation patients (8 percent). "Our study shows that ablation does not have to be reserved for only patients with multiple ICD therapies," said Vivek Reddy, MD, lead author and electrophysiologist, Massachusetts General Hospital, Boston.

Final Results From the Substrate Mapping & Ablation in Sinus Rhythm to Halt Ventricular Tachycardia (SMASH VT) Trial


HEART RHYTHM 2006 is May 17-20 at the Boston Convention and Exhibition Center in Boston. The meeting is the most comprehensive educational event on heart rhythm disorders, offering over 400 educational opportunities in multiple formats and over 125 innovative products and services for the heart rhythm management field. The world's most renowned scientists and physicians will present a wide range of heart rhythm topics including advances in statins, cardiac resynchronization therapy, catheter ablation, cardiac pacing and heart failure and the latest technology, including state-of-the-art pacemakers and defibrillators.

For more information, please visit the Heart Rhythm Society website at

About the Heart Rhythm Society
The Heart Rhythm Society is the international leader in science, education and advocacy for cardiac arrhythmia professionals and patients, and the primary information resource on heart rhythm disorders. Its mission is to improve the care of patients by promoting research, education and optimal health care policies and standards. Incorporated in 1979 and based in Washington, DC, it has a membership of over 4,300 heart rhythm professionals in over 65 countries around the world.

Editor's Note: Please contact Rebecca Leaf at 202-745-5051 or [email protected] to receive complimentary registration to attend HEART RHYTHM 2006.

Last updated: 30 Apr 2016
Last reviewed: By John M. Grohol, Psy.D. on 30 Apr 2016
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