Uterine rupture and factors associated with adverse outcomes.

PURPOSE: To review cases of uterine rupture and identify risk factors associated with adverse outcomes. METHODS: This study is a retrospective cohort of complete uterine ruptures diagnosed in a large hospital system in Massachusetts between 2004 and 2018. Baseline demographics, labor characteristics and outcomes of uterine rupture were collected from medical records. RESULTS: A total of 173 cases of uterine rupture were identified. There were 30 (17.3%) women with an unscarred uterus, while 142 (82.1%) had a scarred uterus. Adverse outcomes (n = 89, 51.4% of cases) included 26 (15.0%) hysterectomies, 55 (31.8%) blood transfusions, 18 (10.4%) bladder/ureteral injuries, 5 (2.9%) reoperations, 25 (14.5%) Apgar scores lower than 5 at 5 min and 9 (5.2%) perinatal deaths. Uterine rupture of a scarred uterus was associated with decreased risk of hemorrhage (OR 0.40, 95% CI 0.17-0.93), blood transfusion (OR 0.27, 95% CI 0.11-0.69), hysterectomy (OR 0.23, 95% CI 0.08-0.69) and any adverse outcome (OR 0.34, 95% CI 0.13-0.91) compared with unscarred rupture. Uterine rupture during vaginal delivery was associated with increased risk of transfusion (OR 6.55, 95% CI 1.53-28.05) and hysterectomy (OR 8.95, 95% CI 2.12-37.72) compared with emergent C-section. CONCLUSIONS: Although rare, uterine rupture is associated with adverse outcomes in over half of cases. Unscarred rupture and vaginal delivery demonstrate increased risk of adverse outcomes, highlighting the need for early diagnosis and operative intervention.

Peri- and Postoperative Outcomes of Outpatient vs Inpatient Laparoscopic Apical Prolapse Repair.

STUDY OBJECTIVE: To assess the feasibility of outpatient laparoscopic management of apical pelvic organ prolapse along with indicated vaginal repairs and anti-incontinence procedures. DESIGN: Retrospective cohort study. SETTING: Tertiary-care academic center, Boston, MA. PATIENTS: Total of 112 patients seen in the minimally invasive gynecologic surgery and urogynecology clinics with symptomatic pelvic organ prolapse. INTERVENTIONS: Laparoscopic hysterectomy, sacrocervico- or sacrocolpopexy along with vaginal prolapse and anti-incontinence procedures as indicated from 2013 to 2017 at Brigham & Women's Hospital and Brigham & Women's Faulkner Hospital performed by a minimally invasive gynecologic surgery and urogynecology team. MEASUREMENTS AND MAIN RESULTS: Of the 112 patients, 52 were outpatient and 60 were admitted (median stay in admission group = 1 day; range 1-3). Patient baseline characteristics, American Society of Anesthesiologists' class, and pelvic organ prolapse quantification stage were similar between the outpatient and admitted cohorts. Most patients underwent hysterectomy at the time of the sacropexy (65.4% outpatient vs 73.3% admitted, p = .08). Concomitant apical prolapse repair was more common in the outpatient group (98.1% vs 85%, p = .02). The proportion of outpatient procedures increased from 17% in 2013 to a peak of 70% in 2016. Operating room time was shorter for the outpatient cohort (103.9 minutes vs 115.5 minutes, p = .04), but other perioperative outcomes were similar. There were no intraoperative complications. The numbers of postoperative complications, readmission, and reoperations were low and similar between outpatient and admitted cohorts. No factor was predictive of admission on regression analysis. CONCLUSION: Laparoscopic apical prolapse repair with concomitant vaginal repairs can be performed safely as an outpatient procedure. A unique team approach may foster a shorter, more efficient procedure without compromising short-term outcomes.

Two-dimensional (2D) versus three-dimensional (3D) laparoscopy for vaginal cuff closure by surgeons-in-training: a randomized controlled trial.

BACKGROUND: Objective evidence is lacking as to the benefit of the addition of 3D vision to conventional laparoscopy in Gynecologic surgery. This study aims to compare 3-D visual system to traditional 2-D laparoscopic visualization for the laparoscopic closure of the vaginal cuff during total laparoscopic hysterectomy by surgeons-in-training [defined as senior OBGYN resident or Minimally Invasive Gynecologic Surgery (MIGS) fellow]. METHODS: 51 patients undergoing total laparoscopic hysterectomy at two tertiary care academic hospitals were randomized to two-dimensional or three-dimensional vision system with cuff closure performed by surgeons-in-training. The primary outcome was the time taken for vaginal cuff closure. Secondary outcomes included peri-operative outcomes and assessment of surgeon's perception of ease of cuff closure. RESULTS: 27 (52.9%) cases were allocated to cuff closure with the 2D system and 24 (47.1%) cases to closure with the 3D vision system. Patient baseline characteristics were similar between the vision systems. Mean vaginal cuff closure time was not significantly different between 2D and 3D vision (10.1 min for 2D versus 12 min for 3D, p = 0.31). An additional 24 s was added to cuff closure time with each 1 kg/m2 increase in BMI, after controlling for potential confounders (p = 0.003). There was no difference in the surgeon rating of ease of cuff closure between 2D and 3D. Peri-operative outcomes are similar among the two groups. CONCLUSION: We did not demonstrate any benefits of 3D vision system over conventional 2D for the task of laparoscopic vaginal cuff suturing performed by surgeons-in-training. RCT Registration Number NCT02192606 https://clinicaltrials.gov/ct2/show/NCT02192606 (July 17, 2014).

Laparoscopic treatment of endometriosis and predictors of major complications: A retrospective cohort study.

INTRODUCTION: Patients with advanced endometriosis may be at an increased risk of surgical complications following laparoscopic treatment of endometriosis; however, this relationship has not been examined. We sought to identify predictors of major complications following laparoscopic treatment of endometriosis. MATERIAL AND METHODS: A retrospective cohort study of women who underwent laparoscopic treatment of suspected endometriosis between 2009 and 2016 within the Division of Minimally Invasive Gynecologic Surgery at Brigham and Women's Hospital, Boston, MA, USA. Predictors of major perioperative complications were assessed by comparing the characteristics of women who had any major intraoperative or postoperative complication with those of women who had no complication. RESULTS: A total of 397 women underwent laparoscopic treatment of suspected endometriosis including excision of superficial endometriosis (55.4%), excision of deep-infiltrating endometriosis (24.9%), fulguration of endometriosis (38.3%), hysterectomy (23.2%), ovarian cystectomy (35.5%), salpingectomy (18.6%), oophorectomy (15.1%), and bowel resection (1.0%). Women were followed for 60 days following surgery, over which time 18 women (4.5%) had a major perioperative complication. Patient characteristics and preoperative imaging were similar between women with and without complications. Women with advanced endometriosis, including stage III or IV endometriosis, deep-infiltrating endometriosis, or rectovaginal disease, were more likely to have a complication, though this did not reach statistical significance (77.8% of women with a complication versus 56.7% of women without a complication had advanced endometriosis, P = 0.077). Women who had a complication were more likely to have undergone adhesiolysis or ureterolysis (88.9% of women with a complication versus 52.5% without a complication underwent adhesiolysis, P = 0.002; and 61.1% of women with a complication versus 28.8% without a complication underwent ureterolysis, P = 0.003). The total number of procedures was greater for women who had a complication (4.3 ± 1.2 vs 3.2 ± 1.5, P = 0.003). All other procedure characteristics were similar between women with and without complications. CONCLUSIONS: Complications following laparoscopic treatment of suspected endometriosis could not be predicted by preoperative patient characteristics or surgical findings of advanced endometriosis. Adhesiolysis, ureterolysis, and an increased number of total procedures may be predictive of perioperative complications, suggesting that surgical complexity as measured by the procedures performed, rather than the disease severity, may increase the risk of a complication compared with women who do not undergo these procedures.

Increased Risk of Infectious Complications in Older Patients With Indolent Non-Hodgkin Lymphoma Exposed to Bendamustine.

Background: Bendamustine is a potent chemotherapy agent increasingly used to treat indolent non-Hodgkin lymphoma (iNHL). While effective, it causes significant T-cell lymphopenia, which may increase risk of infection. We examined infectious complications associated with bendamustine-containing regimens among older patients with iNHL. Methods: For this Surveillance, Epidemiology, and End Results (SEER)-Medicare cohort study, we identified 9395 patients with iNHL (follicular, marginal zone, Waldenström macroglobulinemia) treated with chemotherapy from 2006 to 2013. Thirteen percent received bendamustine-containing regimens. We compared baseline characteristics and infection incidence rates between patients treated with and without bendamustine. We conducted multivariate Cox proportional hazards regression (adjusting for demographics, comorbidities, disease and treatment characteristics, risk factors for infection, and antimicrobial prophylaxis) to determine infectious risks associated with bendamustine. Results: Bendamustine was associated with an increased risk of both common infections such as bacterial pneumonia (hazard ratio [HR], 1.50 [95% confidence interval {CI}, 1.21-4.85]) and opportunistic infections such as cytomegalovirus (HR, 3.98 [95% CI, 1.40-11.26]), varicella zoster virus (HR, 1.49 [95% CI, 1.18-1.89]), histoplasmosis (HR, 3.55 [95% CI, 1.10-11.42]), and Pneumocystis jirovecii pneumonia (when administered as third-line therapy: HR, 3.32 [95% CI, 1.00-11.11]). Risk of infections was more prominent in patients receiving bendamustine as part of later (third-line and above) regimens, and independently associated with well-established factors such as neutropenia and corticosteroid exposure. Conclusions: Bendamustine is associated with an increased risk of common and opportunistic infections in patients with iNHL. Further prospective investigation into the potential role of antimicrobial prophylaxis is needed in these patients.

Vaginal or laparoscopic hysterectomy: Do perioperative outcomes differ? A propensity score-matched analysis.

INTRODUCTION: There are assertions that vaginal mode may be the preferred approach of minimally invasive hysterectomy, yet rates of laparoscopic hysterectomy (LH) continue to rise while vaginal hysterectomy (VH) rate remains relatively unchanged. The aim of this study is to compare the perioperative outcomes of LH vs VH. MATERIAL AND METHODS: We identified women who underwent either LH or VH for benign indications between 2009 and 2015 at a large academic institution. A propensity score-matched analysis was used to adjust for differences between women undergoing VH vs LH. Outcome parameters were perioperative complications (both intraoperative and postoperative), operative time, blood loss, hospital length of stay, conversion and readmission. RESULTS: A total of 1921 patients underwent either LH or VH during the study period. In all, 155 patients from each group were successfully matched using propensity score match analysis. While most intra- and postoperative characteristics did not differ between groups, LH was associated with lower blood loss during surgery (102.8 ± 166.5 mL vs 185.0 ± 179.0 mL, P < 0.001) and shorter hospital stay (0.9 ± 1 days vs 1.2 ± 0.9 days, P < 0.0001). Concomitant adnexal surgery was performed more frequently during LH (47.7% vs 12.3%, P < 0.0001), and concomitant prolapse surgery was performed more frequently at the time of VH (14.2% vs 68.4%, P < 0.0001). CONCLUSIONS: Both VH and LH have overall favorable perioperative outcomes; however, LH is associated with lower blood loss and a shorter hospital stay. The results support the trend toward increasing rates of laparoscopic approach to hysterectomy when appropriate.

Perioperative Outcomes of Myomectomy for Extreme Myoma Burden: Comparison of Surgical Approaches.

STUDY OBJECTIVE: To describe the perioperative outcomes of various modes of myomectomy (abdominal [AM], laparoscopic [LM], or robotic [RM]) in cases of extreme myoma burden. DESIGN: Retrospective cohort study (Canadian Task Force classification II-2). SETTING: A tertiary academic center in Boston, Massachusetts. PATIENTS: All women who underwent an AM, LM, or RM for extreme myoma burden, defined as representing the upper quartile for specimen weight (≥434.6 g) or myoma count (≥7 myomas), between 2009 and 2016. INTERVENTIONS: Baseline demographics and perioperative outcomes were collected from review of medical records, including estimated blood loss, operative time, length of stay, and complications. Univariate linear and logistic regression analyses were conducted. MEASUREMENTS AND MAIN RESULTS: During the study period 659 women underwent myomectomy for extreme myoma burden; 47.2% of cases were AM, 28.1% LM, and 24.7% RM. Overall myoma burden differed across the 3 routes and was greatest in the AM group (mean weight: 696.2 ± 784.5 g for AM vs 586.6 ± 426.1 g for LM and 586.6 ± 426.1 g for RM; mean number: 16.8 ± 15.0 for AM vs 7.2 ± 7.0 for LM and 6.7 ± 4.7 for RM; p <.001 for both). The 3 routes differed in operative time and length of stay, with RM having the longest operative time (mean, 239.7 minutes; p <.001) and AM the longest length of stay (mean, 2.2 ± .9 days; p <.001). Other perioperative outcomes were similar across the surgical approaches. Increasing myoma burden was associated with an increased risk of perioperative complications for all surgical approaches, with a threshold of 13 myomas associated with an almost 2-fold higher risk of perioperative complications (odds ratio, 1.77; 95% confidence interval, 1.17-2.70; p = .009). Cumulative incidence of perioperative complications with increasing specimen weight was greater in the RM cases as compared with AM (p = .002) or LM (p = .020), whereas the cumulative incidence of perioperative complications with increasing myoma count was lowest with AM compared with LM (p <.001) or RM (p <.001). CONCLUSION: Myomectomy for extreme myomas is feasible using an abdominal, laparoscopic, or robotic approach. Increased myoma burden is associated with an increased risk of perioperative complications. A threshold of 13 myomas was associated with an almost 2-fold higher risk of perioperative complications for all modes. Perioperative complication outcomes were more favorable in AM or LM over RM with increased myoma weight and AM over LM or RM with increased myoma number.

Prospective Evaluation of Manual Morcellation Techniques: Minilaparotomy versus Vaginal Approach.

STUDY OBJECTIVE: To compare the number of days required to return to daily activities after laparoscopic hysterectomy with 2 tissue extraction methods: manual morcellation via colpotomy or minilaparotomy. Secondary outcomes were additional measures of patient recovery, perioperative outcomes, containment bag integrity, and tissue spillage. DESIGN: Multicenter prospective cohort study and follow-up survey (Canadian Task Force classification II-2). SETTING: Two tertiary care academic centers in northeastern United States. PATIENTS: Seventy women undergoing laparoscopic hysterectomy with anticipated need for manual morcellation. INTERVENTIONS: Tissue extraction by either contained minilaparotomy or contained vaginal extraction method, along with patient-completed recovery diary. MEASUREMENTS AND MAIN RESULTS: Recovery diaries were returned by 85.3% of participants. There were no significant differences found in terms of average pain at 1, 2, or 3 weeks after surgery or in time to return to normal activities. Patients in both groups used narcotic pain medication for an average of 3 days. After adjusting for patient body mass index, history of prior surgery, uterine weight, and surgeon, there were no differences found for blood loss, operative time, length of stay, or incidence of any intra- or postoperative complication between groups. All patients had benign findings on final pathology. More cases in the vaginal contained extraction group were noted to have bag leakage on postprocedure testing (13 [40.6%] vs 3 [8.3%] tears in vaginal and minilaparotomy groups, respectively; p = .003). CONCLUSION: Regarding route of tissue extraction, contained minilaparotomy and contained vaginal extraction methods are associated with similar patient outcomes and recovery characteristics.

Persistence of Symptoms After Total vs Supracervical Hysterectomy in Women with Histopathological Diagnosis of Adenomyosis.

STUDY OBJECTIVE: To compare symptom persistence in women with adenomyosis based on retention or removal of the cervix at the time of hysterectomy. DESIGN: Retrospective cohort study and follow-up survey (Canadian Task Force classification xx). SETTING: Tertiary care academic hospital in Boston, Massachusetts. PATIENTS: Women (n = 1580) who underwent laparoscopic hysterectomy for benign indications between 2008 and 2012 at Brigham and Women's Faulkner Hospital and Brigham and Women's Hospital. INTERVENTION: Retrospective chart review and follow-up survey. MEASUREMENTS AND MAIN RESULTS: Among the 1580 women contacted, 762 (48%) responded to the postoperative symptom resolution survey. Of these 762 women, 623 agreed to participate in the study. Menopausal women or those who had undergone bilateral salpingo-oophorectomy were excluded. Adenomyosis was identified on histopathologic evaluation of the uterus in 171 of the remaining 443 women (39%). Compared with women without adenomyosis, those with adenomyosis were older on average (mean age, 46.6 ± 6.8 years vs 45.0 ± 5.5 years; p = .009) and more likely to report that abnormal bleeding and pain led to their hysterectomy (87.7% vs 79.8%; p = .03 and 64.9% vs 51.4%; p = .009, respectively). The rates of total and supracervical hysterectomies were similar in the 2 groups. Following surgery, women with adenomyosis were less likely than those without adenomyosis to report persistent pain (adjusted odds ratio [aOR], 0.43; 95% confidence interval [CI], 0.20-0.93; p = .03). Persistent bleeding was similar in the 2 groups (aOR, 0.97; 95% CI, 0.49-1.93; p = .94). Among women with adenomyosis, multivariable logistic regression showed no difference in persistence of symptoms with cervical removal or retention at the time of hysterectomy. CONCLUSION: Compared with women without adenomyosis, those with histopathologically proven adenomyosis were less likely to report persistent pain following hysterectomy. Retention of the cervix does not appear to increase the risk of symptom persistence or postprocedure patient satisfaction.

Increased resource use in men with metastatic prostate cancer does not result in improved survival or quality of care at the end of life.

BACKGROUND: Cancer care and end-of-life (EOL) care contribute substantially to health care expenditures. Outside of clinical trials, to our knowledge there exists no standardized protocol to monitor disease progression in men with metastatic prostate cancer (mPCa). The objective of the current study was to evaluate the factors and outcomes associated with increased imaging and serum prostate-specific antigen use in men with mPCa. METHODS: Using Surveillance, Epidemiology, and End Results-Medicare data from 2004 to 2012, the authors identified men diagnosed with mPCa with at least 6 months of follow-up. Extreme users were classified as those who had either received prostate-specific antigen testing greater than once per month, or who underwent cross-sectional imaging or bone scan more frequently than every 2 months over a 6-month period. Associations between extreme use and survival outcomes, costs, and quality of care at EOL, as measured by timing of hospice referral, frequency of emergency department visits, length of stay, and intensive care unit or hospital admissions, were examined. RESULTS: Overall, a total of 3026 men with mPCa were identified, 791 of whom (26%) were defined as extreme users. Extreme users were more commonly young, white/non-Hispanic, married, higher earning, and more educated (P<.001, respectively). Extreme use was not associated with improved quality of care at EOL. Yearly health care costs after diagnosis were 36.4% higher among extreme users (95% confidence interval, 27.4%-45.3%; P<.001). CONCLUSIONS: Increased monitoring among men with mPCa significantly increases health care costs, without a definitive improvement in survival nor quality of care at EOL noted. Monitoring for disease progression outside of clinical trials should be reserved for those in whom findings will change management. Cancer 2018;124:2212-9. © 2018 American Cancer Society.

Assessment of Risk Evaluation and Mitigation Strategies (REMS) for varenicline (Chantix): A multistage patient survey.

PURPOSE: To evaluate the Risk Evaluation and Mitigation Strategies (REMS) for varenicline by assessing patients' understanding of the varenicline medication guide (MG) at pre-specified time points: 18 months, 3 years, and 7 years after the REMS approval. METHODS: Self-administered surveys were mailed to people who received varenicline based on a pharmacy dispensing. Survey questions assessed understanding of potential risks outlined in the MG: neuropsychiatric symptoms, skin reactions, allergic reactions, and cardiovascular risks. Crude and weighted analyses were conducted. RESULTS: The response to the survey overall was between 18% and 19%. Among responders, approximately 90% recalled receiving the MG, and at least 80% read all or part of it. At least 88% correctly identified neuropsychiatric symptoms as potential medication effects, while 41% did so for skin reactions, 53% for allergic reactions, and 82% for cardiovascular risks. Patients who read the MG had a high proportion of correct responses to the risk comprehension questions. CONCLUSIONS: A large majority of patients who were dispensed varenicline recalled receiving the MG and were able to correctly recall neuropsychiatric and cardiovascular risks in all 3 surveys. The varenicline MG may be an effective tool for patient education.

Incisional Outcomes of Umbilical vs Suprapubic Mini-laparotomy for Tissue Extraction: A Retrospective Cohort Study.

STUDY OBJECTIVE: To compare outcomes following umbilical minilaparotomy and suprapubic minilaparotomy for tissue extraction. DESIGN CLASSIFICATION: Retrospective cohort study (Canadian Task Force classification II-2). SETTING: Two large academic medical centers. PATIENTS: Women who underwent a minilaparotomy for tissue extraction following a laparoscopic hysterectomy or myomectomy between 2014 and 2016. INTERVENTIONS: Umbilical or suprapubic minilaparotomy for tissue extraction. MEASUREMENTS AND MAIN RESULTS: A total of 374 women underwent laparoscopic hysterectomy or myomectomy with minilaparotomy, including 289 (77.3%) with an umbilical minilaparotomy and 85 (22.7%) with a suprapubic minilaparotomy. The 2 groups were similar in terms of age, body mass index, parity, surgical history, procedure type, surgical approach, and surgical indication. The size of the minilaparotomy incision and the specimen weight were significantly smaller in the umbilical minilaparotomy group (mean, 3.3 ± 0.8 cm vs 4.2 ± 0.6 cm [p < .001] and 472.6 ± 357.1 g vs 683.0 ± 475.7 g [p < .001], respectively). Two women in the suprapubic minilaparotomy group sustained a bladder injury during creation of the incision. There were no other complications related to the minilaparotomy in either group. Postoperative outcomes related to the minilaparotomy incision were compiled using the medical record and a follow-up survey. Of the 374 women in this cohort, 163 responded to a detailed survey about their minilaparotomy incision (response rate, 43.5%). With regard to the minilaparotomy, 52.7% of women reported incisional symptoms; 25.9% had increased pain at the incision, 8.3% had an incisional infection, and 2.7% reported an incisional hernia. There was no significant between-group difference in incisional outcomes; however nearly 3 times as many women in the umbilical minilaparotomy group reported concerns about incisional hernia (3.1% vs 1.2%; p = .833). These findings were maintained in a multivariable logistic regression analysis. No patient or procedure characteristics were significantly associated with the development of hernia. CONCLUSION: There were no significant difference in incisional symptoms, pain, or infection following umbilical minilaparotomy vs a suprapubic minilaparotomy for tissue extraction. Although not statistically significant, the rate of incisional hernia was higher at the umbilical site compared with the suprapubic site.

Cost implications and complications of overtreatment of low-risk prostate cancer in the United States.

BACKGROUND: Evidence-based consensus guidelines recommend only observation for men with low-risk prostate cancer and life expectancy less than 10 years. This report describes the incidence, drivers, cost, and morbidity of overtreatment of low-risk prostate cancer within the United States. METHODS: The SEER-Medicare Program was used to identify 11,744 men aged 66 years or older diagnosed with low-risk prostate cancer in 2004 through 2007. Overtreatment of prostate cancer was defined as definitive treatment of a patient with a life expectancy of less than 10 years. Expected survival was estimated using NCCN methodology. Costs were the amount paid by Medicare in years after minus year before diagnosis. Toxicities were relevant Medicare diagnoses/interventions. P values are 2-sided. RESULTS: Of 3001 men with low-risk prostate cancer and a life expectancy of less than 10 years, 2011 men (67%) were overtreated. On multivariable logistic regression, overtreated men were more likely to be married (odds ratio [OR], 1.29; 95% CI, 1.05-1.59; P=.02), reside in affluent regions (P<.001), and harbor more advanced disease at diagnosis (P<.001). Two-year toxicity was greater in overtreated patients (P<.001). Relative to active surveillance/watchful waiting/observation, the median additional cost per definitive treatment was $18,827 over 5 years; the cumulative annual cost attributable to overtreatment in the United States was $58.7 million. The ability to avoid treating the 80% of men with low-grade disease who will never die of prostate cancer would save $1.32 billion per year nationally. CONCLUSIONS: Overtreatment of low-risk prostate cancer is partially driven by sociodemographic factors and occurs frequently, with marked impact on patient quality of life and health-related costs.

A Patient-Centered Intervention Reduces Disparities in Remote Monitoring in Patients With Implanted Cardiac Devices.

BACKGROUND: Remote monitoring (RM) is recommended for patients with cardiovascular implantable electronic devices, yet many individuals, especially those living in underserved communities, fail to receive this guideline-directed care. Multilevel interventions that target patient and clinic-level barriers to RM care may be beneficial. OBJECTIVES: This study sought to evaluate a remotely delivered, patient-centered intervention to improve RM activation and adherence and reduce disparities in RM care. METHODS: The intervention provides home delivery of remote monitor, phone-based education, monitor setup, and facilitation of first transmission. A retrospective cohort analysis was performed using RM data from 190,643 patients (71.6 ± 12.7 years of age, 40.5% female) implanted with a pacemaker or defibrillator at 4,195 U.S. clinics between October 2015 and October 2019. Outcomes included RM activation (12 weeks and 1-year postimplantation) and adherence to clinic-scheduled transmissions. Patients receiving a cardiovascular implantable electronic deviceimplant 0 to 730 days before (control group, n = 95,861) and after (intervention group, n = 94,782) intervention launch were compared using logistic regression and generalized estimating equations. Multivariable models included patient, clinic, and neighborhood socioeconomic characteristics. RESULTS: The odds of achieving guideline-recommended activation were significantly higher in the intervention group at 12 weeks (OR: 2.99; 76.7% vs 60.9%; P < 0.001) and 1 year (OR: 3.05; 88.2% vs 79.3%; P < 0.001). Adherence to scheduled transmissions was also higher in the intervention group compared with the control group (OR: 2.18; 89.1% vs 81.9%; P < 0.001). Preintervention disparities in RM activation and adherence were reduced in underserved groups following the intervention. CONCLUSIONS: A remotely delivered patient-centered intervention was associated with earlier activation and improved adherence to RM while reducing disparities in RM care.

Certificate of need programs, intensity modulated radiation therapy use and the cost of prostate cancer care.

PURPOSE: Certificate of need programs are a primary mechanism to regulate the use and cost of health care services at the state level. The effect of certificate of need programs on the use of intensity modulated radiation therapy and the increasing costs of prostate cancer care is unknown. We compared the use of intensity modulated radiation therapy and change in prostate cancer health care costs in regions with vs without active certificate of need programs. MATERIALS AND METHODS: This population based, observational study using SEER (Surveillance, Epidemiology, and End Results)-Medicare linked data from 2002 through 2009 was comprised of 13,814 men treated for prostate cancer in 3 regions with active certificate of need programs (CON Yes) vs 44,541 men treated for prostate cancer in 9 regions without active certificate of need programs (CON No). We assessed intensity modulated radiation therapy use relative to other prostate cancer definitive therapies and overall prostate cancer health care costs with respect to certificate of need status. RESULTS: In propensity score adjusted analyses, intensity modulated radiation therapy use increased from 2.3% to 46.4% of prostate cancer definitive therapies in CON Yes regions vs 11.3% to 41.7% in CON No regions from 2002 to 2009. Furthermore, we observed greater intensity modulated radiation therapy use with time in CON Yes vs No regions (p <0.001). Annual cost growth did not differ between CON Yes vs No regions (p = 0.396). CONCLUSIONS: Certificate of need programs were not effective in limiting intensity modulated radiation therapy use or attenuating prostate cancer health care costs. There remains an unmet need to control the rapid adoption of new, more expensive therapies for prostate cancer that have limited cost and comparative effectiveness data.

Patterns of care and outcomes of radiotherapy for lymph node positivity after radical prostatectomy.

OBJECTIVE: To evaluate the use and outcomes of adjuvant radiation therapy (ART) for men with lymph node (LN)-positive disease after radical prostatectomy (RP) using a population-based approach. PATIENTS AND METHODS: Surveillance, Epidemiology, and End Results (SEER)-Medicare linked data from 1995 to 2007 was used to identify 577 men with LN metastases discovered during RP and absence of distant metastases, of which 177 underwent ART ≤1 year of RP. Propensity score models were used to compare overall mortality and prostate cancer-specific mortality (PCSM) for men that did and those that did not receive ART. RESULTS: Men in both groups received adjuvant androgen-deprivation therapy at similar rates after propensity weighting adjustments (33.6% vs 33.7%, P = 0.977). ART was not associated with differences in overall (5.09 vs 3.77 events per 100 person-years, P = 0.153) or PCSM (2.89 vs 1.31, P = 0.090) relative to men who did not receive ART. CONCLUSIONS: ART after RP in men with LN-positive prostate cancer was not associated with improved overall or disease-specific survival, in contrast to previous single-centre studies. Prospective randomised studies are needed to assess the effectiveness of ART in this patient population.

Prostate cancer grade migration and facility-level treatment trends for grade group 1 disease.

Overdiagnosis and overtreatment of low-grade prostate cancer (PCa) reflect poor quality of care and prompted changes to guidelines over the past decade. We used the National Cancer Database to characterize Gleason Grade Group (GG)1 PCa diagnosis trends and assess facility-level treatment variability. Between 2010 and 2019, GG1 PCa incidence had a clinically and statistically significant decline, from 45% to 25% at biopsy and from 33% to 9.8% at radical prostatectomy (RP) pathology. Similarly, active surveillance (AS) uptake significantly increased to 49% and 62% among nonacademic and academic sites, respectively. Decreasing rates of definitive therapies were identified: among academic sites, RP decreased from 61.1% to 25.3% and radiation therapy (RT) from 25.2% to 12%, whereas among nonacademic sites, RP decreased from 53.6% to 28% and RT from 37.8% to 21.9% (Ptrend < .001). Declines in the diagnosis and treatment of low-grade disease demonstrate an encouraging shift in PCa epidemiology. However, heterogeneity in AS utilization remains and reflects opportunities for improvement.

Inappropriate utilization of radiographic imaging in men with newly diagnosed prostate cancer in the United States.

BACKGROUND: The use of radiographic imaging (bone scan and computerized tomography) is only recommended for men diagnosed with high-risk prostate cancer characteristics. The authors sought to characterize utilization patterns of imaging in men with newly diagnosed prostate cancer. METHODS: The authors performed a population-based observational cohort study using the US Surveillance, Epidemiology, and End Results-Medicare linked data to identify 30,183 men diagnosed with prostate cancer during 2004 to 2005. RESULTS: Thirty-four percent of men with low-risk and 48% with intermediate-risk prostate cancer underwent imaging, whereas only 60% of men with high-risk disease received imaging before treatment. Radiographic imaging utilization was greater for men who were older than 75 years (odds ratio [OR], 1.28; 95% confidence interval [CI], 1.20-1.37; P < .001), were black (OR, 1.11; 95% CI, 1.01-1.21; P = .030), resided in wealthier areas (OR, 1.19; 95% CI, 1.08-1.32 for median income >$60,000 vs <$35,000; P < .001), lived in rural regions (OR, 1.23; 95% CI, 1.12-1.36; P < .001), or underwent standard radiation therapies (OR, 1.71; 95% CI, 1.60-1.84; P < .001). Imaging utilization was less for men living in areas with greater high school education (OR, 0.83; 95% CI, 0.75-0.91 between highest and lowest graduation rates; P < .001) or opting for active surveillance (OR, 0.17; 95% CI, 0.15-0.19 vs radical prostatectomy; P < .001). The estimated cost of unnecessary imaging over this 2-year period exceeded $3.6 million. CONCLUSIONS: In the United States, there is widespread overutilization of imaging for low-risk and intermediate-risk prostate cancer, whereas a worrisome number of men with high-risk disease did not receive appropriate imaging studies to exclude metastases before therapy.

Influence of surgeon and hospital volume on radical prostatectomy costs.

PURPOSE: While higher radical prostatectomy hospital and surgeon volume are associated with better outcomes, the effect of provider volume on health care costs remains unclear. We performed a population based study to characterize the effect of surgeon and hospital volume on radical prostatectomy costs. MATERIALS AND METHODS: We used SEER (Surveillance, Epidemiology and End Results)-Medicare linked data to identify 11,048 men who underwent radical prostatectomy from 2003 to 2009. We categorized hospital and surgeon radical prostatectomy volume into tertiles (low, intermediate, high) and assessed costs from radical prostatectomy until 90 days postoperatively using propensity adjusted analyses. RESULTS: Higher surgeon volume at intermediate volume hospitals (surgeon volume low $9,915; intermediate $10,068; high $9,451; p = 0.021) and high volume hospitals (surgeon volume low $11,271; intermediate $10,638; high $9,529; p = 0.002) was associated with lower radical prostatectomy costs. Extrapolating nationally, selective referral to high volume radical prostatectomy surgeons at high and intermediate volume hospitals netted more than $28.7 million in cost savings. Conversely, higher hospital volume was associated with greater radical prostatectomy costs for low volume surgeons (hospital volume low $9,685; intermediate $9,915; high $11,271; p = 0.010) and intermediate volume surgeons (hospital volume low $9,605; intermediate $10,068; high $10,638; p = 0.029). High volume radical prostatectomy surgeon costs were not affected by varying hospital volume, and among low volume hospitals radical prostatectomy costs did not differ by surgeon volume. CONCLUSIONS: Selective referral to high volume radical prostatectomy surgeons operating at intermediate and high volume hospitals nets significant cost savings. However, higher radical prostatectomy hospital volume was associated with greater costs for low and intermediate volume radical prostatectomy surgeons.