(240) Evaluation of Factors Associated with Reoperation Rates for Penile Prosthetic Implantation in Erectile Dysfunction: A Medicare Analysis
Authors: Andino J , Leelani N , Rojanasarot S , Shin Y , Paranjpe R , Bernie HL , Halpern JA , Salter CA , Bajic P , Khera M 
Published: February 2024

Abstract

Introduction
As the prevalence of erectile dysfunction (ED) in the U.S. continues to rise due to an aging population, the use of penile prostheses (PP) to treat refractory ED is expected to increase. In 2017, Onyeji et al analyzed a New York state surgical database and found that the highest quartile implanters had lower re-operation rates in long-term follow-up. Due to a higher risk of infection and morbidity in PP reoperations, compared to primary surgery, minimizing PP reoperations is important.

Objective
This study evaluates the association between patient/clinical characteristics and reoperation rates at 90-days and 1-year among men undergoing PP implantation using a national database.

Methods
This retrospective claims data analysis used the 100% Medicare Standard Analytical Files (SAF) to identify men aged ≥65 who received PP (malleable and inflatable) between 2017 and 2020. The patients were required to have a continuous enrollment 1-year pre- and post-index PP encounter. The outcomes of interest were reoperation rates (defined as removal, repair, and removal and replacement of PP with or without infection) at 90 days and 1 year following initial implantation. Multivariable logistic regression was used to examine the relationship between reoperation rates and patient demographics and comorbidities: age, geographic region, race (White, Black, and Others [American Indian, Asian, Hispanic, Other, Unknown]), urbanization, baseline Charlson Comorbidity Index (CCI) and comorbidities (diabetes and prostate cancer therapy), primary diagnosis at the index PP implantation, type of index PP procedure, and prosthetic surgeon procedure volume. Urbanization was categorized as urban vs rural based on patient’s county of residence and the 2013 National Center for Health Statistics Urban-Rural Classification Scheme for Counties. The prosthetic surgeon procedure volume was split into low (1-24 surgeries) and high-volume (≥25 surgeries) based on the 2022 PP International Consensus Forum definition.

Results
This study included 12,350 patients who underwent PP implantation. Nearly 50% were aged 65-69 years, 77.2% White, 82.6% in urban areas, and 56.2% had a CCI score of 0 (Table 1). Most of these men (96.0%) received an inflatable PP and 91.2% had ED as their primary diagnosis. The overall reoperation rates at 90-day and 1-year post-implant were 2.19% and 6.15%, respectively. Logistic regression found that low-volume implanters were associated with a 34% (OR 1.34; 95% CI 1.01, 1.78) and 35% (OR 1.35; 95% CI 1.14, 1.60) higher odds of reoperation at 90-day and 1-year post-implant, respectively, compared to high-volume implanters. Men with a baseline CCI of 0 had 19% higher odds of 1-year reoperation (OR 1.19; 95% CI 1.01, 1.40) compared to their counterparts with a CCI of ≥1. Black patient race was associated with 35% lower odds of 90-day reoperation compared to White patients (OR 0.65; 95% CI 0.43, 0.99) but this difference did not persist at 1-year of follow-up.

Conclusions
This study highlights that higher case volume reduces the risk of reoperation in the short to medium term, consistent with state-specific data of long-term follow-up. The impact of race and comorbidities warrants further evaluation to optimize patient counseling as they seek surgical treatment of ED.

Disclosure
Yes, this is sponsored by industry/sponsor: Boston Scientific.
Clarification: Industry funding only - investigator initiated and executed study.
Any of the authors act as a consultant, employee or shareholder of an industry for: Boston Scientific, Coloplast, BK Medical.