Citations

Abstract Glans hypermobility (GH) is a well-described clinical entity that can have significant implications for cosmesis and function, resulting in sexual dissatisfaction, penile pain, and early device erosion, with an estimated incidence of 0.04–10%. We developed a novel grading scale to assess GH severity intraoperatively during primary inflatable penile prosthesis (IPP) placement and describe a modified glanspexy technique to correct GH when encountered during IPP placement. A total of 530 patients underwent primary device implantation. Of these, 139 (26%) had hypermobility. Employing our new scaling system, grade 1, 2, and 3 GH was seen in 86 (16%), 29 (5.5%), and 24 (4.5%) cases, respectively. Increased implant size correlated with decreased likelihood of GH incidence. Each increase in implant size by 1 cm decreased the incidence of detecting GH by 11% (OR = 0.89; p = 0.015). 11 patients underwent primary GH repair using our described technique. At one-year follow-up, one patient required repeat glanspexy for recurrent bothersome GH and a second patient developed a suture granuloma at the glanspexy incision requiring unilateral cylinder explant. Our modified glanspexy technique can be used to correct GH in any direction and is a useful tool for the prosthetic surgeon’s armamentarium.

AbstractBackground and PurposeTo determine the incidence of acute neuroimaging (NI) findings and comorbidities in the coronavirus disease of 2019 (COVID‐19)‐infected subjects in seven U.S. and four European hospitals.MethodsThis is a retrospective study of COVID‐19‐positive subjects with the following inclusion criteria: age >18, lab‐confirmed COVID‐19 infection, and acute NI findings (NI+) attributed to COVID‐19 on CT or MRI brain. NI+ and comorbidities in total hospitalized COVID‐19‐positive (TN) subjects were assessed.ResultsA total of 37,950 COVID‐19‐positive subjects were reviewed and 4342 underwent NI. NI+ incidence in subjects with NI was 10.1% (442/4342) including 7.9% (294/3701) in the United States and 22.8% (148/647) in Europe. NI+ incidence in TN was 1.16% (442/37,950). In NI (4342), incidence of ischemic stroke was 6.4% followed by intracranial hemorrhage (ICH) (3.8%), encephalitis (0.5%), sinus venous thrombosis (0.2%), and acute disseminated encephalomyelitis (ADEM) (0.2%). White matter involvement was seen in 57% of NI+. Hypertension was the most common comorbidity (54%) before cardiac disease (28.8%) and diabetes mellitus (27.7%). Cardiac disease (p < .025), diabetes (p < .014), and chronic kidney disease (p < .012) were more common in the United States.ConclusionThis multicenter, multinational study investigated the incidence and spectrum of NI+ in 37,950 hospitalized adult COVID‐19 subjects including regional differences in incidences of NI+, associated comorbidities, and other demographics. NI+ incidence in TN was 1.16% including 0.95% in the United States and 2.09% in Europe. ICH, encephalitis, and ADEM were common in Europe, while ischemic strokes were more common in the United States. In this cohort, incidence and distribution of NI+ helped characterize the neurological complications of COVID‐19.

e24078 Background: The addition of anti-CD38 mAbs, daratumumab and isatuximab, to standard anti-myeloma regimens have drawn scrutiny towards long-term safety concerns, including the risk of SPMs. ICARIA-MM study reported SPMs in 3.9% patients (pts.) in the Isatuximab, pomalidomide and dexamethasone (Isa-Pd) arm compared to 0.7% in the Pd arm. We hypothesized that exposure to anti-CD38 mAbs could potentially increase risk of SPMs due to prolonged immunosuppression. An assessment of this association is warranted, given the improved life expectancy and growing prevalence of pts. with MM. Methods: We performed a meta-analysis on data obtained from RCTs published between January 2005 and April 2022 that compared anti-CD38 mAb-based regimens to other standard anti-myeloma regimens (control) in pts. with newly diagnosed or relapsed/refractory (r/r) MM. Total number of SPMs (including categories) were extracted for pts. in both groups. Malignant melanomas were included under solid SPM category. Binary outcome data were analyzed using fixed-effect Peto method. Treatment effect estimates were expressed as odds ratio (OR) and 95% confidence interval (CI). I2 > 50% indicated substantial heterogeneity. Results: 10 RCTs involving 4980 pts. were included, with 2824 (57%) and 2156 (43%) pts. randomized to the anti-CD38 mAb and control arms, respectively (Table). Overall, 191 and 112 SPMs were reported in the anti-CD38 mAb and control arms, respectively. At a median follow-up of 35.3 months, anti-CD38 mAb exposure was associated with an increased risk of developing SPMs compared to control (6.8% vs. 5.2%; OR: 1.53 [95% CI: 1.20-1.95]; I2= 0%). Non-melanoma cutaneous cancers were the most common, and higher in the anti-CD38 mAb vs. control arms (92 versus 47; OR: 1.77 [95% CI: 1.25-2.51]; I2= 0%). The increase in solid cancers (including melanoma) (OR: 1.28 [95% CI: 0.85-1.95]) and hematologic SPMs (OR: 1.86; [95% CI: 0.81-4.27] was not significant. On sensitivity analysis, the total number of SPMs were higher in the anti-CD38 mAb arm vs. control arm, regardless of the presence of immunomodulatory drugs in combination regimen. Conclusions: This meta-analysis shows an increased risk of SPMs in pts. with MM exposed to daratumumab or isatuximab, particularly that of non-invasive cutaneous tumors. This association should be further investigated in real-world settings using large databases. [Table: see text]

Abstract Introduction We report outcomes for patients in which the IPP became unusable by the patient because of pump difficulties or inadequate fluid volume in the IPP system. Objective We sought to assess outcomes of penile implant single component exchange or fluid instillation in a cohort of patients, challenging the entire device replacement dogma. Methods 17 patients underwent single component exchange by a single surgeon. CT scan was obtained to ensure device integrity, assess for air in the system, and to delineate device details. In cases of pump difficulties, the old pump was removed and replaced with a “classic” Genesis Coloplast pump regardless of initial device brand (“Frankenstein” if brands are mixed). Patients are taught pump rocking techniques and have &gt; 6 months of difficulty before exchange. Patients are warned of auto-inflation as there is no lock out valve in the Genesis pump. For fluid addition to the system, the two old connector collars are separated and sometimes re-used after saline is added to only the cylinders. We never add fluid to the reservoir using a piston syringe for fear of reservoir capsule rupture into adjacent structures. Revisions were copiously irrigated, as of 2022, with Irrisept. Results Pump exchange: 14 patients underwent single component pump exchange secondary to inability for the patient to be able to adequately cycle the device (11 AMS MS, 1 Coloplast Touch). Remarkable differences were noted in pump cycling between office exam (difficult), exam under anesthesia prior to incision (sometimes difficult), and once the pump is removed from its capsule (universally easy). Complications of these 14 patients include 1 fungal infection requiring replacement with a malleable device and one repeat pump exchange (AMS MS - AMS MS - Genesis). Two patients noted non-bothersome minor auto-inflation. The single Coloplast case had a remarkably thickened capsule after a likely low grade infection. All patients can successfully use their devices now. Fluid Addition: Three patients underwent fluid addition to the system. One had a significant proximal aneurysm for which we added 35 ml. A different case had both a pump exchange and 30 ml added to the system as the initial reservoir appeared to have folded cordoning off fluid. The final fluid addition occurred 18 months after initial Coloplast 22+2 cm placement in which the patient very aggressively cycled the device and could not obtain 10/10 erection. 30 ml was added to the system totaling 140 cc. All patients have done well with fluid addition with mean time since surgery of 1 year. Conclusions Pump exchange with genesis pump or simple fluid addition to the system are safe and feasible and successfully restores IPP functionality. The Frankenstein strategy is a viable alternative, although patients must be counseled that auto-inflation may occur. With modern day irrigation techniques and CT confirmation of fluid system integrity, the dogma to replace the entire device may actually carry higher morbidity in some patients. Disclosure No

Abstract Introduction Intralesional Collagenase Clostridium histolyticum (CCH) is approved for men with Peyronie’s Disease (PD). Most studies use curve improvement ≥ 20% to define treatment success. Objective Here, we sought to further characterize objective and subjective treatment outcomes with CCH. Methods We reviewed our prospectively maintained database for all patients who underwent CCH at our institution from 2013 through the present. We specifically identified those who completed four series of CCH (or elected to discontinue prior to completing four series due to satisfactory penile straightening or lack of results) and had available curvature assessment data. Treatment outcomes were broken down by level of curve improvement (0%, 10%, 20%, 30%, and &gt; 40% improvement). Treatment success was also evaluated by improvements in the ability to engage in penetrative sexual intercourse and perceived surgery avoidance. Statistical analyses were performed using JMP Pro 14.1.0 (SAS Institute, Cary, NC). Results 127 patients had complete data available. The mean age was 57 years (SD 8.4). The mean PD duration was 27 months (SD 59). The mean baseline curvature was 66.1O, and the mean post-treatment curvature was 45.1O (p&lt;0001). The mean curvature improvement was 32% (SD 33). 68% of patients achieved a 20% or greater improvement in penile curvature, including 38% who achieved ≥ 40% improvement. 72% (n=48/67) felt that CCH prevented the need for surgery, and 68% reported CCH restored the ability to penetrate. Stretched flaccid penile length (SPL) increased by ≥ 1 cm in 50% of patients who used concurrent penile traction (PTT) and CCH, including 28% of patients who experienced ≥ 2 cm of length gain. In contrast, only 16% of patients who did not perform concurrent PTT had a ≥ 1 cm increase in SPL (p&lt;0.0001). Conclusions CCH may restore the ability to penetrate with intercourse, and most patients feel that CCH prevents the need for surgery. Almost 40% of patients experienced a 40% or greater curvature improvement. However, 13% of patients may go through the entire series with minimal improvement. Concurrent PTT allows for simultaneous penile length gain in some patients. These data are helpful when counseling patients on expected outcomes. Disclosure No

Abstract Introduction Obstructive azoospermia accounts for up to 14% of patients presenting for fertility evaluation. Fine-needle vasography (FNV) is a diagnostic procedure that can be performed to identify an obstruction proximal to the ejaculatory duct. Compared to traditional vasography, FNV utilizes a less-invasive method to perform imaging of the vas deferens and distal ejaculatory structures. Herein we report our experience performing FNV in a series of patients with suspected complete or near-complete obstruction. Objective To report our experience using FNV to identify a site of obstruction and determine candidacy for reconstructive procedures in patients presenting with suspected obstructive azoospermia or cryptozoospermia. Methods We report a multi-Institutional case series of patients with suspected complete or partial obstructive azoospermia. Patients that were included had azoospermia or severe oligoasthenospermia, presence of palpable vasa, testicles ≥12 ml, and FSH &lt;7.6 IU/L. All patients underwent testicular biopsy prior to or at the time of FNV to confirm spermatogenesis. Fine-needle vasography was performed using a 25F angiocatheter, with radio-opaque dye visualized under fluoroscopy. Descriptive statistics are reported as median and interquartile range (IQR). Results A total of 16 patients underwent vasography between 2014 and 2022 with three surgeons. Twelve patients presented with azoospermia, and four with severe oligoasthenospermia. Median age at vasography was 35.0 (IQR 17) years. Median pre-vasography semen parameters were sperm concentration 0 million/mL (IQR 0.3), sperm motility 0% (IQR 1), semen volume 2.5 mL (IQR 2.5), and semen pH 8.0 (0.7). Median total testosterone was 445 ng/dL (IQR 433), and FSH 4.5 IU/L (IQR 3.6). Half of patients had a history of inguinal hernia repair, unilateral in two and bilateral in six cases. History of genitourinary infection was present in six (35.3%) patients. A total of 7 (44%) men were found to have distal obstruction on FNV, while 8 (50%) were offered epididymovasal reconstruction. Of the seven patients diagnosed with obstruction/atresia of the vas deferens within the inguinal canal and/or pelvis, only two were related to prior inguinal hernia repair. Of the eight men with prior inguinal hernia repairs, two were confirmed to have an obstruction at the level of the inguinal canal. Of the six patients with a history of genitourinary infection, four had an obstruction at the level of the epididymis (with normal FNV), while two had atresia of the vas deferens in the pelvis. Conclusions Fine-needle vasography is an effective, minimally-invasive way to identify the site of complete or partial obstruction in patients presenting with suspected obstructive azoospermia or severe oligoasthenospermia. It additionally permits identification of men who are candidates for epididymovasostomy reconstruction and helps to differentiate between ejaculatory duct obstruction and other causes of blockage. Disclosure No

AbstractBackgroundLenalidomide maintenance after autologous stem cell transplant (ASCT) in multiple myeloma (MM) results in superior progression‐free survival and overall survival. However, patients with high‐risk multiple myeloma (HRMM) do not derive the same survival benefit from lenalidomide maintenance compared with standard‐risk patients. The authors sought to determine the outcomes of bortezomib‐based maintenance compared with lenalidomide maintenance in patients with HRMM undergoing ASCT.MethodsIn total, the authors identified 503 patients with HRMM who were undergoing ASCT within 12 months of diagnosis from January 2013 to December 2018 after receiving triplet novel‐agent induction in the Center for International Blood and Marrow Transplant Research database. HRMM was defined as deletion 17p, t(14;16), t(4;14), t(14;20), or chromosome 1q gain.ResultsThree hundred fifty‐seven patients (67%) received lenalidomide alone, and 146 (33%) received bortezomib‐based maintenance (with bortezomib alone in 58%). Patients in the bortezomib‐based maintenance group were more likely to harbor two or more high‐risk abnormalities and International Staging System stage III disease (30% vs. 22%; p = .01) compared with the lenalidomide group (24% vs. 15%; p < .01). Patients who were receiving lenalidomide maintenance had superior progression‐free survival at 2 years compared with those who were receiving either bortezomib monotherapy or combination therapy (75% vs. 63%; p = .009). Overall survival at 2 years was also superior in the lenalidomide group (93% vs. 84%; p = .001).ConclusionsNo superior outcomes were observed in patients with HRMM who received bortezomib monotherapy or (to a lesser extent) in those who received bortezomib in combination as maintenance compared with lenalidomide alone. Until prospective data from randomized clinical trials are available, post‐transplant therapy should be tailored to each patient with consideration for treating patients in clinical trials that target novel therapeutic strategies for HRMM, and lenalidomide should remain a cornerstone of treatment.

Abstract The overall survival (OS) has improved significantly in multiple myeloma (MM) over the last decade with the use of proteasome inhibitor and immunomodulatory drug-based combinations, followed by high-dose melphalan and autologous hematopoietic stem cell transplantation (auto-HSCT) and subsequent maintenance therapies in eligible newly diagnosed patients. However, clinical trials using auto-HSCT followed by lenalidomide maintenance have shown an increased risk of second primary malignancies (SPM), including second hematological malignancies (SHM). We evaluated the impact of SPM and SHM on progression-free survival (PFS) and OS in patients with MM after auto-HSCT using CIBMTR registry data. Adult patients with MM who underwent first auto-HSCT in the United States with melphalan conditioning regimen from 2011 to 2018 and received maintenance therapy were included (n = 3948). At a median follow-up of 37 months, 175 (4%) patients developed SPM, including 112 (64%) solid, 36 (20%) myeloid, 24 (14%) SHM, not otherwise specified, and 3 (2%) lymphoid malignancies. Multivariate analysis demonstrated that SPM and SHM were associated with an inferior PFS (hazard ratio [HR] 2.62, P &lt; .001 and HR 5.01, P &lt; .001, respectively) and OS (HR 3.85, P &lt; .001 and HR 8.13, P &lt; .001, respectively). In patients who developed SPM and SHM, MM remained the most frequent primary cause of death (42% vs 30% and 53% vs 18%, respectively). We conclude the development of SPM and SHM leads to a poor survival in patients with MM and is an important survivorship challenge. Given the median survival for MM continues to improve, continued vigilance is needed to assess the risks of SPM and SHM with maintenance therapy post–auto-HSCT.