Publications

BACKGROUND AND AIMS

EUS-FNA is a means of sampling suspected GI stromal tumors (GIST). However, there are limited published data on factors influencing the sampling yield, and on the performance characteristics of this technique in comparison with resection pathology. We analyzed the yield of EUS-FNA for submucosal lesions of the upper GI tract, and determined the performance characteristics of EUS-FNA for diagnosing GISTs.

METHODS

We retrospectively reviewed procedural and pathology data from consecutive patients undergoing EUS-FNA of submucosal lesions from two medical centers over a 4-year period. We analyzed the yield of EUS-FNA, and calculated performance characteristics of EUS-FNA for GIST based on resection pathology.

RESULTS

A total of 65 patients underwent EUS-FNA of 66 submucosal lesions during the study period. EUS-FNA was either diagnostic (68%) or suspicious (12%) in a total of 80%. EUS-FNA yielded the following diagnoses: GIST based on cytology and immunohistochemistry (56%), suspected GIST (12%), leiomyoma (9%), other neoplasm (3%), and non-diagnostic (20%). Larger lesion size, gastric location, and presence of on-site cytopathology were associated with higher yield in univariate analysis. Larger needle size and number of FNA passes were not associated with improved yield. Based on resection pathology from 28 specimens, the EUS-FNA performance characteristics for diagnosing GISTs included a sensitivity of 82%, a specificity of 100%, and an overall accuracy of 86%.

CONCLUSIONS

EUS-FNA provides a high yield for sampling submucosal lesions and is highly accurate for diagnosing GISTs. EUS-FNA has an important role in the evaluation of suspected GISTs.

BACKGROUND

Cardiovascular devices can have different safety and effectiveness profiles in men and women. The type and quality of sex-specific data reviewed by the Food and Drug Administration (FDA) before approval of these devices are unknown.

METHODS AND RESULTS

We performed a systematic review of the demographics, comments on gender bias, and analysis of results by sex for 78 high-risk cardiovascular devices that received premarket approval by the FDA between 2000 and 2007. FDA summaries of evidence did not report sex of enrollees in 34 (28%) of 123 studies. For studies reporting sex distribution, the study populations were, on average, 67% men. There was no increase in the enrollment of women over time. Explanations for the relatively low percentage of women often stated that the trials reflected either underlying disease distribution or referral rates for similar procedures or that the sex distribution reflected similar or previous trials. Forty-one percent of studies included a gender bias comment or analysis, and 12 (26%) of 47 of these analyses identified some difference in device safety or effectiveness by sex.

CONCLUSIONS

There is a lack of sex-specific safety and effectiveness data for high-risk cardiovascular devices before FDA approval. The justifications for this lack of evidence may perpetuate the status quo. More rigorous FDA requirements for sex-specific data before device approval could present an opportunity to improve cardiovascular outcomes.