A Medical Device Daily

Sorin Group's (Milan, Italy) Cardiac Rhythm Management business unit reported the first patient enrollment in the BITAC (BIventricular TAchycardias Outcome in CRT-D Patients) clinical study.

The purpose of the BITAC study is to assess the incidence of slow ventricular tachycardias (VTs) in heart failure patients implanted with cardiac resynchronization therapy (CRT) devices, as well as the clinical relevance of treating slow VTs during a two-year follow-up period. The principal investigator for the study is Alexander Bauer, MD, of University Hospital of Heidelberg (Heidelberg, Germany).

The study will enroll more than 400 patients across Europe, with enrollment anticipated to be completed by the end of 2007.

The first patients to be enrolled were implanted with Sorin Group's Ovatio CRT, the world's smallest CRT-D (cardiac resynchronization therapy plus defibrillator). The device includes the Brady Tachy Overlap function, which allows the setting of low-rate detection zones for slow VTs, while still allowing pacing and delivery of resynchronization therapy during patient exercise.

The implants were performed at the St. Adolf-Stift Hospital (Reinbek, Germany) by Dr. Herbert Nagele, MD, senior assistant medical director, and at the Hospital Fernando Da Fonseca (Amadora, Portugal) by Francisco Madeira, MD, assistant cardiologist and electrophysiologist, and by Pedro Cunha, MD, assistant cardiologist in the pacing and arrhythmia unit.

Madeira commented: “This important study will give physicians better insight into the management of slow VTs for heart failure patients. It will be of particular interest because, until today, technology limitations restricted our ability to monitor and treat slow VTs in HF patients without compromising the delivery of cardiac resynchronization therapy.”

Sorin said sub-analysis of studies performed in a general implantable cardioverter defibrillator (ICD) population has shown that slow VTs (lower than 150 beats per minute) are more prevalent and have more serious consequences in those patients with depressed ventricular function.

The BITAC study specifically aims to address the clinical relevance of slow VTs in a heart failure population and to offer physicians better insight on how to improve the management of ventricular arrhythmias in CRT-D patients.

Patients included in the multi-center study have advanced heart failure and are at increased risk of sudden cardiac death (SCD). Heart failure affects about 10 million Europeans. CRT devices deliver pacing impulses to the heart muscle to resynchronize the contractions of the ventricles and thus increase cardiac pump efficiency.

Since heart failure patients are up to nine times more likely to suffer SCD than the general population, combining CRT with an implantable defibrillator can be life-saving for these patients.

QuickOpt is launched in Europe

St. Jude Medical (St. Paul, Minnesota) last week reported the clinical trial results, receipt of European CE-mark approval and European market launch of its QuickOpt Timing Cycle Optimization.

The trial results were presented by James Porterfield, MD, principal investigator in the trial conducted under an FDA Investigational Device Exemption (IDE), during a late-breaking clinical trial session at Cardiostim 2006 in Nice, France.

The IDE study found that QuickOpt optimization consistently was comparable to a traditional echocardiography procedure for determining optimal conduction delays. QuickOpt procedures in the study were completed within two minutes, while echo optimization typically takes between 30 and 120 minutes and requires a manual investigation by a technician.

Results showed QuickOpt optimization correlated consistently with echo more than 96% of the time for both atrial-ventricular (AV) timing and for ventricular-ventricular (VV) timing. The study endpoint required a correlation greater than 90%.

The prospective, multicenter trial evaluated 115 cases, including heart failure and traditional ICD patients. All patients were implanted with St. Jude Medical dual-chamber implantable cardioverter defibrillators (ICDs) or cardiac resynchronization therapy defibrillators (CRT-Ds).

Patients were evaluated using echocardiography to determine the optimal setting for synchronizing the rhythm of the upper chambers (atria) and lower chambers (ventricles) of the heart, and for properly timing the pumping of the right and left ventricles. Patients then underwent the same testing using the QuickOpt optimization feature.

“My initial experience with QuickOpt is impressive, consistently recommending similar programming when compared to echo. It is a fast and simple way to optimize timing, which has been shown to contribute to improved left ventricular performance,” said Peter Sogaard, MD, of Gentofte University Hospital (Hellerup, Denmark), who was among the first to use the QuickOpt feature.

St. Jude said that because echo can be expensive and time-consuming, most heart failure patients do not undergo timing cycle optimization. But it said QuickOpt optimization “allows efficient and frequent optimization during routine device follow-up visits.”

The QuickOpt feature is compatible with all St. Jude Medical multi-chamber ICDs.

U.S. lab firm adds European network

LabConnect (Seattle) said that Synevo-Medicover Laboratory Services (Bucarest, Romania) has signed a definitive agreement to join the LabConnect network, resulting in LabConnect becoming the first U.S.-based central laboratory with a presence in Central and Eastern Europe.

Synevo-Medicover Laboratory Network is Central and Eastern Europe's largest laboratory services provider. It has 23 facilities and more than 650 employees.

LabConnect and Synevo will jointly provide centralized laboratory services for the European continent from laboratories based in Poland and Romania.

“We're currently managing several global projects with Synevo and we're betting that our clients will increasingly seek out Central and Eastern European investigator sites. Sites in the region are well-known for their recruitment success combined with high-quality and cost-effective research,” said LabConnect President and CEO Eric Hayashi.

Synevo is the laboratory diagnostics division of Medicover (Luxembourg), the leading private healthcare provider in Central and Eastern Europe.

Piper Jaffray sets London conference

Piper Jaffray Ltd. (London) will be holding its first London Health Care Conference this Thursday and Friday in the UK. The conference will feature presentations by management teams in the medical technology and biopharmaceutical and industries from both Europe and the U.S.

CEO David Wilson said, “The conference includes a very strong lineup of leading biopharmaceutical and medical technology companies that will provide clients updated insight on current and new trends in the industry.”

Nearly 70 companies are scheduled to present at the London Health Care Conference.