Are perioperative bundles associated with reduced postoperative morbidity in women undergoing benign hysterectomy? Retrospective cohort analysis of 16,286 cases in Michigan.

Healthcare teams that frequently follow a bundle of evidence-based processes provide care with lower rates of morbidity. Few process bundles to improve surgical outcomes in hysterectomy have been identified. The purpose of this study was to investigate whether a bundle of 4 perioperative care processes is associated with fewer postoperative complications and readmissions for hysterectomies in the Michigan Surgical Quality Collaborative. A bundle of perioperative care process goals was developed retrospectively with 30-day peri- and postoperative outcome data from the Hysterectomy Initiative in Michigan Surgical Quality Collaborative. All benign hysterectomies that had been performed between January 2013 and January 2015 were included. Based on evidence of lower complication rates after benign hysterectomy, the following processes were considered to be the "bundle": use of guideline-appropriate preoperative antibiotics, a minimally invasive surgical approach, operative duration <120 minutes, and avoidance of intraoperative hemostatic agent use. Each process was considered present or absent, and the number of processes was summed for a bundle score that ranged from 0-4. Cases with a score of zero were excluded. Outcomes measured were rates of complications (any and major) and hospital readmissions, all within 30 days of surgery. Postoperative events that were considered a "major complication" included acute renal failure, cardiac arrest that required cardiopulmonary resuscitation, central line infection, cerebral vascular accident, death, deep vein thrombosis, intestinal obstruction, myocardial infarction, pelvic abscess, pulmonary embolism, rectovaginal fistula, sepsis, surgical site infection (deep and organ-space), unplanned intubation, ureteral obstruction, and ureterovaginal and vesicovaginal fistula. The outcome "any complication" included all those events already described in addition to blood transfusion within 72 hours of surgery, urinary tract infection, and superficial surgical site infection. Outcomes were adjusted for patient demographics, surgical factors, and hospital-level clustering effects. There were 16,286 benign hysterectomies available for analysis. Among all hysterectomies that were reviewed, 33.6% met criteria for all bundle processes; however, there was wide variation in the rate among the 56 hospitals in the study sample with 9.1% of cases at the lowest quartile and 60.4% at the highest quartile of hospitals that met criteria for all bundle processes. Overall, the rate of any complication was 6.8% and of any major complication was 2.3%. The rate of hospital readmissions was 3.6%. After adjustment for confounders, in cases in which all bundle criterion were met compared with cases in which all bundle criterion were not met, the rate of any complications increased from 4.3-7.8% (P<.001); major complications increased from 1.7-2.6% (P<.001), and readmissions increased from 2.6-4.1% (P<.001). After adjustment for confounders, hospitals with greater rates of meeting all 4 criteria were associated significantly with lower hospital-level rates of postoperative complications (P<.001) and readmissions (P<.001). This multiinstitutional evaluation reveals that reduced morbidity and readmission are associated with rates of bundle compliance. The proposed bundle is a surgical goal, which is not possible in every case, and there is significant variation in the proportion of cases meeting all 4 bundle processes in Michigan hospitals. Implementation of evidence-based process bundles at a healthcare system level are worthy of prospective study to determine whether improvements in patient outcomes are possible.

Harris JA ，Sammarco AG ，Swenson CW ，Uppal S ，Kamdar N ，Campbell D ，Evilsizer S ，DeLancey JO ，Morgan DM ... -  《-》

Practice patterns and postoperative complications before and after US Food and Drug Administration safety communication on power morcellation.

In April 2014, the US Food and Drug Administration (FDA) published its first safety communication discouraging "the use of laparoscopic power morcellation during hysterectomy or myomectomy for the treatment of women with uterine fibroids." Due to the concern of worsening outcomes for patients with occult uterine malignancy, specifically uterine leiomyosarcoma, the FDA recommended a significant change to existing surgical planning, patient consent, and surgical technique in the United States. We sought to report temporal trends in surgical approach to hysterectomy and postoperative complications before and after the April 17, 2014, FDA safety communication concerning the use of power morcellation during myomectomy or hysterectomy. A retrospective cohort study was performed with patients undergoing hysterectomy for benign indications in the Michigan Surgical Quality Collaborative from Jan. 1, 2013, through Dec. 31, 2014. The rates of abdominal, laparoscopic, and vaginal hysterectomy, as well as the rates of major postoperative complications and 30-day hospital readmissions and reoperations, were compared before and after April 17, 2014, the date of the original FDA safety communication. Major postoperative complications included blood transfusions, vaginal cuff infection, vaginal cuff dehiscence, ureteral obstruction, vesicovaginal fistula, deep and organ space surgical site infection, acute renal failure, respiratory failure, sepsis, pulmonary embolism, deep vein thrombosis requiring therapy, cerebral vascular accident, cardiac arrest, and death. We calculated the median episode cost related to hysterectomy readmissions using Michigan Value Collaborative data. Analyses were performed using robust multivariable multinomial and logistic regression models. There were 18,299 hysterectomies available for analysis during the study period. In all, 2753 cases were excluded due to an indication for cancer, cervical dysplasia, or endometrial hyperplasia, and 174 cases were excluded due to missing covariate data. Compared to the 15 months preceding the FDA safety communication, in the 8 months afterward, utilization of laparoscopic hysterectomies decreased by 4.1% (P = .005) and both abdominal and vaginal hysterectomies increased (1.7%, P = .112 and 2.4%, P = .012, respectively). Major surgical complications not including blood transfusions significantly increased after the date of the FDA safety communication, from 2.2-2.8% (P = .015), and the rate of hospital readmission within 30 days also increased from 3.4-4.2% (P = .025). The rate of all major surgical complications or hospital reoperations did not change significantly after the date of the FDA communication (P = .177 and P = .593, respectively). The median risk-adjusted total episode cost for readmissions was $5847 (interquartile range $5478-10,389). Following the April 2014 FDA safety communication regarding power morcellation, utilization of minimally invasive hysterectomy decreased, and major surgical, nontransfusion complications and 30-day hospital readmissions increased.

Harris JA ，Swenson CW ，Uppal S ，Kamdar N ，Mahnert N ，As-Sanie S ，Morgan DM ... -  《-》

Comparison of robotic and other minimally invasive routes of hysterectomy for benign indications.

Despite a lack of evidence showing improved clinical outcomes with robotic-assisted hysterectomy over other minimally invasive routes for benign indications, this route has increased in popularity over the last decade. We sought to compare clinical outcomes and estimated cost of robotic-assisted vs other routes of minimally invasive hysterectomy for benign indications. A statewide database was used to analyze utilization and outcomes of minimally invasive hysterectomy performed for benign indications from Jan. 1, 2013, through July 1, 2014. A 1-to-1 propensity score-match analysis was performed between women who had a hysterectomy with robotic assistance vs other minimally invasive routes (laparoscopic and vaginal, with or without laparoscopy). Perioperative outcomes, intraoperative bowel and bladder injury, 30-day postoperative complications, readmissions, and reoperations were compared. Cost estimates of hysterectomy routes, surgical site infection, and postoperative blood transfusion were derived from published data. In all, 8313 hysterectomy cases were identified: 4527 performed using robotic assistance and 3786 performed using other minimally invasive routes. A total of 1338 women from each group were successfully matched using propensity score matching. Robotic-assisted hysterectomies had lower estimated blood loss (94.2 ± 124.3 vs 175.3 ± 198.9 mL, P < .001), longer surgical time (2.3 ± 1.0 vs 2.0 ± 1.0 hours, P < .001), larger specimen weights (178.9 ± 186.3 vs 160.5 ± 190 g, P = .007), and shorter length of stay (14.1% [189] vs 21.9% [293] ≥2 days, P < .001). Overall, the rate of any postoperative complication was lower with the robotic-assisted route (3.5% [47] vs 5.6% [75], P = .01) and driven by lower rates of superficial surgical site infection (0.07% [1] vs 0.7% [9], P = .01) and blood transfusion (0.8% [11] vs 1.9% [25], P = .02). Major postoperative complications, intraoperative bowel and bladder injury, readmissions, and reoperations were similar between groups. Using hospital cost estimates of hysterectomy routes and considering the incremental costs associated with surgical site infections and blood transfusions, nonrobotic minimally invasive routes had an average net savings of $3269 per case, or 24% lower cost, compared to robotic-assisted hysterectomy ($10,160 vs $13,429). Robotic-assisted laparoscopy does not decrease major morbidity following hysterectomy for benign indications when compared to other minimally invasive routes. While superficial surgical site infection and blood transfusion rates were statistically lower in the robotic-assisted group, in the absence of substantial reductions in clinically and financially burdensome complications, it will be challenging to find a scenario in which robotic-assisted hysterectomy is clinically superior and cost-effective.

Swenson CW ，Kamdar NS ，Harris JA ，Uppal S ，Campbell DA Jr ，Morgan DM ... -  《-》

Surgical site infection following hysterectomy: adjusted rankings in a regional collaborative.

Surgical site infection after abdominal hysterectomy (defined as open and laparoscopic) will be a metric used to rank and penalize hospitals in the Hospital Acquired Condition Reduction program. Hospitals whose Hospital Acquired Condition Reduction score places them in the bottom quartile will lose 1% of reimbursement from the Centers of Medicaid and Medicare Services. The objectives of this analysis were to develop a risk adjustment model for surgical site infection after hysterectomy, to calculate adjusted surgical site infection rates, to rank hospitals by the predicted to expected (P/E) ratio, and to compare the number of outlier hospitals with the number in the bottom quartile. This was a retrospective analysis of hysterectomies from the Michigan Surgical Quality Collaborative performed between July 1, 2012, and July 1, 2014. Superficial, deep, and organ space surgical site infections were categorized according to Centers for Disease Control and Prevention criteria. Deep and organ space surgical site infections were considered 1 group for this analysis because these spaces are contiguous after hysterectomy. Hospital rankings focused on deep/organ space events because the Hospital Acquired Condition Reduction program will rank and penalize based on them, not superficial surgical site infection. Hierarchical multivariable logistic regression, which takes into account hospital effects, was used to identify risk factors for all surgical site infections and deep/organ space surgical site infections. Predicted to expected ratios for deep surgical site infection were calculated for each hospital and used to determine hospital rankings. Outliers were defined as those hospitals who predicted to expected confidence intervals crossed the reference line of 1. The number of outlier hospitals was compared with the number in the bottom quartile. The overall surgical site infection rate following hysterectomy was 2.1% (351 of 16,548). Deep/organ space surgical site infection accounted for 1.0% (n = 167 of 16,548). Deep surgical site infection was associated independently with younger age, longer surgical times, gynecological cancer, and open hysterectomy. There was a marginal association with blood transfusion. After risk adjustment of rates and ranking by the predicted to expected ratio, there was a change in quartile rank for 42.8% of hospitals (21 of 49). Two hospitals were identified as outliers. However, if the bottom quartile was identified, as called for by the Hospital Acquired Condition Reduction program, 10 additional hospitals would be targeted for a penalty. Hospitals with < 300 beds were most likely to see their quartile rank worsen, whereas those > 500 beds were most likely to see their quartile rank improve (P = .01). After adjusting for patient-related factors and site variation, more than 40% of hospitals will change quartile rank with respect to deep surgical site infection. Identifying a quartile of hospitals that are statistically different from others was not feasible in our collaborative because only 2 of 12 hospitals were outliers. These findings suggest that under the Hospital Acquired Condition Reduction program, many hospitals will be unjustly penalized.

Morgan DM ，Swenson CW ，Streifel KM ，Kamdar NS ，Uppal S ，Burgunder-Zdravkovski L ，Pearlman MD ，Fenner DE ，Campbell DA ... -  《-》

Trainee participation and perioperative complications in benign hysterectomy: the effect of route of surgery.

Intraoperative trainee involvement in hysterectomy is common. However, the effect of intraoperative trainee involvement on perioperative complications depending on surgical approach is unknown. To estimate the effect of intraoperative trainee involvement on perioperative complication after vaginal, laparoscopic, and abdominal hysterectomy for benign disease. Patients undergoing laparoscopic, vaginal, or abdominal hysterectomy for benign disease from 2010 to 2012 were identified from the American College of Surgeons National Surgical Quality Improvement Program database. Patients with and without trainee involvement were compared with regard to perioperative complications. Complications that occurred from the start of surgery to 30-days postoperatively were included. Perioperative complications were defined via the use of the validated Clavien-Dindo scale with ≥grade 3 complications defined as major and ≤grade 2 complications defined as minor. Major complications included myocardial infarction, pneumonia, venous thromboembolism, deep or organ space surgical-site infection, stroke, fascial dehiscence, unplanned return to the operating room, renal failure, cardiopulmonary arrest, sepsis, intubation greater than 48 hours, and death. Minor complications included urinary tract infection, blood transfusion, and superficial wound infection. To estimate the effect of trainee involvement depending on route of surgery, a stratified analysis was performed. Bivariable analysis and adjusted multivariable logistic regression were used. We identified 22,499 patients, of whom 42.1% had trainee participation. Surgical approaches were vaginal (22.7%), abdominal (47.1%), and laparoscopic (30.2%). The rate of major complication was 3.2%, and minor complication was 7.2%. In bivariable analysis, trainee involvement was associated with major complications in vaginal hysterectomy (3.3% vs 2.3%, P = .03), but not laparoscopic (3.0% vs 2.9%, P = .78) or abdominal hysterectomy (4.4% vs 3.6%, P = .07). Trainee involvement was also associated with minor complication in vaginal (7.3% vs 5.4%, P = .007), laparoscopic (5.9% vs 4.3%, P < .001), and abdominal hysterectomy (14.1% vs 9.2%, P < .001). In a multivariable analysis in which we adjusted for age, body mass index, medical comorbidity, American Society of Anesthesiologists score, and surgical complexity, the association between trainee involvement in vaginal hysterectomy and major complication persisted (adjusted odds ratio 1.45, 95% confidence interval 1.03-2.04); however, when operative time was added to the model, there was no longer an association between trainee involvement and major complication (adjusted odds ratio 1.26, 95% confidence interval 0.89-1.80). Surgical approach influences the relationship between trainee involvement and perioperative complication. Operative time is a key mediator of the relationship between trainee involvement and complication, and may be a modifiable risk factor.

Barber EL ，Harris B ，Gehrig PA 《-》