Citations

Abstract Introduction Introduction: Peyronie’s disease (PD) is a fibrosing condition of the tunica albuginea characterized by a palpable plaque with varying impacts on the patient’s erection: curvature, shortening, indentations, hinging, and narrowing. Stepwise intralesional injection of collagenase clostridium histolyticum (CCH) is the only FDA approved medical treatment for PD. We retrospectively reviewed Xiaflex® treated patients for satisfaction with therapy or pursuit of subsequent surgery. Objective Objective: To assess global satisfaction with intralesional Xiaflex based on whether patients subsequently elected surgery. Methods Methods: This is a retrospective review of patients presenting with PD to a single center and managed by a single provider from 2020-2024 with six-month follow-up post-treatment. Patient presentations were recorded in an Institutional Review Board approved database. Data storage and analytics were conducted using REDCap. Results Results: The cohort for this study was 159 men treated with intralesional Xiaflex. 18 of the 159 were excluded from analysis due to ongoing treatment. 48.9% of patients (69/141) were satisfied with CCH outcomes and sought no further therapy. 51.1% of patients (72/141) were not satisfied with their outcomes. Of the patients not satisfied with treatment, 48/72 (66.7%) elected subsequent surgical interventions: 18 penile plications, 8 incision and grafting and 22 inflatable penile prostheses. 51.7% (73/141) of patients completed (8) CCH treatments. Among the 73 men who had a complete set of CCH injections, 24.6% (18/73) elected subsequent surgery. Among the patients who had fewer than 8 treatments 46.9% (30/64) elected surgery following Xiaflex. Conclusions Conclusion: If successful medical management of Peyronie’s disease is defined by men who decline subsequent surgical interventions, Xiaflex® was highly successful 75% (55/73). Patients who have Peyronie’s disease are highly motivated and will pursue surgical interventions following a trial of CCH. Disclosure No

Abstract Introduction Holmium laser enucleation of the prostate (HoLEP) is a safe, effective and durable surgical treatment for benign prostatic hyperplasia (BPH). With increased longevity, there is expanded interest in assessing the safety and efficacy of HoLEP in patients aged 90 years and older. Additionally, these patients are particularly interested in HoLEP when dealing with chronic retention secondary to BPH. Objective To evaluate the safety and functional outcomes of HoLEP in nonagenarian patients. Methods We conducted a retrospective review of patients aged 90 years or older who underwent HoLEP by a single surgeon at our institution from January 2019 to May 2024. Data collected included preoperative prostate volume, postoperative length of hospital stay, complication rates, postoperative American Urological Association Symptom Score (AUASS), quality of life (QOL) scores, and catheter status. Results Eighteen patients met inclusion criteria, with a mean preoperative prostate volume of 106 grams. Fourteen patients were on anticoagulation therapy but all were able to stop their medications at least 2-3 days prior to surgery. Six postoperative complications occurred, including three major events: aspiration, congestive heart failure exacerbation, and one death during admission. At last follow-up, four patients had passed away due to unrelated events, with only one death occurring during the HoLEP hospitalization. Among surviving patients, the mean AUASS was 7 and mean Michigan Incontinence score was 0.9. Preoperatively, 15 patients were catheter-dependent; postoperatively, only one patient required catheter reinsertion after trial of void. Discharge occurred on postoperative day (POD) 0 for six, POD 1 for four, POD 2 for three, and POD 3 for four patients. Conclusions HoLEP is a feasible and effective surgical option for patients aged 90 years and older, providing significant improvement in urinary symptoms, low rates of reported incontinence, and high rates of catheter independence. Nonagenarians anecdotally seem more likely to experience complications, highlighting the importance of careful patient selection/counseling and perioperative management. The 30-day mortality was ultimately due to the patient’s family’s desire to withdraw care and proceed with hospice. Although it’s difficult to objectively evaluate, we believe that overall, these patients do stand to benefit from HoLEP as their catheter-dependency often leads to recurrent infections, admissions, decreased mobility and falls. These medical issues can also lead to poor outcomes in this age group. Disclosure No

Abstract Introduction 0.05% Chlorhexidine Gluconate (CHG) has increasingly been used as an irrigant for inflatable penile prosthesis (IPP) surgery. Recent in vitro data shows mixed results regarding efficacy, but clinical data is lacking. Objective To explore the cultured organisms and infection characteristics of IPP infections with and without intraoperative CHG use from a large multi-institutional cohort. Methods We queried a retrospective multi-institutional database of patients who underwent IPP placement for cases resulting in IPP Infection. We stratified cases by intraoperative use of CHG as an irrigant or dip. We compared patient and infection characteristics using chi squared tests and independent t-tests. Culture data from IPP explant was reviewed for descriptive analysis. Results We identified 70 IPP infections, 43 with intraoperative CHG use. Patient demographics were similar between infection cohorts. (Table 1). Median time to infection was similar, 46.5 days in the CHG cohort and 34 days in the non-CHG cohort (p=0.518). Culture data were available for 57 (81.4%) patients. For CHG IPP infections, 8 had Escherichia coli cultured at time of explant and 6 grew methicillin sensitive Staphylococcus aureus. For non-CHG IPP infections, Staphylococcus epidermidis (4) and Pseudomonas aeruginosa (3) were the most common cultured organisms. A total of nine unique organisms were cultured for both CHG and non-CHG infections. Negative growth cultures were recorded for 2 patients in both the CHG and non-CHG infection groups. (Figure 1) Conclusions In a large, multi-institutional cohort, IPP infections after intraoperative CHG use were associated with a variety of cultured organisms, most commonly Escherichia coli and Methicillin sensitive Staphylococcus aureus. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast: Advisory board, speaker; Endo: Advisory board; Haleon: Advisory board; Halozyme: Advisory board, speaker; Masimo: Intellectual property; Softwave: Advisory board; Sprout: Consultant; Vertica: Research investigator; Xialla: Advisory board.

Abstract » A thorough understanding of glenoid deformity is essential to anticipate intraoperative needs and manage bony deficiencies. Management strategies include eccentric reaming, alternate scapular line baseplate orientation, bone grafting, or metallic augmentation as either “off-the-shelf” or custom baseplates. Accurate implantation of the glenoid component in the presence of glenoid bone loss (GBL) may also benefit from shoulderspecific guides, navigation, or robotic assistance. » GBL can negatively affect outcomes due to compromised bony fixation, altered soft tissue tensioning, and component malposition, which can contribute to impingement, dislocation, aseptic loosening, polyethylene wear, and component failure. » In this article, we provide a comprehensive review of published literature regarding the management of GBL in primary RSA and provide additional insight on the effectiveness of current approaches to manage bony deficiency.

BACKGROUND/OBJECTIVE Patient- and family-centered rounds (PFCR) have become a pediatric standard of care. However, rounds experiences of families using languages other than English (LOE)—particularly languages other than English or Spanish (LOES; eg, Arabic)—receive less focus. We aimed to identify differences in PFCR communication and engagement by language. METHODS We analyzed postintervention data from a 21-center structured PFCR study, assessing communication practices, quality, and family and nurse engagement during PFCR. Logistic regression adjusted by site compared PFCR between families using (1) LOE vs English, (2) Spanish vs English, and (3) LOES vs English. RESULTS Among 3051 PFCR encounters, 348 (11.4%) involved LOE (Spanish = 260; LOES = 85). Interpretation was not used in 7.2%, 5.8%, and 9.4% of encounters using LOE, Spanish, and LOES, respectively. PFCR in the following groups had lower adjusted odds (adjusted odds ratio [95% CI]) for the following domains: (1) LOE vs English: including providing verbal patient summaries (0.66 [0.46–0.95]), explaining diagnoses and differentials (0.62 [0.44–0.88]), family engagement (0.34 [0.20–0.57]), nursing inclusion (0.75 [0.60–0.93]), and nursing engagement (0.69 [0.52–0.90]). (2) Spanish vs English: diagnoses/differentials being explained (0.56 [0.37–0.85]), family engagement (0.35 [0.18–0.67]), nursing inclusion (0.77 [0.59–1.00]), and nursing engagement (0.68 [0.52–0.89]). (3) LOES vs English: families sharing concerns (0.66 [0.47–0.93]), family engagement (0.30 [0.16–0.54]), and nursing inclusion (0.74 [0.55–0.99]). CONCLUSION Even after implementing a PFCR intervention, families using LOE—especially LOES—experienced significant disparities in communication and engagement. Future approaches to improving PFCR should emphasize language access and promote nurse and family engagement for families using LOE, particularly LOES.

Abstract Infection is increasingly recognized as a significant cause of morbidity and mortality in patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL) receiving CD19 chimeric antigen receptor (CAR) T-cell therapy. The current study analyzed the natural history, risk factors, and outcomes of infection in 3350 patients with R/R LBCL receiving commercial CD19 CAR T-cell therapy (n = 2804 axicabtagene ciloleucel [axi-cel], n = 546 tisagenlecleucel) from December 2017 to June 2022. Infection developed in 834 patients (24.9%) within 100 days after infusion, resulting in an infection density of 0.43 per 100 patient days and a 100-day cumulative incidence of 22%. Bacterial, viral, and fungal infections were recorded in 527 (15.7%), 374 (11.2%), and 108 patients (3.2%), respectively, with corresponding infection densities of 0.23, 0.15, and 0.04 per 100 patient days. After a 24-month median follow-up, 1482 patients (44%) had died, with infection as the primary cause in 173 cases (12%). The 100-day infection-related mortality (IRM) was 1.6% (95% confidence interval, 1.2-2.0). Patients with a Karnofsky performance score of ≤80, infection history before CAR T-cell therapy, axi-cel therapy, severe cytokine release syndrome (grade ≥3), and severe immune effector cell–associated neurotoxicity syndrome (grade ≥3) had increased infection risk. Infections within 100 days were an independent risk factor for inferior overall survival beyond day 100 after CD19 CAR T-cell therapy. In conclusion, study results show a significant incidence of infection and IRM in patients with R/R LBCL treated with CD19 CAR T-cell therapy. Furthermore, results identify patients at a heightened risk of infection, offering insights to guide potential interventions aimed at mitigating infection and improving patient outcomes after CAR T-cell therapy.

7023 Background: Axi-cel is an autologous chimeric antigen receptor (CAR) T-cell therapy approved for adults with R/R LBCL after ≥ 1 prior line of therapy (LoT). Adverse events, such as cytokine release syndrome (CRS) and neurologic events (NEs), may deter centers from using axi-cel in an outpatient (OPT) setting, though individual centers have observed comparable safety and effectiveness in OPT and inpatient (IPT) care (Furqan et al. Blood Adv . 2024). Here, we present safety and effectiveness outcomes of axi-cel by intention to treat in OPT and IPT settings in a multicenter real-world dataset. Methods: Pts receiving axi-cel for R/R LBCL in the US from 01/2021-07/2023 with data in the Center for International Blood and Marrow Transplant Research (CIBMTR) registry were eligible for analysis. Pts with prior allogeneic transplant or unknown intended care setting were excluded. Of potential pts, 119 OPT pts were identified from 29 centers where an increasing trend was seen (9.6% of pts in 2021 were OPT, 13.5% in 2022, 22.8% in 2023). Pts were matched to 119 IPT pts by propensity score matching on age, sex, comorbidities, lactate dehydrogenase (LDH), bulky disease, prior LoT, chemosensitivity, and infusion year (see table). Results: OPT pts had median age of 63 y (25% ≥ 70), 66% were male, and 67% had ≥ 1 comorbidity. Half (50%) had elevated LDH and 73% had 1 prior LoT. Bulky disease was reported in 3%, and 60% had chemo-resistant disease. Outcomes were analyzed at median follow-up of 12 mo. Safety and effectiveness outcomes were similar between OPT and IPT pts (see table). In multivariate analyses, no differences were found between intended care setting and CRS (odds ratio [OR] 1.09 [95% CI 0.51-2.35]), CRS Gr ≥ 3 (OR 0.57 [0.12-2.60]), NEs (OR 1.14 [0.65-2.00]), or NEs Gr ≥ 3 (OR 0.98 [0.48-2.00]). Among OPT pts, 24% and 50% did not require hospital admission within 30 d and 3 d, respectively. In pts aged ≥ 70 y, only any Gr NEs were higher in the OPT group. Conclusions: After matching on key factors that may be used to select pts for OPT infusion, outcomes were comparable between intended care settings. These findings corroborate prior results and support the consideration of axi-cel in appropriate OPT care settings. Outcomes between matched pts with R/R LBCL receiving axi-cel intended for OPT or IPT. OPT (n=119) a IPT (n=119) a CRS any Gr / Gr ≥ 3 83 (75−89) / 3 (<1−7) 83 (74−89) / 4 (1−10) NE any Gr / Gr ≥ 3 47 (38−57) / 19 (12−27) 46 (37−56) / 21 (14−30) Overall / complete response rates 78 (69−85) / 68 (59−76) 76 (67−83) / 62 (52-70) Duration of response @ 12 mo 64 (52−74) 69 (58−78) Progression-free survival @ 12 mo 53 (43−62) 53 (43−61) Overall survival @ 12 mo 71 (61−78) 72 (62−79) Non-relapse mortality @ 12 mo 6 (2−11) 4 (1−8) Hospital admission within 30 days of infusion / median duration (range), d 76 (67−83) / 9 (2−53) Not Applicable a Percent (95% CI) unless otherwise specified.

ABSTRACTAlthough recent studies have demonstrated the efficacy of chimeric antigen receptor T‐cell (CAR‐T) therapy in relapsed large B‐cell lymphoma (LBCL) with MYC rearrangement (R‐MYC), the data comparing CAR‐T to autologous hematopoietic cell transplant (auto‐HCT) in such patients who achieve a complete or partial response (CR/PR) after salvage therapies are limited. We compared the clinical outcomes of patients with R‐MYC LBCL (including double and triple hit lymphomas) who underwent CAR‐T or auto‐HCT after achieving a CR/PR with salvage therapies using the Center for International Blood & Marrow Transplant Research registry. Among the 252 patients (auto‐HCT = 98, CAR‐T = 154), relative to auto‐HCT, CAR‐T was associated with significantly lower overall survival (OS) (Hazard Ratio [HR] 2.09, 95% CI 1.38–3.15, p < 0.001) on multivariate analysis. There were no differences in progression‐free survival (PFS) (HR 1.21, 95% CI 0.81–1.8 p = 0.36), risk of relapse (HR 1.1, 95% CI 0.71–1.69 p = 0.68), nonrelapse mortality (NRM) (HR 1.74, 95% CI 0.64–4.7 p = 0.28) while the post‐relapse survival was longer in auto‐HCT relative to CAR‐T (HR 1.93, 95% CI 1.21–3.06 p = 0.01). On propensity score matched analysis accounting for differences in characteristics across the two cohorts, we detected no significant differences in OS (HR 1.72, 95% CI 0.92–3.21 p = 0.09), PFS (HR 1.04, 95% CI 0.64–1.68 p = 0.88), NRM (HR 1.22, 95% CI 0.35–4.2 p = 0.76), relapse (HR = 0.93, 95% CI 0.54–1.6 p = 0.8) and post‐relapse survival (HR 2.25, 95% CI 0.98–5.17, p = 0.06). These data, although retrospective, support consideration for auto‐HCT in patients with R‐MYC LBCL who achieve a CR/PR after salvage therapies, particularly in regions with no or limited access to CAR‐T.