A comparison of approaches to identify possible cases of local anesthetic systemic toxicity in the FDA Adverse Event Reporting System (FAERS) database.

BACKGROUND: Local anesthetic systemic toxicity (LAST) is a rare but potentially serious adverse event . METHODS: Data from the US Food and Drug Administration Adverse Event Reporting System were examined for liposomal bupivacaine (LB), bupivacaine, or other injectable local anesthetics. Possible LAST cases were identified based on MedDRA system organ classes (Approach 1), a recent publication (Approach 2), and a novel approach based on LAST literature (Approach 3). Disproportionality analyses compared possible LAST cases for LB and bupivacaine with other injectable local anesthetics. RESULTS: Approaches 1, 2, and 3 identified 75, 42, and 29 possible LAST cases associated with LB, respectively, compared with 9,595, 3,422, and 549 for other injectable local anesthetics. The proportional reporting ratios (95% CI) for LB versus other injectable local anesthetics for the 3 approaches were 1.9 (1.6-2.3), 2.9 (2.2-3.9), and 1.6 (1.1-2.2), respectively. Based on sales data, the estimated incidence of possible LAST with LB was 0.1 per 10,000 uses; literature estimates for LAST with other injectable local anesthetics were 0 to 18 per 10,000 uses. CONCLUSIONS: Our findings suggest the estimated incidence of possible LAST cases with LB is similar to, or less than, the reported incidence with other injectable local anesthetics.

Validation of a Screening Risk Index for Serious Prescription Opioid-Induced Respiratory Depression or Overdose in a US Commercial Health Plan Claims Database.

Objective: To validate a risk index that estimates the likelihood of overdose or serious opioid-induced respiratory depression (OIRD) among medical users of prescription opioids. Subjects and Methods: A case-control analysis of 18,365,497 patients with an opioid prescription from 2009 to 2013 in the IMS PharMetrics Plus commercially insured health plan claims database (CIP). An OIRD event occurred in 7,234 cases. Four controls were selected per case. Validity of the Risk Index for Overdose or Serious Opioid-induced Respiratory Depression (RIOSORD), developed previously using Veterans Health Administration (VHA) patient data, was assessed. Multivariable logistic regression was used within the CIP study population to develop a slightly refined RIOSORD. The composition and performance of the CIP-based RIOSORD was evaluated and compared with VHA-based RIOSORD. Results: VHA-RIOSORD performed well in discriminating OIRD events in CIP (C-statistic = 0.85). Additionally, re-estimation of logistic model coefficients in CIP yielded a 0.90 C-statistic. The resulting comorbidity and pharmacotherapy variables most highly associated with OIRD and retained in the CIP-RIOSORD were largely concordant with VHA-RIOSORD. These variables included neuropsychiatric and cardiopulmonary disorders, impaired drug excretion, opioid characteristics, and concurrent psychoactive medications. The average predicted probability of OIRD ranged from 2% to 83%, with excellent agreement between predicted and observed incidence across risk classes. Conclusions: RIOSORD had excellent predictive accuracy in a large population of US medical users of prescription opioids, similar to its performance in VHA. This practical risk index is designed to support clinical decision-making for safer opioid prescribing, and its clinical utility should be evaluated prospectively.

Timing of surgical antibiotic prophylaxis and the risk of surgical site infection.

IMPORTANCE: Timing of prophylactic antibiotic administration for surgical procedures is a nationally mandated and publicly reported quality metric sponsored by the Centers for Medicare and Medicaid Services Surgical Care Improvement Project. Numerous studies have failed to demonstrate that adherence to the Surgical Care Improvement Project prophylactic antibiotic timely administration measure is associated with decreased surgical site infection (SSI). OBJECTIVE; To determine whether prophylactic antibiotic timing is associated with SSI occurrence. DESIGN: Retrospective cohort study using national Veterans Affairs patient-level data on prophylactic antibiotic timing for orthopedic, colorectal, vascular, and gynecologic procedures from 2005 through 2009. SETTING: National Veterans Affairs Surgical Care Improvement Project data from 112 Veterans Affairs hospitals and matched Veterans Affairs Surgical Quality Improvement Program data. PATIENTS: Patients undergoing hip or knee arthroplasty, colorectal surgical procedures, arterial vascular surgical procedures, and hysterectomy. INTERVENTION: Timing of prophylactic antibiotic administration with respect to surgical incision time. MAIN OUTCOMES AND MEASURES: Data for prophylactic antibiotic agent, prophylactic antibiotic timing with respect to surgical incision, and patient and procedure risk variables were assessed for their relationship with the occurrence of a composite superficial or deep incisional SSI within 30 days after the procedure. Nonlinear generalized additive models were used to examine the association between antibiotic timing and SSI. RESULTS: Of the 32,459 operations, prophylactic antibiotics were administered at a median of 28 minutes (interquartile range, 17-39 minutes) prior to surgical incision, and 1497 cases (4.6%) developed an SSI. Compared with procedures with antibiotic administration within 60 minutes prior to incision, higher SSI rates were observed for timing more than 60 minutes prior to incision (unadjusted odds ratio [OR] = 1.34; 95% CI, 1.08-1.66) but not after incision (unadjusted OR = 1.26; 95% CI, 0.92-1.72). In unadjusted generalized additive models, we observed a significant nonlinear relationship between prophylactic antibiotic timing and SSI when considering timing as a continuous variable (P = .01). In generalized additive models adjusted for patient, procedure, and antibiotic variables, no significant association between prophylactic antibiotic timing and SSI was observed. Vancomycin hydrochloride was associated with higher SSI occurrence for orthopedic procedures (adjusted OR = 1.75; 95% CI, 1.16-2.65). Cefazolin sodium and quinolone in combination with an anaerobic agent were associated with fewer SSI events (cefazolin: adjusted OR = 0.49; 95% CI, 0.34-0.71; quinolone: adjusted OR = 0.55; 95% CI, 0.35-0.87) for colorectal procedures. CONCLUSIONS AND RELEVANCE: The SSI risk varies by patient and procedure factors as well as antibiotic properties but is not significantly associated with prophylactic antibiotic timing. While adherence to the timely prophylactic antibiotic measure is not bad care, there is little evidence to suggest that it is better care.

Preoperative oral antibiotics reduce surgical site infection following elective colorectal resections.

BACKGROUND: Surgical site infection is a major cause of morbidity after colorectal resections. Despite evidence that preoperative oral antibiotics with mechanical bowel preparation reduce surgical site infection rates, the use of oral antibiotics is decreasing. Currently, the administration of oral antibiotics is controversial and considered ineffective without mechanical bowel preparation. OBJECTIVE: The aim of this study is to examine the use of mechanical bowel preparation and oral antibiotics and their relationship to surgical site infection rates in a colorectal Surgical Care Improvement Project cohort. DESIGN: This retrospective study used Veterans Affairs Surgical Quality Improvement Program preoperative risk and surgical site infection outcome data linked to Veterans Affairs Surgical Care Improvement Project and Pharmacy Benefits Management data. Univariate and multivariable models were performed to identify factors associated with surgical site infection within 30 days of surgery. SETTINGS: This study was conducted in 112 Veterans Affairs hospitals. PATIENTS: Included were 9940 patients who underwent elective colorectal resections from 2005 to 2009. MAIN OUTCOME MEASURE: The primary outcome measured was the incidence of surgical site infection. RESULTS: Patients receiving oral antibiotics had significantly lower surgical site infection rates. Those receiving no bowel preparation had similar surgical site infection rates to those who had mechanical bowel preparation only (18.1% vs 20%). Those receiving oral antibiotics alone had an surgical site infection rate of 8.3%, and those receiving oral antibiotics plus mechanical bowel preparation had a rate of 9.2%. In adjusted analysis, the use of oral antibiotics alone was associated with a 67% decrease in surgical site infection occurrence (OR=0.33, 95% CI 0.21-0.50). Oral antibiotics plus mechanical bowel preparation was associated with a 57% decrease in surgical site infection occurrence (OR=0.43, 95% CI 0.34-0.55). Timely administration of parenteral antibiotics (Surgical Care Improvement Project-1) had a modest protective effect, with no effect observed for other Surgical Care Improvement Project measures. Hospitals with higher rates of oral antibiotics use had lower surgical site infection rates (R = 0.274, p < 0.0001). LIMITATIONS: Determination of the use of oral antibiotics and mechanical bowel preparation is based on retrospective prescription data, and timing of actual administration cannot be determined. CONCLUSIONS: Use and type of preoperative bowel preparation varied widely. These results strongly suggest that preoperative oral antibiotics should be administered for elective colorectal resections. The role of oral antibiotics independent of mechanical bowel preparation should be examined in a prospective randomized trial.

Association between Surgical Care Improvement Program venous thromboembolism measures and postoperative events.

BACKGROUND: In 2006, the Surgical Care Improvement Program (SCIP) implemented measures to reduce venous thromboembolism (VTE). There are little data on whether these measures reduce VTE rates. This study proposed to examine associations between SCIP-VTE adherence and VTE rates. METHODS: SCIP-VTE adherence for 30,531 surgeries from 2006 to 2009 was linked with VA Surgical Quality Improvement Program data. Patient demographics, comorbidities, and surgical characteristics associated with VTE were summarized. VTE rates were compared by SCIP-VTE adherence. Multivariable logistic regression was used to model VTE by adherence, adjusting for multiple associated factors. RESULTS: Of 30,531 surgeries, 89.9% adhered to SCIP-VTE; 1.4% experienced VTE. Logistic regression identified obesity, smoking, functional status, weight loss, emergent status, age older than 64 years, and surgical time as associated with VTE. SCIP-VTE was not associated with VTE (1.4% vs 1.33%; P = .3), even after adjustment. CONCLUSIONS: This study identified several important risk factors for VTE but found no association with SCIP-VTE adherence.

Outcomes for incisional hernia repair in patients undergoing concomitant surgical procedures.

The safety and efficacy of performing concomitant surgical procedures with an incisional hernia repair (IHR) is not well understood. There are conflicting reports on the outcomes for permanent mesh implantation in the setting of clean-contaminated procedures. The purpose of this study was to review the effect of concomitant surgical procedures on IHR outcomes. This is a retrospective multisite cohort of patients undergoing elective IHR at 16 Veterans Affairs hospitals from 1998 to 2002. Concomitant procedure status, hernia characteristics, and operative details were determined using physician-abstracted operative notes. Hernia outcomes of recurrence and mesh explantation were determined from the medical chart. χ(2) tests, Kaplan-Meier curves, and Cox regression were used to evaluate the effects of concomitant status on hernia outcomes. Of the 1495 elective IHRs, 75 (4.8%) were same site and 56 (3.8%) different site concomitant procedures. At median follow-up of 69.3 months (range 19.1-98.3), 33.6 per cent of patients had a recurrence, mesh explantation, or both. Permanent mesh placement was less likely among concomitant procedures as compared with nonconcomitant procedures (P < 0.0001). Adjusted Cox proportional hazards models of hernia outcomes resulted in an increased hazard for recurrence among same site clean procedures (Hazard Ratio (HR) = 1.8, P = 0.03) and an increased hazard for mesh explantation among same site clean-contaminated procedures (HR = 8.4, P = 0.002). Concomitant same site procedures are significantly associated with adverse hernia outcomes as compared with isolated IHR or IHR with other site concomitant procedures. The high failure rate of hernia repairs among same site concomitant procedures should be taken into account during the surgical decision-making process.

Outcomes of emergent incisional hernia repair.

This study examines the effect of emergent repair on incisional hernia repair outcomes at 16 Veteran's Affairs Medical Centers between 1998 and 2002. Of the 1452 cases reviewed, 63 (4.3%) were repaired emergently. Patients undergoing emergent repair were older (P = 0.02), more likely to be black (P = 0.02), and have congestive heart failure (P = 0.001) or chronic obstructive pulmonary disease (P = 0.001). Of emergent repairs, 76.2 per cent involved intestinal incarceration versus 7.2 per cent of elective repairs (P < 0.0001), and 17.5 per cent had concomitant bowel resection compared with 3.9 per cent of elective cases (P < 0.0001). Patients undergoing emergent repair were also more likely to receive primary suture repair (49.2 vs 31.1%, P = 0.003), develop a postoperative complication (26.0 vs 11.3%, P = 0.002), and have increased postoperative length of stay (7 vs 4 days, P < 0.0001). There were nine (14.3%) deaths at 30 days for the emergent group compared with 10 (0.7%) in the elective group (P < 0.001). However, there was no significant difference between emergent and elective repairs in long-term complications. Emergent hernia repair is associated with increased mortality rates, early complications, and longer length of stay; however, long-term outcomes are equivalent to elective cases. These data suggest that technical outcomes for emergent repairs approach those of elective operations.

Surgical site infection prevention: time to move beyond the surgical care improvement program.

OBJECTIVES: The objective of this study was to evaluate whether the Surgical Care Improvement Project (SCIP) improved surgical site infection (SSI) rates using national data at the patient level for both SCIP adherence and SSI occurrence. BACKGROUND: The SCIP was established in 2006 with the goal of reducing surgical complications by 25% in 2010. METHODS: National Veterans' Affairs (VA) data from 2005 to 2009 on adherence to 5 SCIP SSI prevention measures were linked to Veterans' Affairs Surgical Quality Improvement Program SSI outcome data. Effect of SCIP adherence and year of surgery on SSI outcome were assessed with logistic regression using generalized estimating equations, adjusting for procedure type and variables known to predict SSI. Correlation between hospital SCIP adherence and SSI rate was assessed using linear regression. RESULTS: There were 60,853 surgeries at 112 VA hospitals analyzed. SCIP adherence ranged from 75% for normothermia to 99% for hair removal and all significantly improved over the study period (P < 0.001). Surgical site infection occurred after 6.2% of surgeries (1.6% for orthopedic surgeries to 11.3% for colorectal surgeries). None of the 5 SCIP measures were significantly associated with lower odds of SSI after adjusting for variables known to predict SSI and procedure type. Year was not associated with SSI (P = 0.71). Hospital SCIP performance was not correlated with hospital SSI rates (r = -0.06, P = 0.54). CONCLUSIONS: Adherence to SCIP measures improved whereas risk-adjusted SSI rates remained stable. SCIP adherence was neither associated with a lower SSI rate at the patient level, nor associated with hospital SSI rates. Policies regarding continued SCIP measurement and reporting should be reassessed.

Predictors of mesh explantation after incisional hernia repair.

BACKGROUND: Prosthetic mesh used for incisional hernia repair (IHR) reduces hernia recurrence. Mesh infection results in significant morbidity and challenges for subsequent abdominal wall reconstruction. The risk factors that lead to mesh explantation are not well known. METHODS: This is a multisite cohort study of patients undergoing IHR at 16 Veterans Affairs hospitals from 1998 to 2002. RESULTS: Of the 1,071 mesh repairs, 55 (5.1%) had subsequent mesh explantation at a median of 7.3 months (interquartile range 1.4-22.2) after IHR with permanent mesh prosthesis. Infection was the most common reason for explantation (69%). No differences were observed by the type of repair. Adjusting for covariates, same-site concomitant surgery (hazard ratio [HR] = 6.3) and postoperative surgical site infection (HR = 6.5) were associated with mesh explantation. CONCLUSIONS: Patients undergoing IHR with concomitant intra-abdominal procedures have a greater than 6-fold increased hazard of subsequent mesh explantation. Permanent prosthetic mesh should be used with caution in this setting.

Agreement between patient survey and medical chart: Pitfalls in measurement strategies for hernia recurrence.

BACKGROUND: Little information is available on agreement between patient-reported outcomes and data collected from medical chart abstraction (MCA) for recurring events. Recurring conditions pose a risk of misclassification, especially when events occur relatively close together in time. We examined agreement, predictors of agreement, and relative accuracy of patient survey and MCA for assessment of outcomes of incisional hernia repair (IHR). METHODS: Surveys to assess hernia outcomes were mailed to 1,124 living patients who underwent ≥ 1 IHR during 1998-2002 at 16 Veteran's Affairs Medical Center study sites. Patients were asked if they developed a recurrence or an infection at their hernia site. Physician-abstracted data from the medical chart were compared with patient response. Chi-square tests were used to assess significance. RESULTS: Of 487 (43.3%) individuals responding to the survey, 33 (6.8%) with >1 re-repair during 1998-2002 and 98 (20.5%) with a repair before the 1998-2002 period were excluded from the analysis. Although recurrence rates derived from self-reported data and data abstracted from the medical chart were similar (29.3% and 26.1%, respectively), overall concordance was low. Only 49% (n = 54) of self-reported recurrences were confirmed by data abstracted from the medical chart. In addition, 16 (8.3%) recurrences abstracted from the medical chart were not reported by the patient. Factors associated with discordance were high reported pain intensity (P = .02), poorer general health (P = .03), and poorer perceived repair results (P < .0001). CONCLUSION: Multiple recurrences and subsequent operations across the study period complicate the interpretation of both patient response and data abstracted from the medical chart when referring to a hernia repair. Further study on how best to assess treatment outcomes for recurring conditions is warranted.

Effect of mesh type and position on subsequent abdominal operations after incisional hernia repair.

BACKGROUND: The frequency of subsequent abdominal operations (SAO) and complications attributable to earlier ventral incisional hernia repair (VIHR) are unknown. We examined the effect of repair type and technique on the difficulty and complications of subsequent surgery. STUDY DESIGN: A cohort of VIHRs at 16 Veterans Affairs hospitals between 1998 and 2002 was examined for postrepair abdominal operation by chart review. The primary independent variable was type and technique of the index VIHR: suture or mesh repair stratified by mesh type and position in relation to abdominal wall musculature. Subsequent surgery characteristics including operative time, inadvertent enterotomy, mesh removal, and length of postoperative stay were determined by chart review. Regression modeling was used to adjust for potential confounding variables. RESULTS: At a median of 80 months after VIHR in 1,444 patients, 366 (25.3%) experienced SAO. Nearly two-thirds of these involved rerepair of the VIHR with or without a concomitant procedure. Mesh removal was significantly more likely in expanded polytetrafluoroethylene repairs as compared with polypropylene repairs, regardless of technique (odds ratio = 3.6; p = 0.01). On multivariable regression modeling, polypropylene underlay (p = 0.03) and inlay (p = 0.001) and absorbable/biologic mesh (p = 0.05) significantly increased operative time for SAO. Repair type, mesh type, or position had no significant effect on risk of inadvertent enterotomy during the SAO (p≥0.27). CONCLUSIONS: Subsequent abdominal operations after VIHR are common. Underlay or inlay polypropylene mesh increases SAO operative time, but there was no increased risk of intestinal injury. Earlier repair with expanded polytetrafluoroethylene did not increase operative time, but there was equivalent risk for intestinal injury and increased risk for mesh removal.

Hospital-level variability in incisional hernia repair technique affects patient outcomes.

BACKGROUND: Mesh placement during ventral incisional hernia repair has been shown to result in superior outcomes; however, significant variation persists in the adoption of this technique. We performed a multi-institutional study to understand how variation in surgical technique influences outcomes. METHODS: This study is a retrospective, facility-level analysis of incisional hernia repairs performed at 16 veteran's administration medical centers between 1997 and 2002. Operative notes and a postoperative course were physician-abstracted from the medical record. Hospital rates for the type of hernia repair, mesh placement, and recurrence were calculated. Spearman's correlation and generalized linear models were performed. RESULTS: A total of 1,612 incisional hernia repairs with a median follow-up of 66.2 months were included in the study. The mean rate of mesh implantation was 63.7% but ranged from 37.5% to 90%. The 5-year recurrence rate was 25.6% and ranged from 16.0% to 38.4%. The rate of mesh use for the incisional hernia repair at the hospital level was associated significantly with the hospital recurrence rate for all cases (R(2) = .27; P = .04) and elective cases (R(2) = .31; P = .02). For every 10% increase in the rate of mesh placement, a corresponding 3.1% decrease was noted in the recurrence rates (P = .001). The hospital rate of mesh use was not associated significantly with rates of complications or patient satisfaction. CONCLUSION: Hospitals that adopted a higher rate of mesh repair for incisional hernia repairs had lower recurrence rates. These data support that the efficacy of mesh repair previously proven in clinical trials is highly translatable to effective practice in the field. Continued studies on the attributable risk of complications to mesh placement are ongoing.

Translating preoperative smoking cessation interventions into routine clinical care of veterans: provider beliefs.

Smoking among veterans undergoing surgery is estimated to be 36%. Smoking has been linked to postoperative surgical complications including ischemia and cardiac arrhythmias, pneumonia, deep venous thrombosis, pulmonary embolism, and surgical site infection. Preoperative smoking cessation interventions, in which smokers quit at least 6 weeks prior to surgery, have been shown to be effective both in smoking cessation and reduction of postoperative complications; however, little is known about physician beliefs regarding the optimal location and the responsible provider for intervention, or whether surgery should be postponed or delayed based on smoking status. Within the routine coordination from medical to surgical care, how should cessation interventions best be implemented? To better inform the translation of preoperative best practices for smoking cessation into clinical care in VA, a survey regarding preoperative smoking cessation beliefs and practices was administered to primary care physicians, surgeons, and anesthesia providers. Chi-square tests were used to examine differences in proportions by provider type. Most providers agreed that the primary care clinic is the best location for intervention, with preoperative and surgical clinics ranked by few as the optimal location (13% and 11%, respectively); most respondents (82%) reported that they would refuse or delay surgery in some cases based on smoking status. There were no differences in either beliefs on location or delay based on provider type. Primary care providers were most likely to advise (86.7%) and assess (80.0%) while anesthesia providers were least likely (59.1% and 22.7%, respectively). Taking time to counsel and the belief that dedicated resources would improve quit rates were associated with advising patients to quit smoking, while being uncomfortable with counseling, the belief that acute health takes precedence and the belief that there is not always time to counsel were identified as barriers to assessing patients for smoking cessation intervention. Primary care providers were more optimistic (100%) that patients would quit if counseled, more often (73.3%) reported having time to counsel, and were less likely to report that acute health takes precedence. Most providers believe that smoking cessation would reduce postoperative complications, with the ideal location for the intervention being the primary care clinic, and that some surgical cases should be delayed for this intervention.

Long-term follow-up of technical outcomes for incisional hernia repair.

BACKGROUND: Incisional hernia repair (IHR) is plagued by high recurrence rates and lack of long-term outcomes data to guide repair technique. Mesh repair reduces recurrence rates but lacks standardization of technique. We investigated long-term outcomes of elective IHR, focusing on technical predictors of recurrence. STUDY DESIGN: This retrospective multicenter cohort study included elective IHR performed at 16 Veterans Affairs hospitals between 1997 and 2002. Hernia characteristics and operative details were abstracted from operative notes, and chart review was performed to identify recurrence and complications. Kaplan-Meier curves and Cox regression models were used to evaluate the effects of hernia characteristics and operative technique on recurrence. RESULTS: There were 1,346 elective IHRs, of which 22% were recurrent hernias. Repair technique was primary suture in 31%, open inlay or onlay mesh in 30%, open underlay in 30%, and laparoscopic in 9%. At median follow-up of 73.4 months, there were 383 recurrences (28.5%), 23 mesh removals (1.7%), and 7 enterocutaneous fistulas (ECF) (0.5%). On Cox regression modeling with adjustment for hernia and Veterans Affairs site characteristics, the effectiveness of mesh varied by position. Compared with suture repair, laparoscopic (hazard ratio = 0.49; 95% CI, 0.28-0.84) and open underlay mesh repair (hazard ratio = 0.72; 95% CI, 0.53-0.98) substantially reduced the recurrence risk, but onlay or inlay mesh repair did not. Mesh position did not affect mesh removal or ECF rates. CONCLUSIONS: Underlay technique, either laparoscopic or open, for mesh implantation during elective IHR substantially reduces the risk of recurrence, without increasing the risk of serious mesh infection or ECF.

Elective surgical case cancellation in the Veterans Health Administration system: identifying areas for improvement.

BACKGROUND: This study evaluated elective surgical case cancellation (CC) rates, reasons for these cancellations, and identified areas for improvement within the Veterans Health Administration (VA) system. METHODS: CC data for 2006 were collected from the scheduling software for 123 VA facilities. Surveys were distributed to 40 facilities (10 highest and 10 lowest CC rates for high- and low-volume facilities). CC reasons were standardized and piloted at 5 facilities. RESULTS: Of 329,784 cases scheduled by 9 surgical specialties, 40,988 (12.4%) were cancelled. CC reasons (9,528) were placed into 6 broad categories: patient (35%), work-up/medical condition change (28%), facility (20%), surgeon (8%), anesthesia (1%), and miscellaneous (8%). Survey results show areas for improvement at the facility level and a standardized list of 28 CC reasons was comprehensive. CONCLUSIONS: Interventions that decrease cancellations caused by patient factors, inadequate work-up, and facility factors are needed to reduce overall elective surgical case cancellations.

Prevention of post-operative leak following laparoscopic Heller myotomy.

PURPOSE: Laparoscopic Heller myotomy is the preferred treatment for achalasia. Post-operative leaks cause significant morbidity and impair functional outcome. This study assesses the efficacy of intra-operative leak testing on post-operative leak rate. METHODS: A retrospective analysis of 106 consecutive patients undergoing laparoscopic Heller myotomy by a single surgeon between November 2001 and August 2006 was undertaken. Intra-operative leak testing was performed in all patients. Variables associated with intra-operative mucosotomy were assessed by univariate analysis and logistic regression modeling. RESULTS: Intra-operative mucosotomy occurred in 25% of patients. All mucosotomies were repaired primarily and tested with methylene-blue-stained saline. Dor fundoplication was performed in 74% of the patients. There were no post-operative leaks and patients were started on diet day of surgery. Mean LOS was 1.4(+/-0.7) days. Logistic regression modeling demonstrated that prior myotomy was associated with a statistically significant increase in the rate of mucosotomy (p = 0.033), while previous botox injection (p = 0.193), pneumatic dilation (p = 0.599) or concomitant hiatal hernia (p = 0.874) were not significantly associated with mucosotomy. CONCLUSION: Laparoscopic Heller myotomy for the treatment of achalasia is a safe procedure. Intra-operative leak testing minimizes the risk of post-operative leaks and expedites post-operative management. Prior endoscopic treatment does not impair operative results.

Risk of complications from enterotomy or unplanned bowel resection during elective hernia repair.

HYPOTHESIS: Enterotomy or unplanned bowel resection (EBR) may occur during elective incisional hernia repair (IHR) and significantly affects surgical outcomes and hospital resource use. DESIGN: Retrospective review of patients undergoing IHR between January 1998 and December 2002. SETTING: Sixteen tertiary care Veterans Affairs medical centers. PATIENTS: A total of 1124 elective incisional hernia repairs identified in the National Surgical Quality Improvement Program data set. INTERVENTION: Elective IHR. MAIN OUTCOME MEASURES: Thirty-day postoperative complication rate, return to operating room, length of stay, and operative time. RESULTS: Of the 1124 elective procedures, 74.1% were primary IHR, 13.3% were recurrent prior mesh IHR, and 12.6% were recurrent prior suture. Overall, 7.3% had an EBR. The incidence of EBR was increased in patients with prior repair: 5.3% for primary repair, 5.7% for recurrent prior suture, and 20.3% for prior mesh repair (P < .001). The occurrence of EBR was associated with increased postoperative complications (31.7% vs 9.5%; P < .001), rate of reoperation within 30 days (14.6% vs 3.6%; P < .001), and development of enterocutaneous fistula (7.3% vs 0.7%; P < .001). After adjusting for procedure type, age, and American Society of Anesthesiologists class, EBR was associated with an increase in median operative time (1.7 to 3.5 hours; P < .001) and mean length of stay (4.0 to 6.0 days; P < .001). CONCLUSIONS: Enterotomy or unplanned bowel resection is more likely to complicate recurrent IHR with prior mesh. The occurrence of EBR is associated with increased postoperative complications, return to the operating room, risk of enterocutaneous fistula, length of hospitalization, and operative time.

Variation in mesh placement for ventral hernia repair: an opportunity for process improvement?

BACKGROUND: Incisional hernia repair (IHR) with mesh has been associated with decreased hernia recurrence. We analyzed variation in mesh use for IHR. METHODS: A cohort undergoing IHR from 16 Veterans' Administration (VA) Hospitals was identified. Patient-specific variables were obtained from National Surgical Quality Improvement Program (NSQIP) data. Operative variables were obtained from physician-abstracted operative notes. Univariate and multivariable logistic regression analyses were used to model mesh implantation predictors. RESULTS: A total of 1,123 IHR cases were analyzed; Mesh was implanted in 69.6% (n = 781). Regression models demonstrated repair at a high performing facility was associated with a nearly 4-fold increase in mesh utilization. Other significant predictors include repair of recurrent hernia, chronic steroid use, and multiple fascial defects. CONCLUSIONS: There is variation in the rate of mesh placement for IHR by VA facility, even after accounting for key explanatory variables. Patterns of mesh placement in IHR appear to be based on practice style.

Association of timely administration of prophylactic antibiotics for major surgical procedures and surgical site infection.

BACKGROUND: Prophylactic antibiotic (PA) administration 1 to 2 hours before surgical incision (SIP-1) is a publicly reported process measure proposed for performance pay. We performed an analysis of patients undergoing major surgical operations to determine if SIP-1 was associated with surgical site infection (SSI) rates in Department of Veterans Affairs (VA) hospitals. STUDY DESIGN: Patients with External Peer Review Program Surgical Care Improvement Project (SCIP)-1 data with matched National Surgical Quality Improvement Program data were included in the study. Patient and facility level analyses comparing SCIP-1 and SSI were performed. We adjusted for clustering effects within hospitals, validated SSI risk score, and procedure type (percentage of colon, vascular, orthopaedic) using generalized estimating equations and linear modeling. RESULTS: The study population included 9,195 elective procedures (5,981 orthopaedic, 1,966 colon, and 1,248 vascular) performed in 95 VA hospitals. Timely PA occurred in 86.4% of patients. Untimely PA was associated with a rate of SSI of 5.8%, compared with 4.6% in the timely group (odds ratio = 1.29, 95% CI 0.99, 1.67) in bivariable unadjusted analysis. Patient level risk-adjusted multivariable generalized estimating equation modeling found the SSI risk score was predictive of SSI (p < 0.001); SIP-1 was not associated with SSI. Hospital level multivariable generalized linear modeling found procedure mix (p < 0.0001), but not SIP-1 rate or facility volume, to be associated with facility SSI rate. The study had 80% power to detect a 1.75% difference for patient level SSI rates. CONCLUSIONS: Timely PA did not markedly contribute to overall patient or facility SSI rates. These data are important for the ongoing discourse on how to measure and pay for quality of surgical care.

Umbilical herniorrhapy in cirrhosis: improved outcomes with elective repair.

OBJECTIVE: This study was undertaken to examine the effect of cirrhosis on elective and emergent umbilical herniorrhapy outcomes. METHODS: Procedures were identified from the Veterans' Affairs National Surgical Quality Improvement Program at 16 hospitals. Medical records and operative reports were physician abstracted to obtain preoperative and intraoperative variables. RESULTS: Of the 1,421 cases reviewed, 127 (8.9%) had cirrhosis. Cirrhotics were more likely to undergo emergent repair (26.0% vs. 4.8%, p < 0.0001), concomitant bowel resection (8.7% vs. 0.8%, p < 0.0001), return to operating room (7.9% vs. 2.5%, p = 0.0006), and increased postoperative length of stay (4.0 vs. 2.0 days, p = 0.01). Best-fit regression models found cirrhosis was not a significant predictor of postoperative complications. Significant predictors of complications were emergent case (OR 5.4; 95% CI 3.1-9.4), diabetes (OR 2.1; 95% CI 1.2-3.8), congestive heart failure (OR 4.0; 95% CI 1.4-11.4), and chronic obstructive pulmonary disease (OR 2.0; 95% CI 1.1-3.6). Among emergent repairs, cirrhosis (OR 4.4; 95% CI 1.3-14.3) was strongly associated with postoperative complications. CONCLUSION: Elective repair in cirrhotics is associated with similar outcomes as in patients without cirrhosis. Emergent repair in cirrhotics is associated with worse outcomes. Early elective repair may improve the overall outcomes for patients with cirrhosis.