Utility of gastrostomy tube placement at the time of pancreaticoduodenectomy.

PURPOSE: The aim of this study is to investigate the utility of gastrostomy tube (G-tube) placement in reducing delayed gastric emptying (DGE) among patients undergoing pancreaticoduodenectomy (PD). METHODS: We retrospectively reviewed consecutive patients undergoing PD from 2015 to 2020 at our institution. Thirty-day patient outcomes including DGE, length of stay (LOS), reoperation rates, and morbidity were analyzed in patients with or without G-tube placement. RESULTS: 128 patients with resectable pancreatic head cancer (54 females, median age 68.50 [59.00-74.00]) underwent PD (66 had G-tube placement and 62 did not). There was no significant difference in the incidence of DGE (n = 17 vs. n = 17, p = 0.612), and LOS between the groups. Postoperative ileus (p = 0.007) was significantly lower while atrial fibrillation (p = 0.037) was higher among the G-tube group. Gastrostomy-related complications (p = 0.001) developed in ten patients: skin-related complications (n = 6), tube dislodgement (n = 3) and clogging (n = 1). Nine patients required reoperation during index admission (n = 4 vs. n = 5, p = 1.000). There was no difference in 30-day readmissions (n = 7 vs. n = 5, p = 0.471) and no difference in 30 or 90-day mortality. CONCLUSION: Gastrostomy tube placement during index PD did not affect the incidence of DGE. However, patients experienced significant morbidities due to G-tube-related complications. Placement of gastrostomy tubes at the index PD offers no clinical benefits.

Does Fixation of the Gastric Conduit Reduce the Incidence of Gastric Volvulus After Esophagectomy?

BACKGROUND: Acute volvulus of the gastric conduit is a rare complication after esophagectomy that warrants surgical intervention and is associated with increased morbidity and mortality. The aim of the study is to evaluate whether fixation of the gastric conduit would reduce the incidence of postoperative volvulus following esophagectomy. METHODS: This single-center retrospective analysis of patients who underwent esophagectomy was conducted to determine the incidence of acute postoperative volvulus following a change in practice. All patients who underwent an esophagectomy from September 2013 to November 2022 were included. We compared postoperative outcomes of gastric conduit volvulus, reoperations, morbidity, and mortality among those who had fixation versus non-fixation of the conduit to the right pleural edge. RESULTS: Two hundred and forty-two consecutive patients underwent minimally invasive esophagectomy (81% male, 41% were < 67 years old). The first 121 (50%) patients did not undergo fixation of the gastric conduit, while the subsequent 121 (50%) patients did undergo fixation. Comparing both groups, there were no significant differences in major complications, anastomotic leak, and 30-day and 90-day all-cause mortality. Four (2%) patients developed gastric conduit volvulus in the non-fixation group, requiring reoperative intervention. Following implementation of fixation, no patient experienced gastric volvulus. CONCLUSION: Acute volvulus of the gastric conduit is a rare complication after esophagectomy. Early diagnosis and surgical intervention are critical. In this study, although not statistically significant, fixation of the gastric conduit did reduce the number of patients who experienced postoperative volvulus. Additional future studies are needed to validate this technique and the prevention of postoperative acute gastric conduit volvulus among a diverse patient population.

Association of Medicaid expansion with 2-year survival and time to treatment initiation in gastrointestinal cancer patients: A National Cancer Database study.

INTRODUCTION: We evaluated whether Medicaid expansion (ME) was associated with improved 2-year survival and time to treatment initiation (TTI) among patients with gastrointestinal (GI) cancer. METHODS: GI cancer patients diagnosed 40-64 years were queried from the National Cancer Database. Those diagnosed from 2010 to 2012 were considered pre-expansion; those diagnosed from 2014 to 2016 were considered post-expansion. Cox models estimated hazard ratios and 95% confidence intervals (CIs) for 2-year overall survival. Generalized estimating equations (GEE) estimated odds ratios (OR) and 95% CI of TTI within 30- and 90 days. Multivariable Difference-in-Difference models were used to compare expansion/nonexpansion cohorts pre-/post-expansion, adjusting for patient, clinical, and hospital factors. RESULTS: 377,063 patients were included. No significant difference in 2-year survival was demonstrated across ME and non-ME states overall or in site-based subgroup analysis. In stage-based subgroup analysis, 2-year survival significantly improved among stage II cancer, with an 8% decreased hazard of death at 2 years (0.92; 0.87-0.97). Those with stage IV had a 4% increased hazard of death at 2 years (1.04; 1.01-1.07). Multivariable GEE models showed increased TTI within 30 days (1.12; 1.09-1.16) and 90 days (1.22; 1.17-1.27). Site-based subgroup analyses indicated increased likelihood of TTI within 30 and 90 days among colon, liver, pancreas, rectum, and stomach cancers, by 30 days for small intestinal cancer, and by 90 days for esophageal cancer. In subgroup analyses, all stages experienced improved odds of TTI within 30 and 90 days. CONCLUSION: ME was not associated with significant improvement in 2-year survival for those with GI cancer. Although TTI increased after ME for both cohorts, the 30- and 90-day odds of TTI was higher for those from ME compared with non-ME states. Our findings add to growing evidence of associations with ME for those diagnosed with GI cancer.

A Comparison of Whipple Outcomes Between a Safety-Net Hospital and American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) in African Americans.

Purpose The aim of this study was to compare 30-day adverse events following pancreaticoduodenectomy between our safety-net hospital and the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) in a matched cohort of Black/African American (AA) patients. Methods We retrospectively reviewed consecutive Black/AA patients undergoing pancreaticoduodenectomies from 2015 to 2020 at our safety-net institution. The corresponding patients from the ACS-NSQIP (2015-2019) were queried. Propensity-score matching was performed between safety-net and ACS-NSQIP Black/AA cohorts to equate baseline characteristics, and 30-day outcomes were compared between propensity-matched cohorts. Results Thirty-two Black/AAs (16 females; 62.1±10.7 years) were identified from 128 patients undergoing pancreaticoduodenectomies at our safety-net institution and were propensity-score matched to 32 ACS-NSQIP patients. After matching, baseline characteristics did not significantly differ between cohorts. Postoperatively, surgical site infections, wound disruptions, respiratory events, cardiovascular events, urinary tract infections, acute renal failure, sepsis, delayed gastric emptying, and pancreatic fistulas were not significantly different between our safety-net and ACS-NSQIP cohorts. Our length of stay (LOS) was longer (17.0(12.3-27.0) versus 10.0(7.0-16.0) days); however, patients with a LOS>30 days were comparable. Furthermore, 30-day readmissions were similar, and 30-day reoperations were lower (p=0.03) at our safety-net institution. Conclusions Black/AA patients who underwent pancreatectomies at a safety-net hospital had similar outcomes and fewer reoperations compared to a corresponding national cohort. Although we illustrate comparable outcomes, clinical pathways to mitigate and alleviate health disparities in marginalized populations at a safety-net hospital should be emphasized to continue improving outcomes.

A Comparison of Clinical and Cost Outcomes After Pancreatectomies at a Safety-net Hospital using a National Registry.

BACKGROUND: Our institution (UFHJ) meets the criteria of both a large, specialized medical center (LSCMC) and a safety-net hospital (AEH). Our aim is to compare pancreatectomy outcomes at UFHJ against other LSCMCs, AEHs, and against institutions that meet criteria for both LSCMC and AEH. In addition, we sought to evaluate differences between LSCMCs and AEHs. MATERIALS AND METHODS: Pancreatectomies for pancreatic cancer were queried from the Vizient Clinical Data Base (2018 to 2020). Clinical and cost outcomes were compared between UFHJ and LSCMCs, AEHs, and a combined group, respectively. Indices >1 indicated the observed value was greater than the expected national benchmark value. RESULTS: The mean number of pancreatectomy cases performed per institution in the LSCMC group was 12.15, 11.73, and 14.31 in 2018, 2019, and 2020, respectively. At AEHs, 25.33, 24.56, and 26.37 mean cases per institution per year, respectively. In the combined group of both LSCMCs and AEHs, 8.10, 7.60, and 7.22 mean cases, respectively. At UFHJ, 17, 34, and 39 cases were performed each year, respectively. Length of stay index decreased below national benchmarks at UFHJ (1.08 to 0.82), LSCMCs (0.91 to 0.85), and AEHs (0.94 to 0.93), with an increasing case mix index at UFHJ (3.33 to 4.20) from 2018 to 2020. In contrast, length of stay index increased in the combined group (1.14 to 1.18) and overall was the lowest at LSCMCs (0.89). Mortality index declined at UFHJ (5.07 to 0.00) below national benchmarks compared with LSCMCs (1.23 to 1.29), AEHs (1.19 to 1.45), and the combined group (1.92 to 1.99), and was significantly different between all groups ( P <0.001). Thirty-day re-admissions were lower at UFHJ (6.25% to 10.26%) compared with LSCMCs (17.62% to 16.83%) and AEHs (18.93% to 15.51%), and significantly lower at AEHs compared with LSCMCs ( P <0.001). Notably, 30-day re-admissions were lower at AEHs compared with LSCMCs ( P <0.001) and declined over time and were the lowest in the combined group in 2020 (17.72% to 9.52%). Direct cost index at UFHJ declined (1.00 to 0.67) below the benchmark compared with LSCMCs (0.90 to 0.93), AEHs (1.02 to 1.04), and the combined group (1.02 to 1.10). When comparing LSCMCs and AEHs, there were no significant differences between direct cost percentages ( P =0.56); however, the direct cost index was significantly lower at LSCMCs. CONCLUSION: Pancreatectomy outcomes at our institution have improved over time exceeding national benchmarks and often were significant to LSCMCs, AEHs, and a combined comparator group. In addition, AEHs were able to maintain good quality care when compared with LSCMCs. This study highlights the role that safety-net hospitals can provide high-quality care to a medically vulnerable patient population in the presence of high-case volume.

Impact of Medicaid Expansion on Stage at Diagnosis for US Adults with Pancreatic Cancer: a Population-Based Study.

INTRODUCTION: We evaluated whether Medicaid expansion is associated with earlier stage at diagnosis for pancreatic cancer taking into account key demographic, clinical, and geographic factors. METHODS: We obtained Surveillance, Epidemiology, and End-Results (SEER-18) data on individuals diagnosed with pancreatic cancer from 2007 to 2016 (< 65 years of age). We defined non-metastatic as either local or regional disease (vs. metastatic disease). To estimate the association of Medicaid expansion with pancreatic cancer stage at diagnosis, we used a difference-in-differences model, at the individual level, comparing those from early-adopting states in 2014 to non-early-adopting states. We utilized cluster-robust standard errors and explored the role of demographic factors (race, sex, insurance at diagnosis), clinical indicator (disease in the head of the pancreas), and county characteristics (Urban Influence Code, Social Deprivation Index). RESULTS: In the univariable setting, the probability of non-metastatic disease at diagnosis increased by 3.9 percentage points (ppt) for those from Medicaid expansion states post-expansion (n = 36,609). After adjustment for covariates, the ppt was attenuated to 2.7. Of particular note, we observed evidence of interactions with sex and race. The beneficial effect was less pronounced for men (increase in the probability of non-metastatic stage at diagnosis by 2.1ppt) than women (3.6ppt) and non-existent for blacks (- 3.1ppt) compared to whites (4.9ppt) and other races (4.8ppt). CONCLUSION: Medicaid expansion is associated with increased probability of non-metastatic stage at diagnosis for pancreatic cancer; however, this beneficial effect is not uniform across sex and race. This underscores the need to investigate the impact of policy and implementation strategies on pancreatic cancer survival disparities.

Impact of Medicaid Expansion on Pancreatic Cancer: An Examination of Sociodemographic Disparity in 1-Year Survival.

BACKGROUND: This study examined the effect of Medicaid expansion on 1-year survival of pancreatic cancer for nonelderly adults. We further evaluated whether sociodemographic and county characteristics alter the association of Medicaid expansion and 1-year survival. STUDY DESIGN: We obtained data from the Surveillance Epidemiology and End-Results dataset on individuals diagnosed with pancreatic cancer from 2007 to 2015. A Difference-in-Differences model compared those from early-adopting states to non-early-adopting states, before and after adoption (2014), while taking into consideration sociodemographic and county characteristics to estimate the effect of Medicaid expansion on 1-year survival. RESULTS: In the univariable Difference-in-Differences model, the probability of 1-year survival for pancreatic cancer increased by 4.8 percentage points (ppt) for those from Medicaid expansion states postexpansion (n = 35,347). After adjustment for covariates, the probability of 1-year survival was reduced to 0.8 ppt. Interestingly, after multivariable adjustment the effect of living in an expansion state on 1-year survival was similar for men and women (0.6 ppt for men vs 1.2 ppt for women), was also similar for Whites (2.6 ppt), and was higher in those of other races (5.9 ppt) but decreased for Blacks (-2.0 ppt). Those who were insured (-0.1 ppt) or uninsured (-2.2 ppt) experienced a decrease in the probability of 1-year survival; however, those who were covered by Medicaid at diagnosis experienced an increase in the probability of 1-year survival (7.4 ppt). CONCLUSIONS: Medicaid expansion during or after 2014 is associated with an increase in the probability of 1-year survival for pancreatic cancer; however, this effect is attenuated after adjustment for sociodemographic characteristics. Of note, the positive association was more pronounced in certain categories of key covariates suggesting further inquiry focused on these subgroups.

Long-term survival outcomes of esophageal cancer after minimally invasive Ivor Lewis esophagectomy.

OBJECTIVES: The aim of this study was to determine the long-term overall and disease-free survival and factors associated with overall survival in patients with esophageal cancer undergoing a totally minimally invasive Ivor Lewis esophagectomy (MILE) at a safety-net hospital. METHODS: This was a single-center retrospective review of consecutive patients who underwent MILE from September 2013 to November 2017. Overall and disease-free survival were analyzed by Kaplan-Meier estimates, and hazard ratios (HR) were derived from multivariable Cox regression models. RESULTS: Ninety-six patients underwent MILE during the study period. Overall survival at 1, 3, and 5 years was 83.2%, 61.9%, and 55.9%, respectively. Disease-free survival at 1, 3, and 5 years was 83.2%, 60.6%, and 47.5%, respectively. Overall survival (p < 0.001) and disease-free survival (p < 0.001) differed across pathological stages. By multivariable analysis, increasing age (HR, 1.06; p = 0.02), decreasing Karnofsky performance status score (HR, 0.94; p = 0.002), presence of stage IV disease (HR, 5.62; p = 0.002), locoregional recurrence (HR, 2.94; p = 0.03), and distant recurrence (HR, 4.78; p < 0.001) were negatively associated with overall survival. Overall survival significantly declined within 2 years and was independently associated with stage IV disease (HR, 3.29; p = 0.04) and distant recurrence (HR, 5.78; p < 0.001). CONCLUSION: MILE offers favorable long-term overall and disease-free survival outcomes. Age, Karnofsky performance status score, stage IV, and disease recurrence are shown to be prognostic factors of overall survival. Prospective studies comparing long-term outcomes after different MIE approaches are warranted to validate survival outcomes after MILE.

Indocyanine green perfusion assessment of the gastric conduit in minimally invasive Ivor Lewis esophagectomy.

BACKGROUND: Anastomotic leak is a serious complication following esophagectomy. The aim of the study was to report our experience with indocyanine green fluorescence angiography (ICG-FA)-PINPOINT® assisted minimally invasive Ivor Lewis esophagectomy (MILE) and assess factors associated with anastomotic leak. METHODS: We reviewed consecutive patients undergoing MILE from 2013 to 2018. Intraoperative real-time assessment of gastric conduit was performed using ICG-FA with PINPOINT®. Perfusion was categorized as good perfusion (brisk ICG visualization to conduit tip) or non-perfusion (any demarcation along the conduit). RESULTS: 100 patients (81 males, median age 68 [60-72]) underwent MILE for malignancy in 96 patients and benign disease in 4 patients. There were six anastomotic leaks all managed with endoscopic stent placement. There was no intraoperative mortality and no 30-day mortality in leak patients. Patients with a leak were more likely to be overweight with BMI > 25 (100% versus 53%, p = 0.03), have pre-existing diabetes (50% versus 13%, p = 0.04), and have higher intraoperative estimated blood loss (260 mL [95-463] versus 75 mL [48-150], p = 0.03). Anastomotic leaks occurred more frequently in the non-perfusion (67%) versus the good perfusion category (33%, p = 0.03). By multivariable analysis, diabetes (odds ratio [OR] 6.42; p = 0.04) and non-perfusion (OR 6.60; p = 0.04) were independently associated with leak. CONCLUSION: Intraoperative use of ICG-FA may be a useful adjunct to assess perfusion of the gastric conduit with non-perfusion being independently associated with a leak. While perfusion plays an important role in anastomotic integrity, development of a leak is multifactorial, and ICG-FA should be used in conjunction with the optimization of patient and procedural components to minimize leak rates. Prospective, randomized studies are required to validate the interpretation, efficacy, and application of this novel technology in minimally invasive esophagectomies.

Reoperative Surgery After Minimally Invasive Ivor Lewis Esophagectomy.

OBJECTIVE: The aim of this study is to identify factors influencing reoperations following minimally invasive Ivor Lewis esophagectomy and associated mortality and hospital costs. MATERIALS AND METHODS: Between 2013 and 2018, 125 patients were retrospectively analyzed. Outcomes included reoperations, mortality, and hospital costs. Multivariable logistic regression analyses determined factors associated with reoperations. RESULTS: In-hospital reoperations (n=10) were associated with in-hospital mortality (n=3, P<0.01), higher hospital costs (P<0.01), and longer hospital stay (P<0.01). Conversely, reoperations after discharge were not associated with mortality. By multivariable analysis, baseline cardiovascular (P=0.02) and chronic kidney disease (P=0.01) were associated with reoperations. However, anastomotic leaks were not associated with reoperations nor mortality. CONCLUSION: The majority of reoperations occur within 30 days often during index hospitalization. Reoperations were associated with increased in-hospital mortality and hospital costs. Notably, anastomotic leaks did not influence reoperations nor mortality. Efforts to optimize patient baseline comorbidities should be emphasized to minimize reoperations following minimally invasive Ivor Lewis esophagectomy.

Improved Quality of Care and Efficiency Do Not Always Mean Cost Recovery After Minimally Invasive Ivor Lewis Esophagectomy.

PURPOSE: The aim of this study is to determine the financial impact of clinical complications and outcomes after minimally invasive Ivor Lewis esophagectomy (MILE) at a safety-net hospital. METHODS: This was a single-center retrospective analysis of consecutive patients undergoing MILE from 2013 to 2018. Postoperative complications were classified by Clavien-Dindo grade and associated total and direct recovered costs were assessed. Direct cost and LOS index were defined as the ratio of observed to expected values (>1 denotes above nationwide expectations). Annual outcomes were based on Medicare fiscal years. RESULTS: One hundred twenty-four patients (99 males, mean age 65.7 ± 9.3) were surgically treated for esophageal malignancy (n = 118) and benign disease (n = 6) by MILE between 2014 and 2018. Mean ICU LOS (5.8 ± 6.6 versus 4.3 ± 6.3 days) and LOS index (1.16 versus 0.76) improved from 2014 to 2018. Both direct cost index (1.03 versus 0.99) and indirect costs (43.4% versus 41.4%) decreased over time. However, direct costs recovered (213.6 to 159.0%) and total costs recovered (119.1 to 92.5%) declined during this period. Clinical complications grade was not associated with total costs recovered (p = 0.69). Extent of recovered expenditure was significantly higher from commercial/private payers as compared to government-sponsored payers (p < 0.05). CONCLUSION: Improvement in clinical outcomes and efficiency of care are not reflected by annual recovered expenditure. Furthermore, clinical complications do not correlate with the ability to recover hospital spending. Financial recovery was primary payer dependent. Enhanced collaboration with hospital administration may be needed in an effort to maximize financial fidelity in the presence of good quality of care after highly complex procedures.

Psoas muscle area and attenuation are highly predictive of complications and mortality after complex endovascular aortic repair.

OBJECTIVE: The present study evaluated the psoas muscle area and attenuation (radiodensity), quantified by computed tomography, together with clinical risk assessment, as predictors of outcomes after fenestrated and branched endovascular aortic repair (FBEVAR). METHODS: The present single-center study included 504 patients who had undergone elective FBEVAR for pararenal or thoracoabdominal aortic aneurysms. The clinical risk assessment included age, sex, comorbidities, body mass index, glomerular filtration rate, aneurysm size and extent, cardiac stress test results, ejection fraction, and American Society of Anesthesiologists (ASA) score. Preoperative computed tomography was used to measure the psoas muscle area and attenuation at the L3 level. The lean psoas muscle area (LPMA; area in cm2 multiplied by attenuation in Hounsfield units [HU]) was calculated by multiplying the area by the attenuation. The risk factors for 90-day mortality, major adverse events (MAEs), and long-term mortality were determined using multivariable analysis. MAEs included 30-day or in-hospital death, acute kidney injury, myocardial infarction, respiratory failure, paraplegia, stroke, and bowel ischemia. A novel risk stratification method was proposed according to the strongest predictors of mortality and MAEs on multivariable analysis. RESULTS: The 30-day mortality, 90-day mortality, and MAE rates were 2.0%, 5.6%, and 20%, respectively. The independent predictors of 90-day mortality were chronic obstructive pulmonary disease, chronic kidney disease, ASA score, and LPMA. The independent predictors of MAEs were aneurysm diameter, glomerular filtration rate, and LPMA. For long-term mortality, the independent predictors were chronic kidney disease, congestive heart failure, extent I-III thoracoabdominal aortic aneurysms, ASA score, and LPMA. The patients were stratified into three groups according to the ASA score and LPMA: low risk, ASA score II or LPMA >350 cm2HU (n = 290); medium risk, ASA score III and LPMA ≤350 cm2HU (n = 181); and high risk, ASA score IV and LPMA ≤350 cm2HU (n = 33). The 90-day mortality and MAE rates were 1.7% and 16% in the low-, 7.2% and 24% in the medium-, and 30% and 33% in the high-risk patients, respectively (P < .001 and P = .02, respectively). Patients with ASA score IV and LPMA <200 cm2HU, indicating sarcopenia (n = 14) had a 43% risk of death within 90 days. The 3-year survival estimates were 80% ± 3% for the low-, 70% ± 4% for the medium-, and 35% ± 9% for the high-risk patients (P < .001). The mean follow-up time was 3.1 ± 2.3 years. CONCLUSIONS: LPMA was a strong predictor of outcomes and the only independent predictor of both mortality and MAEs after FBEVAR. A high muscle mass was protective against complications, regardless of the ASA score. Risk stratification based on the ASA score and LPMA can be used to identify patients at excessively high operative risk.

Long-term symptom improvement and health-related quality of life after operative management of median arcuate ligament syndrome.

OBJECTIVE: To investigate long-term symptom improvement and health-related quality of life (HRQOL) after operative intervention for median arcuate ligament syndrome (MALS). METHODS: Clinical data of all consecutive patients treated by operative management of MALS from 1999 to 2018 were reviewed. A cross-sectional questionnaire using the Visick score, the Gastrointestinal Quality of Life Index, and Short Form (SF)-12v2 questionnaires was performed to assess long-term outcomes. The SF-12 HRQOL domains were compared between symptom-free and symptomatic patient groups and to averages for the US general population. Treatment failure was defined as no relief after surgery and Visick category 3 to 4 symptoms. Freedom from symptoms was estimated at 5 years. RESULTS: A total of 100 patients were treated for MALS (mean age, 38 ± 18 years; 75% female). Open surgical release was performed in 81 and laparoscopic release in 19 patients. The most common presenting symptom was abdominal pain in 99 patients with postprandial exacerbation in 85. There was no mortality. Major adverse events at 30 days had occurred in 21 patients (open 19, laparoscopic 2) including myocardial infarction (n = 1), pancreatitis (n = 2), respiratory failure (n = 4), estimated blood loss of more than 1 L (n = 8), and postoperative ileus (n = 8). One patient treated by laparoscopic release required conversion for an aortic injury, which was treated by primary repair and splenectomy. Forty-six patients responded to the questionnaire with a mean follow-up of 8 ± 4 years. Initial symptom resolution or improvement was reported by 38 patients (83%), whereas 8 patients (17%) reported treatment failure. Seven of the 38 patients (18%) with initial treatment success reported symptom recurrence. The estimated 5-year freedom from symptoms was 67 ± 7%. All SF-12 HRQOL domains were significantly lower and below the average population range in symptomatic patients compared with those who were symptom free, in which all domains were within the average population range. The Gastrointestinal Quality of Life Index scores were also significantly lower in symptomatic patients. Forty respondents (87%) reported that they would still undergo operative management if given the choice, including all respondents who reported symptom recurrence. CONCLUSIONS: The operative management of MALS can be performed with a low rate of complications. Approximately two-thirds of respondents were free of symptoms 5 years after the procedure. Treatment success in symptom-free patients was associated with an improved HRQOL on par with the population average compared with symptomatic patients. The vast majority of respondents would opt to have the operation again if given a choice. However, patients should be well-informed about the possibility of failure to relieve symptoms and symptom recurrence.

Outcomes of Small Renal Artery Targets in Patients Treated by Fenestrated-Branched Endovascular Aortic Repair.

OBJECTIVE: The aim was to evaluate renal related outcomes in patients who had incorporation of a small (<4.0 mm) renal artery (RA) during fenestrated-branched endovascular aortic repair (F-BEVAR). METHODS: A total of 215 consecutive patients enrolled in a prospective F-BEVAR trial were reviewed. Computed tomography angiography centreline of flow reconstruction was used to measure mean RA diameter. Patients who had at least one <4.0 mm main or accessory RA incorporated by fenestration or directional branch (study group) were compared with patients who had incorporation of two ≥5.0 mm RAs (control group). Endpoints were technical success of RA incorporation, RA rupture and kidney loss, primary and secondary RA patency, RA branch instability and re-interventions, and renal function deterioration. RESULTS: Twenty-four patients with 28 <4.0 mm RAs (16 accessory and 12 main RAs) were compared with 144 patients with 288 ≥5.0 mm incorporated RAs. Study group patients were significantly younger than controls (72 ± 8 vs. 75 ± 8 years, p = .04) and more often females (46% vs. 21%, p = .018); there were no differences in cardiovascular risk factors and aneurysm extent. Technical success was 92% for <4.0 mm and 99% for ≥5.0 mm RA incorporation (p = .05). Inadvertent RA rupture occurred in three patients in the study group (13%) and in one (1%) in the control group (p = .009) resulting in kidney loss in two study group patients (8%) and one (1%) control group patient (p = .05). At one year, primary patency was 79 ± 9% vs. 94 ± 1% (p < .001) and secondary patency was 84 ± 8% vs. 97 ± 1% (p < .001) for study vs. control group; freedom from branch instability was 79 ± 9% vs. 93 ± 2% (p = .005), respectively. There were no differences in re-intervention rates and renal function deterioration between the groups. The mean follow up time was 21 ± 14 months. CONCLUSION: Incorporation of <4.0 mm RAs during F-BEVAR is associated with lower technical success, higher risk of arterial disruption and kidney loss, and lower patency rates at one year.

Outcomes of Onyx® Embolization of Type II Endoleaks After Endovascular Repair of Abdominal Aortic Aneurysms.

BACKGROUND: Type II endoleaks (T2ELs) are common following endovascular repair of abdominal aortic aneurysms (EVAR). Embolization with ethylene vinyl alcohol copolymer (Onyx) may present an effective treatment alternative for T2ELs. Due to limited data supporting its use, we sought to analyze outcomes of Onyx embolization for T2ELs. METHODS: Retrospective review of consecutive patients treated for T2ELs utilizing Onyx embolization agent from 2009-2018. All pre- and post-Onyx intervention CT scans were analyzed for diameter and volume changes with 3D reconstruction software. The primary outcomes were change in maximum AAA diameter and volume. Secondary outcomes included additional interventions, rupture, and mortality. A subset analysis was performed with patients with isolated T2ELs (no other types of endoleaks present). RESULTS: We identified 85 patients (73 males, mean age 77.6 ± 7.6 years) who underwent 112 Onyx interventions. Average time to first Onyx intervention after index EVAR was 3.3 ± 2.6 years and average sac growth was 6.3 ± 6.7 mm. Patients underwent mean 1.3 Onyx interventions using a mean of 4.9 ± 4.7 ml for treatment. Three complications occurred (Onyx extravasation, colon ischemia, and access site hematoma). Mean follow-up was 2.5 ± 2.1 years after initial Onyx treatment. At the most recent follow-up, sac diameter stabilization was seen in 47% and reduction >5 mm was seen in 19%. Sac growth of >5 mm was seen in 34% of patients following the first Onyx intervention. In our subset of isolated T2EL, 72% had sac stabilization or reduction >5 mm. Four patients experienced a ruptured aneurysm (3 had active type 1 endoleaks). Rupture-free survival was 95% at 5 years, and overall survival was 54% at 5 years. Notably, increasing Onyx interventions were not associated with sac stabilization or reduction (OR 0.6, P = 0.1). On multivariable analysis, AAA sac diameter stabilization or reduction was independently associated with BMI >30 kg/m2 (OR 4.2, P = 0.01) and having only 1 Onyx intervention (OR 3.8, P = 0.02). CONCLUSIONS: Onyx for embolization of T2ELs resulted in AAA sac diameter stabilization or reduction in 66% of patients, and up to 72% in isolated T2ELs. Further, increasing Onyx interventions were not associated with either aneurysm sac stabilization or reduction. Given its similar outcomes to other embolization strategies in the literature, Onyx embolization for management of T2ELs needs to be judiciously considered, particularly for T2ELs persisting after an initial Onyx embolization intervention.

Outcomes of a novel upper extremity preloaded delivery system for fenestrated-branched endovascular repair of thoracoabdominal aneurysms.

OBJECTIVE: The aim of this study was to evaluate the feasibility and outcomes of endovascular repair of thoracoabdominal aortic aneurysms (TAAAs) using a novel low profile (LP) device with upper extremity preloaded guidewire system (PGS) and compare procedural metrics and outcomes with a standard multibranch stent graft (t-Branch; Cook Medical, Bloomington, Ind). METHODS: We reviewed the clinical data of 232 consecutive patients treated by fenestrated-branched endovascular aortic repair for TAAA and enrolled in a prospective nonrandomized trial between 2014 and 2017. Patients who had repair using t-Branch or patient-specific TAAA devices using upper extremity LP-PGS were included. End points were technical success, operative and fluoroscopic time, patient radiation exposure, time from arterial access to complete device deployment, total contrast volume, and 30-day rates of major adverse events (MAEs) and mortality. RESULTS: There were 54 patients, including 33 males (67%) and 21 females (33%), with a mean age of 73 ± 9 years old. Forty-nine patients (91%) had extent I-III and five patients (9%) had extent IV TAAAs. Device design was t-Branch in 24 patients (44%) and LP-PGS in 30 patients (56%). A total of 206 renal-mesenteric arteries were incorporated with no difference between groups (mean, 3.8 ± 0.6 target vessels/patient; P = .92). Patients treated by t-Branch device had larger mean aneurysm diameter (79 ± 16 vs 66 ± 10 mm; P = .0006). All patients had transbrachial approach. Technical success was achieved in all patients in both groups. Patients treated by LP-PGS devices had lower radiation dose (1250 ± 849 vs 3154 ± 2421 mGy; P = .003) and shorter operating time for complete device deployment (105 ± 42 vs 123 ± 34 minutes; P = .043). There was no difference in mean operative time (252 ± 69 vs 273 ± 56 minutes; P = .23), fluoroscopy time (82 ± 29 vs 96 ± 35 minutes; P = .08) or contrast volume (163 ± 59 vs 197 ± 75 mL; P = .07) comparing LP-PGS and t-Branch respectively. There was no 30-day or in-hospital mortality. There were no differences in MAEs, which occurred in 18 patients (33%) in both groups (P > .05). CONCLUSIONS: Endovascular TAAA repair using the standard or LP-PGS multibranch stent graft was associated with high technical success, no mortality, and a low rate of MAEs in this study. Patients treated by upper extremity LP-PGS had shorter time to complete device deployment, suggesting decreased technical demand with preloaded systems.

Outcomes of fenestrated-branched endovascular aortic repair in patients with a solitary functional kidney.

OBJECTIVE: The aim of this study was to evaluate outcomes of fenestrated-branched endovascular aortic repair (F-BEVAR) of pararenal abdominal aortic aneurysms or thoracoabdominal aortic aneurysms (TAAAs) in patients with a solitary functional kidney (SFK). METHODS: We analyzed the outcomes of 287 consecutive patients (206 male; mean age, 74 ± 8 years old) enrolled in a prospective nonrandomized study to investigate use of F-BEVAR for treatment of patients with pararenal abdominal aortic aneurysms or TAAAs between 2013 and 2018. Outcomes were analyzed in patients with solitary kidney (functional or congenital) and compared with control patients who had two functioning kidneys. Acute kidney injury (AKI) was defined using Risk, Injury, Failure, Loss of kidney function, and End-stage renal disease criteria, and renal function deterioration (RFD) was defined by a decline in estimated glomerular filtration the estimated glomerular filtration rate of more than 30% from baseline. End points included 30-day mortality and major adverse events, AKI, freedom from RFD, and patient survival. RESULTS: There where 30 patients (10%) with a SFK and 257 patients with two functioning kidneys. Patients with a SFK were younger and had significantly (P < .05) higher baseline creatinine (+0.3 mg/dL), lower estimated glomerular filtration rate (-16 mL/minute/1.73 m2) and more often had stage III to V chronic kidney disease (73% vs 43%). There were no differences in cardiovascular risk factors and aneurysm extent. Technical success was achieved in 98.9% of patients with SFK and in 99.8% of controls (P = .10). At 30 days, there was no significant differences in mortality (0% vs 1%) and major adverse events (40% vs 24%; P = .08), including rates of AKI (20% vs 12%) and new-onset dialysis (3% vs 1%) between patients with a SFK and the control group, respectively. Mean follow-up was 18 ± 15 months. At 2 years, there was no difference (P = .36) in patient survival (92 ± 5% vs 84 ± 3%) and freedom from RFD (100 ± 0% vs 84 ± 3%) for patients with SFK and controls, respectively. Presence of a SFK was not a predictor for AKI or RFD. By multivariable analysis, estimated blood loss of more than 1 L (odds ratio [OR], 2.9; P = .04) and total fluoroscopy time (OR, 1.8; P = .05) were predictors for AKI, and postoperative AKI (OR, 4.9; P < .001), renal branch occlusion/stenosis (OR, 3.1; P = .001), and Crawford extent II TAAA (OR, 2.4; P = .007) were predictors for RFD. CONCLUSIONS: Despite the worse baseline renal function, F-BEVAR is safe and effective with nearly identical outcomes in patients with a SFK as compared with patients with two functioning kidneys. Development of postoperative AKI is the most important predictor for RFD.

Outcomes of target vessel endoleaks after fenestrated-branched endovascular aortic repair.

OBJECTIVE: The objective of this study was to determine the incidence rate, outcomes, and risk factors of target vessel-related endoleaks after fenestrated-branched endovascular aortic repair (F-BEVAR) for pararenal aneurysms or thoracoabdominal aortic aneurysms (TAAAs). METHODS: We reviewed consecutive patients treated by F-BEVAR between 2007 and 2017. Target vessel endoleaks were identified by computed tomography angiography (CTA). Follow-up included CTA and duplex ultrasound before discharge, at 2 months, at 6 months, and annually thereafter. Primary endoleaks were detected by predismissal CTA; secondary endoleaks were absent on the first CTA and were identified during follow-up. End points were spontaneous resolution of primary endoleaks, secondary interventions, and aneurysm rupture. Multivariable analyses were performed for risk factors of target vessel endoleaks and predictors of spontaneous resolution. RESULTS: A total of 382 patients (mean age, 75 ± 8 years; 75% male) underwent F-BEVAR for 195 pararenal aneurysms and 187 TAAAs with 1204 renal-mesenteric arteries targeted by 981 fenestrations and 223 directional branches. Fifty-two target vessel endoleaks were identified in 41 patients; 41 were type IIIC (interattachment), 10 were type IC (distal bridging stent sealing zone), and 1 was type IIIB (bridging stent fabric tear). Thirty-three patients (9%) had primary target vessel endoleaks in 41 target vessels (3%). Eight patients (2%) developed 11 secondary target vessel endoleaks. Directional branches were more prone to primary endoleaks (13/223 [6%]) in comparison to fenestrations (28/981 [3%]; P = .03). However, branch endoleaks resolved more often spontaneously (11/14 [79%]) compared with fenestration endoleaks (14/38 [37%]; P = .008). Other risk factors for target vessel endoleaks included inner aortic diameter ≥30 mm at the target vessel origin, four or more targeted vessels, TAAA (for primary endoleaks), and physician-modified endograft (for secondary endoleaks). Four patients with primary endoleaks underwent successful reintervention before discharge, and 29 were observed with a mean follow-up of 24 ± 21 months. Of the 41 primary endoleaks, 25 resolved spontaneously in 20 patients (61%) at first follow-up with no recurrences. Of the observed endoleaks, 11 persisted in 9 patients, and 8 of those endoleaks were treated in 7 patients. All secondary target vessel endoleaks required reintervention. There was one possible aneurysm rupture attributed to persistent secondary target vessel endoleak. CONCLUSIONS: Target vessel endoleak on CTA at discharge occurs in 1 of 10 patients treated by F-BEVAR. Of these, two-thirds resolve spontaneously, especially those affecting directional branches. Among patients with a persistent endoleak, endovascular reintervention is usually successful and aneurysm rupture is rare.

Should endovascular approach be considered as the first option for thoraco-abdominal aortic aneurysms?

Open surgical repair has been the gold standard for treatment of thoracoabdominal aortic aneurysms (TAAAs). The technique of open TAAA repair has evolved from the use of "island" patch incorporation to separate branch vessel bypass, from "clamp and go" to routine use of distal perfusion, and towards more extensive repair in patients with connective tissue disorders. Open TAAA repair can be done with excellent results in highly specialized centers. However, these operations continue to carry excessive risk when performed outside large aortic centers, with 30-day mortality estimated on 20% according to statewide and national databases. In octogenarians, the mortality of elective open TAAA repair can be up to 40%. Endovascular repair was introduced as an alternative to open surgical repair in the elderly or higher risk patients using hybrid reconstruction, parallel grafts or fenestrated and branched endografts. Several large aortic centers have developed dedicated clinical programs to advance techniques of fenestrated-branched endovascular repair using patient-specific and off-the-shelf devices, offering a minimally invasive alternative to open repair allowing treatment of increasingly older and sicker TAAA patients. During the last decade, improvements in device design, patient selection, spinal cord injury protocols, and perioperative management have contributed to a continued decline in morbidity and mortality of fenestrated-branched endovascular aortic repair, challenging open surgical repair as the new "gold standard" for treatment of TAAAs. Despite the improved results, endovascular repair is a highly technical procedure that requires vast experience, involves a significant risk of complications, and also, has an impact on patients' physical quality of life. In this article, we review the current technical aspects of endovascular TAAA repair with the main focus on the evidence of open versus endovascular outcomes of TAAA repair.

Activation of the endoplasmic reticulum unfolded protein response by lipid disequilibrium without disturbed proteostasis in vivo.

The Mediator is a conserved transcriptional coregulator complex required for eukaryotic gene expression. In Caenorhabditis elegans, the Mediator subunit mdt-15 is essential for the expression of genes involved in fatty acid metabolism and ingestion-associated stress responses. mdt-15 loss of function causes defects in reproduction and mobility and shortens lifespan. In the present study, we find that worms with mutated or depleted mdt-15 (mdt-15 worms) exhibit decreased membrane phospholipid desaturation, especially in phosphatidylcholine. Accordingly, mdt-15 worms exhibit disturbed endoplasmic reticulum (ER) homeostasis, as indicated by a constitutively activated ER unfolded protein response (UPR(ER)). Activation of this stress response is only partially the consequence of reduced membrane lipid desaturation, implicating other mdt-15-regulated processes in maintaining ER homeostasis. Interestingly, mdt-15 inactivation or depletion of the lipid metabolism enzymes stearoyl-CoA-desaturases (SCD) and S-adenosyl methionine synthetase (sams-1) activates the UPR(ER) without promoting misfolded protein aggregates. Moreover, these worms exhibit wild-type sensitivity to chemically induced protein misfolding, and they do not display synthetic lethality with mutations in UPR(ER) genes, which cause protein misfolding. Therefore, the constitutively activated UPR(ER) in mdt-15, SCD, and sams-1 worms is not the consequence of proteotoxic stress but likely is the direct result of changes in ER membrane fluidity and composition. Together, our data suggest that the UPR(ER) is induced directly upon membrane disequilibrium and thus monitors altered ER homeostasis.