Early results of trans-oral endoscopic plication and revision of the gastric pouch and stoma following Roux-en-Y gastric bypass surgery.

OBJECTIVE: A new technique for endoscopic plication and revision of the gastric pouch (EPRGP) for patients who underwent gastric bypass (RGB) surgery was evaluated in patients with severe GERD, dumping syndrome, failure of weight loss, or all of these. PATIENTS AND METHODS: Patients underwent EPRGP over a 12-month period. The StomaphyX device (Endogastric Solutions, Redmond, WA) was utilized over a standard flexible gastroscope. Patients were kept on a liquid diet for 1 week. RESULTS: The study included 64 patients with a mean age of 48 years who underwent 67 procedures. EPRGP was performed an average of 5 years after RGB. The mean preoperative BMI was 39.5 kg/m². The primary indications for the procedure were inadequate weight loss, dumping syndrome (42), and GERD (15). The mean follow-up period was 5.8 months (range, 3 to 12). The average operative time was 50 minutes, with a significant reduction with increased operator experience. There were only 2 (3%) intraoperative complications during the early period (equipment failure), which did not result in any morbidity. All symptoms from dumping syndrome or reflux improved, with no further operative-related complications. The mean weight loss was 7.3 kg. CONCLUSIONS: This study demonstrates the technical feasibility, safety, and efficacy of EPRGP.

A report card system using error profile analysis and concurrent morbidity and mortality review: surgical outcome analysis, part II.

BACKGROUND: An effective report card system for adverse outcome error analysis following surgery is lacking. We hypothesized that a memorialized database could be used in conjunction with error analysis and management evaluation at Morbidity & Mortality conference to generate individualized report cards for Attending Surgeon and System performance. STUDY DESIGN: Prospectively collected data from September 2000 through April 2005 were reported following Morbidity & Mortality review on 1618 adverse outcomes, including 219 deaths, following 29,237 operative procedures, in a complete loop to approximately 60 individual surgeons and responsible system personnel. RESULTS: A 40% reduction of gross mortality (P < 0.001) and 43% reduction of age-adjusted mortality were achieved over 4 years at the Academic Center. Quality issues were identified at a rate three times greater than required by New York State regulations and increased from a baseline 4.96% to 32.7% (odds ratio 1.94; P < 0.03) in cases associated with mortality. A detailed review demonstrated a significant increase (P < 0.001) in system errors and physician-related diagnostic and judgment errors associated with mortality highlighted those practices and processes involved, and contrasted the results between academic (43% mortality improvement) and community (no improvement) hospitals. CONCLUSIONS: The findings suggest that structured concurrent data collection combined with non-punitive error-based case review and individualized report cards can be used to provide detailed feedback on surgical performance to individual surgeons and possibly improve clinical outcomes.

Risk factors contributing to cardiac events following general and vascular surgery.

BACKGROUND: Cardiac events (CE) following surgery have been associated with morbidity and mortality. Defining risk factors that contribute to CE is essential to improve surgical outcomes. STUDY DESIGN: This was a retrospective study at a large urban teaching hospital for surgery performed from 2013 to 2015. Adult patients (≥18 years) that underwent general and vascular surgery were analyzed. Patients were grouped into those who experienced postoperative CE and those who did not. Univariate and multivariate regression analyses were used to identify predictors of postoperative CE, and association of CE with adverse postoperative outcomes. Separate subgroup analyses were also conducted for general and vascular surgery patients to assess predictors of CE. RESULTS: Out of 8441 patients, 157 (1.9%) experienced CE after major general and vascular surgery. Underlying predictors for CE included age >65 years(OR 4.9, 95%CI 3.4-6.9,p < 0.01), ASA >3(OR 12.0, 95%CI 8.5-16.9,p < 0.01), emergency surgery(OR 3.7, 95%CI 2.7-5.1,p = 0.01), CHF(OR 11.2, 95%CI 6.4-16.7,p = 0.02), COPD(OR 3.9, 95%CI 2.4-6.4,p = 0.04), acute renal failure or dialysis(OR 8.0, 95%CI 5.2-12.1,p = 0.04), weight loss(OR 3.3, 95%CI 1.7-6.7,p < 0.01), preoperative creatinine >1.2 mg/dL(OR 5.1, 95%CI 3.7-7.1,p = 0.01), hematocrit <34%(OR 4.0, 95%CI 2.8-5.7,p < 0.01), and operative time >240 min(OR 2.0, 95%CI 1.3-3.3,p = 0.02). Following surgery, CE was associated with increased mortality(OR 3.5, 95%CI 1.2-6.5,p < 0.01), pulmonary complications(OR 5.0, 95%CI 3.1-8.9,p < 0.01), renal complications(OR 2.3, 95%CI 1.9-4.5,p < 0.01), neurologic complications(OR 2.5, 95%CI 1.4-5.2,p < 0.01), systemic sepsis(OR 2.2, 95%CI 1.7-4.0,p < 0.01), postoperative RBC transfusion(OR 4.4, 95%CI 2.7-6.5,p < 0.01), unplanned return to operating room(OR 4.0, 95%CI 2.3-6.9,p < 0.01), and prolonged hospitalization (OR 5.5, 95%CI 3.1-8.8,p = 0.03). There was no statistical difference in incidence of CE between general and vascular surgery patients (p = 0.44); however, predictors of CE differed between the two surgical groups. CONCLUSION: Postoperative CE are associated with significant morbidity and mortality. Identified predictors of CE should allow for adequate risk stratification and optimization of perioperative surgical management.

Unplanned postoperative reintubation following general and vascular surgical procedures: Outcomes and risk factors.

BACKGROUND: Unplanned postoperative reintubation (UPR) is a marker for severe adverse outcomes following general and vascular surgery. STUDY DESIGN: A retrospective analysis of 8809 adult patients, aged 18 years and older, who underwent major general and vascular surgery at a large single-center urban hospital was conducted from January 2013 to September 2016. Patients were grouped into those who experienced UPR and those who did not. Univariate and multivariate regression analyses were used to identify predictors of UPR, and association of UPR with adverse postoperative outcomes. All regression models had Hosmer-Lemeshow P > 0.05, and C-statistic >0.75, indicating excellent goodness-of-fit and discrimination. RESULTS: Of the 8809 patients included, 138 (1.6%) experienced UPR. There was no statistical difference in incidence of UPR between general and vascular surgery patients (p = 0.53). Independent predictors of UPR advanced age (OR 5.1, 95%CI 3.5-7.5, p < 0.01), higher ASA status (OR 7.9, 95%CI 5.6-11.1, p < 0.01), CHF (OR 7.0, 95%CI 3.6-13.9, p = 0.02), acute renal failure or dialysis (OR 3.1, 95%CI 1.8-5.7, p = 0.01), weight loss (OR 5.2, 95%CI 2.8-9.6, p = 0.01), systemic sepsis (OR 4.8, 95%CI 3.4-6.9, p < 0.01), elevated preoperative creatinine (OR 4.2, 95%CI 3.0-5.9, p = 0.01), hypoalbuminemia (OR 5.3, 95% CI 3.8-7.5, p = 0.01), and anemia (OR 4.0, 95%CI 2.8-5.9, p < 0.01). Following surgery, UPR was associated with increased mortality (OR 3.8, 95%CI 2.7-5.2, p < 0.01), pulmonary complications (OR 1.8, 95%CI 1.7-2.0, p < 0.01), renal complications (OR 2.6, 95%CI 1.7-3.5, p < 0.01), cardiac complications (OR 4.6, 95%CI 2.0-6.7, p < 0.01), postoperative RBC transfusion (OR 5.7, 95%CI 3.8-8.6,p < 0.01), and prolonged hospitalization (OR 1.8, 95%CI 1.5-2.4, p < 0.01). CONCLUSION: UPR is significantly associated with postoperative morbidity and mortality. Perioperative management aimed at decreasing incidences of UPR after noncardiac surgery should target preoperative anemia in addition to previously identified predictors.

Open repair of large abdominal wall hernias with and without components separation; an analysis from the ACS-NSQIP database.

BACKGROUND: Components separation technique emerged several years ago as a novel procedure to improve durability of repair for ventral abdominal hernias. Almost twenty-five years since its initial description, little comprehensive risk adjusted data exists on the morbidity of this procedure. This study is the largest analysis to date of short-term outcomes for these cases. METHODS: The ACS-NSQIP database identified open ventral or incisional hernia repairs with components separation from 2005 to 2012. A data set of cohorts without this technique, matched for preoperative risk factors and operative characteristics, was developed for comparison. A comprehensive risk-adjusted analysis of outcomes and morbidity was performed. RESULTS: A total of 68,439 patients underwent open ventral hernia repair during the study period (2245 with components separation performed (3.3%) and 66,194 without). In comparison with risk-adjusted controls, use of components separation increased operative duration (additional 83 min), length of stay (6.4 days vs. 3.8 days, p < 0.001), return to the OR rate (5.9% vs. 3.6%, p < 0.001), and 30-day morbidity (10.1% vs. 7.6%, p < 0.001) with no increase in mortality (0.0% in each group). CONCLUSIONS: Components separation technique for large incisional hernias significantly increases length of stay and postoperative morbidity. Novel strategies to improve short-term outcomes are needed with continued use of this technique.

Barriers to implementing a surgical beta-blocker protocol.

BACKGROUND: Experience with a quality improvement (QI) program undertaken to increase the use of beta-adrenergic blockade in at-risk patients at both a major academic medical center and a community hospital suggests barriers to implementation. METHODS: A retrospective and prospective cohort study was performed to establish the incidence and effectiveness of beta-blockade use pre- and postimplementation of a standardized screening tool and a major education program as part of a QI project. Data gathering involved a baseline phase pre-intervention; 6 weeks postintervention; and 3-6 months postintervention. RESULTS: During phase I (baseline) 56% of eligible received beta-blockers, but targeted measures (a pre-induction heart rate < 70 or a systolic blood pressure [BP] < 110 mmHg) were achieved in only 11% of patients. Phase II saw a significant overall increase in beta-blocker administration (79%) and efficacy (50%). However, during phase III (3-6 months postimplementation), the rate of beta-blocker administration fell to 61% overall, while overall efficacy remained stable at 52%. Significant differences between the academic and community hospitals were observed throughout the study. CONCLUSION: Implementation of a quality program for beta-blockade is significantly affected by the presence or absence of ongoing physician and staff education beyond the study period.

Quality assurance initiative at one institution for minimally invasive breast biopsy as the initial diagnostic technique.

BACKGROUND: In 2005, the American College of Surgeons Consensus Conference issued a statement about the diagnostic workup of image-detected breast abnormalities. Guidelines include use of image-guided percutaneous needle biopsy as the gold standard for diagnosing image-detected breast abnormalities. In this study, we evaluate a method to audit use of excisional biopsy among different breast surgeons at our institution. STUDY DESIGN: From March to September 2007, 465 patients undergoing breast operation for benign or malignant lesions at our institution were interviewed by a surgical resident or physician's assistant. If an excisional biopsy was scheduled for initial diagnosis, the patient and surgeon were asked whose preference it was to perform the operation. Three attending groups were designated: academic breast surgeons, private practice breast surgeons on clinical faculty, and general surgeons who perform breast operations in addition to other procedures. Use of excisional biopsy was compared between these groups. RESULTS: Compliance for preoperative interview completion was 79%, differing substantially between surgeon groups with rates of 91%, 74%, and 58% for the academic breast, private practice, and general surgeons, respectively. Excisional biopsy for diagnosis made up 10%, 35%, and 37% of the case load for academic breast, private practice, and general surgeons, respectively. Patient and surgeon agreed 85% of the time for preference of performing diagnostic excisional biopsies. CONCLUSIONS: Excisional biopsies continue to be performed as the initial diagnostic procedure for 40% of patients. Tracking biopsy practices by surgeon can improve adherence with current recommendations.

A morbidity and mortality conference-based classification system for adverse events: surgical outcome analysis: part I.

BACKGROUND: We hypothesized that an archive database in conjunction with Morbidity and Mortality (M&M) review could be used to define a systematic list of post-surgical adverse events and identify areas for performance improvement. STUDY DESIGN: Adverse event data following surgery were prospectively collected at the Beth Israel Medical Center in NYC from academic, specialty, community hospital, and ambulatory care settings over a 5-year period from September 2000 through April 2005. A classification system and analysis methodology was developed to guide and maximize the effectiveness of M&M review. RESULTS: A total of 1618 adverse events, including 219 deaths, were analyzed following 29,237 operative procedures according to the analysis method described. A list of 245 adverse events was classified among 15 groups, and a subgroup of 25 adverse events accounted for over 80% of total adverse events. Five categories of adverse events were associated with death in surgical patients and 4 of 5 categories were post-operative events. Used in conjunction with M&M review, data derived from this analysis highlighted those adverse events with the greatest clinical frequency to the department's quality profile. CONCLUSIONS: We present a classification system for surgical adverse events and propose a specific analysis method which may be used in conjunction with Morbidity and Mortality Conference to standardize the profiling of surgical performance.

Benchmarking surgical incident reports using a database and a triage system to reduce adverse outcomes.

OBJECTIVE: To study the profile of incidents affecting quality outcomes after surgery by developing a usable operating room and perioperative clinical incident report database and a functional electronic classification, triage, and reporting system. Previously, incident reports after surgery were handled on an individual, episodic basis, which limited the ability to perceive actuarial patterns and meaningfully improve outcomes. DESIGN, SETTING, AND PARTICIPANTS: Clinical incident reports were experientially generated in the second largest health care system in New York City. Data were entered into a functional classification system organized into 16 categories, and weekly triage meetings were held to electronically review and report summaries on 40 to 60 incident reports per week. System development and deployment reviewed 1041 reports after 19,693 operative procedures. During the next 4 years, 3819 additional reports were generated from 83,988 operative procedures and were reported electronically to the appropriate departments. MAIN OUTCOME MEASURES: Number of incident reports generated annually. RESULTS: A significant decrease in volume-adjusted clinical incident reports occurred (from 53 to 39 reports per 1000 procedures) from 2001 to 2005 (P < .001). Reductions in incident reports were observed for ambulatory conversions (74% reduction), wasted implants (65%), skin breakdown (64%), complications in the operating room (42%), laparoscopic conversions (32%), and cancellations (23%) as a result of data-focused process and clinical interventions. Six of 16 categories of incident reports accounted for more than 88% of all incident reports. CONCLUSION: These data suggest that effective review, communication, and summary feedback of clinical incident reports can produce a statistically significant decrease in adverse outcomes.