Breast Ultrasound Screening Marches into Practice
More states are pondering the legislative bandwagon mandating breast ultrasound screening for women with heterogeneous or dense breasts. While lawmakers debate the merits of ultrasound screening, some breast imagers are transitioning from handheld ultrasound screening to automated ultrasound systems to image women with heterogeneous or dense breasts.

Legislation spurs demand

Jefferson Radiology in Hartford, Conn., launched a breast ultrasound screening program in 2005, encountering a lukewarm reception. "Anecdotally, 5 to 10 percent of women wanted ultrasound screening prior to 2009," recalls Jinnah A. Phillips, MD, director of breast imaging.

However, in October 2009, Connecticut became the first state to pass breast density legislation, which requires providers to notify women if their mammogram reveals dense breast tissue. It also requires insurers to cover adjunctive testing, such as screening ultrasound or MRI for these women.

"After the law passed, we saw overwhelming demand," says Phillips. Within a few months of its passage, the practice had a backlog of more than 500 patients requesting ultrasound screenings. At that point, Jefferson Radiology added automated breast ultrasound screening to its handheld ultrasound screening program. To keep up with increasing demand, the practice would have had to eliminate other ultrasound studies. The automated breast ultrasound system provides the throughput to image 25 to 30 patients daily, says Phillips.

The automated screening model can succeed without legislation and reimbursement. Susan J. Ward, MD, radiologist with Renown Breast Health Center in Reno, Nev., decided to integrate automated ultrasound into practice after reviewing a study published in the European Journal of Radiology in March 2008, which showed breast ultrasound screening doubled the cancer detection rate among women with dense breasts compared with mammography.

In October 2010, the center installed an automated system while seeking to educate women and referring physicians about breast density and screening ultrasound. The practice modified its screening mammography patient letter to add information about breast density.

Dense Breast Legislative Update
Connecticut: Breast Density Inform law and insurance coverage for supplemental breast ultrasound screening as an adjunct to mammography (October 2009)
Illinois:
Insurance coverage for whole breast ultrasound screening as an adjunct to mammography (March 2009)
Texas: Breast Density Inform law * (September 2011)
Florida, New York: Pending Breast Density Inform * legislation
    *Breast Density Inform legislation requires providers to notify women of heterogeneous or dense breast tissue, but does not require payors to reimburse for the study.
    Source: Are You Dense? (www.areyoudense.com)
    "Patients and referring physicians were confused at first," admits Ward. "In the last six months, medical and popular literature have addressed the topic, and we've added posters and pamphlets. Now, women understand the importance of screening ultrasound."

    The effort led to a spike in ultrasound volume. In Nevada, where women pay out of pocket for the study, the practice has scanned 110 women since formally launching the program in November 2010. However, most studies were requested in the last six months.

    Ward estimates that half of the 10,000 mammograms she reads annually indicate heterogeneous or dense breast tissue. "I've been frustrated for a long time because you can only see so much on the mammograms in these cases." The challenge has been exacerbated by increasing constraints on screening MRI. Beginning in 2010, some payors started re-categorizing breast MRI as experimental for anyone with less than a 25 percent risk of breast cancer and tightened reimbursement parameters.

    Ultrasound can provide another screening option for women with dense or heterogenous breast tissue.

    Marla R. Lander, MD, a breast radiologist at Desert Comprehensive Breast Center in Palm Springs, Calif., participated in a three-year study that provided 3D ultrasound to women with breast density greater than 50 percent. "About 98 percent of women jumped on the screening opportunity when offered," she says.

    Plus, patients continue to return for ultrasound screenings. "Women like ultrasound because it is more comfortable [than mammography], and our discovery rate of cancer is higher. Women feel more secure with the additional study and referring physicians appreciate the supplementary coverage," she says.

    In the trial, Lander detected 30 cancers in 1,006 screening patients and 1,050 diagnostic patients using automated ultrasound from January 2005 to July 2007. She estimates that mammography would have detected three to six cancers in a similar screening cohort of 1,000 patients.

    Screening in practice

    Three dimensional breast ultrasound screening systems automate image capture and provide more consistent image quality than handheld studies. Studies depend less on the sonographer's skill and automation ensures the study covers every plane, says Phillips.

    At Jefferson Radiology, the automated protocol entails three views of each breast,  and the appointment is completed in 15 to 20 minutes. The software reconstructs the images into a cine loop or coronal reformats, with most experienced imagers completing review in three to seven minutes. Any findings are marked with annotations to provide a roadmap if a targeted diagnostic ultrasound is required.

    According to Lander, the learning curve for automated 3D ultrasound lasts one to three months, and may be associated with increased callbacks, which drop after the initial period.

    Other issues include efficiency glitches associated with hybrid ultrasound and multimodality workflow.

    Jefferson Radiology offers both automated and handheld ultrasound screening. Handheld studies are read from the PACS workstation, while automated scans are read at a separate workstation next to the PACS workstation. The radiologist reads ultrasound studies in conjunction with current and previous mammograms. "We're working with the ultrasound vendor to develop a more enterprise-friendly system. If it were web-based or thin-client, we could better distribute the screening workflow," shares Phillips.

    As pioneers refine their practices and lawmakers mull legislation, the automated screening breast ultrasound market could expand. Such systems offer a standardized, efficient model, enabling practices to tailor their breast imaging programs to population subsets.

    Automated Breast Ultrasound FAQs
    Q: How does practice decide when to shift from handheld to automated ultrasound?
    A: Practices need to consider how many time slots they want to give up for screening breast ultrasound. If handheld screening is monopolizing a room or sonographer, it may be time to look at an automated solution, says Jinnah A. Phillips, MD, director of breast imaging at Jefferson Radiology in Hartford, Conn.

    Q: What is the ideal interval for screening ultrasound?
    A: Researchers have not yet determined the ideal interval. Some women schedule a screening ultrasound followed by screening mammogram six months later, and undergo a screening MRI every two years. Others prefer to pair the screening ultrasound and screening mammogram in the same visit.

    Q: How can a practice maintain screening ultrasound efficiency?
    A: “We felt like we were re-inventing the wheel at first,” admits Phillips. Today, the practice treats ultrasound as screening mammography, batch-reading studies on an enterprise basis and utilizing a reporting system for both patients and referring physicians that mimics the screening mammography model. Workflows for the technologists have been optimized, and the practice is beginning to offer same-day mammogram and ultrasound screening to improve the efficiency of the process for patients.

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