Prostatic artery embolization compared to transurethral resection of the prostate and prostatic urethral lift: a real-world population-based study.

BACKGROUND: There are growing interests for minimally invasive surgical techniques (MISTs) for the treatment of benign prostatic hyperplasia (BPH)-associated lower urinary tract symptoms (LUTS). Prostatic artery embolization (PAE) uses selective angioembolization of prostatic arteries, thereby reducing size to improve LUTS/BPH. However, real-world data comparing surgical outcomes between MISTs and tissue resective techniques are lacking. We assessed the differences in surgical outcomes between PAE, transurethral resection of the prostate (TURP), and prostatic urethral lift (PUL) in a real-world population for LUTS/BPH. METHODS: We present an observational population-based study of 12,902 men with BPH in New York State who received PAE, TURP, and PUL in outpatient and ambulatory surgery settings from 2014 to 2018. For short-term outcomes, we report 30-day and 90-day risks of readmission to inpatient and emergency room (ER) with/without complications and compared them across groups using χ2 tests and mixed-effect logistic regressions. For long-term outcomes, we report surgical retreatment and stricture rates using Kaplan-Meier failure curves and compared them using Log rank tests and Cox regression models. RESULTS: Of 12 902 men, 335 had PAE, 11,205 had TURP, and 1362 had PUL. PAE patients had the highest 30-day (19.9%) and 90-day (35.6%) risks of readmission to inpatient or ER (p < 0.01). Non-specific abdominal pain was the main diagnosis associated with 30-day and 90-day readmissions to inpatient or ER after PAE (14.3% and 26.8%, respectively). After 2 years of follow-up, PAE patients had the highest retreatment rate of 28.5% (95%CI 23.7-34.2%) compared to TURP (3.4% (95%CI 3.1-3.8%)) and PUL (8.5% (95%CI 5.6-12.9%)) (p < 0.001). CONCLUSION: In a real-world population, PAE was associated with the most frequent 30-day and 90-day readmission to inpatient or ER and the highest retreatment rate among all surgical techniques even when controlled for individual patient comorbidities and surgical volume.

Evaluation of Treatment Differences Between Men and Women Undergoing Ventral Hernia Repair: An Analysis of the Abdominal Core Health Quality Collaborative.

BACKGROUND: Sex is emerging as an important clinical variable associated with surgical outcomes and decision making. However, its relevance in regard to baseline and treatment differences in primary and incisional ventral hernia repair remains unclear. STUDY DESIGN: This is a retrospective cohort study using the Abdominal Core Health Quality Collaborative database to identify elective umbilical, epigastric, or incisional hernia repairs. Propensity matching was performed to investigate confounder-adjusted treatment differences between men and women. Treatments of interest included surgical approach (minimally invasive or open), mesh use, mesh type, mesh position, anesthesia type, myofascial release, fascial closure, and fixation use. RESULTS: A total of 8,489 umbilical, 1,801 epigastric, and 16,626 incisional hernia repairs were identified. Women undergoing primary ventral hernia repair were younger (umbilical 46.4 vs 54 years, epigastric 48.7 vs 52.7 years), with lower BMI (umbilical 30.4 vs 31.5, epigastric 29.2 vs 31.1), and less likely diabetic (umbilical 9.9% vs 11.4%, epigastric 6.8% vs 8.8%). Women undergoing incisional hernia repair were also younger (mean 57.5 vs 59.1 years), but with higher BMI (33.1 vs 31.5), and more likely diabetic (21.4% vs 19.1%). Propensity-matched analysis included 3,644 umbilical, 1,232 epigastric, and 12,480 incisional hernias. Women with incisional hernia were less likely to undergo an open repair (60.2% vs 63.4%, p < 0.001) and have mesh used (93.8% vs 94.8%, p = 0.02). In umbilical and incisional hernia repairs, women had higher rates of intraperitoneal mesh placement and men had higher rates of preperitoneal and retro-muscular mesh placement. CONCLUSIONS: Small but statistically significant treatment differences in operative approach, mesh use, and mesh position exist between men and women undergoing ventral hernia repair. It remains unknown whether these treatment differences result in differing clinical outcomes.

Real-world data comparing minimally invasive surgeries for benign prostatic hyperplasia.

OBJECTIVES: To assess the differences in surgical outcomes between the prostatic urethral lift (PUL) and previous thermal energy procedures for the treatment of benign prostatic hyperplasia (BPH). METHODS: We present an observational population-based study of 2694 men with BPH in New York State and California who received PUL, transurethral needle ablation (TUNA), or transurethral microwave therapy (TUMT) in outpatient and ambulatory surgery settings from 2005 to 2018. For these surgical procedures, short-term outcomes were reported and compared using a Chi-square test and mixed-effect logistic regressions. Long-term outcomes were described using Kaplan-Meier failure curves and compared using a Log-rank test and Cox regressions. RESULTS: A significant portion of PUL patients had a comorbidity count ≥ 2 (n = 838, 37.0%). PUL exhibited the lowest 30 day and 90-day inpatient or ER readmission rates among all surgical techniques except for 90-day ER readmission (p < 0.05). No differences were observed for 1- and 3-year risks of reoperation between PUL [5.5% (95% CI 4.4-6.8%) and 14.9% (95% CI 10.9-20.1%)], TUNA [7.4% (95% CI 5.0-10.9%) and 11.3% (95% CI 8.3-15.4%)] and TUMT [8.5% (95% CI 4.7-15.2%) and 15.3% (95% CI 9.5-24.0%)]. 1- and 3-year risks of stricture development for PUL were 0.2% (95% CI 0.0-0.7%) and 0.2% (95% CI 0.0-0.07%), respectively. CONCLUSION: In a patient population with chronic conditions, patients treated with PUL exhibited similar 30- and 90-day inpatient or ER readmission rates when compared to previous reports. However, 1- and 3-year reoperation risks for PUL closely resembled previous thermal energy surgical procedures.

Safety and efficacy of TURP vs. laser prostatectomy for the treatment of benign prostatic hyperplasia in multi-morbid and elderly individuals aged ≥ 75.

PURPOSE: To compare the safety and durability of transurethral resection of the prostate (TURP) and Laser prostatectomy (LP) among multi-morbid and elderly patients. METHODS: Using data retrieved from the New York State Department of Health Statewide Planning and Research Cooperative System and the California Office of Statewide Health Planning and Development, we selected cohorts of 1) multi-morbid (Charlson comorbidity index ≥ 3) and 2) elderly (aged ≥ 75) patients with benign prostatic hyperplasia who underwent laser coagulation, vaporization, enucleation, or TURP between January 2005 and December 2016. We assessed the post-operative incidence of hospital readmission and ER visit at 30 days and 90 days, complications at 90 days, and reoperation and the development of urethral stricture at 6 months or longer. RESULTS: We found 12,815 and 29,806 patients in the multi-morbid and elderly cohort, respectively. Compared to LP, TURP was associated with lower odds of 90-day hospital readmission and ER visit in the multi-morbid cohort (OR 0.92, 95% CI 0.85-1.00) and higher odds in the elderly cohort (OR 1.07, 95% CI 1.01-1.14). The multi-morbid cohort showed lower odds of urinary tract infections (Ref: LP, OR 0.83, 95% CI 0.73-0.93). The elderly cohort showed higher odds of experiencing hematuria (OR 1.28, 95% CI 1.03-1.59) post TURP. TURP was associated with a 19% (95% CI 0.66-1.00) and 20% (95% CI 0.71-0.91) reduced hazard of reoperation at 6 months or longer for multi-morbid and elderly cohorts, respectively. CONCLUSION: Compared to LP, TURP was associated with higher complication rates for the multi-morbid and elderly cohorts overall but a lower hazard of reoperation, supporting its durability.

Safety and Efficacy of Outpatient Surgical Procedures for the Treatment of Benign Prostatic Enlargement in New York State and California (2005-2016).

PURPOSE: We compared outcomes of transurethral prostatectomy and laser prostatectomy in a real-world setting. MATERIALS AND METHODS: We present a prospectively collected observational cohort study of 85,682 men with benign prostatic enlargement in New York State and California who received transurethral prostatectomy or laser prostatectomy in outpatient and ambulatory surgery settings from January 2005 to December 2016. We used propensity score matching to adjust for differences in patient characteristics between groups. We analyzed short-term outcomes using mixed-effect logistic regressions and long-term outcomes using Cox regressions with a time-dependent treatment variable to account for nonproportionality. We performed a sensitivity analysis using multivariable regression models. RESULTS: Mean±SD patient age was 70.5±9.7 years, 71% of patients were White, and median followup was 3.8 years (IQR 1.8-6.3). Transurethral prostatectomy recipients had increased risk of 30-day hospital readmission/emergency room visit (OR 1.09, 95% CI 1.04-1.13, p <0.001) and decreased risk of reoperation (HR 0.81, 95% CI 0.76-0.88, p <0.001). Transurethral prostatectomy had a higher rate of urethral stricture (HR 1.47, 95% CI 1.22-1.75, p <0.001). CONCLUSIONS: Transurethral prostatectomy was associated with higher risk of short and long-term complications but a lower rate of long-term reoperation than laser prostatectomy for benign prostatic enlargement.

Real World Performance of Sacral Neuromodulation and OnabotulinumtoxinA for Overactive Bladder: Focus on Safety and Cost.

PURPOSE: We aimed to determine the real world safety and cost of third line overactive bladder therapies, including onabotulinumtoxinA and sacral neuromodulation. MATERIALS AND METHODS: We performed an all-inclusive, population based cohort study of third line therapies of overactive bladder (sacral neuromodulation or onabotulinumtoxinA) using the statewide surgical data captured in the New York Statewide Planning and Research Cooperative System. The main outcome measures were 30-day safety events, and 1 and 3-year health care utilization costs. Propensity score matching was done to control for confounding factors and comparative analyses of safety events were also performed. RESULTS: Our cohort included 2,680 patients, of whom 1,328 underwent sacral neuromodulation and 1,352 received onabotulinumtoxinA from January 1, 2013 through December 31, 2016. Average ± SD age was 61.7 ± 16.3 years and 82.7% of the patients were female. Sacral neuromodulation implantation led to re-intervention in 15.8% of cases within 1 year and in 26.1% at 3 years. In this comparative analysis patients who received onabotulinumtoxinA therapy were at higher risk for urinary tract infection, hematuria, urinary retention and an emergency room visit compared to those treated with sacral neuromodulation. The overall cost of onabotulinumtoxinA was lower than the cost of the sacral neuromodulation device (cost at 1 year $2,896 vs $15,343 and at 3 years $3,454 vs $16,189, each p <0.01). CONCLUSIONS: Sacral neuromodulation implantation was more expensive than onabotulinumtoxinA injection. However, patients who underwent sacral neuromodulation had a lower complication rate than patients treated with onabotulinumtoxinA. A quality improvement collective database must be created to track information on onabotulinumtoxinA and sacral neuromodulation treatment. This would help generate better performance and comparative data for patient and physician decision making.

Association of Type and Frequency of Postsurgery Care with Revision Surgery after Total Joint Replacement.

CONTEXT: Postmarket surveillance is limited in the ability to detect medical device problems. Electronic health records can provide real-time information that might help with device surveillance. Specifically, the frequency of postsurgery care might indicate early problems and determine high-risk patients requiring more active surveillance. OBJECTIVE: To evaluate whether intensity of postsurgery care is associated with revision risk after total joint arthroplasty (TJA). DESIGN: Using an integrated health care system's TJA registry, we identified primary TJA performed between April 2001 and July 2013 (22,953 knees and 9904 hips). Survival analyses evaluated the frequency of specific types of outpatient and inpatient utilization 0 to 90 and 91 to 180 days postoperatively and revision risk. MAIN OUTCOME MEASURES: Revision surgery occurring at least 6 months after primary TJA. RESULTS: Knee arthroplasty recipients with 3 or more outpatient orthopedic allied health/nurse visits within 90 days had a 2.2 times (95% confidence interval [CI] = 1.6-2.9) higher risk of revision within the first 2 years postoperatively and 10.1 times higher risk (95% CI = 7.6-13.3) after 2 years. Compared with hip arthroplasty recipients who had 0 to 3 visits, patients with 6 or more outpatient orthopedic office visits within 90 days had a 15.7 times (95% CI = 5.7-42.9) higher risk of revision. Similar results were observed for 91-day to 180-day visits. CONCLUSION: Future studies are needed to determine if more specific data on reasons for the higher frequency of outpatient visits can refine these findings and elicit more specific recommendations for TJA devices.

Development of a Nationally Representative Coordinated Registry Network for Prostate Ablation Technologies.

PURPOSE: The accumulation of data through a prospective, multicenter coordinated registry network is a practical way to gather real world evidence on the performance of novel prostate ablation technologies. Urological oncologists, targeted biopsy experts, industry representatives and representatives of the FDA (Food and Drug Administration) convened to discuss the role, feasibility and important data elements of a coordinated registry network to assess new and existing prostate ablation technologies. MATERIALS AND METHODS: A multiround Delphi consensus approach was performed which included the opinion of 15 expert urologists, representatives of the FDA and leadership from high intensity focused ultrasound device manufacturers. Stakeholders provided input in 3 consecutive rounds with conference calls following each round to obtain consensus on remaining items. Participants agreed that these elements initially developed for high intensity focused ultrasound are compatible with other prostate ablation technologies. Coordinated registry network elements were reviewed and supplemented with data elements from the FDA common study metrics. RESULTS: The working group reached consensus on capturing specific patient demographics, treatment details, oncologic outcomes, functional outcomes and complications. Validated health related quality of life questionnaires were selected to capture patient reported outcomes, including the IIEF-5 (International Index of Erectile Function-5), the I-PSS (International Prostate Symptom Score), the EPIC-26 (Expanded Prostate Cancer Index Composite-26) and the MSHQ-EjD (Male Sexual Health Questionnaire for Ejaculatory Dysfunction). Group consensus was to obtain followup multiparametric magnetic resonance imaging and prostate biopsy approximately 12 months after ablation with additional imaging or biopsy performed as clinically indicated. CONCLUSIONS: A national prostate ablation coordinated registry network brings forth vital practice pattern and outcomes data for this emerging treatment paradigm in the United States. Our multiple stakeholder consensus identifies critical elements to evaluate new and existing energy modalities and devices.

Evaluation of Trends in the Use of InterStim for Fecal Incontinence.

BACKGROUND: Fecal incontinence (FI) represents a large source of morbidity and is a challenging clinical problem to manage. InterStim was approved to treat FI in 2011. Little is known about its adoption. We sought to characterize patterns of use of Interstim since Food and Drug Administration approval for FI. METHODS: The New York State SPARCS database was used to evaluate InterStim use for FI from 2011 to 2014. The primary endpoint was the number of successful implantations of InterStim. Secondary endpoints included device removal, median time to removal of device, 90-day infection rates, and percentage of procedures performed by surgeon specialty and geographic location. RESULTS: A total of 369 patients with FI underwent "Stage 1" of InterStim from 2011 to 2014. A total of 302 patients underwent "Stage 2," yielding a trial period failure rate of 18.2%. The majority of patients who underwent successful implantation were female (87.7%) and White (78.8%). Twenty-nine patients underwent device removal after a median duration of 147 days. Estimated risk of removal at median follow-up of 2 years was 11.8%. Colorectal surgeons comprised 51.1% of all providers followed by gynecologic (24.4%) and urologic surgeons (17.8%). A total of 71.7% of providers performed <5 procedures, while 3 of the highest volume providers performed 50.7% of all procedures. CONCLUSIONS: InterStim for FI has been used by a wide variety of providers in New York State although only a few high-volume providers have performed the majority of procedures. White, female patients with Medicare are the most common recipients of InterStim. Further work must be done to develop strategies for improving access to this technology and to determine whether volume relates to outcomes.

Trends and Utilization of Laser Prostatectomy in Ambulatory Surgical Procedures for the Treatment of Benign Prostatic Hyperplasia in New York State (2000-2011).

INTRODUCTION: There has been a significant change in surgical treatment of benign prostatic hypertrophy (BPH) over the last two decades. Most importantly, laser surgery (coagulation, vaporization, or enucleation) has been growing in popularity as an alternative to standard transurethral prostatectomy (TURP) or other procedures. Our goal was to analyze the trends of BPH surgeries and compare outcomes of laser surgery to TURP, the two most common alternative surgeries. MATERIALS AND METHODS: We used the New York Statewide Planning and Research Cooperation System (SPARCS) data to identify patients diagnosed as having BPH who underwent BPH-related surgery from October 2000 to December 2011. Age, insurance, individual comorbidities, and average hospital volumes were assessed. Bivariate and multivariate regression models were used to analyze predictors of laser use. In-hospital outcomes were then compared between laser and TURP in a balanced propensity-matched cohort. RESULTS: Ninety thousand six hundred seventy patients underwent BPH surgery. Laser surgery usage increased from 6.4% to 44.5% over 10 years (p<0.0001). TURP declined significantly from 72.2% to 48.3% (p<0.0001). Patients with Medicaid were less likely to undergo laser therapy than those with private insurance (odds ratio [OR]: 0.58, 95% confidence interval [CI]: 0.48, 0.69). Mid- and high-volume institutions were more likely to use laser treatment than low-volume centers (OR: 2.26, 95% CI: 1.22, 4.2; OR: 4.07, 95% CI: 1.75, 9.46, respectively). In the matched cohort, both laser and TURP patients had similar complication rates with more frequent electrolyte disorders in TURP patients (2.9% vs 2.3%, p=0.001). CONCLUSIONS: TURP remains the most common procedure. However, the rate of use has declined over time. In contrast, laser use has significantly increased. Laser treatment was utilized more in younger patients, in those privately insured, in hospitals with high volumes of BPH procedures, and in patients with fewer comorbid conditions. Both surgeries are safe with no differences in terms of occurrences of morbidity and complications.

Long term safety of sacral nerve modulation in medicare beneficiaries.

AIMS: Sacral nerve stimulation (SNS) is FDA approved as second-line therapy for both urinary and bowel control. However, there is limited evidence regarding long term safety. We determined adverse events associated with SNS among Medicare beneficiaries. METHODS: We used the 5% national random sample of Medicare claims for 2001-2011 to identify patients. Patients who underwent SNS implantation were identified with Current Procedure Terminology (CPT-4) codes. We determined safety of SNS using analysis of complication occurrences on day of surgery and during 5 years following initial procedure. SAS v9.3 statistical package was used. RESULTS: One thousand four hundred seventy-four patients underwent treatment with SNS in the 5% national sample of Medicare patients within the time period. Representative of real-world patients undergoing SNS surgery, comorbidities included hypertension (69.3%), diabetes (29.4%), chronic pulmonary disease (25.5%), hypothyroidism (25.2%), and depression (22.7%). Few complications occurred on day of surgery. At 90 days, 3.2% of patients had bowel complications, 2.0% urological, 9.4% infectious, and 1.5% stroke. Overall, bowel, neurological health event occurrences were consistent with prior year rates, while infectious events decreased. Of 206 patients who were followed for at least 5 years, 17.3% had devices removed and 11.3% replaced, with 26.1% having at least one of those, leaving 73.9% with original devices. CONCLUSIONS: Urological, infectious, and bowel complication occurrences were low after SNS among Medicare beneficiaries with multiple comorbidities. There were infrequent serious complications like hemorrhage and stroke postoperatively. Although SNS appears safe in this high-risk population, a comprehensive registry will ensure continuous safety.

Evaluation of total hip arthroplasty devices using a total joint replacement registry.

PURPOSE: The purpose of this paper is to describe the infrastructure of the total joint replacement registry of a large integrated healthcare system's and emphasize challenges associated with orthopedic device classification and evaluation. METHODS: Using a large integrated healthcare system innovative infrastructure including electronic health record data, administrative data sources, and registry data collection, we evaluated device choice and outcomes of total hip arthroplasty (THA). Devices were classified into type of bearing surface (alternative versus traditional). Multiple imputation was used to accommodate missing data, and a logistic regression model was applied to assess the impact of patient and surgeon factors on choice of bearing surface. A Cox regression model was used to evaluate risk of aseptic revision while controlling for surgeon, site, and patient characteristics. Adjusted cumulative probability-of-event curves were created, comparing survival of alternative against traditional bearings of devices, with aseptic revision as the outcome of interest. RESULTS: The study sample consisted of 25,377 primary THAs with an average follow-up of 2.7 years. Choice of bearing surface varied by surgeon and patient characteristics. After adjusting for patient, surgeon, and hospital covariates, results showed that the risk of aseptic revision associated with alternative bearings did not differ significantly from traditional bearing surfaces (hazard ratio = 1.33; 95% confidence interval: 0.90, 1.98). CONCLUSIONS: Clinically rich data from a registry with linkages to electronic health records and other administrative databases improve identification of exposures, outcomes, and patient subgroups in medical device evaluation. These various data sources facilitate refined adjustment for potential confounders such as hospital, surgeon, and patient factors and ensure comprehensive device performance evaluation within registries.

Adverse events after stopping clopidogrel in post-acute coronary syndrome patients: Insights from a large integrated healthcare delivery system.

BACKGROUND: A prior study from the Veterans Health Administration found a clustering of cardiovascular events after clopidogrel cessation. We sought to confirm and expand these findings. METHODS AND RESULTS: This was a retrospective cohort study of 2017 patients with acute coronary syndrome discharged on clopidogrel from an integrated health care delivery system. Rates of all-cause mortality or acute myocardial infarction (MI) within 1 year after stopping clopidogrel were assessed among patients who did not have an event before stopping clopidogrel. Death/MI occurred in 4.3% (n=71) of patients. The rates of death/MI were 3.07, 1.62, 0.70, and 0.95 per 10 000 patient-days for the time intervals of 0 to 90, 91 to 180, 181 to 270, and 271 to 360 days after stopping clopidogrel. In multivariable analysis, the 0- to 90-day interval after stopping clopidogrel was associated with higher risk of death/MI (incidence rate ratio, 2.74; 95% confidence interval, 1.69 to 4.44) compared with 91- to 360-day interval. There was a similar trend of increased events after stopping clopidogrel for various subgroups (women versus men, medical therapy versus percutaneous coronary intervention, stent type, and > or =6 months or <6 months of clopidogrel treatment). Among patients taking clopidogrel but stopping ACE inhibitor medications, the event rates were similar in the 0- to 90-day versus the 91- to 360-day interval (2.67 versus 2.91 per 10 000 patient-days; P=0.91). CONCLUSIONS: We observed a clustering of adverse events in the 0 to 90 days after stopping clopidogrel. This clustering of events was not present among patients stopping ACE inhibitors. These findings are consistent with a possible rebound platelet hyper-reactivity after stopping clopidogrel and additional platelet studies are needed to confirm this effect.