Long-Term Follow-Up of Peritoneal Interposition Flap in Symptomatic Lymphocele Reduction following Robot-Assisted Radical Prostatectomy: Insights from the PIANOFORTE Trial.

The available randomised controlled trials (RCTs) assessing the influence of peritoneal interposition flaps (PIF) on the reduction of symptomatic lymphoceles (sLCs) post robot-assisted radical prostatectomy (RARP) do not constitute a sufficient follow-up (FU) to assess the long-term effects. The PIANOFORTE trial was the first of these RCTs, showing no sLC reduction at the 3-month FU. Therefore, all 232 patients from the PIANOFORTE trial were invited for long-term FU. One hundred seventy-six patients (76%) presented themselves for FU and constituted the study group (SG). The median FU duration was 43 months. No significant differences in group allocation or LC endpoints at 90 days were observed between SG patients and patients not presenting themselves for the FU. During the FU period, four patients (2.3%) in the SG developed sLCs, and six patients (3.4%) developed asymptomatic lymphoceles (aLCs), which persisted in five patients (2.9%). There were no significant differences between PIF and non-PIF regarding sLC/aLC formation or persistence, newly developed complications, stress urinary incontinence or biochemical/clinical tumour recurrence. Therefore, this long-term FU confirms the primary outcomes of the PIANOFORTE trial that, while PIF does not impact complications or functionality, it does not reduce sLC/aLC rates. Furthermore, it shows the potential occurrence of LC after the third postoperative month.

Endocrine immune-related adverse events in patients with metastatic renal and urothelial cancer treated with immune checkpoint-inhibitors.

PURPOSE: To evaluate the incidence, diagnosis and treatment of immune-related adverse events (e-irAE) of checkpoint inhibition (ICI) in metastatic urothelial carcinoma (mUC) and metastatic renal cell carcinoma (mRCC). METHODS: A retrospective, single-center study was conducted to identify a cohort that received ICI for mUC or mRCC. e-irAE were classified according to the CTCAE V.5.0. Patients received ICI for mUC or mCC between 01/2017 and 03/2021. A retrospective chart review was performed. T-Test, the chi-squared test, and Fisher's exact test were performed. RESULTS: 102 Patients received ICI [mUC: 40 (39%), mRCC: 62 (61%)]. 64 (63%) received an ICI monotherapy, 27 (27%) a dual ICI therapy, 11 (11%) a combination with VEGFi. e-irAE occurred in 19 (19%) patients [grade 1-2: 17 (84%), grade 3: 3 (16%)]. The median time until e-irAE was 42 days (range 11-211 days). 14 Patients developed thyroidism (14%), 4 (4%) a hypophysitis, 1 (1%) an adrenal insufficiency (AI). 7 patients (7%) had to discontinue ICI therapy [hypophysitis (100%), AI (100%), thyroidism (14%)]. 6 (86%) received cortisone. After a median range of 34 days 5 patients (71%) restarted ICI therapy. All patients (n = 4) with hypophysitis continued ICI [4 (100%) prednisone, 3 (75%) levothyroxine]. 11 (79%) presented with hyperthyroidism. 4 (37%) needed therapy (1 (7%) prednisone, 3 (21%) thiamazole, 2 (14%) beta blocker). The 9 (64%) patients with hypothyroidism received levothyroxine. Hypophysitis appears only on dual ICI (CTLA-4/PD-1) inhibition (p 0.007). CONCLUSION: This study shows the importance of adequate diagnosis and therapy of e-irAEs.

Prophylactic ECMO during TAVI in patients with depressed left ventricular ejection fraction.

BACKGROUND: This study investigated the impact of prophylactic veno-arterial extracorporeal membrane oxygenation (pECMO) in patients with depressed left ventricular ejection fraction (dLVEF) undergoing transcatheter aortic valve implantation (TAVI). METHODS: Out of 1490 patients undergoing TAVI at two centers (2010-2015), 222 patients had dLVEF (≤ 40%). Of these, 21 patients (10%) underwent TAVI with pECMO. Complications and outcome according to pECMO were analyzed in the entire and in a propensity-matched population. RESULTS: In the entire population, patients with pECMO had a higher logEuroScore I (33% ± 19 vs. 25% ± 17; p = 0.037), worse LVEF (26% ± 7 vs. 32% ± 7; p = 0.001), more major bleedings (29% vs. 9%; p = 0.015), higher transfusion rate (30% vs. 10%; p = 0.019) and longer in-hospital stay (9.0 [7.0;14.0] vs. 7.0 [5.0;10.0] days; p = 0.024). After propensity matching only transfusion rate remained higher with pECMO (30% vs. 7%; p = 0.025). In the entire population, rate and risk of 30-day mortality was higher with pECMO (24% vs. 6%, HR 95%CI 4.29 [1.51-12.19]; p = 0.006). In the matched population, this effect was attenuated (24% vs. 12%, HR 95%CI 2.09 [0.61-7.23]; p = 0.243). Cumulative rate and risk of 1-year mortality did not differ in the entire (log-rank p = 0.069; 39% vs. 22%, HR 95%CI 1.99 [0.94-4.24]; p = 0.074) nor in the matched population (log-rank p = 0.520; 39% vs. 31%, HR 95%CI 1.34 [0.55-3.28]; p = 0.523). CONCLUSION: In patients with dLVEF undergoing TAVI, periprocedural pECMO support does not seem to improve patient outcome.