Application of the Symptoms-Varices-Pathophysiology classification system in patients with pelvic venous disorders.

Introduction: In 2021, the American Vein and Lymphatic Society convened a multi-disciplinary group to develop a valid and reliable discriminative instrument for the classification of patients suffering from pelvic venous disorders (PeVD) referred to as the Symptoms-Varices-Pathophysiology (SVP) system. Limited data exists regarding the utility of this instrument in the care of patients with PeVD. The goal of this investigation is to apply the SVP classification system to a group of patients treated for PeVDs. Methods: From January 2018 to January 2019, we retrospectively reviewed the records of 70 female patients treated for a PeVD at the Center for Vascular Medicine. Age, race, gender, medical/surgical histories, CEAP classification and intervention types were assessed and patients were categorized according to their SVP classification. The prevalence of each S and V class, their association with gonadal or iliac vein obstructive lesions and the prevalence of lower extremity varicosities was evaluated. Results: The average age of the entire cohort was 47.4 ± 13.4. The race distribution was as follows: African American (6), Hispanic (1), and Caucasian (63). Of the 140 limbs, 57% were C3 or greater with an average rVCSS score of 4.53. At the time of intervention, 54 patients (77%) demonstrated CEAP class 2 disease or greater with 25 patients (35%) demonstrating lower extremity varicosities. Medical co-morbidities included the following: Endometriosis (n = 1), Uterine Fibroids (n = 1), Ovarian cysts (n = 4), history of venous thrombosis (n = 2) and prior lower extremity venous procedures (n = 3). Overall, 47 patients (67.1%) demonstrated S2 disease secondary to dyspareunia, post-coital pain, or dysmenorrhea. S2 alone was observed in 17 patients (24.3%), S2,3a and S2,3a,3b in nine patients each (12.9%), and S2,3b was in 12 patients (17.1%). Thirteen patients presented with isolated extra-pelvic symptoms (19%); four (5.7%) were classified as S3a,3b, and nine (12.9%) were classified as S3b only. Finally, 10 patients (14%) had no pelvic symptoms and thus were classified as S0. V0 disease was observed in 17 patients (24.3%) secondary to a high incidence of iliac vein stenoses (IVS). V1 disease was observed in 1 patient (1.43%). V2 disease was observed in 53 patients (74.3%) secondary to iliac or ovarian vein reflux. Of these, 45 patients (64.3%) presented with reflux in the iliac veins. Sixteen patients had reflux in the common iliac veins, 17 patients exhibited reflux of the external iliac veins, and 41 patients demonstrated reflux of the internal iliac veins. Thirty-two patients (45.7%) presented with V2 disease secondary to reflux of the ovarian veins, 8 of whom presented with isolated ovarian vein reflux without IVS. Bilateral ovarian vein reflux was observed in 6 patients (9%) and unilaterally in 26 (37%) patients with concomitant ovarian vein reflux and IVS observed in 31 patients (44%). In patients with ovarian vein reflux, 89% had a concomitant iliac vein stenosis: (96.9% in the common iliac vein, 81.3% in the external iliac vein and 3.1% in the internal iliac vein). Conclusion: In our patient cohort, 70 women demonstrated 14 different SV classifications. The most common was S2V2, found in 10 patients. Chronic pelvic pain of venous origin, S2 disease, was the most common symptom, present in 47 patients (67.1%); followed by extra-pelvic symptoms as 22 patients demonstrated symptoms of the external genitalia (S3a), and 21 patients had symptoms secondary to the non-saphenous leg veins (S3b). Pelvic varicosities, V2, were also the most common variceal pattern seen in 53 patients, and 17 patients did not have any varices noted by venogram. Non-thrombotic IVS either alone or with ovarian vein reflux was the most common cause of PeVD in this cohort and may reflect referral patterns to our center. To determine the true incidence of these SVP patterns, larger cohort studies are necessary.

MSG-15: Super-Bioavailability Itraconazole Versus Conventional Itraconazole in the Treatment of Endemic Mycoses-A Multicenter, Open-Label, Randomized Comparative Trial.

Background: Invasive fungal disease caused by dimorphic fungi is associated with significant morbidity and mortality. Super-bioavailability itraconazole (SUBA-itra) is a novel antifungal agent with pharmacokinetic advantages over currently available formulations. In this prospective comparative study, we report the outcomes of patients with endemic fungal infections (histoplasmosis, blastomycosis, coccidioidomycosis, and sporotrichosis). Methods: This open-label randomized trial evaluated the efficacy, safety, and pharmacokinetics SUBA-itra compared with conventional itraconazole (c-itra) treatment for endemic fungal infections. An independent data review committee determined responses on treatment days 42 and 180. Results: Eighty-eight patients were enrolled for IFD (SUBA-itra, n = 42; c-itra, n = 46) caused by Histoplasma (n = 51), Blastomyces (n = 18), Coccidioides (n = 13), or Sporothrix (n = 6). On day 42, clinical success was observed with SUBA-itra and c-itra on day 42 (in 69% and 67%, respectively, and on day 180 (in 60% and 65%). Patients treated with SUBA-itra exhibited less drug-level variability at days 7 (P = .03) and 14 (P = .06) of randomized treatment. The concentrations of itraconazole and hydroxyitraconazole were comparable between the 2 medications (P = .77 and P = .80, respectively). There was a trend for fewer adverse events (AEs; 74% vs 87%, respectively; P = .18) and serious AEs (10% vs 26%; P = .06) in the SUBA-itra-treated patients than in those receiving c-itra. Serious treatment-emergent AEs were less common in SUBA-itra-treated patients (12% vs 50%, respectively; P < .001). Conclusions: SUBA-itra was bioequivalent, well tolerated, and efficacious in treating endemic fungi, with a more favorable safety profile than c-itra. Clinical Trials Registration: NCT03572049.

Outcomes by Candida spp. in the ReSTORE Phase 3 trial of rezafungin versus caspofungin for candidemia and/or invasive candidiasis.

Rezafungin is a long-acting, intravenously administered echinocandin for the treatment of candidemia and invasive candidiasis (IC). Non-inferiority of rezafungin vs caspofungin for the treatment of adults with candidemia and/or IC was demonstrated in the Phase 3 ReSTORE study based on the primary endpoints of day 14 global cure and 30-day all-cause mortality. Here, an analysis of ReSTORE data evaluating efficacy outcomes by baseline Candida species is described. Susceptibility testing was performed for Candida species using the Clinical and Laboratory Standards Institute reference broth microdilution method. There were 93 patients in the modified intent-to-treat population who received rezafungin; 94 received caspofungin. Baseline Candida species distribution was similar in the two treatment groups; C. albicans (occurring in 41.9% and 42.6% of patients in the rezafungin and caspofungin groups, respectively), C. glabrata (25.8% and 26.6%), and C. tropicalis (21.5% and 18.1%) were the most common pathogens. Rates of global cure and mycological eradication at day 14 and day 30 all-cause mortality by Candida species were comparable in the rezafungin and caspofungin treatment groups and did not appear to be impacted by minimal inhibitory concentration (MIC) values for either rezafungin or caspofungin. Two patients had baseline isolates with non-susceptible MIC values (both in the rezafungin group: one non-susceptible to rezafungin and one to caspofungin, classified as intermediate); both were candidemia-only patients in whom rezafungin treatment was successful based on the day 30 all-cause mortality endpoint. This analysis of ReSTORE demonstrated the efficacy of rezafungin for candidemia and IC in patients infected with a variety of Candida species.

Developing Crowdsourced Clinical Registry Studies.

ABSTRACT: Crowdsourced registries have been used to quickly gather information, especially during emerging public health concerns. Registries that began during the COVID-19 pandemic were used to rapidly answer key questions on coinfections, experimental treatments, and morbidity and mortality outcomes. Registries are also used more frequently to support clinical trials and track long-term outcomes in patient populations. This article reviews registry methodology, including the collection of data from crowdsourcing and real-world sources, that can be applied to nurse researcher and clinical research nurse skill sets. The authors illustrate a recently reported crowdsourced COVID-19 and cryptococcal disease registry that followed project management strategies and the Agency for Healthcare Research and Quality registry guidelines for planning, execution, and analysis of registries and other research methods.

Effect of junctional reflux on the venous clinical severity score in patients with insufficiency of the great saphenous vein (JURY study).

OBJECTIVE: Effective treatment options are available for chronic venous insufficiency associated with superficial venous reflux. Although many patients with C2 and C3 disease based on the CEAP (Clinical-Etiological-Anatomical-Pathophysiological) classification have combined great saphenous vein (GSV) and saphenofemoral junction (SFJ) reflux, some may not have concomitant SFJ reflux. Several payors have determined that symptom severity in patients without SFJ reflux does not warrant treatment. In patients planned for venous ablation, we tested whether Venous Clinical Severity Scores (VCSS) are equivalent in those with GSV reflux alone compared with those with both GSV and SFJ reflux. METHODS: This cross-sectional study was conducted at 10 centers. Inclusion criteria were: candidate for endovenous ablation as determined by treating physician; 18 to 80 years of age; GSV reflux with or without SFJ reflux on ultrasound; and C2 or C3 disease. Exclusion criteria were prior deep vein thrombosis; prior vein ablation on the index limb; ilio-caval obstruction; and renal, hepatic, or heart failure requiring prior hospitalization. An a priori sample size was calculated. We used multiple linear regression (adjusted for patient characteristics) to compare differences in VCSS scores of the two groups at baseline, and to test whether scores were equivalent using a priori equivalence boundaries of +1 and -1. In secondary analyses, we tested differences in VCSS scores in patients with C2 and C3 disease separately. RESULTS: A total of 352 patients were enrolled; 64.2% (n = 226) had SFJ reflux, and 35.8% (n = 126) did not. The two groups did not differ by major clinical characteristics. The mean age of the cohort was 53.9 ± 14.3 years; women comprised 74.2%; White patients 85.8%; and body mass index was 27.8 ± 6.1 kg/m2. The VCSS scores in patients with and without SFJ reflux were found to be equivalent; SFJ reflux was not a significant predictor of VCSS score; and mean VCSS scores did not differ significantly (6.4 vs 6.6, respectively, P = .40). In secondary subset analyses, VCSS scores were equivalent between C2 patients with and without SFJ reflux, and VCSS scores of C3 patients with SFJ reflux were lower than those without SFJ reflux. CONCLUSIONS: Symptom severity is equivalent in patients with GSV reflux with or without SFJ reflux. The absence of SFJ reflux alone should not determine the treatment paradigm in patients with symptomatic chronic venous insufficiency. Patients with GSV reflux who meet clinical criteria for treatment should have equivalent treatment regardless of whether or not they have SFJ reflux.

Description of Cryptococcosis Following SARS-CoV-2 Infection: A Disease Survey Through the Mycosis Study Group Education and Research Consortium (MSG-19).

BACKGROUND: Invasive fungal infections have been described throughout the COVID-19 pandemic. Cryptococcal disease after infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been reported in several isolated case reports and 1 larger case series. We sought to describe cryptococcal infections following SARS-CoV-2 through establishing a database to investigate underlying risk factors, disease manifestations, and outcomes. METHODS: We created a crowdsourced call for cases solicited through the Mycoses Study Group Education and Research Consortium, the Centers for Disease Control and Prevention Emerging Infectious Diseases Network, and infectious diseases Twitter groups. Data were collected in a web-based and secure REDCap survey without personal identifiers. RESULTS: Sixty-nine cases were identified and submitted by 29 separate institutional sites. Cryptococcosis was diagnosed a median of 22 days (interquartile range, 9-42 days) after SARS-CoV-2 infection. Mortality among those with available follow-up was 72% (26/36) for the immunocompetent group and 48% (15/31) for the immunocompromised group (likelihood ratio, 4.01; P = .045). We observed a correlation between disease manifestation (central nervous system infection, proven/probable disseminated disease, and respiratory) and mortality (P = .002). CONCLUSIONS: The mortality rate of 59% for patients with cryptococcosis following SARS-CoV-2 is higher than that of modern Cryptococcus cohorts. There was an association between immunocompromised status and cryptococcal disease manifestations as well as mortality. Moreover, our series emphasizes the need for clinical and laboratory assessment of opportunistic infections beyond 30 days when concerning symptoms develop.

Efficacy and safety of rezafungin and caspofungin in candidaemia and invasive candidiasis: pooled data from two prospective randomised controlled trials.

BACKGROUND: Rezafungin, a new US Food and Drug Administration-approved, long-acting echinocandin to treat candidaemia and invasive candidiasis, was efficacious with a similar safety profile to caspofungin in clinical trials. We conducted pooled analyses of the phase 2 STRIVE and phase 3 ReSTORE rezafungin trials. METHODS: ReSTORE was a multicentre, double-blind, double-dummy, randomised phase 3 trial conducted at 66 tertiary care centres in 15 countries. STRIVE was a multicentre, double-blind, double-dummy, randomised phase 2 trial conducted at 44 centres in 10 countries. Adults (≥18 years) with candidaemia or invasive candidiasis were treated with once-a-week intravenous rezafungin (400 mg and 200 mg) or once-a-day intravenous caspofungin (70 mg and 50 mg). Efficacy was evaluated in a pooled modified intent-to-treat (mITT) population. Primary efficacy endpoint was day 30 all-cause mortality (tested for non-inferiority with a pre-specified margin of 20%). Secondary efficacy endpoint was mycological response. Safety was also evaluated. The STRIVE and ReSTORE trials are registered with ClinicalTrials.gov, NCT02734862 and NCT03667690, and both studies are complete. FINDINGS: ReSTORE was conducted from Oct 12, 2018, to Oct 11, 2021, and STRIVE from July 26, 2016, to April 18, 2019. The mITT population, pooling the data from the two trials, comprised 139 patients for rezafungin and 155 patients for caspofungin. Day 30 all-cause mortality rates were comparable between groups (19% [26 of 139] for the rezafungin group and 19% [30 of 155] for the caspofungin group) and the upper bound of the 95% CI for the weighted treatment difference was below 10% (-1·5% [95% CI -10·7 to 7·7]). Mycological eradication occurred by day 5 in 102 (73%) of 139 rezafungin patients and 100 (65%) of 155 caspofungin patients (weighted treatment difference 10·0% [95% CI -0·3 to 20·4]). Safety profiles were similar across groups. INTERPRETATION: Rezafungin was non-inferior to caspofungin for all-cause mortality, with a potential early treatment benefit, possibly reflecting rezafungin's front-loaded dosing regimen. These findings are of clinical importance in fighting active and aggressive infections and reducing the morbidity and mortality caused by candidaemia and invasive candidiasis. FUNDING: Melinta Therapeutics and Cidara Therapeutics.

Cryptococcal Meningoencephalitis in Phenotypically Normal Patients.

Cryptococcosis is an invasive fungal infection found worldwide that causes significant morbidity and mortality among a broad range of hosts. There are approximately 223,000 new cases of cryptococcosis annually throughout the world, and at least 180,000 deaths are attributed to this infection each year. Most of these are due to complications of cryptococcal meningoencephalitis among HIV-infected patients in resource-limited environments. The majority of individuals diagnosed with cryptococcosis have underlying conditions associated with immune dysfunction such as HIV, solid organ transplant, hematologic malignancy, organ failure syndromes, and/or the use of immunosuppressive agents such as glucocorticosteroids and biologic agents. In most clinical series, there is a small proportion of patients with cryptococcosis who are phenotypically normal; that is, they have no clinically obvious predisposition to disease. Cryptococcal meningoencephalitis (CME) presentation and management differ substantially between these normal individuals and their immunocompromised counterparts. In this review, we will focus on CME in the phenotypically normal host and underscore differences in the clinical presentation, management, outcome, and potential risk factors for these patients compared to immunocompromised persons who develop this potential devastating invasive fungal infection.

Clinical Testing Guidance for Coccidioidomycosis, Histoplasmosis, and Blastomycosis in Patients with Community-Acquired Pneumonia for Primary and Urgent Care Providers.

Coccidioidomycosis, histoplasmosis, and blastomycosis are underrecognized and frequently misdiagnosed fungal infections that can clinically resemble bacterial and viral community-acquired pneumonia (CAP). This guidance is intended to help clinicians in outpatient settings test for these fungal diseases in patients with CAP to reduce misdiagnoses, unnecessary antibacterial use, and poor outcomes.

A conceptual framework for nomenclatural stability and validity of medically important fungi: a proposed global consensus guideline for fungal name changes supported by ABP, ASM, CLSI, ECMM, ESCMID-EFISG, EUCAST-AFST, FDLC, IDSA, ISHAM, MMSA, and MSGERC.

The rapid pace of name changes of medically important fungi is creating challenges for clinical laboratories and clinicians involved in patient care. We describe two sources of name change which have different drivers, at the species versus the genus level. Some suggestions are made here to reduce the number of name changes. We urge taxonomists to provide diagnostic markers of taxonomic novelties. Given the instability of phylogenetic trees due to variable taxon sampling, we advocate to maintain genera at the largest possible size. Reporting of identified species in complexes or series should where possible comprise both the name of the overarching species and that of the molecular sibling, often cryptic species. Because the use of different names for the same species will be unavoidable for many years to come, an open access online database of the names of all medically important fungi, with proper nomenclatural designation and synonymy, is essential. We further recommend that while taxonomic discovery continues, the adaptation of new name changes by clinical laboratories and clinicians be reviewed routinely by a standing committee for validation and stability over time, with reference to an open access database, wherein reasons for changes are listed in a transparent way.

Challenges in management of invasive fungal infections in stem cell transplant.

Invasive fungal infections cause significant morbidity and mortality in hematopoietic stem cell transplant recipients. In order to minimize these infections, prophylaxis has become routine, although the agents used have changed over time. This presents new challenges as we consider an approach to breakthrough infections and recognize the epidemiologic shift toward isolates with higher rates of drug resistance. This review outlines the management of the most common pathogens (Candida, Aspergillus, Mucorales) as well as rarer pathogens that have higher rates of resistance (Trichosporon, Fusarium, Scedosporium, and Lomentospora). We discuss potential approaches to proven or possible breakthrough infections with yeast and pulmonary mold disease. Finally, we outline the role for combination therapy and newer antifungals, acknowledging current knowledge gaps and areas for future exploration.

Update on Outbreak of Fungal Meningitis among U.S. Residents who Received Epidural Anesthesia at Two Clinics in Matamoros, Mexico.

BACKGROUND: Public health officials are responding to an outbreak of fungal meningitis among patients who received procedures under epidural anesthesia at two clinics (River Side Surgical Center and Clinica K-3) in Matamoros, Mexico, during January 1-May 13, 2023. This report describes outbreak epidemiology and outlines interim diagnostic and treatment recommendations. METHODS: Interim recommendations for diagnosis and management were developed by the Mycoses Study Group Research Education and Consortium (MSGERC) based on the clinical experience of clinicians caring for patients during the current outbreak or during previous outbreaks of healthcare-associated fungal meningitis in Durango, Mexico, and the United States. RESULTS: As of July 7, 2023, the situation has evolved into a multistate and multinational fungal meningitis outbreak. A total of 185 residents in 22 U.S. states and jurisdictions have been identified who might be at risk of fungal meningitis because they received epidural anesthesia at the clinics of interest in 2023. Among these patients, 11 suspected, 10 probable, and 10 confirmed U.S. cases have been diagnosed, with severe vascular complications and eight deaths occurring. Fusarium solani species complex has been identified as the causative agent, with antifungal susceptibility testing of a single isolate demonstrating poor in vitro activity for most available antifungals. Currently, triple therapy with intravenous voriconazole, liposomal amphotericin B, and fosmanogepix is recommended. CONCLUSIONS: Efforts to understand the source of this outbreak and optimal treatment approaches are ongoing, but infectious diseases physicians should be aware of available treatment recommendations. New information will be available on CDC's website.

Real-world Use of Mold-Active Triazole Prophylaxis in the Prevention of Invasive Fungal Diseases: Results From a Subgroup Analysis of a Multicenter National Registry.

Background: Antifungal prophylaxis can prevent invasive fungal diseases (IFDs) in high-risk, immunocompromised patients. This study assessed the real-world use of mold-active triazoles (MATs) for the prevention of IFDs. Methods: This subgroup analysis of a multicenter, observational, prospective registry in the United States from March 2017 to April 2020 included patients who received MATs for prophylaxis (isavuconazole, posaconazole, and voriconazole) at study index/enrollment. The primary objective was to describe patient characteristics and patterns of MAT use. Exploratory assessments included the frequency of breakthrough IFDs and MAT-related adverse drug reactions (ADRs). Results: A total of 1177 patients (256 isavuconazole, 397 posaconazole, 272 voriconazole, and 252 multiple/sequenced MATs at/after index/enrollment) were included in the prophylaxis subgroup analysis. Patient characteristics were similar across MAT groups, but risk factors varied. Hematological malignancy predominated (76.5%) across all groups. Breakthrough IFDs occurred in 7.1% (73/1030) of patients with an investigator's assessment (5.0% [11/221] isavuconazole; 5.3% [20/374] posaconazole; 4.0% [9/226] voriconazole; and 15.8% [33/209] multiple/sequenced MATs). Aspergillus (29.5% [18/61]) and Candida (36.1% [22/61]) species were the most common breakthrough pathogens recovered. ADRs were reported in 14.1% of patients, and discontinuation of MATs due to ADRs was reported in 11.1% of patients (2.0% [5/245] isavuconazole; 8.2% [30/368] posaconazole; and 10.1% [27/267] voriconazole). Conclusions: Breakthrough IFDs were uncommon in patients who received MATs for prophylaxis. Candida and Aspergillus species were the most commonly reported breakthrough pathogens. The discontinuation of MATs due to ADRs was infrequent. These findings support prophylactic strategies with isavuconazole, posaconazole, and voriconazole in high-risk patients.

Clinical safety and efficacy of novel antifungal, fosmanogepix, for the treatment of candidaemia: results from a Phase 2 trial.

BACKGROUND: Fosmanogepix is a first-in-class antifungal targeting the fungal enzyme Gwt1, with broad-spectrum activity against yeasts and moulds, including multidrug-resistant fungi, formulated for intravenous (IV) and oral administration. METHODS: This global, multicenter, non-comparative study evaluated the safety and efficacy of fosmanogepix for first-line treatment of candidaemia in non-neutropenic adults. Participants with candidaemia, defined as a positive blood culture for Candida spp. within 96 h prior to study entry, with ≤2 days of prior systemic antifungals, were eligible. Participants received fosmanogepix for 14 days: 1000 mg IV twice daily on Day 1, followed by maintenance 600 mg IV once daily, and optional switch to 700 mg orally once daily from Day 4. Eligible participants who received at least one dose of fosmanogepix and had confirmed diagnosis of candidaemia (<96 h of treatment start) composed the modified intent-to-treat (mITT) population. Primary efficacy endpoint was treatment success at the end of study treatment (EOST) as determined by the Data Review Committee. Success was defined as clearance of Candida from blood cultures with no additional antifungal treatment and survival at the EOST. RESULTS: Treatment success was 80% (16/20, mITT; EOST) and Day 30 survival was 85% (17/20; 3 deaths unrelated to fosmanogepix). Ten of 21 (48%) were switched to oral fosmanogepix. Fosmanogepix was well tolerated with no treatment-related serious adverse events/discontinuations. Fosmanogepix had potent in vitro activity against baseline isolates of Candida spp. (MICrange: CLSI, 0.002-0.03 mg/L). CONCLUSIONS: Results from this single-arm Phase 2 trial suggest that fosmanogepix may be a safe, well-tolerated, and efficacious treatment for non-neutropenic patients with candidaemia, including those with renal impairment.

Fungal Endocarditis: Pathophysiology, Epidemiology, Clinical Presentation, Diagnosis, and Management.

Fungal endocarditis accounts for 1% to 3% of all infective endocarditis cases, is associated with high morbidity and mortality (>70%), and presents numerous challenges during clinical care. Candida spp. are the most common causes of fungal endocarditis, implicated in over 50% of cases, followed by Aspergillus and Histoplasma spp. Important risk factors for fungal endocarditis include prosthetic valves, prior heart surgery, and injection drug use. The signs and symptoms of fungal endocarditis are nonspecific, and a high degree of clinical suspicion coupled with the judicious use of diagnostic tests is required for diagnosis. In addition to microbiological diagnostics (e.g., blood culture for Candida spp. or galactomannan testing and PCR for Aspergillus spp.), echocardiography remains critical for evaluation of potential infective endocarditis, although radionuclide imaging modalities such as 18F-fluorodeoxyglucose positron emission tomography/computed tomography are increasingly being used. A multimodal treatment approach is necessary: surgery is usually required and should be accompanied by long-term systemic antifungal therapy, such as echinocandin therapy for Candida endocarditis or voriconazole therapy for Aspergillus endocarditis.

Transabdominal ultrasound accurately identifies a significant iliac vein area-reducing lesion in patients with pelvic venous insufficiency.

BACKGROUND: In patients with pelvic venous disorders secondary to pelvic venous insufficiency (PVI), the optimal imaging modality is ill-defined. Transabdominal ultrasound (TAU) is widely used to identify the presence of iliac vein stenosis. The purpose of the present investigation is to determine the accuracy of TAU for determining the presence of an iliac vein area-reducing lesion compared with intravascular ultrasound (IVUS). METHODS: From January to December 2020, a retrospective review of prospectively collected data from 96 patients treated for symptomatic PVI at the Center for Vascular Medicine was performed. All patients had complete history and physical examination findings, demographics, CEAP (clinical, etiologic, anatomic, pathophysiologic), revised venous clinical severity score, and TAU, diagnostic venography, and IVUS measurements recorded in our electronic medical record system. All TAU measurements were performed by the same ultrasound technician with the patient in the supine position. Iliac vein diameters of the common femoral, external iliac, and common iliac veins and the inferior vena cava were obtained. Differences in body habitus were normalized by dividing the minimum diameter measurement of the stenotic vessel with that of the ipsilateral common femoral vein, subtracting this number from 1 and multiplying by 100 (stenosis = [1 - minimal diameter/common femoral diameter] × 100). The normalized stenoses were then compared with the IVUS-derived area reducing measurements. A receiver operating characteristic curve was created, and logistic regression analysis for the probability of predicting an area-reducing lesion of >50% and >60% with TAU was performed. The sensitivity, specificity, and positive and negative predictive values were calculated. RESULTS: The average age of the entire cohort was 49.8 ± 13.5 years, with 69 women and 27 men. The CEAP distribution was as follows: C0, 5%; C1, 5%; C2, 10%; C3, 40%; C4a,b, 30%; C5, 7%; and C6, 3%. The average revised venous clinical severity score was 6.2 ± 2.6. The indications for intervention were leg symptoms alone in 43%, pelvic symptoms alone in 3%, and combined leg and pelvic symptoms in 54%. TAU identified a stenosis of ≥50% in 92 of the 96 patients (96%). For a ≥50% stenosis, a normalized diameter of ≤3 mm demonstrated a sensitivity, specificity, and positive and negative predictive value of 75%, 75%, 98%, and 12%, respectively. Logistic regression analysis indicated that TAU was significant in predicting the presence of a ≥60% area-reducing lesion (odds ratio, 1.03; 95% confidence interval, 1.01-1.05; P = .009). The area under the receiver operating characteristic curve (c-statistic) was 68.6%. The sensitivity, specificity, and positive and negative predictive values were 66.7%, 66.7%, 81.5%, and 47.6%, respectively, for a normalized diameter of ≥4 mm. CONCLUSIONS: The ability of TAU to identify an iliac vein stenosis of ≥50% is 96%. The positive predictive value for TAU to identify a ≥60% iliac vein area-reducing lesion is high, with moderate sensitivity and specificity. For patients with symptoms consistent with pelvic venous disorders secondary to PVI, TAU is a good preintervention screening modality for properly trained vascular imaging specialists with findings that correlate well with IVUS measurements.