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National trends in hospital-acquired preventable adverse events after major cancer surgery in the USA
Objectives: While multiple studies have demonstrated variations in the quality of cancer care in the USA, payers are increasingly assessing structure-level and process-level measures to promote quality improvement. Hospital-acquired adverse events are one such measure and we examine their national trends after major cancer surgery. Design: Retrospective, cross-sectional analysis of a weighted-national estimate from the Nationwide Inpatient Sample (NIS) undergoing major oncological procedures (colectomy, cystectomy, oesophagectomy, gastrectomy, hysterectomy, lung resection, pancreatectomy and prostatectomy). The Agency for Healthcare Research and Quality Patient Safety Indicators (PSIs) were utilised to identify trends in hospital-acquired adverse events. Setting: Secondary and tertiary care, US hospitals in NIS Participants: A weighted-national estimate of 2 508 917 patients (>18 years, 1999–2009) from NIS. Primary outcome measures Hospital-acquired adverse events. Results: 324 852 patients experienced ≥1-PSI event (12.9%). Patients with ≥1-PSI experienced higher rates of in-hospital mortality (OR 19.38, 95% CI 18.44 to 20.37), prolonged length of stay (OR 4.43, 95% CI 4.31 to 4.54) and excessive hospital-charges (OR 5.21, 95% CI 5.10 to 5.32). Patients treated at lower volume hospitals experienced both higher PSI events and failure-to-rescue rates. While a steady increase in the frequency of PSI events after major cancer surgery has occurred over the last 10 years (estimated annual % change (EAPC): 3.5%, p<0.001), a concomitant decrease in failure-to-rescue rates (EAPC −3.01%) and overall mortality (EAPC −2.30%) was noted (all p<0.001). Conclusions: Over the past decade, there has been a substantial increase in the national frequency of potentially avoidable adverse events after major cancer surgery, with a detrimental effect on numerous outcome-level measures. However, there was a concomitant reduction in failure-to-rescue rates and overall mortality rates. Policy changes to improve the increasing burden of specific adverse events, such as postoperative sepsis, pressure ulcers and respiratory failure, are required
Prediction of Locally Advanced Urothelial Carcinoma of the Bladder Using Clinical Parameters before Radical Cystectomy - A Prospective Multicenter Study
Introduction: We aimed at developing and validating a pre-cystectomy nomogram for the prediction of locally advanced urothelial carcinoma of the bladder (UCB) using clinicopathological parameters. Materials and Methods: Multicenter data from 337 patients who underwent radical cystectomy (RC) for UCB were prospectively collected and eligible for final analysis. Univariate and multivariate logistic regression models were applied to identify significant predictors of locally advanced tumor stage (pT3/4 and/or pN+) at RC. Internal validation was performed by bootstrapping. The decision curve analysis (DCA) was done to evaluate the clinical value. Results: The distribution of tumor stages pT3/4, pN+ and pT3/4 and/or pN+ at RC was 44.2, 27.6 and 50.4%, respectively. Age (odds ratio (OR) 0.980; p < 0.001), advanced clinical tumor stage (cT3 vs. cTa, cTis, cT1; OR 3.367; p < 0.001), presence of hydronephrosis (OR 1.844; p = 0.043) and advanced tumor stage T3 and/or N+ at CT imaging (OR 4.378; p < 0.001) were independent predictors for pT3/4 and/or pN+ tumor stage. The predictive accuracy of our nomogram for pT3/4 and/or pN+ at RC was 77.5%. DCA for predicting pT3/4 and/or pN+ at RC showed a clinical net benefit across all probability thresholds. Conclusion: We developed a nomogram for the prediction of locally advanced tumor stage pT3/4 and/or pN+ before RC using established clinicopathological parameters
Association between the surgical apgar score and perioperative complications after radical prostatectomy
To evaluate whether the Surgical Apgar Score (SAS) can identify patients who are at risk for perioperative adverse events (PAE) following radical prostatectomy for prostate cancer.
At a single academic institution, 994 patients undergoing radical prostatectomy between 2010 and 2013 were analyzed retrospectively. The SAS was calculated from anesthesia records, evaluated to predict PAE within a 30-day time period postoperatively; these events were classified according to standardized classification systems.
We observed adverse events in 45.4% (451/994) of patients with a total of 694 events. Overall, 41% (408/994) had low- and 9.9% (98/994) had highgrade events. A lower SAS was identified as an independent predictor of any (p < 0.001) and low-grade adverse events (p = 0.001) for those patients who had undergone open retropubic radical prostatectomy (ORRP). Each 1-point increment resulted in a 24% decrease in the odds of any (95% CI 0.66–0.88) and a 21% decrease in the odds of a low-grade (95% CI 0.69–0.91) event. Adverse events of robot-assisted prostatectomy were not associated with the SAS.
Lower SAS values indicate patients at risk for adverse events after ORRP. The SAS might serve as one variable for outcome assessment, reflecting the challenge of mutual surgical and anesthesiology procedure management
Efficacy of Vinflunine for Patients with Metastatic Urothelial Cancer after Immune Checkpoint Inhibitor Pretreatment—A Retrospective Multicenter Analysis
Background: Immune checkpoint inhibitors (ICI) are standard of care in patients with metastatic urothelial carcinoma (mUC) ineligible for cisplatin, and as second-line therapy after platinum-based chemotherapy. To date, few data exist about the efficacy of the former second-line chemotherapeutic agent vinflunine after the failure of sequential platinum-based chemotherapy and ICI treatment. The aim of this analysis was to examine the efficacy of vinflunine in a post-ICI third- or later-line setting. Methods: In this retrospective German multicenter study, data of mUC patients treated with vinflunine were reviewed in six centers between February 2010 and December 2021. All of the 105 included patients had radiologic progression after first-line platinum-based chemotherapy. The objective was to describe the efficacy of vinflunine in terms of overall response rate (ORR), clinical benefit rate (CBR), overall survival (OS), and progression-free survival (PFS) for post-ICI and ICI-naïve patients, respectively. Results: In our cohort, 61 patients (58.1%) had preceding immunotherapy before vinflunine administration, and 44 patients (41.9%) were ICI-naïve. Patients with ICI pretreatment showed an ORR of 22.4% compared to 15.6% within ICI-naïve patients (p = 0.451), and CBR was 51.0% vs. 25.0% (p = 0.020), respectively. Post-ICI patients showed longer OS (8.78 vs. 5.72 months; p = 0.467) and longer PFS (3.09 vs. 2.14 months; p = 0.105). Conclusion: This analysis supports the sequential use of vinflunine in post-ICI patients since the vinca-alkaloid retains a measurable clinical activity in these heavily pretreated patients. The therapeutic benefit may be higher than demonstrated in previous studies
Impact of adequate pelvic lymph node dissection on overall survival after radical cystectomy: A stratified analysis by clinical stage and receipt of neoadjuvant chemotherapy.
PURPOSE: An adequate pelvic lymph node dissection (LND) during radical cystectomy (RC) for muscle-invasive bladder cancer (BCa) has been shown to provide a survival benefit. We designed a study to assess the effect of adequate LND on overall survival (OS) according to cT stage and receipt of neoadjuvant chemotherapy (NAC).
MATERIAL AND METHODS: We identified 16,505 patients with localized BCa who received RC in the National Cancer Database (2004-2012). Inverse probability of treatment weighting (IPTW)-adjusted Kaplan-Meier and Cox regression analyses were used to compare OS between patients who received adequate LND (defined as ≥10 nodes removed) and those who did not, stratified by cT stage and receipt of NAC.
RESULTS: Overall 8,673 (52.55%) patients underwent adequate LND at RC for localized BCa. Median time to last follow-up was 55.49 months (IQR, 34.73-75.96 months). IPTW-adjusted Kaplan-Meier curves showed that median OS was improved in patients who received adequate LND (60.06 vs. 46.88 months). In patients who did not receive NAC, adequate LND was associated with an OS benefit for cT1/a/cis, cT2, and cT3/4 disease (P ≤ 0.008). Among patients who received NAC, adequate LND was not associated with any OS difference regardless of cT stage.
CONCLUSION: Our data suggest that patients who did not receive NAC benefit from an adequate LND. However, the receipt of an adequate LND was not associated with an OS benefit in patients pretreated with NAC. Our study indicates that the receipt of NAC may eradicate micrometastatic disease, and thus limit the benefit of an adequate LND
Urothelial Carcinoma in Bladder Diverticula: A Multicenter Analysis of Characteristics and Clinical Outcomes
BACKGROUND Urothelial carcinoma arising in a bladder diverticulum (UCBD) is uncommon, and data on treatment and outcome are sparse. OBJECTIVE To analyze clinicopathological characteristics of UCBD and to compare outcome after radical cystectomy (RC) and partial cystectomy (PC). DESIGN, SETTING, AND PARTICIPANTS Data of 115 UCBD patients treated with RC (n=81) or PC (n=34) between 2000 and 2016 were collected from 11 institutional databases and were analyzed retrospectively. Median follow-up was 5.0yr (95% confidence interval [CI]: 4.0-6.2). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Upstaging of tumor stage at diagnostic transurethral resection (TUR) to the RC/PC specimen was investigated. Overall survival (OS) and metastasis-free survival (MFS) after RC and PC were analyzed using Kaplan-Meier estimates, and compared using the log-rank test. Intravesical recurrences after PC were reported. A multivariable Cox proportional-hazard model was used to identify factors associated with OS. RESULTS AND LIMITATIONS There were no statistically significant differences in clinicopathological characteristics between RC and PC groups. Fifty-five percent of patients with cTa/is/1 at diagnostic TUR had ≥pT2 tumors at RC/PC. Five-year OS and MFS were, respectively, 62% and 66% for RC and 66% and 55% for PC (p=0.9 and p=0.6). Intravesical tumor recurrence was seen in six of 34 (18%) PC patients. In multivariable analysis, positive surgical margins and extravesical disease (≥pT2) were associated with worse OS, whereas treatment modality was not (RC: reference; PC: hazard ratio 0.94, [95% CI: 0.47-1.90], p=0.9). CONCLUSIONS Upstaging of UCBD was frequent, indicating an inaccuracy in clinical staging. We found no differences in OS or MFS between PC and RC groups; therefore, PC may represent a feasible surgical alternative to RC in selected UCBD patients. PATIENT SUMMARY In this report, we looked at the treatment of urothelial carcinoma arising in a bladder diverticulum (UCBD). We found that bladder-sparing treatment by partial cystectomy may be an alternative to radical cystectomy in carefully selected UCBD patients
Racial disparities in operative outcomes after major cancer surgery in the United States.
BACKGROUND: Numerous studies have recorded racial disparities in access to care for major cancers. We investigate contemporary national disparities in the quality of perioperative surgical oncological care using a nationally representative sample of American patients and hypothesize that disparities in the quality of surgical oncological care also exists.
METHODS: A retrospective, serial, and cross-sectional analysis of a nationally representative cohort of 3,024,927 patients, undergoing major surgical oncological procedures (colectomy, cystectomy, esophagectomy, gastrectomy, hysterectomy, pneumonectomy, pancreatectomy, and prostatectomy), between 1999 and 2009.
RESULTS: After controlling for multiple factors (including socioeconomic status), Black patients undergoing major surgical oncological procedures were more likely to experience postoperative complications (OR: 1.24; p \u3c 0.001), in-hospital mortality (OR: 1.24; p \u3c 0.001), homologous blood transfusions (OR: 1.52; p \u3c 0.001), and prolonged hospital stay (OR: 1.53; p \u3c 0.001). Specifically, Black patients have higher rates of vascular (OR: 1.24; p \u3c 0.001), wound (OR: 1.10; p = 0.004), gastrointestinal (OR: 1.38; p \u3c 0.001), and infectious complications (OR: 1.29; p \u3c 0.001). Disparities in operative outcomes were particularly remarkable for Black patients undergoing colectomy, prostatectomy, and hysterectomy. Importantly, substantial attenuation of racial disparities was noted for radical cystectomy, lung resection, and pancreatectomy relative to earlier reports. Finally, Hispanic patients experienced no disparities relative to White patients in terms of in-hospital mortality or overall postoperative complications for any of the eight procedures studied.
CONCLUSIONS: Considerable racial disparities in operative outcomes exist in the United States for Black patients undergoing major surgical oncological procedures. These findings should direct future health policy efforts in the allocation of resources for the amelioration of persistent disparities in specific procedures
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