Evaluating sensitivity and specificity of handheld point-of-care ultrasound testing for gynecologic pathology: a pilot study for use in low resource settings.

BACKGROUND: Point-of-care ultrasound (POC-US) is a diagnostic test conducted at the site of patient care with direct interpretation by the clinician, providing immediate results. POC-US for gynecologic application is not well characterized by current literature yet has the potential to increase access in limited resource settings. We compared the diagnostics of three POC-US devices for gynecologic (GYN) pathology and then performed evaluation of sensitivity and specificity of a single best POC-US device for intended use in a low resource setting. METHODS: This is prospective, pilot descriptive study of 60 subjects. In part 1, comparison of three POC-US devices was performed. Twenty subjects underwent POC-US with three test units [GE Vscan (Vscan), Sonosite Iviz (Iviz), Philips Lumify (Lumify)] followed by diagnostic ultrasound (Dx-US) for reference imaging. Image quality and correlation for devices was scored by blinded reviewers and quantitative measurements of GYN pathology were compared. In part 2, forty subjects underwent POC-US validation with the highest scoring device (Lumify) and Dx-US for reference imaging. Concordance of POC-US operator-interpreted diagnosis with reference imaging interpretation were assessed by Cohen's unweighted kappa coefficient. Accuracy and agreement of POC-US were assessed by linear regression and Bland-Altman plot analysis. Sensitivity and specificity of POC-US for gynecologic pathologies were calculated. RESULTS: In aggregate qualitative measurements, Lumify and Iviz units performed superiorly to Vscan. There was no statistically significant difference in quantitative measurements between devices, but a trend towards lower mean error was seen for Lumify and Iviz as compared to Vscan. Lumify device had highest overall scoring and was selected for further testing. In validation comparison of Lumify to Dx-US, no statistically significant differences were found for measurements of endometrium, uterus, ovaries, adnexal pathology, or leiomyomata, (P < 0.02) with excellent agreement in operator-interpreted diagnosis (Kappa > 0.7). Sensitivity and specificity of detecting pathology was 80-100% with PPV and NPV 76-100%. CONCLUSION: Among three POC-US devices, Lumify and Iviz devices show highest potential for successful application to clinical gynecologic ultrasound. Clinician-performed POC-US has high diagnostic accuracy, sensitivity, and specificity for basic GYN anatomy and pathology. POC-US is an acceptable and feasible diagnostic tool with potential for future application in a low resource setting to increase access to ultrasound.

Pharmacovigilance assessment of the association between Fournier's gangrene and other severe genital adverse events with SGLT-2 inhibitors.

Objective: Sodium glucose cotransporter-2 inhibitors (SGLT2i) exert cardiorenal protection in people with diabetes. By inducing glycosuria, SGLT2i predispose to genital infections. In addition, rare occurrence of Fournier's gangrene (FG) has been reported. We aimed to investigate such association through the U.S. Food and Drug Administration (FDA) adverse event (AE) reporting system (FAERS). Research design and methods: We mined the FAERS up to 2018q3 (before FDA warning about SGLT2i-associated FG) to retrieve reports including FG as an AE and SGLT2i as suspect or concomitant drugs, and calculated proportional reporting ratios (PRR). Results: We retrieved 47 cases of FG and 17 cases of other severe AEs of the genital area associated with SGLT2i. Patients with FG were ~10 years older than those with other severe genital AEs. Overall, 77% occurred in men. Three patients were concomitantly treated with systemic immunosuppressive drugs. Increased reporting frequency emerged for SGLT2i compared with other drugs, with a PRR ranging from 5 to 10. The disproportional reporting of FG with SGLT2i remained robust and consistently significant when restricting to the period when SGLT2i were available, to reports filed for glucose-lowering medications or for drugs with the diabetes indication, and after refining the definition of FG. FG was disproportionally associated with psoriasis and with the combination of immunosuppressants and SGLT2i. Conclusions: Although causality cannot be demonstrated, SGLT2i may predispose to FG and other severe genital AEs. Since the use of SGLT2i is expected to increase significantly, clinicians should be aware of these severe, although rare, AEs and their predisposing factors.

Normal Variants and Pitfalls Encountered in PET Assessment of Gynecologic Malignancies.

Combined PET/computed tomography is used for oncological indications. PET/computed tomography benefits from the metabolic information of PET and the anatomic localization of computed tomography. The integrated scanner provides data with accurate registration of anatomy and molecular information. Many physiologic conditions, normal variants, and benign lesions within the pelvis and the body can cause confusion and uncertainty. False-negative results owing to low 18F-fluorodeoxyglucose uptake from the tumor can produce diagnostic challenges and inaccurate conclusions. This article reviews normal variants and potential pitfalls encountered in PET assessment of gynecologic malignancies to provide useful information for the referring and reporting physicians.

Compliance and complications of culdotomy.

BACKGROUND: Culdotomy is a practically exclusive appanage of gynaecological surgeons. Today the transvaginal access to pelvis and abdominal cavity is also utilized for non-gynecological surgery. METHODS: The authors report the complications and compliance of 326 culdotomies performed in the Simple Maternity Unit of Asiago Hospital (Asiago, Vicenza, Italy). The casuistry includes 18 adnexetomies, 90 ovarian cysts and fibroids enucleations and/or resections, 23 paraovarian cysts removals, 59 myomectomies, 120 sterilizations, 11 salpingectomies, 1 adesiolysis, 2 ovarian biopsies and 1 abscess drainage. RESULTS: Couldtomy showed to be a procedure with good results in terms of 18 grade 1 and 1 grade IV (5.8%) of Clavien-Dindo grading system for classification of surgical complications, the incidence of conversions in laparotomies, laparoscopies and vaginal hysterectomy (3.1%), the average hospital postoperatory admission (25 hours), low cost of culdotomy compared to laparotomic and laparoscopic surgery; absence of dispareunia and/or other discomforts at long term. CONCLUSIONS: Culdotomy is a simple, proper and alternative route, especially when morcellation is unavoidable.

Malignant tumors of the female pelvic floor: self-assessment module.

The educational objectives for this self-assessment module are for the participant to exercise, self-assess, and improve his or her understanding of malignant tumors of the female pelvic floor and the imaging features that determine therapy.

The use of contrasted transvaginal sonography in the diagnosis of gynecologic diseases: a preliminary study.

OBJECTIVE: The purpose of this study was to evaluate the efficacy of a new contrast-dedicated ultrasound technology, contrast-tuned imaging (CnTI), implemented on an endovaginal probe and using the second-generation contrast agent SonoVue (Bracco International BV, Amsterdam, the Netherlands), compared with the standard ultrasound examination in different gynecologic diseases. METHODS: Eighty-nine patients were enrolled in the study in 4 different clinical centers. The study included 40 patients with uncertain pelvic adnexal masses, 10 patients with pelvic masses indicative of recurrences of gynecologic tumors, 26 patients with uterine pathologic features, and 13 patients with cervical lesions. RESULTS: Application of CnTI technology after the SonoVue injection gave a picture of the intralesional microvascularization dramatically different from that obtained during color Doppler examination. Of the 40 pelvic masses, 15 (37.5%) were considered benign and 25 (62.5%) were considered malignant at B-mode and color Doppler examinations. Contrast-enhanced sonography showed no intralesional contrast perfusion in 11 (73%) of 15 cases, and all these were benign at final diagnosis. Of the 4 (27%) cases that had perfusion, 2 were malignant. Conversely, of the 25 cases with positive findings at color Doppler examination and therefore expected to show the appearance of contrast tissue-filling morphologic characteristics, 13 (52%) were malignant at final diagnosis. For evaluation of uterine pathologic features, the CnTI-SonoVue technology did not appear to be superior to the B-mode and color Doppler examinations; however, for the evaluation of cervical cancer, CnTI-SonoVue technology revealed a better definition of the margins of the neoplastic lesions in 4 (40%) of 10 cases. CONCLUSIONS: In the evaluation of uncertain pelvic masses, the CnTI technology led to an improvement in the ability of the practitioner to differentiate benign from malignant adnexal lesions.

ThinPrep pap test: a platform for gynecological diagnosis.

Many of the limitations of the conventional method of Pap smear preparation have been overcome by collection of the cervical sample in liquid, and subsequent preparation to create a thin-layer microscope slides. Particularly impressive has been the large body of literature that describes the benefits of the ThinPrep Pap Test, in terms of increased sensitivity of high-grade disease detection, excellent specificity, robust cost effectiveness, and a platform from which additional testing can be performed. The benefits of the ThinPrep are particularly evident in underscreened populations, or in women who are infrequently screened, or in the setting of a national program.

French gynecologic cytology.

Diagnostic schema may be developed on a national or global level, but may be varied depending on the local conditions. In this article, the differences between French and North American gynecologic cytology are discussed. This article emphasizes the training, diagnostic, technologic, and regulatory differences that exist in France. By studying such differences, local practices can learn potential benefits and why their currently used systems may be optimal.

Peritoneal washing cytology is unnecessary in gynecologic surgery for benign diseases.

BACKGROUND: The presence of tumor cells in peritoneal washing cytology specimens taken during surgery affects the staging of many gynecologic malignancies. Peritoneal washings are often collected routinely, even in cases of presumed benign disease. This study was designed to address whether evaluation of these specimens is justified. METHODS: We reviewed diagnostic reports from all peritoneal washings and the corresponding surgical pathology specimens from patients undergoing gynecologic surgery during a 1-year period in one institution and a 20-month period in the other. Cases were divided into benign and malignant categories based on the surgical pathology diagnosis. RESULTS: Three hundred forty-six patients had peritoneal washings collected during the study period. The proportion of cases with malignancy was 30% in one institution and 49% in the other. Of these, 119 had an endometrial or ovarian malignancy, including 16 ovarian tumors of low malignant potential. Malignant cells were detected in 19 cases. In 10 of these 19, grossly apparent peritoneal tumor implants were present at the time of surgery. The remaining 227 were found to have benign disease, and the peritoneal washing cytology diagnosis was negative in all cases. Potential savings of $13,000 to $17,000 based on current insurance reimbursement could have been realized for these 227 patients without compromising patient care. CONCLUSIONS: These data suggest that peritoneal washing cytology specimens collected at the time of gynecologic surgery for presumed benign disease can be held and processed later if an unsuspected malignancy is discovered. This practice can result in cost savings without compromising patient care. Cancer (Cancer Cytopathol)

External anogenital lesions in organ transplant recipients. A clinicopathologic and virologic assessment.

BACKGROUND AND DESIGN: In a series of patients treated at a university department of dermatology, we assessed the clinicopathologic features of external anogenital lesions in organ transplant recipients. For 6 years, 1002 recipients with various dermatologic problems underwent assessment for the presence of proliferative external anogenital lesions; these lesions were examined histologically and virologically for the presence of human papillomaviruses (HPV). RESULTS: Twenty-three patients (2.3%) presented with anogenital lesions, women being more often involved. Clinicopathologic examination revealed 18 anogenital warts, 3 cases of bowenoid papulosis, 1 giant condyloma, and 1 in situ carcinoma. Other viral coinfections were frequent. The lesions were extensive and refractory to treatment in 13 patients, but lesions in 7 were cured alter the immunosuppressive treatment was tapered of discontinued. Dysplastic changes were frequent on histologic examination. Twenty-one lesions contained HPV; 6 of 13 patients with HPV DNA in their lesions harbored oncogenic types that predominated in dysplastic lesions. In some patients, the same HPV types were detected within cutaneous and anogenital lesions, suggesting self-contamination. CONCLUSIONS: External anogenital lesions are more rare than cutaneous lesions in organ transplant recipients. These lesions may represent a marker of immunosuppression, especially when they are extensive. Their clinical aspect is often misleading; furthermore, because of the presence of dysplastic histologic aspects and oncogenic HPV types, they could be susceptible to malignant transformation, necessitating regular surveillance.

Assessment of cervicovaginal smear adequacy. The Bethesda System guidelines and reproducibility.

Criteria for assessing adequacy of cervicovaginal smears according to the Bethesda System include cellular composition and quantity, specimen preservation, fixation, and absence of obscuring elements. The reproducibility of adequacy assessment using these parameters was the focus of this study. Specimens were chosen to include a wide spectrum of clinical history and adequacy interpretations, but excluded cases with epithelial abnormalities and those judged "limited" because of insufficient transformation zone component. The 114 specimens were independently evaluated twice by five reviewers, with interceding randomization. Full interobserver concordance was obtained in 50.4% of cases, with consensus reached by three or more observers in 97.4% of cases. Of 2280 paired interpretations, 74% (1692) concurred. Pairwise kappa values for interobserver agreement ranged from .71 to .54 (very good to fair), with overall kappa = .61. Interobserver agreement for each category was near excellent for "satisfactory" (kappa = .73), good for "unsatisfactory" (kappa = .63), and only fair for "satisfactory but limited" (kappa = .48). Paired intraobserver reproducibility (agreement for two separate readings by the same observer) ranged from 69% to 77% (average, 74%), with good to fair kappa values (.66-.51). These findings indicate that the specimen adequacy guidelines of the Bethesda System provide good inter- and intraobserver reproducibility. The "satisfactory but limited" category appears to show the lowest concordance. Problem areas include evaluation of adequate minimum cellularity and estimation of number of cells obscured.

An assessment of the value of frozen sections in gynecological surgery.

In 203 consecutive gynecological operations where frozen sections were performed, 35.6% were from conditions of the ovary, 22.7% from the cervix, 18.2% from the endometrium, and 11.4% from the vulva. There were 0.5% false-positive, 1.0% false-negative and 2.0% deferred diagnosis. Incorrect interpretation was the cause of the single false-positive diagnosis, while the false-negative diagnoses were due to errors in block selection. The deferred diagnoses mainly occurred in gynecological conditions where diagnosis was difficult, required extensive sampling or a formal mitotic count. As in other surgical fields, gynecological frozen sections were used principally to guide the extent of surgery. The most valuable frozen sections were in those instances where the operation was affected most. These were on lymph nodes in cases of carcinoma of the vulva and cervix, myometrial lesions in young women where myomectomy was being considered, and ovarian tumours to distinguish primary from secondary tumours. Occasionally, frozen sections were also found useful to establish margins of vulval and cervical tumours, in hysterectomy specimens of endometrial carcinomas to determine prognostic factors, and in suspected recurrences and metastases of tumours to determine the adequacy of the biopsy material. Frozen sections in obviously benign conditions, e.g., ovarian cysts without papillary or solid areas, were found to be unnecessary. Frozen sections are contraindicated when only a small amount of crucial material is available, as the paraffin diagnosis may be compromised. Pathologists should have a clear idea of the role of frozen sections in gynecological surgery and work closely with the surgeon in the management of gynecological oncology patients.

An assessment of the Mi-Mark endoemtrial sampling technique.

One hundred and twenty cytological smears and 106 histological specimens were obtained from 115 patients using a new technique of endometrial sampling. It proved an atraumatic procedure and was well accepted by the patients. Some problems were encountered in the preparation of satisfactory cytological specimens and in their interpretation. The method was not completely reliable for detecting endometrial pathology and is therefore considered unsuitable for monitoring patients on hormone replacement therapy. It was found to be useful as a gynaecological outpatient technique for sampling the endometrium when formal curettage was unsuccessful, in avoiding the necessity for a preoperative curettage to confirm suspected carcinoma, and in the investigation of infertility.