Cheney, Scott

Purpose: The Manufacturer and User Facility Device Experience database contains anonymous, voluntary medical device reports. A review of device-related adverse events associated with Benign Prostatic Hyperplasia surgeries was completed. The objective was to evaluate the occurrence and contributing factors to clinically significant complications in a cohort of patients electing to undergo surgical intervention for Benign Prostatic Hyperplasia. Methods: The Manufacturer and User Facility Device Experience database was queried for “Aquablation, Greenlight Laser, Holmium Laser, Morcellator, Water Vapor Thermal Therapy, Loop Resection, and Prostatic Urethral Lift” from 2018 through 2021. A complication classification system (Level I–IV) based on the Clavien-Dindo system was used to categorize events. These events were then correlated with procedural technology malfunctions and classified as “device related” and “non-device related.” Chi squared analysis was performed to identify associations between procedural technology and complication classification distribution. Results: A total of 873 adverse events were identified. The adverse events were classified into level I (minimal harm) versus levels II–IV (clinically significant). Aquablation ( p < 0.017) and Water Vapor Thermal Therapy ( p < 0.012) were associated with a higher proportion of reports with Level II-IV complications compared with other procedure types. Level II-IV complications were not associated with a reported device related malfunction. Conclusions: Aquablation and water vapor thermal therapy demonstrated noteworthy clinically significant complications which were not driven by device-related malfunctions.

AbstractPurpose/ObjectivesHolmium laser enucleation of the prostate (HoLEP) is commonly performed in patients with significant bladder outlet obstruction. However, there are few reports on the toxicity of external beam irradiation (RT) for prostate cancer in patients after prior HoLEP. In this study, we evaluate the side effects and treatment outcomes of RT after HoLEP.Materials/MethodsEighteen patients who had HoLEP and subsequently received RT for prostate cancer were included. Data collected included patient and disease characteristics, urinary function, and radiation dose. Acute and late urinary (GU) and gastrointestinal (GI) side effects were evaluated. Disease control and survival rates were calculated using Kaplan–Meier method.ResultsMedian follow‐up was 18 months (range: 4–46 months). Median prostate volume was 107 ml before HoLEP and 24 ml after HoLEP. Median International Prostate Symptom Score (IPSS) was 17 (range: 5–32) before HoLEP. Median decline in IPSS score after HoLEP was 7 (range: −2–21). On uroflow study, peak flow rate, and post‐void residual were significantly improved after HoLEP. After radiation, peak flow rate and average flow rate showed a decline but remained significantly improved compared to pre‐HoLEP measurements. Maximum acute Common Terminology Criteria for Adverse Events (CTCAE) adverse events were 12 grade 1 and 3 grade 2 for GU, and 3 grade 1 for GI, respectively. Maximum late adverse events were 13 grade 1 and 2 grade 2 for GU, and all grade 0 for GI, respectively. At last follow‐up, there were 8 grade 1 and 1 grade 2 late GU, and 3 grade 1 late GI adverse events, respectively. There was no significant increase in urinary incontinence after RT compared to before RT. The 18‐month biochemical control, local control, distant control rates were 78%, 94%, and 80%, respectively.ConclusionsPatients who received RT as definitive treatment for prostate cancer after prior HoLEP had low risk of serious acute and late side effects. HoLEP can be safely performed and should be considered in patients with significant bladder outlet obstruction and large prostate volume before RT.

SAGE-Journals-Accessible-Video-Player 10.1089/vid.2020.0132.M1 sj-vid-1-vid-10.1089_vid.2020.0132

Objectives To compare the enucleation efficiency of Moses 2.0 with non‐Moses technology in patients undergoing holmium laser enucleation of the prostate (HoLEP). Patients and Methods A double‐blinded, randomised study of patients undergoing HoLEP at the Mayo Clinic in Arizona, using the Lumenis Pulse™ 120H laser system. Patients were randomised to either right lobe enucleation using Moses 2.0 and left lobe enucleation using non‐Moses, or the opposite. The primary outcome was individual lobe enucleation efficiency. Secondary outcomes included individual lobe laser time, laser energy, individual enucleation and haemostasis laser energies, and fibre burn back. Two independent reviewers watched videos of the procedures and provided a subjective evaluation of the technologies. Results A total of 27 patients were included in the study. For the entire cohort, Moses 2.0 had less fibre degradation (3.5 vs 16.8 mm, P < 0.01) compared to non‐Moses. When HoLEP procedures were performed by an expert, Moses 2.0 resulted in shorter enucleation time (21 vs 36.7 min, P = 0.016) and higher enucleation efficiency (1.75 vs 1.05 g/min, P = 0.05) compared to non‐Moses. When HoLEP was performed by trainees, the Moses 2.0 cohort had a shorter haemostasis laser time (4.1 vs 9 min, P = 0.035) compared to the non‐Moses. Fibre degradation was lower with Moses 2.0 compared to non‐Moses for both experts and trainees. Moses 2.0 received a higher score than the standard technology for the incision sharpness, fibre control, tissue separation, tissue damage, haemostasis, visibility, and charring. The overall inter‐observer correlation coefficient was 0.63. Conclusion Moses 2.0 has higher enucleation efficiency compared to non‐Moses when used by experts. The subjective evaluation favoured Moses 2.0.

536 Background: The management of malignant mesothelioma of the tunica vaginalis of the testes (MMTVT) is not clearly defined, though retroperitoneal lymph node dissection has been reported as a diagnostic and potentially therapeutic option. Herein we present our experience with robot assisted retroperitoneal lymph node dissection (RARPLND) in a series of patients with MMTVT. Methods: The Mayo Clinic cancer registry was queried from 1972-present for all patients who had a diagnosis of MMTVT. Six patients were identified, five of whom were treated with RPLND, where four underwent RARPLND. Data was collected on pertinent demographic, preoperative, perioperative, postoperative outcomes and follow-up oncological data. Results: In five patients who underwent RPLND, the median age was 50 years (IQR 34-51), median BMI was 26.9 (IQR 26.4-30.6). Four patients originally presented with right sided symptomatic hydroceles, while one presented with right sided chronic epididymitis. Orchiectomy (one simple, two inguinal radical) was performed in three patients and hydrocelectomy in the other two patients prior to presentation. Preoperative cross-sectional imaging, including PET-CT scan in three patients, was negative for lymphadenopathy or metastasis. RARPLND was performed in 4/5 (80%) cases and concomitant hemiscrotectomy in 4/5 (80%) cases. Full bilateral template was performed in three patients and right modified template was performed in the remaining two. Median lymph node yield was 29 (IQR 22-32) and median blood loss was 275 cc (IQR 200-300). Positive retroperitoneal lymph nodes were found in 3/5 (60%) cases. Final margins of hemiscrotectomy were negative in all four cases. All patients who underwent RARPLND were discharged home on postoperative day one. One patient received four cycles of adjuvant Cisplatin and Pemetrexed. Mean follow-up was 27 months (range 2-47). No patients recurred. Conclusions: MMTVT is a very rare malignancy with high potential for retroperitoneal lymph node dissemination. Regardless of the approach, RPLND may provide both a diagnostic and therapeutic benefit, with the robotic approach affording a potentially expedited recovery.

492 Background: There is scant information about intermediate and long-term comparative outcomes between RARC and ORC, with the exception of a recent, small randomized-trial. We present our experience with RARC and ORC in managing bladder cancer patients who require cystectomy. Methods: A query of all patients who underwent radical cystectomy for a primary bladder tumor between 01/2007 and 6/2017 at our institution yield 469 patients. Data was collected on patient demographics, pre-operative information, operative details, pathology, and follow-up. Most RARCs were performed by a high-volume robotic surgeon who preferentially used the robotic approach at the start of all cases. Statistical analyses were generated using SPSS 22.0. Any open conversions were analyzed in the RARC cohort. Results: In 469 total patients, 197 (42.0%) and 272 (58.0%) underwent RARC and ORC, respectively. There were 163 (82.7%) and 224 (82.4%) males in each group and the mean ages (SD) were 71.5 (8.6) and 70.2 (10.5) years. Mean follow-up (SD) was 75 (37.7) and 61 (35.7) months, respectively. There were 130 (66.0%) and 172 (63.2%) patients who presented with T2 or greater disease (p=0.605). Soft-tissue margin rates were 4.1% for RARC and 6.7% for ORC patients (p=0.232). Neoadjuvant chemotherapy was used in 56.9% of RARC and 45.9% of ORC patients with ≥ cT2 disease (p=0.058). The 5-year overall survival was 60.0% vs 57.0% and the 10-year overall survival was 40.3% vs 44.8% for RARC vs. ORC patients, respectively (p=0.283). The 5-year recurrence-free survival was survival (RFS) was 71.7% vs 65.7% and the 10-year RFS was 70.5% vs 62.3% for the RARC vs. open groups, respectively (p=0.078). Aggressive histological variants, which were associated with greater likelihood for recurrence, were more common in the ORC group (13.7 vs. 22.4% p=0.013). Atypical recurrences (i.e. peritoneal, extrapelvic nodes) occurred in 6 (3.0%) and 14 (5.1%) RARC and ORC patients, respectively (p=0.266). Conclusions: In experienced hands, intermediate and long-term outcomes of RARC appear equivalent to ORC with regards to recurrence free survival, overall survival, and risk of atypical recurrences.

Objective To evaluate outcomes of the first 18 patients treated with robot‐assisted retroperitoneal lymph node dissection ( RA‐RPLND ) for non‐seminomatous germ cell tumours ( NSGCT ) and paratesticular rhabdomyosarcoma ( RMS ) at our institution. Patients and Methods Between M arch 2008 and M ay 2013, 17 patients underwent RA‐RPLND for NSGCT and one for paratesticular RMS . Data were collected retrospectively on patient demographics, preoperative tumour characteristics, and perioperative outcomes including open conversion rate, lymph node ( LN ) yield, rate of positive LNs , operative time, estimated blood loss ( EBL ), and length of stay ( LOS ). Perioperative outcomes were compared between patients receiving primary RA‐RPLND vs post‐chemotherapy RA‐RPLND . Medium‐term outcomes of tumour recurrence rate and maintenance of antegrade ejaculation were recorded. Results RA‐RPLND was completed robotically in 15 of 18 (83%) patients. LNs were positive in eight of 18 patients (44%). The mean LN yield was 22 LNs . For cases completed robotically, the mean operative time was 329 min, EBL was 103 mL, and LOS was 2.4 days. At a mean (range) follow‐up of 22 (1–58) months, there were no retroperitoneal recurrences and two of 17 (12%) patients with NSGCT had pulmonary recurrences. Antegrade ejaculation was maintained in 91% of patients with a nerve‐sparing approach. Patients receiving primary RA‐RPLND had shorter operative times compared with those post‐chemotherapy (311 vs 369 min, P = 0.03). There was no significant difference in LN yield (22 vs 18 LNs , P = 0.34), EBL (100 vs 313 mL, P = 0.13), or LOS (2.75 vs 2.2 days, P = 0.36). Conclusion This initial selected case series of RA‐RPLND shows that the procedure is safe, reproducible, and feasible for stage I – IIB NSGCT and RMS in the hands of experienced robotic surgeons. Larger studies are needed to confirm the diagnostic and therapeutic utility of this technique.