The Market Reacts Quickly: Changes in Paclitaxel Vascular Device Purchasing Within the Ascension Healthcare System.

BACKGROUND: A meta-analysis of trials in endovascular therapy suggested an increased mortality associated with treatment exposure to paclitaxel. Multiple publications and corrections of prior data were performed, and the United States Food and Drug Administration has issued multiple advisories regarding paclitaxel use. We analyzed how this controversy impacted device purchasing and related utilization patterns in the period immediately following publication of the meta-analysis. METHODS AND RESULTS: Ascension Healthcare System purchase data over a 14-month period were synthesized across centers for both paclitaxel and non-paclitaxel devices. A fixed-effects regression model and a binary regression model with facility-level controls were used to compare purchasing patterns before and after the meta-analysis. Purchase volumes of each paclitaxel device fell. Pooled purchase volumes of all paclitaxel devices decreased from a 14-month peak of 631 devices in October 2018 to a 14-month nadir of 359 devices in February 2019. An F-test comparing the pooled-month specific fixed effects for the months before vs after the publication of the meta-analysis has an F-statistic of 11.64, suggesting that average purchasing levels in the two periods are statistically different (P<.001). Utilization of non-paclitaxel devices did not decline. CONCLUSIONS: Purchase volumes of paclitaxel devices decreased immediately during the months following publication of the related meta-analysis. Total Ascension-wide paclitaxel device purchase volume in February 2019 demonstrated a 43.1% reduction from peak monthly purchase volume during the assessed period and a 32.5% reduction compared with November 2019, the last month preceding publication of the meta-analysis.

Electrical impedance scanning as a new breast cancer risk stratification tool for young women.

BACKGROUND: Electrical impedance scanning (EIS) measures changes in breast tissue associated with breast cancer (Br-Ca) development. The T-Scan(tm2000 (ED is designed to use EIS to identify women ages 30-39 with elevated risk of breast cancer (i.e., T-Scan+ women). AIM: To estimate the relative probability of breast cancer in a T-Scan+ woman compared to a randomly selected young woman. METHODS: A prospective, two-cohort trial was conducted in pre-menopausal women. The Specificity (S(p))-Cohort evaluated T-Scan specificity in 1,751 asymptomatic women ages 30-39. The Sensitivity)S(n))-Cohort evaluated T-Scan sensitivity in 390 women ages 45-30 scheduled for biopsy. Specificity, sensitivity, and conservative estimate of disease prevalence were used to calculate relative probability. RESULTS: In the S(p)-Cohort, 93 of 1,751 women were T-Scan+ (S(p) = 94.7%; 95% CI: 93.7-95.7%). In the S(n)-Cohort, 23 of 87 biopsy-proven cancers were T-Scan+ (S(n) = 26.4%; 95% CI: 17.4-35.4%). Given S(p) = 94.7%, S(n) = 26.4% and prevalence of 1.5 cancers/1,000 women (ages 30-39), the relative probability of a T-Scan+ woman having Br-Ca is 4.95: (95% CI: 3.16-7.14). CONCLUSION: EIS can identify a subset of young women with a relative probability of breast cancer almost five times greater than in the population of young women at-large. T-Scan+ women have a sufficiently high risk of Br-Ca to warrant further surveillance or imaging.

Electrical impedance scanning for the early detection of breast cancer in young women: preliminary results of a multicenter prospective clinical trial.

PURPOSE: To evaluate the feasibility and patient satisfaction with electrical impedance scanning (EIS) for early detection of breast cancer in young women. METHODS: Women undergoing screening clinical breast examination, imaging, or biopsy were eligible for EIS examination with T-Scan 2000ED (Mirabel Medical Systems, Austin, TX). Multiple logistic regression analysis evaluated the association between clinical variables and EIS performance. Patients completed a screening EIS satisfaction questionnaire (1 = least satisfied to 5 = most satisfied). RESULTS: Twenty-nine cancers were identified among 1,103 women. Sixty-six percent (19 of 29) of cancers were nonpalpable and 55% (16 of 29) were in women age < or = 50 years. EIS sensitivity and specificity in women younger than 40 years was 50% and 90%, respectively. Exogenous estrogen use (P < .001) and menopausal status (P = .007) correlated significantly with EIS performance. False-positive rates were increased in postmenopausal women and those taking exogenous hormones. No correlation was evident between EIS performance and family history, prior breast cancer, breast density, or palpability. EIS-positive women younger than age 40 were 4.5 times more likely to have breast carcinoma than were women randomly selected from the general population. Patients were highly satisfied with the comfort, speed, and reporting of EIS screening (mean score, 4.8). CONCLUSION: EIS seems promising for early detection of breast cancer, and identification of young women at increased risk for having the disease at time of screening. Positive EIS-associated breast cancer risk compares favorably with relative risks of conditions commonly used to justify early breast cancer screening. Patients are satisfied with a screening paradigm involving breast EIS.

Electrical impedance scanning of thyroid nodules before thyroid surgery: a prospective study.

BACKGROUND: Electrical impedance scanning (EIS) is a novel imaging technique based on differential electrical conductivity and capacitance of malignant and normal human tissues. The aim of this study was to evaluate the accuracy of EIS in the detection of thyroid malignancies. METHODS: Patients with thyroid nodules scheduled for thyroid surgery were eligible for the study. Enrolled patients underwent EIS with a T-Scan 2000ED. Nodule location, size, and type (cystic vs. solid) measured by ultrasound, cytology results, thyroid conductivity, and capacitance calculated by EIS were recorded. EIS results were interpreted as positive or negative for malignancy and compared with final histopathology results. Study end points included EIS accuracy, sensitivity, specificity, negative and positive predictive values, and false-positive and false-negative rates. RESULTS: Sixty-four patients were enrolled onto the study, and all underwent either lobectomy-isthmusectomy (20%) or total thyroidectomy (80%). The mean tumor diameter was 2.64 +/- 14.8 mm. Thyroid cancers were identified by histology in 30 patients (46.9%). There were 11 false-positive and four false-negative cases. The overall diagnostic accuracy of EIS was 76.6% (49 of 64 correct diagnoses). The sensitivity and specificity of EIS were 86.7% (26 of 30 true positive) and 67.6% (23 of 34 true negative), respectively. The corresponding positive and negative predictive values were 70.3% and 85.2%. CONCLUSIONS: EIS is a potentially useful imaging modality for differentiating thyroid neoplasms. If these results are confirmed in large-scale trials, EIS may be an important part of the evaluation of thyroid nodules.

Novel EIS postprocessing algorithm for breast cancer diagnosis.

A new postprocessing algorithm was developed for the diagnosis of breast cancer using electrical impedance scanning. This algorithm automatically recognizes bright focal spots in the conductivity map of the breast. Moreover, this algorithm discriminates between malignant and benign/normal tissues using two main predictors: phase at 5 kHz and crossover frequency, the frequency at which the imaginary part of the admittance is at its maximum. The thresholds for these predictors were adjusted using a learning group consisting of 83 carcinomas and 378 benign cases. In addition, the algorithm was verified on an independent test group including 87 carcinomas, 153 benign cases and 356 asymptomatic cases. Biopsy was used as gold standard for determining pathology in the symptomatic cases. A sensitivity of 84% and a specificity of 52% were obtained for the test group.