Voices on Zika: Reproductive Autonomy and Shared Decision-Making During an Evolving Epidemic.

INTRODUCTION: We aimed to understand the degree to which pregnant individuals exposed to emerging infections, such as Zika, are engaged by providers in shared decision-making and explore potential barriers to inform strategies to improve care for those most at risk for inequities. Studies have demonstrated that Latinx and Black people are less likely to engage in shared decision-making and are less engaged by providers. Limited research explores factors impacting shared decision-making in prenatal care and in the setting of recent epidemics. METHODS: We conducted an exploratory qualitative study of individuals eligible for prenatal screening owing to Zika exposure during pregnancy. Given an established connection between autonomy and shared decision-making, we used the Reproductive Autonomy Scale and the Three Talk Model for shared decision-making to inform our semistructured interview guide. Interviews were conducted in Spanish or English. and participants were recruited from a federally qualified health center and a tertiary care obstetric clinic until thematic saturation was achieved. Interviews were recorded, translated, and transcribed and two coders used modified grounded theory to generate themes. RESULTS: We interviewed 18 participants from May to December 2017. Participant narratives demonstrated reproductive autonomy in pregnancy decision-making, with decision support from families, fatalism in pregnancy planning, and limited engagement by providers around decisions and implications of Zika virus testing. Hierarchy in provider dynamics, perceived stigma around emigration and travel, and language barriers impacted participant engagement in shared decision-making. CONCLUSIONS: Participants demonstrated personal autonomy in reproductive decision-making, but demonstrated limited engagement in shared decision-making with regard to prenatal Zika testing. Provider promotion of shared decision-making using culturally centered decision tools to elicit underlying beliefs and deepen context for option, choice, and decision talk is critical in prenatal counseling to support equitable outcomes during evolving pandemics.

Externalized conductors and electrical dysfunction in transvenous ventricular leads: Results of the Cardiac Lead Assessment Study.

Background: The Cardiac Lead Assessment Study (CLAS) was a large prospective, multicenter, international postmarket surveillance study conducted at 45 sites. Objective: The purpose of CLAS was to examine the prevalence and incidence of externalized conductors and electrical dysfunction in subjects with selected St. Jude Medical defibrillator and left ventricular leads. Methods: Cinefluoroscopy was used to determine the presence of externalized conductors at enrollment and at 12-, 24-, and 36-month follow-up visits. Lead electrical measurements were collected systematically. Results: The study enrolled 2216 subjects with a total of 2847 study leads. The prevalence of externalized conductors through 36 months for Riata leads was 30.9%, Riata ST leads 12.6%, Durata leads 0.5%, and QuickSite/QuickFlex leads 4.7%. The prevalence of electrical dysfunction through 36 months for Riata was 4.0%, Riata ST 3.3%, Durata 2.4%, and QuickSite/QuickFlex 0.3%. In Riata and Riata ST leads with externalized conductors, there was a low risk of electrical dysfunction. None of the Durata or QuickSite/QuickFlex leads with externalized conductors developed electrical dysfunction. There was no evidence of an electrical short in a high-voltage shocking circuit leading to failed shock. Conclusion: A high prevalence of externalized conductors was found in Riata and Riata ST defibrillator leads, with a higher risk of externalization for 8F Riata leads than for 7F Riata ST leads. The 98% reduction in prevalence of externalized conductors in Durata leads compared to Riata/Riata ST leads confirms that the design improvements culminating in Durata leads significantly improved abrasion resistance and durability.

Postoperative opioid use for patients with chronic pelvic pain undergoing robotic surgery for resection of endometriosis.

We aimed to identify the amount of opioids used in the postoperative setting for patients with a history of chronic pelvic pain undergoing robotic surgical excision of endometriosis and compare this to patients undergoing benign robotic gynecologic surgery for other indications. We conducted a retrospective cohort study in an urban academic university hospital from January 2019 to March 2020. Data regarding opioid use was collected via a patient-reported survey that was given at the 3 weeks follow-up visit. Data regarding opioid use was compared to patients undergoing robotic surgery for other benign gynecologic indications. Our study included 158 patients, 119 undergoing surgery for endometriosis and 39 patients undergoing robotic surgery for other benign gynecologic indications. Patients undergoing surgery for endometriosis used on average 105.9 morphine milligram equivalents (MME), equivalent to 14 tabs of oxycodone 5 mg. There was no statistically significant difference in the amount of opioids used postoperatively based on stage of endometriosis or need for hysterectomy. Patients undergoing surgery for other benign indications used on average 49.4 MME, equivalent to 6 tabs of oxycodone 5 mg. The difference in amount of opioids used between patients with and without endometriosis was statistically significant. In conclusion, patients undergoing robotic surgery for endometriosis used over two times as many opioids postoperatively as patients without endometriosis and have a higher perceived postoperative pain. Providers should be aware of this difference in order to provide better pain control for this patient population.

Comparison of Transvaginal and Transumbilical Laparoscopic Single-Site Surgery for Ovarian Cysts.

BACKGROUND: Minimally invasive surgery is currently a preferred treatment for symptomatic ovarian cyst(s), with single-site techniques, such as transumbilical laparoendoscopic single-site surgery (TU-LESS) and transvaginal laparoendoscopic single-site surgery (TV-LESS), gaining increasing popularity. Although both methods have delivered positive outcomes, there is currently limited literature directly comparing TU-LESS and TV-LESS. OBJECTIVES: This study had two primary objectives: (1) to evaluate the safety and feasibility of TV-LESS and TU-LESS for the treatment of ovarian cysts and (2) to compare the surgical and postoperative outcomes of the two procedures. METHOD: This was a prospective observational clinical analysis of 81 patients with a diagnosis of benign ovarian cyst with indication for TV-LESS or TU-LESS. Surgeries were performed at a tertiary hospital between February 1, 2018 and January 31, 2020. Patients were divided into TV-LESS (n = 40) and TU-LESS groups (n = 40), with one excluded due to severe pelvic adhesive disease. Demographics, operation outcomes, and follow-up details were compared. RESULTS: All 80 patients underwent uncomplicated procedures. The two groups were demographically matched (except age), with no difference in operation time, intra-operative blood loss, hemoglobin loss, and hospitalization costs (P > 0.05). However, TV-LESS patients had significantly faster time to ambulation (P < 0.001), faster time to return of bowel function (P < 0.001), less postoperative pain level (P < 0.001), and shorter length of hospital stay (P < 0.001). The cosmetic scores at 1, 4, and 24 weeks after surgery were also higher for the TV-LESS group. CONCLUSION: Our preliminary experience suggested that TU-LESS and TV-LESS are both feasible and safe for ovarian cystectomy and salpingo-oophorectomy. However, TV-LESS may provide three main advantages including: (1) fewer postoperative complications (i.e. incisional hernia); (2) less postoperative pain; and (3) improved cosmetic satisfaction.

Minimally invasive surgical management of a cornual ectopic pregnancy, with and without a concurrent intrauterine pregnancy.

OBJECTIVE: To describe techniques for resection of a cornual heterotopic pregnancy. DESIGN: This video demonstrates a surgical technique for excision of a cornual heterotopic pregnancy with narrative video footage using two case examples. SETTING: The incidence of cornual heterotopic pregnancy is unknown; however, the incidence of heterotopic pregnancy itself has increased through the use of assisted reproductive technologies and the majority of cornual heterotopic pregnancies occur after assisted reproductive technologies use. These cases have been treated traditionally using exploratory laparotomy and cornual wedge resection with good outcomes. With advancements in minimally-invasive surgical techniques, laparoscopic resection of cornual heterotopic pregnancies has been demonstrated to be safe and feasible. PATIENT(S): A patient with an 8-week cornual heterotopic pregnancy and a patient with a 10-week cornual ectopic pregnancy. INTERVENTIONS: Laparoscopic resection of the cornual ectopic pregnancy. MAIN OUTCOME MEASURE(S): Feasibility of a "purse-string" technique for the resection of a heterotopic cornual pregnancy. RESULT(S): Robotic-assisted laparoscopic resection of a cornual heterotopic pregnancy can be performed with minimal blood loss with the use of the "purse-string" technique in settings where vasopressin cannot be used for hemostasis. This technique includes the use of a 2-0 V-Loc suture in a circumferential fashion around the ectopic pregnancy, which allows for faster suturing and immediate tension at the myometrium. The same suture is then used to close the defect, which allows for a simpler and efficient closure with minimal entry into the myometrium. CONCLUSION(S): In this video, we demonstrate the successful resection of cornual heterotopic pregnancy using a "purse-string" surgical technique. This technique allows for minimal blood loss in cases where additional techniques for hemostasis cannot be used, such as injection of vasopressin and uterine artery ligation.

Robot-assisted Transvaginal Natural Orifice Transluminal Endoscopic Surgery for Management of Endometriosis: A Pilot Study of 33 Cases.

STUDY OBJECTIVE: To describe the surgical techniques and short-term outcomes for 33 cases of robot-assisted transvaginal natural orifice transluminal endoscopic surgery (RvNOTES) to treat endometriosis. DESIGN: Retrospective case series study. SETTING: Academic tertiary care university hospital in Houston, TX. PATIENTS: Patients who underwent RvNOTES resection of endometriosis between March 2020 and March 2021. INTERVENTIONS: RvNOTES. MEASUREMENTS AND MAIN RESULTS: A total of 33 cases of patients, with pathology-confirmed endometriosis, who underwent RvNOTES total hysterectomy with resection of endometriosis were included in the study. Thirty-two cases were completed successfully by RvNOTES, and 1 case was converted to robotic transumbilical single-incision laparoscopic surgery plus 1 additional port owing to an obliterated posterior cul-de-sac and upper abdominal wall endometriosis. The average operative time was 141.93 ± 40.22 (85-264) minutes, and the mean estimated blood loss was 52.25 ± 33.82 (25-150) mL. The mean preoperative pain score using the visual analog scale (VAS) score was 8.08 ± 2.39 (2-10). The mean VAS pain score 1 week after surgery was 6.73 ± 2.62 (0-10), which was significantly lower than the preoperative scores (p = .059). The mean VAS pain score in the second and third week after surgery was 4.81 ± 2.42 (0-9) and 2.63 ± 2.36 (0-7) respectively, which were both significantly lower than those before surgery (p = .001). There were 4 postoperative complications: urinary tract infection, pneumonia, headache requiring admission, and conversion disorder. CONCLUSION: RvNOTES is a safe and feasible approach for the treatment of endometriosis, with promising short-term improvements in pain.

Surgical Outcomes of Hysterectomy via Robot-assisted versus Traditional Transvaginal Natural Orifice Transluminal Endoscopic Surgery.

STUDY OBJECTIVE: To evaluate the safety and feasibility of robot-assisted transvaginal natural orifice transluminal endoscopic surgery (R-vNOTES) hysterectomy when compared with traditional vNOTES (T-vNOTES) hysterectomy. DESIGN: Retrospective chart review. SETTING: Academic tertiary setting. PATIENTS: Total of 114 patients with benign gynecologic indication for hysterectomy. INTERVENTIONS: T-vNOTES or R-vNOTES hysterectomy performed by a single minimally invasive gynecologic surgeon in the study period. MEASUREMENTS AND MAIN RESULTS: The primary outcome of this study was surgical equivalence, measured principally by total operative time between T-vNOTES and R-vNOTES hysterectomy. Secondary operative outcomes that were measured included estimated blood loss, length of hospital stay, reported postoperative pain levels, and number of conversions. A total of 79 women underwent T-vNOTES hysterectomy, and 35 women underwent R-vNOTES hysterectomy without differences in operative time (p = .37), estimated blood loss (p = .27), length of hospital stay (p = .06), or reported postoperative pain levels at weeks 1, 2, and 3 after surgery (p = .78, p = .36, p = .38, respectively). A total of 6 patients underwent conversion in the T-vNOTES hysterectomy group compared with 0 in the R-vNOTES hysterectomy group; however, this was not statistically significantly different, and there were no conversions to laparotomy. CONCLUSION: R-vNOTES hysterectomy is a feasible approach to surgery when compared with T-vNOTES hysterectomy and warrants further consideration as a skill set in a gynecologic surgeon's toolbox. Wristed instruments may allow surgeons who are inexperienced in single-site laparoscopy to adopt vNOTES more quickly as a new technique when performing hysterectomy through a comparable minimally invasive approach.

Integration of a Robotic Platform for Sacrocolpopexy in Transvaginal Natural Orifice Transluminal Endoscopic Surgery: A Novel Surgical Technique.

OBJECTIVE: To demonstrate the feasibility and the simplified surgical techniques of intraabdominal suturing and knot-tying in robotic transvaginal natural orifice transluminal endoscopic surgery (RV-NOTES) sacrocolpopexy. MATERIALS AND METHODS: We report on two patients with symptomatic stage II apical pelvic organ prolapse who underwent a new technique of RV-NOTES sacrocolpopexy. Case one: A 69-year-old G2P2002 with a history of two prior vaginal deliveries presented with a vaginal bulge and pressure symptoms. She was initially fitted for a pessary but was unsatisfied and elected to proceed with surgical intervention. Case two: A 50-year-old G2P0011 female with a history of one prior vacuum-assisted vaginal delivery presented with symptoms of vaginal mass and bleeding due to an endometrial polyp. She was noted to have stage 2 apical prolapse and opted for transvaginal sacrocolpopexy. RESULTS: Both patients were observed overnight and discharged home twelve hours after surgery on postoperative day 1, after completing a voiding trial. For both patients, the postoperative course was unremarkable, and they only required one day of pain medications. At the three-week follow-up visit, they endorsed no postoperative pain or complications, and the POP-Q stage was noted to be 0. Patients had telemedicine visits at eight weeks postoperatively, at which time they had returned to their regular activities and denied symptoms of vaginal bulge or pressure. CONCLUSION: Robotic assisted transvaginal NOTES sacrocolpopexy is a feasible and an alternative to traditional laparoscopic NOTES sacrocolpopexy.

A comparison of three approaches for laparoscopic single-site (LESS) myomectomy: conventional, robotic, and hand assisted.

The objective of this study is to determine the feasibility and explore criteria for patient selection for three methods of LESS myomectomy: conventional (C-LESS), robotic-assisted (RA-LESS), and hand-assisted (HA-LESS). This was a retrospective case review of 72 patients with uterine myomas, conducted in a large academic tertiary care hospital between March 1, 2015, and November 7, 2018. LESS myomectomy via conventional, robotic, and hand-assisted routes. 43 patients underwent C-LESS, 15 underwent RA-LESS, and 14 underwent HA-LESS, with no conversions to open abdominal myomectomy. The operative outcomes were compared across the three approaches. The HA-LESS group had the largest mean number (HA: 6.9; C: 3.7; RA: 2.9, P=0.001), diameter (HA: 11.3 cm; C: 9.3 cm; RA: 7.1 cm, P=0.035), and weight (HA: 850.1 g; C: 320.7 g; RA: 181.1 g, P=0.003) of myomas removed per patient. The use of this method was also found to have a direct correlation with estimated preoperative uterine size (HA: 20.1 weeks; C: 16.2 weeks; RA: 12.0 weeks, P=0.001. Operative time and postoperative stay were found to be not statistically different across groups. We conclude that all three types of LESS myomectomy are feasible with comparable surgical outcomes. Most importantly, our findings indicate that hand assistance can be combined with C-LESS myomectomy for large or multi-fibroid uterus without compromising operating time or patient recovery. Notably, we found that uterine size could be a useful tool for the determination of the surgical approach.

Multi-centered evaluation of a novel fixed-dose four-factor prothrombin complex concentrate protocol for warfarin reversal.

INTRODUCTION: Previous studies have shown fixed-dose 4PCC to be as effective as standard-dose 4PCC for warfarin reversal. However, certain patient populations such as those with high total body weight (TBW) or elevated baseline INR may be at increased risk for treatment failure. The purpose of this study was to validate the efficacy of a novel fixed-dose 4PCC protocol for warfarin reversal. METHODS: This was a multi-centered observational comparison of patients who received 4PCC for warfarin reversal. Fixed-dose patients received 1500 units of 4PCC with the dose increased to 2000 units in patients with a baseline INR ≥ 7.5, a TBW ≥ 100 kg, or for intracranial hemorrhage (ICH). Standard-dosing followed manufacturer recommendations. The primary outcome was achievement of a post-4PCC INR of ≤1.4. Secondary outcomes included target INR achievement among patients with a baseline INR ≥ 7.5, a TBW ≥ 100 kg, or neurologic bleeding indications; hospital length of stay; cost of therapy; and thromboembolic complications. RESULTS: A total of 116 patients were included in the standard-dose group and 75 in the fixed-dose group. There was no difference in the primary outcome (65% vs 57%, p = 0.32). There was no difference in secondary outcomes aside from cost of therapy in which fixed-dose 4PCC was less expensive than standard-dose 4PCC. CONCLUSION: A fixed-dose 4PCC regimen for warfarin reversal of 1500 units, with an increased dose of 2000 units for select patients, is as effective as standard-dose 4PCC for INR reversal.

Hemodynamic Effects of Propofol for Induction of Rapid Sequence Intubation in Traumatically Injured Patients.

Present guidelines for emergency intubation in traumatically injured patients recommend rapid sequence intubation (RSI) as the preferred method of airway management but specific pharmacologic agents for RSI remain controversial. To evaluate hemodynamic differences between propofol and other induction agents when used for RSI in trauma patients. Single-center, retrospective review of trauma patients intubated in the emergency department. Patients were divided in two groups based on induction agent, propofol or nonpropofol. The primary outcome was incidence of hypotension within 30 minutes of intubation. Secondary outcomes included hospital length of stay and inhospital mortality. The study protocol was approved by the Institutional Review Board. Of the 744 patients identified, 83 were analyzed, 43 in the propofol group and 40 in the nonpropofol group. Groups were similar at baseline in terms of pre-RSI hemodynamics, injury mechanism, initial Glasgow Coma Score, and Injury Severity Score. On univariate analysis, although not statistically significant, postintubation hypotension was more common in patients who received propofol compared with those who did not, 39.5 per cent versus 22.5 per cent (P = 0.9). When adjusted for age, Injury Severity Score, and pre-RSI hemodynamics, the risk of hypotension among propofol-treated patients was significantly higher (OR = 3.64; 95% Confidence interval 1.16-13.24). There were no significant differences between groups in hospital length of stay or mortality. Propofol increases the odds of postintubation hypotension in traumatically injured patients. Considerable caution should be used when contemplating the use of propofol the for induction of injured patients requiring RSI because other agents possess more favorable hemodynamic profiles.

Shape-Changing Photodegradable Hydrogels for Dynamic 3D Cell Culture.

Inspired by natural examples of swelling-actuated self-folding, we utilize photodegradable hydrogels as dynamically tunable, shape-changing scaffolds for culturing cells. Poly(ethylene glycol) diacrylate-based thin films incorporating ortho-nitrobenzyl (o-NB) moieties are transformed from flat 2D sheets to folded 3D structures by exposure to 365 nm UV light. As the UV light is attenuated through the thickness of the gel, a cross-link density gradient is formed. This gradient gives rise to differential swelling and a bending moment, resulting in gel folding. By tuning the UV light dose and the molar ratio of photodegradable to nondegradable species, both the initial degree of folding and the relaxation of tubular structures can be accurately controlled. These self-folding photodegradable gels were further functionalized with a cell-adhesive RGD peptide for both seeding and encapsulation of C2C12 mouse myoblasts. Light-induced folding of RGD functionalized hydrogels from flat sheets to tubular structures was demonstrated 1 or 3 days after C2C12 seeding. The C2C12s remained adhered on the inner walls of folded tubes for up to 6 days after folding. The minimum measured diameter of a tubular structure containing C2C12s was 1 mm, which is similar to the size of muscle fascicles. Furthermore, the viability of encapsulated C2C12s was not adversely affected by the UV light-induced folding. This is the first account of a self-folding material system that allows 2D-3D shape change in the presence of both seeded and encapsulated cells at a user-directed time point of choice.

Measurement of consensual accommodation in vision-impaired eyes.

PURPOSE: To measure the accommodative response in unsighted or profoundly vision impaired (PVI) eyes when accommodation is elicited in the fellow, sighted eye. METHODS: Eighty-eight unilaterally PVI subjects (UPS) and 97 bilaterally sighted subjects (BSS) (10 to 45 years) were enrolled. Subjects had clear ocular media for auto-refraction and could steadily fixate targets with the sighted eye. For BSS, a long-pass filter was placed in front of one eye to simulate unilateral blindness. Both eyes were measured with a Shin-Nippon auto-refractor while fixating a 4/40 letter at 4 m and then an N8 letter at 40 cm and at 33 cm. Accommodation was calculated as the difference between distance and near refraction. RESULTS: Only subjects with repeatable alignment between measurements were included in the analyses (64 UPS, 95 BSS). Results were analyzed using t test and a generalized linear mixed model including age, sightedness, distance spherical equivalent, and accommodation as factors. The t test found no significant difference between eyes for UPS (p = 0.981 at 40 cm and p = 0.663 at 33 cm). For BSS, the sighting eye produced statistically significant but only slightly greater amounts of accommodation than the filtered eye (0.098 diopters [D], p = 0.002 at 40 cm and 0.189 D, p < 0.001 at 33 cm). The generalized linear mixed model found no difference between BSS and UPS in terms of difference in accommodation between eyes (p = 0.128 at 40 cm and p = 0.157 at 33 cm). CONCLUSIONS: The PVI eyes of unilaterally PVI individuals display similar accommodative response to their fellow, sighted eyes when accommodation is elicited by near target of up to 3 D to the fellow eye. However, the difference in accommodative response between PVI and fellow, sighted eye is related to the amount of accommodation elicited.

Effects of substrate mechanics on contractility of cardiomyocytes generated from human pluripotent stem cells.

Human pluripotent stem cell (hPSC-) derived cardiomyocytes have potential applications in drug discovery, toxicity testing, developmental studies, and regenerative medicine. Before these cells can be reliably utilized, characterization of their functionality is required to establish their similarity to native cardiomyocytes. We tracked fluorescent beads embedded in 4.4-99.7 kPa polyacrylamide hydrogels beneath contracting neonatal rat cardiomyocytes and cardiomyocytes generated from hPSCs via growth-factor-induced directed differentiation to measure contractile output in response to changes in substrate mechanics. Contraction stress was determined using traction force microscopy, and morphology was characterized by immunocytochemistry for α-actinin and subsequent image analysis. We found that contraction stress of all types of cardiomyocytes increased with substrate stiffness. This effect was not linked to beating rate or morphology. We demonstrated that hPSC-derived cardiomyocyte contractility responded appropriately to isoprenaline and remained stable in culture over a period of 2 months. This study demonstrates that hPSC-derived cardiomyocytes have appropriate functional responses to substrate stiffness and to a pharmaceutical agent, which motivates their use in further applications such as drug evaluation and cardiac therapies.

Influence of accommodation on off-axis refractive errors in myopic eyes.

INTRODUCTION: This study aims to understand off-axis refraction during accommodation and to identify whether the relative hyperopia generally observed in myopic eyes changes with accommodation. METHOD: Twenty bilateral myopes (18 to 33 years) between -0.50 D and -4.25 D (spherical equivalent) and astigmatism less than 1.25 D participated in this study. A soft contact lens was used to correct refractive error for all measurements. Non-cycloplegic autorefraction was measured at the fovea and 20 degrees, 30 degrees, and 40 degrees eccentricities in the nasal and temporal retina at distances of 2 m, 40 cm, and 30 cm. RESULTS: Peripheral refractive error, relative to central refraction, became less hyperopic with increasing eccentricity and with increasing accommodation. Lag of accommodation increased with accommodation (p < 0.001) shifting the image-shell backward relative to the retina. In the farther periphery, there was either no change in refractive error or increased myopic shifts with accommodation. Astigmatism increased with eccentricity and significantly increased in the farther eccentricities with accommodation (p < 0.001). CONCLUSION: Myopes display hyperopic shifts in the center and near peripheral field during near-viewing, while the farther periphery either remains unshifted or demonstrates a myopic shift. These results are due to the combined effect of lag of accommodation and an increased curvature of field during accommodation.