Validity and reliability evidence support task-specific metrics for laparoscopic fundoplication.

BACKGROUND: Laparoscopic hiatal hernia repair (LHHR) is a complex operation requiring advanced surgical training. Surgical simulation offers a potential solution for learning complex operations without the need for high surgical volume. Our goal is to develop a virtual reality (VR) simulator for LHHR; however, data supporting task-specific metrics for this procedure are lacking. The purpose of this study was to develop and assess validity and reliability evidence of task-specific metrics for the fundoplication phase of LHHR. METHODS: In phase I, structured interviews with expert foregut surgeons were conducted to develop task-specific metrics (TSM). In phase II, participants with varying levels of surgical expertise performed a laparoscopic Nissen fundoplication procedure on a porcine stomach explant. Video recordings were independently assessed by two blinded graders using global and TSM. An intraclass correlation coefficient (ICC) was used to assess interrater reliability (IRR). Performance scores were compared using a Kruskal-Wallis test. Spearman's rank correlation was used to evaluate the association between global and TSM. RESULTS: Phase I of the study consisted of 12 interviews with expert foregut surgeons. Phase II engaged 31 surgery residents, a fellow, and 6 attendings in the simulation. Phase II results showed high IRR for both global (ICC = 0.84, p < 0.001) and TSM (ICC = 0.75, p < 0.001). Significant between-group differences were detected for both global (χ2 = 24.01, p < 0.001) and TSM (χ2 = 18.4, p < 0.001). Post hoc analysis showed significant differences in performance between the three groups for both metrics (p < 0.05). There was a strong positive correlation between the global and TSM (rs = 0.86, p < 0.001). CONCLUSION: We developed task-specific metrics for LHHR and using a fundoplication model, we documented significant reliability and validity evidence. We anticipate that these LHHR task-specific metrics will be useful in our planned VR simulator.

The effect of bedside assistant technical performance on outcomes in robotic surgery.

Technical performance in surgery has been associated with patient outcomes. Robotic surgery is unique in that both a console surgeon and bedside surgeon are required. A systematic review according to PRISMA guidelines identified all pertinent literature regarding skill level of the bedside assistant with regards to patient outcomes in robotic surgery. 10 studies met inclusion criteria. In all studies, the skill level of the assistant was based on experience, either by post-graduate year of the resident or number of cases previously performed by the assistant. Five studies reported significant, shorter operative times with increasing experience of the bedside assistant. No study reported a significant difference in postoperative outcomes. The existing literature fails to show improved patient outcomes with more experienced bedside assistants in robotic surgery. Metrics should be developed to measure actual technical performance of the bedside assistant rather than using arbitrary assessments of experience in future studies.

Laparoscopic Nissen fundoplication improves disease-specific quality of life in patients with gastroesophageal reflux disease and functional gastroesophageal outflow obstruction.

INTRODUCTION: The optimal management of functional esophagogastric junction outflow obstruction (EJOO) remains controversial particularly in the setting of concomitant gastroesophageal reflux disease (GERD). There remains a paucity of data regarding the outcomes of laparoscopic Nissen fundoplication (LNF) in this patient population. We hypothesized that GERD patients with manometric findings of EJOO on preoperative manometry do not have increased rates of postoperative dysphagia compared to those with normal or hypotensive LES pressures. MATERIALS AND METHODS: This retrospective cohort study of patients undergoing LNF for GERD compared outcomes in patients with and without functional EJOO (fEJOO). The outcomes of interest included disease-specific quality of life improvement, dysphagia scores, and the need for endoscopic dilation following fundoplication. RESULTS: Two hundred and eleven patients underwent LNF for GERD and 15 (7.1%) were classified as having fEJOO. Baseline GERD-HRQL [30.0 (21.5-37) vs. 31 (21-37), p = 0.57] were similar between fEJOO and control patients, respectively. There was no difference in baseline dysphagia scores [3.5 (2-5) vs. 2.0 (1-4), p = 0.64] between the two groups. Postoperative GERD-HRQL [5.0 (2-13) vs. 4.0 (1-8), p = 0.59] scores did not differ between fEJOO and control patients at 6-week follow-up. One year after surgery, GERD-HRQL [8.0 (3-9) vs. 4.5 (2-13), p = 0.97] did not differ between groups. Dysphagia rates were similar at 6-week (p = 0.78) and 1-year follow-ups (p = 0.96). The need for dilation at 1 year following fundoplication was similar in both cohorts (13%, p = 0.96). CONCLUSION: GERD patients with functional EJOO achieved similar improvements in disease-specific quality of life without increased incidence of dysphagia postoperatively.

Impact of psychiatric disorders on patient satisfaction after Nissen Fundoplication.

BACKGROUND: Anxiety and depression have been associated with an increased perception of gastroesophageal reflux symptoms, but there is a paucity of data regarding the outcomes of laparoscopic Nissen Fundoplication (LNF) in this patient population. METHODS: We performed a retrospective cohort study including all patients undergoing LNF between 2011 and 2017. Patients were stratified by baseline usage of serotonin-modulating medication or benzodiazepines as a proxy for depression and anxiety, respectively. Outcome measures included postoperative gastroesophageal health-related quality of life (GERD-HRQL) scores and overall satisfaction rates after surgery. A p value of < 0.05 was considered statistically significant. RESULTS: The population consisted of 271 patients of which 103 patients had depression and 44 patients had anxiety. Patients with depression reported no significant difference in pre- or postoperative GERD-HRQL scores compared to patients without depression and long-term satisfaction rates after surgery were similar in both groups at 76% vs 71%, respectively (p = 0.55). Patients with anxiety reported higher baseline HRQL scores (34 vs. 29, p = 0.05). At long-term follow-up (15 months), patients with anxiety reported slightly worse HRQL scores compared to controls (7 vs. 4, p = 0.11) despite no difference in usage of anti-acid medications or need for endoscopic dilations between the two groups. Patients with anxiety were less likely to report being "satisfied" after surgery (40% vs. 71%, p = 0.01) compared to controls. CONCLUSION: Patients with anxiety have higher subjective reporting of GERD symptoms and are more likely to report being "satisfied" during long-term follow-up after LNF. Patients on medication for depression appear to have similar reporting of GERD symptoms and derive as much benefit from LNF as patients that are not. While LNF does improve the symptom burden in patients with anxiety, satisfaction is rarely achieved in long-term follow-up.

Bariatric surgery is associated with renal function improvement.

INTRODUCTION: Weight loss after bariatric surgery improves both blood pressure and glycemic control following surgery. The effect of bariatric surgery on renal function is not well characterized. In this study, we sought to quantify the change in renal function over time following surgery. METHODS: We retrospectively reviewed all patients who underwent laparoscopic Roux-en-Y gastric bypass (LRYGB) or laparoscopic sleeve gastrectomy (LSG) between 2012 and 2014 at our institution. The glomerular filtration rate (GFR, mL/min) was calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation. Body mass index (BMI, kg/m2) and percent weight loss (%WL) were calculated following the surgery. RESULTS: A total of 149 patients who underwent bariatric surgery were included in this study: LRYGB (n = 86 and LSG (n = 63). In LRYGB group, baseline BMI (kg/m2, ±SD) and GFR (mL/min, ±SD) were 48.5 ± 6.8 and 94.7 ± 23.8, respectively. In comparison, BMI and GFR were 49.1 ± 11.9 kg/m2 and 93.1 ± 28.0 mL/min in the LSG group, respectively. Over the follow-up period (19.89 ± 10.93 months), the patients who underwent LRGYB lost a larger percentage of weight as compared to those in the LSG group (29.9 ± 11.7% vs 22.3 ± 10.7%; p = <0.0001). Overall, GFR improved in both LRYGB (101.0 ± 25.8 mL/min) and LSG groups (97.9 ± 25.8 mL/min) and was not significantly different between the two groups. Of patients with a GFR < 90 mL/min prior to weight loss surgery (n = 62), 42% had improvement of their GFR to > 90 mL/min postoperatively (p < 0.001). There was no relationship between weight loss percentage and GFR improvement (p = 0.8703). CONCLUSIONS: Bariatric surgery was associated with improvement in postoperative renal function at almost two years following surgery but was not different for LRYGB versus LSG. The gain in GFR was independent of percentage of weight lost suggesting an alternate mechanism in the improvement of renal function other than weight loss alone.

Coronary angiography and failure to rescue after postoperative myocardial infarction in patients with coronary stents undergoing noncardiac surgery.

BACKGROUND: We evaluated coronary angiography use among patients with coronary stents suffering postoperative myocardial infarction (MI) and the association with mortality. METHODS: Patients with prior coronary stenting who underwent inpatient noncardiac surgery in Veterans Affairs hospitals between 2000 and 2012 and experienced postoperative MI were identified. Predictors of 30-day post-MI mortality were evaluated. RESULTS: Following 12,096 operations, 353 (2.9%) patients had postoperative MI and 58 (16.4%) died. Post-MI coronary angiography was performed in 103 (29.2%) patients. Coronary angiography was not associated with 30-day mortality (odds ratio [OR]: .70, 95% CI: .35-1.42). Instead, 30-day mortality was predicted by revised cardiac risk index ≥3 (OR 1.91, 95% CI: 1.04-3.50) and prior bare metal stent (OR 2.12, 95% CI: 1.04-4.33). CONCLUSIONS: Less than one-third of patients with coronary stents suffering postoperative MI underwent coronary angiography. Significant predictors of mortality were higher revised cardiac risk index and prior bare metal stent. These findings highlight the importance of comorbidities in predicting mortality following postoperative MI.

Pre-operative echocardiography among patients with coronary artery disease in the United States Veterans Affairs healthcare system: A retrospective cohort study.

BACKGROUND: Echocardiography is not recommended for routine pre-surgical evaluation but may have value for patients at high risk of major adverse cardiovascular events (MACE). The objective of this study was to evaluate whether pre-operative echocardiography is associated with lower risk of post-operative MACE among patients with coronary artery disease. METHODS: Using administrative and registry data, we examined associations of echocardiography within 3 months prior to surgery with postoperative MACE (myocardial infarction, revascularization, or death within 30 days) among patients with coronary artery disease undergoing elective, non-cardiac surgeries in the United States Veterans Affairs healthcare system in 2000-2012. RESULTS: Echocardiography preceded 4,378 (16.4 %) of 26,641 surgeries. MACE occurred within 30 days following 944 (3.5 %) surgeries. A 10 % higher case-mix adjusted rate of pre-operative echocardiography assessed at the hospital level was associated with a hospital-level risk of MACE that was 1.0 % (95 % confidence interval [CI] 0.1 %, 2.0 %) higher overall and 1.7 % (95 % CI 0.2 %, 3.2 %) higher among patients with recent myocardial infarction, valvular heart disease, or heart failure. At the patient level, pre-operative echocardiography was associated with an odds ratio for MACE of 1.9 (95 % CI 1.7, 2.2) overall and 1.8 (95 % CI 1.5, 2.2) among patients with recent myocardial infarction, valvular heart disease, or heart failure adjusting for MACE risk factors. CONCLUSIONS: Pre-operative echocardiography was not associated with lower risk of post-operative MACE, even in a high risk population. Future guidelines should encourage pre-operative echocardiography only in specific patients with cardiovascular disease among whom findings can be translated into effective changes in care.

Association of Coronary Stent Indication With Postoperative Outcomes Following Noncardiac Surgery.

IMPORTANCE: Current guidelines for delaying surgery after coronary stent placement are based on stent type. However, the indication for the stent may be an important risk factor for postoperative major adverse cardiac events (MACE). OBJECTIVE: To determine whether the clinical indication for a coronary stent is associated with postoperative MACE. DESIGN, SETTING, AND PARTICIPANTS: Retrospective cohort study in patients at US Veterans Affairs hospitals who had a coronary stent placed between January 1, 2000, and December 31, 2010, and underwent noncardiac surgery within the following 24 months. The association between the indication for stent and postoperative MACE rates was examined using logistic regression to control for patient and procedure factors. EXPOSURES: Three subgroups of stent indication were examined: (1) myocardial infarction (MI); (2) unstable angina; and (3) revascularization not associated with acute coronary syndrome (non-ACS). MAIN OUTCOMES AND MEASURES: Composite 30-day postoperative MACE rates including all-cause mortality, MI, or revascularization. RESULTS: Among 26 661 patients (median [IQR] age, 68 [61.0-76.0] years; 98.4% male; 88.1% white) who underwent 41 815 surgical procedures within 24 months following coronary stent placement, the stent indication was MI in 32.8% of the procedures, unstable angina in 33.8%, and non-ACS in 33.4%. Postoperative MACE rates were significantly higher in the MI group (7.5%) compared with the unstable angina (2.7%) and non-ACS (2.6%) groups (P < .001). When surgery was performed within 3 months of percutaneous coronary intervention, adjusted odds of MACE were significantly higher in the MI group compared with the non-ACS group (odds ratio [OR] = 5.25; 95% CI, 4.08-6.75). This risk decreased over time, although it remained significantly higher at 12 to 24 months from percutaneous coronary intervention (OR = 1.95; 95% CI, 1.58-2.40). The adjusted odds of MACE for the unstable angina group were similar to those for the non-ACS group when surgery was performed within 3 months (OR = 1.11; 95% CI, 0.80-1.53) or between 12 and 24 months (OR = 1.08; 95% CI, 0.86-1.37) from stent placement. Stent type was not significantly associated with MACE regardless of indication. CONCLUSIONS AND RELEVANCE: Surgery in patients with a coronary stent placed for MI was associated with increased postoperative MACE rates compared with other stent indications. The risk declined over time from PCI, and delaying surgery up to 6 months in this cohort of patients with stents may be important regardless of stent type.

Blood Transfusion and 30-Day Mortality in Patients With Coronary Artery Disease and Anemia Following Noncardiac Surgery.

IMPORTANCE: Although liberal blood transfusion thresholds have not been beneficial following noncardiac surgery, it is unclear whether higher thresholds are appropriate for patients who develop postoperative myocardial infarction (MI). OBJECTIVE: To evaluate the association between postoperative blood transfusion and mortality in patients with coronary artery disease and postoperative MI following noncardiac surgery. DESIGN, SETTING, AND PARTICIPANTS: Retrospective cohort study involving Veterans Affairs facilities from January 1, 2000, to December 31, 2012. A total of 7361 patients with coronary artery disease who underwent inpatient noncardiac surgery and had a nadir postoperative hematocrit between 20% and 30%. Patients with significant bleeding, including any preoperative blood transfusion or transfusion of greater than 4 units during the intraoperative or postoperative setting, were excluded. Mortality rates were compared using both logistic regression and propensity score matching. Patients were stratified by postoperative nadir hematocrit and the presence of postoperative MI. EXPOSURE: Initial postoperative blood transfusion. MAIN OUTCOMES AND MEASURES: The 30-day postoperative mortality rate. RESULTS: Of the 7361 patients, 2027 patients (27.5%) received at least 1 postoperative blood transfusion. Postoperative mortality occurred in 267 (3.6%), and MI occurred in 271 (3.7%). Among the 5334 patients without postoperative blood transfusion, lower nadir hematocrit was associated with an increased risk for mortality (hematocrit of 20% to <24%: 7.3%; 24% to <27%: 3.7%; and 27% to 30%: 1.6%; P < .01). In patients with postoperative MI, blood transfusion was associated with lower mortality, for those with hematocrit of 20% to 24% (odds ratio, 0.28; 95% CI, 0.13-0.64). In patients without postoperative MI, transfusion was associated with significantly higher mortality for those with hematocrit of 27% to 30% (odds ratio, 3.21; 95% CI, 1.85-5.60). CONCLUSIONS AND RELEVANCE: These findings support a restrictive postoperative transfusion strategy in patients with stable coronary artery disease following noncardiac surgery. However, interventional studies are needed to evaluate the use of a more liberal transfusion strategy in patients who develop postoperative MI.

The Incremental Risk of Coronary Stents on Postoperative Adverse Events: A Matched Cohort Study.

OBJECTIVE: To determine the incremental risk of coronary stents on adverse events in surgical patients and whether it varies over time from stent placement. BACKGROUND: Postoperative adverse cardiac events decrease as the time from stent placement increases, but the risk attributable to the stent versus the underlying cardiac disease is uncertain, as prior studies lack a control surgical population. METHODS: Data for patients with coronary stents implanted in a VA hospital from 2000 to 2010 were matched with VA Surgical Quality Improvement Program data to identify noncardiac surgery within 24 months of stent placement. Each patient with stent was matched with 2 surgical patients without stent on surgical characteristics and cardiac risk factors. Outcomes of myocardial infarction (MI), revascularization, and death within 30 days after surgery were modeled using logistic regression. Adjusted risk differences between stented and nonstented populations were compared across time after stent placement. RESULTS: Adverse cardiac events followed surgery in 531 (5.7%) of the 9391 patients with stent and 680 (3.6%) of the 18,782 patients without stent (P < 0.001). In adjusted models, 30-day postoperative MI (odds ratio = 1.90; 95% confidence interval, 1.57-2.30) and revascularization (odds ratio = 2.03; 95% confidence interval, 1.65-2.50) but not mortality (odds ratio = 0.84; 95% confidence interval, 0.69-1.02) were higher in the stented cohort. Assessing trends over the 2 years after stent placement, the incremental risk for MI decreased from 5% immediately after stent placement to 2% at 1 year and then was no longer significantly elevated. The incremental risk did not vary by stent type. CONCLUSIONS: Surgery after coronary stent placement is associated with an approximate 2% absolute risk for postoperative MI but no difference in mortality compared with nonstented matched controls.

Association Between Inpatient Surveillance and Venous Thromboembolism Rates After Hospital Discharge.

IMPORTANCE: Venous thromboembolism (VTE) surveillance practices in hospitals, but not adherence to Surgical Care Improvement Program VTE prophylaxis measures, have been reported to explain the variation in VTE rates in hospitals. OBJECTIVE: To examine the relationship between inpatient surveillance testing for VTE and postdischarge VTE rates at the hospital level to determine whether more frequent inpatient surveillance is associated with reduced occurrence of postdischarge VTEs. DESIGN, SETTING, AND PARTICIPANTS: Retrospective study of a US national cohort of Veterans Affairs (VA) patients. National VA Surgical Quality Improvement Program outcome data were linked to VA administrative data on patients undergoing inpatient surgery from 2005 to 2009 and were included in the Surgical Care Improvement Program VTE measurement population. MAIN OUTCOMES AND MEASURES: Surveillance was identified using Current Procedural Terminology codes for diagnostic VTE imaging. Relationships between hospital-level surveillance and VTE rates were assessed with Pearson correlation coefficients, and the postdischarge VTE rate was modeled using linear regression, adjusting for hospital volume, inpatient VTE rate, inpatient surveillance rate, and case mix. RESULTS: Of 25 975 patients at 79 VA facilities, 296 (1.4%) experienced a VTE during the index hospitalization, and 114 (0.4%) experienced a postdischarge VTE within 30 days after surgery. The median length of stay was 11 days for those with a positive surveillance test result and 9 days for those with a negative test result. There was a positive correlation between inpatient surveillance and inpatient VTE rates (R = 0.33, P = .003) but no significant correlation of inpatient surveillance with either postdischarge surveillance (R = 0.11, P = .29) or postdischarge VTE rates (R = 0.03, P = .76). In an adjusted regression model of the postdischarge VTE rate, only the inpatient VTE rate was significant (ß = 0.13, P = .05). CONCLUSIONS AND RELEVANCE: Hospitals with higher VTE surveillance rates have higher inpatient VTE rates but not decreased postdischarge VTE rates. However, hospitals with higher inpatient VTE rates have higher postdischarge VTE rates, which suggests that surveillance may be influenced by higher observed rates and not surveillance practices alone.

The incremental risk of noncardiac surgery on adverse cardiac events following coronary stenting.

BACKGROUND: Recent coronary stent placement and noncardiac surgery contribute to the risk of adverse cardiac events, but the relative contributions of these two factors have not been quantified. OBJECTIVES: This research was designed to determine the incremental risk of noncardiac surgery on myocardial infarction (MI) and coronary revascularization following coronary stenting. METHODS: A U.S. retrospective cohort study of patients receiving coronary stents at Veterans Affairs medical centers between 2000 and 2010 was used to match patients undergoing noncardiac surgery within 24 months of stent placement to two patients with stents not undergoing surgery. Patients were matched on stent type and cardiac risk factors present at the time of stent placement. A composite endpoint of MI and/or cardiac revascularization for the 30-day interval post-surgery was calculated. Adjusted risk differences (RD) were compared across time periods following stent implantation, using generalized estimating equations. RESULTS: We matched 20,590 surgical patients to 41,180 nonsurgical patients. During the 30-day interval following noncardiac surgery, the surgical cohort had higher rates of the composite cardiac endpoint (3.1% vs. 1.9%; RD: 1.3%; 95% confidence interval: 1.0% to 1.5%). The incremental risk of noncardiac surgery adjusted for surgical characteristics ranged from 3.5% immediately following stent implantation to 1% at 6 months, after which it remained stable out to 24 months. Factors associated with a significant reduction in risk following surgery more than 6 months post-stent included elective inpatient procedures (ΔRD: 1.8%; p = 0.01), high-risk surgery (ΔRD: 3.7%; p = 0.01), and drug-eluting stent (DES) (ΔRD: 1.3%; p = 0.01). CONCLUSIONS: The incremental risk of noncardiac surgery on adverse cardiac events among post-stent patients is highest in the initial 6 months following stent implantation and stabilizes at 1.0% after 6 months. Elective, high-risk, inpatient surgery, and patients with DES may benefit most from delay from a 6-month delay after stent placement.