“Real-World” ICD Benefit Displayed In Boston Sci Latitude Network Data

Full article reprinted from "The Gray Sheet" - May 18, 2009

New "real-world" data affirming the long-term benefits of implantable cardioverter defibrillators for heart failure patients highlighted the late-breaking trial sessions of the Heart Rhythm Society's 2009 conference in Boston last week. Find out more...

“Real-World” ICD Benefit Displayed In Boston Sci Latitude Network Data

Full article reprinted from "The Gray Sheet" - May 18, 2009

cardioverter defibrillators for heart failure patients highlighted the late-breaking trial sessions of the Heart Rhythm Society's 2009 conference in Boston last week.

On May 13, lead investigator Leslie Saxon, M.D., University of Southern California, presented data from ALTITUDE, an observational study designed to address prospectively defined questions with data collected from implantable devices linked to Boston Scientific's Latitude remote-monitoring network.

The purpose of ALTITUDE was to collect outcomes data for heart-failure patients with implantable defibrillators in actual clinical practice, Saxon explained at a press briefing at the HRS conference. ALTITUDE includes data from about 85,000 patients. By comparison, the major randomized clinical trials of ICDs and cardiac resynchronization therapy in heart failure patients completed in 2003 and 2004 - MADIT-II and SCD-HeFT and COMPANION - enrolled only about 5,300 patients in total (¹"The Gray Sheet" Sept. 20, 2004, p. 17).

Large data sets collected by remote-monitoring networks like Latitude may "redefine how we're going to be looking at outcomes in these large populations," Saxon said. "Clinical trials are essential and won't go away, but these data sets are very rich and reflect practice and outcomes in most patients who are receiving the devices. And we need to pay attention to that."

Biotronik (Home Monitoring), St. Jude Medical (Merlin.net) and Medtronic (CareLink)also maintain networks that remotely monitor and collect data from implanted cardiac devices.

Latitude began collecting data from new Boston Scientific implantable cardiac management devices in 2006, but some older devices implanted as early as 2003 are now transmitting data to the network. ALTITUDE includes about 47,000 patients with regular ICDs and 38,000 with cardiac resynchronization devices with defibrillation capabilities (CRT-D).