Clinical Consensus Statement: Vaginal Energy-Based Devices.

ABSTRACT: This clinical consensus statement on vaginal energy-based devices (EBDs) reflects an update by content experts from the American Urogynecologic Society's EBD writing group. In 2019, the American Urogynecologic Society's EBD writing group used a modified Delphi process to assess statements that were evaluated for consensus after a structured literature search. A total of 40 statements were assessed and divided into 5 categories: (1) patient criteria, (2) health care provider criteria, (3) efficacy, (4) safety, and (5) treatment considerations. Of the 40 statements that were assessed, 28 reached consensus and the remaining 12 did not. Lack of evidence was among the main reasons that vulvovaginal EBD treatment statements did not reach consensus. In March 2022, these statements were reassessed using the interim literature.

A Non-Invasive Determination of LOXL1 and Fibulin-5 Levels in the Vaginal Secretions of Women with and Without Pelvic Organ Prolapse.

OBJECTIVES: The aim of this study was to determine if lysyl oxidase-like 1 (LOXL1) and Fibulin-5 (Fib-5), two crucial proteins in the elastin metabolism pathway, are detectable in the vaginal secretions of women with and without pelvic organ prolapse (POP). We then sought to quantify levels of these proteins in relation to prolapse. METHODS: Vaginal secretions were obtained from 48 subjects (13 (27.1%) without and 35 (72.9%) with POP-Q Stage 2-4 prolapse). Eleven (22.9%) subjects were premenopausal and 37 (77.1%) were postmenopausal. Presence of LOXL-1 and Fibulin-5 within specimens were first identified via western blotting. Enzyme-Linked Immunosorbent Assays specific for LOXL1 and Fibulin-5 were conducted to quantify total protein secretion. RESULTS: LOXL1 was detected in 45/48 (93.8%) and Fibulin-5 was seen in 24/48 (50%) of subjects. LOXL1 values were lower in women without prolapse (13.3 ng/100 mg median, 24.4 IQR) vs. those with prolapse (26.4 ng/100 mg, 102.2 IQR). On multivariate analysis controlling for age, women with prolapse had a 544% (p=0.0042 higher LOXL1 protein level compared to those without. There was no significant differences in LOXL1 or Fibulin-5 protein detection with relation to menopausal status in bivariate analysis. CONCLUSIONS: This is the first published report of non-invasively measuring urogenital LOXL1 and Fibulin-5. In vaginal secretions, LOXL1 protein is higher in subjects with POP than those without.

Cosmetic gynecology-a systematic review and call for standardized outcome measures.

OBJECTIVE: Cosmetic gynecology, a field which has garnered substantial attention over recent years, lacks a universally accepted nomenclature. The aim of this systematic review is to evaluate techniques, outcome measures reported, and adverse events in patients undergoing cosmetic gynecology procedures and offer recommendations to improve reporting metrics. METHODS: A systematic literature search was performed using electronic databases from inception to April 2019. The search was based on 51 unique cosmetic gynecology keywords such as: "labiaplasty," "vaginal rejuvenation," and "liposuction mons pubis." All English full-text prospective and retrospective observational and interventional studies with at least five subjects that describe a cosmetic gynecology procedure were included. Only full-text articles were included. This protocol has been registered with PROSPERO (CRD 42019131860). RESULTS: A total of 1837 articles were identified from the search strategy with 42 included in the quantitative synthesis. Procedures described included: labia minora reduction with or without clitoral hood reduction, labia majora augmentation, surgical vaginal caliber reduction, mons pubis reduction/suspension, and energy-based therapy for vaginal laxity or vulvar laxity. Efficacy and satisfaction metrics were highly variable ranging from validated questionnaires to no outcome subjectively or objectively quantified. Complication rates varied by procedure but were generally low and ranged between Clavien-Dindo grades I-III. CONCLUSIONS: Although there is a breadth of literature on cosmetic gynecology surgical techniques and short-term complication rates, the terminology and outcome measures utilized are heterogeneous. To address this, standardized terminology along with uniform cosmetic and functional endpoints must be developed.

Vaginal Energy-Based Devices.

This clinical consensus statement on vaginal energy-based devices (EBDs) reflects statements drafted by content experts from the American Urogynecologic Society's EBD writing group. The American Urogynecologic Society's EBD writing group used a modified Delphi process to assess statements that were evaluated for consensus after a structured literature search. A total of 40 statements were assessed and divided into 5 categories: (1) patient criteria, (2) health care provider criteria, (3) efficacy, (4) safety, and (5) treatment considerations. Of the 40 statements that were assessed, 28 reached consensus and the remaining 12 did not. Lack of evidence was among the main reasons that vulvovaginal EBD treatment statements did not reach consensus.

Contemporary approaches to perioperative management of coronary stents and to preoperative coronary revascularization: a survey of 374 interventional cardiologists.

BACKGROUND: We sought to assess contemporary approaches of interventional cardiologists to preoperative evaluation and perioperative management of coronary stents. METHODS: Online survey sent in December 2008 to 3771 US interventional cardiologists (10% completion rate). RESULTS: Patients with coronary stents needing noncardiac surgery are frequently encountered: 49% and 30% of the cardiologists saw two to four and five or more such patients, respectively, every month. The majority of participants recommended (a) ≥6 weeks delay as optimal for surgery after bare metal stent implantation; (b) continuing dual antiplatelet therapy in stent patients undergoing minor bleeding risk procedure; (c) avoiding drug-eluting stent implantation in patients known to need noncardiac surgery within 12 months from percutaneous coronary intervention; (d) treating perioperative stent thrombosis with primary percutaneous coronary intervention; and (e) performing nuclear stress testing in stable patients who need major noncardiac surgery. There was equipoise in the need for "bridging" with glycoprotein IIb/IIIa inhibitors in patients needing early surgery after drug-eluting stent implantation. CONCLUSION: Interventional cardiologists frequently treat patients who require surgery after stent implantation. Although agreement exists on the optimum delay for surgery after stenting, on the need for bare metal stents or balloon angioplasty alone if early noncardiac surgery is needed, and on the treatment of perioperative stent thrombosis, there is divergence of opinion on the need for preoperative stress testing and on the "bridging" therapy for patients who need surgery early after stent implantation.

Reproducibility of near-infrared spectroscopy for the detection of lipid core coronary plaques and observed changes after coronary stent implantation.

OBJECTIVES: To evaluate the reproducibility of catheter-based intracoronary near-infrared spectroscopy (NIRS) for the detection of lipid core coronary plaques (LCPs) and to examine stenting-induced changes in NIRS findings. BACKGROUND: The in-vivo reproducibility of coronary NIRS findings and their changes after stenting have not previously been characterized. METHODS: NIRS assessment using an automated pullback catheter was performed in duplicate in 36 vessels in 31 patients. The reproducibility of the Lipid Core Burden Index (LCBI) and the presence and number of LCPs was assessed. The changes in LCBI after stenting were also assessed in 25 vessels in 22 patients. RESULTS: LCBI of the first and second pullback was 64 ± 43 and 70 ± 62, respectively, with excellent correlation (Spearman's rho 0.927, intraclass correlation coefficient 0.925). Depending on LCP definition, mean LCP length, and median LCP number ranged from 2.44 to 17.25 mm, and from 0 to 2, respectively per artery studied. High correlation was observed between the two pullbacks for total LCP length (depending on the LCP definition used, the Spearman's rho and the intraclass correlation coefficient ranged from 0.72 to 0.89, and from 0.76 to 0.91, respectively) and for LCP number (depending on the LCP definition used, the Spearman's rho and the intraclass correlation coefficient ranged from 0.70 to 0.87, and from 0.67 to 0.88, respectively). The mean LCBI decreased by 40% from 78 ± 47 to 48 ± 38 after stenting (P < 0.001). CONCLUSION: The LCBI and LCP length NIRS measurements have high reproducibility. LCBI significantly decreases after coronary stenting.

Analysis of saphenous vein graft lesion composition using near-infrared spectroscopy and intravascular ultrasonography with virtual histology.

OBJECTIVE: To examine the composition of saphenous vein graft (SVG) lesions using two novel modalities, near-infrared spectroscopy (NIRS) and intravascular ultrasonography with virtual histology (IVUS-VH). METHODS: We performed NIRS and IVUS-VH imaging of 23 SVGs in 21 patients undergoing clinically-indicated angiography. RESULTS: Mean patient and SVG age was 66±7 and 10±7 years, respectively. SVG lesion location was aorto-ostial in 8 (35%), body in 13 (57%) and distal anastomotic in 2 (9%). Compared to anastomotic lesions, body lesions had larger mean lumen area (6.4±1.8 mm2 vs. 4.2±6.4 mm2, P=0.02) but similar mean plaque burden (73±5% vs. 70±10%, P=0.66). A NIRS lipid core plaque was identified in 9 of 13 body lesions vs. 1 of 10 anastomotic lesions (69% vs. 10%, P=0.005). SVG body lesions had higher lipid core burden index (LCBI) compared to anastomotic lesions (184±76 vs. 49±54, P<0.001). By IVUS-VH, SVG lesions had high % necrotic core (28±10%) and % dense calcium (13±10%), without any significant difference between body and anastomotic sites. Older SVG age was associated with higher lesion and vessel LCBI (r=0.76 and r=0.64, respectively, P<0.001), but was not associated with IVUS-VH determined plaque composition. Higher HDL-cholesterol was associated with lower lesion LCBI (r=-0.43, P=0.04). CONCLUSIONS: NIRS-measured lipid core plaque in SVGs increases with increasing SVG age and is infrequent in anastomotic lesions. No association was found between IVUS-VH plaque composition measurements and SVG lesion location or age.

Validation of a method for determination of the ankle-brachial index in the seated position.

OBJECTIVE: To validate a method for determination of the ankle-brachial index (ABI) in the seated position. BACKGROUND: Peripheral arterial disease (PAD) is a prevalent disorder that is associated with quality of life impairment and increased risk of a major cardiovascular event. The ABI is the initial test for screening and diagnosis of PAD. To prevent error due hydrostatic pressure, accurate measurement of the ABI requires supine patient positioning. Access to ABI measurement is limited for patients who are immobilized or unable to lie flat. METHODS: Patients presenting to a vascular laboratory for suspected arterial disease were enrolled. Arm and ankle blood pressures were measured in the supine and seated positions. Seated ankle pressures were corrected by the following physiology-based formula: Corrected ankle pressure = Measured ankle pressure - D*(.078), where D = the vertical distance between the arm and ankle cuffs (mm). This formula equates to a correction factor of 78 mm Hg per meter distance between the arm and ankle cuffs. Corrected ankle pressure measurements were used for seated ABI calculation. RESULTS: Complete data were available for 100 patients. Mean ABI was 0.97, and 31% of patients had an ABI < or =0.9. There was excellent correlation between supine and corrected seated ankle pressure measurements (r = 0.884-0.936, P < .001). The difference between measurements was negligible (<5 mm Hg). Similarly, there was excellent correlation between supine and seated ABI measures (r = 0.936, P < .001). There was no significant difference between the supine and seated ABI measures. CONCLUSION: We have developed and validated a method for determination of the ABI in the seated position which can be used to broaden availability of PAD testing. This method could also be incorporated into new technologies for ABI determination in the seated position.