Matthew M. Hutter

A lexicon for endoscopic adverse events: report of an ASGE workshop

Patients and practitioners expect that their endoscopy procedures will go smoothly and according to plan. There are several reasons why they may be disappointed. The procedure may fail technically (eg, incomplete colonoscopy, failed biliary cannulation). It may seem to be successful technically but turn out to be clinically unhelpful (eg, a diagnosis missed, an unsuccessful treatment), or there may be an early relapse (eg, stent dysfunction). In addition, some patients and relatives may be disappointed by a lack of courtesy and poor communication, even when everything otherwise works well. The most feared negative outcome is when something ‘‘goes wrong’’ and the patient experiences a ‘‘complication.’’ This term has unfortunate medicolegal connotations and is perhaps better avoided. Describing these deviations from the plan as ‘‘unplanned events’’ fits nicely

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.

The Impact of the 80-Hour Resident Workweek on Surgical Residents and Attending Surgeons

Objective:To assess the impact of the 80-hour resident workweek restrictions on surgical residents and attending surgeons. Summary Background Data:The ACGME mandated resident duty hour restrictions have required a major workforce restructuring. The impact of these changes needs to be critically evaluated for both the resident and attending surgeons, specifically with regards to the impact on motivation, job satisfaction, the quality of surgeon training, the quality of the surgeons life, and the quality of patient care. Methods:Four prospective studies were performed at a single academic surgical program with data collected both before the necessary workforce restructuring and 1 year after, including: 1) time cards to assess changes in components of daily activity; 2) Web-based surveys using validated instruments to assess burnout and motivation to work; 3) structured, taped, one-on-one interviews with an external PhD investigator; and 4) statistical analyses of objective, quantitative data. Results:After the work-hour changes, surgical residents have decreased “burnout” scores, with significantly less “emotional exhaustion” (Maslach Burnout Inventory: 29.1 “high” vs. 23.1 “medium,” P = 0.02). Residents have better quality of life both in and out of the hospital. They felt they got more sleep, have a lighter workload, and have increased motivation to work (Herzberg Motivation Dimensions). We found no measurable, statistically significant difference in the quality of patient care (NSQIP data). Resident training and education objectively were not statistically diminished (ACGME case logs, ABSITE scores). Attending surgeons perceived that their quality of their life inside and outside of the hospital was “somewhat worse” because of the work-hour changes, as they had anticipated. Many concerns were identified with regards to the professional development of future surgeons, including a change toward a shift-worker mentality that is not patient-focused, less continuity of care with a loss of critical information with each handoff, and a decrease in the patient/doctor relationship. Conclusion:Although the mandated restriction of resident duty hours has had no measurable impact on the quality of patient care and has led to improvements for the current quality of life of residents, there are many concerns with regards to the training of professional, responsible surgeons for the future.

Handoffs causing patient harm: a survey of medical and surgical house staff.

BACKGROUND Communication lapses at the time of patient handoffs are believed to be common, and yet the frequency with which patients are harmed as a result of problematic handoffs is unknown. Resident physicians were surveyed about their handoffpractices and the frequency with which they perceive problems with handoffs lead to patient harm. METHODS A survey was conducted in 2006 of all resident physicians in internal medicine and general surgery at Massachusetts General Hospital (MGH) concerning the quality and effects of handoffs during their most recent inpatient rotations. Surveys were sent to 238 eligible residents; 161 responses were obtained (response rate, 67.6%). RESULTS Fifty-nine percent of residents reported that one or more patients had been harmed during their most recent clinical rotation because of problematic handoffs, and 12% reported that this harm had been major. Overall quality of handoffs was reported to be fair or poor by 31% of residents. A minority of residents (26%) reported that handoffs usually or always took place in a quiet setting, and 37% reported that one or more interruptions during the receipt of handoffs occurred either most of the time or always. DISCUSSION Although handoffs have long been recognized as potentially hazardous, further scrutiny of handoffs has followed recent reports that handoffs are often marked by missing, incomplete, or inaccurate information and are associated with adverse events. In this study, reports of harm to patients from problematic handoffs were common among residents in internal medicine and general surgery. Many best-practice recommendations for handoffs are not observed, although the extent to which improvement of these practices could reduce patient harm is not known. MGH has recently launched a handoff-safety educational program, along with other interventions designed to improve the safety and effectiveness of handoffs, for its house staff and clinical leadership.

Surgical Site Infection Prevention: The Importance of Operative Duration and Blood Transfusion—Results of the First American College of Surgeons–National Surgical Quality Improvement Program Best Practices Initiative

BACKGROUND Surgical site infections (SSI) continue to be a significant problem in surgery. The American College of Surgeons-National Surgical Quality Improvement Program (ACS-NSQIP) Best Practices Initiative compared process and structural characteristics among 117 private sector hospitals in an effort to define best practices aimed at preventing SSI. STUDY DESIGN Using standard NSQIP methodologies, we identified 20 low outlier and 13 high outlier hospitals for SSI using data from the ACS-NSQIP in 2006. Each hospital was administered a process of care survey, and site visits were conducted to five hospitals. Comparisons between the low and high outlier hospitals were made with regard to patient characteristics, operative variables, structural variables, and processes of care. RESULT Hospitals that were high outliers for SSI had higher trainee-to-bed ratios (0.61 versus 0.25, p < 0.0001), and the operations took significantly longer (128.3+/-104.3 minutes versus 102.7+/-83.9 minutes, p < 0.001). Patients operated on at low outlier hospitals were less likely to present to the operating room anemic (4.9% versus 9.7%, p=0.007) or to receive a transfusion (5.1% versus 8.0%, p=0.03). In general, perioperative policies and practices were very similar between the low and high outlier hospitals, although low outlier hospitals were readily identified by site visitors. Overall, low outlier hospitals were smaller, efficient in the delivery of care, and experienced little operative staff turnover. CONCLUSIONS Our findings suggest that evidence-based SSI prevention practices do not easily distinguish well from poorly performing hospitals. But structural and process of care characteristics of hospitals were found to have a significant association with good results.

Laparoscopic versus open gastric bypass for morbid obesity : A multicenter, prospective, risk-adjusted analysis from the national surgical quality improvement program

Objective:To compare laparoscopic versus open gastric bypass procedures with respect to 30-day morbidity and mortality rates, using multi-institutional, prospective, risk-adjusted data. Summary Background Data:Laparoscopic Roux-en-Y gastric bypass for weight loss is being performed with increasing frequency, partly driven by consumer demand. However, there are no multi-institutional, risk-adjusted, prospective studies comparing laparoscopic and open gastric bypass outcomes. Methods:A multi-institutional, prospective, risk-adjusted cohort study of patients undergoing laparoscopic and open gastric bypass procedures was performed from hospitals (n = 15) involved in the Private Sector Study of the National Surgical Quality Improvement Program (NSQIP). Data points have been extensively validated, are based on standardized definitions, and were collected by nurse reviewers who are audited for accuracy. Results:From 2000 to 2003, data from 1356 gastric bypass procedures was collected. The 30-day mortality rate was zero in the laparoscopic group (n = 401), and 0.6% in the open group (n = 955) (P = not significant). The 30-day complication rate was significantly lower in the laparoscopic group as compared with the open group: 7% versus 14.5% (P < 0.0001). Multivariate logistic regression analysis was performed to control for potential confounding variables and showed that patients undergoing an open procedure were more likely to develop a complication, as compared with patients undergoing an laparoscopic procedure (odds ratio = 2.08; 95% confidence interval, 1.33–3.25). Propensity score modeling revealed similar results. A prediction model was derived, and variables that significantly predict higher complication rates after gastric bypass included an open procedure, a high ASA class (III, IV, V), functionally dependent patient, and hypertension as a comorbid illness. Conclusions:Multicenter, prospective, risk-adjusted data show that laparoscopic gastric bypass is safer than open gastric bypass, with respect to 30-day complication rate.

Systematic review on reoperative bariatric surgery: American Society for Metabolic and Bariatric Surgery Revision Task Force.

BACKGROUND Reoperative bariatric surgery has become a common practice in many bariatric surgery programs. There is currently little evidence-based guidance regarding specific indications and outcomes for reoperative bariatric surgery. A task force was convened to review the current evidence regarding reoperative bariatric surgery. The aim of the review was to identify procedure-specific indications and outcomes for reoperative procedures. METHODS Literature search was conducted to identify studies reporting indications for and outcomes after reoperative bariatric surgery. Specifically, operations to treat complications, failed weight loss, and weight regain were evaluated. Abstract and manuscript reviews were completed by the task force members to identify, grade, and categorize relevant studies. RESULTS A total of 819 articles were identified in the initial search. After review for inclusion criteria and data quality, 175 articles were included in the systematic review and analysis. The majority of published studies are single center retrospective reviews. The evidence supporting reoperative surgery for acute and chronic complications is described. The evidence regarding reoperative surgery for failed weight loss and weight regain generally demonstrates improved weight loss and co-morbidity reduction after reintervention. Procedure-specific outcomes are described. Complication rates are generally reported to be higher after reoperative surgery compared to primary surgery. CONCLUSION The indications and outcomes for reoperative bariatric surgery are procedure-specific but the current evidence does support additional treatment for persistent obesity, co-morbid disease, and complications.

Survival and changes in comorbidities after bariatric surgery.

Objective:To evaluate survival rates and changes in weight-related comorbid conditions after bariatric surgery in a high-risk patient population as compared with a similar cohort of morbidly obese patients who did not undergo surgery. Summary Background Data:Morbid obesity is increasingly becoming a major public health issue. Existing studies are limited in their ability to assess the risks and benefits of bariatric surgery because few studies compare surgical patients to a similar, morbidly obese, nonsurgical cohort, especially in high-risk populations like the elderly and disabled. Methods:A retrospective cohort analysis using Medicare fee-for-service patients from 2001 to 2004. Survival rates and diagnosed presence of 5 conditions commonly comorbid with morbid obesity were examined for morbidly obese patients who did and did not undergo bariatric surgery, with up to 2 years follow-up. Results:Morbidly obese Medicare patients who underwent bariatric surgery had increased survival rates over the 2 years of this study when compared with a similar morbidly obese nonsurgical group (P < 0.001). For patients under the age of 65, this survival advantage started at 6 months postoperatively and for patients over age 65, at 11 months. The surgical group also experienced significant improvements in the diagnosed prevalence of 5 weight-related comorbid conditions (diabetes, sleep apnea, hypertension, hyperlipidemia, and coronary artery disease) relative to the nonsurgical cohort after 1 year postsurgery (P < 0.001). Conclusions:Bariatric surgery appears to increase survival even in the high-risk, Medicare population, both for individuals aged 65 and older and those disabled and under 65. In addition, the diagnosed prevalence of weight-related comorbid conditions declined after bariatric surgery relative to a control cohort of morbidly obese patients who did not undergo surgery.

Utility of the surgical apgar score: Validation in 4119 patients

OBJECTIVES To confirm the utility of a 10-point Surgical Apgar Score to rate surgical outcomes in a large cohort of patients. DESIGN Using electronic intraoperative records, we calculated Surgical Apgar Scores during a period of 2 years (July 1, 2003, through June 30, 2005). SETTING Major academic medical center. PATIENTS Systematic sample of 4119 general and vascular surgery patients enrolled in the National Surgical Quality Improvement Program surgical outcomes database at a major academic medical center. MAIN OUTCOME MEASURES Incidence of major postoperative complications and/or death within 30 days of surgery. RESULTS Of 1441 patients with scores of 9 to 10, 72 (5.0%) developed major complications within 30 days, including 2 deaths (0.1%). By comparison, among 128 patients with scores of 4 or less, 72 developed major complications (56.3%; relative risk, 11.3; 95% confidence interval, 8.6-14.8; P < .001), of whom 25 died (19.5%; relative risk, 140.7; 95% confidence interval, 33.7-587.4; P < .001). The 3-variable score achieves C statistics of 0.73 for major complications and 0.81 for deaths. CONCLUSIONS The Surgical Apgar Score provides a simple, immediate, objective means of measuring and communicating patient outcomes in surgery, using data routinely available in any setting. The score can be effective in identifying patients at higher- and lower-than-average likelihood of major complications and/or death after surgery and may be useful for evaluating interventions to prevent poor outcomes.

Significant perioperative morbidity accompanies contemporary infrainguinal bypass surgery: An NSQIP report

OBJECTIVES A variety of clinical and anatomic factors influence the choice between infrainguinal bypass surgery (BPG) and percutaneous endovascular procedures (PTA) to treat lower extremity vascular disease. The decision, in part, is dependant on periprocedural morbidity. The goal of this study was to document the contemporary morbidity and mortality of infrainguinal BPG, utilizing the previously validated National Surgical Quality Improvement Program (NSQIP) database. METHODS Data from the private sector NSQIP, a prospectively validated systematic-sample database, using Current Procedural Terminology (CPT) codes for all infrainguinal BPG performed between January 1, 2005, and December 31, 2006, were analyzed. Study endpoints included 30-day death and NSQIP-defined major complications, including graft failure, differentiated between systemic vs operative-site related complications. Potentially associated clinical variables were assessed by univariate methods to create the multivariate models of factors associated with study endpoints. RESULTS There were 2404 infrainguinal BPG (infrapopliteal distal anastomosis 42%, prosthetic 29%) performed in the study interval with patient variables: age 67 +/- 12, male 66%, diabetes 44%, limb salvage indications 48%. The 30-day composite mortality/major morbidity was 19.5%. The overall mortality was 2.7% and correlated with (P value, odds ratio [OR]): patient age (<.001, 1.056), low body weight (.007, 0.988), significant preoperative dyspnea (.03, 1.97), dialysis (.003, 5.26), history transient ischemic attack (.03, 2.43), and bleeding disorder (.02, 2.01). Major complications occurred in 18.7% patients, including 7.4% graft thromboses, and 9.4% wound infections. Major systemic complications occurred in 5.9% and correlated with: age (.001, 1.03), history myocardial infarction (.02, 2.37), dialysis (<.001, 2.52), impaired sensorium (.005, 2.93), and general (vs regional) anesthesia (.04, 1.9). Major operative site-related complications occurred in 15.1% and correlated with: history chronic obstructive pulmonary disease (.04, 1.40), limb salvage indication (<.001, 1.71), impaired sensorium (.01, 2.26), non-independent preoperative functional status (.03, 1.37), and operative time (<.001, 1.002). The combination of dialysis and age >80 was identified as the most powerful high-risk composite for death (13.3-fold) and major complications (2.2-fold). CONCLUSION Infrainguinal BPG is accompanied by significant major morbidity and mortality in contemporary practice. These results reinforce the precept that stringent indications for BPG should be maintained, when considering the method of lower extremity revascularization.