Over the past 30 years, no other area in medicine has undergone the revolution in fundamental care seen in the management of breast cancer. Acceptable options for local control have evolved, from the radical mastectomy to the modified radical mastectomy to the lumpectomy with or without radiation.^1-2 In the appropriate clinical context, patients are being presented with the option of sentinel-node mapping as an alternative to initial complete axillary-node dissection.^2-3

The single most important development stimulating these changes has been the development of screening mammography, with its ability to discover smaller, more curable, nonpalpable breast cancers.⁴ The primary diagnostician of breast cancer has therefore become the radiologist, and the cornerstone of any breast center model must be a high-quality, comprehensive breast-imaging center.

With increasing patient volumes in the United States, many health facilities are introducing new (or modifying current) breast-care delivery. This brings recognition to a facility, but the breast center must be designed efficiently in the context of a difficult economic climate in the United States that has forced some breast centers to close down.⁵

The five key imaging components to be considered in the implementation and design of a comprehensive imaging center are screening mammography, diagnostic mammography, ultrasound, intervention, and quality assurance (QA). Each component is as vital as the others, and a symbiotic and logical relationship between the components is critical for efficiency and the economic success of a breast imaging center.

THE SCREENING COMPONENT

Screening mammography is still the only proven preventative method of reducing breast cancer mortality.  The randomized Swedish two-county trial demonstrated a reduction in mortality of more than 40% in women aged 40-70. ⁴ A screening mammogram refers to a routine mammogram for a patient 40 or more years old who has no clinical concerns. Overcoming earlier and recent debates, many medical authorities and organizations now recommend annual screening mammography for women 40 or more years old. These organizations include the American College of Radiology (ACR), the American Cancer Society, and the American College of Surgeons.

With increasing awareness and the aging of the Baby Boomer population, the screening patient volume has increased significantly over the past quarter century in the United States, Canada, and other countries.  An efficient screening mammography program with positive revenue is essential for a successful breast-imaging center. Timely appointments, efficient patient flow, pleasant and sufficient support staff, and an acceptable recall rate are all key ingredients in the success of the screening component.⁶

Many analysts in the late 1980s and early 1990s supported the next-day batch reading of screening mammograms in an effort to be efficient, to enable double reading, and to improve scheduling. Many breast centers designed at that time were planned around that model.

Recent articles^7,8 have challenged this stance, with some breast centers offering online reading of screening mammograms. The advantages of online reading include the opportunity for prompt retakes when they are required by the radiologist for technical reasons, the reduction of patient stress created by waiting for the results, and the fulfillment of current Mammography Quality Standards Act (MQSA) requirements that all patients must know their results.⁹ Expenses are reduced because it is not necessary to mail results to the patients, because less staff time is spent chasing hard-to-reach and noncompliant patients for recalls, and because it minimizes the reregistering of patients. A disadvantage of online screening is that it occupies more radiologist time. Waiting times for the patients who present to the facility might be slightly longer because of the unpredictability of the schedule.

THE DIAGNOSTIC COMPONENT

Diagnostic mammography, in its essential form, refers to the mammogram of a patient with a problem. Ten percent or less of all screened patients will need recall for diagnostic workup.^10-11 Many women in the United States will, at some point in their lives, present with a breast concern (for example, nipple discharge, a lump, or tenderness). An efficient, revenue-generating diagnostic program is fundamental to the survival of any imaging center.

With health care becoming increasingly patient centered,12 the practice of having patients make repeated visits to the breast center for different components of the diagnostic workup is vanishing. It is vital for the image of the center and for optimal patient care that the different components of diagnostic breast imaging be in proximity to each other and readily available. These components include physical examination rooms, mammography units, dedicated breast ultrasound units, and interventional suites organized around efficient patient flow.

BREAST ULTRASOUND

Breast ultrasound is an integral component of a comprehensive breast-imaging center.^13,14 One of the primary benefits is the absence of breast exposure to ionizing radiation. The 2000-2001 Standard for the Performance of Breast Ultrasound Examination by the ACR recommends breast ultrasound as the initial modality of evaluation for women with breast masses who are pregnant, lactating, and/or less than 30 years old.¹⁵ The ACR and National Cancer Center Network guidelines¹⁶ also recognize other indications for breast ultrasound. It is indicated in the evaluation of certain screening-detected breast abnormalities, such as masses and asymmetric densities. Ultrasound is an appropriate adjunctive study to mammography in the evaluation of clinical concerns such as palpable masses, palpable thickening, and focal mastodynia in women aged 30 years or older. The ACR 2000-2001 Standard for the Performance of Ultrasound-Guided Percutaneous Breast Interventional Procedure recognizes that breast interventional procedures can be directed by ultrasound guidance,¹⁷ and that breast sonography is indicated in the evaluation of problems associated with breast implants.

Some centers are now using breast ultrasound in the screening of dense breast tissue,^18-22 evaluation of malignant versus benign solid masses,²³ evaluation for multifocal and multicentric disease,²⁴ detection of malignant axillary lymphadenopathy,²⁵ and even detection of mammographically guided clusters of microcalcifications.²⁶ Color and power Doppler are being researched at some facilities.¹³ Other uses for breast sonography will develop as the technology and resolution improve.

THE INTERVENTIONAL COMPONENT

The breast center that has available a platform of diverse interventional breast procedures optimizes patient care by improving clinical quality and decreasing psychological morbidity. Confidence increases in referring caregivers and patients, elevating the status of the breast center. Interventional breast services do generate significant revenue and help enable breast-imaging centers to survive economically.

In image-guided needle localization, radiologists guide and assist their surgical colleagues to improve accuracy during the excision of nonpalpable breast malignancies. These procedures can be done freehand or under mammographic, sonographic, or stereotactic guidance. Multiple wires bracketing a region sometimes further assist the surgeon. A critical preoperative communication between the radiologist and surgeon helps optimize patient care and team building. Specimen mammography should be encouraged with every needle localization. Other interventional services include image-guided cyst aspiration/pneumocystography, ductography, fine-needle aspiration (if cytopathologists are available), sentinel-node injection, and percutaneous guided abscess drainage.

Of all image-guided procedures, however, the core-needle biopsy remains the cornerstone of an interventional breast program. Technical issues such as approach, technique, complications, and postprocedural patient care are beyond the scope of this article, but the vital integration of a core-needle biopsy program into a comprehensive breast-imaging center deserves special attention.

CORE-NEEDLE BIOPSY

Empowered by improved imaging technology and image-guided needle biopsy, many women are saved the emotional and physical traumas of open surgical biopsy for benign diseases of the breast. A preoperative (needle) biopsy diagnosis of malignancy empowers the patient to become part of the decision-making process, helps reduce her number of breast surgeries, is cost-effective, and, in some cases, justifies axillary staging at the time of surgery.^27-29 Most breast centers are doing biopsies under sonographic or stereotactic guidance. MRI-guided core-needle biopsies are predominantly being done at academic centers in the United States.

Sonographically guided core-needle biopsies are a valuable source of revenue for a breast-imaging center. Sonographic guidance of breast biopsies is relatively easy to learn³⁰ and can be done in virtually any breast-care setting. From an economic standpoint, there is little overhead cost, the equipment and staffing required are minimal, and the procedure is relatively inexpensive for the patient. As an ultrasound-guided core biopsy typically takes less than 30 minutes, it can be added to a patient's visit without massively disrupting the schedule, avoiding rescheduling costs and enabling the facility to deliver efficient, high-quality patient care. These biopsies are done with the woman in a comfortable supine position, without added compression or radiation.

Stereotactically guided core-needle biopsies31 are typically reserved for impalpable lesions not visualized by sonography. This technique requires more training to learn and has a longer learning curve.³² The economic factors involved include larger overhead costs due to additional staffing requirements and space needs.

Stereotactic biopsies may be done with either upright or prone systems. The advantages of prone systems include that the patient does not have to see the needle, that the patient is already in a helpful position if there should be a vasovagal episode (such as loss of consciousness), and that most prone tables come equipped for digital imaging. Patients may experience minor neck discomfort, shoulder discomfort, or decreased finger circulation.

Lesions in the subareolar location, far posterior location, or axilla are not always amenable to prone stereotactic biopsy. Because of weight limits, the table is not available to heavier patients. In addition, prone systems usually require a dedicated room that serves no other purpose. This potentially idle time can be devastating in a tight medical economic climate. The typical cost of a prone table can range from $50,000 to $250,000, depending on the age of the equipment, whether or not the equipment is refurbished, and the number of technical options.

Upright stereotactic biopsy devices are an acceptable alternative to prone systems, especially in the setting of a low-to-medium volume breast imaging center. Upright stereotactically guided needle biopsies can be done on any size breast and any size patient as long as she can sit in a reclined chair. Posterior, subareolar, and axillary lesions can usually be successfully biopsied. Some centers are now offering the upright approach with the patient in a recumbent position.³³

Upright stereotactic biopsy equipment is less expensive than a prone system and is attached to standard mammography units; this avoids the need for the dedicated space of the prone system. Idle time is minimized because the upright biopsy apparatus is dismantled after procedures are complete, making the space available for mammography. Disadvantages include the possibility that the patient will see the needle during the procedure, patient discomfort, and increased vasovagal episodes.³⁴

THE QA COMPONENT

Quality assurance should be introduced at the birth of a breast center, when it has the most impact. It needs to be monitored and reinforced on an ongoing basis. An individualusually a technologistshould be assigned the responsibility of being in charge of quality assurance, and should receive the support and assistance of the medical imaging director. Time and space should be allocated for the QA to be effectively carried out. These requirements9 must be met annually for accreditation by the US Food and Drug Administration. The MQSA requirements are beyond the scope of this article and can be accessed through the web site www.fda.gov/cdrh/mammography/. Certain key issues are noteworthy regarding personnel, auditing, and guidelines development.

The MQSA currently requires physicians who interpret mammograms to read 480 studies per year. Most interpreting physicians are radiologists in the United States. There is increasing data indicating that performance is higher in radiologists who read a minimum of 2,500 mammograms per year.^35-36 At least two studies have compared community radiologists to expert breast imagers and have shown improved performance in dedicated breast radiologists.^37-38 Many breast imaging centers are staffed by dedicated breast radiologists,³⁹ or are attempting to recruit fellowship-trained breast radiologists. Realistically, many breast imaging centers will be continued to be staffed by general radiologists. Attempts to limit the number of radiologists reading mammograms in these facilities will help improve quality of interpretation and gain confidence in the facility from the referring physicians. The MQSA also requires interpreting physicians to have 15 hours of continuing medical education every 3 years to remain accredited.

In a breast-imaging center, a medical imaging director should be established.⁴⁰ This typically is the radiologist who champions excellence in breast imaging. This individual is the most trusted by the referring physicians and is considered most passionate and compassionate by colleagues and patients. The imaging director is responsible for establishing breast imaging algorithms and guidelines within the facility, and supervising the performance of the interpreting radiologists.

The MQSA requires technologists who do mammography to perform 200 studies every 2 years to remain accredited. The technologists are required to obtain 15 hours of continuing education every 3 years to remain accredited. Dedicated mammography technologists are ideal but may not be justified in low volume centers. Again, limiting the number of technologists doing mammography is a helpful compromise. In addition, a dedicated personusually a technologistshould be assigned for quality assurance.

AUDITING AND BENCHMARKS

Regular auditing in a mammography facility enables comparisons to national benchmarks and can be used as a teaching tool.⁴¹ Fundamental data that should be collected include cancer detection rates, recall rates, positive predictive value, tumor size, and axillary node involvement.⁴²

The cancer detection rate (cancers detected per 1,000 screened patients) ranges from 2-10 per 1,000. The prevalent cancers found per 1,000 first-time cancers range from 6-10 per 1,000. The incident cancers found per 1,000 follow-up cancers range from 2-4 per 1,000.43-44 If the number of cancers is less than 2 per 1,000, the sensitivity is suspect.⁴²

Recall rates from screening should be 10% or lower.^10,42 These can be higher in facilities where there is a higher prevalence of breast cancerseg, an older population, previous history of breast cancer, strong genetic risk. Aberrantly high recall rates reduce cost-effectiveness and credibility of the screening program.¹⁰ The individual audited recall rate should be compared to the group and used as an objective method to educate outliers.

The positive predictive value when biopsy is recommended mammographically should be documented. The accepted range is 25-40%.^11,45 In addition, with the use of core biopsy in a breast program, a goal for the true positive surgical biopsy rate is 50%, with two centers reporting a 1.5:1 ratio and 1.6 ratio of open surgical biopsy/carcinoma ratio.⁴⁶

Breast cancer mortality is directly related to tumor size.⁴⁷ Therefore, a goal of screening is to detect smaller, nonpalpable tumors. In several series, more than 50% of detected cancers diagnosed by mammography were stage 0 or 1. Many series also have shown that more than 30% of screening-detected cancers diagnosed by mammography were minimal cancers (ie, invasive cancers <=1 cm or ductal carcinoma in situ).^10,41,42,48

Breast cancer mortality is also proportional to axillary node involvement at the time of surgical staging.⁴² Therefore, a goal of screening is to detect node-negative nonpalpable breast cancers. In several series, the rate of lymph node involvement has been less than 25% of screen-detected cancers.^10,41,42,48

The screening data should not be confused with diagnostic statistics. Recall rates and recommendations for biopsy will be inherently higher in the diagnostic population than the screening population.

GUIDELINES DEVELOPMENT

Under the supervision of the medical imaging director,⁴⁰ guidelines should be instituted at each facility for defining the screening population, the workup of abnormal screening mammograms, indications for diagnostic mammography, indications for breast ultrasound, and indications and methods of image-guided percutaneous needle biopsy. Internal auditing can then ascertain how much these guidelines are adhered to. The work of Katterhagen et al shows cost, savings, and improvement of outcomes from the institution of guidelines in a community-based breast center.⁴⁹

In a breast imaging center, the data collected regarding the screening population can be used as a springboard to monitor clinical guidelines by surgeons and oncologists. These guidelines should be developed under the supervision of the medical clinical director. The lumpectomy vs mastectomy rate can be readily monitored. Some authors advocate a lumpectomy rate of more than 60%.³⁹ The rate of specimen mammograms received for lesions surgically excised after preoperative needle localization also can be evaluated. Some authors advocate specimen mammography after every preoperative needle localization.⁵⁰

ANCILLARY IMAGING COMPONENTS

Ancillary imaging is being used increasingly to help optimize patient management. Staging, in this context, may use modalities such as body ultrasound, CT, MRI, and nuclear medicine (including positron-emission tomography). While these modalities are showing increasing promise in breast-cancer staging and management, equipment and overhead costs can be relatively expensive, compared with more common breast-imaging modalities. While it is optimal to ensure that patients who require these modalities have access to them, the majority of breast-imaging centers in the United States do not routinely incorporate this equipment. Often, general radiology departments provide these services.

CONCLUSION

The power of screening mammography, with its ability to discover smaller, more curable nonpalpable cancers, empowers women with more options than ever before for the management of breast cancer. With this revolution, the radiologist has now evolved into the primary diagnostician of breast cancer, and the foundation of any breast center model must be a high-quality comprehensive breast-imaging center. The five essential components of a state-of-the-art comprehensive breast imaging center are screening mammography, diagnostic mammography, breast ultrasound, intervention, and quality assurance.  By understanding these fundamental building blocks, breast-imaging centers can be designed that offer efficient patient flow and care while optimizing efficiency and revenue. The breast-imaging center represents a valuable entry point for the multidisciplinary care of women with breast cancer.

NOTE: The references for this article are available in the online version at www.imagingeconomics.com.

Jay R. Parikh, MD, is medical director, Interventional Breast Imaging, Swedish Breast Care Centers/WDIC, Swedish Medical Center, Seattle. The author wishes to thank Claudia Z. Lee and G. William Eklund for their help in preparing the manuscript.

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