(012) USE OF REAR TIP EXTENDERS IS ASSOCIATED WITH INCREASED RISK OF POST-OPERATIVE COMPLICATIONS AND PENILE PROSTHESIS REVISION IN PATIENTS UNDERGOING PRIMARY INFLATABLE PENILE PROSTHESIS PLACEMENT: RESULTS FROM A LARGE MULTI-INSTITUTIONAL COLLABORATIVE
Abstract Introduction The utilization of rear tip extenders (RTE) is often imperative during Inflatable Penile Prosthesis (IPP) placement. The impact of RTE on perioperative morbidity of IPP surgery is underexplored. Objective In this study, we assess intraoperative and postoperative outcomes among patients undergoing primary IPP implantation with or without RTE. Methods We performed a multicenter, retrospective analysis of men undergoing primary IPP placement between July 2016 and July 2021. A total of 4308 patients were identified, of which 2963 had no RTE and 1345 had RTE. After 1:1 propensity score matching for all confounding variables, 840 patients without RTE were compared to patients with RTE for intraoperative and postoperative outcomes. Chi-square and Mann–Whitney tests were used for statistical analysis for categorial and continuous variables respectively. For multivariable analysis, we used a forward stepwise model and included significant variables found on preoperative characteristics of patients. Kaplan–Meier time to event analysis were compared with Mantel-Cox log-rank test. Results Patients with RTE use had more postoperative complications (9.6% vs 5.2%, p < 0.001). More specifically, RTE patients had more episodes of postoperative hematoma and bleeding (2.0% vs 0.7%, p = 0.033), device malfunction (2.7% vs 1.8%, p = 0.006), and glans-related complications (0.8% vs 0, p = 0.015). On multivariable analysis, use of RTE (OR 1.58, 95% CI 1.07-2.34, p = 0.021), AMS 700 series device (OR 1.93, 95% CI 1.27-2.94, p = 0.002), penoscrotal approach (OR 2.60, 95% CI 1.61-4.18, p < 0.001), and older age (OR 1.02, 95% CI 1.00-1.04, p = 0.035) were associated with increased risk of postoperative complications. Patients with RTE use had increased rate of postoperative IPP revision (5.0% vs 2.1%, p = 0.002). The use of RTE (OR 1.71, 95% CI 1.00-2.90, p = 0.046), AMS 700 series device (OR 1.73, 95% CI 1.01-2.97, p = 0.048), penoscrotal approach (OR 3.16, 95% CI 1.63-6.17, p < 0.001), and history of Peyronie’s disease (OR 2.24, 95% CI 1.31-3.82, p = 0.003) were associated with increased risk of postoperative IPP revision or explantation. On Kaplan–Meier analysis, use of RTE was associated with increased risk of postoperative complications and IPP revision or explantation within 48 months (log rank p = 0.001 and p = 0.002 respectively). Conclusions In this large multi-institutional cohort, patients with RTE experienced more hematoma, device malfunctioning, and glans related post operative complications. The use of RTE is an independent predictor of post-operative complications and IPP revision or explanation. Disclosure No.
New findings regarding predictors of Poor Corporal Integrity in Penile Implant Recipients: A Multicenter International Invesigation
Objectives To evaluate the pre‐ and intraoperative variables that impact the integrity of the corporal bodies over time after inflatable penile prosthesis (IPP) placement, as predictors of intraoperative corporal perforation and delayed cylinder complications have not been well characterized. Patients and Methods We retrospectively reviewed a 16‐centre multi‐institutional database of IPP surgeries performed by experienced implanters from 2016 to 2021. Poor corporal integrity (PCI) was defined as intraoperative (iPCI) corporal complications or postoperative (pPCI) corporal complications. Multivariable analysis was performed to identify independent predictors of PCI, iPCI, and pPCI. Primary outcomes included intra‐ and postoperative corporal complications. Results We identified 5153 patients for analysis from 5406 IPP cases, finding 152 (2.95%) cases of PCI. On multivariable analysis, predictors of PCI included revision IPP surgery (odds ratio [OR] 8.16, 95% confidence interval [CI] 5.15–12.92; P < 0.001), sequential dilatation (OR 2.12, 95% CI 1.32–3.39; P = 0.002), coronary artery disease (CAD)/peripheral vascular disease (PVD) (OR 1.81, 95% CI 1.18–2.77; P = 0.006), older age (OR 1.02, 95% CI 1.01–1.04; P = 0.013), and corporal scarring (OR 1.58, 95% CI 1.0–2.5; P = 0.049). Predictors of iPCI included revision IPP surgery (OR 7.34, 95% CI 4.18–12.88; P < 0.001), corporal scarring (OR 2.77, 95% CI 1.64–4.69; P < 0.001), radiation therapy (OR 2.25, 95% CI 1.0–5.04; P = 0.049), and older age (OR 1.03, 95% CI 1.0–1.05; P = 0.025). Revision IPP surgery (OR 7.92, 95% CI 3.69–17.01; P < 0.001), sequential dilatation (OR 3.4, 95% CI 1.61–7.19; P = 0.001), CAD/PVD (OR 2.98, 95% CI 1.56–5.72; P = 0.001), and history of priapism (OR 3.59, 95% CI 1.08–11.99; P = 0.038) were predictive of pPCI. Conclusion Coronary artery disease/PVD, being of older age, having corporal scarring, undergoing IPP revision surgery and sequential dilatation were predictive risk factors for complications associated with PCI. Identifying patients who are at risk of having PCI may improve patient‐specific counselling, consideration of referral to more experienced implanters, and surgical planning to potentially promote longer‐term device viability.
(181) Prior Radiation Therapy is Associated with Increased Risk of Intra-Operative Complications in Patients Undergoing Primary Inflatable Penile Prosthesis Placement: Results from a Large Multi-Institutional Collaborative
Abstract Introduction Radiation therapy (RT) can predispose the onset of corporal fibrosis and microvasculopathy. The impact of RT on intra-operative complications is not well described in the literature. Objective In this study, we assess intra-operative and post-operative outcomes among patients with or without prior history of RT following primary Inflatable Penile Prosthesis (IPP) implantation. Methods We performed a multicenter, retrospective analysis of men undergoing primary IPP placement between January 2015 and December 2022. A total of 3530 patients were identified, of which 3319 had no prior history of RT and 211 patients had history of RT. After 1:1 propensity score matching for all confounding variables, 211 patients with a history of RT were compared to 211 nonradiated patients for intra-operative and post-operative outcomes. Chi-square and Mann-Whitney tests were used for statistical analysis for categorial and continuous variables respectively. For multivariable analysis, we used a forward stepwise model and included significant variables found on pre-operative characteristics of patients. Kaplan-Meier time to event analysis were compared with Mantel-Cox log-rank test. Results Patients with history of RT encountered more intra-operative complications (4.3% vs 0.9%, p=0.032); specifically, these men experienced more distal crossover events (1.9% vs 0, p=0.044). On multivariable analysis, history of prior RT (OR 5.29, 95% CI 1.07-26.3, p=0.041) and diabetes mellitus (OR 10.5, 95% CI 2.58-43.5, p=0.01) were associated with increased risk of intra-operative complications. History of obesity (OR 0.11, 95% CI 0.01-0.91, p=0.040) reduced risk of intra-operative complications. There was no significant difference in early or late post-operative non-infectious complications between both groups and there was also no significant difference in risk of post-operative complications within 24 months on Kaplan Meier analysis (log rank p=0.9). Conclusions In this large multi-institutional cohort, history of RT is an independent predictor of intra-operative complications but not post-operative complications during primary IPP placement. These findings may help inform patient-specific counseling while guiding surgical planning to prevent untoward morbidity following surgery. Disclosure No.
(505) New Findings Regarding Independent Predictors of Poor Corporal Integrity in Penile Implant Recipients: A Multicenter International Investigation
Abstract Introduction Predictors of intraoperative corporal perforation and delayed cylinder complications in inflatable penile prosthesis (IPP) placement have not been well-delineated in the literature. Inflatable penile prosthesis (IPP) can offer high satisfaction rates of patients, but this procedure is not without complications that can be encountered intraoperatively and postoperatively. Particularly, predictors of intraoperative corporal perforation and delayed cylinder complications in IPP placement have not been well-delineated in the literature. Objective We evaluated our retrospective multi-institutional database of IPP surgeries performed by expert implant surgeons to identify risk factors that are predictive of the development of these non-infectious complications. Methods IPP cases performed by sixteen international implanters from 2016-2021 were identified. All primary and revision cases were included. Salvage cases for infection were excluded. Demographic characteristics, intraoperative variables, and postoperative outcomes were assessed. Poor corporal integrity (PCI) was defined as intraoperative corporal complications (proximal and/or distal perforation of the corpora, corporal crossover) or postoperative corporal complications (cylinder erosion, extrusion, impending erosion, or deformity). Risk factor analysis and multivariate analysis were performed to identify predictors of PCI. Results A total of 5406 IPP cases across 16 separate institutions were assessed. There were 163 (3.0%, mean age 64) cases of PCI. Of the 156 complications that occurred, 101 (64.7%) occurred intraoperatively, while 55 (35.3%) occurred postoperatively. The rates of diabetes (p=0.669), vascular disease (p=0.054), and history of intracavernosal injections (p=0.111) all had no statistically significant effect on corporal integrity. Patients with PCI tended to have hypertension (p=0.045), current smoking (p=0.03), history of IPP infection (p<0.001), and history of shunt for priapism (p<0.001). On multivariate analysis, predictors of PCI include hypertension (OR 1.64 (1.09-2.47), p=0.018), history of IPP infection (OR 4.41 (2.52-7.84), p<0.001), and age (OR 1.02 (1.00-1.04), p=0.027). Obesity was found to be protective (OR 0.63 (0.42-0.95), p=0.027). Conclusions Our multicenter analysis found that hypertension, current smoking, history of IPP infection and age were risk factors for complications associated with poor corporal integrity. Recognizing these risk factors preoperatively can allow for improved patient-specific counseling and changes in surgical strategy to potentially prevent these complications. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast and Boston Scientific.
(484) Single Dilation in Primary Inflatable Penile Prosthesis Placement is Associated with Less Corporal Complications than Sequential Dilation
Abstract Introduction In primary implant patients without significant corporal fibrosis, penile implant surgical technique varies in implementation of either single dilation (SingD) or sequential dilation (SeqD). Vigorous debate exists regarding both methods, but there is no robust evidence supporting one technique over the other in the literature. Objective We compared the rates of intraoperative complications and postoperative outcomes from a large international database of inflatable penile prostheses (IPP) performed by expert implant surgeons to determine if there were any significant differences in rates between SingD and SeqD. Methods We analyzed IPP cases performed by international implanters from 2016-2021. All primary implant cases were included, while revision cases, salvage operations, and patients with evidence of corporal fibrosis were excluded. Intraoperative complications and postoperative noninfectious outcomes were assessed between the two groups. These included proximal/distal perforation and cylinder crossover. Results After exclusion based on aforementioned criteria, we identified 3045 patients who underwent IPP. After 1:1 propensity matching of both groups, we analyzed 572 patients who underwent SingD and 572 patients who underwent SeqD. Between the two groups, more men of non-Caucasian race underwent SingD vs SeqD (p<0.001). There was a significant difference in cylinder length in the SeqD group vs the SingD group (20cm ± 1.5 vs. 20 cm ±2 respectively, p=0.018). There were 8 (0.7%) intraoperative complications in total, 7 in the SeqD group and 1 in the SingD group (p=0.034). Of these intraoperative complications, 3 (37.5%) patients who underwent SeqD sustained a proximal perforation, 3 (37.5%) sustained distal crossover, and 1 (12.5%) sustained proximal crossover. 1 patient (12.5%) with intraoperative complication who underwent SingD sustained a proximal perforation. Postoperatively, 78 (82%) of complications were in the SeqD group and 17 (18%) in the SingD group (p<0.001). Of these postoperative complications, there were 15 patients with bleeding or hematoma, of which 14 were in the SeqD group vs 1 in the SingD group (p<0.001). Of the 35 patients who were noted to have device-related malfunction, 29 underwent SeqD and 6 underwent SingD (p<0.001). Postoperative complications were more related to technical error in the SeqD vs the SingD group (11 patients and 1 patient respectively, p<0.011). On multivariate analysis, prior radical prostatectomy was predictive of intraoperative complications (OR 4.59 with IQR 1.39-15.16, p=0.024), while larger cylinder size seemed to be protective (OR 0.66 with IQR 0.50-0.89, p=0.006). On multivariate analysis, SeqD was predictive of postoperative complications (5.16 with IQR 3.01-8.83, p<0.001), as was history of priapism (4.15 with IQR 1.30-13.29, p=0.017). Patients who undergo SeqD may be calibrated by the surgeon to have more complex corpora, which could explain higher complication rates. We identified 3045 patients who underwent IPP. Conclusions In our international multicenter assessment of primary IPPs without corporal fibrosis performed by expert surgeons, patients undergoing single dilation appear to have slight benefit in total cylinder length. Sequential dilation may confer greater risk of intraoperative and postoperative complications, including bleeding and hematoma. Single dilation is a safe technique for primary inflatable penile prosthesis. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast and Boston Scientific