The clinical utility of an elevated-risk multivariate index assay score in ovarian cancer patients.

OBJECTIVE: Early involvement of specialists is associated with improved survival in ovarian cancer patients. However, only 33-60% of patients are currently being referred. A more effective strategy to get patients with an elevated risk of ovarian cancer to gynecologic oncologists is needed. The objective of this study was to evaluate the clinical utility of a multivariate index assay, OVA1 * , by assessing its ability to drive referral of ovarian cancer patients to gynecologic oncologists prior to their first surgical intervention. RESEARCH DESIGN AND METHODS: Information on patients who received a multivariate index assay was collected retrospectively from 22 obstetricians/gynecologists through a chart review. Physicians were recruited from a variety of practices and hospitals representing major geographic regions within the United States. Clinical utility of the multivariate index assay was assessed by examining the rate at which obstetricians/gynecologists involved a gynecologic oncologist for patients with elevated-risk results prior to first surgical intervention. RESULTS: A total of 136 patients with elevated-risk assay results were assessed, of whom 122 underwent surgery to remove an adnexal mass. Prior to surgery, 98 (80%) of the patients were referred to a gynecologic oncologist with an additional 11 (9%) having a gynecologic oncologist available if required by intra-operative findings. Primary ovarian cancer was found in 65 (53%) patients, and gynecologic oncologists performed 61 (94%) of the initial surgeries these patients. Similar results were found in premenopausal and postmenopausal patients. CONCLUSIONS: A high proportion of patients with elevated-risk assay results were referred to a gynecologic oncologist prior to their initial surgery. Nearly all of the patients who had primary ovarian malignancies were appropriately referred to gynecologic oncologists, highlighting the clinical utility of the multivariate index assay. Nearly all patients identified with ovarian cancer received their initial surgery by a gynecologic oncologist - demonstrating a higher rate of gynecologic oncologist involvement in comparison to past studies. The study may be limited by unintentional bias in physician response and recall.

A brief review of ventricular assist devices and a recommended protocol for pathology evaluations.

UNLABELLED: Heart failure is a leading cause of death in human populations, and as people live longer, it is becoming an increasingly prominent problem. Because of the insufficient numbers of donor hearts, physicians and engineers are turning to mechanical circulatory support in the form of ventricular assist devices (VADs). Their clinical performance and increasing availability of various types, sizes, and functions are increasing VAD recognition. However, for any implantable medical device, especially one that is life supporting, performance and safety must be evaluated both pre- and postmarket. It has been demonstrated that specific pathology analysis can provide unique and important information to augment the evaluation of performance and safety. To help ensure the safety and efficacy of a device, we propose that regulatory agencies include pathology analysis by experienced, independent pathologists with relevant expertise as an integral component of device submissions. We believe that this analysis should include both gross and microscopic components and, when warranted, supplementary data obtained through radiography, electron microscopy, or both. The pathology data acquired through these analyses should be correlated with clinical data to yield a more thorough data set for submission to the governing regulatory body. Submitting this coordinated analysis of data will demonstrate to regulatory agencies (United States Food and Drug Administration, Therapeutic Goods Administration, Brazilian Health Surveillance Agency, etc.) that the device manufacturer shares their objective: making medical devices as safe and effective as possible. SUMMARY: This review of ventricular assist devices introduces a recommended protocol for pathology evaluations of devices from organizations or researchers seeking approval by a governing regulatory agency.