Siemens Medical Solutions (Malvern, Pennsylvania) unveiled its newest device for the electrophysiology lab at the scientific sessions of the Heart Rhythm Society (HRS; Washington) in Denver last week. With the roll-out of syngo DynaCT Cardiac, it billed the system as potentially rendering obsolete the pre-procedural computed tomography (CT) and MRI scanning procedures currently used, and necessary, prior to treating such conditions as atrial fibrillation (AF).

The syngo DynaCT has FDA clearance, but the company is conducting additional trials of the system before it is offered for clinical use, according to Regina Radtke, senior director of product marketing for cardiology at Siemens, speaking last week from the conference.

She said that commercial roll-out is targeted for a November/December timeframe.

The major benefit of syngo DynaCT Cardiac is that it will enable imaging of the heart directly in the electrophysiology (EP) lab, without the additional time for full CT scans.

"We're launching basically a new product that we've gotten a lot of traffic for, because it really does change the workflow of a typical procedure — and it's already generating some interest," Radtke told Medical Device Daily.

While the system has the term "CT" in the name, Radtke described the images it produces as "CT-like," and not having the same resolution as a typical CT scan.

"If you look at a typical AF procedure and the [imaging] technology [needed], it's really not [designed] to get so much detail," Radtke said. She said that what clinicians are most interested in "is the gross anatomy of the left atrium, obviously, and the pulmonary vein," as well as the location of the esophagus.

The syngo DynaCT has been used for about two years for neural radiology, where the "ability to do a quick spin with the angiography systems and see if there's any bleeding, for example," and there it is "clinically a very good tool," Radtke said.

"We're hoping to use the same concept in a cardiac application," she said. "Of course, going from a static anatomy to a beating heart is always somewhat challenging, so it's taken a couple of years to do that."

The primary advantage of syngo DynaCT Cardiac to the electrophysiologist is that, with it, a scan can be completed in real-time on the day of the procedure and so more immediately capture the movement of the heart and blood flow volume, with changes in these significantly impacting a doctor's decisions if performing an ablation, for example.

"Pulmonary veins actually can change in perspective" within a day, so the real-time image is designed to provide "more accuracy" for doctors planning a procedure, Radtke said.

"That's really our goal, and we're hoping that with all the clinical testing that we're doing between now and November, that we can prove that statement," she said.

This immediacy is in contrast to the normal procedure of doing CT or MRI scans the day before the procedure and the significant amount of time those procedures take. Radtke said a typical CT scan, for instance, can take from two to six hours.

Siemens also said that during an interventional procedure, moving the patient out of the sterile environment and onto a CT scanner not only is cumbersome, but can pose a "risk of complications."

The syngo DynaCT Cardiac device works in conjunction with fluoroscopy, or with the angiography system, which at Siemens is the Axiom Artis family of imaging devices. Radtke said the systems can be set up in any configuration, including "floor-mounted, ceiling-mounted or even a biplane system."

Essentially, in rotational angiography, the device would "spin around the patient and receive the data set that you would need to create the 3-D model" using the syngo DynaCt device.

Whether it's a small or large model affects what type of image can be gleaned.

"Electrophysiology is sort of half-half," she said. "Some go with the smaller detector — some go with the larger."

Those doctors choosing a smaller detector would only be able to view an image of the left atrium.

"Having said that, if you look at electrophysiologists that do AF, which is the majority, that's all they need," Radtke said.

Siemens said that electrophysiology is the fastest growing of all cardiovascular disciplines for dealing with arrhythmia, with about 550,000 new patients diagnosed with cardiac arrhythmias in the U.S. each year.

"Syngo DynaCT Cardiac brings a whole new level of efficient, integrated workflow to the EP lab to meet the increasing demand to diagnose and treat patients with cardiac arrhythmias," said Claus Grill, VP, Angiography, Cardiac and X-ray Systems at Siemens Medical Solutions.

Amin Al-Ahmad, MD, assistant professor of cardiovascular medicine at Stanford University Medical Center (Palo Alto, California), added in a statement: "Syngo DynaCT Cardiac has the potential to revolutionize imaging and interventional practices in the cardiac EP lab.

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