QuickOpt optimizes cardiac resynchronization therapy in under two
20 June 2006
Nice, France. A clinical trial of St Jude Medical's
(NYSE:STJ) QuickOpt timing cycle optimization feature for its implantable
defibrillators found that it was consistently comparable to a traditional
echocardiography (echo) 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.
The trial results were presented by
James G. Porterfield, M.D., principal investigator in the trial conducted
under a U.S. Food and Drug Administration (FDA) Investigational Device
Exemption (IDE), during a late-breaking clinical trial session at Cardiostim
2006 in Nice, France.
Results showed QuickOpt optimization correlated
consistently with echo more than 96 percent of the time for both
atrial-ventricular (AV) timing and for ventricular-ventricular (VV) timing.
The study endpoint required a correlation greater than 90 percent.
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 echo 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
"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 Dr. Peter Sogaard of Gentofte
University Hospital in Hellerup, Denmark, who was among the first to use the
Because echo can be expensive and time consuming, most
heart failure patients do not undergo timing cycle optimization. QuickOpt
optimization, which takes less than two minutes, allows efficient and
frequent optimization during routine device follow-up visits, and is now
clinically proven to be as effective as echo-based optimization.
is to provide patients and physicians with easier access to AV and VV timing
optimization," said Michael J. Coyle, president of St. Jude Medical's
Cardiac Rhythm Management Division. "With the QuickOpt feature, optimization
can be performed quickly as part of the normal in-office follow-up visit,
which should result in a greater percentage of patients undergoing
optimization of timing intervals than when they need to be scheduled for a
separate echo study."
Other previously published studies, including a
prospective pilot study and a retrospective study comparing optimization
methods, had findings similar to the clinical trial results. Several studies
have evaluated the benefits of optimized cardiac device programming, showing
improved quality of life and improvements in heart failure class (as
measured by New York Heart Association standards) for patients.
Medical has filed a pre-market approval (PMA) supplement application with
the FDA for programmer software with the QuickOpt feature. The FDA is
currently reviewing the QuickOpt optimization clinical trial results and the
The QuickOpt feature, available outside the United
States on the St. Jude Medical Merlin(TM) Patient Care System and 3510
programmer, quickly provides information on a results screen. Clinicians can
then accept or modify the recommended results and program the device
accordingly. The QuickOpt feature is compatible with all St. Jude Medical
St. Jude Medical, Inc. also announced receipt of European CE Mark
approval and the European market launch of its QuickOpt Timing Cycle