Medical Device Daily Associate

A new software program released by St. Jude Medical (St. Paul, Minnesota) earlier this week gives clinicians the ability to provide their patients with the benefits of echocardiography when they come in to have their cardiac resynchronization therapy defibrillators (CRT-Ds) or implantable cardioverter-defibrillators (ICDs) evaluated, without the added time and expense of having to actually undergo an echocardiogram.

The FDA has approved the launch of QuickOpt Timing Cycle Optimization. This new programmer feature is designed to help physicians improve patient outcomes by providing a programmer-based optimization method that provides comparable results to echocardiography (echo).

The company said that in less than two minutes, the QuickOpt feature electrically characterizes the conduction properties of the heart and uses an exclusive algorithm to calculate the optimal timing values. This allows for efficient and frequent optimization during routine device follow-up visits. In comparison, a typical echo optimization procedure takes between 30 and 120 minutes and requires manual interpretation by a technician.

“This is the only way to optimize without doing an echo,” company spokesperson Kathleen Janasz told Medical Device Daily.

Janasz said that when a patient with a CRT-D or ICD device goes in for a regularly scheduled follow-up visit – which typically occurs every three months – the patient sits down next to the programmer and the physician then interrogates the device by holding a wand over it. The software then calculates the optimal settings for the individual patient.

With the push of a button, the physician can choose to accept the recommended settings for the device, or customize the settings based on the needs of the patient, such as the recent introduction of new medications that may need to be accounted for in the device algorithm.

The new program has been incorporated into the company's recently introduced universal Merlin patient care system programmer for its ICDs and pacemakers, approved by the FDA in April (Medical Device Daily, April 18, 2006).

Previous studies have shown that CRT and ICD patients can benefit from timing cycle optimization. However, the company noted, few patients undergo optimization because echo – the current clinical standard – can be expensive and time-consuming.

St. Jude said it developed QuickOpt optimization as an easy, practical and effective method for making the benefits of optimization more accessible to more patients.

“Many patients may not have their CRT device or ICD optimized, meaning that they recognize some benefits, but may not realize all of the benefits these sophisticated devices can deliver. In those patients, it's like running an air conditioner on a hot day with the windows open,” said Raffaele Corbisiero, MD, of the Deborah Heart and Lung Center (Browns Mills, New Jersey), investigator in the U.S. investigational device exemption clinical trial, and one of the first physicians to use the QuickOpt feature. “QuickOpt provides the accuracy of echo-based optimization without the clinic time it takes to schedule, perform and interpret an echo procedure.”

A recent IDE study demonstrated that QuickOpt optimization correlates consistently with echo-based optimization more than 96% of the time for both atrial-ventricular (AV/PV) timing and ventricular-ventricular (VV) timing.

For patients who believe they are not getting the most out of their CRT-D or ICD, a doctor today might order an echo to determine whether patients are getting the maximum benefit from their therapy and to reset. However, noted Janasz, for the patients who think they are getting the maximum benefit from their device and are not, doctors cannot arbitrarily order the expensive echo tests.

“[Patients] think that 'well, I'm better than I used to be so I guess I'm fine,' when in reality instead of being able to just walk around the block, they may be able to play tennis again.” She estimated that for CRT-D patients alone, roughly 80% have never had an echo, “and consequently, their devices may not be optimized.”

“As the only company to offer this feature to physicians and patients, our goal is to help ensure that all patients with devices can take advantage of optimization,” said Michael Coyle, president of St. Jude Medical's Cardiac Rhythm Management division. “QuickOpt has the potential to change clinical practice by providing patients and clinicians a fast, convenient and reliable way to quickly maximize the value of their devices, while potentially reducing healthcare costs.”

QuickOpt was developed over a period of about two years specifically because of physician requests, according to Janasz. She said they had expressed frustration that the echocardiography technology already was out there, but that they could not easily provide the benefits of it to all of their eligible CRT-D and dual-chamber ICD patients.

The company said the QuickOpt feature is compatible with all St. Jude Medical CRT-D and dual-chamber ICDs, including those that have been previously implanted prior to the availability of this new feature.

The company believes the new QuickOpt feature will help to boost sales of the company's CRM products.

“If you're a physician and you're having to decide [which devices to use]” said Janasz, “I can imagine that [this new feature] would be a significant factor in your decision-making.”