Ureteroscopy in Patients Taking Anticoagulant or Antiplatelet Therapy: Practice Patterns and Outcomes in a Surgical Collaborative.

PURPOSE: AUA guidelines recommend ureteroscopy as first line therapy for patients on anticoagulant or antiplatelet therapy and advocate using a ureteral access sheath. We examined practice patterns and unplanned health care use for these patients in Michigan. MATERIALS AND METHODS: Using the Michigan Urological Surgery Improvement Collaborative (MUSIC) clinical registry we identified ureteroscopy cases from 2016 to 2019. We assessed outcomes and adherence to guidelines based on therapy at time of ureteroscopy: 1) anticoagulant: continuous warfarin or novel oral agent therapy; 2) antiplatelet: continuous clopidogrel or aspirin therapy; 3) control: not on anticoagulant/antiplatelet therapy. We fit multivariate models to assess anticoagulant or antiplatelet therapy association with emergency department visits, hospitalization and ureteral access sheath use. RESULTS: In total, 9,982 ureteroscopies were performed across 31 practices with 3.1% and 7.8% on anticoagulant and antiplatelet therapy, respectively. There were practice (0% to 21%) and surgeon (0% to 35%) variations in performing ureteroscopy on patients on anticoagulant/antiplatelet therapy regardless of volume. After adjusting for risk factors, anticoagulant or antiplatelet therapy was not associated with emergency department visits. Hospitalization rates in anticoagulant, antiplatelet and control groups were 4.3%, 5.5% and 3.2%, respectively, and significantly increased with antiplatelet therapy (OR 1.48, 95% CI 1.02-2.14). Practice-level ureteral access sheath use varied (23% to 100%) and was not associated with anticoagulant/antiplatelet therapy. Limitations include inability to risk stratify between type/dosage of anticoagulant/antiplatelet therapy. CONCLUSIONS: We found practice-level and surgeon-level variation in performing ureteroscopy while on anticoagulant/antiplatelet therapy. Ureteroscopy on anticoagulant is safe. However, antiplatelet therapy increases the risk of hospitalization. Despite guideline recommendations, ureteral access sheath use is not associated with anticoagulant/antiplatelet therapy.

One-year monitoring of an oligonucleotide fluorescence in situ hybridization probe panel laboratory-developed test for bladder cancer detection.

BACKGROUND: Previously, we had developed and manufactured an oligonucleotide fluorescence in situ hybridization (OligoFISH) probe panel based on the most clinically sensitive chromosomes found in a reference set of bladder carcinoma cases. The panel was clinically validated for use as a diagnostic and monitoring assay for bladder cancer, reaching 100% correlation with the results of the UroVysion test. After 1 year of using this probe panel, we present here the comparison of cytology, cystoscopy, and pathology findings to the OligoFISH probe panel results to calculate its clinical performance. MATERIALS AND METHODS: In order to calculate clinical performance, we compared the OligoFISH results to the cytology and cystoscopy/pathology findings for 147 initial diagnoses and 399 recurrence monitorings. Finally, we compared clinical performance to published values for the UroVysion test, including both low- and high-grade tumors. RESULTS: Chromosomes 3, 6, 7, and 20 were highly involved in bladder carcinoma aneuploidy. At the initial diagnosis, we obtained 90.5% (95% confidence interval [CI]: 84.5%-94.7%) accuracy, 96.8% sensitivity (95% CI: 91.0%-99.3%), 79.2% specificity (95% CI: 65.9%-87.8%), 89.2% positive predictive value (PPV; 95% CI: 81.5%-94.5%), and 93.3% negative predictive value (NPV; 95% CI: 81.7%-97.3%). When monitoring for recurrence, we obtained 85.2% accuracy (95% CI: 81.3%-88.5%), 82.0% sensitivity (95% CI: 76.0%-87.1%), 88.4% specificity (95% CI: 83.2%-92.5%), 87.7% PPV (95% CI: 82.1%-92.0%), and 83.0% NPV (95% CI: 77.3%-87.8%). When looking at low- and high-grade tumors, the test showed 100% sensitivity for high-grade tumors (95% CI: 92.5%-100%) and 87.5% sensitivity (95% CI: 68.8%-95.5%) for low-grade tumors. All the clinical parameters for the OligoFISH panel were higher than the UroVysion test's published performance. We found significantly higher clinical sensitivity and NPV at initial diagnosis and significantly higher specificity and PPV for recurrence. CONCLUSION: The OligoFISH probe panel is a fast, easy, and reproducible test for bladder cancer diagnosis and monitoring, with excellent clinical performance and utility.