Ryan P. Merkow

First Report from the American College of Surgeons -- Bariatric Surgery Center Network: Laparoscopic Sleeve Gastrectomy has Morbidity and Effectiveness Positioned Between the Band and the Bypass

Objective:To assess the safety and effectiveness of the laparoscopic sleeve gastrectomy (LSG) as compared to the laparoscopic adjustable gastric band (LAGB), the laparoscopic Roux-en-Y gastric bypass (LRYGB) and the open Roux-en-Y gastric bypass (ORYGB) for the treatment of obesity and obesity-related diseases. Background:LSG is a newer procedure being done with increasing frequency. However, limited data are currently available comparing LSG to the other established procedures. We present the first prospective, multiinstitutional, nationwide, clinically rich, bariatric-specific data comparing sleeve gastrectomy to the adjustable gastric band, and the gastric bypass. Methods:This is the initial report analyzing data from the American College of Surgeons—Bariatric Surgery Center Network accreditation program, and its prospective, longitudinal, data collection system based on standardized definitions and collected by trained data reviewers. Univariate and multivariate analyses compare 30-day, 6-month, and 1-year outcomes including morbidity and mortality, readmissions, and reoperations as well as reduction in body mass index (BMI) and weight-related comorbidities. Results:One hundred nine hospitals submitted data for 28,616 patients, from July, 2007 to September, 2010. The LSG has higher risk-adjusted morbidity, readmission and reoperation/intervention rates compared to the LAGB, but lower reoperation/intervention rates compared to the LRYGB and ORYGB. There were no differences in mortality. Reduction in BMI and most of the weight-related comorbidities after the LSG also lies between those of the LAGB and the LRYGB/ORYGB. Conclusion:LSG has morbidity and effectiveness positioned between the LAGB and the LRYGB/ORYGB for data up to 1 year. As obesity is a lifelong disease, longer term comparative effectiveness data are most critical, and are yet to be determined.

Underlying Reasons Associated With Hospital Readmission Following Surgery in the United States

IMPORTANCE Financial penalties for readmission have been expanded beyond medical conditions to include surgical procedures. Hospitals are working to reduce readmissions; however, little is known about the reasons for surgical readmission. OBJECTIVE To characterize the reasons, timing, and factors associated with unplanned postoperative readmissions. DESIGN, SETTING, AND PARTICIPANTS Patients undergoing surgery at one of 346 continuously enrolled US hospitals participating in the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) between January 1, 2012, and December 31, 2012, had clinically abstracted information examined. Readmission rates and reasons (ascertained by clinical data abstractors at each hospital) were assessed for all surgical procedures and for 6 representative operations: bariatric procedures, colectomy or proctectomy, hysterectomy, total hip or knee arthroplasty, ventral hernia repair, and lower extremity vascular bypass. MAIN OUTCOMES AND MEASURES Unplanned 30-day readmission and reason for readmission. RESULTS The unplanned readmission rate for the 498,875 operations was 5.7%. For the individual procedures, the readmission rate ranged from 3.8% for hysterectomy to 14.9% for lower extremity vascular bypass. The most common reason for unplanned readmission was surgical site infection (SSI) overall (19.5%) and also after colectomy or proctectomy (25.8%), ventral hernia repair (26.5%), hysterectomy (28.8%), arthroplasty (18.8%), and lower extremity vascular bypass (36.4%). Obstruction or ileus was the most common reason for readmission after bariatric surgery (24.5%) and the second most common reason overall (10.3%), after colectomy or proctectomy (18.1%), ventral hernia repair (16.7%), and hysterectomy (13.4%). Only 2.3% of patients were readmitted for the same complication they had experienced during their index hospitalization. Only 3.3% of patients readmitted for SSIs had experienced an SSI during their index hospitalization. There was no time pattern for readmission, and early (≤7 days postdischarge) and late (>7 days postdischarge) readmissions were associated with the same 3 most common reasons: SSI, ileus or obstruction, and bleeding. Patient comorbidities, index surgical admission complications, non-home discharge (hazard ratio [HR], 1.40 [95% CI, 1.35-1.46]), teaching hospital status (HR, 1.14 [95% CI 1.07-1.21]), and higher surgical volume (HR, 1.15 [95% CI, 1.07-1.25]) were associated with a higher risk of hospital readmission. CONCLUSIONS AND RELEVANCE Readmissions after surgery were associated with new postdischarge complications related to the procedure and not exacerbation of prior index hospitalization complications, suggesting that readmissions after surgery are a measure of postdischarge complications. These data should be considered when developing quality indicators and any policies penalizing hospitals for surgical readmission.

Optimal Preoperative Assessment of the Geriatric Surgical Patient: A Best Practices Guideline from the American College of Surgeons National Surgical Quality Improvement Program and the American Geriatrics Society

The population of the United States (US) is growing and aging.The US Census Bureau projects that the number of Americans age 65 years and older will more than double between 2010 and 2050. The percentage of Americans 65 and older will grow from 13% to more than 20% of the total population by 2030, and the fastest growing segment of this group (individuals 85 years and older) is expected to triple in number over the next 4 decades.These changes in the age demographics of the US population are largely due to people living longer and the “baby boomer” generation

Effect of Body Mass Index on Short-Term Outcomes after Colectomy for Cancer

BACKGROUND Obesity is associated with an increased risk of postoperative complications after colectomy for cancer, but it is unclear which specific complications occur more frequently in obese patients. Our objective was to assess the association of body mass index (BMI) on short-term outcomes after colectomy for cancer. STUDY DESIGN Using the American College of Surgeons National Surgical Quality Improvement Project (ACS NSQIP) dataset, we identified patients who underwent colectomy for malignancy at 121 hospitals. Logistic regression models were developed to assess risk-adjusted 30-day outcomes by BMI while adjusting for preoperative risk factors. RESULTS There were 3,202 patients identified: 33.4% normal weight (BMI 18.5 to 24 kg/m(2)), 35.1% overweight (BMI 25 to 29 kg/m(2)), 19.0% obese (BMI 30 to 34 kg/m(2)), and 12.4% morbidly obese (BMI>/=35 kg/m(2)). Compared with normal weight patients, complications occurred more frequently in the morbidly obese (31.8% versus 20.5%, odds ratio [OR] 1.75, 95% CI 1.33 to 2.31). Specifically, the morbidly obese had a higher risk of surgical site infection (20.7% versus 9.0%; OR 2.66, 95% CI 1.91 to 3.73), dehiscence (3.3% versus 1.1%; OR 3.51, 95% CI 1.55 to 7.95), pulmonary embolism (1.3% versus 0.3%; OR 6.98, 95% CI 1.62 to 30.06), and renal failure (3.0% versus 1.5%; OR 2.75, 95% CI 1.21 to 6.26). Pneumonia, urinary tract infection, stroke, cardiac arrest, myocardial infarction, deep venous thrombosis, length of stay, sepsis, and 30-day mortality did not differ significantly by BMI. CONCLUSIONS Compared with normal weight patients, morbidly obese patients had a higher risk of surgical site infection, dehiscence, pulmonary embolism, and renal failure, but not other complications or mortality. Quality initiatives should include these specific complications.

Validation of new readmission data in the American College of Surgeons National Surgical Quality Improvement Program.

BACKGROUND Hospital readmissions are gathering increasing attention as a measure of health care quality and as a cost-saving target. The American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) recently began collecting data related to 30-day postoperative readmissions. Our objectives were to assess the accuracy of the ACS NSQIP readmission variable by comparison with the medical record, and to evaluate the readmission variable against administrative data. STUDY DESIGN Readmission data captured in ACS NSQIP at a single academic institution between January and December 2011 were compared with data abstracted from the medical record and administrative data. RESULTS Of 1,748 cases captured in ACS NSQIP, 119 (6.8%) had an all-cause readmission event identified, and ACS NSQIP had very high agreement with chart review for identifying all-cause readmission events (κ = 0.98). For 1,110 inpatient cases successfully matched with administrative data, agreement with chart review for identifying all-cause readmissions was also very high (κ = 0.97). For identifying unplanned readmission events, ACS NSQIP had good agreement with chart review (κ = 0.67). Overall, agreement with chart review on cause of readmission was higher for ACS NSQIP (κ = 0.75) than for administrative data (κ = 0.46). CONCLUSIONS The ACS NSQIP accurately captured all-cause and unplanned readmission events and had good agreement with the medical record with respect to cause of readmission. Administrative data accurately captured all-cause readmissions, but could not identify unplanned readmissions and less consistently agreed with chart review on cause. The granularity of clinically collected data offers tremendous advantages for directing future quality efforts targeting surgical readmission.

Post-discharge venous thromboembolism after cancer surgery: extending the case for extended prophylaxis.

Objective:To (1) define the frequency of overall and postdischarge venous thromboembolism (VTE) after cancer surgery, (2) identify VTE risk for individual cancer operations, and (3) assess mortality rates in patients who experienced a VTE. Summary and Background Data:Cancer is a known risk factor for VTE but less is known about VTE risk after specific cancer operations. Moreover, most cancer patients routinely receive VTE prophylaxis postoperatively while in the hospital, but few receive prolonged prophylaxis despite strong evidence it reduces postdischarge events. Methods:From 211 ACS NSQIP hospitals, 44,656 patients undergoing surgery for 9 cancers were identified (2006–2008). The frequency of VTE within 30-days of surgery was evaluated by cancer site and categorized as occurring before or after discharge. Multivariable logistic regression models were constructed to assess risk factors associated with VTE. Results:VTE occurred in 1.6% of all patients, most frequently after esophagogastric (4.2%) and hepatopancreaticobiliary (3.6%) surgery. Overall, 33.4% of VTEs occurred postdischarge (from 17.9% for esophagogastric to 100% for endocrine operations). Factors associated with VTE were age (≥65 years), cancer/procedure type, metastatic disease, congestive heart failure, body mass index (BMI; ≥25 kg/m2), ascites, thrombocytosis (>400,000 cells/mm3), albumin (<3.0 g/dL), and operation duration (>2 hours; all P < 0.001). Overall VTE was significantly more likely after gastrointestinal, lung, prostate, and ovarian/uterine operations (all P < 0.001). In those experiencing a VTE, mortality increased over 6-fold (8.0% vs. 1.3%; P < 0.001). Conclusion:One-third of VTE events in cancer surgery patients occurred postdischarge. Postoperative VTE was associated with operation type. Routine postdischarge VTE prophylaxis should be considered for high-risk patients.

Postoperative complications reduce adjuvant chemotherapy use in resectable pancreatic cancer

Objective:To assess the impact of postoperative complications on the receipt of adjuvant chemotherapy. Background:Randomized trials have demonstrated that adjuvant chemotherapy is associated with improved long-term survival. However, pancreatic surgery is associated with significant morbidity and the degree to which complications limit subsequent treatment options is unknown. Methods:Patients from the American College of Surgeons National Surgical Quality Improvement Program and the National Cancer Data Base who underwent pancreatic resection for cancer were linked (2006–2009). The associations between complications and adjuvant chemotherapy use or treatment delay (≥70 days from surgery) were assessed using multivariable regression methods. Results:From 149 hospitals, 2047 patients underwent resection for stage I-III pancreatic adenocarcinoma of which 23.2% had at least 1 serious complication. Overall adjuvant chemotherapy receipt was 57.7%: 61.8% among patients not experiencing any complication and 43.6% among those who had a serious complication. Serious complications increased the likelihood of not receiving adjuvant therapy over twofold [odds ratio (OR) = 2.20, 95% confidence interval (CI): 1.73–2.80]. Specific complications associated with adjuvant chemotherapy omission were reintubation (OR = 7.79, 95% CI: 3.59–16.87), prolonged ventilation (OR = 5.92, 95% CI: 3.23–10.86), pneumonia (OR = 2.83, 95% CI: 1.63–4.90), sepsis/shock (OR = 2.76, 95% CI: 2.02–3.76), organ space/deep surgical site infection (OR = 2.19, 95% CI: 1.53–3.13), venous thromboembolism (OR = 1.92, 95% CI: 1.08–3.43), and urinary tract infection (OR = 1.61, 95% CI: 1.02–2.54). Serious complications also doubled the likelihood of delaying adjuvant treatment administration (OR = 2.08, 95% CI: 1.42–3.05). Sensitivity analysis in a younger, healthier patient cohort demonstrated similar associations. Conclusions:Postoperative complications are common following pancreatic surgery and are associated with adjuvant chemotherapy omission and treatment delays.

Effect of postoperative complications on adjuvant chemotherapy use for stage III colon cancer.

Objective: The National Quality Forum has endorsed a quality metric concerning the use of adjuvant chemotherapy administration in stage III colon cancer, yet a substantial treatment gap exists. Our objective was to evaluate the association of postoperative complications on the use of adjuvant therapy after colectomy for cancer. Patients and Methods: Data from the American College of Surgeons National Surgical Quality Improvement Program and National Cancer Data Base were linked to augment cancer registry information with robust clinical data on comorbidities and postoperative complications (2006–2008). The association of complications on adjuvant chemotherapy use was assessed using hierarchical multivariable regression models. Results: From 126 hospitals, 2368 patients underwent resection for stage III colon adenocarcinoma. Overall utilization of adjuvant chemotherapy was 63.2% (1497/2368). Of the 871 patients who did not receive chemotherapy, 652 met National Quality Forum exclusion criteria: death, severe comorbidity, refusal of care, advanced age (≥80 years), or prior malignancy. Of the remaining 219 patients, 19.1% (42/219) had 1 or more serious postoperative complications (eg, pneumonia, pulmonary failure). After accounting for the aforementioned potential explanations, the utilization rate was 87.2% (1497/1716). The strongest predictors of adjuvant chemotherapy omission were prolonged postoperative ventilation, renal failure, reintubation, and pneumonia (all Ps < 0.05). Superficial surgical site infection did not decrease adjuvant therapy receipt but delayed the time to its use by 3-fold. Serious complications increased time to chemotherapy by 65%. Abscess/anastomotic leak increased time to adjuvant chemotherapy by more than 5-fold. Conclusions: Serious postoperative complications explained nearly 20% of the adjuvant chemotherapy treatment gap for patients with stage III colon cancer. The use of clinical data remains important when judging provider performance.

Relevance of the C-Statistic When Evaluating Risk-Adjustment Models in Surgery

BACKGROUND The measurement of hospital quality based on outcomes requires risk adjustment. The c-statistic is a popular tool used to judge model performance, but can be limited, particularly when evaluating specific operations in focused populations. Our objectives were to examine the interpretation and relevance of the c-statistic when used in models with increasingly similar case mix and to consider an alternative perspective on model calibration based on a graphical depiction of model fit. STUDY DESIGN From the American College of Surgeons National Surgical Quality Improvement Program (2008-2009), patients were identified who underwent a general surgery procedure, and procedure groups were increasingly restricted: colorectal-all, colorectal-elective cases only, and colorectal-elective cancer cases only. Mortality and serious morbidity outcomes were evaluated using logistic regression-based risk adjustment, and model c-statistics and calibration curves were used to compare model performance. RESULTS During the study period, 323,427 general, 47,605 colorectal-all, 39,860 colorectal-elective, and 21,680 colorectal cancer patients were studied. Mortality ranged from 1.0% in general surgery to 4.1% in the colorectal-all group, and serious morbidity ranged from 3.9% in general surgery to 12.4% in the colorectal-all procedural group. As case mix was restricted, c-statistics progressively declined from the general to the colorectal cancer surgery cohorts for both mortality and serious morbidity (mortality: 0.949 to 0.866; serious morbidity: 0.861 to 0.668). Calibration was evaluated graphically by examining predicted vs observed number of events over risk deciles. For both mortality and serious morbidity, there was no qualitative difference in calibration identified between the procedure groups. CONCLUSIONS In the present study, we demonstrate how the c-statistic can become less informative and, in certain circumstances, can lead to incorrect model-based conclusions, as case mix is restricted and patients become more homogenous. Although it remains an important tool, caution is advised when the c-statistic is advanced as the sole measure of a model performance.

Treatment Trends, Risk of Lymph Node Metastasis, and Outcomes for Localized Esophageal Cancer

BACKGROUND Endoscopic resection is increasingly used to treat localized, early-stage esophageal cancer. We sought to assess its adoption, characterize the risks of nodal metastases, and define differences in procedural mortality and 5-year survival between endoscopic and surgical resection in the United States. METHODS From the National Cancer Data Base, patients with T1a and T1b lesions were identified. Treatment patterns were characterized, and hierarchical regression methods were used to define predictors and evaluate outcomes. All statistical tests were two-sided. RESULTS Five thousand three hundred ninety patients were identified and underwent endoscopic (26.5%) or surgical resection (73.5%). Endoscopic resection increased from 19.0% to 53.0% for T1a lesions (P < .001) and from 6.6% to 20.9% for T1b cancers (P < .001). The strongest predictors of endoscopic resection were depth of invasion (T1a vs T1b: odds ratio [OR] = 4.45; 95% confidence interval [CI] = 3.76 to 5.27) and patient age of 75 years or older (vs age less than 55 years: OR = 4.86; 95% CI = 3.60 to 6.57). Among patients undergoing surgery, lymph node metastasis was 5.0% for T1a and 16.6% for T1b lesions. Predictors of nodal metastases included tumor size greater than 2 cm (vs. <2 cm) and intermediate-/high-grade lesions (vs low grade). For example, 0.5% of patients with low-grade T1a lesions less than 2 cm had lymph node involvement. The risk of 30-day mortality was less after endoscopic resection (hazard ratio [HR] = 0.33; 95% CI = 0.19 to 0.58) but greater for conditional 5-year survival (HR = 1.63; 95% CI = 1.07 to 2.47). CONCLUSIONS Endoscopic resection has become the most common treatment of T1a esophageal cancer and has increased for T1b cancers. It remains important to balance the risk of nodal metastases and procedural risk when counseling patients regarding their treatment options.