30-day Reintervention Research Articles

Prediction of thirty-day morbidity and mortality after laparoscopic sleeve gastrectomy: data from an artificial neural network.

Multiple patient factors may convey increased risk of 30-day morbidity and mortality after laparoscopic vertical sleeve gastrectomy (LVSG). Assessing the likelihood of short-term morbidity is useful for both the bariatric surgeon and patient. Artificial neural networks (ANN) are computational algorithms that use pattern recognition to predict outcomes, providing a potentially more accurate and dynamic model relative to traditional multiple regression. Using a comprehensive national database, this study aims to use an ANN to optimize the prediction of the composite endpoint of 30-day readmission, reoperation, reintervention, or mortality, after LVSG. A cohort of 101,721 LVSG patients was considered for analysis from the 2016 Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program national dataset. Select patient factors were chosen a priori as simple, pertinent and easily obtainable, and their association with the 30-day endpoint was assessed. Those factors with a significant association on both bivariate and multivariate nominal logistic regression analysis were incorporated into a back-propagation ANN with three nodes each assigned a training value of 0.333, with k-fold internal validation. Logistic regression and ANN models were compared using area under receiver-operating characteristic curves (AUROC). Upon bivariate analysis, factors associated with 30-day complications were older age (P = 0.03), non-white race, higher initial body mass index, severe hypertension, diabetes mellitus, non-independent functional status, and previous foregut/bariatric surgery (all P < 0.001). These factors remained significant upon nominal logistic regression analysis (n = 100,791, P < 0.001, r2= 0.008, AUROC = 0.572). Upon ANN analysis, the training set (80% of patients) was more accurate than logistic regression (n = 80,633, r2= 0.011, AUROC = 0.581), and it was confirmed by the validation set (n = 20,158, r2= 0.012, AUROC = 0.585). This study identifies a panel of simple and easily obtainable preoperative patient factors that may portend increased morbidity after LSG. Using an ANN model, prediction of these events can be optimized relative to standard logistic regression modeling.

Comparing Venous Reconstructions and Antimicrobial Graft Reconstructions in Mycotic Abdominal Aortic Aneurysms and Aortic Graft Infections

The perioperative mortality and morbidity rates of surgical repair of mycotic abdominal aortic aneurysms and aortic graft infections are high, and the appropriate treatment is debated. This retrospective study compared venous and antimicrobial prosthetic aortic graft reconstructions. All patients of the Northwest Clinics and St. Antonius Hospital who were treated for mycotic abdominal aortic aneurysms or aortic graft infections between January 1, 2008, and January 1, 2018, were analyzed. Exclusion criterion was treatment other than venous or antimicrobial reconstructions. Primary end points were 30-day complications and mortality rates and 3-year overall survival. Secondary end points were reintervention-free survival, persistent infection and reinfection rates, and hospital length of stay. Fifty-one patients met the inclusion criteria, of whom 32 underwent venous reconstructions and 19 antimicrobial prosthetic aortic graft reconstructions. Baseline characteristics did not differ significantly between these groups, except for duration of surgical repair, which was longer in the venous group. The 30-day and 1-year mortality rates, reinfection rates, complication rates, and hospital length of stay did not significantly differ between the groups. The 3-year overall survival was 77% for venous reconstruction compared with 66% for antimicrobial reconstruction (P=0.781). The 30-day reintervention rate was 19% for the venous group compared with 42% for the prosthetic group (P=0.071). Reintervention-free survival at 3years was 46% for the venous group compared with 52% for the prosthetic group (P=0.615). Venous reconstruction tends to have better 3-year overall survival and lower 30-day reintervention rates compared with antimicrobial prosthetic graft reconstruction in patients with mycotic abdominal aortic aneurysms or abdominal aortic graft infections. In the acute setting, antimicrobial prosthetic graft reconstruction is a valuable solution due to the shorter operation time and similar 30-day mortality and complication rates.

Endosonography-Guided Gallbladder Drainage versus Percutaneous Cholecystostomy in Patients Suffering from Acute Cholecystitis That Are Unsuitable for Surgery. A Randomized Controlled Trial (DRAC)

Background: The optimal management of acute cholecystitis in patients at very high-risk for cholecystectomy is uncertain. The aim of the current study was to compare EUS-guided gallbladder drainage (EUS-GBD) to percutaneous cholecystostomy (PT-GBD) as a definitive treatment in these patients under a randomized controlled trial. Methods: Consecutive patients suffering from acute calculous cholecystitis but were at very high-risk for cholecystectomy were recruited. The primary outcome was the 1-year adverse events rate. Secondary outcomes include technical and clinical success, 30-day adverse events, pain scores, unplanned readmissions, re-interventions and mortalities. Findings: Between August 2014 to February 2018, 80 patients were recruited. EUS-GBD significantly reduced 1-year adverse events [10 (25.6%) vs 31 (77.5%), P < 0.001], 30-day adverse events [5 (12.8%) vs 19 (47.5%), P = 0.001], re-interventions after 30-days [1/39 (2.6%) vs 8/40 (30%), P = 0.001], number of unplanned readmissions [6/39 (6%) vs 20/40 (50%), P = 0.002] and recurrent cholecystitis [1/39 (2.6%) vs 8/40 (20%), P = 0.029]. Post-procedural pain scores and analgesic requirements were also less (P = 0.034). The technical success (97.4% vs 100%, P = 0.494), clinical success (92.3% vs 92.5%, P = 1) and 30-day mortality (7.7% vs 10%, P = 1) were statistically similar. The predictors to recurrent acute cholecystitis were ASA grading ≥ 3 (P = 0.025) and performance of PT-GBD (P = 0.032). Interpretation: EUS-GBD improved outcomes as compared to PT-GBD in those at very high-risk of cholecystectomy. EUS-GBD should be the procedure of choice provided that the expertise is available. Clinical Registration No.: Clinicaltrials.gov identified: NCT02212717. Funding Statement: study was supported by the American Society of Gastrointestinal Endoscopy research awards. Declaration of Interests: Prof. Anthony Y.B. Teoh is also a consultant for Boston Scientific, Cook, Taewoong and Microtech Medical Corporations. Other co-authors do not have any conflicts of interest to disclose. Ethical Approval Statement: The study was conducted according to the Declaration of Helsinki and the International Conference on Harmonisation, good clinical practice guidelines (ICH-GCP). This study was approved by the Joint-CUHK-NTEC Research Ethic Committee.

Thirty-day outcomes from the Society for Vascular Surgery Vascular Quality Initiative thoracic endovascular aortic repair for type B dissection project

ObjectiveThe purpose of the Society for Vascular Surgery Vascular Quality Initiative thoracic endovascular aortic repair (TEVAR) for dissection project is to assess the effectiveness of TEVAR for type B dissection by evaluation in a prospective quality improvement registry. Here we describe the project cohort and 30-day outcomes of TEVAR for both acute dissection (AD) and chronic dissection (CD) patients and focus specifically on outcomes of uncomplicated AD patients based on timing of treatment. MethodsSummary statistics were performed comparing patients with AD (<30 days) and patients with CD. Both groups were further divided into those with complicated (ie, malperfusion or rupture) or uncomplicated presentation. Further subdivision of the uncomplicated AD patients into treatment at ≤48 hours, >48 hours to <7 days, ≥7 days to ≤14 days, and >14 days to <30 days was performed. Kaplan-Meier analysis was performed for 30-day survival and freedom from reintervention. ResultsData for 397 patients (204 AD patients and 193 CD patients) were collected from 40 institutions. Overall, AD patients were younger than CD patients (58.8 vs 62.2 years; P = .003). Technical success, including coverage of the primary entry tear, was 98.0% for AD patients and 99.0% for CD patients, with a trend toward a higher 30-day mortality in AD patients (AD, 9.3%; CD, 5.2%; P = .126). Any degree of procedure-related spinal cord ischemia occurred in 4.4% of AD patients vs 2.1% of CD patients (P = .261), with a deficit at discharge in 3.4% of AD patients vs 0.5% of CD patients (P = .068). Disabling stroke occurred in 2.5% of AD patients vs 1.6% of CD patients (P = .725); retrograde type A dissection occurred in 1.1% of AD patients vs 2.6% of CD patients (P = .412). There was a trend toward a lower freedom from reintervention in AD patients (90.7% vs 94.8%; P = .13). In uncomplicated AD patients, rapid aortic expansion was more common in the treatment groups of ≥7 days to ≤14 days and >14 days to <30 days compared with those treated within 7 days of dissection (P = .042). The uncomplicated AD cohorts based on timing of treatment were otherwise similar in demographics and presentation, with no significant differences in 30-day mortality or serious complications, such as spinal cord ischemia, stroke, or retrograde type A dissection. The 30-day reintervention rate for uncomplicated AD patients was 5.8%, with no apparent differences in reintervention rates according to timing of treatment of initial TEVAR. ConclusionsAs expected, AD patients demonstrated a trend toward a higher 30-day mortality and lower freedom from reintervention compared with CD patients. Mortality at 30 days after TEVAR for uncomplicated AD was 5.8%, and there were no clear patterns in mortality or reintervention based on timing of treatment. Further study and evaluation at longer follow-up are needed to determine the impact of timing of intervention in uncomplicated AD patients.

Heller myotomy is the optimal index procedure for esophageal achalasia in adolescents and young adults.

There is limited and conflicting data on the optimal intervention for the treatment of achalasia in adolescents and young adults (AYA), Heller myotomy (HM), esophageal dilation (ED) or botulinum toxin injection (botox). The goal of this study is to determine the most appropriate index intervention for achalasia in the AYA population. We completed a longitudinal, population-based analysis of the California (2005-2010) and New York (1999-2014) statewide databases. We included patients 9-25years old with achalasia who underwent HM, ED or botox. Comparisons were made based on the patients' index procedure. Rates of 30-day complications, long-term complications, and re-intervention up to 14years were calculated. Cox regression was performed to determine the risk of re-intervention, adjusting for patient demographics. A total of 442 AYAs were analyzed, representing the largest cohort of young patients with this disease studied to date. Median follow-up was 5.2years (IQR 1.8-8.0). The overall rate of re-intervention was 29.3%. Rates of re-intervention for ED and botox were equivalent and higher than HM (65.0% for ED, 47.4% for botox and 16.4% for HM, p < 0.001). Ultimately, 46.9% of ED and botox patients underwent HM. The overall short-term complication rate was 4.3% and long-term, 1.9%. There was no difference in the short-term and long-term complication rates between intervention groups (p > 0.05). On adjusted analysis, ED and botox were associated with increased risks of re-intervention when compared to HM (HR 5.9, HR 4.8, respectively, p < 0.01). Black patients were found to have a risk of re-intervention twice that of white patients (HR 2.0, p = 0.05). HM has a similar risk of complications but a significantly lower risk of re-intervention when compared to ED and botox. Based on our findings, we recommend HM as the optimal index procedure for AYAs with achalasia.

AA10. Safety, Feasibility, and Efficacy of the Gore Excluder Side Branch Endoprosthesis in the Treatment of Aortobi-Iliac Aneurysms With Preservation of the Internal Iliac Artery in 23 Consecutive Patients

The Gore Excluder (W. L. Gore & Associates, Flagstaff, Ariz) side branch endoprosthesis for iliac arteries (iliac branch endoprosthesis [IBE]) is a new device for the treatment of solitary or combined aortobi-iliac arterial aneurysms, mainly to prevent major complications occurring from an occluded internal iliac artery. The objective of our study was to evaluate the safety, feasibility, and efficacy of the Gore Excluder IBE in the treatment of iliac artery aneurysms. All consecutive patients who underwent iliac artery repair using the Gore Excluder IBE device in our clinic since 2016 were included. Indication, localization, operation time, blood loss, and hospitalization time as well as complication, reintervention, and patency rates were evaluated. All values are given as median (range). Statistical analysis was performed by non parametric paired tests. Between February 2016 and December 2017, there were 29 asymptomatic iliac aneurysms (4 solitary, 25 combined; 5 double sided) treated in 23 consecutive patients (age, 68 [53-82] years; body mass index, 29 [23-29] kg/m2; 1 female) using the Gore Excluder IBE. The implantation was successful in 28 of 29 cases (97%); in one case, implantation failed because of distinctive atherosclerosis of the internal iliac artery. Hospitalization time was 7 (5-15) days, operation time, 179 (80-541) minutes; and blood loss, 400 (100-3000) mL. Hemoglobin concentration was 14 (11-16) g/dL preoperatively and 12 (9-14) g/dL directly postoperatively (P = .0001). The transfusion of two (two patients) and four, respectively, red cell concentrates was necessary in three patients. Creatinine concentration was 1.02 (0.5-1.62) mg/dL preoperatively and 0.88 (0.39-1.51) mg/dL directly postoperatively (P = .07). Perioperative mortality rate and 30-day reintervention rate were 0%. Double platelet aggregation was used for 6 months postoperatively. Major complications were one cholesterol embolism and one contrast agent-induced nephropathy, not requiring dialysis. The median follow-up time was 5 months (2 weeks-1 year), with an overall patency rate of 96% of the IBEs (27/28 devices) as one patient refused the double platelet inhibitor application. The treatment of aortobi-iliac arterial aneurysms using the Gore Excluder IBE is safe and feasible and results in high short-term patency rates. To validate long-term results, long-term follow-up of the treated patients is required, ideally using duplex ultrasound and contrast-enhanced ultrasound or computed tomography angiography.

A Nationwide Safety Analysis of Discharge on the First Postoperative Day After Bariatric Surgery in Selected Patients.

Enhanced recovery after surgery has led to early recovery and shorter hospital stay after laparoscopic Roux-en-Y gastric bypass (LRYGB) and laparoscopic sleeve gastrectomy (LSG). This study aims to assess feasibility and outcomes of postoperative day (POD) 1 discharge after LRYGB and LSG from the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) 2015 dataset. Patients who underwent elective LRYGB and LSG and were discharged on POD 1 and 2 were extracted from the MBSAQIP dataset. A 1:1 propensity score matching was performed between cases with POD 1 vs POD 2 discharge, and the 30-day outcomes of the cohorts were compared. A total of 80,464 patients met the study criteria: 8862 LRYGB and 31,370 LSG cases, which were discharged on POD 1, and matched 1:1 with those discharged on POD 2. Within the LRYGB cohort, patients discharged on POD 2 had higher all-cause morbidity (7.5% vs 6.1%; p < 0.001) and 30-day re-intervention (2.0% vs 1.5%; p = 0.004) in comparison with patients discharged on POD 1. There were no statistical differences with respect to serious morbidity (0.5% vs 0.4%; p = 0.15), 30-day readmission (4.9% vs 4.5%; p = 0.2), and 30-day reoperation (1.3% vs 1.2%; p = 0.7). Within the LSG cohort, patients discharged on POD 2 had higher all-cause morbidity (4.2% vs 3.4%; p < 0.001), serious morbidity (0.4% vs 0.3%; p < 0.001), 30-day re-intervention (1.0% vs 0.6%; p < 0.001), and 30-day readmission (2.9% vs 2.5%; p = 0.002) in comparison with patients discharged on POD 1. Early discharge on POD 1 may be safe in a selective group of bariatric patients without significant comorbidities.

Impact of Physician-Owned Office-Based Laboratories on Physician Practice Patterns and Outcomes After Percutaneous Vascular Interventions for Peripheral Artery Disease

Percutaneous vascular interventions (PVIs) for peripheral artery disease have shifted from a hospital-based setting (HBS) to physician-owned office-based laboratories (OBLs). We sought to evaluate the changes of physicians’ treatment decisions and patients’ outcomes after the transition to OBLs. We identified patients with peripheral artery disease with PVI from 2006 to 2013 in a 20% Medicare sample and identified physicians who transitioned from predominantly HBS to OBLs (switch physicians) and compared them with those who performed procedures primarily in the HBS (control physicians). Patients’ outcomes included procedure type (balloon vs atherectomy vs stent), reintervention rates, major adverse limb events, hospitalizations, and mortality. We used a difference in difference model to control for time effects. The cohort comprised 290 switch physicians who treated 8011 patients (4373 before OBL and 3638 patients after the transition to OBL) and 3756 control physicians treating 53,629 patients (40,405 in the period before the transition and 13,224 in the period afterward). Patients’ demographics and indication for interventions are recorded in Table I. Switch physicians were observed to increase atherectomy use from 24% to 27% after the switch; however, the increase was larger for control physicians (20% to 30%; P < .001; Table II). Switching to OBL was independently associated with increased reintervention rates at 30 days and 1 year (P < .001), decreases in hospitalization rates at 30 days and 1 year (P < .001), and similar 30-day and 1-year mortality compared with control physicians. Differences for major adverse limb events were not statistically significant in controlling for patients’ demographics; however, the 30-day and 1-year amputation rates decreased at a greater rate after switching to OBL. Transition to OBLs was associated with lower amputation and hospitalization rates at the expense of increased 30-day and 1-year reintervention rates after PVI. Further study is warranted to evaluate the financial implications of OBLs to justify or to expand the current use.Table IPatients’ demographics and procedure indication by switch and control physiciansSwitch physicians (n = 290)Control physicians (n = 3756)P valueaPatients (n = 8011)Patients (n = 53,629)Age, years75.0 ± 9.675.23 ± 9.8***Male sex51.850.7NSCharlson Index5.8 ± 3.36.1 ± 3.4***ESRD10.612.0**Race Unknown<0.2<0.2*** White84.780.8 Black11.313.9 Other0.81.2 Asian0.60.8 Hispanic1.83.0 North American Native0.7<0.2Indication for intervention PAD + wound33.835.2NSESRD, End-stage renal disease; PAD, peripheral arterial disease.Categorical variables are presented as percentage. Continuous variables are presented as mean ± standard deviation.aNS, Not significant, P ≥ .05; *P < .05; **P < .01; ***P < .001. Open table in a new tab Table IIProcedure type and patients’ outcomes by switch and control physicians, stratified by periodSwitch physiciansControl physiciansP valueaBefore (n = 4373) vs after (n = 3638) switch, %Before (n = 40,405) vs after (n = 13,224) transition, %Type of first interventionb Balloon22.5 vs 23.2NS23.4 vs 19.0∗∗∗<.001 Stent53.2 vs 49.6∗∗56.7 vs 51.1∗∗∗.32 Atherectomy24.3 vs 27.2∗∗19.6 vs 29.9∗∗∗<.001Reintervention ratesc 30-day9.8 vs 14.9∗∗∗8.9 vs 8.8NS<.001 1- year28.8 vs 34.8∗∗∗25.3 vs 23.4∗∗<.001Atherectomy as subsequent procedurec 30-day3.7 vs 5.6 ∗∗∗2.5 vs 3.4 ∗∗∗.27 1-year10.6 vs 13.4∗∗∗8.3 vs 9.8∗∗∗.18MALEd 30-day5.7 vs 5.0NS5.7 vs 5.0∗∗.81 1-year15.6 vs 12.0∗∗∗14.6 vs 12.4∗∗∗.09Above-ankle amputationd 30-day2.5 vs 1.2%∗∗2.2 vs 2.2NS.002 1-year7.7 vs 4.6∗∗∗6.7 vs 5.6∗.001Hospitalizationd 30-day23.9 vs 18.0∗∗∗23.8 vs 22.9NS<.001 1-year61.0 vs 48.4∗∗∗58.9 vs 49.8∗∗∗.003MALE, Major adverse limb event.aDetermined by difference in difference analysis.bAdjusted for age, race, Charlson score, sex, wound.cAdjusted for procedure type.dAdjusted for reinterventions.NS, Not significant, P ≥ .05; *P < .05; **P < .01; ***P < .001. Open table in a new tab

Abdominal Aortic Aneurysm Anatomic Severity Grading Score: Identifying Anatomic Attributes That Best Predict Endovascular Aneurysm Repair Outcomes

The Society for Vascular Surgery anatomic severity grading (ASG) score is a classification system for abdominal aortic aneurysms (AAAs) stratifying candidates for endovascular aneurysm repair (EVAR). Our objective was to determine the predictive capability of total ASG score, subscores, and individual attributes for implant-related complications, endoleak, and reinterventions. Patients who underwent EVAR between 2009 and 2012 with M2S (West Lebanon, NH) three-dimensional computed tomography reconstructions were retrospectively reviewed. ASG scores were calculated from morphologic measurements by two blinded observers. Twenty-five attributes compose subscores for aortic neck, AAA, iliac arteries, and total ASG score. We identified 100 patients with mean ASG score of 18.6 ± 4.5 (range, 7.5-29). Mean AAA diameter was 54 ± 10 mm. Mean follow-up was 3.93 ± 2.5 years. Interobserver variability was determined using intraclass correlation coefficient, reflecting degree of correlation and agreement. Inter-rater agreement was good to excellent for total ASG score calculations (intraclass correlation coefficient, 0.86; 95% confidence interval, 0.70-0.92). Area under the receiver operating curve (AUROC) analysis was performed to study outcomes. Total ASG score was not a significant predictor of any outcomes. A neck subscore of ≥3 was highly predictive for type IA endoleak (AUROC, 0.82; P = .005; 95% confidence interval, 0.71-0.93) and aneurysm enlargement (AUROC, 0.71; P = .003). AAA tortuosity predicted 30-day reinterventions (AUROC, 0.84; P = .02). Iliac calcification predicted 30-day reinterventions (AUROC, 0.84; P = .021) and 30-day implant complications (AUROC, 0.8; P =. 027). The AAA and iliac subscores did not correlate with any significant outcomes. Total ASG score consists of several subscores and attributes, not all of which predict outcomes. The aortic neck subscore was predictive of type IA endoleak and sac enlargement; AAA tortuosity and iliac calcification predicted 30-day reinterventions or 30-day implant complications. This study suggests that total ASG score can be simplified to reflect attributes most predictive of EVAR outcomes.

Does the future of laparoscopic sleeve gastrectomy lie in the outpatient surgery center? A retrospective study of the safety of 3162 outpatient sleeve gastrectomies

BackgroundLaparoscopic sleeve gastrectomy (LSG) is a safe and effective procedure that can be performed as an outpatient procedure. ObjectivesThe aim of the study was to determine whether same-day discharge LSG is safe when performed in an outpatient surgery center. SettingOutpatient surgery centers. MethodsThe medical records of 3162 patients who underwent primary LSG procedure by 21 surgeons at 9 outpatient surgery centers from January 2010 through February 2018 were retrospectively reviewed. ResultsThree thousand one hundred sixty-two patients were managed with enhanced recovery after surgery protocol and were included in this analysis. The mean age and preoperative body mass index were 43.1 ± 10.8 years and 42.1 ± 7.1 kg/m2, respectively. Sleep apnea, type 2 diabetes, gastroesophageal reflux disease, hypertension, and hyperlipidemia were seen in 14.4%, 13.5%, 24.7%, 30.4%, and 17.6% patients, respectively. The mean total operative time was 56.4 ± 16.9 minutes (skin to skin). One intraoperative complication (.03%) occurred. The hospital transfer rate was .2%. The 30-day follow-up rate was 85%. The postoperative outcomes were analyzed based on the available data. The 30-day readmission, reoperation, reintervention, and emergency room visit rates were .6%, .6%, .2%, and .1%, respectively. The 30-day mortality rate was 0%. The total short-term complication rate was 2.5%. ConclusionsSame-day discharge seems to be safe when performed in an outpatient surgery center in selected patients. It would appear that outpatient surgery centers are a viable option for patients with minimal surgical risks.

Prospective study of the E-liac Stent Graft System in patients with common iliac artery aneurysms: 30-Day results.

To study the safety and feasibility of the E-liac Stent Graft System® in patients with aorto/iliac aneurysms. A prospective multicentric European registry of patients receiving the E-liac Stent Graft System® was conducted. Endpoints of the study included the technical success as well as periprocedural events and 30-day endoleaks, reinterventions, internal and external iliac artery patency and mortality. Between July 2014 and June 2016, a total of 45 patients (93% men, mean age 72 years, range 53-90 years) were enrolled at 11 sites in four European countries. Five patients received an isolated iliac treatment. Thirty-seven patients were treated with a combination of an abdominal stent graft and a unilateral E-liac and three in combination with bilateral E-liac. All E-liac Stent Grafts (48) were implanted in the intended position and the internal iliac arteries were successfully bridged. Two patients did not receive clinical success, due to endoleak type Ia of the aortic stent graft. At 30-day follow-up, clinical success rate was 96%. Three successful endovascular reinterventions were performed within the 30-day follow-up: one due to a type Ia endoleak in the common iliac artery, one due to type Ia endoleak of the aortic stent graft, and one due to bilateral lower limb claudication provoked by stent graft limb stenosis. At 30-day, a 100% survival rate and complete absence of pelvic or buttock ischemia/claudication were reported. Primary patency at 30 days was 100% for the internal iliac artery and 98% for the external iliac artery with an assisted patency of 100% in the latter. The high clinical success rate, low rates of device-related reinterventions (2%), and excellent patency rate demonstrate the safety and feasibility of the E-liac Stent Graft System. Long-term results are awaited to state efficacy and durability. Clinical Trials.gov. Identifier no. NCT02209194.

Utilisation of an operative difficulty grading scale for laparoscopic cholecystectomy

BackgroundA reliable system for grading operative difficulty of laparoscopic cholecystectomy would standardise description of findings and reporting of outcomes. The aim of this study was to validate a difficulty grading system (Nassar scale), testing its applicability and consistency in two large prospective datasets.MethodsPatient and disease-related variables and 30-day outcomes were identified in two prospective cholecystectomy databases: the multi-centre prospective cohort of 8820 patients from the recent CholeS Study and the single-surgeon series containing 4089 patients. Operative data and patient outcomes were correlated with Nassar operative difficultly scale, using Kendall’s tau for dichotomous variables, or Jonckheere–Terpstra tests for continuous variables. A ROC curve analysis was performed, to quantify the predictive accuracy of the scale for each outcome, with continuous outcomes dichotomised, prior to analysis.ResultsA higher operative difficulty grade was consistently associated with worse outcomes for the patients in both the reference and CholeS cohorts. The median length of stay increased from 0 to 4 days, and the 30-day complication rate from 7.6 to 24.4% as the difficulty grade increased from 1 to 4/5 (both p < 0.001). In the CholeS cohort, a higher difficulty grade was found to be most strongly associated with conversion to open and 30-day mortality (AUROC = 0.903, 0.822, respectively). On multivariable analysis, the Nassar operative difficultly scale was found to be a significant independent predictor of operative duration, conversion to open surgery, 30-day complications and 30-day reintervention (all p < 0.001).ConclusionWe have shown that an operative difficulty scale can standardise the description of operative findings by multiple grades of surgeons to facilitate audit, training assessment and research. It provides a tool for reporting operative findings, disease severity and technical difficulty and can be utilised in future research to reliably compare outcomes according to case mix and intra-operative difficulty.

Strategy of endovascular versus open repair for patients with clinical diagnosis of ruptured abdominal aortic aneurysm: the IMPROVE RCT.

Ruptured abdominal aortic aneurysm (AAA) is a common vascular emergency. The mortality from emergency endovascular repair may be much lower than the 40-50% reported for open surgery. To assess whether or not a strategy of endovascular repair compared with open repair reduces 30-day and mid-term mortality (including costs and cost-effectiveness) among patients with a suspected ruptured AAA. Randomised controlled trial, with computer-generated telephone randomisation of participants in a 1 : 1 ratio, using variable block size, stratified by centre and without blinding. Vascular centres in the UK (n = 29) and Canada (n = 1) between 2009 and 2013. A total of 613 eligible participants (480 men) with a ruptured aneurysm, clinically diagnosed at the trial centre. A total of 316 participants were randomised to the endovascular strategy group (immediate computerised tomography followed by endovascular repair if anatomically suitable or, if not suitable, open repair) and 297 were randomised to the open repair group (computerised tomography optional). The primary outcome measure was 30-day mortality, with 30-day reinterventions, costs and disposal as early secondary outcome measures. Later outcome measures included 1- and 3-year mortality, reinterventions, quality of life (QoL) and cost-effectiveness. The 30-day mortality was 35.4% in the endovascular strategy group and 37.4% in the open repair group [odds ratio (OR) 0.92, 95% confidence interval (CI) 0.66 to 1.28; p = 0.62, and, after adjustment for age, sex and Hardman index, OR 0.94, 95% CI 0.67 to 1.33]. The endovascular strategy appeared to be more effective in women than in men (interaction test p = 0.02). More discharges in the endovascular strategy group (94%) than in the open repair group (77%) were directly to home (p < 0.001). Average 30-day costs were similar between groups, with the mean difference in costs being -£1186 (95% CI -£2997 to £625), favouring the endovascular strategy group. After 1 year, survival and reintervention rates were similar in the two groups, QoL (at both 3 and 12 months) was higher in the endovascular strategy group and the mean cost difference was -£2329 (95% CI -£5489 to £922). At 3 years, mortality was 48% and 56% in the endovascular strategy group and open repair group, respectively (OR 0.73, 95% CI 0.53 to 1.00; p = 0.053), with a stronger benefit for the endovascular strategy in the subgroup of 502 participants in whom repair was started for a proven rupture (OR 0.62, 95% CI 0.43 to 0.89; p = 0.009), whereas aneurysm-related reintervention rates were non-significantly higher in this group. At 3 years, considering all participants, there was a mean difference of 0.174 quality-adjusted life-years (QALYs) (95% CI 0.002 to 0.353 QALYs) and, among the endovascular strategy group, a cost difference of -£2605 (95% CI -£5966 to £702), leading to 88% of estimates in the cost-effectiveness plane being in the quadrant showing the endovascular strategy to be 'dominant'. Because of the pragmatic design of this trial, 33 participants in the endovascular strategy group and 26 in the open repair group breached randomisation allocation. The endovascular strategy was not associated with a significant reduction in either 30-day mortality or cost but was associated with faster participant recovery. By 3 years, the endovascular strategy showed a survival and QALY gain and was highly likely to be cost-effective. Future research could include improving resuscitation for older persons with circulatory collapse, the impact of local anaesthesia and emergency consent procedures. Current Controlled Trials ISRCTN48334791 and NCT00746122. This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 31. See the NIHR Journals Library website for further project information.

Older Age Confers a Higher Risk of 30-Day Morbidity and Mortality Following Laparoscopic Bariatric Surgery: an Analysis of the Metabolic and Bariatric Surgery Quality Improvement Program.

There is a paucity of literature describing the association of age with the risk of adverse events following bariatric surgery. The purpose of this study is to investigate the association of age with 30-day morbidity and mortality following laparoscopic bariatric surgery using the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) database. All adult patients undergoing laparoscopic Roux-en-Y gastric bypass (RNGYB) or sleeve gastrectomy (SG) were identified within the MBSAQIP database. Patients were divided into five equal age quintiles. Binary outcomes of interest, including cardiac, pulmonary, wound, septic, clotting, and renal events, in addition to the incidence of related 30-day unplanned reintervention, related 30-day mortality, and a composite morbidity and mortality outcome were compared across the age quintiles and procedures. A total of 266,544 patients met inclusion criteria. Older age was associated with an increased risk of all morbidity outcomes except venous thromboembolism events, 30-day mortality, and the composite morbidity and mortality outcome. Patients who underwent Roux-en-Y gastric bypass had worse outcomes per quintile for almost every outcome of interest when compared to patients who underwent sleeve gastrectomy. Older patients and patients who undergo Roux-en-Y gastric bypass are at an increased risk of perioperative morbidity and mortality following laparoscopic bariatric surgery. Additional studies are needed to determine the association of age with long-term weight loss and cardiometabolic comorbidity resolution following bariatric surgery in order to determine if the increased perioperative risk is offset by improved long-term outcomes in older patients undergoing bariatric surgery.

Treatment outcomes in diabetic patients with chronic limb-threatening ischemia

ObjectiveThere are conflicting reports about outcomes after infrainguinal bypass for chronic limb-threatening ischemia (CLTI) in patients with diabetes. We compared perioperative outcomes between patients with and patients without diabetes in the current era. MethodsThe National Surgical Quality Improvement Program vascular module, 2011 to 2014, was used to identify patients undergoing infrainguinal revascularization for CLTI. Patients with and without diabetes were compared in terms of presentation, comorbidities, operative approach, and 30-day outcomes. Major adverse limb events (MALEs) included 30-day major reintervention or amputation, and major adverse cardiovascular events (MACEs) included 30-day myocardial infarction, cardiac arrest, stroke, or death. Multivariable logistic regression was used to adjust for baseline differences. ResultsWe identified 8887 patients undergoing open (5744; 50% diabetic) or endovascular (3143; 62% diabetic) treatment for CLTI. Patients with diabetes were younger and more often nonwhite, nonsmokers, and obese. Patients with diabetes presented more often with tissue loss (71% vs 47%; P < .001) and were more likely to be treated with endovascular intervention (41% vs 29%; P < .001). The 30-day mortality was similar before (open, 3.1% vs 2.8% [P = .53]; endovascular, 2.6% vs 2.1% [P = .37]) and after adjustment for baseline differences (open: odds ratio [OR], 1.1 [95% confidence interval (CI), 0.7-1.5]; endovascular: OR, 1.2 [95% CI, 0.7-2.0]). Patients with diabetes had longer lengths of stay (open, 8 vs 6 days [P < .001]; endovascular, 3 vs 2 days [P < .001]) and higher 30-day readmission rates (open, 21% vs 18% [P < .01]; endovascular, 20% vs 15% [P < .01]); however, these differences were no longer significant after adjustment for baseline differences. Patients with diabetes had a higher rate of MACEs (7.0% vs 5.1%; P < .01) and lower rate of MALEs (8.1% vs 10%; P < .01) after bypass. After adjustment, patients with diabetes still had a lower rate of MALEs (OR, 0.7; 95% CI, 0.6-0.9) but no longer had a higher rate of MACEs (OR, 1.2; 95% CI, 0.9-1.6). ConclusionsCLTI patients with diabetes undergoing revascularization have similar 30-day outcomes compared with those without diabetes, although they appear to be at lower risk for MALEs after bypass. Prolonged length of stay and readmission in patients with diabetes is not due to underlying diabetic disease but likely secondary to other baseline comorbidities, such as higher rates of tissue loss. Concern for worse perioperative outcomes in patients with diabetes after lower extremity bypass is unsubstantiated and should not discourage a physician from performing an open bypass.

Cryopreserved Homografts in Infected Infrainguinal Fields are Associated with Frequent Reinterventions and Poor Amputation Free Survival

Background Single-length saphenous vein continues to be the conduit of choice in infected-field critical limb ischemia. However, half of these individuals have inadequate vein secondary to previous use or chronic venous disease. We reviewed our outcomes of infected-field infrainguinal bypasses performed with cryopreserved homografts (CHs), a widely accepted alternative to autogenous vein in this setting. Methods This is a retrospective, institutional descriptive analysis of infected-field infrainguinal revascularizations between 2012 and 2015. Results Twenty-four operations were performed in the same number of patients for limb ischemia with signs of active infection. The mean age of the cohort examined was 62.5 ± 14.4 (standard deviation) years. Mean Society of Vascular Surgery risk score was 3.9 with a baseline Rutherford's chronic ischemia score of 4.3 at presentation. Emergent procedures constituted 29% of cases, and the remainder cases were urgent procedures. The CH bypass captured was a reoperative procedure in all but one of the patients. Culture positivity was present in 75% of cases with Staphylococcus aureus (29%), the most commonly isolated organism. Thirty-day mortality and major adverse cardiovascular events were both 4%. Amputation-free survival (AFS) was 75% at 30 days. Similarly, 30-day reintervention was 38% with debridement (43%) and bleeding (29%), the most common indications. Average duration of follow-up was 27.9 ± 20.4 months (range: 0.5–60.4). Mean length of stay was 14.8 days. Reinfection requiring an additional procedure or antibiotic regimen separate from the index antibiotic course was 13%. Primary patency and AFS at 1 year was 50% and 58%, respectively. Primary patency and AFS at 2 years was 38% and 52%, respectively. Limb salvage at 1 and 2 years was 70% and 65%, respectively. Fifteen patients (63%) required reintervention during the follow-up period with 40% of those subjects undergoing multiple procedures. Conclusions CHs remain a marginal salvage conduit in the setting of infection and no autogenous choices. Therefore, clinicians should individualize usage of this high-cost product in highly selected patients only.

Perioperative Outcomes are Adversely Affected by Poor Pretransfer Adherence to Acute Limb Ischemia Practice Guidelines

The accepted treatment for acute limb ischemia (ALI) is immediate systemic anticoagulation and timely reperfusion to restore blood flow. In this study, we describe the retrospective assessment of pretransfer management decisions by referring hospitals to an academic tertiary care facility and its impact on perioperative adverse events. A retrospective analysis of ALI patients transferred to us via our Level I Vascular Emergency Program from 2010 to 2013 was performed. Patient demographics, comorbidities, Rutherford ischemia classification, time to anticoagulation, and time to reperfusion were tabulated and analyzed for correlation to incidence of major adverse limb events (MALEs), mortality, and bypass patency in the perioperative period (30-day postoperative). All intervals were calculated from the onset of symptoms and categorized into 3 subcohorts (<6hr, 6-48hr, and >48hr). Eighty-seven patients with an average age of 64.0 (±16.2) years presented to outlying hospitals and were transferred to us with lower extremity ALI. The mean delay from symptom onset to initial referring physician evaluation was 18.3hr. At that time of evaluation, 53.8% had Rutherford class IIA ischemia and 36.3% had class IIB ischemia. Seventy-six patients (87.4%) were started on heparin previous to transfer. However, only 44 patients (57.9%) reached therapeutic levels as measured by activated partial thromboplastin time before definitive revascularization. A delay of anticoagulation initiation >48hr from symptom onset was associated with increased 30-day reintervention rates compared with the <6hr group (66.7% vs. 23.5%; P<0.05). However, time to reperfusion had no statistically significant impact on MALE, 30-day mortality, or 30-day interventional patency in our small cohorts. Additionally, patients with a previous revascularization had a higher 30-day reintervention rate (46.5%; P<0.05). The practice of timely therapeutic anticoagulation of patients referred for ALI from community facilities occurs less frequently than expected and is associated with an increased perioperative reintervention rate.

Cryopreserved Homografts in Infected Infrainguinal Fields Are Associated with Frequent Reinterventions and Poor Amputation-Free Survival

Single-length saphenous vein continues to be the conduit of choice in infected-field critical limb ischemia. However, half of these individuals have inadequate vein secondary to previous use or chronic venous disease. We reviewed our outcomes of infected-field infrainguinal bypasses performed with cryopreserved homografts (CHs), a widely accepted alternative to autogenous vein in this setting. This is a retrospective, institutional descriptive analysis of infected-field infrainguinal revascularizations between 2012 and2015. Twenty-four operations were performed in the same number of patients for limb ischemia with signs of active infection. The mean age of the cohort examined was 62.5±14.4 (standard deviation) years. Mean Society of Vascular Surgery risk score was 3.9 with a baseline Rutherford's chronic ischemia score of 4.3 at presentation. Emergent procedures constituted 29% of cases, and the remainder cases were urgent procedures. The CH bypass captured was a reoperative procedure in all but one of the patients. Culture positivity was present in 75% of cases with Staphylococcus aureus (29%), the most commonly isolated organism. Thirty-day mortality and major adverse cardiovascular events were both 4%. Amputation-free survival (AFS) was 75% at 30 days. Similarly, 30-day reintervention was 38% with debridement (43%) and bleeding (29%), the most common indications. Average duration of follow-up was 27.9±20.4months (range: 0.5-60.4). Mean length of stay was 14.8days. Reinfection requiring an additional procedure or antibiotic regimen separate from the index antibiotic course was 13%. Primary patency and AFS at 1 year was 50% and 58%, respectively. Primary patency and AFS at 2 years was 38% and 52%, respectively. Limb salvage at 1 and 2 years was 70% and 65%, respectively. Fifteen patients (63%) required reintervention during the follow-up period with 40% of those subjects undergoing multiple procedures. CHs remain a marginal salvage conduit in the setting of infection and no autogenous choices. Therefore, clinicians should individualize usage of this high-cost product in highly selected patients only.

Invited commentary

This study is a retrospective analysis of the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) vascular module database. The authors compared the 30-day reintervention and mortality rates after endovascular aneurysm repair (EVAR) and open repair for 5877 abdominal aortic aneurysms (AAAs). Surprisingly, the 30-day reintervention rate was higher after open repair than after EVAR. Also, reintervention was associated with a 12 times higher mortality after either procedure. There have been a number of large-scale randomized controlled trials comparing open repair vs EVAR, but most are outdated and have not investigated the 30-day reintervention rate and its impact on mortality; therefore, this study provides valuable and updated information. In this study, even though the authors have selected only infrarenal AAA and have not included juxtarenal and pararenal AAAs, and although the open group patients were younger than the EVAR group, it is likely that the open group consisted of AAAs including those with shorter proximal neck, concomitant aortoiliac occlusive disease, shaggy aorta, and angulated anatomy, all of which make EVAR difficult. Because of this selection bias, it is likely that the open group consisted of more difficult AAAs, and this probably affected the poor outcome in the open group. Having said that, and despite these shortcomings, I believe that this study is bright news for EVAR technology, for which confidence had somewhat been lost following publication of the long-term results of the EVAR 1 trial.1Patel R. Sweeting M.J. Powell J.T. Greenhalgh R.M. EVAR trial investigatorsEndovascular versus open repair of abdominal aortic aneurysm in 15-years' follow-up of the UK endovascular aneurysm repair trial 1 (EVAR trial 1): a randomized controlled trial.Lancet. 2016; 388: 2366-2374Abstract Full Text Full Text PDF PubMed Scopus (600) Google Scholar The current study confirms that with modern devices and improved techniques, EVAR can be performed with extremely low mortality, open conversion, and early reintervention rate. On the contrary, this study showed an alarmingly high reoperation rate after open repair, even considering the aforementioned selection bias. This may be due to deterioration of open AAA repair training and performance, something that we have been concerned about since EVAR became the first-line treatment and the number of open repairs decreased dramatically. This alarming finding has been confirmed in a recent international study, and this observation appears to be real.2Budtz-Lilly J. Venermo M. Debus S. Behrendt C.A. Altreuther M. Beiles B. et al.Assessment of international outcomes of intact abdominal aortic aneurysm repair over 9 years.Eur J Vasc Endovasc Surg. 2017; 54: 13-20Abstract Full Text Full Text PDF PubMed Scopus (86) Google Scholar The study also showed that reoperation was higher in patients who underwent open repair, those who had larger AAAs, and those with hypertension and chronic kidney disease. These data should be considered to further improve the care of AAAs, which is exactly the goal of the NSQIP program. In summary, although this study is retrospective and nonrandomized and suffers from selection bias, it represents modern AAA practice in the United States and shows progressively improving EVAR outcome and, on the contrary, dwindling and deteriorating open repair, something that the vascular surgeons need to take seriously. I would like to thank the NSQIP program and the authors for providing us valuable information that has pointed out what we need to do to improve the overall care of AAAs. The opinions or views expressed in this commentary are those of the authors and do not necessarily reflect the opinions or recommendations of the Journal of Vascular Surgery or the Society for Vascular Surgery. Early reintervention after open and endovascular abdominal aortic aneurysm repair is associated with high mortalityJournal of Vascular SurgeryVol. 67Issue 2PreviewAlthough reinterventions are generally considered more common after endovascular aneurysm repair (EVAR) than after open surgical repair (OSR), less is known about reintervention in the early postoperative period. Furthermore, there are few data regarding the impact of early reintervention on 30-day mortality. We sought to evaluate the rates and types of reintervention after abdominal aortic aneurysm (AAA) repair and the impact of reintervention on postoperative mortality. Full-Text PDF Open Archive

Aortic Bifurcation Morphology Alone is Not Able to Predict Outcome in Patients Submitted to Elective Endovascular Abdominal Aortic Aneurysm Repair.

The aim of the present study was to evaluate the impact of the aortic bifurcation (AB) morphological characteristics, analyzed on computed tomography angiography (CTA), on outcomes of patients with abdominal aortic aneurysms (AAAs), treated by endovascular aneurysm repair (EVAR) in a single-center experience. A retrospective analysis was conducted using a prospectively collected database. Morphological features considered as potentially impacting outcomes were maximum AB diameter (ABmax), minimum diameter (ABmin), mean diameter (ABaverage), AB area (ABarea), and AB calcification (ABcalcification) and thrombosis (ABthrombosis). Outcome measures were perioperative, 30-day, and midterm AAA-related reinterventions and all-cause mortalities. Investigators reviewed 306 preoperative CTA scans. Maximum aortic diameter was 51.4±12.4mm (range 40-110), and mean ABmax was 24.2±8.8mm (range 10-60), ABmin 17.0±5.4mm (range 4-40), ABaverage 20.6±6.5mm (range 9-47.5), and ABarea 35.2±24.2mm2 (range 6-176). ABcalcification ≥50% was present in 63 patients (20.6%), and ABthrombosis ≥50% in 102 patients (33.3%). Technical success was obtained in all cases, without perioperative reintervention or death. At 30-day follow-up, the reintervention rate was 3.3%, and mortality rate was 1.3%. At a mean follow-up period of 35±28.6 (range, 1-72) months, reintervention and mortality rates were 6.5 and 4.9%, respectively. None of the analyzed thresholds were predictive of adverse outcomes. At multivariate analysis, association of a narrowed AB with severe calcification of the distal aorta showed a significant differences in terms of reinterventions (p=0.009). Our limited experience seems to reveal that a cutoff of ≤20mm for AB diameter, as in current guidelines, is ineffective in predicting outcomes after EVAR.