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Introduction: Paroxysmal nocturnal hemoglobinuria (PNH) is a rare, acquired, life-threatening, stem cell disorder that renders red blood cells vulnerable to complement-mediated hemolysis. This study describes the health-related quality of life (HRQoL) and symptom-specific functional impairment of patients with PNH in a real-world setting. Methods: US-based adults with PNH treated with a parenterally administered complement inhibitor (PACI) for ≥6 months completed an online, cross-sectional, observational survey; a subset of patients also participated in individual semi-structured qualitative interviews after completing the survey. The survey included the PROMIS® 29+2 Profile v2.1 (PROMIS 29+2) to measure HRQoL. The FACIT Fatigue, Neuro-QOL Item Bank v2.0 Cognitive Function Short Form, and PROMIS Item Bank v1.0 Dyspnea Functional Limitations 10a Short Form measured functional impairment associated with specific symptoms of PNH. For each patient with PNH who completed the online survey, up to 3 age- (+/- 3 years) and sex-matched adults without PNH also completed the survey. The HRQoL and functional impairment of the PNH sample was compared to that of general population (GP) sample using independent samples t-tests or Mann-Whitney tests. To further explore the experiences of patients with PNH, the association between HRQoL/functional impairment and fatigue severity was investigated. Patients with PNH were grouped according to their self-reported fatigue severity over the past 7 days (very mild or mild vs moderate, severe, or very severe [no patients reported no fatigue]). Differences in scores across these 2 groups were tested. Data from the qualitative interviews were coded using thematic analysis to explore key concepts related to HRQoL and impairment due to PNH symptoms. Data collection began in March 2023; results are based on interim data. Results: Demographic characteristics of the study samples (PNH survey sample: N=31, GP survey sample: N=62, PNH interview sample: N=10) are shown in Table 1. Patients were treated for PNH with eculizumab, pegcetacoplan, or ravulizumab, with an average duration of current PACI treatment of 3.4 years. Compared to the age and sex-matched GP sample, patients with PNH had significantly higher median scores on the PROMIS 29+2 fatigue domain (GP: 48.70 vs PNH: 57.10, p=0.041) and PROMIS Dyspnea Functional Limitations short form (GP: 40.70 vs PNH: 48.60, p=0.036), indicating that patients with PNH experience more fatigue and dyspnea limitations than the GP sample. Patients with PNH also had significantly lower median scores on the PROMIS 29+2 ability to participate in social roles/activities domain (GP: 53.50 vs PNH: 44.20, p=0.013), indicating greater role/activity limitations among patients with PNH. Compared to the GP sample, patients with PNH had numerically lower (i.e., worse) median PROMIS 29+2 cognitive functioning domain scores (GP: 50.00 vs PNH: 46.30, p=0.058) and FACIT Fatigue scores (GP: 39.50 vs PNH: 30.00, p=0.057). Within the PNH sample, statistically significant associations (p<0.05) were observed between fatigue severity and HRQoL/functional impairment for all outcomes except for the PROMIS 29+2 sleep disturbance and cognitive functioning domains (Table 2). Patients with more severe fatigue had worse HRQoL and more functional impairment than patients with less severe fatigue. Interview participants described fatigue-related functional impairments in their physical, social, and cognitive functioning. Fatigue made daily activities (e.g., cooking, cleaning, going for a walk) difficult and sometimes impossible. Planning social activities in advance was also challenging as patients could not predict how they would feel on any given day, and often found they had to miss, postpone, or cancel social engagements. Finally, patients described experiencing “brain fog” including difficulty concentrating, forgetfulness, and delayed cognitive processing. Conclusions: Despite receiving treatment for PNH, patients experienced deficits in areas of HRQoL related to fatigue, participation in social roles, cognitive function, and functional limitations due to dyspnea, relative to a sample of GP adults. During follow-up interviews, patients emphasized the deep and broad impacts that fatigue and cognitive functioning had, making daily activities and their social lives very difficult.

AbstractBackgroundCOVID‐19 convalescent plasma (CCP) is an important therapeutic option for outpatients at high risk of hospitalization from SARS‐CoV‐2 infection. We assessed the safety of outpatient CCP transfusions administered during clinical trials.Study Design and MethodsWe analyzed data pertaining to transfusion‐related reactions from two randomized controlled trials in the U.S. that evaluated the efficacy of CCP versus control plasma in various ambulatory settings. Multivariable logistic regression was used to assess whether CCP was associated with transfusion reactions, after adjusting for potential confounders.ResultsThe combined study reported 79/1351 (5.9%) adverse events during the transfusion visit, with the majority 62/1351 (4.6%) characterized by mild, allergic‐type findings of urticaria, and/or pruritus consistent with minor allergic transfusion reactions; the other reported events were attributed to the patients' underlying disease, COVID‐19, or vasovagal in nature. We found no difference in the likelihood of allergic transfusion reactions between those receiving CCP versus control plasma (adjusted odds ratio [AOR], 0.75; 95% CI, 0.43–1.31). Risk of urticaria and/or pruritus increased with a pre‐existing diagnosis of asthma (AOR, 2.33; 95% CI, 1.16–4.67). We did not observe any CCP‐attributed antibody disease enhancement in participants with COVID‐19 or increased risk of infection. There were no life‐threatening severe transfusion reactions and no patients required hospitalization related to transfusion‐associated complications.DiscussionOutpatient plasma administration was safely performed for nearly 1400 participants. CCP is a safe therapeutic option for outpatients at risk of hospitalization from COVID‐19.

Abstract Introduction Erectile dysfunction continues to be a concern for patients and physicians after surgical treatment of prostate pathology. Objective To analyze doppler diagnosis on patients who underwent prostate surgery for benign or malignant pathology of the prostate. Methods We retrospectively analyzed all patients who underwent either robotic assisted prostatectomy (RALP), open retropubic prostatectomy (RRP), endoscopic procedures such as greenlight procedure, laser resection of the prostate or transurethral resection of the prostate (TURP); and High Intensity Focused Ultrasound (HIFU) treatment for prostate pathology and who underwent intracavernous injection followed by Color Doppler Duplex Ultrasound (CDDU) at our institution between 2005 and 2019. CDDU findings were recorded following injection of low dose alprostadil (10-20 mcg) and again after a period of privacy and visual sexual stimulation. CCDU findings including peak systolic velocities (PSV), and resistive indices (RIs) were recorded. Arterial insufficiency (AI) was defined as either a post-stimulation PSV < 25 with any RI or a PSV 25-34.9 with RI≥0.9. Cavernous Venous Occlusion Disease (CVOD) was defined as post-stimulation PSV ≥35 with RI < 0.9. Mixed was defined as post-stimulation PSV 25-34.9 with RI < 0.9. Vascular normal was defined as post-stim PSV ≥ 35 with RI ≥ 0.9. Results 380/1917 (19.8%) patients had a past surgical history of prostate surgery. 111/380 (29.2%) underwent RRP, 168/380 (44.2%) patients underwent RALP, 85/380 (22.3%) underwent endourological resection of the prostate and 2/380 (0.5%) patients underwent HIFU. Median age for the RALP group was 60.5 (IQR 23.7-82.8), RRP group was 64.2 (29.7-87.7), endourological resection of the prostate 64.6 (30.8 – 85.6) and HIFU 65.0 (46.9-79.4). 87.1% of patients who had an endoscopic procedure were using phosphodiesterase-5 inhibitors at the time of CDDU. CVOD was the most common etiology of ED in patients who underwent RRP (28.8%) and Endourological procedures of the prostate (32.9%); In patient who underwent RALP the most common etiology of ED was noted to be AI (28.6%), however none of these values were statistically significant (p=0.428). Conclusions There is no difference in etiology of ED in patients who underwent open, robotic or endoscopic manipulation of the prostate as shown by CDDU. Disclosure No

Abstract Introduction Vasectomy is a highly effective, permanent method of contraception. Poor compliance rates have been observed for patients in obtaining their post-vasectomy semen analyses (PVSA). Few studies have looked at associations with low compliance. Objective The objective of our study was to identify compliance rates of post-vasectomy semen analysis and to identify associations that may increase or decrease the rates of compliance. Methods We studied 111 patients between November 2018 and April 2022 who underwent vasectomy at a single institution. Only patients who underwent vasectomy for fertility-related reasons were included in our final analysis. We excluded any patients who had undergone previous vasectomy or vasectomy reversal. Variables analyzed included age, relationship status, presence of primary care provider, anxiety diagnosis, and race. Variables were obtained via chart review which included but was not limited to reviewing notes, summary diagnostic pages, problem lists, and medication lists. All analyses were performed using R version 4.1.2 (R Foundation for Statistical Computing, Vienna, Austria). Categorical data were described with the number and percentage of patients. Continuous data were described with the median, minimum, and maximum. Associations of race and anxiety diagnosis with PVSA were explored using Fisher’s exact test. All p-values were two-sided at the 5% significance level without adjustment for multiple testing. Results Our cohort included 111 men who underwent vasectomy with exclusion of 1 patient who underwent vasectomy for non-fertility reasons. The median age of vasectomy was 38 years (range 26-59 years). Of 110 patients, 83 (75%) returned for PVSA. There were 103 (94%) married patients. Additional cohort characteristics can be seen in Table 1. As shown in Table 2, African American patients were less likely to return for PVSA than either white patients (14% vs. 79%, p<0.001) or Hispanic patients (14% vs. 100%, p=0.015). we did not find evidence of difference between white and Hispanic patients (p=0.58). Patients with an anxiety diagnosis were more likely to undergo PVSA compared to patients without an anxiety diagnosis (p<0.001). Conclusions Patients in our cohort of African American race were significantly less likely to undergo PVSA compared to white and Hispanic patients. This suggests an opportunity for improved counseling in the African American population. We do recognize a disparity in the number of white patients studied (n=95) versus African American (n=7) and Hispanic (n=5) patients. Additionally, patients with an anxiety disorder were more likely to undergo PVSA compared to patients without an anxiety disorder. The prevalence of anxiety disorder in our cohort is somewhat high relative to the overall population in the United States. This could be due to questionnaires used at our institution and the timeliness of those questionnaires. Personality traits could also lead to confounding in anxiety diagnoses. Overall, a 75% rate of PVSA speaks to an opportunity for better counseling regarding PVSA, especially in particular populations such as the African American population. Disclosure No

Abstract Introduction The presence and extent of penile calcifications is an important factor in disease management of Peyronie’s Disease (PD). Calcified plaques may necessitate plaque excision and grafting (E&G) in addition to other therapies or surgeries. PD pathology such as corporal septal involvement, multifocal calcifications, and circumferential corporal calcification can be difficult to assess on color doppler ultrasound (CDDU) due to device limitations. Computed tomography (CT) can be utilized for further characterization of PD. Objective The objective of our study was to review patients who underwent CT imaging for characterization of their Peyronie's Disease. Methods Twenty-three patients with a diagnosis of PD were retrospectively evaluated between 2017 and 2021. Patients underwent CDDU examination with artificial erection and were evaluated based on erectile function, plaque dimension, hourglass deformity, plaque septal involvement, and suspected calcification status. Patients with CDDU examination suggestive of calcification or significant complexity underwent non-contrast CT scan for 3-dimensional evaluation of the plaque prior to surgical discussion. CT complexity was defined as concern for multifocal calcified plaques (>2), partial/complete circumferential corpus cavernosum involvement, or septal involvement. Results All 23 patients had concerning findings on initial examination for calcified plaque which led to their CT evaluation; 9 of 23 (39.1%) patients had exam findings with hourglass deformity. On CT evaluation, calcification was confirmed in 22 of 23 patients (95.7%). Plaque dimensions on CT scan ranged from 0.4 x 0.2 x 0.5 cm to 4.0 x 2.0 x1.7 cm. Many of these measurements were approximations due to circumferential calcified plaque. A classic “gull-wing” appearance was noted in 6 of 23 (26%) patients; 12 of 23 (52.2%) of patients had septal involvement on CT; 8 of 23 patients (34.8%) had significant multifocal disease; 8 of 23 patients (34.8%) decided to proceed with surgical correction via E&G (n = 3), IPP with E&G (n =1), or via IPP with manual remodeling via Wilson technique (n = 4). Conclusions Non-contrast penile CT scan identifies calcification well in patients with Peyronie's Disease. CT allows for increased accuracy of surgical planning especially when evaluating for multifocal disease, circumferential plaque and/or septal involvement. These elements are critical for for providing accurate surgical recommendations and preoperative discussions. Disclosure No