Lindsey R. Haas

Comparative risk of gastrointestinal bleeding with dabigatran, rivaroxaban, and warfarin: population based cohort study.

Objective To determine the real world risk of gastrointestinal bleeding associated with the use of the novel oral anticoagulants dabigatran and rivaroxaban compared with warfarin. Design Retrospective, propensity matched cohort study. Setting: Optum Labs Data Warehouse, a large database including administrative claims data on privately insured and Medicare Advantage enrollees. Participants New users of dabigatran, rivaroxaban, and warfarin from 1 November 2010 to 30 September 2013. Main outcome measures Incidence rates (events/100 patient years) and propensity score matched Cox proportional hazards models were used to estimate rates of total gastrointestinal bleeds, upper gastrointestinal bleeds, and lower gastrointestinal bleeds for the novel oral anticoagulants compared with warfarin in patients with and without atrial fibrillation. Heterogeneity of treatment effect related to age was examined using a marginal effects model. Results The incidence of gastrointestinal bleeding associated with dabigatran was 2.29 (95% confidence interval 1.88 to 2.79) per 100 patient years and that associated with warfarin was 2.87 (2.41 to 3.41) per 100 patient years in patients with atrial fibrillation. In non-atrial fibrillation patients, the incidence of gastrointestinal bleeding was 4.10 (2.47 to 6.80) per 100 patient years with dabigatran and 3.71 (2.16 to 6.40) per 100 patient years with warfarin. With rivaroxaban, 2.84 (2.30 to 3.52) gastrointestinal bleeding events per 100 patient years occurred in atrial fibrillation patients (warfarin 3.06 (2.49 to 3.77)/100 patient years) and 1.66 (1.23 to 2.24) per 100 patient years in non-atrial fibrillation patients (warfarin 1.57 (1.25 to 1.99)/100 patient years). In propensity score matched models, the risk of gastrointestinal bleeding with novel oral anticoagulants was similar to that with warfarin in atrial fibrillation patients (dabigatran v warfarin, hazard ratio 0.79 (0.61 to 1.03); rivaroxaban v warfarin, 0.93 (0.69 to 1.25)) and in non-AF patients (dabigatran v warfarin, hazard ratio 1.14 (0.54 to 2.39); rivaroxaban v warfarin, 0.89 (0.60 to 1.32)). The risk of gastrointestinal bleeding increased after age 65, such that by age 76 the risk exceeded that with warfarin among atrial fibrillation patients taking dabigatran (hazard ratio 2.49 (1.61 to 3.83)) and patients with and without atrial fibrillation taking rivaroxaban (2.91 (1.65 to 4.81) and 4.58 (2.40 to 8.72), respectively). Conclusions: The risk of gastrointestinal bleeding related to novel oral anticoagulants was similar to that for warfarin. Caution should be used when prescribing novel oral anticoagulants to older people, particularly those over 75 years of age.

Prospective assessment of survival, morbidity, and cost associated with lymphadenectomy in low-risk endometrial cancer.

OBJECTIVE Since 1999, patients with low risk endometrial cancer (EC) as defined by the Mayo criteria have preferably not undergone lymphadenectomy (LND) at our institution. Here we prospectively assess survival, sites of recurrence, morbidity, and cost in this low risk cohort. METHODS Cause-specific survival (CSS) was estimated using the Kaplan-Meier method and compared using the log-rank test. Complications were graded per the Accordion Classification. Thirty-day cost analyses were expressed in 2010 Medicare dollars. RESULTS Among 1393 consecutive surgically managed cases, 385 (27.6%) met inclusion criteria, accounting for 34.1% of type I EC. There were 80 LND and 305 non-LND cases. Complications in the first 30 days were significantly more common in the LND cohort (37.5% vs. 19.3%; P<0.001). The prevalence of lymph node metastasis was 0.3% (1/385). Over a median follow-up of 5.4 years only 5 of 31 deaths were due to disease. The 5-year CSS in LND and non-LND cases was 97.3% and 99.0%, respectively (P=0.32). None of the 11 total recurrences occurred in the pelvic or para-aortic nodal areas. Median 30-day cost of care was

Enhanced recovery in gynecologic surgery.

15,678 for LND cases compared to

Factors predictive of postoperative morbidity and cost in patients with endometrial cancer.

11,028 for non-LND cases (P<0.001). The estimated cost per up-staged low-risk case was

Trends in computed tomography utilization rates: a longitudinal practice-based study.

327,866 to

Risk of stroke after catheter ablation versus cardioversion for atrial fibrillation: A propensity-matched study of 24,244 patients.

439,990, adding an additional

30-day hospital readmission of older adults using care transitions after hospitalization: a pilot prospective cohort study.

1,418,189 if all 305 non-LND cases had undergone LND. CONCLUSION Lymphadenectomy dramatically increases morbidity and cost of care without discernible benefits in low-risk EC as defined by the Mayo criteria. In these low-risk patients, hysterectomy with salpingo-oophorectomy alone is appropriate surgical management and should be standard of care.

Use of Post-acute Care Services and Readmissions After Left Ventricular Assist Device Implantation in Privately Insured Patients

OBJECTIVE: To investigate the effects of enhanced recovery (a multimodal perioperative care enhancement protocol) in patients undergoing gynecologic surgery. METHODS: Consecutive patients managed under an enhanced recovery pathway and undergoing cytoreduction, surgical staging, or pelvic organ prolapse surgery between June 20, 2011, and December 20, 2011, were compared with consecutive historical controls (March to December 2010) matched by procedure. Wilcoxon rank-sum, &khgr;2, and Fisher’s exact tests were used for comparisons. Direct medical costs incurred in the first 30 days were obtained from the Olmsted County Healthcare Expenditure and Utilization Database and standardized to 2011 Medicare dollars. RESULTS: A total of 241 enhanced recovery women in the case group (81 cytoreduction, 84 staging, and 76 vaginal surgery) were compared with women in the control groups. In the cytoreductive group, patient-controlled anesthesia use decreased from 98.7% to 33.3% and overall opioid use decreased by 80% in the first 48 hours with no change in pain scores. Enhanced recovery resulted in a 4-day reduction in hospital stay with stable readmission rates (25.9% of women in the case group compared with 17.9% of women in the control group) and 30-day cost savings of more than

Health Insurance Portability and Accountability Act (HIPAA) authorization and survey nonresponse bias.

7,600 per patient (18.8% reduction). No differences were observed in rate (63% compared with 71.8%) or severity of postoperative complications (grade 3 or more: 21% compared with 20.5%). Similar, albeit less dramatic, improvements were observed in the other two cohorts. Ninety-five percent of patients rated satisfaction with perioperative care as excellent or very good. CONCLUSIONS: Implementation of enhanced recovery was associated with acceptable pain management with reduced opioids, reduced length of stay with stable readmission and morbidity rates, good patient satisfaction, and substantial cost reductions. LEVEL OF EVIDENCE: II

Perceptions and practices of therapeutic hypothermia in American neonatal intensive care units.

OBJECTIVE: To identify patient characteristics and perioperative factors predictive of 30-day morbidity and cost in patients with endometrial carcinoma. METHODS: Data of consecutive patients treated with hysterectomy for endometrial carcinoma between 1999 and 2008 were collected prospectively. Thirty predictors were chosen from more than 130 collected based on anticipated clinical relevance and prevalence (more than 3%). Complications were graded per the Accordion Classification. Multivariable models were developed using stepwise and backward variable selection methods. Thirty-day cost analyses were expressed in 2010 Medicare dollars. RESULTS: Of 1,369 patients, significant predictors (P<.01) of grade 2 and higher morbidity included American Society of Anesthesiologists physical status classification system class higher than 2 (odds ratio [OR] 2.1), preoperative white blood count (OR 2.1 per doubling), history of deep vein thrombosis (OR 2.1), pelvic and para-aortic lymphadenectomy (OR 2.3 compared with no lymphadenectomy), laparotomy (OR 2.8 compared with minimally invasive surgery), myometrial invasion more than 50% (OR 2.4), operating time (OR 1.9 per doubling), and grade 4 surgical complexity (OR 2.7 compared with grade 1). After controlling for patient factors in a multivariable model, laparotomy, pelvic, and para-aortic lymphadenectomy were associated with significant increases in cost compared with the use of minimally invasive surgery or hysterectomy alone. CONCLUSION: This analysis identifies patient and perioperative care factors predictive of 30-day morbidity and cost. These data are useful for preoperative counseling, for defining equitable reimbursement and factors critical for risk-adjustment when comparing outcomes, and for identifying areas for quality improvement in patients with endometrial carcinoma. Given the marked increases in morbidity and cost associated with laparotomy and lymphadenectomy, minimally invasive surgery and selective lymphadenectomy should be standard treatment for patients with endometrial carcinoma. LEVEL OF EVIDENCE: II