Toshiba America Medical Systems Inc.’s
Infinix 4D CT at the CARTI Cancer Center

Faster technology, stricter regulations are taking CT to the next level

September 23, 2016
by Lauren Dubinsky, Senior Reporter
It used to take Dr. David Hays of CARTI Cancer Center in Little Rock, Arkansas, an hour to perform an interventional radiology procedure, but that’s been cut down to 12 minutes, thanks to the center’s new 4D CT system. In late May, CARTI became the first facility in the U.S. to acquire Toshiba America Medical Systems Inc.’s Infinix 4D CT. The system merges the Infinix-i angiography system and the Aquilion ONE ViSION Edition CT scanner.

Hays can now use CT to visualize hepatoma embolization procedures and confirm that the treatment is hitting the right areas. He can also guide catheters into the vessels with the angiography system’s 3-D road map. “There is a path and all I have to do is push my needle down that line and I go right to it,” said Hays. “It takes what I used to be really good at doing and makes it so almost anyone can do it.”

One of his patients had a metastatic lesion in her liver in a location that was very difficult to access. Previously, he would have passed the needle through the lung and diaphragm to reach the liver, which could lead to complications. With the Infinix 4D CT, he was able to bypass the lung and diaphragm and place the needle directly through the liver.

Dual-source CT
Another popular technology is dual-source CT, according to MD Buyline. Siemens Healthineers’ SOMATOM Force is currently the only system on the market. It has two X-ray tubes and two detectors, which makes it much faster than conventional systems. There has been particular interest in using it for cardiac and pediatric imaging. “From a cardiac standpoint, it’s all about trying to stop cardiac motion and having the fastest temporal resolution possible,” says Christine Ziemba-Landon, CT product marketing manager at Siemens.

When you have one X-ray source spinning, you can only spin it so fast and it results in slow temporal resolution. The SOMATOM Force has two Vectron X-ray tubes spinning simultaneously, which cuts the temporal resolution to 66 milliseconds — the industry’s gold standard. Many patients entering the emergency department can’t hold their breath or don’t understand the breathing instructions. With the Force, it only takes one second to scan the chest, abdomen and pelvis, and that significantly reduces breath-hold times for patients.

Before a CT exam, some children have to be sedated because they are frightened by large pieces of equipment. But it’s a controversial practice. New research shows that sedation can cause long-term negative effects in children, says Ziemba-Landon. The Force can scan a child in less than a second, which eliminates the need for sedation. The system also has new X-ray tube technology. It has plenty of mA available as the Vectron tube allows clinicians to use low kV imaging, even on adult patients.

Traditionally, 70kV has been used primarily on pediatric patients because the conventional X-ray tubes didn’t have enough mA to accommodate older patients. But the Force has 2,600 mA combined, which allows clinicians to image adult patients at 70, 80 and 90 kV.

XR-29, also known as the Medical Imaging and Technology Alliance (MITA) Smart Dose, was put into place in 2014. As of Jan. 1, 2016, services performed on noncompliant CTs are reimbursed with a 5 percent reduction, and in 2017 reimbursement will be cut by 15 percent. The penalties only apply to the technical component and only affect Medicare and outpatient facilities — not hospital inpatient settings. The facilities have to comply with four criteria to avoid a reimbursement cut.

The scanners must be able to notify the user about potential over-radiation and document it as well as capture and report the dose information in a consistent manner. Pediatric and adult reference protocols need to be in place and the X-ray tube current must be regulated based on the region of the body that is scanned. “I think it has caused financial discomfort for some hospitals,” says Keith Mildenberger, CT product manager at Neusoft Medical Systems USA Inc. “There was a feeling by many in the diagnostic imaging community that the deadline for compliance would be delayed by CMS.”

Because of that, many hospitals didn’t budget for their systems to be replaced or upgraded, and as a result, were not prepared for the deadline. Mildenberger believes that the biggest impacts will come when hospitals realize that the used equipment they purchased that was promised to be compliant, actually isn’t. They may also find out that the “NEMA XR-29 compliance solution” from a third-party company “doesn’t pass muster with CMS.”

The FDA has not yet explicitly stated that regulatory clearance is a requirement for third-party XR-29 solutions. However, Medic Vision’s SafeCT-29 is the one solution on the market that scored FDA approval. When faced with the decision to purchase a new CT or retrofit an existing CT, it depends on the facility, says Judith Schmalzing, CT product marketing manager at Siemens.

If a hospital has multiple scanners and some are compliant, they can operate in that environment, but they need to triage their Medicare patients to the compliant CTs. “We advise our customers that it makes sense to upgrade their entire fleet because triaging patients can result in an administrative nightmare for hospitals, because they have to change their workflow,” says Schmalzing.

Mildenberger says that if a hospital’s Medicare outpatient business doesn’t make up a significant amount of the payor mix, then it might not make sense to upgrade, from a financial perspective. Most Siemens customers have invested in its Evolve program, which updates the hardware and software during the life of the scanner. The company upgraded those CTs to make them compliant with the requirements. But for the older CT technology, some of the features are not available. Those facilities have the option to acquire software solutions from a third-party company, but Siemens doesn’t recommend it.

“It remains unclear about how they interact with the OEM software,” says Schmalzing. “Some third-party solutions only can achieve a portion of the four XR-29 requirements.” For GE Healthcare’s CT installed base, 75 percent of the systems were brought into compliance with the XR-29 standards with a free software update. The remaining 25 percent of the systems were not able to be upgraded because they were on average over 12 years old.

“If budgets/capital expense plans permit, replacement is the preferred option, as it offers additional clinical, operational and financial benefits over these older CT systems,” says Scott Merriman, region product marketing manager at GE. “However, we realize capital budgets are often limited, so we have developed different financing (lease/loan) packages to provide options to address this need.” If replacement is not an option, Merriman cautions that it’s important for the facility to only consider purchasing an FDA-cleared, third-party solution, as well as the workflow, administrative and service implications associated with the solution.

Most facilities have chosen to retrofit their scanners, but there were quite a few that did make new purchases, says Cris Bennett, clinical analyst at MD Buyline. “A lot of hospitals saw it as a way to buy a new system,” he adds. “That way they can make that capital purchase to help out their bottom line with a faster scanner and [also] be compliant to get their reimbursement rate.” In addition, there is some compelling functionality on newer CT scanners that might actually improve the hospital’s business, says Mildenberger. “Systems are much faster and workflow often is more flexible, so there are definite efficiencies to be realized,” he adds.

Monitoring radiation dose
In January 2015, The Joint Commission started requiring facilities to focus on monitoring and reducing radiation dose. WellStar Health System in Georgia took that seriously. “The most important reason to do it is patient care,” says Kelly Golkin, medical imaging CT clinical specialist at WellStar. “In addition, it allows you to identify the areas that may benefit from process reform.” WellStar performs over 175,000 CT exams per year and Golkin has to review them once a month. A dose report for one of the 16 locations could be over 1,500 pages.

Previously, Golkin would identify the protocols that were out of line and put them in an Excel spreadsheet. She would then go to the PACS system to look at the images and then to the EMR system to find out the patient’s BMI. That process took her a week. But Well-Star recently implemented Philips Healthcare’s DoseWise dose management program and she’s now able to do that in one day. The program automatically separates the exams that exceed the set dose level and places them in a notification category. Golkin then retrieves patient information and reviews the exams.

The American College of Radiology defines the average patient as 5-foot-7 and 154 pounds, but that is not consistent with the patient population in some states. Golkin decided to develop appropriate reference levels for patients with higher BMIs at WellStar. “This regulation has affected CT more than any other mandates in the last decade,” says Golkin. “But the point of it is not that it makes you in compliance, it’s that it really does help the patients.”

GE Healthcare partnered with the University of Wisconsin School of Medicine and Public Health in 2012 to reduce CT dose, acquire more clinically useful images and lower the amount of repeat scans. In order to do that, they developed a set of protocols that cover most clinical indications including neuro, MDK, chest, body, vascular and pediatric.

The GE engineers and hospital staff adjusted the type, amount and timing of oral and intravenous contrast, and also modified patient positioning and scan reconstruction parameters to optimize each protocol. At many hospitals, the technologist has to arbitrarily modify the protocol based on the patient’s weight or BMI. With UW’s new protocols, the technologist chooses the protocol that’s tailored for the patient’s body size and proceeds with the scan. Over the past few years, the focus in CT has shifted from increasing the number of slices and getting better resolution to ensuring the diagnosis is accurate and done with the appropriate dose.