FOR IMMEDIATE RELEASE
Contact: Kennesha Baldwin
Heart Rhythm Society
(202) 464-3476
kbaldwin@HRSonline.org

Cindy Rahman: (703) 283-8499
Heart Rhythm 2011 Press Room: (415) 978-3514 (this phone number active through Saturday, May 7, 1:00 p.m. PT)

Late-Breaking Clinical Trial Results Announced at Heart Rhythm 2011: Risk Stratification and Therapy Selection in Brugada Syndrome – the PRELUDE Registry
Multi-center, prospective study confirms lack of predictive accuracy of VT/VF inducibility and identifies novel risk indicators for arrhythmic events in Brugada patients

SAN FRANCISCO, May 5, 2011 — Results of a large multi-center experience found a ventricular effective refractory period of <200 ms and QRS fragmentation to be significant and independent predictors of arrhythmias in Brugada syndrome. The PRELUDE registry, a late-breaking clinical trial presented today at Heart Rhythm 2011, the Heart Rhythm Society’s 32nd Annual Scientific Sessions, adopted for the first time a standardized programmed electrical stimulation protocol to test ventricular tachycardia/ventricular fibrillation (VT/VF) inducibility accuracy, and other predictors of cardiac events in a prospective fashion. While the predictive accuracy of VT/VF inducibility in Brugada syndrome has been debated for several years, results of this study showed that VT/VF inducibility is not a predictor of arrhythmic events. Download PRELUDE abstract (PDF, 9K) »

The prospective study included 308 individuals, enrolled in 41 electrophysiology centers in Italy, who had a type I electrocardiogram (ECG) and did not have a history of cardiac arrest. During an average follow-up of 34 months, 14 arrhythmic events (4.5 percent) occurred, with 13 patients experiencing appropriate shocks and one patient being resuscitated from sudden cardiac arrest. Traditionally, VT/VF inducibility is widely used to select patients with Brugada syndrome to receive a prophylactic implantable defibrillator. However, in the results of the PRELUDE registry nine of the 14 patients were non-inducible, revealing that VT/VF inducibility during programmed electrical stimulation is not predictive of cardiac events.

“Our study, which is the largest experience using a standardized inducibility protocol to date, aimed to assess the predictive accuracy of VT/VF inducibility and to identify additional predictors of arrhythmic events in Brugada syndrome,” said Carlo Napolitano, MD, Ph.D., of IRCCS Fondazione Maugeri in Pavia, Italy and New York University School of Medicine. “While our observations show that VT/VF inducibility was not a predictor of arrhythmic events in this patient group, we provided demonstration that QRS fragmentation and a ventricular refractory period can be considered novel robust risk stratification metrics.”

A ventricular effective refractory period <200 ms and QRS fragmentation were identified as two new significant and independent predictors of arrhythmic events in Brugada syndrome within a large cohort of patients prospectively investigated. Furthermore, a multivariate survivorship analysis reconfirmed the prognostic value of current known markers, the presence of spontaneous type I ECG and a history of syncope, by showing an increased risk of arrhythmic events.

Correct classification of subjects at risk of life-threatening arrhythmias is extremely important in Brugada syndrome. No pharmacological therapy is available and individuals identified at “high-risk” should receive an ICD.

Session details:
“Late-Breaking Clinical Trials” [May 5, 2011, 10:30 a.m. – 12:00 p.m., Moscone South, Room 305]

About Heart Rhythm 2011
Heart Rhythm 2011 takes place May 4-7, 2011 at the Moscone Center in San Francisco, CA. The Society's Annual Scientific Sessions is the most comprehensive educational event on heart rhythm disorders, offering more than 250 educational opportunities in multiple formats. The world’s most renowned scientists and physicians will present a wide range of heart rhythm topics including cardiac resynchronization therapy, catheter ablation, cardiac pacing and heart failure as well as the latest technology, including state-of-the-art pacemakers and defibrillators.

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 more than 5,300 heart rhythm professionals in more than 70 countries around the world.