Rational peri-operative management of antithrombotic therapy in patients undergoing radical cystectomy: A 30-day morbidity analysis based on the updated European Association of Urology guidelines for standardized complication reporting.

BACKGROUND: Radical cystectomy (RC) in bladder cancer patients with cardiovascular comorbidity poses challenges due to the need for antithrombotic therapy and high perioperative risk. We aimed to assess 30-day complications after RC in patients receiving antithrombotic therapy. PATIENTS AND METHODS: Retrospective study of 416 bladder cancer patients (2009-2017) undergoing open RC with pelvic lymph node dissection, with or without antithrombotic therapy. Antithrombotic therapy and complication reporting followed European guidelines. Procedure-specific 30-day complications were cataloged, graded (Clavien-Dindo), and quantified using the 30-day Comprehensive Complication Index. Multivariable regressions evaluated antithrombotic therapy's independent effect on key morbidity outcomes. RESULTS: Median age was 70 years, 78% were male. Patients on antithrombotic therapy were mostly male, had higher comorbidity burden, worse kidney function, more frequent incontinent diversion, and shorter operative time (all p ≤ 0.027). Bleeding complications occurred in 135 patients (32%; 95%CI = 28-37%), more prevalent with antithrombotic therapy (46% vs. 29%; p = 0.004). Thromboembolic complications occurred in 18 patients (4.3%; 95%CI = 2.6-6.8%), no difference between patients with and without antithrombotic therapy (8.4% vs. 3.3%; p = 0.063). Prevalence of myocardial infarction, new-onset hypertension, acute congestive heart failure, and angina pectoris showed no difference (all p ≥ 0.3). Multivariable analyses indicated no association between antithrombotic therapy and cardiac complications, 30-day major complications, or cumulative morbidity (all p ≥ 0.2). Antithrombotic therapy was associated with bleeding complications (OR = 1.92; 95%CI = 1.07-3.45; p = 0.028), predominantly transfusion-related (75% of 152 bleeding complications). Limitations include retrospective data assessment with biases. CONCLUSIONS: RC in patients on antithrombotic therapy exhibits a higher incidence of adverse events due to underlying comorbidities. Adherence to thromboprophylaxis guidelines enables safe RC in patients with significant comorbidities, without substantial increase in major bleeding or severe thromboembolic events.

Improving Estimates of Perioperative Morbidity After Radical Cystectomy Using the European Association of Urology Quality Criteria for Standardized Reporting and Introducing the Comprehensive Complication Index.

BACKGROUND: No procedure-specific definitions in complication reporting have been universally accepted in urological surgery, and conventional classification systems do not reflect cumulative morbidity. OBJECTIVE: To conduct a rigorous assessment of 30-d complications after radical cystectomy and improve morbidity estimates by introducing the novel Comprehensive Complication Index (CCI). DESIGN, SETTING, AND PARTICIPANTS: A retrospective proof-of-concept study of 506 patients with bladder cancer between 2009 and 2017. INTERVENTION: Radical cystectomy with pelvic lymph node dissection. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSES: Thirty-day complications were extracted from digital charts based on a procedure-specific catalog. Each complication was graded by the Clavien-Dindo classification (CDC), and each individual CCI was calculated. We evaluated traditional morbidity endpoints and tested the ability of both classification tools to mirror cumulative morbidity. Multivariable regression analyses were employed for risk modeling using conventional and novel endpoints. The study fulfilled all the European Association of Urology (EAU) criteria of standardized reporting. Limitations include restricted follow-up of 30 d. RESULTS AND LIMITATIONS: Of 506 patients, 503 (99%) experienced a total of 2485 complications, of which the majority was classified as "minor" (CDC grade ≤ IIIa; 89%). Overall, 29 (5.7%), 20 (4.0%), and 12 (2.4%) patients were reoperated, readmitted, and died within 30 d, respectively. When using the CCI to capture cumulative morbidity, the proportion of patients with most severe complication burden (CDC grade ≥ IIIb or corresponding CCI > 33.7) increased to 31% as compared with 11% when considering only the highest-grade complication according to the CDC. Age-adjusted comorbidity and delta hemoglobin were the main drivers of perioperative complications for all outcomes in multivariable models. CONCLUSIONS: The assessment of short-term morbidity after radical cystectomy may be refined and optimized by employing the EAU criteria of standardized reporting and using the CCI to capture cumulative morbidity. These are the cornerstones of urgently needed procedure-tailored benchmarking to improve comparability and quality control. PATIENT SUMMARY: Characterization of short-term morbidity after radical cystectomy was improved by using several validated assessment tools and adhering to existing guidelines for reporting surgical complications.