Jialin Mao

Variations in Abdominal Aortic Aneurysm Care: A Report from the International Consortium of Vascular Registries

Background: This project by the ICVR (International Consortium of Vascular Registries), a collaboration of 11 vascular surgical quality registries, was designed to evaluate international variation in the contemporary management of abdominal aortic aneurysm (AAA) with relation to recommended treatment guidelines from the Society for Vascular Surgery and the European Society for Vascular Surgery. Methods: Registry data for open and endovascular AAA repair (EVAR) during 2010 to 2013 were collected from 11 countries. Variations in patient selection and treatment were compared across countries and across centers within countries. Results: Among 51 153 patients, 86% were treated for intact AAA (iAAA) and 14% for ruptured AAA. Women constituted 18% of the entire cohort (range, 12% in Switzerland–21% in the United States; P<0.01). Intact AAAs were repaired at diameters smaller than recommended by guidelines in 31% of men (<5.5 cm; range, 6% in Iceland–41% in Germany; P<0.01) and 12% of women with iAAA (<5 cm; range, 0% in Iceland–16% in the United States; P<0.01). Overall, use of EVAR for iAAA varied from 28% in Hungary to 79% in the United States (P<0.01) and for ruptured AAA from 5% in Denmark to 52% in the United States (P<0.01). In addition to the between-country variations, significant variations were present between centers in each country in terms of EVAR use and rate of small AAA repair. Countries that more frequently treated small AAAs tended to use EVAR more frequently (trend: correlation coefficient, 0.51; P=0.14). Octogenarians made up 23% of all patients, ranging from 12% in Hungary to 29% in Australia (P<0.01). In countries with a fee-for-service reimbursement system (Australia, Germany, Switzerland, and the United States), the proportions of small AAA (33%) and octogenarians undergoing iAAA repair (25%) were higher compared with countries with a population-based reimbursement model (small AAA repair, 16%; octogenarians, 18%; P<0.01). In general, center-level variation within countries in the management of AAA was as important as variation between countries. Conclusions: Despite homogeneous guidelines from professional societies, significant variation exists in the management of AAA, most notably for iAAA diameter at repair, use of EVAR, and the treatment of elderly patients. ICVR provides an opportunity to study treatment variation across countries and to encourage optimal practice by sharing these results.

Increase in Prostate Cancer Distant Metastases at Diagnosis in the United States

This population-based study assesses the effect of the decline in prostate-specific antigen screening and incidence on prostate cancer presentation.

Use, complications, and costs of stereotactic body radiotherapy for localized prostate cancer

Stereotactic body radiotherapy (SBRT) for localized prostate cancer has potential advantages over traditional radiotherapies. Herein, the authors compared national trends in use, complications, and costs of SBRT with those of traditional radiotherapies.

Safety and efficacy of hysteroscopic sterilization compared with laparoscopic sterilization: an observational cohort study.

Objective To compare the safety and efficacy of hysteroscopic sterilization with the “Essure” device with laparoscopic sterilization in a large, all-inclusive, state cohort. Design Population based cohort study. Settings Outpatient interventional setting in New York State. Participants Women undergoing interval sterilization procedure, including hysteroscopic sterilization with Essure device and laparoscopic surgery, between 2005 and 2013. Main outcomes measures Safety events within 30 days of procedures; unintended pregnancies and reoperations within one year of procedures. Mixed model accounting for hospital clustering was used to compare 30 day and 1 year outcomes, adjusting for patient characteristics and other confounders. Time to reoperation was evaluated using frailty model for time to event analysis. Results We identified 8048 patients undergoing hysteroscopic sterilization and 44 278 undergoing laparoscopic sterilization between 2005 and 2013 in New York State. There was a significant increase in the use of hysteroscopic procedures during this period, while use of laparoscopic sterilization decreased. Patients undergoing hysteroscopic sterilization were older than those undergoing laparoscopic sterilization and were more likely to have a history of pelvic inflammatory disease (10.3% v 7.2%, P<0.01), major abdominal surgery (9.4% v 7.9%, P<0.01), and cesarean section (23.2% v 15.4%, P<0.01). At one year after surgery, hysteroscopic sterilization was not associated with a higher risk of unintended pregnancy (odds ratio 0.84 (95% CI 0.63 to 1.12)) but was associated with a substantially increased risk of reoperation (odds ratio 10.16 (7.47 to 13.81)) compared with laparoscopic sterilization. Conclusions Patients undergoing hysteroscopic sterilization have a similar risk of unintended pregnancy but a more than 10-fold higher risk of undergoing reoperation compared with patients undergoing laparoscopic sterilization. Benefits and risks of both procedures should be discussed with patients for informed decisions making.

Perioperative Outcomes, Health Care Costs, and Survival After Robotic-assisted Versus Open Radical Cystectomy: A National Comparative Effectiveness Study☆

BACKGROUND Radical cystectomy is the gold-standard management for muscle-invasive bladder cancer, and there is debate concerning the comparative effectiveness of robotic-assisted (RARC) versus open radical cystectomy (ORC). OBJECTIVE To compare utilization, perioperative, cost, and survival outcomes of RARC versus ORC. DESIGN, SETTING, AND PARTICIPANTS We identified bladder urothelial carcinoma treated with RARC (n=439) or ORC (n=7308) during 2002-2012 using the Surveillance, Epidemiology, and End Results Program-Medicare linked data. INTERVENTION Comparison of RARC versus ORC. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS We used propensity score matching to compare perioperative and survival outcomes, including lymph node yield, perioperative complications, and healthcare costs. RESULTS AND LIMITATIONS Utilization of RARC increased from 0.7% of radical cystectomies in 2002 to 18.5% in 2012 (p<0.001). Women comprised 13.9% versus 18.1% (p=0.007) of RARC versus ORC, respectively. RARC was associated with greater lymph node yield with 41.5% versus 34.9% having ≥10 lymph nodes removed (relative risk 1.1, 95% confidence interval [CI] 1.01-1.22, p=0.03) and shorter mean length of hospitalization at 10.1 (± standard deviation 7.1) d versus 11.2 (± 8.6) d (p=0.004). While inpatient costs were similar, RARC was associated with increased home healthcare utilization (relative risk 1.14, 95% CI 1.04-1.26, p=0.009) and higher 30-d (p<0.01) and 90-d (p<0.01) costs. With a median follow-up of 44 mo (interquartile range 16-78), overall survival (hazard ratio 0.88, 95% CI 0.74-1.05) and cancer-specific survival (hazard ratio 0.91, 95% CI 0.66-1.26) were similar. CONCLUSIONS RARC provides equivalent perioperative and intermediate term outcomes to ORC. Additional long-term and randomized studies are needed for continued comparative effectiveness assessment of RARC versus ORC. PATIENT SUMMARY Our population-based US study demonstrates that robotic-assisted radical cystectomy has similar perioperative and survival outcomes albeit at higher costs.

Long term survival with stereotactic ablative radiotherapy (SABR) versus thoracoscopic sublobar lung resection in elderly people: national population based study with propensity matched comparative analysis

Objectives To compare cancer specific survival after thoracoscopic sublobar lung resection and stereotactic ablative radiotherapy (SABR) for tumors ≤2 cm in size and thoracoscopic resection (sublobar resection or lobectomy) and SABR for tumors ≤5 cm in size. Design National population based retrospective cohort study with propensity matched comparative analysis. Setting Surveillance, Epidemiology, and End Results (SEER) registry linked with Medicare database in the United States. Participants Patients aged ≥66 with lung cancer undergoing SABR or thoracoscopic lobectomy or sublobar resection from 1 Oct 2007 to 31 June 2012 and followed up to 31 December 2013. Main outcome measures Cancer specific survival after SABR or thoracoscopic surgery for lung cancer. Results 690 (275 (39.9%) SABR and 415 (60.1%) thoracoscopic sublobar lung resection) and 2967 (714 (24.1%) SABR and 2253 (75.9%) thoracoscopic resection) patients were included in primary and secondary analyses. The average age of the entire cohort was 76. Follow-up of the entire cohort ranged from 0 to 6.25 years, with an average of three years. In the primary analysis of patients with tumors sized ≤2 cm, 37 (13.5%) undergoing SABR and 44 (10.6%) undergoing thoracoscopic sublobar resection died from lung cancer, respectively. The cancer specific survival diverged after one year, but in the matched analysis (201 matched patients in each group) there was no significant difference between the groups (SABR v sublobar lung resection mortality: hazard ratio 1.32, 95% confidence interval 0.77 to 2.26; P=0.32). Estimated cancer specific survival at three years after SABR and thoracoscopic sublobar lung resection was 82.6% and 86.4%, respectively. The secondary analysis (643 matched patients in each group) showed that thoracoscopic resection was associated with improved cancer specific survival over SABR in patients with tumors sized ≤5 cm (SABR v resection mortality: hazard ratio 2.10, 1.52 to 2.89; P<0.001). Estimated cancer specific survival at three years was 80.0% and 90.3%, respectively. Conclusions This propensity matched analysis suggests that patients undergoing thoracoscopic surgical resection, particularly for larger tumors, might have improved cancer specific survival compared with patients undergoing SABR. Despite strategies used in study design and propensity matching analysis, there are inherent limitations to this observational analysis related to confounding, similar to most studies in healthcare of non-surgical technologies compared with surgery. As the adoption of SABR for the treatment of early stage operable lung cancer would be a paradigm shift in lung cancer care, it warrants further thorough evaluation before widespread adoption in practice.

Use and risks of surgical mesh for pelvic organ prolapse surgery in women in New York state: population based cohort study

Objective To assess the use of mesh in pelvic organ prolapse surgery, and compare short term outcomes between procedures using and not using mesh. Design All inclusive, population based cohort study. Setting Statewide surgical care captured in the New York Statewide Planning and Research Cooperative System. Participants Women who underwent prolapse repair procedures in New York state from 2008 to 2011. Main outcomes measures 90 day safety events and reinterventions within one year, after propensity score matching. Categorical, time to event, and subgroup analyses (<65 and ≥65 year age groups) were conducted. Results Of 27 991 patients in total, 7338 and 20 653 underwent prolapse repair procedures with and without mesh, respectively. Mesh use increased by 44.7%, from 1461 procedures in 2008 to 2114 procedures in 2011. Most patients in the cohort were younger than 65 years (62.3% (n=17 424/27 991)). However, more patients were aged 65 years and older in the mesh group than in the non-mesh group (44.3% (n=3249) v 35.4% (n=7318)). Complications after surgery were not common, irrespective of the use or non-use of mesh. After propensity score matching, patients who received the surgery with mesh had a higher chance of having a reintervention within one year (mesh 3.3% v no mesh 2.2%, hazard ratio 1.47 (95% confidence interval 1.21 to 1.79)) and were more likely to have urinary retention within 90 days (mesh 7.5% v no mesh 5.6%, risk ratio 1.33 (95% confidence interval 1.18 to 1.51)), compared with those who received surgery without mesh. In subgroup analyses based on age, mesh use was associated with an increased risk of reintervention within one year in patients under age 65 years, and increased risk of urinary retention in patients aged 65 years and over. Conclusions Despite multiple warnings released by the US Food and Drug Administration since 2008, use of mesh in pelvic organ prolapse surgery continues to grow. In this statewide comprehensive study, mesh procedures were associated with an increased risk of reinterventions within one year and urinary retention after surgery.

Comparative Effectiveness of Cancer Control and Survival after Robot-Assisted versus Open Radical Prostatectomy

Purpose: Robot‐assisted surgery has been rapidly adopted in the U.S. for prostate cancer. Its adoption has been driven by market forces and patient preference, and debate continues regarding whether it offers improved outcomes to justify the higher cost relative to open surgery. We examined the comparative effectiveness of robot‐assisted vs open radical prostatectomy in cancer control and survival in a nationally representative population. Materials and Methods: This population based observational cohort study of patients with prostate cancer undergoing robot‐assisted radical prostatectomy and open radical prostatectomy during 2003 to 2012 used data captured in the SEER (Surveillance, Epidemiology, and End Results)‐Medicare linked database. Propensity score matching and time to event analysis were used to compare all cause mortality, prostate cancer specific mortality and use of additional treatment after surgery. Results: A total of 6,430 robot‐assisted radical prostatectomies and 9,161 open radical prostatectomies performed during 2003 to 2012 were identified. The use of robot‐assisted radical prostatectomy increased from 13.6% in 2003 to 2004 to 72.6% in 2011 to 2012. After a median followup of 6.5 years (IQR 5.2–7.9) robot‐assisted radical prostatectomy was associated with an equivalent risk of all cause mortality (HR 0.85, 0.72–1.01) and similar cancer specific mortality (HR 0.85, 0.50–1.43) vs open radical prostatectomy. Robot‐assisted radical prostatectomy was also associated with less use of additional treatment (HR 0.78, 0.70–0.86). Conclusions: Robot‐assisted radical prostatectomy has comparable intermediate cancer control as evidenced by less use of additional postoperative cancer therapies and equivalent cancer specific and overall survival. Longer term followup is needed to assess for differences in prostate cancer specific survival, which was similar during intermediate followup. Our findings have significant quality and cost implications, and provide reassurance regarding the adoption of more expensive technology in the absence of randomized controlled trials.

Surgeon Annual and Cumulative Volumes Predict Early Postoperative Outcomes after Rectal Cancer Resection.

Objective: To determine if 5-year surgeon cumulative and annual volumes predict improved early postoperative outcomes in patients with rectal cancer. Background: Operative experience has been shown to effect surgical outcomes. The differential role of cumulative versus annual volume has not yet been explored for rectal surgery. Methods: The Statewide Planning and Research Cooperative System database was used to capture patients undergoing surgery in New York State from 2000 to 2013. A population-based sample of patients undergoing major rectal or rectosigmoid resection as their principal procedure during hospitalization between 2000 and 2013 were identified using International Classification of Diseases, Ninth Revision, Clinical Modification procedure codes. Surgeons were identified using a unique physician number from 1995 to 2013. Results: The percentage of surgeries performed by high cumulative/high annual (HC/HA) surgeons increased from 38.3% to 58.4% (P < 0.01) with a simultaneous decrease in that performed by low cumulative/low annual (LC/LA) surgeons (52.5% to 29.8%, P < 0.01). HC/HA volume surgeons had a significantly lower rate of surgical complications (odd ratio = 0.71, 95% confidence interval = 0.60–0.83, P < 0.05) as compared with LC/LA volume surgeons. There was no significant difference in rates of anastomotic leak, nonroutine discharges or readmission among all four groups. Conclusions: The best early postoperative surgical outcomes are achieved in centers where there are high cumulative and high annual volume surgeons caring for these patients. This suggests the need for specialized designation of rectal cancer centers to support ongoing regionalization of care.OBJECTIVE To determine if 5-year surgeon cumulative and annual volumes predict improved early postoperative outcomes in patients with rectal cancer. BACKGROUND Operative experience has been shown to effect surgical outcomes. The differential role of cumulative versus annual volume has not yet been explored for rectal surgery. METHODS The Statewide Planning and Research Cooperative System database was used to capture patients undergoing surgery in New York State from 2000 to 2013. A population-based sample of patients undergoing major rectal or rectosigmoid resection as their principal procedure during hospitalization between 2000 and 2013 were identified using International Classification of Diseases, Ninth Revision, Clinical Modification procedure codes. Surgeons were identified using a unique physician number from 1995 to 2013. RESULTS The percentage of surgeries performed by high cumulative/high annual (HC/HA) surgeons increased from 38.3% to 58.4% (P < 0.01) with a simultaneous decrease in that performed by low cumulative/low annual (LC/LA) surgeons (52.5% to 29.8%, P < 0.01). HC/HA volume surgeons had a significantly lower rate of surgical complications (odd ratio = 0.71, 95% confidence interval = 0.60-0.83, P < 0.05) as compared with LC/LA volume surgeons. There was no significant difference in rates of anastomotic leak, nonroutine discharges or readmission among all four groups. CONCLUSIONS The best early postoperative surgical outcomes are achieved in centers where there are high cumulative and high annual volume surgeons caring for these patients. This suggests the need for specialized designation of rectal cancer centers to support ongoing regionalization of care.

Indications, Utilization and Complications Following Prostate Biopsy: New York State Analysis

Purpose: Uptake of active surveillance and changes in prostate cancer care may affect the utilization of and complications following prostate needle biopsy. We characterized recent trends and risk factors for prostate needle biopsy complications using a statewide, all‐payer cohort. Materials and Methods: We used SPARCS (New York Statewide Planning and Research Cooperative System) to identify prostate needle biopsies performed between 2011 and 2014 via the transrectal and the transperineal approach (9,472 and 421 patients, respectively). We characterized trends in utilization and complications using Poisson regression and the Cochrane‐Armitage test. We applied logistic regression to examine predictors of complications within 30 days of prostate needle biopsy. Results: Ambulatory use of prostate needle biopsy decreased with time (p <0.01). The most common indication for prostate needle biopsy was elevated prostate specific antigen in 53.2% of patients, followed by active surveillance for cancer in 26.7%, abnormal digital rectal examination in 2.6% and atypia in 1.6%. The prostate needle biopsy associated infection rate increased from 2.6% to 3.5% during the study period (p = 0.02). Among the 777 repeat prostate needle biopsies, the complication rate was comparable to that of initial prostate needle biopsy. Preprocedural rectal swab was done in less than 1% of prostate needle biopsies. On multivariable analysis, patient race, procedure year, diabetes (OR 1.92, 95% CI 1.29–2.86, p <0.01), transrectal approach (OR 3.48, 95% CI 1.27–9.54, p = 0.02) and recent hospitalization (OR 2.03, 95% CI 1.43–2.89, p <0.01) were significantly associated with infection. The median total charge for infectious complications was