Citations

4580 Background: ICIs are used for UC in different settings. Most cases have pure urothelial carcinoma (PUC) but about a third have UC mixed with SH. We examined pts with UC treated with ICI and hypothesized that outcomes would not differ between PUC and mixed with SH. Methods: We retrospectively included pts with PUC and any SH component treated with ICI as adjuvant, 1st line [1L] upfront, maintenance avelumab [mAV], ≥2nd line [2+L] therapy; pts were divided by SH type. Pts with multiple SH were included as separate group. We excluded pts with pure non-UC histology and pts treated with neoadjuvant ICI. We calculated overall response rate (ORR), median overall, progression-free and disease-free survival [mOS, mPFS, mDFS] using KM method from ICI start. Analysis was stratified by therapy line; multivariable models were adjusted by Khaki factors for 1L/upfront, mAV and Bellmunt factors for 2+L; reference group was PUC. We used descriptive statistics for small subsets. Results: We included 1525 pts from 26 sites; n=752 1L, n=609 2+L; 76% men, 80% White, 69% smoking history, 80% lower urinary tract primary, 28% SH. Median f/u time from 1L ICI start 24 months (mo): mPFS was 3 (95%CI 2.8-3.2) mo for PUC (n=340), 3 (95%CI 2-4) mo for squamous (n=60) (HR=1, [95%CI 0.7-1.4]), 2 (95%CI 1.4-3.2) mo for micropapillary (n=36) (HR=1.3 [95% 0.9-2]) and 4 (3.5-4.5) mo for ≥2 SH (n=20) (HR=0.9 [95%CI 0.6-1.5]). Median f/u time from 2+L ICI start 26 mo: mPFS was 3 (95%CI 2.4-3.2) mo for PUC (n=264), 4 (95%CI 2-5) mo for squamous (n=33) (HR=0.8, [95%CI 0.6-1.2]), 3 (95%CI 1.6-3.7) mo for micropapillary (n=17) (HR=0.9 [95% 0.6-1.7]) and 3 (2.5-3.1) mo for ≥2 SH (n=10) (HR=1.2 [95%CI 0.6-2.2]); Table shows ORR/OS data. Data on adjuvant and mAV settings will also be presented. Conclusions: We found no significant survival difference between PUC and SH. ORR was numerically higher with sarcomatoid SH and ≥2 SH in the 1L upfront setting. Limitations: retrospective design, small sample size in a few subsets, lack of randomization and central scan/path (% SH) review, selection bias, unmeasured confounders. [Table: see text]

Abstract Lung transplant recipients are at higher risk of developing COVID-19 infection compared to other solid organ transplants. The risk further increases in the unvaccinated patients. We present a case of a 43-year-old male who underwent bilateral sequential lung transplantation for pulmonary alveolar microlithiasis (PAM) and had an uneventful recovery. However, two years post-transplantation, the patient developed chronic lung allograft dysfunction (CLAD) with bronchiolitis obliterans syndrome and two episodes of COVID-19 infection. During the second episode of COVID-19 infection, the patient developed sepsis and multi-organ dysfunction ultimately resulting in death. Our case report highlights the increased susceptibility of PAM patients’ post-lung transplant to COVID-19 infection. Continuous follow-up of PAM patients’ post-lung transplantation is necessary to prevent unfavorable outcomes.

654 Background: MSI and TMB correlate with ICI efficacy. We assessed the association between TMB and MSI with outcomes in pts with aUC treated with anti-PD1/L1 in a ‘real-world’ cohort. We hypothesize that pts with high TMB and MSI-high (H) have better outcomes with ICI. Methods: In this retrospective study we included pts from 13 sites treated with ICI for aUC. We calculated overall response rate (ORR), median overall and progression-free survival (mOS, mPFS) using KM method from ICI start. TMB and MSI were assessed by NGS. TMB was analyzed as dichotomous (≥10 vs <10 mut/Mb) and continuous variable. The analysis was stratified by therapy line (1L/upfront, 2+L). Multivariable models were adjusted by Khaki factors for 1L/upfront and Bellmunt factors for 2+L. We separately analyzed pts on maintenance avelumab (mAV). MSI is reported with descriptive statistics only. Results: 342 pts were treated with ICI 1L/upfront or 2+L (69% pure UC, median age at ICI start 69, 77% men, 90% White, 16% upper tract primary, 12% liver metastases [mets], 78% ECOG PS 0-1). Median f/u from ICI start was 34 months (mo). ORR was 36% (95%CI 26-46%) in pts with TMB≥10 vs 30% (95%CI 23-36%) with TMB<10 (OR=1.4 [95%CI 0.8-2.5] p=0.3). ORR was 75% (6/8) in pts with MSI-H and 30% (60/200) with MSI stable (MSI-S). mPFS was similar between TMB≥10 and <10 groups (6 vs 4 mo; HR=0.88 [95%CI 0.61-1.26] p=0.48) and between MSI-H and MSI-S (5 mo). mOS was numerically longer (not significant) in pts with TMB≥10 vs TMB<10: 25 vs 21 mo; (HR=0.7 [95%CI 0.50-1.09] p=0.12) and with MSI-H and MSI-S (NR and 20 mo). A significant association was found between TMB (continuous variable) and OS (HR=0.97 [95%CI 0.95-0.99] p=0.01). TMB analyses by therapy line are shown in Table. In the 1L/upfront setting (N=144), ORR 71% (5/7) vs 33% (45/135), mPFS 5 and 4 mo, mOS NR and 22 mo for MSI-H and MSI-S, respectively. Pts on mAV (n=77) were 77% men, 92% White, 16% upper primary, 13% liver mets, 84% ECOG PS 0-1 with median f/u 15 mo from avelumab start; mOS was NR for MSI-H and 24 mo for MSI-S; mPFS was 4 mo for both groups. Of 3 pts on mAV with MSI-H: 1 CR, 2 SD; of 58 pts with MSI-S: 4CR, 4PR, 24 SD, 21 PD, 5 unknown. Conclusions: MSI-H had numerically higher ORR and higher TMB was associated with longer OS with ICI, but further validation is needed. Limitations: retrospective design, small sample size for MSI-H cases, lack of randomization and central scan review, selection/confounding. [Table: see text]

Abstract Background Impella is an advanced ventricular assist device frequently used as a bridge to heart transplantation. The association of Impella with increased rates of gout flares has not been studied. Our primary aim is to determine the rates of gout flares in patients on Impella support. Methodology A retrospective study was conducted between January 2017 and September 2022 involving all patients who underwent heart transplantation. The cohort was divided into groups based on Impella support for statistical analysis. In patients receiving Impella support, outcome measures were compared based on the development of gout flares. Results 213 patients were analyzed, with 19.71% supported by Impella. Impella and non-Impella groups had similar age, race, and BMI, but more males were in the Impella group. Gout and chronic kidney disease were more prevalent in Impella-supported patients, while coronary artery disease was less common. The incidence of gout flare was significantly higher in Impella patients (31% vs. 5.3%). The Impella group had an adjusted odds ratio for in-hospital gout flare of 8.069 (95% CI = 2.13–35.08, P = 0.003). Impella-supported patients with gout flares had longer intensive care unit and hospital stays but no difference in mortality or other outcomes. Conclusion Our study is the first to identify the potential association between Impella support and increased rates of gout flares in hospitalized patients. Future studies are required to confirm this association and further elucidate the biological pathways. It is imperative to consider introducing appropriate measures to prevent and promptly manage gout flares in Impella-supported patients.

Abstract Bronchopleural fistulas (BPFs) are a dreaded complication following pulmonary surgery. Endobronchial valves (EVs), with endobronchial sealant (ES), instilled with robotic bronchoscopy (RB), allow occlusion of BPF, avoiding surgery. The patient was a 71-year-old woman with a history of chronic obstructive pulmonary disease and bronchiectasis who underwent bilateral lung transplantation and wedge resection of the right middle lobe and left lingula. A BPF was discovered on postoperative day (POD) 21. Conservative measures with chest tubes failed, and robotic-assisted bronchoscopy aided in reaching the bronchial segment and instilling ES, and EV was deployed with the conventional bronchoscope. The pneumothorax was cleared 12 days later, and on POD 56, she was discharged. The RB procedure was successful, with no pneumothorax or BPF symptoms after a median follow-up of POD 284. Robotic endobronchial closure of BPF with EV and ES is an effective treatment option avoiding invasive surgeries.

OBJECTIVES: To evaluate the 30-day postoperative mortality and palliative care consultations in patients that underwent surgical procedures in the United States before and after Medicare Access and Children’s Health Insurance Program Reauthorization Act (MACRA) implementation. DESIGN: Retrospective, Observational cohort study. SETTING: Secondary data were collected from the U.S. National Inpatient Sample, the largest hospital database in the country. The time span was from 2011 to 2019. PATIENTS: Adult patients that electively underwent 1 of 19 major procedures. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: The primary outcome was cumulative postoperative mortality in two study cohorts. The secondary outcome was palliative care use. We identified 4,900,451 patients and categorized them into two study cohorts: PreM: 2011–2014 (n = 2,103,836) and PostM: 2016–2019 (n = 2,796,615). Regression discontinuity estimates and multivariate analysis were used. Across all procedures, 149,372 patients (7.1%) and 156,610 patients (5%) died within 30 days of their index procedures in the PreM and PostM cohorts, respectively. There was no statistically significant increase in mortality rates around postoperative day (POD) 30 (POD 26–30 vs 31–35) for both cohorts. More patients had inpatient palliative consultations during POD 31–60 compared with POD 1–30 in PreM (8,533 of 2,081,207 patients [0.4%] vs 1,118 of 22,629 patients [4.9%]) and PostM (18,915 of 2,791,712 patients [0.7%] vs 417 of 4,903 patients [8.5%]). Patients were more likely to receive palliative care consultations during POD 31–60 compared with POD 1–30 in both the PreM (odds ratio [OR] 5.31; 95% CI, 2.22–8.68; p < 0.001) and the PostM (OR 7.84; 95% CI, 4.83–9.10; p < 0.001) cohorts. CONCLUSIONS: We did not observe an increase in postoperative mortality after POD 30 before or after MACRA implementation. However, palliative care use markedly increased after POD 30. These findings should be considered hypothesis-generating because of several confounders.