Second asymptomatic carotid surgery trial (ACST-2): a randomised comparison of carotid artery stenting versus carotid endarterectomy.

BACKGROUND: Among asymptomatic patients with severe carotid artery stenosis but no recent stroke or transient cerebral ischaemia, either carotid artery stenting (CAS) or carotid endarterectomy (CEA) can restore patency and reduce long-term stroke risks. However, from recent national registry data, each option causes about 1% procedural risk of disabling stroke or death. Comparison of their long-term protective effects requires large-scale randomised evidence. METHODS: ACST-2 is an international multicentre randomised trial of CAS versus CEA among asymptomatic patients with severe stenosis thought to require intervention, interpreted with all other relevant trials. Patients were eligible if they had severe unilateral or bilateral carotid artery stenosis and both doctor and patient agreed that a carotid procedure should be undertaken, but they were substantially uncertain which one to choose. Patients were randomly allocated to CAS or CEA and followed up at 1 month and then annually, for a mean 5 years. Procedural events were those within 30 days of the intervention. Intention-to-treat analyses are provided. Analyses including procedural hazards use tabular methods. Analyses and meta-analyses of non-procedural strokes use Kaplan-Meier and log-rank methods. The trial is registered with the ISRCTN registry, ISRCTN21144362. FINDINGS: Between Jan 15, 2008, and Dec 31, 2020, 3625 patients in 130 centres were randomly allocated, 1811 to CAS and 1814 to CEA, with good compliance, good medical therapy and a mean 5 years of follow-up. Overall, 1% had disabling stroke or death procedurally (15 allocated to CAS and 18 to CEA) and 2% had non-disabling procedural stroke (48 allocated to CAS and 29 to CEA). Kaplan-Meier estimates of 5-year non-procedural stroke were 2·5% in each group for fatal or disabling stroke, and 5·3% with CAS versus 4·5% with CEA for any stroke (rate ratio [RR] 1·16, 95% CI 0·86-1·57; p=0·33). Combining RRs for any non-procedural stroke in all CAS versus CEA trials, the RR was similar in symptomatic and asymptomatic patients (overall RR 1·11, 95% CI 0·91-1·32; p=0·21). INTERPRETATION: Serious complications are similarly uncommon after competent CAS and CEA, and the long-term effects of these two carotid artery procedures on fatal or disabling stroke are comparable. FUNDING: UK Medical Research Council and Health Technology Assessment Programme.

Fluoroless Ureteroscopy: Experience in More Than 100 Patients.

BACKGROUND: Ureteroscopy is becoming the primary treatment for ureteral stones. As a standard of care, ureteroscopy is performed under the supervision of fluoroscopy. Recent advances in endourological technology make the need for fluoroscopy questionable. OBJECTIVES: To summarize our experience with a no-fluoroscopy technique for selected cases of ureteral stones. METHODS: Patients were considered suitable for fluoroless ureteroscopy if they had one or two non-impacted stones, in any location in the ureter, 5-10 mm size, with a normal contralateral renal unit and no urinary tract infection. Procedures were performed using rigid scopes, nitinol baskets/forceps for stone retrieval, and Holmium:YAG laser for lithotripsy. Stents were placed per surgeon's decision. RESULTS: During an 18-month period, 103 patients underwent fluoroless ureteroscopy. In 94 patients stones were removed successfully. In six, the stones were pushed to the kidney and treated successfully on a separate session by shock wave lithotripsy. In three patients no stone was found in the ureter. In five patients, miniature perforations in the ureter were noted and an indwelling double J stent was placed. CONCLUSIONS: Fluoroless ureteroscopy resulted in a high rate of success. We believe that in selected cases it can be used with minimal adverse events.

Association between time to stent dysfunction and the anti-tumour effect of systemic chemotherapy following stent placement in patients with pancreaticobiliary cancers and malignant gastric outlet obstruction: a retrospective cohort study.

BACKGROUND: Malignant gastric outlet obstruction (MGOO) occasionally occurs due to pancreaticobiliary cancer. Endoscopic duodenal stenting (DS) is a common treatment for MGOO. However, it has been reported that DS does not have sufficient patency time for it to be used in patients who have a potentially increased lifespan. Nowadays, systemic chemotherapy for pancreaticobiliary cancer has developed, and its anti-tumour effect would make time to stent dysfunction longer. Therefore, we retrospectively evaluated the association between objective response to systemic chemotherapy, followed by DS and time to stent dysfunction in patients with advanced pancreaticobiliary cancer. METHODS: This retrospective study included 109 patients with advanced pancreaticobiliary cancer who received systemic chemotherapy after DS. Patients who showed complete or partial response were defined as responders. The rest were defined as non-responders. Time to stent dysfunction was compared between responders and non-responders using the landmark analysis at 2 months after DS. Death without recurrence of MGOO was considered as a competing risk for time to stent dysfunction. RESULTS: Combination and monotherapy regimens were adopted for 46 and 63 patients, respectively. Median progression-free survival and overall survival were 3.2 months (95% confidence interval [CI], 2.4-4.0) and 6.0 months (95% CI, 4.6-7.3). Objective response was observed in 21 patients (19.3%). Median time to stent dysfunction was 12.5 months (95% CI, 8.4-16.5) in the entire cohort. In 89 patients, responders had a lower cumulative incidence of stent dysfunction than non-responders: 9.5 and 19.1% at 6 months, and 19.0 and 27.9% at 1-year, respectively. There was difference of time to stent dysfunction between responders and non-responders among patients who received combination regimen as the first-line treatment with p-value of 0.009: cumulative incidence was 0 and 42.9% at 6 months, and 9.3 and 57.1% at 1-year, respectively. CONCLUSIONS: Longer time to stent dysfunction is expected when systemic chemotherapy following DS suppresses tumour progression; DS is slated to be a standard treatment for MGOO even in patients with pancreaticobiliary cancer and a long lifespan.

Safety of decreasing ureteral stent duration following radical cystectomy.

PURPOSE: We aim to assess the safety of decreasing ureteral stenting duration following Radical Cystectomy with Urinary Diversion (RCUD). MATERIALS AND METHODS: We analyzed a prospectively and retrospectively collected dataset for cystectomy patients at our tertiary center. Adult patient who underwent RCUD for malignancy from January 2013 to February 2018 were included. Patients with a history of abdominal/pelvic radiation and continent diversions were excluded. The patient population was divided to late stent removal group (LSR-POD 14) and early stent removal group (ESR-POD5). Our endpoints were total stent duration, 90-day readmission, 90-day total-UTI, 90-day urinary-readmissions, complications and Ureteroenteric Stricture (UES) rates. Statistical methods included t test, Chi-squared test and multivariate logistic regression. RESULTS: One hundred and seventy-eight patients were included in the final analysis after inclusion/exclusion criteria were applied. The LSR (n = 74) and ESR (n = 104) groups were similar in preoperative characteristics except higher intracorporeal ileal conduit formation in ESR. The duration of stenting decreased significantly from approximately 15.5-5 days (P < 0.001). The LSR had higher 90-day overall readmission rates (OR = 2.57, 95% CI 1.19-5.53, P = 0.016) and total-UTIs (OR = 2.36, 95%CI 1.11-5.04, P = 0.026). With a median follow-up of 9.8 months, UES was similar between the two groups. CONCLUSION: Shorter ureteral stent duration is a safe and non-inferior option following RCUD. It allows for stent removal prior to discharge and less outpatient visits. In addition, decreasing stent duration was linked decreased readmissions and total-UTIs without increased risk of UES. However, future studies are needed to establish causality and promote stent duration change.

Iatrogenic Ureteral Injury and Prophylactic Stent Use in Veterans Undergoing Colorectal Surgery.

INTRODUCTION: Iatrogenic ureteral injury (IUI) is an uncommon complication in colorectal surgery. Prophylactic ureteral stenting (PUS) gained acceptance to aid in intraoperative identification of the ureter. Despite its use, the benefit of pus to avoid IUI remains debatable. We sought to analyze the rates of IUI after colorectal surgery in veterans and to compare the outcomes after PUS using a large matched cohort. METHODS: The veterans affairs surgical quality improvement program database was queried for patients who underwent colorectal surgery from 2008-2015. To analyze the outcomes of PUS, we created two matched groups using propensity-score matching accounting for demographical and clinical cofactors to assess variable outcomes. Cross-tabulation was used to calculate rates of IUI and univariate and multivariate analyses were performed to evaluate risk factors associated with IUI. RESULTS: 27,448 patients were identified and 458 underwent PUS placement (1.6%). The majority of procedures were performed electively and with an open approach. Mean age was 65 y, 96.3% were male, and colorectal cancer was the most common indication. 45 patients (0.2%) were diagnosed with IUI. IUI incidence was higher in female patients, after left-sided colorectal resection, and in those undergoing open procedures. After matching, PUS use was associated with longer length of stay and operative time and increased creatinine levels from baseline. CONCLUSION: We demonstrated that the use of PUS is independently associated with increased operative time and change in creatinine levels. Although no IUI occurred in the PUS group, this finding was not statistically significant. The risk and/or benefit ratio of PUS should be considered for each individual case, with its selective use based on the presence of risk factors for IUI, such as female patients and left-sided resections.

Colonic Stent Use by Indication and Patient Outcomes: A Nationwide Inpatient Sample Study.

BACKGROUND: Colonic stent placement can avoid urgent surgery for large bowel obstruction in selected patients. Population-wide stent utilization patterns and outcomes are unknown. MATERIALS AND METHODS: Using retrospective, population-based, Nationwide Inpatient Sample data, we studied patients with colonic stents discharged during 2010-2015. The primary outcome was ostomy creation during the same hospitalization. Other outcomes were perforation or peritonitis, and in-hospital death. Associations of outcomes with stent indication were investigated, adjusting for patient-, admission-, and hospital characteristics. We estimated annual population-wide stent use volumes. RESULTS: Of 4257 patients with stent placement (52% male, mean age 64.6 years), 9.9% had non-metastatic colon cancer, 12.9% metastatic colon cancer, 37.8% extracolonic malignancy (ECM), and 39.3% had benign obstruction. In 8.1% of patients, ostomy creation surgery was performed. Perforation or peritonitis occurred in 16.7%, and in-hospital death in 4.5%. Relative to ECM, ostomy creation was several-fold more likely among nonmetastatic colon cancer (adjusted odds ratio (OR) 3.4; 95%CI, 2.1-5.5), metastatic colon cancer (adjusted OR 2.5; 95%CI, 1.7-3.7), and benign obstruction patients (adjusted OR 3.1; 95%CI, 2.1-4.7). Benign obstruction was associated with high risk of perforation/peritonitis (adjusted OR 3.1 relative to non-metastatic CC (95%CI, 2.1-4.5)). Perforation/peritonitis was highly associated with inpatient death (adjusted OR 6.8 (95%CI, 4.9-9.5)). Annually, about 3,580 patients underwent stent placement, with benign obstruction showing an increasing trend (P=0.0002). CONCLUSIONS: Over 75% of stent placements were done for patients with benign disease and ECM obstruction. Subsequent ostomy creation during the hospitalization was least likely among ECM patients. Rates of perforation/peritonitis in benign obstructions were concerningly high. (22.2%).

Atherectomy Combined with Balloon Angioplasty versus Balloon Angioplasty Alone for de Novo Femoropopliteal Arterial Diseases: A Systematic Review and Meta-analysis of Randomised Controlled Trials.

OBJECTIVE: The efficacy and cost effectiveness of atherectomy for femoropopliteal (FP) arterial diseases have not been determined yet. A systematic review and meta-analysis were performed to compare the efficacy and safety between atherectomy combined with balloon angioplasty (BA) and BA alone for patients with de novo FP steno-occlusive lesions. METHODS: The Cochrane Library, Medline, and Embase were used to search for studies evaluating outcomes of atherectomy combined with BA compared with BA alone in FP arterial diseases from inception to July 2020. The methodological quality of the included studies was evaluated with the Cochrane Risk of Bias Tool. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) framework was used to assess the level of evidence for each outcome. The fixed effects model was chosen to combine the data when I2 < 50%; otherwise, the random effects model was used. Subgroup and sensitivity analyses were performed to further analyse the results. RESULTS: Four RCTs were included. The meta-analysis showed that atherectomy combined with BA was associated with improved technical success rate (risk ratio [RR] 0.22, 95% confidence interval [CI] 0.13-0.38, p < .001; I2 = 0; high quality), reduced bailout stenting (RR 0.15, 95% CI 0.07-0.32, p < .001; I2 = 16%; high quality), and flow limiting dissection (RR 0.24, 95% CI 0.13-0.47, p < .001; I2 = 0; high quality). No statistically significant difference was found in target lesion revascularisation (TLR), primary patency, mortality, major adverse event (MAE), or ankle brachial index (ABI) after one year follow up. CONCLUSION: Compared with BA alone, atherectomy combined with BA may not improve primary patency, TLR, mortality rate, or ABI, but may reduce the need for bailout stenting and the incidence of flow limiting dissection and increase the technical success rate in FP arterial diseases. More studies are warranted to further confirm the conclusion.

Editor's Choice - Distribution of Care and Hospital Incidence of Carotid Endarterectomy and Carotid Artery Stenting: A Secondary Analysis of German Hospital Episode Data.

OBJECTIVE: This is a description of the German healthcare landscape regarding carotid artery disease, assessment of hospital incidence time courses for carotid endarterectomy (CEA) and carotid artery stenting (CAS), and simulation of potential effects of minimum hospital caseload requirements for CEA and CAS. METHODS: The study is a secondary data analysis of diagnosis related group statistics data (2005-2016), provided by the German Federal Statistical Office. Cases encoded by German operation procedure codes for CEA or CAS and by International Classification of Diseases (ICD-10) codes for carotid artery disease were included. Hospitals were categorised into quartiles according to annual caseloads. Linear distances to the closest hospital fulfilling hypothetical caseload requirements were calculated. RESULTS: A total of 132 411 and 33 709 patients treated with CEA and CAS from 2012 to 2016 were included. CEA patients had lower rates of myocardial infarction (1.4% vs. 1.8%) and death (1.2% vs. 4.0%), and CAS patients were more often treated after emergency admission (38.1% vs. 27.1%). Age standardised annual hospital incidences were 67.2 per 100 000 inhabitants for CEA and 16.3 per 100 000 inhabitants for CAS. The incidence for CEA declined from 2005 to 2016, with CAS rising again until 2016 after having declined from 2010 to 2013. Regarding distance from home to hospital, centres offering CEA are distributed more homogeneously across Germany, compared with those performing CAS. Hypothetical introduction of minimum annual caseloads (> 20 for CEA; > 10 for CAS) imply that 75% of the population would reach their hospital after travelling 45 km for CEA and 70 km for CAS. CONCLUSION: Differences in spatial distribution mean that statutory minimum annual caseloads would have a greater impact on CAS accessibility than CEA in Germany. Presumably because of a decline in carotid artery disease and a transition towards individualised therapy for asymptomatic patients, hospital incidence for CEA has been declining.

An Empirical Study on the Operative Treatment of Symptomatic Urolithiasis in Germany.

PURPOSE: The guidelines of the German, European, and American Urological Associations on urolithiasis advise against general ureteral stenting before and after an uncomplicated ureterorenoscopy (URS). However, German and European guidelines state that stenting prior to URS facilitates stone extraction and reduces intraoperative complications. According to the published literature, German practice seems to deviate from recommendations. This nationwide survey aimed to evaluate the treatment modalities of urolithiasis. METHODS: In November 2018 and March 2019, a total of 199 urological hospital departments in Germany were anonymously surveyed about operative care of symptomatic urolithiasis. The response rate was 72.9%. The survey consisted of 25 questions about diagnostics, surgical technique, and aftercare of the URS. This questionnaire is available in the appendix. RESULTS: A primary URS is performed in ≤10% in 49.6% of the hospitals. In every second urological department (49.7%), the German Diagnosis Related Group (G-DRG) system influences the period of pre-stenting before a secondary URS. After a secondary URS, which is performed in 53.8% of the departments in over 80% of the patients, 14% of the departments omit stenting. The standard for stenting seems to be a 28-cm-long 7 Charrière double-J stent in Germany. CONCLUSION: In Germany, the percentage of primary URS is low, and a ureter stenting is performed in most of the urological departments after URS. Delaying therapy due to economic aspects is the standard in almost half of all urological departments.

Impact of Coronary Stent Design in Proximal Balloon Edge Dilation Technique for Bifurcation Percutaneous Coronary Intervention.

The proximal optimizing technique (POT) -proximal balloon edge dilation (PBED) sequence for side branch (SB) dilatation with cross-over single-stent implantation decreases both strut obstruction at the SB ostium and stent deformation at the main branch (MB).The purpose of this experimental bench test was to assess the impact of stent design on stent deformation, obstruction by stent struts at a jailed SB ostium, and stent strut malapposition in the POT-PBED sequence.Fractal coronary bifurcation bench models (60- and 80-degree angles) were used, and crossover single-stent implantation (3-link stent: XIENCE Sierra, Abbott Vascular, Santa Clara, CA, n = 10; 2-link stent: Synergy, Boston Scientific, Marlborough, MA, n = 10) was performed from the MB using the POT-PBED sequence. Jailing rates at the SB ostium, stent deformation, and stent strut malapposition of the bifurcation segment were assessed using videoscopy and optical coherence tomography.After SB dilatation using the PBED technique, jailing rates at the SB ostium and stent deformation did not differ significantly between the two types of stents. Conversely, the rate of malapposed struts of the bifurcation segment after the PBED procedure was significantly lower with 3-link stents than with 2-link stents for both 60- and 80-degree angles (60-degree angle: 4.3% ± 4.4% versus 22.0% ± 11.1%, P = 0.044; 80-degree angle: 20.8% ± 15.1% versus 57.2% ± 17.0%, P < 0.001, respectively).In the POT-PBED sequence, 3-link stents might be a preferable coronary bifurcation stent, maintaining a jailed SB ostium while significantly reducing stent strut malapposition of the bifurcation segment when compared with 2-link stents.

Real-World Practice Patterns in the Era of Rectal Indomethacin for Prophylaxis Against Post-ERCP Pancreatitis in a High-Risk Cohort.

INTRODUCTION: The benefit of indomethacin suppositories for prophylaxis against post-ERCP pancreatitis (PEP) in high-risk patients was established in a landmark trial published in 2012. The aims of this study were to measure the adoption of indomethacin prophylaxis in widespread clinical practice, evaluate concurrent trends in pancreatic duct (PD) stent utilization, and estimate the impact of these changes on PEP in a high-risk population. METHODS: Data were extracted from a commercial database (Explorys, IBM Watson Health, Somers, NY) that aggregates electronic health records from 26 US healthcare systems from 2009 to 2018. Using Systematized Nomenclature of Medicine Clinical Terms, we identified a cohort of patients who underwent endoscopic retrograde cholangiopancreatography (ERCP) and were at high risk for PEP based on narrow criteria. PEP was defined as an emergency department or hospital admission 1-5 days after ERCP with an associated diagnosis of pancreatitis. RESULTS: Twenty six thousand eight hundred twenty ERCPs were performed on this high-risk cohort from 2009 to 2018. The overall PEP rate during the study period was 8.6%. There was no decrease in PEP rates from 2012 to 2018. Beginning in 2012, indomethacin usage increased linearly (P < 0.001), but remained below 50% in 2018. As indomethacin increased, utilization of PD stents declined abruptly from 2013 to 2014 (40.7%-8.5%) and trended to a nadir of 3.0%. DISCUSSION: Despite its low cost, widespread availability, and level I evidence of benefit in reducing the risk of PEP in high-risk patients, the adoption of rectal indomethacin during ERCP has been slow and the medication continues to be under-utilized. In parallel, the PD stent usage has declined dramatically. The lack of change in PEP rates during the study period could be attributable to the persistent low usage of rectal indomethacin or the decline in PD stent use. Further educational efforts and quality assurance measures are warranted to ensure that rectal indomethacin and PD stent placement are more appropriately used in clinical practice.

A Systematic Review of Procedural Outcomes in Patients With Proximal Common Carotid or Innominate Artery Disease With or Without Tandem Ipsilateral Internal Carotid Artery Disease.

OBJECTIVE: To establish 30 day and mid term outcomes in patients treated for significant stenoses affecting the proximal common carotid artery (CCA) or innominate artery (IA) with/without tandem disease of the ipsilateral internal carotid artery (ICA). METHODS: Systematic review of early and mid term outcomes in 1 969 patients from 77 studies (1960-2017) who underwent: (i) hybrid open retrograde angioplasty/stenting of the IA/proximal CCA plus carotid endarterectomy (CEA) in patients with tandem disease of the ipsilateral proximal ICA (n = 700); (ii) isolated open surgery to the IA or proximal CCA (no CEA) (n = 686); or (iii) an isolated endovascular approach to IA or proximal CCA stenoses (no CEA) (n = 583). RESULTS: In the hybrid group with tandem disease (66% involving proximal CCA), the 30 day death/stroke was 3.3%, with a late ipsilateral stroke rate of 3.3% at a median six years follow up. Late re-stenosis was 10.5% for proximal CCA/IA and 4.1% for the ICA. In the isolated open surgery group (78% involving the IA), the 30 day death/stroke was 7%, with a late ipsilateral stroke rate of 1% at a median 12 years follow up. Late re-stenosis within aortic bypasses was 2.6%. In the isolated endovascular group (52% IA, 47% proximal CCA), the majority of procedures were done percutaneously (84%), with a 30 day death/stroke rate of 1.5%. Late ipsilateral stroke was 1% at a median four years follow up, with a re-stenosis rate of 9%. CONCLUSION: Procedural risks were higher following isolated open surgical interventions involving the proximal CCA/IA, compared with proximal lesions treated by isolated angioplasty/stenting, or in tandem with CEA. This higher morbidity/mortality may, however, reflect a greater proportion of innominate (vs. proximal CCA) lesions in open surgical series, changes in patient selection, time dependent evolution of medical interventions, and publication bias. The available data were limited and related to very different patient groups and management strategies spanning 57 years. Caution is raised, particularly for open surgery IA and CCA surgery, and for any procedures in asymptomatic patients. In symptomatic patients, the data cautiously support an "endovascular first" strategy for isolated proximal CCA/IA lesions and a hybrid approach for tandem proximal CCA/IA and ICA stenoses.

Risk factors of post-ERCP pancreatitis in high-risk patients despite prevention with prophylactic pancreatic stents.

Objectives: To analyze risk factors of post-ERCP pancreatitis (PEP) in high risk patients in whom prophylactic pancreatic stents (PPSs) were intended to use to prevent endoscopic retrograde cholangiography (ERCP)-related complications.Patients and methods: Three hundred and seventeen high-risk patients for developing PEP were considered for preventive pancreatic stent placement in our endoscopy unit over 5 years. 5 Fr, 3-5 cm long PPSs were used. All data were collected in a predefined database. Development of PEP despite PPS placement was analyzed.Results: PEP occurred in 29 of 288 successfully stented patients (10.07%; 24 mild, four moderate, one severe). PPS was protective against all risks factors except for sphincter of Oddi dysfunction (SOD). PPS related complication rate was 2.78% (n = 8). Unsuccessful stenting occurred in 29 patients (9.15%), PEP developed in 41.38% (n = 12; seven mild, four moderate, one severe). Those patients who had more patient related risk factors were more likely to develop PEP despite preventive measures with PPS. On the contrary, PPS placement was less successful in patients who had more procedure related risk factors.Conclusions: PPS is protective against all risks factors of PEP except for SOD in high-risk patients. More vulnerable patients who have more patient-related risk factors are more likely to develop PEP despite PPS is used, while more complex procedures predispose to unsuccessful PPS placement in patients with more procedure-related risk factors. PPS insertion in high-risk patients is effective and safe preventive method and the procedure related complication rate is reasonably low.

Retrospective Comparative Study of Side-by-Side and Stent-in-Stent Metal Stent Placement for Hilar Malignant Biliary Obstruction.

BACKGROUND: In patients with unresectable hilar malignant biliary obstruction (MBO), bilateral metal stent placement is recommended. However, treatment selection between partially stent-in-stent (SIS) and side-by-side (SBS) methods is still controversial. STUDY: Clinical outcomes of bilateral metal stent placement by SBS and SIS methods for hilar MBO were retrospectively studied in four Japanese centers. While large-cell-type uncovered metal stents were placed above the papilla in SIS, braided-type uncovered metal stents were placed across the papilla in SBS. RESULTS: A total of 64 patients with hilar MBO (40 SIS and 24 SBS) were included in the analysis. Technical success rate was 100% in SIS and 96% in SBS. Functional success rate was 93% in SIS and 96% in SBS. Early adverse event rates were higher in SBS (46%) than in SIS (23%), though not statistically significant (P = 0.09). Post-procedure pancreatitis was exclusively observed in SBS group (29%). Recurrent biliary obstruction rates were 48% and 43%, and the median time to recurrent biliary obstruction was 169 and 205 days in SIS and SBS, respectively. CONCLUSIONS: Other than a trend to higher adverse event rates including post-procedure pancreatitis in SBS, clinical outcomes of SIS and SBS methods were comparable in patients with unresectable hilar MBO.

Why we fail: mechanisms and co-factors of unsuccessful thrombectomy in acute ischemic stroke.

PURPOSE: Mechanical thrombectomy (MT) is an effective treatment for patients suffering from acute ischemic stroke. However, recanalization fails in about 16.5% of interventions. We report our experience with unsuccessful MT and analyze technical reasons plus patient-related parameters for failure. METHODS: Five hundred ninety-six patients with acute ischemic stroke in the anterior circulation and intention to perform MT with an aspiration catheter and/or stent retriever were analyzed. Failure was defined as 0, 1, or 2a on the mTICI scale. Patients with failing MT were analyzed for interventional progress and compared to patients with successful intervention, whereby parameters included demographics, medical history, stroke presentation, and treatment. RESULTS: One hundred of the 596 (16.8%) interventions failed. In 20 cases, thrombus could not be accessed or passed with the device. Peripheral arterial occlusive disease is common in those patients. In 80 patients, true stent retriever failure occurred. In this group, coagulation disorders are associated with poor results, whereas atrial fibrillation is associated with success. The administration of intravenous thrombolysis and intake of nitric oxide donors are associated with recanalization success. Intervention duration was significantly longer in the failing group. CONCLUSION: In 20% of failing MT, thrombus cannot be reached/passed. Direct carotid puncture or surgical arterial access could be considered in these cases. In 80% of failing interventions, thrombus can be passed with the device, but the occluded vessel cannot be recanalized. Rescue techniques can be an option. Development of new devices and techniques is necessary to improve recanalization rates. Assessment of pre-existing illness could sensitize for occurring complications.

Long-term (10-year) outcomes of stenting or bypass surgery for acute coronary syndromes and stable ischemic heart disease with unprotected left main coronary artery disease.

BACKGROUND: Acuity of clinical presentation may influence decision making of percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) for left main coronary artery (LMCA) disease. However, it is undetermined whether clinical indication for myocardial revascularization may affect the relative long-term effect after PCI and CABG. METHODS: In the MAIN-COMPARE study including 2,240 patients with LMCA disease treated with PCI (n = 1102) or CABG (n = 1138), we examined interaction between acuity of clinical presentation (acute coronary syndromes [ACS] or non-ACS) and revascularization strategy on 10-year outcomes. Primary outcome was a composite of all-cause death, Q-wave myocardial infarction, or stroke. Secondary outcomes were all-cause death or target vessel revascularization. RESULTS: In overall patients, 1,603 patients (71.6%) presented with ACS and 637 patients (28.4%) presented with non-ACS. The 10-year adjusted risks for primary composite outcome were similar after PCI and CABG among patients who presented with non-ACS (hazard ratio [HR] 1.07; 95% CI 0.71-1.61) and those who presented with ACS (HR 1.00; 95% CI 0.81-1.24) (P for interaction = .29). The adjusted risks of death were also similar between 2 groups in non-ACS (HR 0.98; 95% CI 0.63-1.51) and ACS (HR 1.02; 95% CI 0.81-1.28) patients (P for interaction = .62). The adjusted risks of target vessel revascularization were consistently higher after PCI in non-ACS (HR 6.38; 95% CI 3.14-12.96) and ACS (HR 3.96; 95% CI 2.80-5.60) patients (P for interaction = .39). CONCLUSIONS: In patients with LMCA disease, we have identified no significant interaction between the acuity of clinical indication and the relative treatment effect of PCI versus CABG on 10-year clinical outcomes.

Expanding opportunities to understand quality and outcomes of peripheral vascular interventions: The ACC NCDR PVI Registry.

Lower extremity peripheral artery disease (PAD) and cerebrovascular disease (CeVD) are prevalent conditions in the United States, and both are associated with significant morbidity (eg, stroke, myocardial infarction, and limb loss) and increased mortality. With a growth in invasive procedures for PAD and CeVD, this demands a more clear responsibility and introduces an opportunity to study how patients are treated and evaluate associated outcomes. The American College of Cardiology (ACC) National Cardiovascular Data Registry (NCDR) Peripheral Vascular Intervention (PVI) Registry is a prospective, independent collection of data elements from individual patients at participating centers, and it is a natural extension of the already robust NCDR infrastructure. As of September 20, 2018, data have been collected on 45,316 lower extremity PVIs, 12,417 carotid artery stenting procedures, and 11,027 carotid endarterectomy procedures at 208 centers in the United States. The purpose of the present report is to describe the patient and procedural characteristics of the overall cohort and the methods used to design and implement the registry. In collecting these data, ACC and ACC PVI Registry have the opportunity to play a pivotal role in scientific evidence generation, medical device surveillance, and creation of best practices for PVI and carotid artery revascularization.

Prognostic Factors and Management of Patients with Choanal Atresia.

OBJECTIVE: To analyze prognostic factors in the management of patients with choanal atresia. STUDY DESIGN: This is a review of 114 patients operated on for choanal atresia in a tertiary care center between November 1986 and November 2016, including clinical characteristics, surgical management, and postoperative course with final nasal patency. The data were collected in a database that was updated over time. RESULTS: Among the 114 patients, 78 were female, 77 presented with unilateral choanal atresia, and 37 presented with bilateral unilateral choanal atresia, corresponding to 151 nasal fossae. Forty-seven patients had associated abnormalities (41.2%), including CHARGE, diagnosed in 20 children (17.5%). At the end of follow-up, 91 patients (79.8%) had normal choanal patency. The identified risk factors of surgical failure were age <6 months (P = .004), weight <5 kg (P = .007), and bilateral choanal atresia (P < .001). The type of atresia, presence of associated abnormalities, surgical approach, stenting, and use of mitomycin were not significantly linked with the surgical results. CONCLUSIONS: This series highlights the importance of the timing of surgery, which is guided by the clinical ability of the infant to tolerate the procedure. Endoscopic approaches are widely performed, but a transpalatal approach, necessary in some cases of bilateral choanal atresia, does not alter the results. Unilateral choanal atresia surgery should be delayed after age 6 months and/or weight >5 kg when possible.

Pediatric Endoscopy Practice Patterns in the United States, Canada, and Mexico.

BACKGROUND AND AIMS: Endoscopic procedures are important for diagnosis and management of many gastrointestinal, liver, and biliary conditions in children. Therapeutic endoscopy procedures, including endoscopic retrograde cholangiopancreatography (ERCP), are performed less frequently in children relative to adults. A formal study to evaluate institutional volumes and practice patterns for advanced therapeutic pediatric endoscopy procedures has, however, not been previously undertaken. METHODS: A self-administered 16-question (5-minute) online survey assessing practice patterns for performance of pediatric endoscopy procedures was distributed to all registered North American Society for Pediatric Gastroenterology, Hepatology and Nutrition programs. Results were analyzed using descriptive statistics and thematic analysis of free-text comments. RESULTS: Respondents from 82.9% of North American Society for Pediatric Gastroenterology, Hepatology and Nutrition centers completed this survey. Responses revealed that esophagogastroduodenoscopy/colonoscopy are performed at the vast majority of centers (>90%), with most performing >50/year. Therapeutic endoscopy procedures are performed less frequently in the pediatric population, with 18.97% reporting that ERCP is not performed at their institution. Where ERCP is performed, 91.38% reported <25/year. Endoscopic ultrasound is not performed at more than half (53.33%) of institutions. Approximately 71.67% of respondents do not believe their institution's current arrangement for performing pediatric therapeutic endoscopy procedures is adequate. CONCLUSIONS: Although the range of endoscopic procedures performed in children parallels that performed in adults, there are notable differences in pediatric and adult gastroenterologists' endoscopy training and procedure volumes. Our results and respondent comments suggest that pediatric patients would benefit from a partnership between pediatric and adult gastroenterologists, with adult gastroenterologists performing more complex therapeutic endoscopic procedures.

International Variation in Surgical Practices in Units Performing Oesophagectomy for Oesophageal Cancer: A Unit Survey from the Oesophago-Gastric Anastomosis Audit (OGAA).

BACKGROUND: Anastomotic leaks are associated with significant risk of morbidity, mortality and treatment costs after oesophagectomy. The aim of this study was to evaluate international variation in unit-level clinical practice and resource availability for the prevention and management of anastomotic leak following oesophagectomy. METHOD: The Oesophago-Gastric Anastomosis Audit (OGAA) is an international research collaboration focussed on improving the care and outcomes of patients undergoing oesophagectomy. Any unit performing oesophagectomy worldwide can register to participate in OGAA studies. An online unit survey was developed and disseminated to lead surgeons at each unit registered to participate in OGAA. High-income country (HIC) and low/middle-income country (LMIC) were defined according to the World Bank whilst unit volume were defined as < 20 versus 20-59 versus ≥60 cases/year in the unit. RESULTS: Responses were received from 141 units, a 77% (141/182) response rate. Median annual oesophagectomy caseload was reported to be 26 (inter-quartile range 12-50). Only 48% (68/141) and 22% (31/141) of units had an Enhanced Recovery After Surgery (ERAS) program and ERAS nurse, respectively. HIC units had significantly higher rates of stapled anastomosis compared to LMIC units (66 vs 31%, p = 0.005). Routine post-operative contrast-swallow anastomotic assessment was performed in 52% (73/141) units. Stent placement and interventional radiology drainage for anastomotic leak management were more commonly available in HICs than LMICs (99 vs 59%, p < 0.001 and 99 vs 83%, p < 0.001). CONCLUSIONS: This international survey highlighted variation in surgical technique and management of anastomotic leak based on case volume and country income level. Further research is needed to understand the impact of this variation on patient outcomes.