Timeliness of Breast Diagnostic Imaging and Biopsy in Practice: 15 Years of Collecting, Comparing, and Defining Quality Breast Cancer Care.

BACKGROUND: The literature lacks well-established benchmarks for expected time between screening mammogram to diagnostic imaging and then to core needle breast biopsy. METHODS: Timeliness of diagnostic imaging workup was evaluated using aggregate data from 2005 to 2019 submitted to The National Quality Measures for Breast Centers (NQMBC). RESULTS: A total of 419 breast centers submitted data for 1,805,515 patients on the time from screening mammogram to diagnostic imaging. The overall time was 7 days with 75th, 25th, and 10th percentile values of 5, 10, and 13.5 days, respectively. The average time in business days decreased from 9.1 to 7.1 days (p < 0.001) over the study period with the greatest gains in poorest-performing quartiles. Screening centers and centers in the Midwest had significantly shorter time to diagnostic imaging. Time from diagnostic imaging to core needle biopsy was submitted by 406 facilities representing 386,077 patients. The average time was 6 business days, with 75th, 25th, and 10th percentiles of 4, 9, and 13.7 days, respectively. Time to biopsy improved from a mean of 9.0 to 6.3 days (p < 0.001) with the most improvement in the poorest-performing quartiles. Screening centers, centers in the Midwest, and centers in metropolitan areas had significantly shorter time to biopsy. CONCLUSIONS: In a robust dataset, the time from screening mammogram to diagnostic imaging and from diagnostic imaging to biopsy decreased from 2005 to 2019. On average, patients could expect to have diagnostic imaging and biopsies within 1 week of abnormal results. Monitoring and comparing performance with reported data may improve quality in breast care.

A Three-Dimensional Bioabsorbable Tissue Marker for Volume Replacement and Radiation Planning: A Multicenter Study of Surgical and Patient-Reported Outcomes for 818 Patients with Breast Cancer.

BACKGROUND: Accurate identification of the tumor bed after breast-conserving surgery (BCS) ensures appropriate radiation to the tumor bed while minimizing normal tissue exposure. The BioZorb® three-dimensional (3D) bioabsorbable tissue marker provides a reliable target for radiation therapy (RT) planning and follow-up evaluation while serving as a scaffold to maintain breast contour. METHODS: After informed consent, 818 patients (826 breasts) implanted with the BioZorb® at 14 U.S. sites were enrolled in a national registry. All the patients were prospectively followed with the BioZorb® implant after BCS. The data collected at 3, 6, 12, and 24 months included all demographics, treatment parameters, and provider/patient-assessed cosmesis. RESULTS: The median follow-up period was 18.2 months (range, 0.2-53.4 months). The 30-day breast infection rate was 0.5 % of the patients (n = 4), and re-excision was performed for 8.1 % of the patients (n = 66), whereas 2.6 % of the patients (n = 21) underwent mastectomy. Two patients (0.2 %) had local recurrence. The patient-reported cosmetic outcomes at 6, 12, and 24 months were rated as good-to-excellent by 92.4 %, 90.6 %, and 87.3 % of the patients, respectively and similarly by the surgeons. The radiation oncologists reported planning of target volume (PTV) reduction for 46.2 % of the patients receiving radiation boost, with PTV reduction most commonly estimated at 30 %. CONCLUSIONS: This report describes the first large multicenter study of 818 patients implanted with the BioZorb® tissue marker during BCS. Radiation oncologists found that the device yielded reduced PTVs and that both the patients and the surgeons reported good-to-excellent long-term cosmetic outcomes, with low adverse effects. The BioZorb® 3D tissue marker is a safe adjunct to BCS and may add benefits for both surgeons and radiation oncologists.

Impact of Breast Center Accreditation on Compliance with Breast Quality Performance Measures at Commission on Cancer-Accredited Centers.

PURPOSE: This study was designed to determine whether accreditation by the National Accreditation Program for Breast Centers (NAPBC) is associated with improved performance on six breast quality measures pertaining to adjuvant treatment, needle/core biopsy, and breast conservation therapy rates at Commission on Cancer (CoC) centers. METHODS: National Cancer Database 2015 data were retrospectively reviewed to compare patients treated at CoC centers with and without NAPBC accreditation for compliance on six breast cancer quality measures. Mixed effects modeling determined performance on the quality measures adjusting for patient, tumor, and facility factors. RESULTS: Of 1308 CoC facilities, 484 (37%) were NAPBC-accredited and 111,547 patients (48%) were treated at NAPBC centers. More than 80% of patients treated at both NAPBC and non-NAPBC centers received care in compliance with breast quality measures. NAPBC centers achieved significantly higher performance on four of the five quality measures than non-NAPBC centers at the patient level and on five of six measures at the facility level. For two measures, needle/core biopsy before surgical treatment of breast cancer and breast conservation therapy rate of 50%, NAPBC centers were twice as likely as non-NAPBC centers to perform at the level expected by the CoC (respectively odds ratio [OR] 1.96, 95% confidence interval [CI] 1.85-2.08, p < 0.0001; and OR 2.05, 95% CI 1.94-2.15, p < 0.0001). CONCLUSIONS: While NAPBC accreditation at CoC centers is associated with higher performance on breast quality measures, the majority of patients at all centers receive guideline-concordant care. Future studies will determine whether higher performance translates into improved oncologic and patient-reported outcomes.

Increasing Role of Oncoplastic Surgery for Breast Cancer.

PURPOSE OF REVIEW: The goals of surgery for breast cancer have remained the same over the years, to eliminate breast cancer from the breast with the least degree of deformity. With the current expectation of long-term survival after breast cancer treatment, more attention has turned to the cosmetic result of the surgical treatment. Whether lumpectomy or mastectomy, the need for aesthetic improvement was recognized by surgeons both in and outside the USA. RECENT FINDINGS: Oncoplastic surgery combines the skills of the cancer surgeon with those of the plastic surgeon. Sometimes, this means a team approach with a breast surgeon and a plastic surgeon both performing their mutual skills for the patient. Other times, the properly trained breast surgeon may perform some of the plastic techniques at the time of cancer surgery. Breast surgeons are rapidly gaining the ability to improve the post-cancer treatment appearance. To simplify the classification of oncoplastic techniques, we have used lower level, upper level, and highest level. The assignment of techniques to levels is based on both the technique and the surgeon's training and experience. Much data has accumulated demonstrating the safety and efficacy of the "aesthetic cancer cure." We describe the development of oncoplastic surgery, the techniques available, matching the right candidate with the right technique, and some comments about the future. It is clear from both clinical benefit and patient satisfaction that oncoplastic breast cancer procedures are here to stay. Plastic surgeons will likely focus on the upper- and highest-level procedures while breast/general surgeons will learn lower-level procedures and some of upper-level procedures as needed by their locale. Opportunities to educate breast/general surgeons in these techniques will continue to increase over the next several years. Formal education in oncoplastic surgery during breast fellowships will be necessary to catch up with the rest of the surgical world outside the USA.

The role of the American College of Surgeons' cancer program accreditation in influencing oncologic outcomes.

The multidisciplinary Commission on Cancer (CoC) and National Accreditation Program for Breast Centers (NAPBC), administered by the American College of Surgeons (ACoS), defines evidence and consensus-based standards, require an operational infrastructure, collect high quality cancer data, and validate compliance with standards through external peer review. A survey of our constituents confirms a high level of agreement that accreditation is regarded as important in improving oncologic outcomes through compliance with standards that include continuous quality improvement.

Can we measure the quality of breast surgical care?

Many studies have demonstrated gaps in healthcare quality for all medical and surgical specialties including breast surgical care. How to optimally measure and improve quality has generated debate at the local, state, and national level. Attempts to judge medical performance by private companies using non-risk-adjusted administrative databases may not be accurate and may unfairly penalize surgical care. An overview of concepts to measure and improve quality of breast cancer care is presented with specific examples relevant to breast surgeons. Breast surgeons and their professional organizations need to take ownership of quality measure programs because others will surely do so if we do not. Participation in one or more of these programs is beneficial because peer performance comparison allows identification of potential areas for individual or institutional improvement and demonstrates the commitment of breast surgeons to quality improvement. This commitment may gain even greater importance if trends continue toward performance-based physician payment, patient steerage, licensure, and board certification.

National Accreditation Program for Breast Centers Demonstrates Improved Compliance with Post-Mastectomy Radiation Therapy Quality Measure.

BACKGROUND: The National Accreditation Program for Breast Centers (NAPBC) was established in 2008 by the American College of Surgeons as a quality-improvement program for patients with breast disease. An NAPBC quality measure states post-mastectomy patients with ≥4 positive lymph nodes should receive lymph node radiation therapy (PMRT). Our objective was to examine how NAPBC accreditation has affected compliance with this quality measure. STUDY DESIGN: Women who underwent mastectomy at either an NAPBC-accredited center or a Commission on Cancer-only accredited hospital were identified (2006 to 2013) in the National Cancer Data Base. The NAPBC centers accredited from 2009 to 2011 were included in the analysis. Patients were nested within centers using a mixed effects model to identify PMRT rates at each center before and after accreditation, adjusting for patient and tumor characteristics. RESULTS: Of 34,752 patients from 477 NAPBC-accredited centers and 958 Commission on Cancer-only accredited hospitals who underwent mastectomy with ≥4 positive lymph nodes, 21,638 patients received PMRT during the study period (62.3%). The NAPBC centers yielded a significantly higher rate of PMRT than Commission on Cancer hospitals (66.0% vs 59.2%; p < 0.001). For each year of accreditation (2009 to 2011), centers had significantly higher rates of radiation in the accreditation year compared with the year before accreditation (p < 0.001). Within those centers, the rate of radiation increased post-accreditation in each accreditation year (2009: 62.1% to 71.9%; 2010: 65.5% to 73.2%; 2011: 67.5% to 70.4%). CONCLUSIONS: The NAPBC accreditation is associated with higher PMRT rates and better adherence to the PMRT quality measure. Future studies with more centers and longer follow-up are needed to determine whether this trend continues.

Digital documentation of the physical examination: moving the clinical breast exam to the electronic medical record.

BACKGROUND: Documentation of the clinical breast examination (CBE) has consisted of simple hand-drawings and stick figures without a common lexicon. There is a need for a device that can accurately depict the CBE in digital format while being objective, reproducible over time, and useable in the electronic medical record. This new device is called palpation imaging (PI). METHODS: We examined 110 patients with a complaint of a breast mass using PI. This laptop-sized device creates a real-time digital display of the palpable area in both video and still formats. The size, hardness, shape, homogeneity, and mass location may be extracted from the image. RESULTS: Of those with a true mass, PI identified the mass in 94% while physical examination identified 86%. The positive predictive value (PPV) for breast cancer using PI was 94% and 78% for physical examination. A survey of primary care physicians revealed the inclusion of the PI record in a consultation note implied competence, experience, and skill by the surgeon. CONCLUSIONS: PI documented the CBE in a timely, efficient, and accurate manner. A reproducible record allows objective review by multiple examiners at varied times. Continued work will optimize examination methods.

Intraoperative digital specimen mammography: prompt image review speeds surgery.

Specimen mammograms are often a time-consuming event for image-guided surgery. The use of an intraoperative imaging device may improve the speed of surgery, but comparison must be made to ensure accuracy is maintained. One hundred fifty consecutive image localized patients underwent both intraoperative digital specimen mammogram (in the operating room) and standard specimen mammogram (in radiology). Intraoperative mammograms as read by breast surgeons were as accurate as standard films while saving an average of 19 minutes per operative procedure. Intraoperative digital specimen mammograms can accurately identify target lesions while saving operating room time.

Office-based cryoablation of breast fibroadenomas: 12-month followup.

BACKGROUND: Fibroadenomas comprise between 30% and 50% of all breast biopsies. Despite their benign nature, many women have their fibroadenomas surgically removed. We previously reported on a minimally invasive therapy using cryoablation to treat fibroadenomas. We now report on 12-month followup using this technique. STUDY DESIGN: A prospective, nonrandomized trial was initiated in June 2000 with IRB approval. The Visica Treatment System was used to cryoablate 70 biopsy-proved fibroadenomas in 57 patients using a freeze-thaw-freeze cycle lasting 6 to 30 minutes. Each patient was serially evaluated for safety, efficacy, and satisfaction. RESULTS: Fifty-seven fibroadenomas (mean 2.1 cm, range 0.8 to 4.2 cm) in 47 patients were followed for 12 months. At 1 year, with 89% median tumor volume reduction measured by ultrasonography, 75% of fibroadenomas were nonpalpable. There were no adverse events and only minor complications. Two patients (4%) had their lesions excised after 12 months; pathology revealed no viable fibroadenoma. Serial mammograms showed resorption of the fibroadenoma leaving minimal residual density without calcifications. Cosmesis was excellent with no volume deficit, as no tissue is removed. Ninety-one percent of patients were satisfied at 12 months. CONCLUSIONS: Cryoablation is safe and effective in treating breast fibroadenomas. It offers a nonsurgical, office-based treatment that is well tolerated by patients and accurately monitored with ultrasonographic guidance. At 12 months we found progressive tumor volume reduction and reduced palpability, with no volume deficit, excellent cosmesis, and satisfied patients. Ultrasonography-guided cryoablation is a preferred option for treatment of breast fibroadenomas without open surgery.

Cryosurgery for breast cancer.

As the majority of breast cancers present as small non-palpable lesions, alternatives for surgical lumpectomy come into consideration. Breast tumor ablation without surgical excision may be a less morbid procedure without sacrificing cancer control. Cryosurgery is one of several ablative options for the treatment of small unifocal breast cancer. The potential advantages include avoidance of a surgical procedure, less overall discomfort, improved cosmesis, quicker recovery and the prospect of overall cost benefits. Clinical experience in 29 patients is reviewed demonstrating effectiveness in properly chosen patients. A comparison of ablation methods is discussed. Finally, future research of the role of cryosurgery in the management of breast cancer is described.

Intraoperative ultrasonography guidance is accurate and efficient according to results in 100 breast cancer patients.

BACKGROUND: The frequency of nonpalpable breast cancer has doubled in the last 10 years. Surgical use of high quality portable ultrasound units has made it possible to evaluate the time-saving method of intraoperative ultrasonography localization. METHODS: Ultrasonography localization in the operating room immediately prior to definitive surgery was performed by the surgeon. All tissue underwent specimen mammography and ink orientation. The presence of negative margins, the closest margins, the need for reexcision, and the cosmetic result were examined for each patient. RESULTS: Ultrasonography correctly localized all breast cancers at surgery (100% sensitivity). Negative margins for invasive carcinoma were found in 90% of patients. Negative margins were at least 10 mm in 27%, at least 5 mm in 62%, and at least 1 mm in 90%. Positive margins were due to the presence of noncalcified ductal carcinoma in-situ (4 of 10) or multifocal invasive disease (6 of 10) noted at final histology. Reexcisions were performed in 9% of patients. CONCLUSIONS: Surgical use of intraoperative ultrasonography for localization of breast cancer is accurate and efficient. Ultrasonography localization is easier on the patient, is time and cost efficient, and convenient to schedule. Surgeons should embrace this new skill and utilize this tool whenever a nonpalpable breast cancer can be seen with ultrasonography.

Encircling guidewire facilitates complete excision of image-localized breast lesions.

BACKGROUND: An innovative encircling guidewire defines three sides of a target lesion with a single puncture to achieve negative margins. METHODS: Twenty-five patients requiring image-guided surgery were localized with an encircling guidewire. Although the deployed wire is circular, it is straight when placed, using a straight outer needle. After image-guided placement of the wire around the lesion, all patients underwent standard surgical excision. Each patient was categorized by proper localization of the target lesion, presence of negative margins, closest margin, and need for reexcision. RESULTS: The circlewire wire identified the target lesion in all cases. There were no complications relative to either version of the leading tip on the guidewire. Negative margins were achieved in all pure invasive ductal carcinomas. Positive margins were found in all 3 patients with extensive noncalcified in-situ disease and 1 patient with multifocal invasive lobular carcinoma. CONCLUSIONS: An innovative encircling localizing guidewire device gives the surgeon a new option to completely remove a nonpalpable breast lesion.

Office-based ultrasound-guided cryoablation of breast fibroadenomas.

BACKGROUND: Fibroadenomas commonly found by palpation and routine mammography account for approximately 20% of open surgical breast biopsies. Alternatives to open surgery include tumor removal using an automated coring device and tumor ablation using heating or cooling elements. We report our initial experience with cryoablation of biopsy-proven benign fibroadenomas. METHODS: A table-top cryoablation system employing a 2.4-mm cryoprobe was used to treat biopsy-proven benign fibroadenomas up to 4 cm in maximum diameter in a prospective nonrandomized fashion. The cryoprobe was placed under ultrasound guidance. Using a treatment algorithm based on fibroadenoma size, all tumors were subjected to two freeze cycles with an interposing thaw. Skin appearance and temperature, probe temperature, iceball size, and patient comfort were closely monitored during the procedure. Follow-up examinations including ultrasonography and photographs were scheduled for up to 12 months postablation. RESULTS: Fifty patients with 57 core biopsy-proven benign fibroadenomas were treated. Seven early cases were treated in an ambulatory surgery center setting. The remaining procedures were completely office-based using only local anesthetic. Tumor diameter varied from 7 mm to 42 mm (mean 21 mm). The iceball engulfed the target lesion in each case. Transient postoperative side effects were local swelling and ecchymosis. Postoperative discomfort rarely required medication beyond acetaminophen or ibuprofen. Lesions showed progressive shrinkage and disappearance over 3 to 12 months. No skin injury was noted and appearance remained excellent. Patient satisfaction was excellent. CONCLUSIONS: With office-based use of ultrasound-guided cryoablation for fibroadenomas there was little or no pain, target lesions were reduced in size or eliminated, scarring was minimal, cosmesis outstanding, and patient satisfaction was excellent. Cryoablation offers a useful office-based alternative to surgical excision of benign fibroadenomas.

Cryoablation treatment of benign breast lesions with 12-month follow-up.

OBJECTIVE: Eighty percent of all breast biopsies reveal benign findings. The most common benign tumor is a fibroadenoma. Despite their benign nature, many women eventually choose to have their bothersome lumps surgically removed. We report the use of cryoablation to treat these benign breast lesions with minimum 12-month follow-up. METHODS: After receiving Institutional Review Board approval, a prospective nonrandomized trial was initiated in June 2000. Ultrasound-guided cryoablation of core biopsy-proven benign fibroadenomas, other benign breast nodules, or nodular fibrocystic change was performed on 78 lesions in 63 patients. Eighty-five percent of lesions treated were benign fibroadenomas. The cryoablation procedure consisted of a double freeze-thaw cycle that lasted between 6 and 30 minutes and was performed most often in an office setting. Each patient was serially evaluated for treatment efficacy, complications, and patient satisfaction. RESULTS: Sixty-four of 78 lesions (mean size 2.0 cm [range 0.8 to 4.2]) were followed-up for at least 12 months after cryoablation per protocol, which included 53 fibroadenomas. At 1 year, ultrasound tumor volume resorption was 88.3% overall (87.3% for fibroadenomas), and 73% of the entire group became nonpalpable to both clinician and patient (75% for fibroadenomas). Two of the fibroadenoma patients had their palpable residual nodule excised, both revealing necrotic debris and no viable tumor in the treated volume. Serial mammograms showed resorption of the lesion leaving minimal residual density without calcifications. Cosmesis was excellent with only a small scar remaining at the probe insertion site. There was no report of visual or palpable volumetric deficit. Patient satisfaction was good to excellent in 92% of cases. CONCLUSIONS: Cryoablation was successful in treating core biopsy-proven benign breast lesions in 63 patients. At 12 months, we found gradual resorption of treated tissue with no cosmetic deficit. Ultrasound-guided cryoablation is an effective and safe treatment for benign breast lesions, as seen at 12-month follow-up, and offers an office-based, minimally invasive alternative to surgical excision.

National quality validation programs for breast centers.

With the emphasis on quality of care spurred by the Institute of Medicine, two breast care quality programs have been developed. The National Accreditation Program for Breast Centers is composed of 13 national organizations interested in setting structural standards for breast care. Accreditation occurs during an on-site survey review of the three types of breast centers every 3 years. A second program uses a web-based set of questions called the National Quality Measurements for Breast Centers established by the National Consortium of Breast Centers. Yearly confidential submission of data allows the centers to compare themselves with like-centers across the country using a real-time results program. These two programs herald a new phase of quality monitoring based on comparisons with other providers of breast care. In this new paradigm, simply being licensed to provide care will not be satisfactory proof of quality of care.

Validating quality breast care: three new validation programs for 2007.

BACKGROUND: Despite advances in treatment and decreases in mortality, high-quality breast care is distributed unevenly across the country. Efforts to measure and monitor the quality of breast care have been initiated for breast centers and breast surgeons. METHODS: The current efforts to define measures of breast care quality were examined. Each program was defined by their quality indicators, ease of use, and potential problems. RESULTS: Three new innovative programs were identified: (1) the National Accreditation Program for Breast Centers uses an on-site survey of the structural components of breast center care to offer breast center accreditation; (2) the National Quality Measures for Breast Care (National Consortium of Breast Centers, Inc, Warsaw, IN) uses a confidential online questionnaire of process indicators to offer quality breast center certification; and (3) the American Society of Breast Surgeons program uses a confidential online questionnaire to validate breast surgeon quality. CONCLUSIONS: Three new programs to validate quality breast care are available in 2007. One or more of these programs likely will be used to validate increased payments for quality care. Breast centers and breast surgeons are advised to consider participation in these programs.